Yu Yi, Xie Xiao-Li, Wu Jie, Li Zhong-Yue, He Zhi-Gang, Liang Chun-Jie, Jin Zhong-Qin, Wang Ai-Zhen, Gu Jian, Huang Ying, Mei Hong, Shi Wei, Hu Si-Yuan, Jiang Xun, Du Juan, Hu Chi-Jun, Gu Li, Jiang Mao-Lin, Mao Zhi-Qin, Xu Chun-Di
Department of Pediatrics, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Department of Pediatric Gastroenterology, Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.
Front Pharmacol. 2022 Feb 4;13:831912. doi: 10.3389/fphar.2022.831912. eCollection 2022.
Treatment of functional dyspepsia (FD) in children is generally symptomatic and unsatisfactory. Traditional Chinese medicines, such as Shenqu Xiaoshi Oral Liquid (SXOL), have been recommended to alleviate dyspeptic symptoms. However, evidence of their safety and efficacy remains limited to date. AIM: To assess whether 2 weeks of therapy with SXOL was non-inferior to domperidone syrup in children with FD. In this randomized, double-blind, double-simulated, non-inferiority, multi-center clinical trial, we recruited children (3-14 years) with FD according to the Rome IV criteria from 17 tertiary medical centers across China. Patients were randomly allocated (1:1) to receive SXOL or domperidone syrup for 2 weeks. We compared the participants' clinical scores from both groups based on the severity and frequency of dyspepsia symptoms according to Rome IV criteria (0, 1, 2, and 4 weeks after randomization). The primary endpoint was the total response rate, which was defined as the proportion of patients with a decrease of 30% or more in the FD symptoms clinical score from baseline, at the end of the 2-weeks treatment. A non-inferiority margin of -10% was set. Secondary endpoints and adverse events were assessed. This trial is registered with www.Chictr.org.cn, number ChiCTR1900022654. Between February 2019 and March 2021, a total of 373 patients were assessed for eligibility, and 356 patients were enrolled and randomized. The clinical response rate at week two was similar for SXOL [118 (83.10%) of 142] and domperidone [128 (81.01%) of 158]; difference 2.09; 95% CI -6.74 to 10.71, thereby establishing non-inferiority. The total FD symptom scores were significantly improved in the two groups at 1-, 2-, and 4-weeks follow-up periods ( < 0.005). The decrease in symptom score compared with the baseline were similar between these two groups. Over the total study period, 10 patients experienced at least one treatment-related adverse event [six (3.37%)] in the SXOL group, four [(2.25%) in the domperidone group], although no serious adverse event was noted. Treatment with SXOL effectively improves dyspeptic symptoms and is well tolerated. In addition, it is not inferior to domperidone syrup and leads to sustained improvement in Chinese children with FD.
儿童功能性消化不良（FD）的治疗通常只是对症治疗，效果并不理想。诸如神曲消食口服液（SXOL）之类的传统中药已被推荐用于缓解消化不良症状。然而，迄今为止，其安全性和有效性的证据仍然有限。目的：评估SXOL治疗2周对FD患儿的疗效是否不劣于多潘立酮糖浆。在这项随机、双盲、双模拟、非劣效性、多中心临床试验中，我们根据罗马IV标准，从中国17家三级医疗中心招募了3至14岁的FD患儿。患者被随机分配（1:1）接受SXOL或多潘立酮糖浆治疗2周。我们根据罗马IV标准（随机分组后0、1、2和4周），比较两组参与者消化不良症状的严重程度和频率的临床评分。主要终点是总缓解率，定义为在2周治疗结束时，FD症状临床评分较基线下降30%或更多的患者比例。设定非劣效界值为-10%。评估次要终点和不良事件。本试验已在www.Chictr.org.cn注册，注册号为ChiCTR1900022654。在2019年2月至2021年3月期间，共有373例患者接受资格评估，356例患者入组并随机分组。SXOL组[142例中的118例（83.10%）]和多潘立酮组[158例中的128例（81.01%）]在第2周的临床缓解率相似；差异为2.09；95%CI为-6.74至10.71，从而确定了非劣效性。在1周、2周和4周的随访期内，两组的FD症状总评分均显著改善（<0.005）。两组症状评分较基线的下降情况相似。在整个研究期间，10例患者经历了至少一次与治疗相关的不良事件[SXOL组6例（3.37%），多潘立酮组4例（2.25%）]，尽管未观察到严重不良事件。SXOL治疗可有效改善消化不良症状，耐受性良好。此外，它不劣于多潘立酮糖浆，可使中国FD患儿症状持续改善。
