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 sputum production in absence of localized suppurative disease. This observational open label study was undertaken to evaluate the effects of homoeopathic medicine in SMCB. Methods: 1902 patients were screened from 07centres 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 changes in symptoms score using chronic bronchitis symptom scale (CBSS) and changes in FEV1/ FVC ratio using spirometry 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 21. Results: 532 patients were analyzed under 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 homoeopathic treatment in early stage of SCMB patients. However, controlled trials are required for further validation.