Diapositiva 1

CHIROPRACTIC PEDIATRICS CHIROPRACTIC PEDIATRICS RESEARCHRESEARCH

AEQ, Hotel NH Nacional de MadridMadrid, SPAINApril 3, 2005

Anthony L. Rosner, Ph.D., LL.D[Hon.]Foundation for Chiropractic Education and ResearchBrookline, Massachusetts, USA 02446

Diapositiva 2 OUTLINE OF PRESENTATION

1. Background:a. Pitfalls in allopathic medicine.b. Medical errors and drug side-effects:

1] NSAIDs.2] Antibiotics.

2. Evidence supporting SMT for managing specific conditions.3. Stress and interactions with body systems.4. Strength of evidence and right to be informed.5. Integrative medicine.6. Future directions.

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19

Randomized Clinical News

Cover. American Journal of Public Health 2004 [March]; 94.

Diapositiva 4 MEDICINE IS SLOW TO ADAPT

1. Edward Jenner, 1797: Thought of smallpox vaccine, Royal Society of Medicine reprimanded him for risking his reputation on something "so much at variance with established knowledge, and withal so incredible."

2. Ignaz Semmelweis, 1850s: Discovered that physicians' unwashed hands caused infections among new mothers at the University of Vienna. When he pointed this out, he lost his position there and died in disgrace.

3. Oliver Wendell Holmes: Published an article on prevention of "childhood fever"through hand washing and brought on bitter abuse.

4. Kilmer McCully: As wonder boy pathologist from Harvard in late 1960s, proposed role of folate deficiency and homocysteine in cardiovascular disease and was banished to continue his work at the Veterans Administration Hospital in Rhode Island.

Manga P, Hyman M. Paradigm shift: The end of “normal science” in medicine: Understanding function in nutrition, health and disease. Alternative Therapies in Health and Medicine 2004; 10(5): 10 -15; 90-94.

Diapositiva 5 OUTMODED MEDICAL MODELS1

1. Pellagra: Once thought to be caused by "foreign invaders" or some external "toxic factor" until Joseph Goldberger in 1914 demonstrated that it was absence of something in food that caused illness.

2. Peptic Ulcers: 1967 review blamed dominant mothers and passive fathers2 until Barry Marshall, M.D., ingested cultures of Heliobacter pylori and developed gastritis:a. He then underwent endoscopy and biopsy and pathogen was re-isolated,

completing Koch's Postulates.b. Only when discovery was published in the National Enquirer in 1990 did it

come to popular attention.3. Sugar, Not Fat, as Precursor to Cardiovascular Disease:

a. Cholesterol is formed from fructose via acetate.b. 100% of diabetic men have atherosclerosis.c. 2/3 of all patients presenting with MI in ER are glucose intolerant3 or are

undiagnosed diabetics when given 2-hour glucose intolerance test.

1Hyman M. Paradigm shift: The end of "normal science" in medicine: Understanding function in nutrition, health, and disease. Alternative Therapies in Health and Medicine 2004; 10(5): 10-15; 90-94.2Susser M. Causes of Peptic Ulcer: A Selective Epidemiological Reivew Journal of Chronic Diseases, 1967, 20: 435-456.3Norhammar A. Glucose metabolism in patients with acute myocardia l infarction and no previous diagnosis of diabetes mellitus: A prospective study. Lancet 2002: 359: 2140 -2144.

Diapositiva 6 A TOUGH CROWD: RELUCTANCE TO LEAVE

THE BOX

Diapositiva 7 DESCRIPTION OF EARLY YEARS OF

CHIROPRACTIC RESEARCH?

"...falsely conceived and rather clumsily executed...[with a text]...that should never have been accepted, on a subject that should never

have been chosen, by [those] who never have attempted it."

Description of George Gershwin's opera, Porgy and Bess, by Virgil Thompson.

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PROPOSED MECHANISMS OF SPINAL MANIPULATION

Action Mechanism References

Mechanical/anatomic Alleviation of entrapped facet joint inclusion of meniscoid 2,3

that has been shown to be heavily innervated.

Mechanical/anatomic Repositioning of a fragment of posterior annular material from 3,4

the innervated disc.

Mechanical/anatomic Alleviation of stiffness induced by fibrotic tissue from previ- 5,6

ous injury or degenerative changes that may include adaptive

shortening of fascial tissue.

Neurologic/mechanical Inhibition of excessive reflex activity in the instrinsic spinal 7-10

musculature or limbs and/or facilitation of inhibited muscle

activity.

Neurologic/mechanical Reduction of compressive or irritative insults to neural tissues. 11

Biochemical Release of endogenous opioids. 12,13

Biochemical Suppression of aldosterone, which promotes inflammation. 14,15

Biochemical Suppression of PGE2a, believed to cause uterine cramping. 16

Psychoneurochemical Reduction of anxiety [which aggravates pain sensation]. 17

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ESTIMATED ANNUAL MORTALITY/COST OF MEDICAL INTERVENTIONS

Condition Deaths Cost Reference

Adverse Drug Reactions 106,000 $ 12 B 1,2Medical Error 98,000 2 B 3Bedsores 115,000 55 B 4,5Infection 88,000 5 B 6,7Malnutrition 108,000 --- 8Outpatients 199,000 77 B 9,10Unnecessary Procedures 37,136 122B 11,12Surgery-Related 32,000 9 B 13

TOTALS: 783,936 $282 B

1Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. Journal of the American Medical Association1998; 279(15): 1200-1205.2Drug giant accused of false claims. Suh DC, Woodall BS, Shin SK, Hermes-De Santis ER. Clinical and economic impact of adverse drug reactions in hospitalized patients. Annals of Pharmacotherapy 2000; 34(12):1373 -1379.3Thomas EJ, Studdert DM, Burstin HR, et al. Incidence and types of adverse events and negligent care in Utah and Colorado. Medical Care 2000; 38(3): 261-271.4Xakellis GC, Frantz R, Lewis A. Cost of pressure ulcer prevention in long-term care. American Geriatric Society 1995; 43(5): 496 -501.5Barczak CA, Barnett RI, Childs EJ, Bosley LM. Fourth national pressure ulcer prevalence survey. Advances in Wound Care 1997; 10(4): 18-26.6Weinstein RA. Nosocomial infection update. Emergency and Infectious Diseases 1998; 4(3): 416-420.7Fourth Decennial International Conference on Nosocomial and Health-Associated Infections. Morbidity and Mortality Weekly Report. February 25, 2000. Vol. 49, No. 7, p. 138.8Burger SG, Kayser-Jones J, Bell JP. Malnutrition and dehydration in nursing homes: Key issues in prevention and treatment. National Citizens' Coalition for Nursing Home Reform, June 2000. Available at: http:www.cmwf.org/programs/elders/burger_mal_386.asp. Accessed December 13, 2003.9Starfield B. Is US health really the best in the world? Journal of the American Medical Association 2000; 284(4): 483 -485.

