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Work-Related Disorders

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Journal of Volume 5, Number 2 ) 2011

TherapyBiomedical

• Pathologies Associated With the Workplace• Repetitive Strain Injury as a Model of Inflammation

Integrating Homeopathyand Conventional Medicine

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Contents

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Published by/Verlegt durch: International Academy for Homotoxicology GmbH, Bahnackerstraße 16, 76532 Baden-Baden, Germany, www.iah-online.com, e-mail: [email protected] Editor in Chief/verantwortlicher Redakteur: Dr. Alta A. SmitEditor: Dr. David W. Lescheid Managing Editor: Silvia BartschPrint/Druck: Dinner Druck GmbH, Schlehenweg 6, 77963 Schwanau, Germany© 2011 International Academy for Homotoxicology GmbH, Baden-Baden, Germany

Cover © iStockphoto.com/Steve Cole

I n Fo c u sPathologies Associated With the Workplace . . . . . . . . . . . . . . 4

Wh a t E l s e I s N e w ? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

P ra c t i c a l P r o t o c o l sWork-Related Psychological Stress and the Hypothalamic-Pituitary-Adrenal Axis . . . . . . . . . . . . . . . 16

Bioregulatory Management of “Mouse Arm” . . . . . . . . . . . . 20

A r o u n d t h e G l o b e iMosaic Integrative Medicine Conference . . . . . . . . . . . . . . . . 23

Re f r e s h Yo u r H o m o t ox i c o l o g yRepetitive Strain Injury as a Model of Inflammation . . . . . . 24

E x p a n d Yo u r Re s e a r ch K n o wl e d g e Clinical Trials: An Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Re s e a r ch H i g h l i g h t sThe Role of Vertigoheel as an Adjuvant Treatment in Patients With Transient Ischemic Attacks: An Observational Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

M e e t t h e E x p e r t Dr. Jan Kersschot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

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Dr. Alta A. Smit

Journal of Biomedical Therapy 2011 ) Vol. 5, No. 2

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According to the Merriam-Web-ster Dictionary, work can be de-

fined as the “activity where one ex-erts strength or faculties to do or perform something:a) sustained physical or mental ef-

fort to overcome obstacles and achieve an objective or result

b) the labor, task, or duty that is one’s accustomed means of live-lihood

c) a specific task, duty, function, or assignment often being a part or phase of some larger activity.”1

The way we work has changed dra-matically in the past 120 years, in terms of decreased working hours (from 3000 to 1500 hours per year in industrialized countries) and the introduction of technology in the workplace. The result of these changes is that the output has stayed the same, despite the fewer hours worked.2 Although we could argue that we are more affluent in our cur-rent society, there are people who believe that the hunter-gatherers were, in fact, the original affluent society, because they only needed to work 15 to 20 hours per week and the remainder of the time was lei-sure time.3 Despite working fewer hours than 120 years ago, the concept of nega-tive work-life balance was intro-duced as early as the mid-1800s. The causes range from personal am-bition and the pressure of family ob-ligations to the accelerating pace of technology.4

According to a recent study per-formed by the Center for Work-Life Policy,5 50% of top corporate execu-tives are leaving their current posi-tions. Although 64% of workers be-lieve that their work pressures are “self-inflicted,” they state that it is taking a toll on them. The study also shows that 70% of US respon-dents and 81% of global respon-dents say their jobs are affecting their health. The increased use of technology has also taken its toll, and new medical diagnoses, such as “mouse arm” or “Blackberry thumb,” are recognized.6

Therefore, we dedicate this issue of the Journal of Biomedical Therapy to work-related disorders. These disor-ders are very good examples of dys-regulation syndromes. Often chron-ic and insidious in nature, they may be present for a long time, until the patient finally seeks medical advice. In the focus article, we, therefore, provide an overview of the range of disorders associated with work. In the Practical Protocols, we then go more in-depth discussing “mouse arm” and the effect of psychological stress at work. In Refresh Your Homotoxicology, the intricate network of disturbances in repetitive strain injury is described, demonstrating the dysregulatory nature of the disease.Our research section has 2 features: the follow-up article on clinical tri-als and an innovative study with

Vertigoheel after transient ischemic attack.Lastly, our Meet the Expert column features Dr. Jan Kersschot, the founder of Biopuncture. This fits well in this journal because Bio-puncture is one of the effective in-tervention methods in work disor-ders involving the musculoskeletal system.7

We wish you success and health in your work!

Dr. Alta A. Smit

References 1. Work. Merriam-Webster Dictionary Web site.

http://www.merriam-webster.com/diction-ary/work. Accessed November 8, 2011.

2. Bosch G. Working time and working time policy in Germany. http://www.jil.go.jp/english/reports/documents/jilpt-reports/no.7_bosch.pdf. Accessed November 8, 2011.

3. Sahlins M. The original affluent society. http://www.eco-action.org/dt/affluent.html. Accessed November 8, 2011.

4. John R, Henkel A, Rückert-John J, eds. Die Methodologien des Systems: Wie kommt man zum Fall und wie dahinter? Wiesbaden, Ger-many: VS Verlag; 2010.

5. Hewlett SA, Luce CB, Southwell S, Bernstein L. Seduction and Risk: The Emergence of Ex-treme Jobs. New York, NY: Center for Work-Life Policy; 2007.

6. Hewlett SA, Luce CB. Extreme jobs: the dan-gerous allure of the 70-hour workweek. Harv Bus Rev. 2006;84(12):49-59, 162.

7. Biopuncture. International Academy of Bio-puncture Web site. http://www.iabp-online.com. Accessed November 8, 2011.

How Work Affects Our Health

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Introduction

Work-related disorders (WRDs) comprise physical and psychosocial disorders that have their origin in the workplace. Work-related physi-cal disorders include disorders in-volving the musculoskeletal system, dermatitis, and deafness; in addition, they include diseases that have been shown or suspected to have been caused by a workplace activity or environment. Musculoskeletal disor-ders (MSDs), such as lower back pain and repetitive strain injury, are the most common WRDs in Eu-rope.1 Work-related psychosocial disorders (eg, burn-out syndrome and anxi-ety) generally arise from stress caused or made worse by the indi-viduals’ work or work environment. Work stress combines the harmful physical and emotional responses that occur when the job require-ments do not match the capabilities, resources, or needs of the worker. Work stress can lead to poor mental and physical health and injury. Acute reactions, such as stress and fatigue; adverse health behavior, such as smoking; and chronic out-comes, such as cardiovascular disor-ders and MSDs, are associated with extended and irregular hours.2 High exposure to a combination of physi-cal and psychosocial work risk fac-tors produces the greatest risk of developing self-reported musculo-skeletal complaints compared with

exposure to either physical or psy-chosocial factors alone.3 The working environment continues to change with the world economy, technical developments, and better use of resources; this change has led to changes in the balance between physical and mental activity.4 Devel-opments to reduce the amount of heavy physical work aim to mini-mize the risk of physical injury. In contrast, new working environments that are characterized by greater part-time and contract work, greater workload demands, lack of time, more uncontrollable factors, and job insecurity have resulted in an in-crease in mental and emotional stressors,4 psychological ill health, and sickness absence in staff.5 This article reviews WRDs, covering in-cidence/prevalence, cost to society and the individual, types of WRDs and associated risk factors, patholo-gy, intervention strategies, and treat-ment options.

The Size of the Problem

Number of Workers AffectedData from the 2007 Labour Force Survey indicate that 8.6% of the Eu-ropean Union workforce (average, 27 countries [EU-27]) reported one or more work-related health prob-lems.6 Of those EU-27 workers re-porting a problem caused or made worse by work, 50% reported that their daily activity was affected “to some extent” and 22% reported that

their daily activity was affected “considerably.” Sick leave was taken by 62.0% of EU-27 workers, and long-term sick leave (longer than 1 month) was taken by 27% of these workers. The 2005 European Work-ing Conditions Survey shows that 34% of EU-27 employees report that work affects their health.6 Esti-mates from EU Member States indi-cate that more than 600 million working days are lost because of work-related ill health each year in Europe.7 Of all WRDs, work-related stress and work-related MSDs (WRMSDs*) are the leading occupa-tional health problems in the EU.8 In Great Britain, MSDs have consis-tently been the most commonly re-ported WRDs in the national La-bour Force Survey.6 From 2009 to 2010, the estimated prevalence of people who worked in the past year and who experienced an MSD, caused or made worse by their cur-rent or past work, equated to 1900 (1.9%) per 100,000 people; the esti-mated incidence rate was 630 (0.63%) per 100,000 people. Stress has consistently been the second most commonly reported type of work-related illness in the national Labour Force Survey in Great Brit-ain.6 From 2009 to 2010, the esti-mated prevalence of people who worked in the past year and experi-enced stress caused or made worse by their current or past work equat-ed to 1500 (1.5%) per 100,000 people; the estimated incidence was

Pathologies Associated With the Workplace A Review Article By Wulf Saur, MD Orthopedic Surgeon

* WRMSDs are also designated in the literature as WMSDs.

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780 (0.78%) per 100,000 people. Records of the US Department of Labour Bureau of Labor Statistics report that, in 2009, the number of injury and illness cases was 3,277,700; cases involving days away from work totaled 965,000. The number of sprains, strains, and tears composed 379,340 cases; and cases involving the back (including the spine and spinal cord) totaled 195,150.9 A comprehensive study10 of the US workforce indicated that the state of health of the US work-force is deteriorating. The percent-age of employees rating their overall health as “excellent” declined from 34% in 2002 to 28% in 2008, whereas the percentage of people reporting that they did not experi-ence minor health problems in the past month declined from 36% to 29%. Such conditions can be caused or aggravated by stress, which may be reflected by the 41% of employ-ees experiencing 3 or more indica-tors of stress sometimes, often, or very often. A review11 of illness in the workplace indicated that 30.8% of Canadians reported that most days at work were either a bit or ex-tremely stressful and that those indi-viduals who experienced work-re-lated stress appear to be at a higher risk of mental health problems.

Economic CostsThe economic cost of WRDs is huge. Costs to business include lost production; sick leave compensation

and insurance costs; loss of experi-enced staff and costs of recruiting and training new staff; and the ef-fects of discomfort or ill health on work quality. Estimates from EU Member States indicate that the eco-nomic costs of all work-related ill health range from 2.6% to 3.8% of the gross national product.12 A high proportion (up to 50%) of the costs was for MSDs, estimated to repre-sent between 0.5% and 2% of the gross net product.13 Data show that, from 2009 to 2010, an estimated 9.3 million working days were lost through WRMSDs in Great Britain.6 There are also high costs to primary and secondary care in terms of consultations, treatment, and hospitalization.14

Costs to Workers and Their Families In addition, WRDs affect the quality of life of those affected both at work and in their home life. For example, in Great Britain, subjective costs of WRMSDs, including reduced quality of life (eg, pain and suffer-ing), concern caused to family and friends, and the loss of functioning from incapacity, are estimated at approximately £2.2 billion.15 The financial cost (ie, loss of income) to each individual forced to stop work-ing permanently until retirement age because of a work-related illness is estimated to be, on average, £51,000.15

The link between unemployment and health is well established.16,17

Evidence supports a positive associ-ation between unemployment and increased mortality and between un-employment and increased physical or mental morbidity.16,17 Generally, studies16 report a positive associa-tion between national unemploy-ment rates and rates of overall mortality and mortality due to car-diovascular disease and suicide. Compared with people with em-ployment, self-reported health is lower during periods of unemploy-ment and use of health services is increased.16,17 In addition, nonwork-ing young people generally report more somatic and psychological symptoms during recession than boom.18

The Relationship Between Work and WRDs

Work-related disorder is multifacto-rial,19 indicating that several risk factors contribute to causing such diseases. However, it is reasonable to assume that working conditions and exposures may also aggravate, accel-erate, or exacerbate disease. Risk factors contributing to WRDs in-clude physical, work organizational, psychosocial, and individual factors (Table 1).

Physical Risk FactorsMusculoskeletal disorders cover a broad range of WRDs, which vary in severity from minor aches and pains to more serious medical con-

Working environments and work- related activities can have a significant impact on people’s health.

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ditions requiring time off from work and medical treatment. They also vary in specificity from carpal tunnel syndrome, with well-defined signs and symptoms, to nonspecific pain or discomfort, without evidence of a clear specific disorder (Table 2). They mainly affect the back, neck, shoulders, and upper limbs, but they can also affect the lower limbs. Ac-cording to a 2005 European survey, at least 60 million workers report-edly experience MSDs in Europe, with up to 25% of the workers in the EU-27 reporting back pain and 23% reporting muscular pain.20 Approximately 17% of European workers complain of muscular pains in their arms and legs.7 Most WRMSDs are cumulative, resulting from repeated exposure to loads over a long period, but they can also be acute traumas (eg, fractures) that occur during an accident.1 Heavy lifting, awkward postures, and ex-cessive repetition are the most com-monly reported biomechanical risk factors, with at least reasonable evi-

dence for causing WRMSDs.21 In Europe, it is estimated that 62% of workers are exposed to repetitive hand or arm movements, 46% re-port working in painful or tiring po-sitions for at least a quarter of their working time, 18% of blue-collar workers report having to move heavy loads all or almost all of the time, and 50% of women and 45% of men work on computers every day.20 Systematic reviews have been consistent in their findings in re-porting a positive relationship be-tween physical workplace risk fac-tors and WRMSDs. Physical features of the working environment that are cited as risk factors for WRDs in-clude limited space, local or whole-body exposure to cold or excessive heat, poor lighting, and high noise levels (Table 1). Such stressors cause the body to tense, affect body pos-ture, and may cause distractions and accidents. For example, employees increasingly work with computers, resulting in a new epidemic of work-related neck and upper limb

disorders. In addition to the manual aspects of the work, workers using display screen equipment are fre-quently exposed to lack of space, noise, poor lighting, and poor ergo-nomics.20 From 2009 to 2010, an estimated 21,000 individuals in Great Britain who worked in the past 12 months were experiencing hearing problems that they believed to be work related.6 Symptoms of sick building syndrome, such as in-flammation, respiratory infections, and asthma symptoms, are linked to low ventilation rates in offices and molds have been implicated in their development.22,23 Occupational ex-posure to chemicals, dusts, fumes, smoke, or gas is a well-known risk factor for WRDs (Table 3). The on-set of many of these diseases does not occur until years after the expo-sures; therefore, most new cases or deaths largely reflect heavy expo-sures in the past and mainly occur in individuals who have retired.6 More recently, inhalation of laser printer toner dust has been shown to result

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Physical Factors Organizational and Psychosocial Factors Individual Factors

Physical aspects of work

• Loads

• Force application

• Repetition of movements

• Direct mechanical pressure on body tissues

• Body vibrations

• Awkward and static postures

• Acute trauma

Work environment

• Extreme temperatures

• Poor lighting

• High noise levels

• Limited space

• Exposure to chemicals, dusts, fumes, smoke, or gas

• Demanding work at a high pace

• Lack of control over the tasks performed; low levels of autonomy

• Low levels of job satisfaction; repetitive and monotonous work

• Shift work; time patterns

• Fatigue

• How workers perceive the work organization; lack of support from colleagues, supervisors, and managers

