Department of Oral Mucosal Diseases, Ninth People's Hospital，Shanghai Jiao Tong University School of Medicine, Shanghai, China.
School of Stomatology, Shanghai Jiao Tong University, Shanghai, China.
BMC Oral Health. 2024 May 24;24(1):603. doi: 10.1186/s12903-024-04318-2.
This randomized controlled trial compared the efficacy and tolerability of danzhixiaoyao pills in the accurate treatment of patients with burning mouth syndrome (BMS).
Collect a total of 78 patients (75 female patients and 3 male patients) from the oral mucosa department who were considered eligible fromOctober 2020 to October 2022.The patients were randomized and divided into trial group and control group.The trail group received danzhixiaoyao pills and mecobalamine tablets while the control group was given mecobalamine tablets.The Visual Analogue Scale (VAS), Beck Anxiety Inventory(BAI), Beck Depression Inventory (BDI), Oral Health Impact Profile (OHIP-14), Traditional Chinese medicine(TCM) syndrome integral and adverse reactions were performed at baseline and after 2, 4, and 6 weeks of treatment. Descriptive statistics, including the Wilcoxon rank-sum test and the Chi-square test for median comparisons between different times, were used.
1.After treatment, the VAS, BDI,OHIP-14, and TCM syndrome integral in the trial group had a significant decrease than the control group(P< 0.05).However, there was no statistical difference in the BAI scores between the two groups (P> 0.05). 2.According to the efficacy determination criteria , the total effective rate of the test group was 73.68% , the control group was 52.94% and the recurrence rate was 0. There was a significant difference between the two groups (Z=-2.688, P < 0.05). The results showed that the curative effect of test group was better than that of control group.3. No adverse effects occurred in patients in either group.
Danzhixiaoyao pills has demonstrated to have a positive effect in relieving BMS symptoms and in improving a patient's overall quality of life with no AEs compared with the control group. The efficacy evaluation systems that can be verified and complementary in this study provide a perfect, effective and referential evaluation system for the use of Chinese patent medicine in the treatment of oral mucosal diseases.
Registry name: Chinese Clinical trail Registry Registration number: ChiCTR2000038189 Date of Registration: 2020-09-13 Please visit ( https://www.chictr.org.cn/showproj.html?proj=61462 ) to the protocol.
本随机对照试验比较了丹栀逍遥丸精准治疗灼口综合征（BMS）患者的疗效和耐受性。
从 2020 年 10 月至 2022 年 10 月，从口腔黏膜科共收集 78 例（75 例女性，3 例男性）符合条件的患者。将患者随机分为试验组和对照组。试验组服用丹栀逍遥丸和甲钴胺片，对照组服用甲钴胺片。分别在基线、治疗 2、4、6 周时采用视觉模拟量表（VAS）、贝克焦虑量表（BAI）、贝克抑郁量表（BDI）、口腔健康影响程度量表（OHIP-14）、中医证候积分及不良反应。采用描述性统计，包括秩和检验和中位数比较的卡方检验。
丹栀逍遥丸治疗灼口综合征疗效确切，能有效缓解患者的症状，改善患者的整体生活质量，与对照组相比无不良反应。本研究验证并补充的疗效评价体系，为中药在口腔黏膜病治疗中的应用提供了一个完善、有效、有参考价值的评价体系。
注册机构名称：中国临床试验注册中心注册登记号：ChiCTR2000038189 登记日期：2020-09-13 请访问（https://www.chictr.org.cn/showproj.html?proj=61462）查看方案。