10Weingart SN, McL Wilson R, Gibberd RW, Harrison B. Epidemiology of medical error. Western Journal of Medicine 2000; 172(6): 390-393.11"Unnecessary Surgery" HCUPnet , Healthcare Cost and Utilization Project, Agency for Health Research and Quality, Rockville, MD. Available at:http://www.ahrq.gov/data/hcup/hcupnet.htm. Accessed December 18, 2003.12HCUPnet, Healthcare Cost and Utilization Project. Agency for Healthcare Research and Quality, Rockville, MD. Available at: http: //www.ahrq.gov/data/hcup/hcupnet.htm. AccessedDecember 18, 2003.13Tunis SR, Gelband H. Health care technology in the United States. Health Policy 1994; 30(1-3): 335-396.

Diapositiva 10 EXCESS BAGGAGE: THE RATES OF

MEDICAL ERRORS1

"When all sources of error are added up, the likelihood that a mishap will injure a patient in a hospital is at least three percent and probably much higher. This isa serious health problem. When one considers that a typical airline handles customer's baggage at a far lower error rate than we handle the administration of drugs to patients, it is also an embarrassment."

-J.L. ReinertsenCEO, CareGroup andBeth Israel Deaconess Medical Center,

Boston

1Reinertsen JL. Let's talk about error. Leaders should take responsibility for mistakes. British Medical Journal 2000; 320: 730.

Diapositiva 11 ADVANCES IN MEDICINE

Diapositiva 12 RESPONSE TO DRUG DOSAGE:

VARIABILITY AMONG PATIENTS

With any drug at any given dose, the range of variability in patient response is 4-fold to 40-fold. Such variability is the rule, not the exception.1,2

1American Medical Association. Drug response variation and dosing information. In Drug Evaluations Annual. Philadelphia, PA: WB Saunders, 1993, chapter 2.2Clark WG, Brater DC, Johnson AR. Pharmacogenetics: The individual response to drugs. In Goth A. Medical Pharmacology, 12thedition. St. Louis, MO: Mosby, 1988, chapter 6.

Diapositiva 13 MEDICATION ERRORS/ADVERSE DRUG EVENTS

IN PEDIATRIC PATIENTS1

1. Prospective cohort of 1120 patients admitted to 2 urban teaching hospitals during 6 weeks in April and May, 1999.

2. Main outcome measures: Medication errors, potential and actual ADEs identified by clinical staff reports, review of medication order sheets, medication administration records, and patient charts.

3. Results:a. 616 medication errors out of 10,778 medication orders [5.7%].b. 115 potential ADEs [1.1%], 26 ADEs [0.24%].c. Significant elevation of potential ADEs in neonates in NICU.d. Most potential ADEs occurred at stage of drug ordering, involving incorrect

dosing, anti-infective drugs, and intravenous medications.e. Physician reviewers judged that computerized physician order entry could

potentially have prevented 93% of potential ADEs.

1Kaushal R, Bates DW, Landrigan C, McKenna KJ, Clapp MD, Federico F, Goldmann DA. Medication errors and adverse drug events in pediatric inpatients. Journal of the American Medical Association 2001; 285 (16): 2114-2120.

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ADVERSE DRUG EVENTS IN INFANTS AND CHILDREN UNDER 2 YEARS OF AGE1

1. Of >500,000 MedWatch adverse drug events reported to the FDA from 11/97-12/00, 7111 reports [5976 unique cases] identified involving children and infants younger than 2:a. Reports analyzed for health outcome, principal suspect drug, and whether drug exposure was

direct or indirect [via mother during prenatal period].b. Outcomes grouped into 4 clusters: death; congenital anomaly or disability; serious nonfatal;

other or no outcome given.

2. 1902 different drugs, biological agents, other chemical identified in reports with 54% of all serious and fatal ADRs attributed to 17 drugs administered directly.

3. 1432 [24%] of ADRs of all levels of severity involved exposure from the mother during pregnancy.

1Moore TJ, Weiss SR, Kaplan S, Blaisdell CJ. Reported adverse drug events in infants and children under 2 years of age. Pediatrics 2002; 110(5): e53.

Diapositiva 15

ADVERSE DRUG EVENTS IN INFANTS AND CHILDREN UNDER 2 YEARS OF AGE1

Most Common Suspect Drugs

Drug Cases Percentage Major Drug ClassPalivizumab 705 27.9 ImmunologicsCisapride 102 4.0 Disorders, acid/pepticIndomethacin 97 3.8 NSAIDNitric oxide 86 3.4 Medicinal gasesAzithromycin 52 2.1 Lincosamides/macrolidesAcetominophen 41 1.6 Analgesics, generalFluconazole 37 1.5 AntifungalsIbuprofen 33 1.3 NSAIDRespigam 32 1.3 Immune serumsCeftriaxone 28 1.1 CephalosporinsCefaclor 26 1.0 CephalosporinsCefoperazone 25 1.0 CephalosporinsZidovudine 25 1.0 AntiviralsErythromycin 22 0.9 Lincosamides/macrolidesVincristine 21 0.8 AntineoplasticsSevoflurane 20 0.8 Anesthetics, generalVancomycin 20 0.8 Antibacterials, miscellaneous

1Moore TJ, Weiss SR, Kaplan S, Blaisdell CJ. Reported adverse drug events in infants and children under 2 years of age. Pediatrics2002; 110(5): e53.

Diapositiva 16 NSAIDS AND RISK OF MISCARRIAGE1

1. Two different study designs [data from Danish registry, North Jutland, DENMARK]:a. Cohort: 1462 pregnant women who had taken up prescriptions of NSAIDs in period from 30 days before conception to

birth and 17,259 pregnant women who were not prescribed any such drugs during pregnancy.b. Case-control: 4268 women who had miscarriages [of whom 63 had taken NSAIDs in 12 weeks before date of discharge

from hospital after miscarriage] and 29,750 primiparous controls who had live births.2. NSAID dosage for prescription: equivalent to 400-600 mg ibuprofen.3. Cohort:

a. Odds ratios for congenital abnormality, low birth weight, and preterm births not affected by NSAID prescriptions.

4. Case control: Odds ratios for miscarriages are affected by NSAID prescriptions:a. Odds ratio increases with age of patient:

1] 0.99 for 25-29 years of age.2] 1.36 for 30-34 years of age.3] 2.13 for >35 years of age.

b. Odds ratio increases with proximity of taking NSAIDs prescription to miscarriage:1] 1.26 at 10-12 weeks before.2] 2.69 at 7-9 weeks before.3] 4.38 at 4-6 weeks before.4] 3.00 at 2-3 weeks before.5] 6.00 at 1 week before.

1Nielsen GL, Sorensen HT, Larsen H, Pedersen L. Risk of adverse birth outcome and miscarriage in pregnant users of non-steroidal anti-inflammatory drugs: Population based observational study and case-control study. British Medical Journal 2001; 322: 266-270.

Diapositiva 17 NSAIDS AND PERSISTENT PULMONARY

HYPERTENSION IN NEWBORN1

1. Case-control study of inborn and outborn nurseries in large urban medical center in Detroit, MI:a. Meconium collected from 101 newborn infants, 40 with diagnosis of PPHN.b. Meconium analyzed for NSAIDs by gas chromatography/mass spectrometry.

