Safety and Efficacy of Individualised Homeopathic Treatment in Sciatica – a Phase I Pre-Post Comparison Study
05 February 2020 (online)
Background: Cochrane reviews in 2008 and 2016 both showed that the efficacy of NSAIDs in sciatica for pain reduction and disability were comparable to placebo. A systematic review in 2011 failed to show any long-term benefit from surgery after 1–2 years. We developed a set algorithm for individualized homeopathic treatment, which can potentially contribute to the reproducibility of the method. The algorithm was developed based on the principles of classical repertorization of local and general symptoms and differential diagnosis of 10 commonly used remedies in sciatica.
Objectives: A phase I trial of a set of algorithms for sciatica is being conducted, in which the primary objective is to compare the difference in the pain intensity of sciatica patients at baseline, day 3, day 7 and at 1 month. The secondary objectives include comparing the effects on acute, sub-acute and chronic sciatica, documenting the frequency and direction of any modification of the standardized dosage regimen, any aggravation, adverse event, or rescue medications used.
An RCT focusing first on acute sciatica will be done when these data are available, and the potential for further studies in chronic cases will be revealed. The data from the study will be able to provide more information about the effect size and dosage regimen for a more sensitive RCT design.
Methods: A prospective observational single group pre-post comparison study is being carried out from April 2018 to April 2019. The pain score pre- and post- treatment will be compared to baseline using paired t-test (Normal distribution) or the Wilcoxon signed-rank test (non-Normal). Comparison with relevant controls in other studies will be referred in the discussion.
Results: In the data updated in January 2019, 42 participants had been recruited and 34 (81%) of them had finished the follow up at day 7. 64.5% of them reported improvement/significant improvement. The most commonly indicated remedies were Rhus toxicodendron, Colocynthis and Lycopodium clavatum, representing 45.2% of all prescriptions. 16.7% of the subjects had reported an aggravation; 2.4% had reported the use of rescue medications. The final results are due in May 2019.
Keywords: Homeopathy, sciatica, individualized, algorithm