An open-label randomized pragmatic non-inferiority pilot trial comparing the effectiveness of Curare 30CH against individualized homeopathic medicines in post-stroke hemiparesis
| Autor: | Subhranil Saha, Usha Uchat, Abhijit Chattopadhyay, Anaitulah Ahmad Mir, Jaytilak Pramanick, Munmun Koley |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
business.industry Context (language use) Homeopathy medicine.disease Confidence interval 030205 complementary & alternative medicine 03 medical and health sciences Curare 0302 clinical medicine Hemiparesis Complementary and alternative medicine Paralysis Physical therapy Medicine 030212 general & internal medicine medicine.symptom business Complication Stroke medicine.drug |
| Zdroj: | Advances in Integrative Medicine. 7:79-88 |
| ISSN: | 2212-9588 |
| DOI: | 10.1016/j.aimed.2019.06.002 |
| Popis: | 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 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. |
| Databáze: | OpenAIRE |
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