• Payment systems

• Medical history

• Physical and mental capacity

• Age

• Obesity

• Smoking

• Lifestyle and work style

• Coping mechanisms

• Previous experiences

• Expectations

• Self-confidence

Table 1: Risk Factors Contributing to Work-Related Disorders

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Upper Limb Lower Limb Back and Neck

N o n s p e c i f i c W o r k - R e l a t e d D i s o r d e r s

• Overuse syndrome

• Cumulative trauma disorder

• Repetitive strain injury

• Chronic upper limb pain syndrome

None Back • Low back pain

Neck • Nonradiating neck pain (ie, tension neck syndrome)

S p e c i f i c W o r k - R e l a t e d D i s o r d e r s

Shoulder

• Painful shoulder

• Bursitis

• Tendon-related disorders

• Tendinitis of the shoulder

• Bicipital tendinitis

• Infraspinatus tendinitis

• Supraspinatus tendinitis

• Subscapularis tendinitis

• Rotator cuff lesions

• Impingement syndrome

• Frozen shoulder

Elbow

• Epicondylitis

• Lateral epicondylitis

• Medial epicondylitis

• Beat elbow

• Olecranon bursitis

Hand and wrist

• Carpal tunnel syndrome

• Cubital tunnel syndrome

• Radial tunnel syndrome

• Ulnar tunnel syndrome

• Pronator and anterior interosseous syndrome

• Tenosynovitis

• De Quervain’s tenosynovitis

• Intersection syndrome

• Beat hand

• Hand and wrist pain

• Hand-arm vibration syndrome

• Vibration-induced white finger

Hip and thigh

• Osteoarthritis

• Piriformis syndrome

• Trochanteritis

• Hamstring strains

• Sacroiliac pain

Knee and lower leg

• Beat knee/hyperkeratosis

• Bursitis

• Meniscal lesions

• Osteoarthritis

• Patellofemoral pain syndrome

• Prepatellar tendinitis

• Shin splints

• Infrapatellar tendinitis

• Stress fractures

Ankle and foot

• Achilles tendinitis

• Blisters

• Foot corns

• Hallux valgus

• Hammer toes

• Pes traverse planus

• Plantar fasciitis

• Sprained ankle

• Stress fractures

• Varicose veins

• Venous disorders

• Spinal disk problems (eg, hernias and spondylolisthesis)

• Muscle strain

• Radiating neck pain

Table 2. Types of Work-Related Musculoskeletal Conditions According to Body Region

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in submesothelial deposition of car-bon nanoparticles in the peritone-um, affecting the respiratory health of persons exposed.24 The cancer burden study25 estimated that 5.3% of all cancer-related deaths were at-tributable to occupation in 2005 and that associated incidence esti-mates were 4.0% of cancer registra-tions. The study showed that 56% of cancer registrations in men (mainly mesotheliomas and lung, stomach, bladder, and nonmelano-ma skin cancers) are attributable to work in the construction industry and that 54% of cancer registrations in women (ie, breast cancer) are at-tributable to shift work.

Psychosocial and Organizational FactorsPsychosocial factors include an indi-vidual’s subjective perceptions re-garding aspects of the work organi-zation, such as perceived demands of the work, job satisfaction, im-pending redundancies/unwanted job transfers, conflicts and threats within the role, and relationships with and degree of support from

managers and work colleagues. Psy-chosocial risk factors have the po-tential for causing psychological and physical damage to health be-cause they can place individuals un-der considerable stress. Stress is of-ten related directly to the work specifications or to relationships with people at work, and conflicts with managers or colleagues may in-crease as work becomes more pres-sured.26,27 Higher levels of perceived job stress were found among sub-jects with a higher education level and those who were administrators or managers.26 Critical reviews28,29 have found that psychosocial risk factors are also related to WRMSDs. Work organization factors describe characteristics of the work system, such as hours worked, work-rest cycles (“shifts”), culture, manage-ment style, control over the work, level of autonomy, and payment sys-tems. Shift workers vary greatly in their capacity to adjust to the atypi-cal work schedules and tolerate cir-cadian misalignment. The desyn-chronization that occurs in circadian rhythms, with respect to sleep cy-

cles, predisposes employees to coro-nary heart disease, impaired glucose and lipid metabolism, gastrointesti-nal disturbances, increased risk of breast cancer, and poor pregnancy outcomes.30,31

Individual FactorsAn individual’s risk of WRDs relates to his or her specific demographic characteristics, medical history and physical capacity, and factors such as beliefs, attitudes, and personality traits. The amount of stress experi-enced by a person also depends on various factors, such as his or her behavioral type, personal pattern of coping with demands, attitude to-wards unpredictable and difficult situations, previous experiences, self-confidence in his or her own abilities, and lifestyle.4,32 Other work factors related to WRMSDs may in-clude rewards concerning money and career opportunities.3,32 In Eu-rope, upper limb disorders are re-ported to affect more female than male workers, mainly because of the type of work they do (eg, hand-in-tensive tasks); for example, 35% of

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Table 3. Diseases Associated With Occupational Exposure to Chemicals, Dusts, Fumes, Smoke, or Gasa

Organ Occupational Exposure Disease

Lung Inhalation of fumes, chemicals, and dusts Chronic obstructive pulmonary disease

Inhalation and retention in the lungs of mineral dusts

Asbestosis (asbestos fibers)

Pneumoconiosis (coal dust)

Silicosis (crystalline silica)

Inhalation of cotton dust Byssinosis

Inhalation of organic material Allergic reactions (eg, farmer’s lung)

Skin Absorption of lead Lead poisoning

Contact with soaps and cleaners, “wet work,” and rubber chemicals and materials

Contact dermatitis

a Data from HSE (Health and Safety Executive).6

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female workers perform permanent repetitive work compared with 31% of male workers.7 Other factors thought to be important in the ob-served sex differences are anthropo-metric differences (eg, body size and strength), which might disadvantage the female worker in work systems in which no such consideration has been taken. Moreover, there is evi-dence that previous injury predis-poses workers to further injury, par-ticularly when they engage in little or no physical activity outside of work.33 It is generally reported that older workers are more predisposed to WRMSDs than younger workers because of natural body aging and because older workers have worked (and, therefore, been exposed) for a longer period. Thus, older workers in Europe report more WRMSDs, with an average of 25% of people aged 15 to 24 years and 35% aged 55 years or older reporting back-ache.7 Advanced age, female sex, and obesity (ie, high body mass in-dex) are reported as risk factors for work-related lower limb disorders (ie, hip and knee osteoarthritis).33 In addition, individuals’ psychological fear-avoidance beliefs have been identified as predictors of progres-sion to chronic disorders and pro-longed work disability.34 Fear-avoid-ance beliefs about work in individuals with acute low back pain were significant predictors of 4-week disability and work status,

even after controlling for initial lev-els of pain intensity, physical impair-ment and disability, and therapy type received.

Link Between WRMSDs and StressSeveral epidemiological studies3,35 have implicated exposure to physi-cal and psychosocial risk factors in the workplace in the development of WRMSDs. Perceived job stress has also been implicated as an inter-mediate factor between high expo-sure to physical and psychosocial work risk factors and the reporting of some MSDs.36 In addition, once a MSD is present, psychosocial factors (eg, depression and maladaptive pain responses) play a role in the transition from acute to chronic pain and in the development of disabili-ty.37 A comprehensive review3 of the literature found most evidence aris-ing from cross-sectional studies, which have shown a positive asso-ciation between stress and WRMSD but make it difficult to determine causation. However, there are a few prospective epidemiological studies providing support for a predictive relationship between symptoms of psychological strain and MSD. For example, prospective studies have shown a positive association be-tween symptoms of stress/psycho-logical strain and lower back prob-lems and symptoms of stress/psychological strain and neck/shoulder problems. The review not-

ed that prospective studies have also shown no relationship between stress/psychological strain and low-er back problems and work-related stress and self-reported hand/wrist problems.

Pathology of WRDs

Mechanisms underlying the associa-tion between work stress and dis-ease, such as cardiovascular disease, possibly involve direct activation of neuroendocrine responses to stress-ors and indirect activation through unhealthy behaviors (eg, smoking, alcohol use, and lack of physical ex-ercise).38 The cardiovascular risk factors found to be most common in managers were obesity, hyperten-sion, and elevated levels of blood glucose and low-density lipopro-tein, whereas cigarette smoking, fa-milial congestive heart disease, and a high fibrinogen level were more common in physical workers.39

There is evidence that stress in hu-mans has increased, both physically and psychosocially, as a result of the ever-growing demands of work.40

Stimulation of the hypothalamic-pituitary-adrenal axis by stressors leads to the release of glucocorti-coids, mainly cortisol, in the blood,41 with effects on the metabolism of adipose tissue.42 Globalization and modernization create work situa-tions that impose neurogenic stress that, in turn, increases the impact of

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Physical stressors (eg, repetitive movements, heavy loads, or vibrations) are a risk factor for work-related musculoskeletal disorders such as repetitive strain injury.

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glucocorticoids.40 There is evidence that the increase in knowledge-based work and the decrease of quality/duration of sleep increase cortisolemia and glycemia instabili-ty, resulting in an increase in food intake, a reduction in energy expen-diture, and body fat gain.40 Studies investigating the association be-tween work, psychosocial factors, and carotid atherosclerosis have yielded mixed results, from findings of no association between work-re-lated stress and increased carotid atherosclerosis43 to significantly greater progression of carotid ath-erosclerosis in men with high work demand/low economic reward than in more advantaged men44 and a positive correlation between job de-mands and coronary artery intima-media thickness in men but not in women.45 The finding of no signifi-cant correlation between perceived work-related stress and preclinical atherosclerosis (ie, carotid artery in-tima-media thickness) was consid-ered the result of somatization of stress by individuals with a low level of perceived work-related stress.46 Thus, their stress is not perceived at the conscious level, but it leads to somatic effects, such as intima-media thickening.46 Work-related stressful situations induce emotional disorders that may affect both neu-roendocrine and immune systems.47 Reduced reactivity to mitogens and/or decreased blood natural kill-er (NK) cytotoxic activity was re-ported in unemployed workers or in those with a high perception of job insecurity and/or job stress. Occu-pational stress (eg, from disruption of circadian timing in night shifts) was reportedly associated with an increased incidence of autoimmune disorders.47 Stress from sleep depri-vation and sleep loss is directly con-nected to a reduction of NK cells and increased inflammatory re-sponses,48,49 and job stress has been

shown to exert a negative impact on immune outcomes.50-52 Overtime work was associated with a decrease of NK cell counts but not with other immune indicators, such as NK cell cytotoxicity, the NK cell cytotoxici-ty to NK cell ratio, and T and B cells.53 The decrease of NK cell counts suggests a dampened innate immune defense system. The de-crease in NK cell counts by overtime work may be the result of redistri-bution of NK cells between lym-phoid organs and the periphery, without losing cytotoxic capacity,53 or the down-regulation of β-adrenergic receptors on NK cells.54 This study also showed an association between overtime work and increased body mass index, re-duced sleep hours, and job satisfac-tion; thus, the NK cell decrease was believed to be the result of a combi-nation of factors.

Prevention Strategies

Generally, it is believed that illness and disability associated with non-specific MSDs can be managed only according to a biopsychosocial model that includes biological (ie, physical or mental health factors, such as physiological dysfunction), psychological (ie, personal/psycho-logical factors, such as behavior, be-liefs, coping strategies, and emo-tions), and social (ie, social context, pressures, and constraints on func-tioning, such as culture and social interaction) dimensions that influ-ence functioning.55 The model per-ceives functioning and disability as a dynamic interaction between the individual’s health condition and contextual factors that include both personal/psychological and social/occupational factors.55 The approach is appropriate in WRMSD manage-ment strategies because, although biological considerations are impor-tant, psychosocial factors may be

more influential for occupational outcomes.56 Therefore, interventions designed to reduce the risk of self-reported WRMSDs should consider the degree of exposure to physical and psychosocial work risk factors and the workers’ individual stress reactions.3 Despite risk reduction, interventions that focus on physical and/or psy-chosocial workplace risk factors only may not be entirely successful in preventing WRMSDs. Some workers may still continue to expe-rience these disorders because of musculoskeletal damage caused by other pathological pathways, such as individual psychological reac-tions.3 Recently, a Cochrane re-view57 concluded that workplace interventions were effective for re-ducing sickness absence among workers with MSD but were not ef-fective for improving health out-comes among these individuals. There is a considerable variety of potential interventions for the pre-vention of WRMSDs, depending on the problems in each sector of work-ing life. A systematic review20 of the scientific evidence reported from 2000 to 2006 on the effectiveness of measures to prevent work-related MSDs classified the interventions into 4 main categories:• organizationalandadministrative

(eg, rest breaks) • technical, engineering, or ergo-

nomic (eg, tools, techniques, and mechanical aids)

• personal(eg,protectiveequipment)• behavioral(eg,trainingandwork-

ing postures) Case studies20 drawn from a range of occupations and sectors of work across Europe showed that interven-tions to tackle the risks of MSDs can reduce the rate of sick leave due to MSD, improve the satisfaction and motivation of workers, improve working conditions and overall safety, and positively influence fac-

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Table 4. Pharmacological Therapies Used in the Treatment of Musculoskeletal Disordersa

Type Effect Action

Corticosteroids • Pain relief and reduction of inflammation

• A wide array of activity, affecting most immune system cells• Up-regulate expression of anti- inflammatory proteins and down- regulate expression of proinflammatory proteins • Inhibit conversion of phospholipids into arachidonic acid• Cause profound and varied metabolic effects (eg, exacerbate diabetes mellitus)

Nonsteroidal anti-inflammatory drugs

• Most commonly used for relief of mild-to-moderate pain

• Inhibit prostaglandin synthesis by decreasing COX enzyme activity

Muscle relaxants • Adjunctive therapy for nociceptive pain and chronic pain syndromes

• Thought to act centrally at the level of the spinal cord, brainstem, or cerebrum, by interfering with neurotransmission

Narcotic analgesics • Pain control • Act on the central nervous system and interact with specific receptor sites to interfere with pain impulses • Essential to quality patient care, ensuring patient comfort, enabling physical therapy regimens, and limiting the likelihood of a chronic pain syndrome

Tricyclic antidepressants • Used to treat depression as an adjunct to pain medications and for sedation when sleep is disrupted

• Prolong the effects of neurotrans- mitters by inhibiting the reuptake of norepinephrine and serotonin

Anxiolytic agents • Used to treat anxiety and for sedation when sleep is disrupted

• Act primarily by facilitating γ-aminobutyric transmission in limbic regions of the brain

Abbreviation: COX, cyclooxigenase.a Data from Laker et al.59

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2. Johnson JV, Lipscomb J. Long working hours, occupational health and the changing nature of work organization. Am J Ind Med. 2006;49(11):921-929.

3. Devereux J, Rydstedt L, Kelly V, et al. The role of work stress and psychological factors in the development of musculoskeletal dis-orders: the stress and MSD study. Research Report 273. Health and Safety Executive, 2004. http://www.hse.gov.uk/research/rrp-df/rr273.pdf. Accessed November 3, 2011.

4. von Onciul J. ABC of work related disorders: stress at work. BMJ. 1996;313(7059):745-748.

