An open-label randomized pragmatic non-inferiority pilot trial comparing the effectiveness of Curare 30CH against individualized homeopathic medicines in post-stroke hemiparesis

Abstract

BackgroundPost-stroke hemiparesis is the most common complication following stroke. Due to unsatisfactory results from conventional treatment, alternative treatments including homeopathy are increasingly becoming popular. Curare is the one of the recommended homeopathic medicine prescribed on ‘common symptoms’ of motor paralysis, but has not been researched systematically. We hypothesized that Curare 30CH would be non-inferior to individualized homeopathy (IH) in treatment of post-stroke hemiparesis in the context of standard physiotherapy. MethodsAn open, randomized (1:1), exploratory, two parallel arms, pragmatic, non-inferiority, pilot trial was conducted at the Homoeopathic Materia Medica out-patient departments of National Institute of Homoeopathy (NIH), India on 50 patients comparing the effectiveness of Curare 30CH against IH. Comparative analysis was carried out on the primary outcome to detect non-inferiority by one-tailed t test at alpha = 5% with a prefixed margin (Δ) of 1.0 based on assumption. Oxford muscle strength grading scale and stroke impact scale (SIS) questionnaires were the primary and secondary outcomes respectively; assessed at baseline, after 3 and 6 months of treatment. ResultsFive subjects dropped out (Curare: 3, IH: 2). Groups were comparable at baseline (all P > 0.01). In both groups, both the outcomes improved significantly after 3 and 6 months. Non-inferiority was demonstrated by Curare 30CH against IH, both over 3 months (mean difference = 0.04, lower 95% confidence limit −0.195, t = 7.429, P < 0.001) and 6 months (mean difference = −0.2, lower 95% confidence limit −0.474, t = 4.899, P < 0.001). No adverse events were reported from either group. ConclusionBoth therapies seemed to produce comparable effects, and appeared as safe, still, being a pilot trial, no definite conclusion could be drawn. Further exploration of both efficacy and effectiveness of either of the therapies is necessary by adequately powered trials and independent replications.