Original article Acupuncture and Chinese herbal medicine in the treatment of patients with seasonal allergic rhinitis: a randomized-controlled clinical trial Background In the last two decades, there has been a marked increase in the prevalence of allergic rhinitis (AR) in Western industrialized nations, with studies showing between 10 and 20% of the population to be suffering from this disorder (1). For AR in Europe, direct yearly costs are estimated at 1.0–1.5 billion euros annually, while indirect costs are estimated at 1.0–2.0 billion euros (1). However, despite advances in conventional therapy a remarkable number of patients, including those suffering from atopic diseases, are turning for relief to complementary medical treatments (CAM), such as traditional Chinese medicine (TCM) (2–5). Because of this, CAM has increasingly become the focus of allergy specialists and scientists (6, 7), and well-designed studies of CAM treatments, such as TCM in patients suffering from AR, are needed. Acupuncture and Chinese herbal medicine (CHM), the major components of TCM, have been used for centuries to treat symptoms similar to those of AR and are still broadly administered for this purpose in China (8, 9). However, methodologically sound, controlled clinical trials that investigate the efficacy of TCM in the treatment of this disorder are lacking. Several studies in China and the Western world have suggested that acupuncture and CHM may be beneficial in the treatment of a variety of other allergic conditions (10–12). For example, a number of randomized-controlled studies have demonstrated the efficacy of CHM in treating atopic dermatitis (13–15). To improve efficacy, acupuncture and CHM are often administered together in TCM (16), although no study Background: Patients with allergic rhinitis (AR) increasingly use complementary medicine. The aim of this study was to determine whether traditional Chinese therapy is efficacious in patients suffering from seasonal AR. Methods: Fifty-two patients between the ages of 20 and 58 who had typical symptoms of seasonal AR were assigned randomly and in a blinded fashion to (i) an active treatment group which received a semi-standardized treatment of acupuncture and Chinese herbal medicine, and (ii) a control group which received acupuncture applied to non-acupuncture points in addition to a non- specific Chinese herbal formula. All patients received acupuncture treatment once per week and the respective Chinese herbal formula as a decoction three times daily for a total of 6 weeks. Assessments were performed before, during, and 1 week after treatment. The change in severity of hay fever symptoms was the primary outcome measured on a visual analogue scale (VAS). Results: Compared with patients in the control group, patients in the active treatment group showed a significant after-treatment improvement on the VAS (P ¼ 0.006) and Rhinitis Quality of Life Questionnaire (P ¼ 0.015). Improve- ment on the Global Assessment of Change Scale was noted in 85% of active treatment group participants vs 40% in the control group (P ¼ 0.048). No differences between the two groups could be detected with the Allergic Rhinitis Symptom Questionnaire. Both treatments were well-tolerated. Conclusions: The results of this study suggest that traditional Chinese therapy may be an efficacious and safe treatment option for patients with seasonal AR. B. Brinkhaus 1,4 , J. Hummelsberger 2 , R. Kohnen 3 , J. Seufert 1 , C.-H. Hempen 2 , H. Leonhardy 2 , R. Nçgel 2 , S. Joos 1 , E. Hahn 1 , D. Schuppan 1 1 Department of Medicine I, Friedrich-Alexander- University of Erlangen-Nuremberg, Erlangen; 2 International Society of Chinese Medicine (SMS), Munich; 3 The IMEREM, Institute for Medical Research Management and Biometrics, Nuremberg; 4 Institute of Social Medicine, Epidemiology, and Health Economics, CharitØ University Medical Center, Berlin, Germany Key words: acupuncture; allergic rhinitis; Chinese herbal medicine; clinical trial; complementary medicine; quality of life. Dr Benno Brinkhaus Institute of Social Medicine, Epidemiology, and Health Economics CharitØ University Medical Center Berlin Germany Accepted for publication 9 February 2004 Allergy 2004: 59: 953–960 Printed in UK. All rights reserved Copyright Ó Blackwell Munksgaard 2004 ALLERGY 953