A Randomized Open Comparative Clinical Trial on the Effectiveness, Safety and Tolerability of a Homeopathic Medicinal Product for the Treatment of Painful Teething in Children

摘要

Background: Homeopathic products are sold over the counter and are often used for treatment of self-limiting complaints in children such as painful teething. Objective: To investigate the effectiveness, safety and tolerability of the homeopathic product ChamBell-5-02, in the treatment of children with painful teething in comparison to another homeopathic product. Design: A multicenter, randomized, open, comparative clinical trial with two parallel treatment groups at three outpatient pediatric clinics in Russia. Methods: Children aged ≤ six years with painful teething were enrolled from March-July 2009 in the study and randomized to receive either ChamBell-5-02 tablets (Dentokind®; intervention group) or homeopathic suppositories (Viburcol®; control group). Exclusion criteria were: fever of ≥38°C and severe comorbidity. Primary effectiveness endpoints were change of total severity scores of subjective complaints (TSSC) and clinical signs (TSCS) rated by investigators after seven days of treatment. Treatment satisfaction and safety (via number of adverse events (AEs)) were assessed. Results: A total of 200 children (100 per group) were included and analyzed. TSSC/ TSCS decreased after the 7- day treatment period from median 7.0 to 1.0/6.0 to 1.0 points in the intervention group and from median 5.0 to 1.0/5.5 to 1.0 points in the control group. Compared to the control group children receiving ChamBell-5-02 had about five/2.5 time higher odds of showing improvement (TSSC/TSCS: odds ratio resulting from proportional odds model was 5.1 (95%-CI: 2.7-9.4, p<0.0001) / 2.5 (95%-CI: 1.5-4.4, p=0.0011). Furthermore the intervention group showed a more favorable outcome regarding treatment satisfaction (ratings very satisfied: intervention group: n=94; control group: n=58). No AEs were recorded in the intervention group. In the control group three mild to moderate, nonserious AEs occurred. Conclusions: Overall it can be concluded that in this study ChamBell-5-02 tablets showed to be effective, safe and well tolerated.