5. Mitchie S, Williams S. Reducing work related psychological ill health and sickness absence: a systematic literature review. Occup Environ Med. 2003;60(1):3-9.

6. HSE (Health and Safety Executive). Health and safety statistics 2009/10. http://www.hse.gov.uk/statistics/index.htm. Published 2010. Accessed March 30, 2011.

7. EASHW (European Agency for Safety and Health at Work). Work-related musculoskel-etal disorders in Europe. FACTS 3. 2000a. http://osha.europa.eu/en/publications/factsheets/3. Accessed November 3, 2011.

8. European Commission. Eurostat. http://epp.eurostat.ec.europa.eu/portal/page/portal/statistics/search_database. Published 2011. Accessed November 3, 2011.

9. US Department of Labour Bureau of Labor Statistics. Injuries, illnesses, and fatalities. http://www.bls.gov/iif/. Accessed Novem-ber 3, 2011.

10. Aumann K, Galinsky E. The state of health in the American workforce: does having an effective workplace matter? Families & Work Institute, 2009. http://www.familiesand work.org/site/research/reports/HealthRe port.pdf. Accessed November 3, 2011.

11. Dewa CS, Lesage A, Goering P, Caveen M. Nature and prevalence of mental illness in the workplace. Healthc Pap. 2004;5(2):12-25. http://www.longwoods.com/content/ 16820. Accessed July 19, 2011.

12. EASHW (European Agency for Safety and Health at Work). Economic impact of oc-cupational safety and health in the Member States of the European Union. Agency report, 1998. http://osha.europa.eu/en/pub lica-tions/reports/302. Accessed November 3, 2011.

13. EASHW (European Agency for Safety and Health at Work). Work-related neck and upper limb musculoskeletal disorders: sum-mary of agency report. FACTS 5. 2000b. http://osha.europa.eu/en/publications/factsheets/5. Accessed November 3, 2011.

14. Holmberg SA, Thelin AG. Primary care consultation, hospital admission, sick leave and disability pension owing to neck and low back pain: a 12-year prospective cohort study in a rural population. BMC Musculoske-let Disord. 2006;7:66.

15. EASHW (European Agency for Safety and Health at Work). Inventory of socio-eco-nomic information about work-related mus-culoskeletal disorders in the Member States of the European Union. FACTS 9. 2000c. http://osha.europa.eu/en/publications/factsheets/9. Accessed November 3, 2011.

tors such as process capacity, pro-duction output, and product.

Treatment Options

The management of MSDs is a clini-cal and an occupational issue that requires proper workplace policies, attitudes, and interventions. Many treatment options are commonly used in daily practice for specific and nonspecific disorders.58 Non-pharmacological treatments com-prise therapies such as rest, exercise, physical therapy, behavioral therapy, occupational therapy, and ergonom-ic interventions. The pharmacologi-cal medication (Table 4) includes treatment for physical symptoms (eg, corticosteroids, nonsteroidal anti-inflammatory drugs, muscle re-laxants, and analgesics) and for psy-chiatric symptoms (eg, antidepres-sants).59 Alternative and complementary therapies (eg, acupuncture and transcutaneous electrical nerve stimulation and bioregulating medi-cines) may also be effective. Regard-ing combination treatments, bioreg-ulating medicines can provide a holistic approach. Combinations of treatments are commonly used, whereas a surgical intervention may be an option when conservative treatments fail.58 A review58 of treat-ment studies for repetitive strain in-juries concluded that no strong rec-ommendation for any therapeutic intervention could be made. How-ever, there is support for the use of some therapies in the treatment of specific overuse injuries:• nonspecific disorders: exercise

therapy (relieves symptoms and improves the activities of daily living) and manual therapy (eg, osteopathy or chiropracty)

• carpal tunnel syndrome: localcorticosteroid injections and oral corticosteroids (both short-term),

wrist splint, and open carpal tun-nel surgery release

• lateral epicondylitis (tennis el-bow): topical and oral nonsteroi-dal anti-inflammatory drugs (both short-term), corticosteroid injections, ultrasonography, and percutaneous tenotomy or for-mal open release

• neck pain: exercise andmobili-zation plus exercise

• shoulder pain: subacromial andintra-articular corticosteroid in-jections, physiotherapy (ie, manual treatment and exercise), and sur-gical arthroscopic decompression

The bioregulatory medical treat-ment of WRDs will be included in other articles in this issue of the journal, including an outline of the treatment of repetitive strain injury with Traumeel and practical proto-cols on treating mouse arm and work-related stress disorders.

Conclusions

The management of WRDs remains challenging, with a need to address physical and/or psychosocial work-place risk factors and individual psychological reactions. There is a growing body of evidence for a link between MSDs and mental and emotional stress. The complexity and interactive nature of these con-ditions require a comprehensive multidisciplinary approach if their management is to be effective. A ho-listic approach, considering the commonalities and interactions between WRMSDs and stress, may result in reducing both condi-tions.|

References1. EASHW (European Agency for Safety and

Health at Work). Introduction to work-re-lated musculoskeletal disorders. FACTS 71. http://osha.europa.eu/en/publications/factsheets/71. Published 2007. Accessed November 3, 2011.

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16. Jin R, Shah CP, Svoboda TJ. The impact of unemployment on health: a review of the ev-idence. Can Med Assoc J. 1995;153(5):529-540.

17. NHS. Unemployment and health. http://www.nhsfife.scot.nhs.uk/fifepublichealth dataset/Unemployment%20and%20health %20final.doc. Accessed November 3, 2011.

18. Novo M, Hammarström A, Janlert U. Do high levels of unemployment influence the health of those who are not unemployed? A gendered comparison of young men and women during boom and recession. Social Sci Med. 2001;53(3):293-303.

19. Novak CB, Mackinnon SE. Multilevel nerve compression and muscle imbalance in work-related neuromuscular disorders. Am J Ind Med. 2002;41(5):343-352.

20. EASHW (European Agency for Safety and Health at Work), Podniece Z. Work-related musculoskeletal disorders: prevention report. http://osha.europa.eu/en/publications/re ports/en_TE8107132ENC.pdf. Published 2008. Accessed November 3, 2011.

21. da Costa BR, Vieira ER. Risk factors for work-related musculoskeletal disorders: a systematic review of recent longitudinal studies. Am J Ind Med. 2010;53(3):285-323.

22. Sundell J, Levin H, Nazaroff WW, et al. Ven-tilation rates and health: multidisciplinary review of the scientific literature. Indoor Air. 2011;21(3):191-204.

23. Straus DC. The possible role of fungal con-tamination in sick building syndrome. Front Biosci (Elite Ed). 2011;3:562-580.

24. Theegarten D, Boukercha S, Philippou S, An-henn O. Submesothelial deposition of carbon nanoparticles after toner exposition: case re-port. Diagn Pathol. 2010,5:77.

25. Rushton L, Bagga S, Bevan R, et al. Occu-pation and cancer in Britain. Br J Cancer. 2010;102(9):1428-1437.

26. Cheng Y, Guo YL, Yeh WY. A national survey of psychosocial job stressors and their impli-cations for health among working people in Taiwan. Int Arch Occup Environ Health. 2001;74(7):495-504.

27. Oxenstierna G, Magnusson Hanson LL, Wid-mark M, Finnholm K, Stenfors C, Elofsson S, Theorell T. Conflicts at work: the relation-ship with workplace factors, work character-istics and self-rated health [published online ahead of print June 21, 2011]. Ind Health. doi:10.2486/indhealth.MS1171.

28. Bugajska J, Jedryka-Góral A, Gasik R, Zołnierczyk-Zreda D. Acquired musculo-skeletal dysfunction syndromes in workers in the light of epidemiological studies. Med Pr. 2011;62(2):153-161.

29. Cao L, DU WW, Wang S, et al. The interac-tive effect of job task and psychosocial fac-tors on work-related musculoskeletal disor-ders. Zhonghua Lao Dong Wei Sheng Zhi Ye Bing Za Zhi. 2011;29(3):176-179.

30. Boivin DB, Tremblay GM, James FO. Working on atypical schedules. Sleep Med. 2007;8(6):578-589.

31. Mosendane T, Mosendane T, Raal FJ. Shift work and its effects on the cardiovascular sys-tem. Cardiovasc J Afr. 2008;19(4):210-215.

48. Shakhar K, Valdimarsdottir HB, Guevarra JS, Bovbjerg DH. Sleep, fatigue, and NK cell ac-tivity in healthy volunteers: significant rela-tionships revealed by within subject analyses. Brain Behav Immun. 2007;21(2):180-184.

49. van Leeuwen WM, Lehto M, Karisola P, et al. Sleep restriction increases the risk of devel-oping cardiovascular diseases by augmenting proinflammatory responses through IL-17 and CRP. PLoS One. 2009;4(2):e4589.

50. Morikawa Y, Kitaoka-Higashiguchi K, Tani-moto C, et al. A cross-sectional study on the relationship of job stress with natural killer cell activity and natural killer cell sub-sets among healthy nurses. J Occup Health. 2005;47(5):378-383.

51. Boscolo P, Di Donato A, Di Giampaolo L, et al. Blood natural killer activity is reduced in men with occupational stress and job insecu-rity working in a university. Int Arch Occup Environ Health. 2009;82(6):787-794.

52. Nakata A, Takahashi M, Irie M, Swanson NG. Job satisfaction is associated with elevated natural killer cell immunity among healthy white-collar employees. Brain Behav Immun. 2010;24(8):1268-1275. doi:10.1016/j.bbi.2010.05.004.

53. Nakata A, Takahashi M, Irie M. Associa-tion of overtime work with cellular immune markers among healthy daytime white-collar employees [published online ahead of print July 16, 2011]. Scand J Work Environ Health. doi: 10.5271/sjweh.3183.

54. Dimsdale JE, Mills P, Patterson T, Ziegler M, Dillon E. Effects of chronic stress on beta-ad-renergic receptors in the homeless. Psychosom Med. 1994;56(4):290-295.

55. Waddell G. Preventing incapacity in people with musculoskeletal disorders. Br Med Bull. 2006;77-78:55-69.

56. Burton AK, Kendall NA, Pearce BG, et al. Management of work-relevant upper limb disorders: a review. Occup Med (Lond). 2009;59(1):44-52.

57. van Oostrom SH, Driessen MT, de Vet HC, et al. Workplace interventions for preventing work disability. Cochrane Database Syst Rev. 2009;(2):CD006955.

58. van Tulder M, Malmivaara A, Koes B. Re-petitive strain injury. Lancet. 2007;369(9575): 1815-1822.

59. Laker SR, Sullivan WJ, Strum S. Overuse Injury. Available at: http://emedicine.med scape.com/article/313121-overview. Acces-sed November 3, 2011.

32. Chorus AM, Miedema HS, Wevers CW, van der Linden S. Work factors and behavioural coping in relation to withdrawal from the labour force in patients with rheumatoid arthritis. Ann Rheum Dis. 2001;60(11):1025-1032.

33. Okunribido O. Lower limb MSD. Scoping work to help inform advice and research planning. Research Report 706. Health and Safety Executive, 2009. http://www.hse.gov.uk/research/rrpdf/rr706.pdf. Accessed No-vember 3, 2011.

34. Fritz JM, George SZ, Delitto A. The role of fear-avoidance beliefs in acute low back pain: relationships with current and future disabil-ity and work status. Pain. 2001;94(1):7-15.

35. Punnett L, Wegman DH. Work-related mus-culoskeletal disorders: the epidemiologic evi-dence and the debate. J Electromyogr Kinesiol. 2004;14(1):13-23.

36. Bongers PM, Kremer AM, ter Laak J. Are psychosocial factors, risk factors for symp-toms and signs of the shoulder, elbow, or hand/wrist? A review of the epidemiological literature. Am J Ind Med. 2002;41(5):315-342.

37. Menzel NN. Psychosocial factors in muscu-loskeletal disorders. Crit Care Nurs Clin North Am. 2007;19(2):145-153.

38. Chandola T, Britton A, Brunner E, et al. Work stress and coronary heart disease: what are the mechanisms? Eur Heart J. 2008;29(5):640-648.

39. Bugajska J, Michalak JM, Jedryka-Góral A, Sagan A, Konarska M. Coronary heart dis-ease risk factors and cardiovascular risk in physical workers and managers. Int J Occup Saf Ergon. 2009;15(1):35-43.

40. Huneault L, Mathieu MÈ, Tremblay A. Glo-balization and modernization: an obesogenic combination. Obes Rev. 2011;12(5):e64-e72.

41. Bjorntorp P. Do stress reactions cause ab-dominal obesity and comorbidities? Obes Rev. 2001;2:73-86.

42. Eswar P, Kenneth R, Shang-Jin W, Khose MA. Effects of financial globalisation on de-veloping countries: some empirical evidence. Econ Polit Wkly. 2003;38(41):4319-4330.

43. Rosvall M, Ostergren PO, Hedblad B, Isacs-son SO, Janzon L, Berglund G. Work-related psychosocial factors and carotid atherosclero-sis. Int J Epidemiol. 2002;31(6):1169-1178.

44. Lynch J, Krause N, Kaplan GA, Salonen R, Salonen JT. Workplace demands, economic reward, and progression of carotid athero-sclerosis. Circulation. 1997;96(1):302-307.

45. Hintsanen M, Kivimaki M, Elovainio M, et al. Job strain and early atherosclerosis: the cardiovascular risk in young Finns study. Psy-chosom Med. 2005;67:740-747.

46. Bugajska J, Widerszal-Bazyl M, Radkie-wicz P, et al. Perceived work-related stress and early atherosclerotic changes in healthy employees. Int Arch Occup Environ Health. 2008;81(8):1037-1043.

47. Boscolo P, Di Gioacchino M, Reale M, Mu-raro R, Di Giampaolo L. Work stress and innate immune response. Int J Immunopathol Pharmacol. 2011;24(suppl 1):51S-54S.

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Office Lighting Affects Productivity

The right lighting can help workers be more productive! In this study on the use of blue-enriched white light in an office, 104 white-collar workers were studied over 8 weeks. Two types of light were used for 4 weeks each: blue-enriched white light (17,000 K) and white light (4000 K). For the 94 workers included in the final analy-sis, many factors were significantly improved with the use of blue-en-riched white light, including alert-ness, positive mood, performance, evening fatigue, concentration, and daytime sleepiness (P < .001 for all); eye discomfort (P = .002); irritability (P = .004); and nighttime sleep qual-ity (P = .016). Therefore, individuals in charge of offices should consider the use of “positive” lighting as a po-tential benefit to both their workers and their offices.

Scand J Work Environ Health.2008;34(4):297-306.

Graveyard Shift Leads to Increased Injuries

In this Canadian study, the Survey of Labour and Income Dynamics was used to determine trends in in-jury by shift from 1996 to 2006. Work injury was determined by re-ceipt of workers’ compensation. The results of the study showed that work injury decreased overall from 1996 to 2006, but not in night shift workers. Findings indicated the fol-lowing: (1) night shift was associat-ed with injury for both women (odds ratio [OR], 2.04) and men (OR, 1.91) and (2) a rotating shift was associated with injury for wom-en only (OR, 2.29). Thus, the study concluded that regulatory agencies and employers should determine and help alleviate the issues that lead

to increased work injury in these shift

workers.

