Abstract
Background: 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. Methods: 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. Results: 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 (p < 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. Conclusion: 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.
Highlights
Functional dyspepsia (FD) presents with chronic symptoms of postprandial fullness, early satiation, or epigastric pain/ discomfort when no evidence of systemic, organic, or metabolic disease is found
Subjects would be excluded from the study if they met any of the following exclusion criteria: 1) Dyspepsia caused by organic diseases, such as acute and chronic gastroenteritis, peptic ulcer, history of gastrointestinal surgery, acute and chronic hepatitis, anorexia nervosa, and anorexia caused by certain drugs; 2) Simultaneous treatment that can cause constipation or enhanced GI motility; (3) Moderate or severe malnutrition; 4) Serious primary diseases of the cardiovascular, nervous, respiratory, hepatobiliary and urinary systems; 5) Mental disorders, intellectual disabilities, and/or communication impairments; 6) Allergy to the ingredients of Shenqu Xiaoshi Oral Liquid (SXOL) or domperidone syrup; 7) Participated in a clinical trial within the past 12 weeks; 8) Individuals deemed unsuitable for this clinical trial
Patient demographics and disease characteristics at baseline showed no significant differences between the groups in full analysis set (FAS) analysis, suggesting the backgrounds were comparable between these groups before treatment (Table 1)
Summary
Functional dyspepsia (FD) presents with chronic symptoms of postprandial fullness, early satiation, or epigastric pain/ discomfort when no evidence of systemic, organic, or metabolic disease is found. Most pediatricians commonly personalize the patient’s medical treatment, including dietary modifications, prokinetics, antacids, antispasmodics, antidepressants, and analgesics according to their predominant symptoms and associated comorbidities (Hyams et al, 2016; Browne et al, 2018; Masuy et al, 2019). The prevalence of complementary and alternative medicine, including traditional Chinese medicine (TCM), applied to FGIDs continues to increase worldwide (Deutsch et al, 2020) Among these options, the role of TCM is difficult to ignore in the treatment of FD in children (Saad and Chey, 2006; Yeh and Golianu, 2014). AIM: To assess whether 2 weeks of therapy with SXOL was non-inferior to domperidone syrup in children with FD
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