Efficacy of individualized homeopathic medicines in treatment of lumbar spondylosis: Double-blind, randomized, placebo-controlled clinical trial

Lumbar spondylosis (LS) is a degenerative disorder of the lumbar spine. Despite substantial research efforts, no gold-standard treatment for LS has been identified. The efficacy of individualized homeopathic medicines (IHMs) in LS has remained under-researched. In this study, the efficacy of IHMs was compared with identical-looking placebos in the treatment of LS. A double-blind, randomized (1:1), placebo-controlled trial was conducted at the National Institute of Homoeopathy, West Bengal, India. Patients were randomized to receive IHMs or identical-looking placebos, along with standardized concomitant care for both the groups. The Oswestry low back pain and disability questionnaire (ODQ) was the primary outcome; the Roland Morris questionnaire (RMQ) and the short form McGill pain questionnaire (SF-MPQ) were the secondary outcomes; each was measured at baseline and every month for 3 months. The intention-to-treat (ITT) sample was analyzed to detect any inter-group differences using two-ways repeated measures analysis of variance models overall and by unpaired t-tests at different time points. Enrolment was stopped prematurely because of time restrictions; 55 patients were randomized (verum: 28; control: 27); 49 were analyzed by ITT (verum: 26; control: 23). Inter-group differences in ODQ, RMQ and SF-MPQ total scores at 3 months were not statistically significant. SF-MPQ total score after 2 months revealed statistical significance, favoring IHMs against placebos. Some of the SF-MPQ subscales at different time points were also significant. Rhus toxicodendron, Sulphur and Pulsatilla nigricans were the most frequently indicated medicines. Owing to failure in detecting a statistically significant effect for the primary outcome and in recruiting a sufficient number of participants, our trial remained inconclusive.