Double-blind, placebo-controlled trial of famotidine in children with abdominal pain and dyspepsia: global and quantitative assessment. Enteric-coated, pH-dependent peppermint oil capsules for the treatment of irritable bowel syndrome in children. Double blind placebo controlled trial of pizotifen syrup in the treatment of abdominal migraine.
To determine the benefit of using an H2-receptor antagonist in children with abdominal pain and dyspepsia, 25 such children were enrolled in a double-blind, placebo-controlled trial of famotidine. Global and quantitative pain assessments were done before and after each treatment period. The quantitative assessment was calculated based on the abdominal pain score that was the sum of three components. Based on the global evaluation, there was a clear benefit of famotidine over placebo (68% vs 12%). Using the quantitative assessment, however, the mean improvement of the score using famotidine versus placebo was not statistically significant (3.37+/-3.53 vs 1.66+/-2.7). There was a significant improvement in this score during the first treatment period regardless of medication used (period effect: P = 0.05). A subset of patients with peptic symptoms demonstrated a significant drug effect that outweighed the period effect (drug effect: P = 0.01; period effect: P = 0.02). We conclude that famotidine subjectively improves the symptoms of children with recurrent abdominal pain but not objectively using the derived score. However, famotidine is significantly more effective than placebo among children with peptic symptoms. The use of this simple scoring scale may facilitate selecting those children who will benefit from H2-receptor antagonist therapy. In a randomized, double-blind controlled trial, 42 children with irritable bowel syndrome (IBS) were given pH-dependent, enteric-coated peppermint oil capsules or placebo. After 2 weeks, 75% of those receiving peppermint oil had reduced severity of pain associated with IBS. Peppermint oil may be used as a therapeutic agent during the symptomatic phase of IBS. Fourteen children with abdominal migraine were treated with pizotifen and placebo in a double blind crossover trial. The results showed pizotifen to be clearly superior to placebo in the prophylaxis of abdominal migraine. The importance of clearly distinguishing abdominal migraine from other forms of recurrent abdominal pain is emphasised.
This review provides weak evidence of benefit on medication in children with RAP. The lack of clear evidence of effectiveness for any of the recommended drugs suggests that there is little reason for their use outside of clinical trials. Clinicians may choose to prescribe drugs in children with severe symptoms that have not responded to simple management. However, if using drugs as a "therapeutic trial", clinicians should be aware that, RAP is a fluctuating condition and any "response" may reflect the natural history of the condition or a placebo effect rather than drug efficacy.