Therapeutic effect of melatonin on pediatric functional dyspepsia: A pilot study

• 作者: Craig A Friesen Jennifer V Schurman Katherine Zybach
• 来源期刊: 世界胃肠药理与治疗学杂志：英文版（电子版）
• 学科: 医学
• 关键词: MELATONIN ABDOMINAL pain Functional DYSPEPSIA SLEEP LATENCY SLEEP duration ACTIGRAPHY
• 年，卷（期）: 2016,（1）
• 页码范围: 156-161
• 页数: 6页
• 分类号: R725.7

摘要

AIM: To study the effectiveness of melatonin vs placebo in children with functional dyspepsia(FD).METHODS: The study was conducted as a double blind, randomized, placebo controlled crossover trial. Subjects were aged 8-17 years and diagnosed with FD based on Rome Ⅲ criteria. All subjects had failed to respond to 4 wk of acid suppression. Subjects receive a continuous two weeks of placebo and a continuous two weeks of melatonin in an order blinded to the participant and the study team. A Global Clinical Score was obtained to assess changes in abdominal pain. Pain was self-reported to be worse(grade 1), no change(grade 2), moderate improvement(grade 3), good(grade 4; minimal pain and not interfering with daily activities), or excellent(grade 5; no pain), respectively. A positive clinical response was defined as a grade 3 or greater response. Subjects wore an actigraph to assess sleep during a one week baseline period and during each treatment period. Subjects’ sleep latency and total sleep time were recorded throughout the duration of the study. RESULTS: Fourteen subjects were enrolled and 12 completed the study. One withdrew prior to starting both melatonin and placebo and the other before starting melatonin. A positive clinical response(grade 3-5) was achieved in 42% of subjects on melatonin vs 50% of subjects on placebo(NS). Effect size was calculated and revealed a Cohen’s D of 0.343 which demonstrates a medium effect favoring placebo. A grade 4 or grade 5 response was seen in 4 patients on melatonin and 5 patients on placebo. Baseline sleep parameters were in the healthy range with the longest sleep latency being just over 20 min(mean 7.46 ± 8.53 min) and the shortest sleep duration just over 7 h(mean 10.09 ± 2.72 h). The mean latency did not differ between periods of treatment with melatonin as compared to placebo(4.48 ± 6.45 min vs 3.58 ± 4.24 min; NS). The mean sleep duration did not differ between periods of treatment with melatonin as compared to placebo(9.90 ± 3.53 h vs 9.41 ± 2.70 h; NS).CON