title: Efficacy and Safety of Sanfu Herbal Patch at Acupoints for Persistent Allergic Rhinitis: Study Protocol for a Randomized Controlled Trial.
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.
authors: Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China.
authors: Xiankun
authors: X
authors: Chen
authors: Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China ; Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome, Guangzhou 510120, China.
authors: Chuanjian
authors: C
authors: Lu
authors: Department of Public Health Sciences (Global Health/IHCAR), Karolinska Institutet, 17177 Stockholm, Sweden.
authors: Cecilia
authors: C
authors: Stålsby-Lundborg
authors: Department of Otorhinolaryngology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China.
authors: Yunying
authors: Y
authors: Li
authors: Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China.
authors: Xiaoyan
authors: X
authors: Li
authors: Department of Acupuncture and Moxibustion, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China.
authors: Jian
authors: J
authors: Sun
authors: Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China.
authors: Wenwei
authors: W
authors: Ouyang
authors: Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China.
authors: Geng
authors: G
authors: Li
authors: Department of Public Health Sciences (Global Health/IHCAR), Karolinska Institutet, 17177 Stockholm, Sweden ; Department of Nephropathy, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China.
authors: Guobin
authors: G
authors: Su
authors: Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China.
authors: Liming
authors: L
authors: Lu
authors: Department of Acupuncture and Moxibustion, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China.
authors: Wenbin
authors: W
authors: Fu
authors: Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China ; National Centre for Design Measurement and Evaluation in Clinical Research, Guangzhou University of Chinese Medicine, Guangzhou 510405, China.
authors: Zehuai
authors: Z
authors: Wen