2. PPHN significantly associated with:a. Presence of at least 1 NSAID in meconium (OR - 21.47).b. Specifically, presence of:

1) Aspirin (OR = 8.09).2) Ibuprofen (OR = 3.31)

3. Severe PPHN (requiring extracorporeal membrane oxygenation treatment) associated with ibuprofen and naproxen.

4. Easy access to OTC NSAIDs of pregnant women should be reevaluated.

1Alano MA, Ngougmna E, Ostrea EM Jr. Konduri GG. Analysis of nonsteroidal anti-inflammatory drugs in meconium and its relation to persistent pulmonary hypertension of the newborn. Pediatrics 2001: 107 (3): 519-523.

Diapositiva 18 ABUSE OF ANTIBIOTICS1

`

1. If we continue our present use of antibiotics, protection will not be available 50 years from now sincealmost every major infectious disease is becoming resistant to currently available medicine:a. In underdeveloped countries, biggest problem is the underutilization of drugs due to their

unavailability and expense. Effect is to kill off only the weaker strains of microbes, encouragingresistant strains to emerge and predominate.

b. In wealthy countries, biggest problem is overutilization of drugs:1] Includes purposes for which antibiotics are by definition useless.2] Centers for Disease Control estimates that 1/3 of antibiotics taken on an out-

patient basis in the United States are unnecessary.3] 1/2 of antibiotics produced are for animal use.4] Many anti-microbial soap and cleaners for household use also contribute to drug

resistance.

2 In the United States, 14,000 people die each year from drug-resistant infections picked up inhospitals.

1Abuse of antibiotics. Lead editorial, International Herald Tribune, June 19, 2000, p. 8.

Diapositiva 19 ANTIBIOTICS AND OTITIS MEDIA: AHRQ

LITERATURE REVIEW1

`

1. In otitis media, nearly 2/3 of children recover from pain and fever within 24 hours of diagnosis.

2. 80% recover in 1-7 days.

3. Amoxicillin was as effective as newer, more expensive antibiotics with fewer side effects.

4. In children aged 2 and older, there was no difference between a 5-day course and a 7-day course.

5. In The Netherlands [where a waiting period of 1-2 days is observed before antibiotics are given forotitis media], occurrence of antibiotic resistance is 1% [in the U.S., where antibiotics are givenimmediately, it is 25%].

1Nagourney, E. Vital signs: Treatment; Report questions antibiotics for earache. New York Times, August 22, 2000.

Diapositiva 20 OTITIS MEDIA AND ANTIBIOTICS:

PRAGMATIC RANDOMIZED TRIAL1

1. Secondary analysis of pragmatic randomized controlled trial of two prescribing strategies for acuteotitis media:a. 315 children aged 6 months-10 years.b. Randomization to immediate antibiotics [amoxicillin or erythromycin for those allergic to

penicillin] or delayed 72 hours.c. Outcome measures [recorded by parents]:

1] Daily symptom diaries [earache, sleep disturbance, unwell].2] Perceived severity of pain [scale of 1-10].3] Number of episodes of distress.4] Number of 5 ml doses of paracetamol.5] Temperature.6] Presence of cough, vomiting, rash, and diarrhea.

2. Results:a. Children with high temperature or vomiting benefited from antibiotics.b. Children without higher temperature or vomiting on day one were unlikely to have poor

outcome and unlikely to benefit from immediate antibiotics.

1Little P, Gould C, Moore M, Warner G, Dunleavey J, Williamson I. Predictors of poor outcome and benefit from antibiotics in children with acute otitis media: Pragmatic randomised trial. British Medical Journal2002; 325: 22-25.

Diapositiva 21 ANTIBIOTICS AND ACUTE OTITIS MEDIA1

1. A recent study found that if a physician believes the odds that a patient has AOM are 50% or less, 3 of 4 will still prescribe antibiotics.

2. In the same study, 1 of 4 will prescribe antibiotics if the odds for AOM are <25%.

1Gonzalez-Vallejo C, Sorum PC, Steward TR, Chessare JB, Mumpower JL. Physicians’ diagnostic judgements and treatment decisions for acute otitis media in children. Medical Decision Making 1998; 18: 149-162.

Diapositiva 22 INCREASED RISK OF ASTHMA SYMPTOMS

WITH ANTIBIOTIC USE

Wickens K, Pearce N, Crane J, Beasley R. Antibiotic use in early childhood and the development of asthma. Clinical and

Experimental Allergy 1999; 29: 766-771.

Diapositiva 23 WARNING LABELS FOR ANTIBIOTICS1

Because of global and national increases in drug-resistant bacterial infections, theFood and Drug Administration proposed in September 2000 that all antibioticsdispensed in the United States carry warning labels. Doctors would be reminded to:

• Use antibacterial drugs only where a bacterial infection has been proven or strongly suspected;

• Choose the correct antibacterial drug to prescribe based on the type of bacteria presumed to be present and the pathogen’s antimicrobial susceptibility patterns;

• Modify the antibiotic microbial therapy once microbiologic results are available;

• Counsel patients on the proper use of their prescriptions and the importance of taking them correctly.

1The Nation’s Health (official newspaper of the American Public Health Association), November 2000, pp. 1, 12.

Diapositiva 24 PHYSICIANS’ PRESCRIBING BEHAVIOR FOR

ANTIBIOTICS1

1. Two private pediatric practices surveyed:a. One community-based, one university based.b. Ten physicians [response rate 77%] and consecutive sample of 306 eligible

parents [response rate 86%] who were attending sick visits for their children between October 1996 and March 1997 sampled.

c. Children 2-10 years old complaining of ear pain, throat pain, cough or congestion who were off antimicrobial therapy for the past two weeks.

2. Based on multivariate analysis, physicians’ perceptions of parental expectations for antimicrobials was only significant predictor of prescribing:a. When physician though that parent wanted one:

1] Prescribed 62% of the time.2] Gave bacterial diagnosis 70% of the time.

b. When physician thought that parent did not think that parent wanted one:1] Prescribed 7% of the time.2] Gave bacterial diagnosis 31% of the time.

c. Prescribing was not associated with actual parent expectation.d. Failure to provide antimicrobials did not affect satisfaction.

1Mangione-Smith R, McGlynn EA, Elliott MN, Krogstad P, Brook RH. The relationship between perceived parental expectations and pediatrician antimicrobial prescribing behavior. Pediatrics 1999; 103(4): 711-718.

Diapositiva 25 EFFECT OF EARLY OR DELAYED INSERTION

OF TYMPANOSTOMY TUBES1

1. 429 children aged <3 years out of cohort of 6350 infants tracked from 2-61 days of age diagnosed with middle-ear effusion:a. Divided into 2 groups receiving early or late [up to 9 month] tube insertions.b. In 402 assessed speech, language, cognition, and psychosocial development.

2. Observed no significant differences between early and late-treatment groups at age 3 years.

3. Prompt insertion of tympanostomy tubes in children younger than 3 years does not measurably improve developmental outcomes.

4. Estimated annual frequency and cost of tympanostomies in the U.S.: 700,000 at a cost of $2,000 each for total bill of $1.4B.2

1Paradise JL, Feldman HM, Campbell TF, Dollaghan CA, Colborn DK, Bernard BS, Rockette HE, Janofsky JE, Pitcairn DL, Sabo DL, Kurs-Lasky M, Smith CG. Effect of early or delayed insertion of tympanostomy tubes for persistent otitis media on developmental outcomes at the age of three years. New England Journal of Medicine2001; 344(16): 1179-1187.2American Academy of Otolyaryngology-Head and Neck Surgery, Dallas Morning News, April 19, 2001.

