Multicenter, Randomized, Placebo-Controlled Trial of Amitriptyline in Children With Functional Gastrointestinal Disorders

Saps, Miguel; Youssef, Nader N.; Miranda, Adrian; Nurko, Samuel; Hyman, Paul E.; Cocjin, Jose; Lorenzo, Carlo Di

doi:10.1053/j.gastro.2009.06.060

Cited by 218 publications

(194 citation statements)

References 32 publications

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“…Saps et al (26) detected no difference in the effectiveness of amitriptyline, a tricyclic antidepressant, (63.0%) and placebo (57.5%) in the treatment of pediatric pain-related functional gastrointestinal disorders and pointed toward the fact that in comparable studies among adults, placebo response rates were substantially lower and in the range of 40% across many trials (28).…”

Section: Are Placebo Responses Different Between Children and Adults?mentioning

confidence: 99%

Placebo effects in children: a review

Weimer¹,

et al. 2013

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Of more than 155,000 PubMed citations found with the search term "placebo, " only ~9,000 (5.8%) included the terms "children" or "adolescents. " When all these papers were screened, only ~2,000 of them investigated the placebo effect per se, and of those, only ~50 (2.5%) discussed the placebo effect in children and adolescents. In this narrative review, we explore four aspects of the placebo response in children and adolescents: (i) the legal and ethical limitations and restrictions for the inclusion of children in clinical trials as well as in experimental (placebo) research that may explain the poor knowledge base; (ii) the question of whether or not the placebo effect is larger in children and adolescents as compared with adults; (iii) whether the mechanisms underlying the placebo effect are similar between children and adults; and (iv) whether mediators and moderators of the placebo effect are comparable between children and adults. We finally discuss some of the consequences from the current placebo research in adults that may affect both experimental and clinical research in children and adolescents.

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Section: Are Placebo Responses Different Between Children and Adults?mentioning

confidence: 99%

Placebo effects in children: a review

Weimer¹,

et al. 2013

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“…Placebo responses in trials of adults with IBS vary from 16.0% to 71.4%, 78 and high placebo rates up to 53% were reported in RCTs on children and adolescents. 41,43,79 High placebo responses may also display natural course of FGIDs with fluctuating symptoms. 80 Because symptoms may resolve without active treatment in a significant proportion of children, the first step in management may consist of physician reassurance and education.…”

Section: Alternative Medicinementioning

confidence: 99%

Nonpharmacologic Treatment of Functional Abdominal Pain Disorders: A Systematic Review

et al. 2015

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BACKGROUND AND OBJECTIVE: Various nonpharmacologic treatments are available for pediatric abdominal pain-related functional gastrointestinal disorders (AP-FGIDs). Data on efficacy and safety are scarce. The goal of this study was to summarize the evidence regarding nonpharmacologic interventions for pediatric AP-FGIDs: lifestyle interventions, dietary interventions, behavioral interventions, prebiotics and probiotics, and alternative medicine.METHODS: Searches were conducted of the Medline and Cochrane Library databases. Systematic reviews and randomized controlled trials (RCTs) concerning nonpharmacologic therapies in children (aged 3-18 years) with AP-FGIDs were included, and data were extracted on participants, interventions, and outcomes. The quality of evidence was assessed by using the GRADE approach.RESULTS: Twenty-four RCTs were found that included 1390 children. Significant improvement of abdominal pain was reported after hypnotherapy compared with standard care/wait-list approaches and after cognitive behavioral therapy compared with a variety of control treatments/wait-list approaches. Written self-disclosure improved pain frequency at the 6-month follow-up only. Compared with placebo, Lactobacillus rhamnosus GG (LGG) and VSL#3 were associated with significantly more treatment responders (LGG relative risk: 1.31 [95% confidence interval: 1.08 to 1.59]; VSL#3: P , .05). Guar gum significantly improved irritable bowel syndrome symptom frequency; however, no effect was found for other fiber supplements (relative risk: 1.17 [95% confidence interval: 0.75 to 1.81]) or a lactose-free diet. Functional disability was not significantly decreased after yoga compared with a wait-list approach. No studies were found concerning lifestyle interventions; gluten-, histamine-, or carbonic acid-free diets; fluid intake; or prebiotics. No serious adverse effects were reported. The quality of evidence was found to be very low to moderate. CONCLUSIONS:Although high-quality studies are lacking, some evidence shows efficacy of hypnotherapy, cognitive behavioral therapy, and probiotics (LGG and VSL#3) in pediatric AP-FGIDs. Data on fiber supplements are inconclusive.

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“…Only one of these studies has been multicenter and included more than 50 children, and it did not show a beneficial effect of amitriptyline compared with placebo. 12 A large placebo effect found in this study may explain the negative results. Seventy-five percent of children reported some improvement using placebo alone.…”

Section: Miguel Saps MDmentioning

confidence: 39%