D S Pritchard1, N Baber, T Stephenson. 1. Medicines and Healthcare Products Regulatory Agency, London, UK. deborah.pritchard@mhra.gsi.gov.uk
Abstract
AIM: To determine whether there is robust evidence of efficacy for domperidone in reducing the symptoms of gastro-oesophageal reflux (GOR) and gastro-oesophageal reflux disease (GORD) in children. METHODS: Systematic review of randomized controlled trials (RCTs). A search was made of the Cochrane Library Issue 2004 (Central Register of Controlled Trials and Database of Systematic Reviews), Medline (Pub-med) 1966 to present and Embase from 1974 to 2004, and reference citations of the RCTs that had been found electronically. RESULTS: Four RCTs were identified. Only the two older trials showed any benefits of domperidone on clinical symptoms of GORD in older children, which were the primary outcome measures. In the trial undertaken by Clara, a good or excellent result was obtained in 93% of the domperidone group compared with 33% of the controls (P < 0.05). In the trial undertaken by de Loore, after 2 weeks of treatment 75% of patients treated with domperidone were found not to be vomiting, compared with 43% in the metoclopramide group and 7% in the placebo group. The trial by Corraccio gave no detailed results regarding the primary outcomes of effect of domperidone on symptoms but simply reported 'cured', 'improved' or 'unchanged'. The secondary pH-metric outcome of the number of reflux episodes, was reduced with domperidone. CONCLUSION: From the limited evidence available, there was no robust evidence of efficacy for the treatment of GOR with domperidone in young children. Given the usually benign nature of the condition, the widespread use of unlicensed medicines for GOR is not warranted.
AIM: To determine whether there is robust evidence of efficacy for domperidone in reducing the symptoms of gastro-oesophageal reflux (GOR) and gastro-oesophageal reflux disease (GORD) in children. METHODS: Systematic review of randomized controlled trials (RCTs). A search was made of the Cochrane Library Issue 2004 (Central Register of Controlled Trials and Database of Systematic Reviews), Medline (Pub-med) 1966 to present and Embase from 1974 to 2004, and reference citations of the RCTs that had been found electronically. RESULTS: Four RCTs were identified. Only the two older trials showed any benefits of domperidone on clinical symptoms of GORD in older children, which were the primary outcome measures. In the trial undertaken by Clara, a good or excellent result was obtained in 93% of the domperidone group compared with 33% of the controls (P < 0.05). In the trial undertaken by de Loore, after 2 weeks of treatment 75% of patients treated with domperidone were found not to be vomiting, compared with 43% in the metoclopramide group and 7% in the placebo group. The trial by Corraccio gave no detailed results regarding the primary outcomes of effect of domperidone on symptoms but simply reported 'cured', 'improved' or 'unchanged'. The secondary pH-metric outcome of the number of reflux episodes, was reduced with domperidone. CONCLUSION: From the limited evidence available, there was no robust evidence of efficacy for the treatment of GOR with domperidone in young children. Given the usually benign nature of the condition, the widespread use of unlicensed medicines for GOR is not warranted.
Authors: Y Vandenplas; D Belli; P H Benhamou; S Cadranel; J P Cezard; S Cucchiara; C Dupont; C Faure; F Gottrand; E Hassall; H S Heymans; C M Kneepkens; B K Sandhu Journal: Acta Paediatr Date: 1996-05 Impact factor: 2.299
Authors: Y Vandenplas; A Ashkenazi; D Belli; N Boige; J Bouquet; S Cadranel; J P Cezard; S Cucchiara; C Dupont; K Geboes Journal: Eur J Pediatr Date: 1993-09 Impact factor: 3.183