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Effect of Baclofen on Emesis and 24-Hour Esophageal pH in Neurologically Impaired Children With Gastroesophageal Reflux Disease

Kawai, Masanobu; Kawahara, Hisayoshi; Hirayama, Satoru; Yoshimura, Norikazu; Ida, Shinobu

Journal of Pediatric Gastroenterology & Nutrition: March 2004 - Volume 38 - Issue 3 - pp 317-323
Original Articles-Gastroenterology

Objectives: Gastroesophageal reflux disease (GERD) is difficult to control with medical therapy in neurologically impaired children. The gamma-aminobutyric acid type B receptor agonist baclofen was recently reported to reduce reflux in adult patients with GERD by reducing the incidence of transient lower esophageal sphincter relaxations. The current study was undertaken to investigate the effects of baclofen on GERD in neurologically impaired children.

Methods: Eight neurologically impaired children with GERD between 2 months and 16 years were studied. Baclofen (0.7 mg/kg/day) was administered orally or via nasogastric tube in three divided doses 30 minutes before meals for 7 days. The frequency of emesis on and off baclofen were recorded as a measure of clinical impact. Twenty-four–hour esophageal pH monitoring was conducted before and on the seventh day of the administration of baclofen.

Results: The frequency of emesis was significantly decreased (P = 0.03). The total number of acid refluxes was significantly decreased both during the entire 24-hour period (P = 0.01) and during the postprandial period (P = 0.049). The number of acid refluxes longer than 5 minutes was significantly decreased during the 24-hour period (P = 0.02). The percentage total time of esophageal pH <4.0 and esophageal acid clearance time were not significantly different during the 24-hour period or during the postprandial period. No adverse effects were observed, except for a slight reduction in muscle tone in one subject.

Conclusions: In this 1-week trial, repetitive administration of baclofen reduced the frequency of emesis and the total number of acid refluxes in neurologically impaired children with GERD.

Gastroesophageal reflux disease (GERD) is a common gastrointestinal disorder in the pediatric population. Previously it had been assumed that persistent low resting tone of the lower esophageal sphincter (LES) was responsible for the occurrence of reflux (1,2). It is now thought that transient LES relaxations are more likely to be the predominant mechanism of reflux in children and adults with GERD (3,4). Transient LES relaxation typically is caused by gastric distention and is controlled at the brain stem through the vagus nerve (5,6). In adults with GERD, recent studies have shown that the GABA type B receptor agonist baclofen decreases the number of postprandial acid refluxes by reducing the incidence of transient LES relaxations (7–9). Although baclofen is potentially efficacious in the treatment of GERD, studies of baclofen in GERD have to date been limited to evaluation of single oral doses in adult patients.

Surgical control of reflux is a challenging problem in neurologically impaired children because of high rates of complication and recurrence, even with laparoscopic surgery (10). Medical control of reflux would be attractive in such patients if successful. However, current drug therapies have not been potent enough to control reflux in such patients, especially since the use of cisapride was restricted because of serious adverse effects. In the current study, we investigated the effectiveness of regularly administered baclofen for GERD in neurologically impaired children.

Department of Pediatric Gastroenterology and Nutrition, Department of Pediatric Surgery, Osaka Medical Center and Research Institute for Maternal and Child Health, Osaka, Japan.

Presented in part at the annual meeting of the American Gastroenterological Association, Digestive Disease Week 2003, May 18–21, 2003, Orlando, Florida, U.S.A.

Address correspondence and reprint requests to Dr. Hisayoshi Kawahara, Department of Pediatric Surgery, Osaka Medical Center and Research Institute for Maternal and Child Health, 840 Murodocho Izumi, Osaka, Japan (e-mail:

Received February 27, 2003;

revised August 8, 2003; accepted September 25, 2003.

© 2004 Lippincott Williams & Wilkins, Inc.