Explore (NY). 2022 Aug 29:S1550-8307(22)00160-4. doi: 10.1016/j.explore.2022.08.017. Online ahead of print.
ABSTRACT
BACKGROUND: Hemiparesis is a serious motor impairment following stroke and affecting around 65% of stroke patients. This trial attempts to study the efficacy of individualized homeopathic medicines (IHMs) in comparison with identical-looking placebos in treatment of post-stroke hemiparesis (PSH) in the mutual context of standard physiotherapy (SP).
METHODS: A 3-months, open-label, randomized, placebo-controlled trial (n = 60) was conducted at the Organon of Medicine outpatient departments of National Institute of Homoeopathy, West Bengal, India. Patients were randomized to receive IHMs plus SP (n = 30) or identical-looking placebos plus SP (n = 30). Primary outcome measure was Medical Research Council (MRC) muscle strength grading scale; secondary outcomes were Stroke Impact Scale (SIS) version 2.0, Modified Ashworth Scale (MAS), and stroke recovery 0-100 visual analogue scale (VAS) scores; all measured at baseline and 3 months after intervention. Group differences and effect sizes (Cohen’s d) were calculated on intention-to-treat sample.
RESULTS: Although overall improvements were higher in the IHMs group than placebos with small to medium effect sizes, the group differences were statistically non-significant (all P>0.05, unpaired t-tests). Improvement in SIS physical problems was significantly higher in IHMs than placebos (mean difference 2.0, 95% confidence interval 0.3 to 3.8, P = 0.025, unpaired t-test). Causticum, Lachesis mutus, and Nux vomica were the most frequently prescribed medicines. No harms, unintended effects, homeopathic aggravations or any serious adverse events were reported from either group.
CONCLUSION: There was a small, but non-significant direction of effect favoring homeopathy against placebos in treatment of post-stroke hemiparesis.
TRIAL REGISTRATION: CTRI/2018/10/016196; UTN: U1111-1221-7664.
PMID:36115790 | DOI:10.1016/j.explore.2022.08.017