Scand J Work Environ Health.2011;37(1):54-61.

Working Overtime Associated With Health ComplaintsDon’t work too much! It’s not just what your friends say! This study used information from a 2000 Euro-pean survey on working conditions. Statistics were used to examine the association between working hours and health impairments. It appears that health complaints, including musculoskeletal disorders and psy-chovegetative complaints, were more prevalent in those who worked lon-ger hours! The factors that affect the relationship between working hours and health are both individual (eg, age) and situational (eg, shift work). The association between number of working hours and workers’ health is consistent and may affect numerous conditions. Therefore, longer work hours are definitely not necessarily recommended!

Chronobiol Int. 2006;23(6):1305-1316.

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F O R P R O F E S S I O N A L U S E O N L Y

The information contained in this journal is meant for professional use only, is meant to convey general and/or specific worldwide scientific information relating to the products or ingredients referred to for informational purposes only, is not intended to be a recommendation with respect to the use of or benefits derived from the products and/or ingredients (which may be different depending on the regulatory environment in your country), and is not intended to diagnose any illness, nor is it intended to replace competent medical advice and practice. IAH or anyone connected to, or participating in this publication does not accept nor will it be liable for any medical or legal responsibility for the reliance upon or the misinterpretation or misuse of the scientific, informational and educational content of the articles in this journal.The purpose of the Journal of Biomedical Therapy is to share worldwide scientific information about successful protocols from orthodox and complementary practi-tioners. The intent of the scientific information contained in this journal is not to “dispense recipes” but to provide practitioners with “practice information” for a better understanding of the possibilities and limits of complementary and integrative therapies.Some of the products referred to in articles may not be available in all countries in which the journal is made available, with the formulation described in any article or available for sale with the conditions of use and/or claims indicated in the articles. It is the practitioner’s responsibility to use this information as applicable and in a manner that is permitted in his or her respective jurisdiction based on the applicable regulatory environment. We encourage our readers to share their complementary therapies, as the purpose of the Journal of Biomedical Therapy is to join together like-minded practitioners from around the globe.Written permission is required to reproduce any of the enclosed material. The articles contained herein are not independently verified for accuracy or truth. They have been provided to the Journal of Biomedical Therapy by the author and represent the thoughts, views and opinions of the article’s author.

Blue-enriched white light in the workplace improves employee alert-ness, performance, and concentration.

Working longer hours increases the risk of both musculoskeletal disorders and psychovegetative

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Noise Exposure Affects Cardiovascular Health

Excess noise at work is a real occupa-tional health issue. This study used a national US sample to determine the relationship between self-reported occupational noise exposure and cor-onary heart disease (CHD) and hy-pertension. The sample included 6307 individuals who completed the National Health and Nutrition Ex-amination Survey 1999-2004, aged 20 years and older, and employed when the interview was conducted. When compared with those never exposed to workplace noise, individ-uals with long-term occupational noise exposure experienced a 2- to 3-fold increase of angina pectoris (odds ratio, 2.91), CHD (odds ratio, 2.40), and isolated diastolic hyper-tension (odds ratio, 2.23). The study was adjusted for the following co-variates: race/ethnicity, educational attainment, annual family income, leisure time, physical activity, ciga-rette smoking status, alcohol drink-ing, and hearing loss. One specific finding was that the relationship be-tween noise and angina pectoris, myocardial infarction, and CHD was strong for those younger than 50 years, male, and current smokers. The issue of workplace noise expo-sure deserves further attention.

Occup Environ Med. 2011;68(3):183-190.

Toner Dust Causes Abdominal Symptoms

Laser printers may cause ill respira-tory effects on individuals. These printers emit carbon nanoparticles (CNPs), and individuals may inhale the CNPs from toner dust. Previous data indicate that office workers with long-term exposure to toner dust have more radiographic lung abnor-malities, temporary coughing, and sputum production. The present case report described the experience of a 33-year-old female office worker who had intermittent abdominal pain, weight loss, and diarrhea. Sev-eral tests were performed to deter-mine the reason for her adverse symptoms. The results of laparosco-py showed black spots in the perito-neum, the results of scanning and transmission electron microscopy showed submesothelial aggregates of CNPs (diameter, 31-67 nm), and co-lon biopsy results showed inflamma-tory bowel disease and signs of Crohn disease. However, there were no dust deposits. The authors con-cluded that CNPs were transported by lymphatic and blood vessels after inhalation. In addition, the effects of toner dust on the respiratory system should be further examined.

Diagn Pathol. 2010;5(1):77.

Prolonged exposure to workplace noise results in increased incidence of coronary heart disease and hypertension.

Possible adverse effects of computer use include eyestrain,

headaches, dry eye, and blurred vision.

Visual Problems Linked to Computer Use

Even kindergarteners use comput-ers! The Western world relies on and uses computers 24 hours a day, 7 days a week. Computers are used at home and at work, for play and performance. Unfortunately, use of these sophisticated machines can re-sult in adverse effects. This study examined the visual problems that result from use of computers, a syn-drome termed computer vision syn-drome (CVS). According to this study, between 64% and 90% of computer users are affected by the following eye problems: eyestrain, headaches, ocular discomfort, dry eye, diplopia, and blurred vision. Oculomotor anomalies and dry eye were explored as the main causes of CVS. Unfortunately, there are few efficacious treatments for decreasing the symptoms of CVS. Therefore, additional studies are necessary to determine the physiological aspects of CVS. Then, the proper treatments can be used by practitioners to help patients become more comfortable and effective during computer use.

Ophthalmic Physiol Opt. 2011. doi: 10.1111/j.1475-1313.2011.00834.x.

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) P r a c t i c a l P r o t o c o l s

Work-Related Psychological Stress and the Hypothalamic-Pituitary-Adrenal Axis By David W. Lescheid, PhD, ND

It is also becoming increasingly evident that the psychological

stress associated with unhealthy work environments substantially contributes to the development of many different conditions and dis-eases, including insomnia,1 anxiety and depression,2 cognitive impair-ment,3 irritable bowel syndrome,4 visceral obesity,5 metabolic syn-drome,6 cardiovascular disease7 (in-cluding coronary heart disease8), skin disorders,9 and infertility.10,11 Persistent psychosocial stress also contributes to the development of physical signs and symptoms of dis-ease, but this article will focus only on some of the other effects of pro-longed exposure to inadequate working environments. In particular, it will provide a brief summary of the hypothalamic-pituitary-adrenal (HPA) axis and the negative effects of persistently high levels of corti-sol. One of the pioneers in investigating the impact of chronic stress on the human organism was Dr. Hans Se-lye, who proposed in the mid-

1930s12 that there were distinct phases of compensation that oc-curred with continued exposure to high levels of physical and psycho-social stress. He termed the overall response the general adaptation syn-drome, which included the consecu-tive phases of alarm, resistance or adaptation, and exhaustion.13 Fur-ther research has largely supported his initial work and delineated some of the major anatomical and bio-chemical pathways and messengers involved as well as their impact on different metabolic pathways. The most commonly accepted corner-stone of the stress response is the HPA axis. This includes the primary messenger molecules of corticotro-phin-releasing hormone (CRH) and vasopressin (also termed arginine va-sopressin), synthesized and released from the brain hypothalamus; adre-nocorticotrophic hormone from the anterior pituitary gland; and the corticosteroid family of hormones from the cortex of the adrenal glands. The most commonly referred to cor-ticosteroid is the glucocorticoid cor-

tisol, but the mineralocorticoids (eg, aldosterone) and adrenal androgens (eg, dehydroepiandrosterone and androstenedione) are also affected in this pathway. Negative feedback loops between these hormones assist with providing regulated control of the stress response.14,15 Other major contributors to the control of the HPA axis include cytokines (eg, in-terleukin 1,16 interleukin 6, and tu-mor necrosis factor α17) and numer-ous other hormones, including oxytocin, atrial natriuretic peptide (synthesized and released from car-diomyocytes in the heart atrium), and prolactin.18 Other stress-related molecules that are primarily associ-ated with the immediate response by the sympathetic nervous system include the catecholamines epi-nephrine (also termed adrenaline) and norepinephrine (also termed noradrenaline).19 Many of the mes-senger molecules associated with the HPA axis, and their receptors, have been found in other areas of the body, most notably the gastroin-testinal tract20 and the nervous and immune systems.21 Indeed, because of the extensive overlap between the individual systems, an overarching term for this field of study is psycho-neuroimmunology.22 Prolonged activation of the HPA axis results in persistently high levels of cortisol that have wide-ranging effects on numerous body systems to influence psychological and physical pathology.23 It is well-

The impact of work-related physical stress on the initiation

and perpetuation of different disease processes has been

well documented in the scientific literature and discussed in

other articles within this issue of the Journal of Biomedical

Therapy.

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known that the levels of circulating cortisol wax and wane along with the circadian rhythm, with an early morning peak of 1 to 2 hours before waking (between 3 and 5 AM) and a late-night nadir of approximately 12 PM.15 An abnormal rhythm, in particular an enhanced increase on waking, was positively associ-ated with persistent job stress and poorer health outcomes.24 More re-cently it has been shown that there is also an ultraradian glucocorticoid cycle that is important to maintain receptor sensitivity and additional biological signaling.25,26 Cortisol has also recently been shown to play a predominant role in resetting the circadian clocks of other cycli-cal hor mones and messaging mol-

ecules.27 Continued disruptions to normal daily rhythms are associated with the development of numer-ous pathologies including depres-sion,28 immune system disorders,29 hormone-related cancers (including breast cancer30), and rheumatoid ar-thritis.31 These rhythms can be dis-rupted by several different stressors, including shift work and light at night,32 and the psychological stress of persistently inadequate working environments. It is apparent that acute levels of stress and the resultant high levels of cortisol can have discombobulat-ing effects, including impaired memory.33-35 Furthermore, what is becoming increasingly established in the medical literature is that poor-

ly managed persistently high levels of stress can have long-term impacts on the health of the central nervous system and negative effects on hu-man cognition.36

There also is increasing evidence of direct communication between the HPA axis and the hypothalamic-pi-tuitary-gonadal axis.37 High levels of cortisol suppress circulating tes-tosterone levels,38 whereas testoster-one also feeds back to help regulate CRH-related activity on the HPA axis in men.39 High levels of CRH inhibit gonadotropin-releasing hor-mone and, therefore, reproduction function. They also increase levels of somatostatin and, therefore, affect secretion of growth hormone, thy-roid-releasing hormone, and thy-

DET-Phase Basic and/or Symptomatic Regulation Therapya Optional

Multiple systems and levels of effects possible

• Neurexan/Nervoheel D&D • Basic detoxification and drainage: Detox-Kitb

• In chronic cases: advanced supportive detoxification and drainagec

• Glandula suprarenalis suis-Injeel (to support the functions of the adrenal glands )

• Tonico-Injeel (if there is marked physical and mental exhaustion)

• Testis compositum (in men)

• Ovarium compositum (in women)

IM • Tonsilla compositumd

CTOS • Cerebrum compositum• Coenzyme compositum • Ubichinon compositum

Notes: It is important to determine any modifiable diet and lifestyle factors and address them if possible. A foundation of healthful nutrition and eating habits, sustained periods of restful sleep, and regular stress management activities are important foundational interventions to support any changes imposed by medications.

Dosages: Basic therapy: Neurexan, 10 drops or 1 tablet 3 times per day; Nervoheel, 1 tablet 3 times per day. Regulation therapy: tablets, 1 tablet 3 times per day; drops, 10 drops 3 times per day; ampoules, 1 ampoule of each medication, 1 to 3 times per week. Detox-Kit, 30 drops of each medication in 1.5 L of water (drink throughout the day). Optional therapy: 1 ampoule of each appropriate medication, 1 to 3 times per week.

Table. Bioregulatory Management of Work-Related Stress

Abbreviations: CTOS, cellular, tissue, and organ support; D&D, detoxification and drainage; DET, Disease Evolution Table; IM, immunomodulation. a Antihomotoxic regulation therapy consists of a 3-pillar approach: D&D, IM, and CTOS.b The Detox-Kit consists of Lymphomyosot, Nux vomica-Homaccord, and Berberis-Homaccord. Berberis-Homaccord is also suggested to support the adrenal glands.c Advanced supportive detoxification and drainage consists of Hepar compositum (liver), Solidago compositum (kidney), and Thyreoidea compositum (connective tissue).d Tonsilla compositum contains Hypothalamus suis and Cortex glandulae suprarenalis suis.

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roid-stimulating hormone. This means that CRH indirectly influ-ences the roles of these hormones on reproduction health and devel-opments.40

A brain-gut axis also exists with sev-eral potential avenues of bidirec-tional communication including the cholinergic anti-inflammatory path-way41 and the mucosal mast cells.42 Consistently high levels of psycho-logical stress alter motility and se-cretion (and, therefore, digestive and absorptive capacity) as well as perception of pain in the gastroin-testinal tract, as seen in irritable bowel syndrome,43 as well as con-tribute to the development of hyper-permeability.44 Other diseases share this mucosal distress as an underly-ing etiological factor that could be initiated or perpetuated by persis-tently high psychological stress.45

Finally, because of the documented impact of persistent mental emo-tional stress on the immune system, there is potential for increased infec-tions and immune-related disor-ders.46 For example, continued peri-ods of psychosocial stress, such as that from repetitive overtime work in white collar employees,47 can af-fect the number and ability of natu-ral killer cells to develop and re-spond appropriately.48,49 Natural killer cells play a critical role in our first line of defense against viruses and in the development of neoplas-tic cells (ie, cancer).50 Prolonged pe-riods of elevated glucocorticoids also can influence the secretion of cytokines controlling the T-helper cell type 1/T-helper cell type 2 bal-ance, with a tendency to induce a shift towards a T-helper cell type 2–dominant state.51 This affects the ability to cope with infections and also increases the likelihood of de-veloping disorders associated with atopy, including allergies, asthma, and eczema.

