Sadeghian M, Farahmand F, Fallahi G H, Abbasi A
Department of Pediatric Gastroenterology, Children Medical Center, Tehran University of Medical Sciences Tehran, Iran.
Minerva Pediatr. 2008 Dec;60(6):1367-74.
The management of functional abdominal pain (FAP) in children and adolescents is challenging for health care professionals, and there are only limited or inconclusive studies of pharmacologic or behavioral therapy in childhood FAP. The objective of this randomized placebo-controlled clinical trial was to determine the potential efficacy and safety of cyproheptadine in the treatment of pediatric FAP.
Between January 2006 and March 2007, 29 clinically referred children and adolescents with FAP (aged 4.5 to 12 years) completed a 2-week, double-blinded randomized placebo-controlled trial of cyprohetadine. Primary outcome measure was the self-reported change of frequency and duration of abdominal pain by using a 6-point scale, and the parents' impression or assessment of the children's improvement.
By week 1 and 2 of the intervention, the intensity and frequency of abdominal pain among the patients treated with cyproheptadine, were rated as complete resolved and very much improved or improved for 3 (20%), 10 (66.6%), respectively. However, in the placebo-receiver children, these scales had no change in 7 (50%), rated as improved or very much improved in 5 (35.7%), and become worse in 2 (14.3%). The patients' self-reported and the parents' impression in the cyproheptadine group were significantly better than it in the placebo group (P=0.003).
Among children with functional abdominal pain, cyproheptadine is enough effective to improve the intensity and frequency of abdominal pain in a short-term period.
儿童和青少年功能性腹痛（FAP）的管理对医护人员来说具有挑战性，关于儿童FAP的药物或行为疗法的研究有限或尚无定论。这项随机安慰剂对照临床试验的目的是确定赛庚啶治疗小儿FAP的潜在疗效和安全性。
2006年1月至2007年3月期间，29名临床转诊的患有FAP的儿童和青少年（年龄4.5至12岁）完成了一项为期2周的赛庚啶双盲随机安慰剂对照试验。主要结局指标是使用6分制自我报告的腹痛频率和持续时间的变化，以及父母对孩子改善情况的印象或评估。
在干预的第1周和第2周，接受赛庚啶治疗的患者中，腹痛强度和频率分别被评为完全缓解的有3例（20%）、非常明显改善或改善的有10例（66.6%）。然而，接受安慰剂的儿童中，7例（50%）这些指标无变化，5例（35.7%）被评为改善或非常明显改善，2例（14.3%）情况变差。赛庚啶组患者的自我报告和父母的印象明显优于安慰剂组（P = 0.003）。
在功能性腹痛儿童中，赛庚啶在短期内足以有效改善腹痛强度和频率。
