Journal of Oral Science Research

Journal of Oral Science Research ›› 2021, Vol. 37 ›› Issue (2): 167-172.DOI: 10.13701/j.cnki.kqyxyj.2021.02.017

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Shixin Buccal Tablets on Recurrent Aphthae with Syndrome of Flaring Up of the Stomach-fire: A Randomized Double-blind Placebo-controlled Multicenter Clinical Trial

TIAN Yuan1, ZHOU Gang2, GUAN Xiaobing3, TAN Jin4, LIU Guanjian5, SUI Qiuli1,6, LI Jia7, LIN Mei1*, ZHOU Hongmei1*   

  1. 1. National Clinical Research Center for Oral Diseases ＆ Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China;
    2. Department of Oral Medicine,School and Hospital of Stomatology, Wuhan University, Wuhan 430079, China;
    3. Departmentof Oral Medicine, Beijing Stomatological Hospital, Capital Medical University, Beijing 100050, China;
    4. Department of Stomatology, The First Affiliated Hospital of Hunan University of Chinese Medicine, Changsha 410000, China;
    5. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China;
    6. Department of Periodontal Mucosa, Zhengzhou Stomatological Hospital, Zhengzhou 450000, China;
    7. State Institute of Drug Clinical Trial, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China
  • Received:2020-08-25 Published:2021-02-11

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Abstract: Objective: To study the efficacy and safety of Shixin buccal tablets on the treatment of recurrent aphthae with syndrome of flaring up of the stomach-fire. Methods: A randomized, double-blind, placebo controlled, parallel-group, and multicenter study with single simulation was conducted. The patients in experimental group and the control group were given Shixin buccal tablets and placebo respectively for 5 days. The clinical outcomes consisted of the primary outcome (onset time of pain relief) and the secondary outcomes (rate of ulcer healing, days for ulcer healing, numbers of ulcers, pain scores,size of ulcers and the traditional Chinese medicine(TCM)symptoms of measurements). Adverse events and laboratory results were recorded to evaluate the safety of the agent. Results: 234 patients were enrolled and randomly divided into the experimental group and the control group, with 117 cases each. The primary outcome,namely,onset time of pain relief in experimental group was shorter than that in the control group (P<0.05). For all secondary outcomes,the experimental group showed significantly better efficacy than that in the control group (P<0.01). The main adverse reactions were mild gastrointestinal symptoms such as stomachache or diarrhea,which could be relieved without any treatment. No severe adverse events were observed. The incidence of adverse events and adverse reactions was similar between two groups. Conclusion:Shixin buccal tablets is effective and safe on the treatment of recurrent aphthae with syndrome of flaring up of the stomach-fire.

Key words: Shixin buccal tablets, recurrent aphthous ulcer, syndrome of flaring up of the stomach-fire, multi-center clinical trail pain relief, ulcer healing