The body’s ability to cope with psy-chosocial stress stemming from un-healthy work environments is large-ly an individual process; therefore, it is difficult to quantify the magnitude and length of exposure needed to provoke a pathological response. Furthermore, there is a well-concep-tualized, but relatively poorly de-fined, concept of a personal thresh-old, at which each of the factors that affect the HPA axis might not be able to have an impact on its own; they only have an impact once they collectively exceed a person’s com-pensatory abilities. This idea of an individual’s personal reserve and the cumulative buildup necessary to produce signs and symptoms is termed the allostatic load.52 There are several different potential objective markers that can be used to indicate whether a person is experiencing chronic stress. These markers in-clude plasma and salivary cortisol levels (in particular, a loss or exag-geration of the normal rhythms), levels of urinary catecholamines, and serum levels of hemoglobin A1C, testosterone, and fibrinogen.53

Medical interventions and lifestyle coping strategies that can minimize the impact of persistently high lev-els of work-related stress can pro-vide a foundation that helps reduce current signs and symptoms of dis-ease and prevent any future devel-opment. Mainstream medical thera-pies include pharmaceutical drugs, such as selective serotonin reuptake inhibitors, manual therapies (eg, massage), and psychotherapeutic ap-proaches, including cognitive-be-havioral interventions, different types of meditation,54 and other forms of therapy from mind-body medicine.55,56 More traditional med-ical approaches include acupunc-ture; different forms of body work; and balneotherapy, such as neutral baths. They also include herbal

medicines with well-documented abilities to reduce the stress re-sponse, including Panax ginseng (Ko-rean ginseng), Passiflora incarnata (passionflower), Eleutherococcus senti-cosus (Siberian ginseng), Glycyrrhiza glabra (licorice), Withania somnifera (Ashwagandha), Rhodiola rosea (rho-diola), Valeriana officinalis (Valerian), Matricaria chamo milla (German chamomile), and nutritional medi-cine, including phosphatidyl serine, magnesium, theanine (from green tea extracts), L-tryptophan, and melatonin.57 Bioregulatory Medi-cine also has some effective and safe medications that can be used as part of a stress management system to provide immediate relief and pre-vent progression into more serious disease. A therapy protocol is shown in the Table.|

References1. Jansson-Fröjmark M, Lundqvist D, Lundqvist

N, Linton SJ. Psychosocial work stressors for insomnia: a prospective study on 50-60-year-old adults in the working population. Int J Behav Med. 2007;14(4):222-228.

2. Kawano Y. Association of job-related stress factors with psychological and somatic symp-toms among Japanese hospital nurses: effect of departmental environment in acute care hospitals. J Occup Health. 2008;50(1):79-85.

3. Sandström A, Peterson J, Sandström E, et al. Cognitive deficits in relation to personal-ity type and hypothalamic-pituitary-adrenal (HPA) axis dysfunction in women with stress-related exhaustion. Scand J Psychol. 2011;52(1):71-82.

4. Taché Y, Brunnhuber S. From Hans Selye’s discovery of biological stress to the identi-fication of corticotropin-releasing factor sig-naling pathways: implication in stress-related functional bowel diseases. Ann N Y Acad Sci. 2008;1148:29-41.

5. Kyrou I, Tsiogos C. Chronic stress, visceral obesity and gonadal dysfunction. Hormones (Athens). 2008;7(4):287-293.

6. Kyrou I, Chrousos GP, Tsigos C. Stress, vis-ceral obesity, and metabolic complications. Ann N Y Acad Sci. 2006;1083:77-110.

7. Brotman DJ, Golden SH, Wittstein IS. The cardiovascular toll of stress. Lancet. 2007;370(9592):1089-1100.

8. Chandola T, Britton A, Brunner E, et al. Work stress and coronary heart disease: what are the mechanisms? Eur Heart J. 2008;29(5):640-648.

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9. Magnavita N, Elovainio M, Heponiemi T, Magnavita AM, Bergamaschi A. Are skin disorders related to work strain in hospi-tal workers? a cross-sectional study [pub-lished online ahead of print July 28, 2011]. BMC Public Health. 2011;11(1):600. doi:10.1186/1471-2458-11-600.

10. Tsigos C, Chrousos GP. Hypothalamic-pi-tuitary-adrenal axis, neuroendocrine factors and stress. J Psychosom Res. 2002;53(4):865-871.

11. El-Helaly M, Awadalla N, Mansour M, El-Biomy Y. Workplace exposures and male in-fertility: a case-control study. Int J Occup Med Environ Health. 2010;23(4):331-338.

12. Selye H. A syndrome produced by diverse nocuous agents: 1936. J Neuropsychiatry Clin Neurosci. 1998;10(2):230-231.

13. Selye H. Forty years of stress research: princi-pal remaining problems and misconceptions. Can Med Assoc J. 1976;115(1): 53-56.

14. Guyton AC, Hall JE. Adrenocortical hor-mones. In: Guyton AC, Hall JE, eds. Textbook of Medical Physiology. 11th ed. Philadelphia, PA: Elsevier; 2006:944-960.

15. Berne RM, Levy MN. Adrenal cortex. In: Berne RM, Levy MN, eds. Principles of Physiology. 3rd ed. St Louis, MO: Mosby; 2000:559-571.

16. Turnbull AV, Rivier CL. Regulation of hypo-thalamic-pituitary-adrenal axis by cytokines: actions and mechanisms of action. Physiol Rev. 1999;79(1):1-71.

17. Dunn AJ. Cytokine activation of the HPA axis. Ann N Y Acad Sci. 2000;917:608-617.

18. McCann SM, Antunes-Rodrigues J, Franci CR, Anselmo-Franci JA, Karanth S, Ret-tori V. Role of the hypothalamic pituitary adrenal axis in the control of the response to stress and infection. Braz J Med Biol Res. 2000;33(10):1121-1131.

19. Berne RM, Levy MN. Adrenal medulla. In: Berne RM, Levy MN, eds. Principles of Physiology. 3rd ed. St Louis, MO: Mosby; 2000:572-578.

20. Stengel A, Taché Y. Neuroendocrine control of the gut during stress: corticotropin-releas-ing factor signaling pathways in the spot-light. Annu Rev Physiol. 2009;71:219-239.

21. Ziemssen T, Kern S. Psychoneuroimmunol-ogy: cross-talk between the immune and nervous systems. J Neurol. 2007;254(suppl 2):II8-II11.

22. Irwin MR. Human psychoneuroimmunol-ogy: 20 years of discovery. Brain Behav Im-mun. 2008;22(2):129-139. doi:10.1016/j.bbi.2007.07.013.

23. Michaud K, Matheson K, Kelly O, Anisman H. Impact of stressors in a natural context on release of cortisol in healthy adult humans: a meta-analysis. Stress. 2008;11(3):177-197.

24. Chida Y, Steptoe A. Cortisol awakening re-sponse and psychosocial factors: a system-atic review and meta-analysis. Biol Psychol. 2009;80(3):265-278. doi:10.1016/j.bio-psycho.2008.10.004.

25. Sarabdjitsingh RA, Conway-Campbell BL, Leggett JD, et al. Stress responsiveness varies over the ultradian glucocorticoid cycle in a brain-region-specific manner. Endocrinology. 2010;151(11):5369-5379. doi:10.1210/en.2010-0832.

26. McMaster A, Jangani M, Sommer P, et al. Ul-tradian cortisol pulsatility encodes a distinct, biologically important signal. PLoS One. 2011;6(1):e15766.

27. Son GH, Chung S, Kim K. The adrenal pe-ripheral clock: glucocorticoid and the circa-dian timing system. Front Neuroendocrinol. 2011;32(4):451-465.

28. Boyce P, Barriball E. Circadian rhythms and depression. Aust Fam Physician. 2010;39(5):307-310.

29. Lange T, Dimitrov S, Born J. Effects of sleep and circadian rhythm on the human immune system. Ann N Y Acad Sci. 2010;1193:48-59.

30. Davis S, Mirick DK. Circadian disruption, shift work and the risk of cancer: a summary of the evidence and studies in Seattle. Cancer Causes Control. 2006;17(4):539-545.

31. Cutolo M, Villaggio B, Otsa K, Aakre O, Sulli A, Seriolo B. Altered circadian rhythms in rheumatoid arthritis patients play a role in the disease’s symptoms. Autoimmun Rev. 2005;4(8):497-502.

32. Davis S, Mirick DK, Stevens RG. Night shift work, light at night, and risk of breast cancer. J Natl Cancer Inst. 2001;93(20):1557-1562.

33. Taverniers J, Van Ruysseveldt J, Smeets T, von Grumbkow J. High-intensity stress elicits robust cortisol increases, and impairs work-ing memory and visuo-spatial declarative memory in Special Forces candidates: a field experiment. Stress. 2010;13(4):323-333.

34. Kirschbaum C, Wolf OT, May M, Wippich W, Hellhammer DH. Stress- and treatment-induced elevations of cortisol levels associ-ated with impaired declarative memory in healthy adults. Life Sci. 1996;58(17):1475-1483.

35. Oei NY, Everaerd WT, Elzinga BM, van Well S, Bermond B. Psychosocial stress impairs working memory at high loads: an associa-tion with cortisol levels and memory retriev-al. Stress. 2006;9(3):133-141.

36. Lupien SJ, Maheu F, Tu M, Fiocco A, Schra-mek TE. The effects of stress and stress hor-mones on human cognition: implications for the field of brain and cognition. Brain Cogn. 2007;65(3):209-237.

37. Viau V. Functional cross-talk between the hypothalamic-pituitary-gonadal and -adrenal axes. J Neuroendocrinol. 2002;14(6):506-513.

38. Cumming DC, Quigley ME, Yen SS. Acute suppression of circulating testosterone levels by cortisol in men. J Clin Endocrinol Metab. 1983;57(3):671-673.

39. Rubinow DR, Roca CA, Schmidt PJ, et al. Testosterone suppression of CRH-stimulated cortisol in men. Neuropsychopharmacology. 2005;30(10):1906-1912.

40. Tsigos C, Chrousos GP. Hypothalamic-pi-tuitary-adrenal axis, neuroendocrine factors and stress. J Psychosom Res. 2002;53(4):865-871.

41. Tracey KJ. Physiology and immunology of the cholinergic antiinflammatory pathway. J Clin Invest. 2007;117(2):289-296.

42. Farhadi A, Fields JZ, Keshavarzian A. Mu-cosal mast cells are pivotal elements in inflammatory bowel disease that connect the dots: stress, intestinal hyperpermeabil-ity and inflammation. World J Gastroenterol. 2007;13(22):3027-3030.

43. Katiraei P, Bultron G. Need for a comprehen-sive medical approach to the neuro-immuno- gastroenterology of irritable bowel syndrome. World J Gastroenterol. 2011;17(23):2791-2800.

44. Lambert GP. Stress-induced gastrointestinal barrier dysfunction and its inflammatory ef-fects. J Anim Sci. 2009;87(14)(suppl):E101-E108.

45. Lescheid DW. Intestinal permeability and its role in disease. J Biomed Ther. 2009;3(2):4-11.

46. Calcagni E, Elenkov I. Stress system activity, innate and T helper cytokines, and suscep-tibility to immune-related diseases. Ann N Y Acad Sci. 2006;1069:62-76.

47. Nakata A, Takahashi M, Irie M. Associa-tion of overtime work with cellular immune markers among healthy daytime white-collar employees [published online ahead of print July 16, 2011]. Scand J Work Environ Health. 2011;pii:3183. doi:10.5271/sjweh.3183.

48. Boscolo P, Di Gioacchino M, Reale M, Mu-raro R, Di Giampaolo L. Work stress and innate immune response. Int J Immunopathol Pharmacol. 2011;24(suppl 1):51S-54S.

49. Boscolo P, Di Donato A, Di Giampaolo L, et al. Blood natural killer activity is reduced in men with occupational stress and job insecu-rity working in a university. Int Arch Occup Environ Health. 2009;82(6):787-794.

50. Roitt I, Brostoff J, Male D. Cells of the in-nate immune system. In: Roitt I, Brostoff J, Male D, eds. Immunology. 6th ed. London, England: Harcourt; 2001:21-22.

51. Elenkov IJ. Glucocorticoids and the Th1/Th2 balance. Ann N Y Acad Sci. 2004;1024:138-146.

52. Stewart JA. The detrimental effects of allosta-sis: allostatic load as a measure of cumulative stress. J Physiol Anthropol. 2006;25(1):133-145.

53. Hansen AM, Larsen AD, Rugulies R, Garde AH, Knudsen LE. A review of the effect of the psychosocial working environment on physi-ological changes in blood and urine. Basic Clin Pharmacol Toxicol. 2009;105(2):73-83. doi:10.1111/j.1742-7843.2009.00444.x

54. Manocha R, Black D, Sarris J, Stough C. A randomized, controlled trial of meditation for work stress, anxiety and depressed mood in full-time workers. Evid Based Comple-ment Alternat Med. 2011;2011:960583. doi:10.1155/2011/960583

55. van der Klink JJ, Blonk RW, Schene AH, van Dijk FJ. The benefits of interventions for work-related stress. Am J Public Health. 2001;91(2):270-276.

56. Ruotsalainen J, Serra C, Marine A, Ver-beek J. Systematic review of interventions for reducing occupational stress in health care workers. Scand J Work Environ Health. 2008;34(3):169-178.

57. Head KA, Kelly GS. Nutrients and botanicals for treatment of stress: adrenal fatigue, neu-rotransmitter imbalance, anxiety, and restless sleep. Alt Med Rev. 2009;14(2):114-140.

) 20


Bioregulatory Management of “Mouse Arm” By Natalie C. Tsolakis, MDipH, MTechC


The proliferation of computers in the workplace has also coincid-

ed with an increase in the number of people reporting work-related mus-culoskeletal disorders (WMSDs) in the neck and upper limb.4,5 After receiving relatively minimal attention throughout the first half of the 20th century, WMSDs have be-come one of the main focuses in the area of occupational disease preven-tion, in particular forearm or upper limb WMSDs.5 Conditions such as finger extensor and flexor tendon-itis, carpal tunnel syndrome, and neck-shoulder myofascial pain ac-count for more than 60% of the re-ported occupational illnesses in the United States4 and 45% in Europe.5 They are also the most commonly self-reported work-related illnesses in the United Kingdom, with upper limb disorders being the second highest.6 Women are generally more affected than men in all countries.4,7 In addition to the direct financial costs of medical treatment, loss of workdays, and retraining new em-

ployees, the indirect costs include high absenteeism, high turnover of staff, poor quality of work, and low employee morale.6

Forearm pain or upper limb WMSDs have been the subject of controversy, in terms of the risks connected with exposure to the repetitive motions of computer use and the clinical ter-minology and diagnostic criteria commonly used.8 Recent studies9 conclude that there is a moderate, but consistent, association between computer use and hand/arm symp-toms. Some symptoms may be con-sistent with specific clinical diagno-ses (eg, carpal tunnel syndrome, lateral epicondylitis, or De Quervain syndrome) and are type I work-re-lated upper limb disorders; however, in 50% of reported cases, the symp-toms are nonspecific (eg, myalgia).9 This group of specific and nonspe-cific symptoms is placed under a va-riety of labels, including repetitive strain injury, cumulative trauma dis-order, work-related upper extremity disorder, and type II work-related

upper limb disorders; these symp-toms may simply be referred to as mouse arm.3,8-10

Current hypotheses ascribe the symptoms of type II work-related upper limb disorders or mouse arm to muscle/tendon/soft tissue dam-age, neurogenic disorders, or psy-chogenic causes presumed to arise from biomechanical and/or psycho-social stressors.8-10 Although the ex-act etiology and pathophysiology are not completely understood, it is clear that the use of a computer re-quires interaction between the user and the keyboard and/or other in-put devices and a monitor, which all involve awkward postures, high rep-etition, static load, forceful exer-tions, and localized contact stress.2,5 In people whose working time with computers exceeds 6 hours per day, there is a strong association with neck and upper limb disorders. However, the elbow, arm, or wrist/hand disorders of frequent mouse users are only moderately greater than those of computer users who worked without computer mice.11 The “nonoptimal position” of the mouse (ie, not within the span of the shoulders and away from the mid-line of the body) results in mouse users working with the arm unsup-ported, the shoulder abducted and externally rotated, and the arm in forward flexion.2,10-12 The repetitive motion of typing and dragging the mouse may overload the neck, shoulder, arm, hand muscles, and

