Dialog II: Clinical double-blind study in children with unspecific diarrhoea. Experiences with a preparation of apple pectin – camomile extract

Background

Acute diarrhoea is one of the most common childhood diseases. The main therapeutic aim consists in oral rehydration using a glucoseelectrolyte solution. Results from a previous study (DIALOG I) investigating the adjuvant treatment with a medicinal preparation containing apple pectin and camomile extract (Diarrhoesan®) indicated a significantly reduced duration of diarrhoea in children. The objective of the present clinical placebo-controlled double-blind study (DIALOG II) was to assess the clinical efficacy and tolerability of the apple pectin – camomile extract on a larger number of patients.

Patients

255 patients with acute diarrhoea, aged between 6 month and 6 years, were treated on an outpatient basis with either Diarrhoesan® or placebo. In addition, each child received a glucose-electrolyte solution on the first day of treatment.

Results

The primary outcome included a combined analysis of stool frequency, stool consistency on the 3^rd and 5^th day of treatment and duration of diarrhoea. Statistical analysis revealed a significantly reduced stool frequency of the treatment group compared to placebo thus demonstrating a superior efficacy of the tested preparation over placebo.

Conclusion

These findings confirm the concept of a beneficial influence of the investigated vegetable extract (Diarrhoesan®) shortening the course of the disease and relieving associated symptoms.