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Evidence-Based Complementary and Alternative Medicine
Volume 2015 (2015), Article ID 214846, 10 pages
http://dx.doi.org/10.1155/2015/214846
Research Article

Efficacy and Safety of Sanfu Herbal Patch at Acupoints for Persistent Allergic Rhinitis: Study Protocol for a Randomized Controlled Trial

1Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China
2Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China
3Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome, Guangzhou 510120, China
4Department of Public Health Sciences (Global Health/IHCAR), Karolinska Institutet, 17177 Stockholm, Sweden
5Department of Otorhinolaryngology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China
6Department of Acupuncture and Moxibustion, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China
7Department of Nephropathy, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China
8National Centre for Design Measurement and Evaluation in Clinical Research, Guangzhou University of Chinese Medicine, Guangzhou 510405, China

Received 20 May 2015; Accepted 14 July 2015

Academic Editor: Helmut Hugel

Copyright © 2015 Xiankun Chen et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background. The Sanfu herbal patch (SHP) has been widely used to treat allergic rhinitis (AR) in China. SHP has been reported to be effective for managing the symptoms of AR, but the evidence suffers from methodological limitations. Therefore, we designed a three-armed, randomized, and placebo-controlled trial to evaluate the efficacy and safety of SHP for persistent allergic rhinitis (PAR). Methods. The trial consists of 5 treatment sessions along with a one-year follow-up. This process is then repeated in the second and third years. Eligible participants diagnosed with PAR were randomized at a ratio of 2 : 2 : 1 into one of three groups: (a) SHP group; (b) placebo group; or (c) waiting-list group. The waiting-list group will receive no treatment in the first year but will receive SHP in the following two years. The primary outcome, total nasal symptoms score, is self-assessed at the beginning of each treatment session and during each annual follow-up. Secondary outcomes include the Rhinoconjunctivitis Quality-of-Life Questionnaire, allergic rhinitis attacks, and relief medications. The trial will be stopped if early termination criteria are met during the interim analysis. Ethics. This protocol has been approved by site ethics committee (number B2014-014-01) and is registered with ClinicalTrials.gov NCT02192645.