Efficacy of homoeopathic treatment for diabetic distal symmetric polyneuropathy: A multicentric randomised double-blind placebo-controlled clinical trial.

BACKGROUND: In course of diabetes, some 20-90% of individuals eventually develop diabetic neuropathy. Looking at the disease burden research studies in Homoeopathy were conducted and have shown positive results. These studies were not robust enough to prove the efficacy of individualized homoeopathy. OBJECTIVE: To assess efficacy of individualized homoeopathic medicines in management of DDSP. METHODS: A multi-centric double-blind, placebo controlled, randomised clinical trial was conducted by the Central Council for Research in Homoeopathy at six centres with a sample size of 84. Based on earlier observational studies and repertorial anamnesis of DDSP symptoms 15 homoeopathic medicines were shortlisted and validated scales were used for evaluating the outcomes post-intervention. Primary outcome measure was change in Neuropathy Total Symptom Score-6 (NTSS-6) from baseline to 12 months. Secondary outcomes included changes in peripheral nerve conduction study (NCS), World Health Organization Quality of Life BREF (WHOQOL-BREF) and Diabetic Neuropathy Examination (DNE) Score at 12 months. RESULTS: Data of 68 enrolled cases was considered for data analysis. Statistically significant difference (p<0.014) was found in NTSS-6 post intervention in the Verum group. Positive trend was noted for Verum group as per the graph plotted for DNE score and assessment done for NCS. No significant difference was found between the groups for WHOQOL-Bref. Out of 15 pre-identified homoeopathic medicines 11 medicines were prescribed in potencies in ascending order from 6C to 1M. CONCLUSION: Further studies must be taken up with larger sample size and defined parameters for NCS to assess the effectiveness of homoeopathy.

Management of early years of simple and mucopurulent chronic bronchitis with pre-defined Homoeopathic medicines ­ a Prospective Observational Study with 2-Years Follow-Up

Background Simple and mucopurulent chronic bronchitis (SMCB) is characterized by recurrent mucoid or mucopurulent expectoration in absence of localized suppurative disease. This observational open label study was undertaken to evaluate the effects of homeopathic medicine in SMCB. Methods 1902 patients were screened from 07 centres out of which 1305 were excluded. 597 patients were enrolled as per the inclusion and exclusion criteria. A total of 14 pre-defined homeopathic medicines were shortlisted for prescription after repertorizing the pathological symptoms of SMCB. Outcomes were assessed through chronic bronchitis symptom scale (CBSS) and FEV1/ FVC ratio with spirometry for over a period of two years. Appearance of any change (relief/ worse)/ status quo was immediately followed by placebo/ change in dilution/ change in remedy. Statistical analysis was done using SPSS version 20. Results: 532 patients were analyzed based on the intention to treat principle using last observation carry forward method. Mean CBS score reduced from 29.86±4.5 at baseline to 12.33±7.6 at completion of 2 years. Repeated measures ANOVA, at time points 0 (baseline), 3, 6, 9, 12 ,15, 18, 21 and 24 months, showed significant reduction in CBS scores [Wilk's Lambda 0.104, F=564, df 524; p=00001]. The FEV1 and FEV1/FVC was maintained within normal limits. 86% prescriptions included Lycopodium, Arsenicum album, Pulsatilla, Phosphorus, Stannum metallicum, Calcarea carbonica, Silicea, Bryonia alba. Conclusion: The result suggests effectiveness of homeopathic treatment in early years of SCMB patients. Controlled trials are warranted. (AU)