Diapositiva 26 ADVICE FROM THE SIDELINES

Diapositiva 27

4

Tally of Clinical Trials Involving Spinal Manipulation1

1Meeker WC, Mootz RD, Haldeman S. Back to basics...The state of chiropractic research. Topics in Clinical Chiropractic 2002; 9(1): 1-13.

Positive Equivocal NegativeLow back pain studies:

Acute back pain 10 3 -Subacute and chronic back pain 9 6 -Mixed acute and chronic back pain 10 4 -Sciatica 1 - -

Head and neck pain studies:Migraine headache 2 1 -Muscle tension headache 4 1 -Cervicogenic headache 1 - -Acute, subacute, chronic neck pain 4 7 -

Extremity pain studies:Elbow pain 1 - -Carpal tunnel syndrome - 1 -

Non-neuromusculoskeletal condition studies:Dysmenorrhea 1 1 -Infantile colic 1 1 -Enuresis - 1 -Asthma - 2 -Premenstrual syndrome 1 - -Hypertension 1 1 -

Diapositiva 28

CONDITIONS RESPONDING TO SPINAL MANIPULATION OBSERVED IN CASESTUDIES

Condition ReferencePremenstrual syndrome 1Hot flashes 2Hypertension 3Irritable bowel syndrome 4Multiple sclerosis 5Bell's Palsy 6Hyperactivity 7Epilepsy 8Autism 9Recovery of visual field loss 10Temporomandibular joint dysfunction 11Otitis media 12

1Walsh MJ, Chandraraj S, PolusBI. The efficacy of chiropractic therapy on premenstrual syndrome: A case -series study. Chiropractic Journal of Australia 1994; 24(4): 122-126.2Weber M, Masarsky CS. Cervicothoracic subluxation and hot flashes in a perimenopausal subject: A time-series case report. Journal of Vertebral Subluxation Research 1996; 1(2): 33-38.3Plaugher G, Bachman TR. Chiropractic management of a hypertensive patient. Journal of Manipulative and Physiological Therapeutics 1994; 16(8): 544- 549.4Wagner T, Owen J, Malone E, Mann K. Irritable bowel syndrome and spinal manipulation: A case report. Chiropractic Technique 1995; 7(4): 139-140.5Stude DE, Mick T. Clinical presentation of a patient with multiple sclerosis and response to manual chiropractic adjustive therapies. Journal of Manipulative and Physiological Therapeutics 1993; 16(9): 595-600.6Frach JP, Osterbauer PJ, FuhrAW. Treatment of Bell's Palsy by mechanical force, manually assisted chiropractic adjusting and high-voltage electrotherapy. Journal of Manipulative and Physiological Therapeutics 1992; 5(9): 596-598.7Giesen JM, Center DB, Leach RA. An evaluation of chiropractic manipulation as a treatment of hyperactivity in children. Journal of Manipulative and Physiological Therapeutics 1989; 12(5): 353-363.8Alcantara J, Heschong R, Plaugher G, Alcantara J. Chiropractic management of a patient with low back pain and epileptic seizures. Journal of Manipulative andPhysiological Therapeutics 1998; 21(6): 410-418.9Sandefur R, Adams E. The effect of chiropractic adjustments on the behavior of autistic children: A case review. Journal of Chiropractic 1987; 24(12): 21-25. 10Stephens D, Mealing D, Pollard H, Thompson P, Bilton D, Gorman RF. Treatment of visual field loss by spinal manipulation. Journal of the Neuromusculoskeletal System1998; 6(2): 53-66.11Chinappi AS, Getzoff H. The dental-chiropractic cotreatment of structural disorders of the jaw and temporomandibular joint dysfunction. Journal of Manipulative and Physiological Therapeutics 1995; 18(7): 476-481.12Froehle RM. Ear infection: A retrospective study examining improvement from chiropractic care and analyzing for influencing factors. Journal of Manipulative and Physiological Therapeutics 1996; 19(3): 169-177.

Diapositiva 29 OUTCOMES RESEARCH: PROMISING AND

INVESTIGATIONAL CLINICAL CONDITIONS

1. Promising:a. Back pain.b. Headache.c. Infantile colic.d. Enuresis.e. Otitis media.f. Asthma.

2. Investigational:a. Scoliosis.b. Attention deficit hyperactivity disorder.c. Upper respiratory tract infections.d. Repetitive motion disorders.e. Muscular dystrophy. f. Cerebral palsy.g. Epilepsy.

Diapositiva 30 PREVALENCE OF BACK PAIN IN PEDIATRIC AND

ADOLESCENT POPULATIONSNATIONALITY AGE PREVALENCE [%]

United States1 13-16 30.4

United Kingdom2 Adolescent 11.5

United Kingdom3 11-14 24*

Switzerland4 Schoolchildren 27

Denmark5 8-10; 14-16 39*

All figures represent point prevalence unless shown with an asterisk (*), indicating 1-monthprevalences.

1Olsen TL, Anderson RL, Dearwater SR, Kriska AM, Cauley JA, Aaron DJ, LaPorte RE. The epidemiology of low back pain in an adolescent population. American Journal ofPublic Health 1992; 82(4): 606-608.2Grantham VA. Backache in boys --a new problem. Practitioner 1977; 218(1304): 226-229.3Watson KD, Papageorgiou AC, Jones GT, Taylor S, Symmons DPM, Silman AJ, Macfarlane GJ. Low back pain in schoolchildren: Occurrence and characteristics. Pain 2002;97(1-2): 87-92.4Balague F, Dutoit G, Waldburger M. Low back pain in schoolchildren: An epidemiological study. Scandinavian Journal of Rehabilitative Medicine 1988; 20(4): 175-179.5Wedderkopp N, Lebouef-Yde C, Anderson LB, Froberg K, Hansen HS. Back pain reporting pattern in a Danish population-based sample of children and adolescents. Spine2001; 26(17): 1879-1883.

Diapositiva 31 PEDIATRIC PATIENTS WITH LBP:

A PROSPECTIVE COHORT STUDY1

1. Chiropractors within the cities of Calgary, Alberta and Toronto, Ontario in Canada were randomly selected for the study:a. Eligible to participate if in practice >5 years and saw minimum average of 2 pediatric patients/week.b. Maximum of 5 consecutive cases presenting to each accepted into the study:

1] Between ages of 4-18.2] New episode of mechanical LBP not previously treated by a chiropractor.3] LBP defined as pain/discomfort in area bounded by lowest set of ribs at patient's back to the lower

edge of the buttocks.c. 15 chiropractors provided data on 54 patients:

1] 61% were acute with 47% relating onset to a traumatic event.2] Patients followed until they reported resolution, discharge, referral, or discontinuation of

treatment.

2. Assessment of LBP:a. VAS.b. Subjective 5-point Likert scale.

3. Outcomes within 6 weeks:a. Mean VAS upon presentation = 5.6.b. "Much improvement" [grade 4 on Likert scale] attained in 62% with median time at 16 days.c. "Important" improvement [3.8 on VAS]" seen in 87% on VAS, median time 28 days.