Computer use has progressed extremely rapidly in recent

years, both on the work front and in the home.1,2 It has been

estimated that two-thirds of employees in industrialized

countries use a computer on a daily basis and that 1 of

5 uses a computer at least three-quarters of the total work

time.3

) 21



Table. Bioregulatory Treatment for Mouse Arm

DET-Phase Basic and/or Symptomatic Regulation Therapya Optional

Mesodermal MusculodermalInflammation

• Traumeel (this is suitable for symptomatic treatment and immunomodulation)

D&D • Basic detoxification and drainage: Detox-Kitb

• Neurexan (or Nervoheel) (for nervous restlessness and sleep disturbances)

• Rhododendroneel (location on the forearm, especially with sensitivity to weather changes)

• Cimicifuga-Homaccord (resistant to well-indicated therapy)

• Spascupreel (for muscle spasms)

IM • Traumeel

CTOS • Coenzyme compositum* • Ubichinon compositum*

Notes: Specific clinical diagnoses (eg, carpal tunnel syndrome, lateral epicondylitis, or De Quervain syndrome) must be excluded with the relevant physical examination (eg, joint range of motion, muscle weakness, or pain areas), orthopedic tests (eg, Phalen or Finkelstein test), neurological examination (eg, Tinel sign), and appropriate investigations (eg, electromyography or ultrasonography).1

Dosages: Basic therapy: Traumeel, 10 drops or 1 tablet 3 times per day or 1 ampoule injected into localized pain points 1 to 3 times per week. In acute conditions, the dosage can be increased up to 30 drops 3 times per day or 1 ampoule per day. Traumeel cream can also be liber-ally applied to the affected area 3 to 4 times per day. Regulation therapy: tablets, 1 tablet 3 times per day; drops, 10 drops 3 times per day; ampoules, 1 ampoule of each medication, 1 to 3 times per week. Detox-Kit, 30 drops of each medication in 1.5 L of water (drink throughout the day). Optional therapy: For nervousness and sleep disturbances, prescribe Neurexan, 1 tablet or 10 drops 3 times per day. For location on the forearm, especially with sensitivity to weather changes, prescribe Rhododendroneel. Begin with an initial massive dose of 10 drops every 15 minutes to a maximum of 8 doses and then reduce to 10 drops 2 to 4 times per day. In cases that are resistant to well-indicated therapies, prescribe Cimicifuga-Homaccord. In acute disorders, prescribe 10 drops every 15 minutes for 2 hours or 1 ampoule per day. In general, prescribe 10 drops 3 times per day or 1 ampoule 1 to 3 times per week. For muscle spasms and pain, prescribe Spascupreel. In acute disorders, begin with an initial massive dose of 1 tablet every 15 minutes for a maximum of 8 doses or 1 ampoule per day. In general, pre-scribe 1 tablet 3 times per day or 1 ampoule 1 to 3 times per week. Suppositories: In acute conditions, prescribe 1 suppository every hour. In general, prescribe 1 suppository 2 to 3 times per day.

Abbreviations: CTOS, cellular, tissue, and organ support; D&D, detoxification and drainage; DET, Disease Evolution Table; IM, immunomodulation. a Antihomotoxic regulation therapy consists of a 3-pillar approach: D&D, IM, and CTOS.b The Detox-Kit consists of Lymphomyosot, Nux vomica-Homaccord, and Berberis-Homaccord.

joints, resulting in cumulative trau-ma (ie, the muscles and soft tissues of the forearm become irritated and swollen, together with the sur-rounding tendons, resulting in pain-ful tendonitis).1,3 These structures may then compress nearby nerves, causing ischemic neurophysiologi-cal changes. Progressive reduction in nerve conduction then leads to transient increases in the sensation, numbness, and tingling, which are then followed by weakness and, in advanced cases, diminished coordi-

nation, loss of strength, and hand/wrist pain.1,3

Because there is no consensus on appropriate selection of physical tests, diagnosis can be delayed, un-fortunately leading to the mouse arm also becoming a chronic condi-tion. This is then further complicat-ed by the fact that somatization (ie, the physical representation of psy-chological disorders) may act as a possible confounder or effect modi-fier in this condition.3,8,10

Treatment has been reported to be somewhat unfocused and unsatisfac-tory, with hospital admission rarely needed and physiotherapy giving dubious benefit.1,10,13 Initial manage-ment and prevention are based on modification of ergonomics (eg, al-ternative keyboard supports, mouse and tool redesign, adequate seat-ing, and correction of work surface heights), with appropriate periods of rest and job rotation.1,2,6,14 Keep-ing hands warm, performing fre-quent upper limb and neck stretches

* In Canada, Ubicoenzyme may be substituted.

) 22



and exercises, maintaining a neutral wrist position, paying attention to whole body posture, and even al-ternating activity between the pre-ferred and nonpreferred hands have reduced the load on the preferred upper limb.6 The ergonomic edu-cation/intervention must be com-bined with medical treatment (ie, oral nonsteroidal anti-inflammatory drugs and corticosteroid injections into the target area).14 Vitamin B6, acupuncture, and massage are also reported as treatment options, as is attending to any environmental, socio cultural, and psychological fac-tors that play a role in this disorder.1 It is evident that patients with mouse arm will have a unique clinical pic-ture that can be challenging to treat. Combining the ergonomic changes, together with patient education, various strapping techniques (eg, ki-nesio and/or rigid types), and the use of bioregulating medicines in oral, cream/gel, and injection forms, can make treating this condition more manageable and yield greater success rates. Patient compliance in making the necessary ergonomic changes is vital to the successful management of this condition. In combination with the other treat-ment modalities, a simple mouse arm trauma induced by improper working conditions can take be-tween 2 and 12 weeks to resolve. A bioregulatory protocol for the treatment of mouse arm is shown in the Table.|

References1. Ming Z, Zaproudina N. Computer use relat-

ed upper limb musculoskeletal (ComRULM) disorders. Pathophysiology. 2003;9(3):155-160.

2. Cook C, Burgess-Limerick R, Papalia S. The effect of wrist rests and forearm support dur-ing keyboard and mouse use. Int J Ind Ergon. 2004;33(5):463-472.

3. Jepsen JR, Thomsen G. A cross-sectional study of the relation between symptoms and physical findings in computer operators. BMC Neurol. 2006;6:40. doi:10.1186/1471-2377-6-40.

4. Karlqvist L, Bernmark E, Ekenvall L, Hag-berg M, Isaksson A, Rostö T. Computer mouse and track-ball operation: similari-ties and differences in posture, muscular load and perceived exertion. Int J Ind Ergon. 1999;23(3):157-169.

5. Colombini D, Occhipinti E. Preventing up-per limb work-related musculoskeletal disor-ders (UL-WMSDS): new approaches in job (re)design and current trends in standardiza-tion. Appl Ergon. 2006;37(4):441-450.

6. Ackland T, Hendrie G. Training the non-preferred hand for fine motor control us-ing a computer mouse. Int J Ind Ergon. 2004;35(2):149-155.

7. Won EJ, Johnson PW, Punnett L, Dennerlein JT. Upper extremity biomechanics in com-puter tasks differ by gender. J Electromyogr Kinesiol. 2009;19(3):428-436.

8. Kryger AI, Andersen JH, Lassen CF, et al. Does computer use pose an occupational hazard for forearm pain; from the NUDATA study. Occup Environ Med. 2003;60(11):e14. doi:10.1136/oem.60.11.e14.

9. Burgess RA, Thompson RT, Rollman GB. The effect of forearm posture on wrist flex-ion in computer workers with chronic up-per extremity musculoskeletal disorders. BMC Musculoskelet Disord. 2008;9:47. doi:10.1186/1471-2474-9-47.

10. Povlsen B, Rose RL. Managing type II work-related upper limb disorders in keyboard and mouse users who remain at work: a case se-ries report. J Hand Ther. 2008;21(1):69-79.

11. Chen HM, Leung CT. The effect on forearm and shoulder muscle activity in using dif-ferent slanted computer mice. Clin Biomech (Bristol, Avon). 2007;22(5):518-523.

12. Cook C, Burgess-Limerick R, Chang S. The prevalence of neck and upper extremity mus-

culoskeletal symptoms in computer mouse users. Int J Ind Ergon. 2000;26(3):347-356.

13. MacIver H, Smyth G, Bird HA. Occupational disorders: non-specific forearm pain. Best Pract Res Clin Rheumatol. 2007;21(2):349-365.

14. Bleecker ML, Celio MA, Barnes SK. A med-ical-ergonomic program for symptomatic keyboard/mouse users. J Occup Environ Med. 2011;53(5):562-568.

The term mouse arm describes a type of repetitive strain injury that occurs in frequent computer users. ©

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) 23


) A r o u n d t h e G l o b e

iMosaic Integrative Medicine Conference Minneapolis, MN, April 6 to 10, 2011 By David W. Lescheid, PhD, ND

One of the premier events in inte-grative medicine conferences in

North America in 2011 was the Inte-grative Medicine Offering Science-Based Alternatives in Collaboration (iMosaic) conference held in Minne-apolis, Minnesota, from April 6 to 10. For the first time, 4 different not-for-profit national integrative medicine organizations collaborated together to design, develop, and deliver a confer-ence.The participating organizations are an integral part of the integrative medi-cal consortium and included the American Academy of Environmental Medicine, the American College for the Advancement of Medicine, the American Holistic Medicine Associa-tion, and the International College of Integrative Medicine. The main target audience was physicians and special-ists, but there also were naturopathic physicians, nurse practitioners, chiro-practors, and pharmacists in atten-dance. Approximately 450 to 500 physicians were enrolled in the 3-day conference. Further details can be viewed at the conference Web site (http://www.imosaicconference.com/).The initial 2 days consisted of differ-ent workshops for physicians to learn scientific supporting material and practical tips for their practice. There were multiple unique choices avail-able, including “The Diagnosis and Treatment of Inhalant Allergies,” “Ad-vanced Heavy Metal Toxicology for

the Experienced Physician,” “Chela-tion Therapy Training Course,” “Pedi-atric and Women’s Environmental Medicine,” “The New Endocrinolo-gy,” and “A New Way to Look at Your Practice: Environmental Medicine, Nutrition and Nutritional IV Thera-py,” and workshops on “The Diagno-sis and Treatment of Chemical Sensi-tivities.” These workshops, delivered primarily by physicians, provided a good foundation of scientific knowl-edge for the participants.The main conference was structured with 3 different keynote speakers de-livering 1.5- to 1-hour general ses-sions in the morning and early after-noon and then a series of up to 18 different 1- to 2-hour breakout ses-sions in the late afternoon and early evening. The overall content of the general sessions was diverse and enti-tled “A 360° Look at Current Topics in Integrative Medicine: Educating Physicians to Provide Patients With New Choices and New Hope.” Many of the keynote speakers were exem-plary leaders in integrative medicine, including Alan Gaby, MD; Jim Rob-erts, MD; Tieraona Low Dog, MD; Russell Jaffee, MD; Kenneth Bock, MD; Joseph Brewer, MD; Greg Plot-nikoff, MD; Robert Hedaya, MD; and Michael Murray, ND. Overall, the speakers of the general sessions were excellent and the material delivered was cutting edge, practical, and in alignment with current scientific knowledge. Speakers from the numer-

ous breakout sessions delivered infor-mation ranging from legal, regulatory, and insurance issues to genetic poly-morphisms associated with individual differences in detoxification pathways in the liver. Most of these seminars were well presented, with current sci-entific knowledge from mainstream medical literature supporting alterna-tive medical approaches. Along with the considerable scientific proof pre-sented, there also were many practical clinical pearls that could immediately be implemented in clinical practice to improve patient outcomes.Bioregulatory Medicine was repre-sented at this conference with a “sun-set launch party” of the American So-ciety of Bioregulatory Medicine that included a short introductory lecture by David Riley, MD. Overall, the level of knowledge trans-fer from the chosen speakers and the level of interest by the attendees in the iMosaic conference was high, and there was some discussion of planning another collaborative conference sim-ilar to this one in 2012. The 2011 iMosaic conference definitely deliv-ered its goal of providing a platform for integrative medical physicians to get together to learn about common issues and provide synergy; if this conference continues, it will soon be-come one of the premier educational and collaborative events in North America for integrative medical prac-titioners.|

) 24


) Re f r e s h Yo u r H o m o t ox i c o l o g y

Repetitive Strain Injury as a Model of Inflammation By Konstantin Cesnulevicius, MD, PhD

Introduction

Bioregulatory Medicine is an innova-tive approach to disease management, including conditions with immuno-logical and inflammatory pathophysi-ological features, such as work-related musculoskeletal disorders or repetitive strain injuries (RSIs).1 Repetitive strain injuries affect muscles, tendons, nerves, and other connective tissues, including lymphatic and blood ves-sels. They develop over time, and the physical symptoms (eg, pain, discom-fort, numbness, and tingling) may lin-ger.2 The effects of RSIs may influence work, leisure activities, and sleep. Fi-nally, mental health may be affected, including the possibility of major de-pression. Therefore, it is important to explore all possible treatments to al-leviate the potential lasting impact of RSIs. Although treatment of RSIs with con-ventional medications and even sur-gery can be successful, the Bioregula-tory Medicine approach includes the use of agents with bioregulating prop-erties. Traumeel (Biologische Heilmit-tel Heel GmbH, Baden-Baden, Ger-many) is the most well-known such medication for the treatment of RSIs. The benefits of its 14 natural ingredi-ents include the following: immuno-modulation, modulation of inflamma-tion, antioxidant support, regulation of pain responses, healing, protection of mucosa, control of proliferation, and support of tissue remodeling pro-cesses. It also has antibacterial, antivi-ral, antihemorrhagic, and spasmolytic effects.1

Prevalence, Incidence, and Importance of Studying RSIs

Previous research has indicated that RSIs may develop from and influence a broad range of occupations/activi-ties. Articles have focused on “ultraso-nographers, equestrian athletes, ballet dancers, bicyclists, baseball players, swimmers, triathletes, golfers, bull rid-ers, martial artists, sign language in-terpreters, skeletally immature pa-tients, college students, heavy computer users, assembly line work-ers, tailors (seamstresses), surgeons, dentists, and nurses.”3 Individuals with RSIs may experience chronic pain and discomfort, along with psychological distress.2,4 In most, if not all, cases, RSIs do not lead to mortality. However, they can lead to significant morbidity.3

Repetitive strain injuries can affect the following body areas: neck/shoulder, elbow/lower arm, wrist/hand, back, knee/lower leg, and ankle/foot. The specifically diagnosed conditions that result from RSIs include carpal tunnel syndrome, cubital tunnel syndrome, tendinitis, tenosynovitis, epicondyli-tis, rotator cuff tendinitis, ulnar nerve entrapment, and hand-arm vibration syndrome.2,5 According to recent research, the inci-dence of RSIs may be “nearly impos-sible to estimate.”3 However, the an-nual incidence of upper extremity disorders in the United States has been estimated as between 4.5% and 12.7%.3 A different article indicated that the incidence of RSIs in Canadi-ans was approximately 10%.2 The fac-

tors that may be involved in the inci-dence of RSIs include sex and age. Persons aged 40 to 49 years have been implicated as the individuals who are most affected by RSIs. In women, obesity has been related to RSIs. Comorbidities associated with RSIs include arthritis or rheumatism (in both men and women) and thyroid conditions (in women only). Both workplace stress and daily life stress have also been associated with RSIs.2,3

The causes of RSIs include the fol-lowing: (1) repetitive activity, such that individuals are challenged and do not have sufficient time to recover; (2) malpositioning; (3) lifting; (4) push-ing or pulling; and (5) vibration.3,4 Research3 indicates that the most im-portant factor leading to these types of injuries is the repetitive activity, al-though the specific type of force leads to different outcomes. The causes of RSIs are most often as-sociated with the workplace (>50%); they are secondarily associated with sports or physical exercise (15%-20%). Finally, they can be associated with chores/unpaid work/education (15%-20%) and leisure activities/hobbies (<10%).2 Individuals affected by RSIs tend to have more frequent visits to general practitioners, chiropractors, and phys-iotherapists.2

Current Pathophysiological Model for RSIs

The pathophysiological model for RSIs includes tissue injury, acute in-flammation, and tissue reorganization

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) Re f r e s h Yo u r H o m o t ox i c o l o g y

as the potential major mechanisms in-volved.1 In this article, modulation of the acute inflammatory part of this pathophysiological model by Trau-meel is discussed. There are other products wth bioregulating properties that could potentially be used to treat the other contributing components. Scientific data indicate that Traumeel may be a beneficial addition when caring for patients with RSIs. Trau-meel “modulates inflammatory path-ways by downregulating proinflam-matory cytokines and upregulating antiinflammatory cytokines, reducing edema, promoting phagocytosis, and improving wound healing.”1 Traumeel influences tissue remodeling by affect-ing cells that produce extracellular matrix and inhibiting metalloprotein-ases.1 The specific role of Traumeel for RSIs and other conditions is still be-ing studied. Its potential has not been completely elucidated.

