Effectiveness of Adjunctive Mother Tinctures to Individualized Homeopathic Treatment of Chronic Obstructive Pulmonary Diseases: An Open Randomized Pragmatic Pilot TrialFunding We received no funding for the project. The institution has no role to play in analysis of the study results and publication of the paper.
09 April 2020 (online)
Background We evaluated whether adjunctive mother tinctures (MTs) to individualized homeopathy (IH) have significant effect beyond IH alone in treatment of chronic obstructive pulmonary diseases (COPD).
Methods An open, randomized (1:1; IH + MT versus IH only), two parallel arms, pragmatic trial (n = 60) was conducted at National Institute of Homoeopathy, India. Primary outcomes were forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and FEV1/FVC, measured at baseline and 6 months; secondary outcomes were Bengali COPD assessment test (CAT-B) questionnaire and (clinical COPD questionnaire) CCQ-B, measured at baseline, and after 3 and 6 months; and exacerbation frequencies during 6 months.
Results Five patients dropped out (IH + MT: 3, IH: 2). Though intragroup changes were significant, intergroup differences of spirometric changes over 6 months were nonsignificant (Mann Whitney U test); FEV1 (P 0–6 = 0.761), FVC (P 0–6 = 0.512), and FEV1/FVC (P 0–6 = 0.741). Over 3 and 6 months, differences of changes in CAT-B (P 0–3 = 0.553 and P 0–6 = 0.900) and CCQ-B (P 0–3 = 0.428 and P 0–6 = 0.953) scores were also nonsignificant. Exacerbation frequencies were nonsignificant between groups over 6 months (p = 1.000).
Conclusion Although adjunctive MTs to IH could not produce any treatment benefits in COPD, the trial being underpowered, cautious interpretation is necessary.
Trial registration CTRI/2018/04/013394.
AB, PS, SP, AC, JM, MK and SS: concept, design, literature search, data interpretation, and preparation of the article; AB, LN, SAB, AK and RG: clinical study and data acquisition; SSA and AB: data compilation, management and master chart preparation; SSA, AB, JM, MK and SS: data interpretation, statistical analysis and preparation of the article. All the authors reviewed and approved the final article.
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