Evidence strengths and limitations

Evidence strengths and limitations

Only 1 systematic review was identified (Maganti et al. 2003) that reviewed studies evaluating the efficacy of oral erythromycin for the symptomatic relief of gastroparesis. All of the 5 studies identified by the systematic review were small, methodologically flawed and carried a high risk of bias. The study by Samsom et al. (1997) was a double-blind, placebo-controlled crossover study. This study was considered in the NICE clinical guideline on type 2 diabetes – newer agents, but was excluded for methodological reasons. The study by Erbas et al. (1993) was a single-blind, active-controlled (metoclopramide), crossover study. This found a statistically significant beneficial effect on symptoms from using erythromycin compared with metoclopramide. The authors, however, did not report if the statistically significant benefit translated into a clinically important difference. The small numbers of participants included in these 2 controlled studies (n=12 and n=13 respectively) suggest that it is likely that these studies may not have been sufficiently powered to detect differences between the interventions.

No study identified reliable evidence for the safety and tolerability of erythromycin in either the short or longer term.

The studies included in the systematic review had several limitations. The treated populations had gastroparesis caused by various conditions including diabetes, unknown cause (idiopathic), systemic sclerosis, or surgery. The dose of oral erythromycin differed in the studies, with dosages ranging from 125 mg 3 times daily to 500 mg 4 times daily, and treatment periods ranging from 2 to 4 weeks.

The systematic review searched only one database (MEDLINE) meaning that important relevant trials not indexed on this database could have been missed. In addition, only a descriptive narrative of the included studies was carried out and no statistical analysis was performed, although this may have been appropriate given the differences in the included studies. The review was poorly reported with some results presented that were not published in the original research papers.

A literature search found an additional retrospective chart review that assessed the effect of oral erythromycin on dyspepsia symptoms in 25 people with impaired gastric emptying. Retrospective chart reviews and case series rarely provide evidence which is on its own sufficiently strong to guide clinical practice.