1Hayden JA, Mior SA, Verhoef MJ. Evaluation of chiropractic management of pediatric patients with low back pain: A prospective cohort study. Journal of Manipulative and Physiological Therapeutics 2003; 26(1): 1-8.

Diapositiva 32 PEDIATRIC PATIENTS WITH LBP: A

PROSPECTIVE COHORT STUDY1

Limitations of Study

1. There was no comparison group with natural history of progression.

2. Small sample size limits generalizability.

3. Lack of follow-up to assess permanence of effect.

1Hayden JA, Mior SA, Verhoef MJ. Evaluation of chiropractic management of pediatric patients with low back pain: A prospective cohort study. Journal of Manipulative and Physiological Therapeutics 2003; 26(1): 1-8.

Diapositiva 33

SUMMARY OF LEADING OUTCOMES STUDIES INVOLVING SPINAL MANIPULATION FOR MANAGING SCOLIOSIS

AUTHOR DESIGN #SUBJ. AGE INTERVENTION OUTCOMES RESULT

Plaugher1 Case series 49 NS G SMT Retrolisthesis 34% reduction Sacral base angle No change Cervical lordosis No change Cobb's angle No changeScapular base angle No change

Lantz2 Cohort 42 6-12 yr D, G SMT Cobb's angle No change Heel liftsPostural counseling

Lifestyle counseling

G = GonsteadD = Diversified

1Plaugher, G, CremataEE, Phillips, R. A retrospective consecutive case analysis of pretreatment and comparative static radiological parameters following chiropractic adjustments. Journal of Manipulative and Physiological Therapeutics 1990; 13(9): 498-506.2Lantz CA, Chen J. Effect of chiropractic intervention on small scoliotic curves in younger subjects: A time -series cohort design. Journal of Manipulative and Physiological Therapeutics 2001; 24(6): 385-393.

Diapositiva 34 CHIROPRACTIC TREATMENT OF PEDIATRIC

HEADACHEAuthor n Age[yr] Diagnosis Diagnostic Procedues Adjustive Procedures

Haney1 1 11 Subluxation X-ray, AK muscle Diversified

Hewitt2 1 13 TTH Passive MP Diversified

Kastner3 12 Unspecified TTH, M, U Unspecified Unspecified SMT

Cochran4 1 10 M X-ray, MP Thompson, diversifiedAnderson-Peacock5 5 6-15 CEH [2] ROM, xray, MP Diversified

M [3]

Lisi6 1 8 CEH ROM, MP DiversifiedModified rotary breakSide posture mammilarypush Myofasical release

Legend: CEH, cervicogenic headache; M, migraine headache; TTH, tension-type headache; U, unspecific; ROM, range of motion, AK, applied kinesiology; MP, motion palpation; SMT, spinal manipulative therapy.

1Haney V. Chronic pediatric migraine-type headache treated by long-term inderol prior to chiropractic care: A case report. Proceedings of the National Conference on Chiropractic Pediatrics, Palm Beach, FL, October 1993, pp. 132-140.2Hewitt EG. Chiropractic care of a 13-year old with headache and neck pain: A case report. Journal of the Canadian Chiropractic Association 1994; 34(3): 160-162. 3Kastner U, Deutsch J, Lackner R. Chronic headache in children and chiropractic manipulation. Conference Proceedings of the Chiropractic Centennial Foundation , Washington, DC, July 1995, pp.286-287.4Cochran JA. Chiropractic treatment of childhood migraine headache: A case study. Proceedings of the National Conference on Chiropractic Pediatrics, Vancouver, British Columbia, CANADA,October 1994, pp. 85-90.5Anderson-Peacock ES. Chiropractic care of children with headaches: Five case reports. Journal of Clinical Chiropractic Pediatrics 1996; 1(1): 18 -27.6Lisi AJ, Dabrowski Y. Chiropractic spinal manipulation for cervicogenic headache in an 8-year old. Journal of the Neuromusculoskeletal System 2002; 19(3): 98-103.

Diapositiva 35

SUMMARY OF LEADING OUTCOMES STUDIES INVOLVING SPINAL MANIPULATION FOR MANAGING OTITIS MEDIA

AUTHOR DESIGN #SUBJ. AGE INTERVENTION OUTCOMES RESULT

Froehle1 Cohort 46 <5 yr A SMT Parental decision 93% ep improved SOTAK

Fallon Case series 3322 <5 yr RF Otoscopy Resolved 4013 D, G SMT Tympanography Resolved

STE

Phillips4 Case 1 23 mo A SMT Ear drainage, pain Reduction

A = ActivatorSOT = Sacro-occipital technique [occasionally]AK = Applied kinesiology [occasionally]RF = 3o rotation, 5o lateral flexion D = DiversifiedG = GonsteadSTE = Soft tissue effleurageep = Episodes

1Froehle RM. Ear infection: A retrospective study examining improvement from chiropractic care and analyzing for influencing factors. Journal of Manipulative and Physiological Therapeutics1996; 19(3): 169-177.2Fallon JM. The role of the chiropractic adjustment in the care and treatment of 332 children with otitis media. Journal of Clinical Chiropractic Pediatrics 1997; 2(2): 167-183.3Fallon J, Edelman MJ. Chiropractic care of 401 children with otitis media: A pilot study. Alternative Therapies in Health and Medicine 1998; 4(2): 93.4Phillips NJ. Vertebral subluxation and otitis media: A case study. Journal of Chiropractic Research and Clinical Investigation 1992; 8(2): 38-39.

Diapositiva 36

CROSS-SECTION OF THE MIDDLE, INNER AND OUTER EAR

Diapositiva 37 TYPES OF BACTERIA FOUND IN MIDDLE EAR FLUID

[% Total]

Bacteria 1 2 3 4Streptococcus pneumoniae 29.8 35 33

Hemophilus influenzae 20 20.9 23

Streptococcus gA 8 2

Bacillus catarrhalis 11.7 4Staphylococcus aureus 2 1.6 2

Streptococcus pyogenes 3.1

Gram negative enteric bacteria 1None or non-pathogenic 29 19.6 42 33

1Klein JO. Microbiology of otitis media. Annals of Otology, Rhinology, and Laryngology 1980; 89[Supple 68]: 98-101.2Asman BJ, Fireman P. The role of allergies in the development of otitis media with effusion. International Pediatrics 1988; 3(3).3Pelton SI, Teel, DW, Shurin PA, et al. Disparate cultures of middle ear fluids. American Journal of Diseases of Childhood 1980; 134: 951.4Schwartz R, Rodriguez W, Khan W, Ross S. The increasing incidence of ampicillin-resistant Hemophilus influenzae: A cause of otitismedia. Journal of the American Medical Association 1978; 239(4): 320-323.

Reprinted from Schmidt, MA. Healing Childhood Ear Infections: Prevention, Home Care, and Alternative Treatment, Berkeley, CA: North Atlantic Books, 1996, p. 79.

Diapositiva 38 COMPOSITION OF MIDDLE EAR FLUID IN

CHILDREN WITH OME1

Viral Species Virus Alone +Pathogenic Bacteria Total

Rhinovirus [HRV] 8 9 19*

Respiratory Syncytial [RSV] 7 1 8

Coronavirus [HCV] 2 1 3_________ ___________ ______

TOTAL 17 11 30*

*2 samples were RT-PCR-positive for HRV, but no bacteriologic data were available.1Pitkaranta A, Jero J, Arruda E, Virolainen A, Hayden FG. Polymerase chain-reaction based detection of rhinovirus, respiratory syncytial virus, and coronavirus in otitis media with effusion. Journal of Pediatrics 1998; 133 (3): 390-394.

