Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-Communicable Disease, Isfahan University of Medical Sciences, Isfahan, Iran.
Department of Medicine, Najafabad Branch, Islamic Azad University, Najafabad, Iran.
Am J Gastroenterol. 2020 May;115(5):756-765. doi: 10.14309/ajg.0000000000000589.
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.
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.
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.
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.
迄今为止，药物干预在儿童功能性腹痛（FAP）的治疗中并未取得成功。基于成人研究的证据，丁螺环酮被认为对一些与腹痛相关的功能性胃肠道疾病有效。我们旨在研究丁螺环酮对儿童 FAP 的疗效。
这是一项针对 117 名 6-18 岁儿童 FAP 患者的随机临床试验。我们将患者随机分为丁螺环酮组或安慰剂组，根据年龄调整剂量。参与者在基线时、4 周治疗结束时（第一次随访）和停药 8 周后（第二次随访）完成评估疼痛、抑郁、焦虑、躯体化和睡眠障碍的问卷。主要结局是治疗反应率，定义为疼痛评分降低≥2 或在随访评估时报告无疼痛。
95 名患者完成了 4 周的治疗（丁螺环酮组和安慰剂组各 48 名和 47 名）。丁螺环酮和安慰剂组在 4 周治疗后均减轻了疼痛，并且这些效果在停药 8 周后仍然持续（两组在第 4 周和第 12 周时均 P<0.001）。丁螺环酮和安慰剂组在第 4 周时的治疗反应率分别为 58.3%和 59.6%（P=0.902），在第 12 周时分别为 68.1%和 71.1%（P=0.753）。
丁螺环酮有效改善了儿童 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，但与安慰剂相比无优势。建议进一步开展研究，使用更高剂量的丁螺环酮和更长时间的随访。
