Homeopathy as an Adjuvant to Homeopathy as an Adjuvant to Chemotherapy Improves Clinical Outcome Chemotherapy Improves Clinical Outcome in Relapsed Pulmonary Tuberculosisin Relapsed Pulmonary Tuberculosis

Presenting author: Dr. Presenting author: Dr. NehaNeha SharmaSharma

Authors: S. Sharma, RG Sharma, Chand KAuthors: S. Sharma, RG Sharma, Chand KNMP Medical Research Institute, Jaipur & NMP Medical Research Institute, Jaipur &

SawaliSawali TB Sanitarium, TB Sanitarium, SikarSikarRajasthan, IndiaRajasthan, India

BACKGROUND OF THE STUDYBACKGROUND OF THE STUDYTB is the Single largest infectious disease causing high mortality. Management is never simple endeavor, requires additional considerations in special situations like relapse, DR, MDRChemotherapy is successful , but prolonged, costly and need to be directly observed. Otherwise relapse, drug resistance emerges. Toxicities are frequentAdjunctive treatment Garlic,, herbs, nutrient supplements with anti-TB drugs found to be effective Antimicrobial Effect of Chloroformic Garlic Extract on Mycobacterium Tuberculosis (Pakistan Journal of Biological Sciences 9 (12): 2381-2383, 2006)

REVIEW OF LITERATUREREVIEW OF LITERATUREEffectiveness of homeopathy for upper respiratory tract complaints including allergies; lower respiratory tract complaints; or ear complaintsCase reports highlighted the successful use in Pulmonary TB. Evaluation of Homoeopathic drugs in the treatment of tuberculosis Nehru H. M. C. and Hospital, New Delhi.Homeopathic treatment of multidrug resistant tuberculosis patientsDP Rastogi11 New Delhi, IndiaRandomized trials: individualized homeopathy has an effect over placebo. The evidence, however, is not convincing because of methodological shortcomings and inconsistencies.

RESEARCH QUESTION RESEARCH QUESTION Can Homeopathy improve sputum conversion in Relapsed Pulmonary Tuberculosis Patients following Conventional treatment .Can homeopathy improve the quality of life in Relapsed Pulmonary Tuberculosis Patients following Conventional treatment .Can Homeopathy improve clinical symptoms(haemoptysis, cough, chest pain, fever, and night sweating) .Can Homeopathy bring about favorable modulation in weight, ESR and Hemoglobin.

SELECTION CRITERIASELECTION CRITERIAInclusion CriteriaInclusion Criteria

1. age of 18-60 years,2. Relapse pulmonary

tuberculosis* with acid-fast bacilli smear positive by microscopy, using ZiehlNeelsenstaining as recommended by WHO,

Exclusion CriteriaExclusion Criteria1. Pregnancy, any

concomitant disease I.e. diabetes mellitus, acute renal failure or

2. Infectious disease including TB/HIV and HIV positive,

3. Currently or taken any alternative therapies in past 6 months,

*patients declared cured after one full course of Chemo and remaining well for some time become sputum smear + with radioactive lesion.

MEASUREMENT MEASUREMENT

Clinical symptoms (haemoptysis, cough, chest pain, fever, and night sweating)Sputum AFB status by microscopy was recordedWeightBlood samples for Erythrocyte sedimentation rate and hemoglobin analyses Quality of life was assessed using SF 36

DESIGN OF STUDYDESIGN OF STUDY--Clinical, Randomized,Double Blind Placebo Clinical, Randomized,Double Blind Placebo

Control TrialControl Trial52 patients randomized

26 Homeopathy 26 Placebo

2 months intervention

Continued for 6 months of intervention

Follow up for3 months

24 completed 23 completed

STRATEGIESRecruitment Randomization Blinding: Double blind study Placebo control Measurement approach: standard tools

INTERVENTION INTERVENTION AntiAnti--TB ChemotherapyTB Chemotherapy

Conventional treatment was based on daily regimen with single dose empty stomach for 8 months For 2 months streptomycin along with R, Z, E, H. followed by HERZ 1 month with H,E and R.

