Objective: Erythromycin is a motilin agonist that greatly increases the fractional rate of gastric emptying. Although a number of studies document the efficacy of erythromycin in improving gastric emptying, little information exists concerning symptom improvement in patients with gastroparesis. The aim of this study was to review clinical trials of erythromycin to determine the efficacy of this agent in producing symptom relief in patients with gastroparesis.
Methods: A MEDLINE search from 1966 to 2001 was performed to identify all clinical trials using erythromycin in patients with gastroparesis. The search was further limited to clinical trials using symptom assessment as an endpoint. References from index citations were reviewed to identify additional studies. The search was conducted independently by two authors, and discrepancies were resolved by consensus opinion.
Results: Thirty-five clinical trials were identified, and five met inclusion criteria. One study each involved gastroparesis caused by surgery and systemic sclerosis. Three studies evaluated patients with diabetic or idiopathic gastroparesis. No study used symptoms as a primary endpoint. Improvement was reported in 26 of 60 (43%) patients. Individual symptom scores were available for 23 of 60 subjects in these studies, and symptom improvement was seen in 11 of 23 (48%) patients. One study compared erythromycin and metoclopromide in an open-label, crossover fashion, and found no difference between the two agents. All studies were methodologically weak and highly subject to bias. Four of five studies were open-label trials. Sample sizes in all studies were < or =13 subjects, and treatment duration was < or =4 wk in all studies.
Conclusions: Although clearly a potent prokinetic, limited data exist concerning efficacy of erythromycin in treating gastroparesis. Small sample sizes, uncontrolled designs, short duration, and inadequate symptom assessment limit available studies. Well-designed trials designed to assess symptom relief in gastroparesis are needed.