A double-blind, randomized, placebo-controlled trial of individualized homeopathic medicinal products in the treatment of nocturnal enuresis in children

Abstract

Context: Nocturnal enuresis (NE) is a very common problem in childhood. The prevalence rate varies from 3.5% to 56.4% in different geographical regions and countries. Objective: Homeopathy is claimed to be a safe and effective mode of complementary and alternative therapy; however, robust research evidence supporting the efficacy or effectiveness of homeopathy in NE is scarce. This trial aimed at detecting the group differences between homeopathy and placebo in the treatment of NE in children. Design: Three-month, double-blind, randomized (1:1), placebo-controlled trial. Setting: Pediatric outpatient department of D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal. Patients: One hundred and forty children suffering from NE. Interventions: Active treatment (individualized homeopathic medicinal products, IHMPs plus concomitant care, CC; n = 70) versus control (identical-looking placebos, plus CC; n = 70). Main outcome measures: Primary – the frequency of bedwetting events between groups; secondary – the pediatric quality of life inventory (PedsQL, version 4.0) questionnaire and its subscales – child-rated and parent-rated versions; all were measured at baseline, and every month, up to 3 months. Results: After 3 months of intervention, group differences were statistically significant in the primary outcome favoring IHMPs against placebo (median difference: 2.4, interquartile range -4 to 9.7, Mann Whitney U = 1956.5, p = 0.039). Although the intra-group median reductions were higher in the IHMPs group than in placebos, the differences were statistically non-significant in the secondary outcome – PedsQL total child report version (p = 0.224) and PedsQL total parent report version (p = 0.942). Sulphur (n = 26, 18.6%), Calcarea phosphorica (n = 20, 14.3%), Calcarea carbonica and Kreosotum (n = 9 each, 6.4%), and Mercurius solubilis (n = 8, 5.7%) were the most frequently prescribed medicines. Thus, IHMPs were found superior to placebos in reducing the frequency of bedwetting events in children. Independent replications are warranted to substantiate the findings. Clinical Trials Registry – India CTRI/2022/04/042009.