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| 1 | Therapeutic effect of melatonin on pediatric functional dyspepsia: A pilot study显示文摘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).CONCLUSION: Melatonin does not appear to have efficacy in relieving pain in unselected pediatric FD. Future studies should consider FD subtypes, pathophysiologic mechanisms, and baseline sleep disturbances. | Katherine Zybach Craig A Friesen Jennifer V Schurman | 2016 | World Journal of Gastrointestinal Pharmacology and Therapeutics2016，7，1： | 6 |
| 2 | Present state and future challenges in pediatric abdominal pain therapeutics research: Looking beyond the forest显示文摘At the present time, it is nearly impossible to treat pediatric functional gastrointestinal disorders associated with pain in an evidence based fashion. This is due to the overall lack of controlled studies and, even more importantly, the complexity of the contributors to disease phenotype which are not controlled or accounted for in most therapeutic trials. In this manuscript, we review the challenges of defining entry criteria, controlling for the large number of biopsychosocial factors which may effect outcomes, and understanding pharmacokinetic and pharmacodynamic factors when designing therapeutic trials for abdominal pain in children. We also review the current state of pediatric abdominal pain therapeutics and discuss trial design considerations as we move forward. | Craig A Friesen Jennifer V Schurman Susan M Abdel-Rahman | 2015 | World Journal of Gastrointestinal Pharmacology and Therapeutics2015，6，4： | 3 |
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