Diapositiva 39 TYMPANOGRAM ASSOCIATED WITH A NORMAL

MIDDLE EAR

1Fallon JM, The role of the chiropractic adjustment in the care and treatment of 332 children with otitis media. Journal of Clinical Chiropractic Pediatrics 1997;2(2): 167-183.

Diapositiva 40

TYMPANOGRAM ASSOCIATED WITH VARIOUS MIDDLE EAR CONDITIONS

1Fallon JM, The role of the chiropractic adjustment in the care and treatment of 332 children with otitis media. Journal of Clinical Chiropractic Pediatrics 1997; 2(2): 167-183.

Diapositiva 41

OSTEOPATHIC MANIPULATION AND ACUTE OTITIS MEDIA1

1. A total of 57 patients aged 6 months-6 years with 3 episodes of AOM in previous 6 months or 4 inprevious year [who were not already surgical candidates] randomized into two groups:a. Receiving routine pediatric care.b. Receiving routine pediatric care + osteopathic manipulative treatment.c. Number of encounters equal between the two groups.d. Pediatrician blinded to patient group and study outcomes; osteopathic physician blinded to

patient course.

2. Timelines:a. Baselines taken for 6 months.b. 9 visits: 3 weekly, 3 biweekly, 3 monthly.

3. Osteopathic patients displayed advantages:a. Fewer episodes of AOM [-0.14/month]. P = .04b. Fewer surgical procedures [1 vs 8]. P = .03c. More mean surgery-free months [6.00 vs 5.25]. P = .03d. Baseline and final tympanograms showed higher frequency of normals in intervention group.

4. No adverse reactions were reported, and overall satisfaction with the study was high in both groups.

1Mills MV, Henley CE, Barnes LLB, Carreiro JE, Degenhardt BF. The use of osteopathic manipulative treatment as adjuvant therapy in children with recurrent acute otitis media. Archives of Pediatrics and Adolescent Medicine 2003; 157(9): 861-866.

Diapositiva 42

SUMMARY OF LEADING OUTCOMES STUDIES INVOLVING SPINAL MANIPULATION FOR MANAG-ING INFANTILE COLIC

AUTHOR DESIGN #SUBJ. AGE INTERVENTION OUTCOMES RESULT

Wiberg1 RCT 25 4-6 wk F SMT Crying [hrs] 70% drop in 5 days 20 Dimethicone 20% drop in 5 days

Olasfdottir2 RCT 32 3-9 wk F SMT Symptom scale Improvement in 70%24 Held 10 min Improvement in 60%

Mercer3 RCT 15 0-8 wk SMT Parent diary 93% resolved, 2 wk 15 Detuned ultrasound

Klougart4 Cohort 316 1-5 wk F SMT Crying [hrs] 75% drop in 14 days

Leach5 Case 2 6-9 wk I SMT Crying [hrs] 50% drop after 1-4x

F = Spinal manipulation applied with light fingertip pressureI = Instrument [PulStar FRAS Sense Technology, Inc.]x = Number of treatments

1Wiberg JMM, Nordsteen J, Nilsson N. The short-term effect of spinal manipulation in the treatment of infantile colic: A randomized controlled trial with a blinded observer. Journal of Manipulative and Physiological Therapeutics 1999; 22(8): 517-522.2Olafsdottir E, Forshei S, Fluge G, Markestad T. Randomised controlled trial of infantile colic treated withchiropractic spinal manipulation. Archivesof Diseases of the Child2001; 84(2): 138-141.3Mercer C, Nook BC. The efficacy of chiropractic spinal adjustments as a treatment protocol in the management of infantile colic. Proceedings of the 5th Biennial Congress, Auckland, NEW ZEALAND, May 17- 22, 1999, pp. 170-171.4Klougart N, Nilsson N, Jacobsen J. Infantile colic treated by chiropractors: a prospective study of 316 cases. Journal of Manipulative andPhysiological Therapeutics 1989; 12(4): 281-288.5Leach RA. Differential compliance instrument in the treatment of infantile colic: A report of two cases. Journal of Manipulative and PhysiologicalTherapeutics 2002; 25(1): 58 -62.

Diapositiva 43 MANIPULATION FOR INFANTILE COLIC1

1Klougart N, Nilsson N, Jacobesen J. Infantile colic treated by chiropractors: A prospectivestudy of 316 cases. Journal of Manipulative andPhysiological Therapeutics 1989; 12(4): 281-288.

Diapositiva 44 MANIPULATION FOR INFANTILE COLIC1

1. Inclusion criteria:a. Parental consent.b. Age 2-10 weeks.c. Violent spells of crying: 3 hours with >1 spell in at least 5 of 7 previous days.

2. Treatment: counseling normally given by health visitor nurses plus:a. MEDICAL: daily dimethicone administration x 2 weeks.b. SMT: examination by motion palpation of spine and pelvic + specific light finger pressure [3-5x]

over 2-week period.

3. Results post-treatment:a. MEDICAL:

1] 0-3 days: ~33% decrease from 3.4 hrs to 2.4 hrs of crying.2] Little reduction thereafter [to 38% decrease].3] 9 dropouts in group of 25: FU indicated that symptoms worsened in 7.

b. SMT:1] 0-3 days: ~33% decrease from 3.4 hrs to 2.4 hrs of crying.2] 0-12 days: 67% decrease from 3.4 hrs to 1.1 hrs of crying. 3] 0 dropouts.

1Wiberg JMM, Nordsteen J, Nilsson N. The short-term effect of spinal manipulation in the treatment of infantile colic: A randomized controlled clinical trial with a blinded observer. Journal of Manipulative and Physiological Therapeutics 1999; 22(8): 517-522.

Diapositiva 45 MANIPULATION FOR INFANTILE COLIC1

1Wiberg JMM, Nordsteen J, Nilsson N. The short-term effect of spinal manipulation in the treatment of infantile colic: A randomized controlled clinical trial with a blinded observer. Journal of Manipulative and Physiological Therapeutics1999; 22(8): 517-522.

Diapositiva 46

SUMMARY OF LEADING OUTCOMES STUDIES INVOLVING SPINAL MANIPULATION FOR MANAGING NOCTURNAL ENURESIS

AUTHOR DESIGN #SUBJ. AGE INTERVENTION OUTCOMES RESULT

Reed1 RCT 31 8-11 yr P SMT Wet nights/2 wk 16% < baseline15 Sham 0% < baseline

LeBoeuf2 Cohort 171 4-15 yr SMT Wet nights/wk 75% no response

Gemmell3 Case 1 14 yr T SMT Dry/damp/wet Trend to dryness

P = Spinal manipulation, Palmer Package Adjusting Technique4

T = Spinal manipulation, Toggle RecoilSham = Activator at nontension setting

1Reed WR, Beavers S, Reddy SK, Kern G. Chiropractic management of primary nocturnal enuresis. Journal of Manipulative and Physiological Therapeutics1994; 17(9): 596-600.2Lebouef C, Brown P, Herman A, Leembruggen K, Walton D, Crisp TC. Chiropractic care for children with nocturnal enuresis: A prospective outcome study. Journal of Manipulative and Physiological Therapeutics 1991; 14(2): 110-115.3Gemmell HA, Jacobson BH. Chiropractic management of enuresis: Time-series descriptive design. Journal of Manipulative and Physiological Therapeutics1989; 12(5): 386-389.4Palmer College of Chiropractic Adjusting Manual. Davenport, IA: Palmer College of Chiropractic, 1983.