Initial 2 mo1500 mg1200 mg800 mgZ

8 mo1000 mg800 mg600 mgE

8 mo600 mg450 mg300 mgR

8 mo300 mg300 mg300 mgINH

2 mo.daily1 gm0-75 gm0.75 gS

Time >50 kg30-50 kg<30 kg

INTERVENTION INTERVENTION Adjuvant therapy:Adjuvant therapy:HOMEOPATHYHOMEOPATHY

"It is more important to know what kind of person has a disease than what kind of disease a person has" - Sir William OslerCombinations of medicines ("complex homoeopathy") on the basis of conventional diagnosis and totality of symptoms. Build up a "symptom picture" of the patient. This is matched with a "drug picture" described in the homoeopathic Materiamedicaonly one or two doses or a regular daily dose was used according to patient’s constitution, temperament, and susceptibility.

Homeopathy: Drug picturePHOSPHORUS

Talk, Indisposed to be silent Heat vital lack of Desire for cold drinks HaemoptysisChest pain, lying on leftExpectoration L froathyNumbness : toesFever : Evening Perspiration : night

LYCOPODIUMCompany, desire for

Confidence, want of selfAppetite increased :afternoon Respiration : difficult, exertion after Cough : dry Chest pain, lying while

RESULTSRESULTSBaseline characteristics of relapsed TB patients Baseline characteristics of relapsed TB patients

treated with homeopathy or placebotreated with homeopathy or placebo

43.75%43.75%31.2531.2521%21%4 %4 %

50%50%28.25%28.25%18.75%18.75%3%3%

Work statusWork status

FarmingFarmingIndustries Industries Construction Construction Unemployed Unemployed

57.15 %57.15 %70%70%Educational status, Educational status, literateliterate

16/716/714/1014/10Sex M/FSex M/F, no., no.

31.13 31.13 ±± 4.874.8730.17 30.17 ±± 4.944.94Age yrs, mean Age yrs, mean ±± SDSD

Placebo groupPlacebo group(N=23)(N=23)

Homeopathy group Homeopathy group (N=24)(N=24)

Characteristic Characteristic

RESULTSRESULTSComparing Homeo and placebo at 0,2,8,11 mo.

2/122/12(0.000)(0.000)1/11 1/11 (0.001)(0.001)2/122/12(0.001)(0.001)21/2221/22Night sweat (+)Night sweat (+)

2.752.75±±1.111.114.524.52±±1.951.95(0.002)(0.002)

4.044.04±±1.041.045.175.17±±1.19 1.19 (0.005)(0.005)

5.755.75±± 1.39/1.39/6.56 6.56 ±± 1.441.44

7.467.46±±1.7/1.7/7.837.83±±1.51.5

Chest pain Chest pain (Mean (Mean ±±SD)SD)

3/113/11(0.009)(0.009)4/94/93/113/11(0.009)(0.009)18/2318/23Fever (freq)Fever (freq)

3/143/14(0.001)(0.001)3/33/33/233/23(0.000)(0.000)24/2324/23Cough(Severe) Cough(Severe)

1/101/10(0.002)(0.002)1/10 1/10 (0.002)(0.002)1/14 1/14 (0.000)(0.000)22/ 22/ 2222Haemoptysis(+)Haemoptysis(+)

21/1021/10(0.002)(0.002)21/11 21/11 (0.004)(0.004)19/1119/11(0.02)(0.02)0/00/0Sputum(Sputum(--))

11 mo.11 mo.H/P ( pH/P ( p<)<)

8 mo.8 mo.H/P ( pH/P ( p<)<)

2 mo.2 mo.H/P ( pH/P ( p<)<)

0 mo.0 mo.H/PH/P

parameterparameter

RESULTSRESULTSComparing Comparing HomeoHomeo and placebo at 0,2,8,11 moand placebo at 0,2,8,11 mo

3.423.42±±1.32/1.32/5.485.48±±2.862.86((pp< 0.01)< 0.01)

4.294.29±±0.46/0.46/6.306.30±±2.302.30(p(p<< 0.002)0.002)

5.625.62±±0.57/0.57/7.007.00±±1.831.83( p( p<0.02)<0.02)

7.677.67±±1.3/1.3/7.837.83±±1.21.2

BreathlessBreathless--nessness

9.879.87±±1.57/1.57/36.9136.91±±30.9630.96((pp< 0.05)< 0.05)

11.3311.33±±3.79/3.79/37.1737.17±±27.6427.64((pp< 0.001)< 0.001)

49.5849.58±±6.76/6.76/66.1766.17±±9.619.61( p( p<0.001)<0.001)

75.4675.46±±8.73/8.73/74.2174.21±±6.716.71

ESR ESR Mm/hrMm/hr

11.8711.87±±0.80/0.80/9.959.95±±1.461.46((pp< 0.000)< 0.000)

