Treatment effectiveness of two Chinese herbal medicine formulae in upper respiratory tract infections: a randomized double-blind placebo-controlled trial

Abstract

Aim and objectives To study the effect of two Chinese herbal medicines (CHMs) formulae in treating acute upper respiratory tract infections (URTIs), diagnosed by Traditional Chinese medicine (TCM), compared to placebo. Design Two randomized, double-blind placebo-controlled trials nested in a study of 327 patients who were diagnosed with URTIs in Hong Kong. Subjects were classified into one of two TCM syndrome groups by a Chinese medicine practitioner and randomized to receive the corresponding CHM formulae or placebo up to maximum of 10 days. The proportions of patients who had resolution of illness on Days 4 and 7 were the primary outcomes. The duration of symptom resolution, health-related quality of life scores measured by the SF-36 and ChQOL, and adverse effects were secondary outcomes. Results There was no statistically significant difference between the treatment and placebo in resolution rates at Day 4 or 7. The mean time of resolution of symptoms was Day 10, for either wind-cold or wind-heat syndrome. Both patients in treatment and placebo had significantly improved in health-related quality of life with time, but patients in wind-cold group had significantly more improvement in the SF-36 general health score (P = 0.01) than placebo. Conclusions Two CHM formulae commonly used for URTIs were not found to be more effective than placebo in either cure or reduction of symptoms of URTIs. However, Jing Fan Bai Du san might be able to improve general health more than placebo for patients with wind-cold syndrome. Both formulae were not associated with any more side effects.