Diapositiva 47

SUMMARY OF LEADING OUTCOMES STUDIES INVOLVING SPINAL MANIPULATION FOR MANAGING ASTHMA

AUTHOR DESIGN #SUBJ. AGE INTERVENTION OUTCOMES RESULT

Balon1 RCT 38 7-16 yr D SMT +S PEF Small rise 42 Sham FEV No change

QOL ImprovedBronfort1 Cohort 22 6-17 yr SMT Dr PEF N.S. change

12 FEV N.S. changeQOL Significant riseSeverity Significant dropSymptoms No change

Ali3 RCT 150 C AQ c SF-36h DASSw Cortisol SMT decreases

IgA Centers increases

1Balon J, Aker PD, Crowther ER, Danielson C, Cox PG, O'Shaugnessy D, Walker C, Goldsmith CH, Duku E, Sears MR. A comparison of active and simulated chiropractic manipulation as adjunctive treatment for childhood asthma. New England Journal of Medicine 1998; 339(15): 1013-1020. 2Bronfort G, Evans RL, Kubic P, Filkin P. Chronic pediatric asthma and chiropractic spinal maniulation: A

prospective clinical series and randomized clinical pilot study. Journal of Manipulative and Physiological Therapeutics 2002; 24(6): 369-377.3Ali S, Hayek R, Holland R, McKelvyS-E, Boyce K, CursonP. Effect of chiropractic treatment on the endo-

crine and immune system in asthmatic patients. Proceedings of the 2002 International Conference on Spinal Manipulation, Des Moines, IA: Foundation for Chiropractic Education and Research. In press, 2002.

D = Spinal manipulation, DiversifiedS = Soft tissue techniquesDr = Spinal manipulation with drop tablePEF = Peak expiratory flowFEV = Forced expiratory volumeQOL = Pediatric Quality of Life QuestionnaireC = Treatment at centersc = Nontreatment at centersh = Nontreatment at homew = Nonsymptomatic patients at homeAQ = Asthma questionnaireDASS = Depression and anxiety stress scale

Diapositiva 48

CHRONIC PEDIATRIC ASTHMA AND CHIROPRACTIC SMT: PROSPECTIVE CLINICAL SERIES/RANDOMIZED CLINICAL PILOT STUDY1

1. Prospective clinical case series combined with observer-blinded, pilot RCT:a. 36 patients aged 6-17 years with mild to moderate persistent asthma

admitted.b. Interventions: 20 sessions over 3-month phase:

1] Manipulation [usually HVLA] of dysfunctional joints in spine andpelvis with a drop table.

2] Sham: light manual contact with spine with no thrust with drop table.c. Outcome measures:

1] Pulmonary function tests.2] Asthma-specific quality of life.3] Asthma severity/improvement.4] Diary-based day and nighttime symptoms.

2. For RCT, feasibility rather than outcome measures emphasized.1Bronfort G, Evans RL, Kubic P, Filkin P. Chronic pediatric asthma and chiropractic spinal manipulation: A prospective clinical series and randomized clinical pilot study. Journal of Manipulative and Physiological Therapeutics 2001; 24(6): 369-377.

Diapositiva 49

CHRONIC PEDIATRIC ASTHMA AND CHIROPRACTIC SMT: PROSPECTIVE CLINICAL SERIES/RANDOMIZED CLINICAL PILOT STUDY1

1. Outcome results::a. Lung function tests showed little/no change.b. Day/nighttime symptoms showed little/no change.c. 20% reduction of beta-2 bronchodilator use seen [P =.10].d. Quality of life scores improved 10-28% [P<.01], with activity scale showing the most change.e. Asthma severity ratings showed reduction of 39% [P<.001], with overall improvement rating of

50-75%.f. Improvements in parent/guardian-rated outcomes small and N.S. statistically.g. Pulmonologist-rated improvement small.

2. Conclusions: a. Patients rated quality of life substantially higher and severity substantially lower after 3 months

of chiropractic SMT, improvements maintained at 1 year follow-up.b. No important changes in lung function or hyperresponsiveness seen at any time.c. Specific effect of SMT less likely than other aspect of clinical encounter.d. Statistical intergroup comparisons not made in RCT pilot.e. Feasibility of RCT confirmed in terms of recruitment, evaluation, and treatment.

1Bronfort G, Evans RL, Kubic P, Filkin P. Chronic pediatric asthma and chiropractic spinal manipulation: A prospective clinical series and randomized clinical pilot study. Journal of Manipulative and Physiological Therapeutics 2001; 24(6): 369-377.

Diapositiva 50

ASPECTS OF CHIROPRACTIC CLINICAL ENCOUNTERWHICH MAY CONTRIBUTE TOWARD IMPROVEMENT OF ASTHMA SYMTPOMS1

Actions:

1. Touch and attention.2. Filling out of diaries.3. Continuous monitoring.4. Increased patient focus on condition.

Results:

1. Better compliance.2. Decreased anxiety.3. Appropriate use of prophylactic/abortive medications.

1Bronfort G, Evans RL, Kubic P, Filkin P. Chronic pediatric asthma and chiropractic spinal manipulation: A prospective clinical series and randomized clinical pilot study. Journal of Manipulative and PhysiologicalTherapeutics 2001; 24(6): 369-377.

Diapositiva 51 STRESS RESPONSES: INTERACTIONS WITH

VARIOUS BODY SYSTEMS1

1Morgan LG. Psychoimmunoneurology, the placebo effect and chiropractic. Journal of Manipulative and Physiological Therapeutics 1998; 21(7): 484-491.

Diapositiva 52 PSYCHONEUROENDOCRINE

STRESS RESPONSES1

1Rosner A. Infant and Child Chiropractic Care: An Assessment of Research. Norwalk, IA: Foundation for Chiropractic Education and Research, 2003, p. 11.

Diapositiva 53

6

Clinical Care Methods: Strength of Evidence as Determined by AHRQ1 (1 of 2)

1Bigos S, Bowyer O, Braen G, et al. Acute Low Back Pain in Adults: Clinical Practice Guideline No. 14. AHCPR Publication No. 95-0642. Rockville, 1994, Agency for Health Care Policy and Research, Public Health Service, U.S. Department of Health and Human Services.

Intervention Result Strength of Evidence

1. Patient Education + C2. Structured Patient Education: Back School + C 3. Acetaminophen + C4. NSAIDs + B5. Phenylbutazone - C6. Muscle Relaxants + C7. Opiod Analgesics + C8. Oral Steroids - B9. Colchicine - B

10. Antidepressants - B11. Spinal Manipulation + B12. Physical Agents/Modalities* -# C13. TENS - C

*Includes ice, heat [includingdiathermy], massage,ultrasound, cutaneous lasertreatment, and electrical stimulation excluding TENS.

