Homeopathic treatment in addition to standard care in multi drug resistant pulmonary tuberculosis: a randomized, double blind, placebo controlled clinical trial

Background: Multi drug resistant-tuberculosis (MDR-TB) [resistant to Isoniazid and Rifampicin] is a major global public health problem. In India the incidence is rising in spite of implementation of Revised National Tuberculosis Control Program. Standard MDR-TB drugs are second generation antibiotics taken for 24–27 months. The present study was undertaken to evaluate the efficacy of add on homeopathic intervention to the standard MDR-TB regimen (SR).

Methods: A randomized, double blind, placebo controlled study was conducted from 2003 to 2008. 120 diagnosed MDR-TB patients (both culture positive and negative) were enrolled and randomized to receive Standard Regimen + individualized homeopathic medicine (SR + H) or Standard Regimen + identical placebo (SR + P). The medicines have been used in infrequent doses. The outcome measures were sputum conversion, changes in chest X-ray (CXR), hemoglobin, erythrocyte sedimentation rate (ESR), weight gain, and clinical improvement.

Results: There was an improvement in all the outcome measures as per intention to treat (ITT) and per protocol (PP) analyses. ITT analyses revealed sputum culture conversion from positive to negative in 23 (38.3%) in SR + H; 23 (38.3%) patients in SR + P group; (p = 0.269) and 27 (55.1); 21 (42.8%), p = 0.225 as PP analyses. The mean weight gain in SR + H group was 2.4 ± 4.9 and in SR + P was 0.8 ± 4.4; [p = 0.071], reduction in ESR in SR + H was −8.7 ± 13.2; SR + P was 3.9 ± 15.4 [p = 0.068]. The mean increase in hemoglobin was by 0.6 ± 1.7 in SR + H & 0.3 ± 2.3 [p = 0.440] in SR + P group at 95% confidence interval. Statistically significant improvement was seen in CXR in 37 (61.7%) in SR + H and 20 (33.3%) patients in SR + P group (p = 0.002).

Subgroup analyses of culture positive patients showed statistically significant improvement in CXR (p = 0.0005), weight gain (p = 0.026), increase in hemoglobin (p = 0.017) and reduction in ESR (p = 0.025) with add on homeopathy. The cure rate was 11.4% more in SR + H group as compared to placebo group. Change in sputum culture conversion, was not statistically significant.

Conclusion: Add on homeopathy in addition to standard therapy appears to improve outcome in MDR-TB. Larger scale studies using a standardized homeopathic treatment regime should be conducted.

Keywords

Multi drug resistant-tuberculosis (MDR-TB) - Standard MDR-TB regimen randomized - Double blind - Placebo controlled trial - Sputum conversion - Radiological changes - Add on homeopathy - Efficacy

• References

• 1 India, Ministry of Health & Family Welfare, Central TB Division. Revised National Tuberculosis Control Programme: Guidelines on Programmatic Management of Drug Resistant TB (PMDT) in India. 2012. Ministry of Health & Family Welfare; New Delhi:
• 2 WHO. Global tuberculosis report 2012. 2012. World Health Organization; Geneva:
• 3 India, Ministry of Health & Family Welfare, Central TB Division. DOTS Centers. Organizational – Structure. Available from: http://www.dotsdelhi.org/India ;2011.
• 4 India, Ministry of Health & Family Welfare, Department of AYUSH. AYUSH in India. Available from: http://www.indianmedicine.nic.in/
• 5 Goyal K.K.. Case report of pulmonary tuberculosis. Br Hom J, Simile 4 (02) 1994; April 14-16.
• 6 Goyal K.K.. Case report of collapsed lung with emphysema. Br Hom J, Simile 6 (02) 1996; April 9-12.
• 7 Goyal K.K.. Two cases of pulmonary TB treated with homoeopathy. Homeopathy 2002; 91: 43-46.
• 8 WHO. Treatment of tuberculosis. Guidelines for National programmes. 2003. Available from: http://whqlibdoc.who.int/publications/
• 9 Rastogi D.P.. Homeopathic treatment of multi drug resistance tuberculosis patients. Abstracts of 60th Congress of LMHI, Berlin 2005
• 10 World Medical Association Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects. 48th WMA General Assembly, Somerset West, Republic of South Africa. 1996. October Available from: http://www.wma.net/en/30publications/
• 11 India, Ministry of Health & Family Welfare, Central TB Division. DOTS Centers. Intermediate – Reference Laboratory. Available from: http://www.dotsdelhi.org/India ;2011
• 12 American Thoracic Society. National Tuberculosis Association of the USA. Diagnostic standards and classification of tuberculosis. 1961. National Tuberculosis Association; New York:
• 13 Joseph P., Desai B.R.D., Mohan N.S., Fredrick J.S., Ramachandran R., Raman B.. et al. Outcome of standardized treatment for patients with MDR-TB from Tamil Nadu, India. Indian J Med Res 133 (05) 2011; May 529-534.
• 14 Park K.. Health information and basic medical statistics. 19th edn Textbook of Preventive and Social Medicine. 2007. M/S Banarsidas Bhanot Publishers; India: 706 Chap 18
• 15 Hedwiga F.S., Ferdinand M.M., Mbwambo J.K.. Sputum smear negative pulmonary tuberculosis: sensitivity and specificity of diagnostic algorithm. BMC Res Notes 2011; 4: 475
• 16 Hinshaw H.C.. Diagnosis of tuberculosis. 3rd edn Diseases of the Chest. 1969. W.B. Saunders Company; Asian Philadelphia: 541 Chap 27
• 17 Raviglione M.C., O'Brien R.J., Fauci A.S.. et al. Tuberculosis. 14th edn Harrison's Principles of Internal Medicine. Vol I 1998. Mc-Graw Publishers; New York: 1004-1006 Chap 171
• 18 Dabbagh K., Lewis D.B.. Toll-like receptors and T-helper-1/T-helper-2 responses. Cur Opin Infect Dis 2003; 16: 199-204.
• 19 Lee C.G., Kang F.R., Homer R.J., Chupp G., Elias J.A.. Transgenic modeling of transforming growth factor-β1 – role of apoptosis in fibrosis and alveolar remodeling. Am Thorac Soc 3 (05) 2006; July 418-423.
• 20 Kaushal D., Schroeder B.G., Tyagi S.. et al. Reduced immunopathology and mortality despite tissue persistence in a Mycobacterium tuberculosis mutant lacking alternative σ factor, SigH. PNAS 99 (12) 2002; June 8330-8335.
• 21 Chand K.S., Manchanda R.K., Batra S., Mittal R.. Homeopathy in the treatment of tubercular lymphadenitis (TBLN) an Indian experience. Homeopathy 100 (01) 2011; 157-167.