Homotoxicological remedies versus desmopressin versus placebo in the treatment of enuresis: a randomised, double-blind, controlled trial.
The aim of this trial was to compare the safety and efficacy of homotoxicological remedies versus placebo and versus desmopressin (dDAVP) in the treatment of monosymptomatic nocturnal enuresis (MNE). We conducted a randomised, double-blind, double-dummy, controlled trial in which 151 children with MNE were randomly assigned to receive oral homotoxicological remedies (n = 50), dDAVP (n = 50) or placebo (n = 51). The primary outcomes were: the reduction of wet nights per week after 3 months of therapy; the evaluation of the numbers and percentages of non-responders and responders; the number of children relapsing after initial response and the number of children attaining 14 consecutive dry nights during the treatment. The secondary outcome was the detection of adverse effects. Baseline clinical characteristics were similar in the three groups of patients. After the 3 months of therapy there was a significant difference between the three groups (P < 0.001) in the mean number of wet nights per week. The daily dose of dDAVP produced a statistically significant decrease (62.9%) in wet nights compared to placebo (2.4%) (P < 0.001) and compared to homotoxicological remedies (30.0%) (P < 0.001). There was a significant decrease in wet nights among the group treated with homotoxicological medications if compared with placebo (P < 0.001). The full response achieved with homotoxicological remedies (20%) was superior if compared with placebo (0%) (P < 0.001). Homotoxicology was superior to placebo (P < 0.001) with regard to the number of children attaining 14 consecutive dry nights during treatment. Our study demonstrates that homotoxicology is safe and effective when compared with placebo, even if it is significantly less effective than dDAVP in this clinical condition.
Ferrara
Pietro
P
Department of Paediatric Sciences, Università Cattolica S. Cuore, A. Gemelli Hospital, Largo A. Gemelli, 8, 00168, Rome, Italy. pferrara@rm.unicatt.it
Marrone
Giuseppina
G
Emmanuele
Valentina
V
Nicoletti
Alessandro
A
Mastrangelo
Antonio
A
Tiberi
Eloisa
E
Ruggiero
Antonio
A
Fasano
Alfonso
A
Paolini Paoletti
Fabrizia
F
D000284:Administration, Oral; D000293:Adolescent; D050034:Antidiuretic Agents / Q000627:therapeutic use*; D002648:Child; D003894:Deamino Arginine Vasopressin / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006705:Homeopathy; D006801:Humans; D008297:Male; D053206:Nocturnal Enuresis / Q000188:drug therapy* / Q000503:physiopathology; D010919:Placebos; D016896:Treatment Outcome; D014554:Urination / Q000187:drug effects
D050034:Antidiuretic Agents; D010919:Placebos; D003894:Deamino Arginine Vasopressin