A randomized, double blind, placebo-controlled clinical trial of Chinese herbal medicine in the treatment of acute upper respiratory infections

Abstract

Upper respiratory tract infections (URTIs) are the most common illnesses in primary care but there is no established cure for these conditions in Western medicine. Many patients use Chinese herbal medicine (CHM) for the treatment of URTIs but there is little research evidence on the effectiveness or side effects of it. AIMS AND OBJECTIVES: To determine if CHM guided by Traditional Chinese medicine (TCM) diagnosis will significantly increase recovery rate, severity of symptoms and improve the health-related quality of life (HRQOL) of URTIs patients. DESIGN, SETTING AND SUBJECTS: Double-blind randomized placebo-controlled trial on 326 patients consulting outpatient clinic in Hong Kong, who had developed symptoms of the URTIs within 48 hours before enrolment and diagnosed by the consulting doctor to have URTIs during July 2006 to May 2007. Eligible patients were diagnosed by a registered Chinese medicine practitioner and randomly allocated to 1 of 2 treatment groups: Group A: Wind-cold syndrome (n 161) and Group B Wind-heat syndrome (n 165), which are the most commonly found patterns of URTIs. Patients were randomized to receive for up to 10 days sachets of concentrated CHM granules or placebo and followed for 3 weeks. RESULTS: The preliminary results show that the proportion of patients resolved in the active treatment groups (Wind-heat and Wind-cold groups) did not differ significantly when compared with patients in the placebo groups (p 0.05) on days 4, 7 and 21. CHM can only significantly reduce chills in Wind-cold patients in the treatment of URTIs (p 0.05). Both treatment and placebo groups had significantly improved HRQOL measures including the domains in SF-36 and ChQOL (p 0.01) but no significant difference was be found between both groups. On follow-up 21 days after the treatment, only the Wind-cold group had significant improvement in the general health domains of SF-36 (p 0.016) when compared with placebo group. CONCLUSIONS: The preliminary results show that CHM given according to its TCM diagnosis patterns cannot significantly improve recovery rate, reduce duration and/or severity but improves general HRQOL.