Efficacy and tolerability of a complex homeopathic drug in children suffering from dry cough-A double-blind, placebo-controlled, clinical trial.

BACKGROUND: A randomised, placebo-controlled clinical trial in children suffering from acute dry cough was performed to assess the efficacy and tolerability of a complex homeopathic drug (Drosera, Coccus cacti, Cuprum Sulfuricum, Ipecacuanha=Monapax syrup, short: verum). METHODS: 89 children received verum and 91 received placebo daily for 7 days (age groups 0.5-3, 4-7 and 8-12 years). The primary efficacy variable was the improvement of the Cough Assessment Score. Tolerability and compliance were also assessed. A confirmatory statistical analysis was performed for the primary efficacy variable and a descriptive analysis for the secondary parameters. RESULTS: The Cough Assessment Score showed an improvement of 5.2±2.6 points for children treated with verum and 3.2±2.6 points in the placebo group (p<0.0001). The difference of the least square means of the improvements was 1.9±0.4. The effect size of Cohen´s d was d=0.77. In all secondary parameters the patients in the verum group showed higher rates of improvement and remission than those in the placebo group. In 15 patients (verum: n=6; placebo: n=9) 18 adverse drug reactions of mild or moderate intensity were observed. CONCLUSIONS: Administering verum resulted in a statistically significantly greater improvement of the Cough Assessment Score than the placebo. The tolerability was good and not inferior to that of the placebo.

Propiverine versus tolterodine: efficacy and tolerability in patients with overactive bladder.

OBJECTIVES: Propiverine and tolterodine were compared with respect to efficacy, tolerability and impact on the quality of life in the treatment of patients with idiopathic detrusor overactivity. METHODS: In a randomised, double-blind, multicentre clinical trial, patients with idiopathic detrusor overactivity were treated with 15 mg propiverine twice daily or 2mg tolterodine twice daily over a period of 28 days. The maximum cystometric capacity was determined at baseline and after 4 weeks of therapy. The difference of both values was used as the primary endpoint. Secondary endpoints were voided volume per micturition, evaluation of efficacy (by the investigator), tolerability, post void residual urine, and quality of life. RESULTS: The mean maximum cystometric capacity increased significantly (p < 0.01) in both groups. The volume at first urge and the frequency/volume chart parameters also showed relevant improvements during treatment. 42/100 patients in the propiverine group and 43/102 in the tolterodine group experienced adverse events. The most common adverse event, dry mouth, occurred in 20 patients in the propiverine group and in 19 patients in the tolterodine group. The scores for the quality of life improved comparably in both groups. CONCLUSION: The study demonstrates comparable efficacy, tolerability, and improvement in the quality of life of 15 mg propiverine twice-daily and 2mg tolterodine twice-daily in the treatment of the symptoms of idiopathic detrusor overactivity.