# ”Insufficient proven benefit tojustify their cost.”

Diapositiva 54

7

Clinical Care Methods: Strength of Evidence as Determined by AHRQ1 (2 of 2)

1Bigos S, Bowyer O, Braen G, et al. Acute Low Back Pain in Adults: Clinical Practice Guideline No. 14. AHCPR Publication No. 95-0642. Rockville, 1994, Agency for Health Care Policy and Research, Public Health Service, U.S. Department of Health and Human Services.

Intervention Result Strength of Evidence

14. Shoe Insoles + C15. Shoe lifts [Lower Limb diff <2cm] - D16. Lumbar Corsets/Back Belts - D17. Traction - B18. Biofeedback - C19. Trigger Point Injections - C20. Ligamentous/Sclerosant Injections - C21. Facet Point Injections - C22. Epidural Injections^ [-Radiculopathy] - D23. Epidural Injections^ [+Radiuclopathy]~ + C24. Acupuncture - D25. Limited Activity + D26. Bed Rest >4 Days - B27. Conditioning Exercise + C

^Steroids, lidocaine, opioids.

~After failure of conservativetreatment as a means to avoidsurgery.

Diapositiva 55

ALTERNATIVE MEDICINE AND INFORME CONSENT: RULING OF NEW JERSEY SUPREME COURT IN MATTHIES CASE1

1. "The physician has a duty to disclose information that will enable a patient 'to consider and weighknowledgeably the options available and the risks attendant to each.“

2. “The decisive factor is not whether a treatment alternative is invasive or noninvasive, but whether the physician adequately presents the material facts so that the patient can make an informed de-cision....Otherwise, the patient, in selecting one alternative rather than another, cannot make a decision that is informed.“

3. "For consent to be informed, the patient must know not only of alternatives that the physician re-commends, but of medically reasonable alternatives that the physician does not recommend.

Otherwise, the physician, by not discussing these alternatives, effectively makes the choice for thepatient.“

4. "The negligence lies in the physician's failure to disclose sufficient information for the patient tomake an informed decision about the comparative risks of various treatment options."

5. "Social policy does not accept the paternalistic view that the physician may remain silent becausedivulgence might prompt the patient to forego needed therapy."

6. "The choice is not for the physician, but the patient in consultation with the physician. By not tellingthe patient of all medically reasonable alternatives, the physician breaches the patient's right to

make an informed choice."

1J. Pollock, writing for unanimous court, Jean Matthies v. Edward D. Mastromonaco, D.O., decided 07/08/99.

Diapositiva 56 GUIDELINES FOR MEDICAL TREATMENT, 18991

PRESENTING CONDITION RECOMMENDED THERAPY

Asthma Smoking [sometimes beneficial]Alcoholism Opium or hot water + sucking an orangeBaldness Application of ammonia to bare pate or

taking arsenic orallyCommon cold Inhalation of formaldehydeMale sexual urge [satyriasis] Sedative + alcoholFemale sexual urge [nymphoma- Sulfuric acid, camphor, or tobacco

nia]

1Merck's 1899 Manual, or the Materia Medica. New York, NY: Merck & Co., 1899.

Diapositiva 57 MEDICAL TREATMENT OPTIONS, 18991

PRESENTING CONDITION RECOMMENDED THERAPY

Typhoid fever Morphine, opium, cold bathsStrep infection [puerperal fever] Blood-letting, chloroformTuberculosis meningitis Iodine + turpentine massageDiphtheria Strychnine, ice and lemon juice OR

Diphtheria antitoxinMalaria QuinineHeart failure DigitalisDiabetes SaccharinCoughs CodeineInsomnia Chloral hydrateGout Colchicine

1Merck's 1899 Manual, or the Materia Medica. New York, NY: Merck & Co., 1899.

Diapositiva 58 WHERE DO WE GO FROM HERE?

Diapositiva 59 NUTRITIONAL SUPPLEMENTS: THE EARLY YEARS

Diapositiva 60 THE CONTINUING SEARCH FOR CLINICALLY

RELEVANT PARAMETERS1

“The so-called soft endpoints of sufferers’ own perceptions of parameters oftheir health are exactly what the research needs. Substitution of apparent-ly ‘hard’ surrogate markers is a more likely source of obfuscation.”

1Weze C, Leathard HL, Stevens G. Letter to the editor [response]. American Journal of Public Health2004; 94(7): 1074.

Diapositiva 61 EIGHT GREAT TRUTHS IN MEDICINE

1. The history of medicine is replete with examples of resistance to change and discarded therapies that now appear ludicrous, even at the risk of the patient’s health.1

2. Medicine is rooted in beliefs, not necessarily objective reality.1

3. The current model of medical diagnosis and treatment fails to adequately address the chronic disease burden affecting over 1/3 of the American population.1

4. More medical care is not necessarily better; in fact, in areas where there are more physicians and a higher cost of care, there is less patient satisfaction with poorer outcomes.2,3

5. The “gold standard” research tool—the RCT—lacks insight into lifestyle, nutritional interventions, and long-latency deficiency diseases.4

6. Heavy marketing of off-label uses of medication abounds.57. A positive bias exists in the medical literature due to the lack of publication of negative

medical trials.68. Funding of research by private industry leads to a financial conflict of interest resulting

in the suppression of results and/or incomplete or biased conclustions.71Hyman M. Paradigm shift: The end of “normal science” in medicine: Understanding function in nutrition, health, and disease. Alternative Therapies in Health and Medicine 2004; 10(5): 90-94.2Fisher ES. The implication of regional variations in Medicare spending, Part 2: Health, outcomes and satisfaction with care. Annals of Internal Medicine 2003; 138: 288-298.3Fisher ES. Medical care: Is more always better? New England Journal of Medicine 2003; 349(17): 1665-1667.4Heany R. Long-latency deficiency disease: Insights from calcium and vitamin D. American Journal of Clinical Nutrition 2003; 78: 912-919.5Fonda D. Curbing the drug marketers. Time 2004; 40-42.6Wolfe SM. Direct-to-consumer advertising: Education or emotion promotion? New England Journal of Medicine 2002; 346(7): 524-526.7Kassirer JP. Financial conflicts of interest in biomedical research. New England Journal of Medicine 993; 329L8): 570-571.

Diapositiva 62

TAKE-HOME MESSAGES IN CHIRO-PRACTIC PEDIATRICS RESEARCH

1. A considerable body of evidence exists to call into question the pre-vailing use of analgesics, NSAIDs, and tympanostomy procedures.

2. Robust outcomes evidence supports the further consideration of chi-ropractic management of back pain, headaches, otitis media, colic,enuresis, and perhaps asthma in childhood.

3. The role of chiropractic in relieving stress is supported by some ev-idence and is worth further study.

4. The integration of chiropractic care into mainstream medicine can bejustified by recent research.

5. Future research must address nutrition and clinically relevant out-come measures.

Diapositiva 63 CORRECT INTERPRETATION OF THE DATA

Diapositiva 64 SOMETIMES, NEW CONCEPTS DON’T ALWAYS GET

THE BEST RECEPTION AT FIRST

Diapositiva 65 STAND UP