Original Article Asia Pacific allergy pISSN 2233-8276 · eISSN 2233-8268 http://dx.doi.org/10.5415/apallergy.2012.2.3.187 Asia Pac Allergy 2012;2:187-194 Lack of eicacy of a herbal preparat ion (RCM-102) for seasonal allergic rhinitis: a double blind, randomised, placebo-controlled trial George B. Lenon 1,* , C. G. Li 1 , C. Da Costa 1 , F. C. K. Thien 2 , Y. Shen 1 , and C. C. L. Xue 1 1 Traditional & Complementary Medicine Research Program, Health Innovations Research Institute, Discipline of Chinese Medicine, School of Health Sciences, RMIT University, Bundoora Campus, Victoria 3083, Australia 2 Department of Respiratory Medicine, Box Hill Hospital & Monash University, Box Hill, Victoria 3128, Australia Background: A herbal preparation, known as RMIT Chinese Medicine 102 (RCM-102) consisting of eight herbs which demonstrates inhibition of the release of key inlammatory mediators associated with seasonal allergic rhinitis (SAR) was used. This study evaluated the eicacy and safety of RCM-102 for SAR. Objective: This study evaluated the eicacy and safety of RCM-102 for SAR. Methods: This randomised placebo-controlled trial involved subjects aged between 18 and 65 who were randomly assigned to either RCM-102 or a placebo group. After a two-week baseline period, all subjects took either RCM-102 or placebo capsules (two capsules each time, three times daily with a four hour interval) for a period of eight weeks. The primary end-points were the Five-Point Scale symptom scores. Rhinoconjunctivitis Quality of Life Questionnaire, relief medication usage, adverse events, kidney and liver function tests and full blood examination were secondary end-points. Intention-to-treat analysis was applied. Results: One hundred and four subjects were randomised with 52 in each group. Ninety-ive subjects (47 and 48 subjects in RCM-102 and placebo groups) completed the trial. Nine subjects withdrew from the study prior to the end of the second treatment week. At the end of the trial, there were no signiicant diferences between the two groups with respect to all outcome measures. There were no liver or kidney function abnormalities reported. Conclusion: This mechanism-based RCM-102 was safe but not more beneicial than placebo for patients with SAR. Key words: RCM-102; Seasonal allergic rhinitis; Herbal medicine Correspondence: George B. Lenon Traditional & Complementary Medicine Research Program, Health Innovations Research Institute, Discipline of Chinese Medicine, School of Health Sciences, RMIT University, Bundoora, VIC 3083, Australia Tel: +61-3-99256587 Fax: +61-3-99257178 E-mail: george.lenon@rmit.edu.au Received: March 14, 2012 Accepted: June 12, 2012 This is an Open Access article distributed under the terms of the Creative Commons Attribution. Non-Commercial License (http://creativecommons. org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. Copyright © 2012. Asia Paciic Association of Allergy, Asthma and Clinical Immunology. http://apallergy.org