11.1211.12±±0.85/0.85/9.219.21±±0.800.80((pp< 0.000)< 0.000)

9.759.75±±1.26/1.26/9.169.16±±1.241.24

8.888.88±±1.29/1.29/9.089.08±±1.191.19

HbHbgm%gm%

50.1750.17±±3.64/3.64/41.4841.48±±4.064.06((pp< 0.000)< 0.000)

46.2146.21±±3.23/3.23/41.0441.04±±4.264.26((pp< 0.000)< 0.000)

43.0043.00±±4.30/4.30/39.6539.65±± 4.424.42( p( p<0.01)<0.01)

41.6241.62±±4.58/4.58/40.3940.39±±4.634.63

Weight/kgWeight/kg

11 mo.11 mo.H/PH/P

8 mo.8 mo.H/PH/P

2 mo.2 mo.H/PH/P

0 mo.0 mo.H/PH/P

ParameterParameter

RESULTS Quality of life

58.6158.61±±14.38 0.00014.38 0.00085.0485.04±±8.898.89Role limitation emotional Role limitation emotional

64.5264.52±±12.71 0.00012.71 0.00080.5880.58±±7.367.36Role limitation physical Role limitation physical

62.3062.30±± 14.44 0.00014.44 0.00079.8379.83±±10.9510.95Mental health Mental health

72.2272.22±±10.63 0.00010.63 0.00084.8784.87±±7.997.99Social function Social function

65.6965.69±±12.60 0.00012.60 0.00079.8379.83±±15.9915.99Vitality/energyVitality/energy

69.3669.36±±18.43 0.00018.43 0.00087.5087.50±±8.528.52General health General health

63.7463.74±±7.10 0.0007.10 0.00074.4274.42±±10.3410.34Body pain Body pain

56.3056.30±± 13.76 0.00013.76 0.00080.3380.33±±8.728.72Physical functionPhysical function

Placebo p value Placebo p value HomeopathyHomeopathySF 36 domain SF 36 domain

Change in the symptoms change in symptoms

0

5

10

15

20

25

30

H hemopt ysis P Hemopt ysis H cough P cough

0

2

8

11

Change in the symptoms change in symptoms

0

5

10

15

20

25

H f ever P f ever H nigh swaet ing P Night swaet ung

0

2

8

11

Change in weight and sputumwei ght gai n and sput um conevr si on

0

10

20

30

40

50

60

0 2 8 11

mo n t h s

H Wei ght

P wei ght

H sputum

P sputum

Change in the Hematology

0

10

20

30

40

50

60

70

80

0 2 8 11

H ESR

P ESR

H HB

P HB

Comparing quality of life change in quality of life

0

10

20

30

40

50

60

70

80

90

100

1 2 3 4 5 6 7 8

domain of SF 36

scor

e of

SF

36

Homeopathy group

Placebo group

1-physical function, 2-body pain, 3-general health, 4-vitality/energy, 5-social functioning, 6-mental health, 7-role limitation physical, 8-role limitation emotional.

DISCUSSION Homeopathy supplementation has a significant Homeopathy supplementation has a significant andand favorable effect on favorable effect on weight gain, sputum weight gain, sputum conversionconversion, and , and reduction of symptoms like reduction of symptoms like coughcough. . Reduced coughReduced cough and and increased Mycobacterial increased Mycobacterial clearanceclearance in Sputum observed at 2 month. in Sputum observed at 2 month. There wasnThere wasn’’t any significant side effect or t any significant side effect or worsening symptoms were recordedworsening symptoms were recorded.

STREANGTH OF STUDY Homeopathy in the form in which it is commonly practiced rather than in a form specially modified for clinical trials. More than one homeopath, as negative result might have been attributed to lack of competence of a single therapist. Study design Good adherence

WEAKNESS OF STUDY Limitations of sputum culture of the study populationShorter follow up period of 3 monthsStudy design would have been improved by conducting sample size calculation, by stratifying by tuberculosis conditions, and by choosing outcome measures (or modifying those used) to be more sensitive to change.

WHAT’S NEXT?

Resistance or multi drug resistance Longer follow up Comparing different approach of Homeopathy

Questions? Comments?Questions? Comments?

NMP Medical Research InstituteDr. Neha Sharma 59- A Mahadev Nagar, Dundlod HouseBais Godam, Jaipur, Rajasthan, India 91-09829395513nehabhatra@yahoo.com