Role of Integrative Medicine in Treating RSIs

Initially, RSIs may be treated with watchful waiting or conservative ther-apy, such as rest (ie, avoidance of as-sociated activity), ice on the affected area, and immobilization of the af-fected area.5 Certain types of exercise may also be beneficial. If these conservative treatments are not effective, medications may be ad-ministered. The current treatments for RSIs include steroids and nonsteroi-dal anti-inflammatory drugs. Howev-er, one potential alternative medica-tion for treating RSIs is Traumeel. Traumeel has bioregulating properties and may be used to successfully treat RSIs. Because of the multicomponent nature of its composition, Traumeel has been shown to have multitargeted action, downregulating potentially damaging components of the inflam-matory cascade in addition to upregu-lating components that help to modu-late the intensity of the response.

Furthermore, Traumeel also has the potential to relieve pain, support physiological tissue remodeling, regu-late the vascular response, and act as an antimicrobial agent, if necessary.1 The commonly prescribed conven-tional medical agents (ie, steroids and nonsteroidal anti-inflammatory drugs) are “directed toward suppression of proinflammatory players.”1 In con-trast, medications with bioregulating properties, such as Traumeel, are “aimed at the modulation of both pro-inflammatory and antiinflammatory pathways vs suppression.”1 Traumeel’s natural ingredients act synergistically to modulate inflammation. Preclinical research using human cells and cell lines has proven Traumeel’s anti-in-flammatory properties.1

Other medications that individuals may take for RSIs include muscle re-laxants, opiates, tricyclic antidepres-sants, and sleep medications.3 Finally, surgery remains an option for the treatment of RSIs.The fact is that RSIs should be ad-dressed as soon as possible to avoid long-term physical and mental symp-toms. In addition to conventional and alternative medications, prevention may be a way to help alleviate RSIs. Because RSIs are so often associated with the workplace, employers may benefit from implementing preventa-tive techniques.5 These techniques may help decrease the potential lost productivity and increased medical expenses and disability payments as-sociated with RSIs.5 However, to im-plement prevention, employers must determine the work-related risk fac-tors and make the correct modifica-tions.5 Overall, job modifications may be advantageous for both employers and employees.

Conclusions

The continued and expanded use of medications with bioregulating prop-erties has led to improvements in pa-

tient outcomes. The field of Bioregu-latory Medicine stresses the importance of using complex medica-tions to target multiple components of networks of disease simultaneously and, therefore, increase the ability to provide complete and effective resolu-tion. Furthermore, the use of complex medications in highly diluted concen-trations has been shown to be effec-tive and has a high margin of safety in all population groups. These types of medications are widely used in Eu-rope, South and Latin America, and many other parts of the world. They assist with regulating the body’s own immune system so that the body is more likely to heal efficiently and completely.One of the most studied and charac-terized medications in Bioregulatory Medicine is Traumeel. Traumeel is ef-fective in RSIs specifically because of its anti-inflammatory effects. For indi-viduals with potentially long-term symptoms, such as those with RSIs, new treatment strategies offer an op-portunity for even better results. Further research on medications with bioregulating properties, especially Traumeel, should verify the existing evidence and expand on the potential mechanisms in disorders such as RSIs.|

References 1. Cesnulevicius K. The bioregulatory ap-

proach to work-related musculoskeletal disorders: using the multicomponent ultra low-dose medication Traumeel to target the multiple pathophysiological processes of the disease. Altern Ther Health Med. 2011;17 (2 Suppl):S8-S17.

2. Tjepkema M. Repetitive strain injury. Health Rep. 2003;14(4):11-30.

3. Laker SR, Sullivan WJ, Strum S. Over-use injury. eMedicine Web site. http://emedicine.medscape.com/article/313121-overview#a0104. Updated March 12, 2008. Accessed November 3, 2011.

4. Shanahan EM, Jezukaitis P. Work related upper limb disorders. Aust Fam Physician. 2006;35(12):946-950.

5. Rempel DM, Harrison RJ, Barnhart S. Work-related cumulative trauma disorders of the upper extremity. JAMA. 1992;267(6):838-842.

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Clinical trials are experiments in which the efficacy and safety

of a treatment are investigated. The term clinical trial is subject to a wide variation of use; the main types will be further clarified in this article.

Phases of Clinical TrialsFour phases of clinical trials are dis-tinguished1:• PhaseItrial:Firsttestingofsub-

stances on healthy volunteers.Phase I trials of conventional medicine primarily focus on ob-taining safety and pharmacolog-ical data. Therefore, a homeo-pathic drug proving (also called a homeopathic pathogenetic trial)is similar, but not completely identical, to a phase I trial.

• PhaseIItrial:Initialtrialstoex-amine efficacy. Usually, subjects are allocated at random to study and control groups.

• PhaseIIItrial:Largertrialswithplacebo and/or active treatment control for complete and con-firmative assessment of efficacy and safety.

• Phase IV trial: Conducted afterthe regulatory authority has ap-proved registration. In conven-tional medicine, a common aim is to estimate the occurrence of rare adverse events and other po-tential effects of actual use in clinical practice as part of post-marketing surveillance.

The previously described distinction in phases was primarily developed as a regulatory framework for con-ventional drug development; there-fore, although there are many simi-larities, this phasing cannot always be transferred on a 1-to-1 basis to research on homeopathic and/or bioregulating medications. Theoret-ically, all clinical trials on homeo-pathic medications that are already registered are to be considered phase IV trials; therefore, this would render the previous distinction in phases irrelevant for application in homeopathy. However, in practice, the specific regulatory context for homeopathic medications is ignored and reference is made to these phases.

From a methodological point of view, the term clinical trial does not always imply the presence of a con-trol group. For instance, it is possible to set up a phase II clinical trial without a control group. The key distinguishing feature compared with observational research designs is that, in a clinical trial, the inter-vention is manipulated (eg, a specif-ic dose of a specific medication in a specific patient population) with a view to assessing efficacy and safety.

Pragmatic vs Explanatory Clinical TrialAnother useful distinction is that between a pragmatic and an explan-atory clinical trial. An explanatory trial is primarily aimed at isolating the effects of an intervention from the other determi-nants of outcome (assessing efficacy). Therefore, these trials are usually conducted in highly preselected, as homogeneous as possible, patient populations. A pragmatic trial is a study aimed at investigating how an intervention can improve the health status of a specified population, with a view to inform decision making (assessing effectiveness). Therefore, these trials are usually conducted in more heterogeneous patient popula-tions that are representative of those seen in routine clinical practice. In-forming decision making can also include the (health) economic per-spective.

Clinical Trials: An Overview By Robbert van Haselen, MSc

) E x p a n d Yo u r Re s e a r c h K n o w l e d g e

In the previous article in this series, an overview of the

most important clinical research designs was provided.

Given the importance of clinical trials in evidence-based

medicine, I will elaborate a bit further on the different

types of clinical trials.

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Proof-of-Concept vs Confirmatory TrialA further distinction can be made between proof-of-concept and con-firmatory trials. Proof-of-concept trials are also more loosely referred to as pilot trials. Their main objec-tive is the generation and selection of the most promising hypotheses to be investigated further in confirma-tory trials. Pilot trials are important from the point of view of signal de-tection and from a practical point of view: confirmatory trials will require many subjects and are expensive. Pi-lot trials can be a cost-efficient way to increase the likelihood of success in confirmatory trials. However, care should be taken when conducting small pilot trials. The lower the number of subjects, the greater the likelihood that a false-positive sig-nal is generated simply because of chance. There are no fixed rules on what is a suitable number of subjects in pilot trials because this will de-pend on the expected effect size. As a rough guide, any trial with up to 100 subjects will usually be a proof-of-concept trial. Confirmatory trials are designed to confirm the pres-ence of an effect on a predefined main outcome of interest and are subject to strict predefined rules on the statistical assessment; in proof-of-concept trials, the primary objec-tive is not always to reach statistical significance because the effect sizes are not yet known.

Unit of AnalysisA lesser-known distinction is that based on the unit of analysis in clin-ical trials. The most common situa-tion is that individual patients are the unit of analysis. Average effects are then compared between groups (parallel-group clinical trials) or within groups of patients (crossover clinical trials). In cluster-random-ized trials, a group of individuals is randomized to receive the same treatment together. An example is when children in some schools are given one vaccine and those in other schools are given another vaccine, and the protection offered is com-pared. In this case, the unit of analy-sis is a group (cluster) of individuals (in the previously mentioned exam-ple, the school would be the unit of analysis).2 Cluster-randomized trials are less common, and a more de-tailed discussion is outside the scope of this article. A third option is a so-called N-of-1 trial. This is effective-ly a controlled trial in a single indi-vidual. The most common design is that a single patient receives the study drug or placebo during a study period in which multiple treatment crossovers occur in a ran-domized and double-blind manner. This design is mainly feasible to as-sess treatments with short-term ef-fects that wear off quickly (to pre-vent “carryover” effects of one treatment period into the next), and this is not often the case in home-

opathy. The main types of categori-zations for clinical trials are summa-rized in the Table. The Appendix includes a glossary of terms com-monly used in connection with clin-ical trials.

Further ConsiderationsGiven the wide variety in types of clinical trials previously outlined, possibilities and limitations should primarily be considered and dis-cussed per type of clinical trial. This article, therefore, will be limited to a few general comments. Clinical tri-als are powerful methods for assess-ing cause-and-effect relationships. Historically speaking, the first re-corded clinical trial was conducted in 1747 by a ship’s physician, James Lind, MD, who allocated sailors with scurvy into 3 treatment groups and discovered that those who re-ceived citrus fruits were cured. After World War II, randomized con-trolled trials (RCTs) obtained their current dominance in evidence-based medicine. The James Lind li-brary (http://www.jameslindlibrary.org) provides an extensive overview of the historical development of tests of treatments in medical care. This library also contains references to some of the first proving experi-ments conducted by homeopathic practitioners in the 19th century. For further reading on the topic of clinical trials, the book by Pocock5 is useful.

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Although the enormous contri-butions made by clinical trials to medicine are beyond dispute, there are also some evident limitations. A well-known limitation is that clini-cal trials are not, or are less, suitable to identify less common or rare ad-verse effects. Randomized trials may also prove to be unnecessary, inap-propriate, impossible, or inadequate in several cases.6,7 In general, RCTs have been described as “the best way to assess whether an interven-tion works, but […] arguably the worst way to assess who will ben-efit from it.”8 This generally means that they can only be a potentially effective method of measuring treatment effect on a well-defined study group. Any other use is, in fact, an off- or extended-label use. Randomized controlled trials es-sentially compare average treatment effects across groups, meaning that although some patients will have benefited, others have not respond-ed at all. Therefore, clinical trials, even those with positive results, effectively mask that several indi-vidual patients have not responded to therapy. The calculation of a mea-sure such as the number needed to treat (NNT) in placebo-controlled

trials can provide some indication of the response rate (a high NNT would suggest a relatively high nonresponse rate); this can even be adapted to individual patients,9 but the application and interpretation of such individualized measures remains relatively complex and is not always feasible. Within the con-text of an increasingly reductionist conventional medicine in the 20th century, the issue of nonresponse in clinical trials has long been neglect-ed. Only in recent years, because of advances in genomic technologies, systems biology and systems phar-macology are experiencing a revival and have given a major boost to the concept of a more individualized medicine.10 On the other side of the same spectrum, there is a revival of interest in clinical case reporting that is among others reflected in the emergence of a “cases network” and some new journals dedicated to case re porting (http://casereports.bjm.com). Thus, although RCTs are still dominant and systematic reviews of RCTs are at the top of a hierarchy of evidence, there is an increasing movement into the direc-tion of a nonhierarchical research framework, in which clinical trials

and other methods contribute sub-stantially to the totality of evidence required for optimum patient-cen-tered medicine. These trends fit well with the overall approach in home-opathy and Bioregulatory Medicine; therefore, many opportunities lie ahead in this respect.|

References1. Porta M, Last JM, eds. A Dictionary of Epide-

miology. Oxford, England: Oxford University Press; 2008.

2. Li-Wan-Po A. Dictionary of Evidence Based Medicine. Milton Keynes, England: Radcliffe Medical Press; 1998.

3. Jadad AR, Moore RA, Carroll D, et al. As-sessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17(1):1-12.

4. Schervish MJ. P values: what they are and what they are not. Am Stat. 1996;50(3):203-206.

5. Pocock S. Clinical Trials: A Practical Ap-proach. Chichester, England: John Wiley & Sons Ltd; 1983.

6. Black N. Why we need observational studies to evaluate the effectiveness of health care. BMJ. 1996;312(7040):1215-1218.

7. Grootendorst DC, Jager KJ, Zoccali C, Dekker FW. Observational studies are com-plementary to randomized controlled trials. Nephron Clin Pract. 2010;114(3):c173-c177.

8. Mant D. Can randomized trials inform clini-cal decisions about individual patients? Lan-cet. 1999;353(9154):743-746.

9. Cook RJ, Sackett DL. The number needed to treat: a clinically useful measure of treatment effect. BMJ. 1995;310(6977):452-454.

10. van der Greef J, McBurney RN. Innovation: rescuing drug discovery: in vivo systems pa-thology and systems pharmacology. Nat Rev Drug Discov. 2005;4:961-967.


