RESUMO
OBJECTIVE: To assess whether the addition of a Chinese herbal medicine formula to acupuncture affects the severity of symptoms and quality-of-life scores among patients with seasonal allergic rhinitis. DESIGN: Randomised double-blind placebo-controlled trial. SETTING: University teaching and research clinic, Australia. PARTICIPANTS: Sixty-five patients with seasonal allergic rhinitis, who were recruited through public media. INTERVENTION: Between July and December 1999, patients received acupuncture twice a week for 8 weeks plus either a Chinese herbal drug formula (n=33) or placebo (n=32) at a dosage of four capsules, three times daily. MAIN OUTCOME MEASURES: The severity of nasal and non-nasal symptoms on a five-point scale, as assessed by both patients and an ear, nose, and throat specialist, and quality-of-life scores as measured by the Rhinoconjunctivitis and Rhinitis Quality of Life Questionnaire. RESULTS: Sixty-one patients completed the study (31 in the intervention group and 30 in the control group). After 8 weeks, no significant difference was found between the two groups in the severity of nasal and non-nasal symptoms and in the Rhinoconjunctivitis and Rhinitis Quality of Life Questionnaire scores. Intention-to-treat analysis of categorical variables showed moderate-to-marked improvement rates of 72.7% and 81.2% for intervention and control groups, respectively. Six patients reported mild adverse events-three from each of the study groups. CONCLUSION: The Chinese herbal formulation under investigation did not provide additional symptomatic relief or improvement in quality-of-life scores among patients with seasonal allergic rhinitis who were receiving acupuncture.