INTRODUCTION Pharmacological interventions have not been successful in the treatment of childhood functional abdominal pain (FAP) hitherto. Buspirone is suggested to be efficacious in some of the abdominal pain-related functional gastrointestinal disorders based on evidences from the studies on adults. We aim to investigate the efficacy of buspirone on childhood FAP. METHODS This randomized clinical trial was conducted on 117 patients with childhood FAP aged 6-18 years. We randomly assigned patients to receive buspirone or placebo for 4 weeks, with the adjusted dosage for age. Participants completed the questionnaires assessing pain, depression, anxiety, somatization, and sleep disturbances at baseline, at the end of the 4-week therapy (first follow-up), and at 8 weeks after medication discontinuation (second follow-up). The primary outcome was treatment response rate, defined as reduced pain score of ≥2 or reporting no pain at the follow-up assessments. RESULTS Ninety-five patients completed the 4-week therapy (48 and 47 in buspirone and placebo groups, respectively). Both buspirone and placebo reduced pain after 4 weeks of treatment, and these effects were persistent 8 weeks after medication discontinuation (P < 0.001 for both groups at weeks 4 and 12). Treatment response rates for buspirone and placebo were 58.3% and 59.6% at week 4 (P = 0.902) and 68.1% and 71.1% at week 12 (P = 0.753), respectively. DISCUSSION Buspirone effectively improves pain and associated psychological symptoms including depressive symptoms, anxiety, somatization, and sleep disturbances in childhood FAP but has no superiority over placebo. Further studies, with the higher doses of buspirone and longer follow-ups are recommended.

中文翻译：

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丁螺环酮与安慰剂治疗儿童功能性腹痛的疗效比较

介绍 迄今为止，药物干预尚未成功治疗儿童功能性腹痛 (FAP)。根据成人研究的证据，建议丁螺环酮对某些与腹痛相关的功能性胃肠道疾病有效。我们旨在调查丁螺环酮对儿童 FAP 的疗效。方法 这项随机临床试验对 117 名 6-18 岁儿童 FAP 患者进行。我们随机分配患者接受丁螺环酮或安慰剂治疗 4 周，并根据年龄调整剂量。参与者在基线、4 周治疗结束时（第一次随访）和停药后 8 周（第二次随访）完成了评估疼痛、抑郁、焦虑、躯体化和睡眠障碍的问卷。主要结果是治疗反应率，定义为疼痛评分降低 ≥ 2 或在后续评估中报告无疼痛。结果 95 名患者完成了 4 周的治疗（丁螺环酮组和安慰剂组分别为 48 和 47 名）。丁螺环酮和安慰剂在治疗 4 周后均能减轻疼痛，并且这些作用在停药后 8 周持续存在（两组在第 4 周和第 12 周的 P < 0.001）。丁螺环酮和安慰剂的治疗反应率在第 4 周时分别​​为 58.3% 和 59.6%（P = 0.902），在第 12 周时分别​​为 68.1% 和 71.1%（P = 0.753）。讨论 丁螺环酮可有效改善儿童 FAP 的疼痛和相关心理症状，包括抑郁症状、焦虑、躯体化和睡眠障碍，但没有优于安慰剂。深度学习，