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

Xiankun Chen, Chuanjian Lu, Cecilia Stålsby-Lundborg, Yunying Li, Xiaoyan Li, Jian Sun, Wenwei Ouyang, Geng Li, Guobin Su, Liming Lu, Wenbin Fu, Zehuai Wen, Xiankun Chen, Chuanjian Lu, Cecilia Stålsby-Lundborg, Yunying Li, Xiaoyan Li, Jian Sun, Wenwei Ouyang, Geng Li, Guobin Su, Liming Lu, Wenbin Fu, Zehuai Wen

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.

Figures

Figure 1
Figure 1
Trial flow diagram in the SPAR study. SPAR: Sanfu herbal patch at acupoints for persistent allergic rhinitis, SHP: Sanfu herbal patch, TNSS: Total Nasal Symptom Score, RQLQ: rhinitis quality-of-life questionnaire, ARA: allergic rhinitis attack, RM: relief medication, AE: adverse event, PE: placebo effect, T1: treatment in the first year, FU1: follow-up in the first year, T2: treatment in the second year, FU2: follow-up in the second year, T3: treatment in the third year, and FU3: follow-up in the third year.
Figure 2
Figure 2
Diagram of prescribed acupoints from the WHO Standard Acupuncture Point Locations in the Western Pacific Region in the SPAR(1) study in 2014. (1)SPAR: Sanfu herbal patch at acupoints for persistent allergic rhinitis.

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