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.

The actual role of sodium cromoglycate in the treatment of asthma--a critical review.

INTRODUCTION: Despite international consensus and clearly written guidelines urging wider use of corticosteroids or combinations of inhaled short- and long-acting ß-agonists (SABA and LABA) and corticosteroids in persistent asthma, prescribing patterns and compliance rates fall far short of recommendations. OBJECTIVES: The failure to use steroids more aggressively is due, in part, to their side effects, even with inhaled forms of the drug. There is a role for expanded use of sodium cromolyn in asthma. Its potent anti-inflammatory effects, lack of side effects, and acceptable dosing and method of delivery, as well as its special role in exercise-induced asthma, make it a very suitable choice in the initial therapy for control of asthma. CONCLUSION: Compared to SABA and LABA, cromoglycates alone are unsuspicious of being used to enhance physical performance.