Variable Category Comment

Phase of trial Phase I-IV This categorization is primarily driven by a conventional regulatory perspective

Outcome focus Explanatory vs pragmatic Perspectives range from understanding the specific effects of medications under ideal conditions (efficacy) to the roles of medications in disease management in routine clinical practice (effectiveness)

Hypothesis focus Proof of concept vs confirmatory The main perspective is hypothesis generation vs hypothesis confirmation

Unit of analysis Clusters of individuals, individuals, or single patients

The perspective can range from comparing clusters of individuals to deciding on the optimal treatment for single patients

Table. Overview of Different Types of Categorizations for Clinical Trials

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Appendix. Glossary of Terms Used in the Context of Clinical Trials

Bias:Systematic deviations of results or inferences from the truth. Many subtypes of bias are distinguished, such as selection bias, information bias, and performance bias. In clini-cal trials, it can be the result of con-ceptual or methodological flaws in study design, data collection, or analysis or interpretation of results.

95% Confidence interval: A range of values known to con-tain the true parameter value with 95% certainty.

Crossover trial: This is a clinical trial in which sub-jects, on completion of treatment A, are switched to treatment B after an appropriate “washout” period. Half of the subjects are randomly allocated to receive the treatments in the order “first A, then B” and the other half in the order “first B, then A.” Such trials are only feasi-ble if the washout period is suffi-ciently long to exclude that effects in the first treatment period are carried over into the second treat-ment period.

Institutional review board (also called ethical committee): A committee of physicians, statisti-cians, researchers, community ad-vocates, and others that ensures that a clinical trial is ethical and that the rights of study participants (including animals) are protected. All clinical trials must be approved by an institutional review board before they begin.

Intention to treat: Analysis of clinical trial results that includes all data from participants in the groups to which they were randomized, even if they never received the treatment. The oppo-site is a “per-protocol analysis” in which only the subjects that com-pleted the study per protocol are included. The consensus is that the exclusion of study subjects from the analysis can lead to bias. Therefore, in general, an analysis by intention to treat, in which values for miss-ing data are statistically imputed, is recommended.

Jadad score: This is a score conceived by Jadad et al,3 commonly used to indepen-dently assess the quality of a clini-cal trial. The score is calculated on the basis of an assessment of the following study elements: random-ization, blinding, and handling of dropouts. The score ranges from 0 (very poor) to 5 (rigorous).

Number needed to treat (NNT): In clinical trials, a variable that ex-presses the number of persons who need to be treated with the treat-ment of interest for 1 additional patient to benefit compared with control treatment. This parameter can be useful in assisting clini-cal decision making. For example, in a comparative study, treatment A is compared with treatment B (placebo). Suppose the propor-tion of patients treated successfully with treatment A is 60% and those treated successfully with placebo is 40%. The difference in success rate is 20% (0.2). The reciprocal of this

value, 5 (1/0.2), is the NNT. This is interpreted as follows: on average, 5 patients need to be treated with treatment A for 1 additional pa-tient to be successfully treated than would be the case if they received treatment B. The number needed to harm applies to the risk of adverse events. Suppose in the same trial that 20% of patients who received treatment A experienced a head-ache, compared with 15% who received treatment B (placebo), in-dicating a difference of 5% (0.05). This results in a number needed to harm of 20 (1/0.05). In plain language, this means that treating patients with A instead of B would, on average, result in 1 more case of headache per 20 patients.

Standard deviation (SD): The most commonly used measure of the spread of a data set, repre-senting the average deviation of the mean of the data set.

Statistical significance:The probability that an event or difference occurred by chance alone. The P value assesses the strength of the evidence against the null hypothesis, which postu-lates that there is no effect. In gen-eral, results with P ≥ .05 are not considered strong evidence. The P value needs to be considered with other data from the experiment to provide a more objective measure of the support for the hypothesis.4 In clinical trials, the level of statisti-cal significance depends on the number of participants studied in conjunction with the magnitude of the differences observed.

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) Re s e a r c h H i g h l i g h t s

Introduction

The objective of this study was to examine the clinical use of Vertigo-heel in the management of patients with a transient ischemic attack (TIA). From our observations, approxi-mately 15% of rescue service clients are patients who have experienced an acute cerebrovascular accident. The most frequent diagnoses en-countered by the rescue service in the Czech Republic are cerebrovas-cular accidents with neurological symptoms, epilepsy, and TIA. Pa-tients with a TIA experience a short period of unconsciousness that is usually resolved by the time the res-cue service arrives. Almost all pa-tients complain of vertigo. Multiple other symptoms can occur, such as vision disorders, dysarthria, concen-tration disorders, nausea, and uncer-tain gait. Conventional management of patients with TIA consists of eto-phylline, 160 mg intravenously or 240 mg intramuscularly, and the in-struction to stay at home. In approx-imately 50% of the patients, the res-cue service is called back after 2 to 4 hours, with vertigo as the main per-sistent symptom in most cases. The conventional management of pa-tients with TIA is, therefore, not al-ways fully effective.

The use of homeopathic medica-tions in the treatment of emergency conditions is not common in the Czech Republic. Vertigoheel is well established as a homeopathic me-dicinal product for the treatment of vertigo.1-5 The group of patients with TIA is of high interest because of the high incidence of persistence of vertigo. We, therefore, investigat-ed if Vertigoheel is useful as an add-on treatment in patients with TIA. The results of this study were previ-ously reported at the homeopathic LIGA conference in 2010.6

Materials and Methods

This was an observational cohort study with historical controls. The study base consisted of patients with TIA treated with Vertigoheel as an adjuvant treatment by the rescue service in Vlašim, Czech Republic. Patients seen from February 2007 to October 2008 were included. The ingredients of Vertigoheel and their characteristic homeopathic symptoms are given in the Table.In this study, 1 ampoule (1.1 mL) of Vertigoheel injection solution was administered intramuscularly, in a single dose. Conventional standard treatment is ambulant and consists of etophylline, 160 mg intravenous-ly or 240 mg intramuscularly, and

the instruction to stay at home. Data before the adjuvant use of Vertigo-heel demonstrated that, in approxi-mately 50% of patients, the rescue service in Vlašim would be called back after 2 to 4 hours. Vertigo was the main persistent symptom report-ed by most of these patients.

Results

A total of 64 patients (age range, 55-89 years) were included. Four patients (6%) called back after 2 to 4 hours with vertigo: 2 of them devel-oped acute cerebrovascular acci-dents with neurological symptoms and 2 experienced recurrences of TIA, with short-term unconscious-ness. Compared with historical data before the introduction of Vertigo-heel, this amounts to a reduction of almost 90% in the call-back inci-dence.

Discussion

The results of this study suggest that adjuvant Vertigoheel treatment can substantially reduce the incidence of persistent vertigo in patients with a TIA. Surprisingly, nausea also often disappeared. A limitation of this study is that the study population was relatively small. Also, the use of historical, rather than placebo, con-

The Role of Vertigoheel as an Adjuvant Treatment in Patients With Transient Ischemic Attacks An Observational Study By Petr Sedláček, MD, and Stanislav Růžička, MD

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) Re s e a r c h H i g h l i g h t s

trol data implies that the results should be interpreted with caution. However, Vertigoheel was a suitable supplement to the therapy in the study population. Vertigoheel is a medication for diz-ziness; it stimulates the central ner-vous system. It can be demonstrated by neuro-otological examination that Vertigoheel activates the stato-acoustic regulation systems in the infratentorial area of the brain stem. Treatment with Vertigoheel decreas-es vertigo and nausea, reduces light-headedness and postural instability, and improves central vestibulo-ocu-lar nystagmus reactions. Electroen-cephalographic computer audiome-try has revealed increased activity of the pathways from the acoustic nerve to the inferior colliculus of the corpora quadrigemina.7,8 Other treatment combinations, which are able to inhibit or suppress the described symptoms, can be used to treat TIA with manifesta-tions of the previously mentioned symptoms in patients receiving home care. Partial success has been reported for the etophylline plus thiethylperazine (Torecan) combina-tion.9 Additional volume replace-

ment with crystalloids is sometimes successful, especially in elderly pa-tients, in whom hypovolemia due to simple dehydration is one of the most frequent causes of TIA. It would be interesting to initiate a randomized, comparative, 3-armed trial evaluating the efficacy of the following treatments:• etophylline+Vertigoheel• etophylline+thiethylperazine• etophylline+500to1000mL

of crystalloidsAn additional important study would be to conduct a randomized controlled trial comparing standard treatment plus Vertigoheel with stan dard treatment plus a suitable placebo. A special focus should be the treatment of the most perturb-ing symptoms, such as vertigo and nausea. Despite the absence of confirmatory data, this study clearly suggests that Vertigoheel has beneficial effects in the treatment of patients with TIA. |

References1. Weiser M, Strösser W, Klein P. Homeo-

pathic vs conventional treatment of vertigo: a randomized double-blind controlled clini-cal study. Arch Otolaryngol Head Neck Surg. 1998;124(8):879-885.

2. Issing W, Klein P, Weiser M. The homeo-pathic preparation Vertigoheel versus Ginkgo biloba in the treatment of vertigo in an elder-ly population: a double-blinded randomized, controlled clinical trial. J Altern Complement Med. 2005;11(1):155-160.

3. Weiser M, Strösser W. Behandlung des Schwindels: Vergleichsstudie Homöopathi-kum vs Betahistin. Der Allgemeinarzt. 2000;22(13):692-694.

4. Wolschner U, Strösser W, Weiser M, Klein P. Behandlung des Schwindels mit einem mod-ernen Homöopathikum: Ergebnisse einer referenzkontrollierten Kohortenstudie. Biol Med. 2001;30(4):184-190.

5. Schneider B, Klein P, Weiser M. Treatment of vertigo with a homeopathic complex remedy compared with usual treatments: a meta-anal-ysis of clinical trials. Arzneimittelforschung. 2005;55(1):23-29.

6. Růžička S, Sedláček P. Report on the use of the homeopathic remedy Vertigoheel in field practice of the rescue service. Poster present-ed at: 65th World Homeopathic Congress of Liga Medicorum Homoeopathica Internatio-nalis; May 18-22, 2010; Redondo Beach, CA.

7. Claussen CF. Die Behandlung des Syndroms des verlangsamten Hirnstammes mit Verti-goheel. Biol Med. 1985;14(3):447-470, and 1985;14(4):510-514.

8. Claussen CF, Bergmann J, Bertora G, Claussen E. Clinical experimental test and equilibrimetric measurements of the thera-peutic action of a homeopathic drug con-sisting of ambra, Cocculus, Conium and mineral oil in the diagnosis of vertigo and nausea [in German]. Arzneimittelforschung. 1984;34(12):1791-1798.

9. Macek Z, et al. Neurologie in der arztli-chen Praxis. München, Germany: Urban & Schwarzenberg; 1970.

Ingredient Potency/Amount in 1.1 mL of Injection Solution

Main Homeopathic Indications

Anamirta cocculus (Indian cockle)

D3/7.7 µL Feeling of dizziness as the result of various causes, associated with nausea and severe fatigue; motion sickness, especially in the car or train, or sea sickness; hardening of the arteries in the brain; cerebral sclerosis; neurologi-cal disorders; and moodiness, including sleeplessness because of overwork, staying up late, and/or emotional worries.

Conium maculatum (hemlock)

D2/1.1 µL Hardening of the arteries in the brain; cerebral sclerosis; moodiness; dizziness triggered by head rotation, on standing, and/or when lying down; rotational dizziness; light intolerance; and generalized functional, physical, and mental sluggishness.

Ambra grisea (ambergris)

D5/1.1 µL Nerve hypersensitivity and nervous exhaustion, autonomic nervous system imbalance, moodiness and sadness, calcification of blood vessels, aging, insomnia due to worries and fears, and nervousness.

Petroleum rectificatum (rock oil)

D7/1.1 µL Inflammation of the gastrointestinal tract, dizziness, sensitivity to cold, nervousness, and motion sickness improved by closing the eyes.

Table. Ingredients of Vertigoheel: Potency, Amount, and Main Homeopathic Indications

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Dr. Jan Kersschot was born on August 15, 1960, in Reet,

close to Antwerp, Belgium. He stud-ied medicine at the University of Antwerp and graduated in 1986. In 1988, he married Christine, with whom he has 2 daughters, now aged 17 and 20 years. When Jan was still a student, his fa-ther, a general practitioner, had pa-tients who traveled from Belgium to Germany to be treated with neural therapy, an unknown method of in-jection therapy in Belgium at that time. On his father’s request, Jan participated in a course on neural therapy in Freudenstadt, Germany, in September 1984. Jan believed that this was an interesting modality that could be useful in medicine. He was also surprised that he had not heard about it in his medical train-ing at the university. As soon as Jan had completed his studies, he start-ed his own practice and extensively used the injection therapy tech-niques whenever they were well in-dicated.

Within this bioregulatory environment of neural therapy in Germany, Jan quickly discovered that, in addition to procaine, there were other bio-therapeutic medications available as injectable ampoules. Although he discovered a few companies that provided these medications, the piv-otal point came at a medical con-gress in Baden-Baden, Germany, when he met a representative of Heel who claimed interesting results with injectable biotherapeutic agents. He gave Jan some samples of Traumeel ampoules and asked him to report on his experience. Jan was surprised to observe that his patients had better and longer-lasting results when he added these ampoules to the procaine or lidocaine injections that he routinely administered. When he noticed the benefits of Traumeel in his practice over and over again, his confidence in this type of medication grew, and he started injecting other products, such as Zeel and Discus composi-tum. Over time, he used more and more biotherapeutic medications and fewer local anesthetics.Jan’s treatment approach became even more integrative when he stud-ied mesotherapy and trigger-point therapy. He began to combine his already standardized biotherapeutic injections with insights from meso-therapy, trigger-point therapy, and prolotherapy and developed new techniques and strategies.

In 1991, Jan gave a lecture at a med-ical congress in Ostend, Belgium. For the first time, he introduced his integrative method as Biopuncture and a new injection method was born. Jan chose the term Biopuncture because it described the technique: local injections in specific locations with safe and effective biotherapeu-tic medications. During the past 20 years, the method of Biopuncture has evolved, and it is still evolving now. Recently, the technique has been standardized by a team of ex-perts, resulting in a new book, The Clinical Guide to Biopuncture, that describes the method in-depth. Since the beginning of Biopuncture some 20 years ago, Jan Kersschot has traveled the world to teach his therapy approach. In the meantime, physicians have been trained, in col-laboration with the International Academy for Homotoxicology, to become certified international spea-kers on Biopuncture. These speakers help answer the growing demand for Biopuncture training worldwide, although Jan still does a large part of lecturing himself.In his spare time, Jan likes swim-ming, hiking in nature, cycling, and traveling (his favorite countries are India and Egypt). He is also interest-ed in modern art, photography, and architecture and likes visiting muse-ums while traveling (eg, Museum of Modern Art, Metropolitan, and Tate Modern). Like most Belgians, he en-joys fine cuisine. In particular, red wine and dark chocolate contribute to his joy in life.|

Dr. Jan KersschotBy Bruno Van Brandt

) M e e t t h e E x p e r t

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