Saturday, June 15, 2019

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

My God, what stupidity. Homeopathy has exactly no scientific evidence to back it up.  Comparing one useless homeopathic product to another is complete nonsense. And doing it during spontaneous recovery, in my opinion would be considered akin to fraud. Your choice on what to believe. 

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

UshaUchatb1AbhijitChattopadhyayc2Anaitulah AhmadMird3MunmunKoleye4SubhranilSahaf5

Abstract

Background

Post-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.

Methods

An 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.

Results

Five 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.

Conclusion

Both 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.
Trial registration: CTRI/2017/05/008532; UTN: U1111-1196-3761.

Keywords

Effectiveness
Homeopathy
Post-stroke hemiparesis
Non-inferiority trial
Curare
1
Reader, Dept. of Homoeopathic Materia Medica, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal, India.
2
Professor and Head, Dept. of Homoeopathic Materia Medica, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal, India.
3
Former Postgraduate Trainee, Dept. of Homoeopathic Materia Medica, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal, India.
4
Independent Researcher; Champsara, Baidyabati, Hooghly 712222, West Bengal, India.
5
Independent Researcher; 93/2/1, Shibpur Road, Shibpur, Howrah 711102, West Bengal, India.

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