Cisapride treatment for gastro-oesophageal reflux in children

Abstract

Background Gastro-oesophageal reflux (GOR) is common and usually self-limiting in infants. Cisapride, a pro-kinetic agent, was commonly prescribed until reports of possible serious adverse events were associated with its use. Objectives To determine the e ectiveness of cisapride versus placebo or non-surgical treatments for symptoms of GOR. Search methods We searched the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group Specialised Register and Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE, reference lists of relevant review articles and searched in the Science Citation Index for all the trials identified. All searches were updated in February 2009. Selection criteria Randomised controlled trials comparing oral cisapride therapy with placebo or other non-surgical treatments for children diagnosed with GOR were included. We excluded trials with a majority of participants less than 28 days of age. Data collection and analysis Primary outcomes were a change in symptoms at the end of treatment, presence of adverse events, occurrence of clinical complications and weight gain. Secondary outcomes included physiological measures of GOR or histological evidence of oesophagitis. We dichotomised symptoms into 'same or worse' versus 'improved' and calculated summary odds ratios (OR). Continuous measures of GOR (for example reflux index) were summarised as a weighted mean di erence. All outcomes were analysed using a random-e ects method. Main results Ten trials in total met the inclusion criteria. Nine trials compared cisapride with placebo or no treatment, of which eight (262 participants) reported data on symptoms of gastro-oesophageal reflux. There was no statistically significant di erence between the two interventions (OR 0.34; 95% CI 0.10 to 1.19) for 'same or worse' versus 'improved symptoms' at the end of treatment. There was significant heterogeneity between the studies, suggesting publication bias. Four studies reported adverse events (mainly diarrhoea); this di erence was not statistically significant (OR 1.80; 95% CI 0.87 to 3.70). Another trial found no di erence in the electrocardiographic QTc interval a er three to eight weeks of treatment. Cisapride significantly reduced the reflux index (weighted mean di erence-6.49; 95% CI-10.13 to-2.85; P = Cisapride treatment for gastro-oesophageal reflux in children (Review)

Changes in Prescription Patterns of Acid‐Suppressant Medications by Belgian Pediatricians

“…GER is defined as the passage of gastric contents into the esophagus and is a normal physiological phenomenon in healthy infants and children (7)(8)(9)(10)12,15). The use of acid suppressants in this uncomplicated GER indication is off-label and not advocated by guidelines, as is the case for the widely used prokinetic agents (eg, metoclopramide, domperidone) and mucosal surface antacids (1,9,18). The use of acid suppressants in this uncomplicated GER indication is off-label and not advocated by guidelines, as is the case for the widely used prokinetic agents (eg, metoclopramide, domperidone) and mucosal surface antacids (1,9,18).…”

Gastroesophageal Reflux

“…However, there is no effective and safe prokinetic agent on the market. Cisapride was probably the prokinetic for which efficacy data were the strongest, although only a decrease of the reflux index (% time pH was < 4.0) has been shown: Cisapride significantly reduced the reflux index (weighted mean difference − 6.49; 95 % CI − 10.13 to − 2.85; P = 0.0005) [120]. But cisapride was taken off the market in the beginning of this century by the American and European authorities because of its cardiac adverse effects such as QT prolongation and torsades de pointes.…”

Drugs Acting on the Gut: Prokinetics, Antispasmodics, Laxatives

“…The consensus statements issued by NASPGHAN and ESPGHAN in 2000 states that cisapride is recommended for pediatric GERD when non-pharmacologic treatment fails, but that the medication does require close monitoring, and speci fi c precautions should be taken [ 59,60 ] . However, more recently the 2010 Cochrane Review did not show any difference in symptom improvement or weight gain when cisapride is compared to placebo [ 61 ] . Nine studies comparing cisapride with placebo or no treatment, that met inclusion criteria, were included in the meta-analysis [62][63][64][65][66][67][68][69] .…”