Efficacy of Dioscorea villosa 6CH in treatment of dyslipidemia: A double-blind, randomized, placebo-controlled, clinical trial

Abstract

Background: Keeping in view the current scenario of increasing risk of dyslipidemia leading to coronary heart diseases in Indian population and dearth of conclusive evidences in support of homeopathic treatment of dyslipidemia, we intended to evaluate the efficacy of a frequently prescribed medicine Dioscorea villosa 6CH in comparison with placebo. Methods: In this prospective, double-blind, randomized, parallel arm, placebo-controlled trial, 100 patients diagnosed with dyslipidemia were randomized in 1:1 ratio to one of the two interventions – D. villosa 6CH or identical looking placebo in the mutual context of lifestyle modification advices. The outcome measure was the blood lipid profile – triglyceride, total cholesterol (TC), low-density lipoprotein cholesterol (LDLc), very LDLc (VLDLc), and high-density lipoprotein cholesterol (HDLc), assessed at baseline and 2 months after intervention. Comparative analysis was conducted on intention-to-treat basis to detect group differences using SPSS. Results: The groups were comparable at baseline. After 2 months of intervention, pre–post comparison showed significant changes in triglyceride, TC, and VLDLc in the verum group and triglyceride, TC, and LDLc in the placebo group; however, the group differences were non-significant: triglyceride (P = 0.809), TC (P = 0.316), HDLc (P = 0.430), LDLc (P = 0.192), and VLDLc (P = 0.251). Per protocol analysis also revealed similar non-significant trends. Conclusion: D. villosa 6CH could not produce any differentiable effect from placebo in treatment of dyslipidemia. Trial registration: Clinical Trials Registry – India/2018/04/013511.