Guidance
4 Efficacy
4 Efficacy
This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
4.1 A meta-analysis of 4 studies including 169 patients with diabetic gastroparesis treated by gastroelectrical stimulation (part of a systematic review of 601 patients) reported improvement in total symptom severity score (weighted mean difference 8.96 [95% confidence interval {CI} 6.1 to 11.8]; p<0.00001; I2=68.6%). A meta-analysis of 3 studies including 58 patients with idiopathic gastroparesis treated by gastroelectrical stimulation reported improvement in total symptom severity score (weighted mean difference 7.5 [95% CI 5.4 to 9.7]; p<0.00001; I2=52.9%). A meta-analysis of 2 studies including 33 patients with post-surgical gastroparesis treated by gastroelectrical stimulation reported improvement in total symptom severity score (weighted mean difference 8.3 [95% CI 5.5 to 11.1]; p<0.00001; I2=0%). Length of follow-up was unclear in all the analyses.
4.2 A meta-analysis of 7 studies including 378 patients with diabetic, idiopathic or post-surgical gastroparesis treated by gastroelectrical stimulation (part of a systematic review of 601 patients) reported a statistically significant improvement in gastric emptying at 4 hours (assessed using standardised radionucleotide scans of a solid meal: weighted mean difference 13.0 [95% CI 7.4 to 18.6]; p<0.00001; I2=87.4%). Subgroup analysis showed that the improvement was statistically significant in patients with diabetic or idiopathic gastroparesis but not in patients with post-surgical gastroparesis. Length of follow-up was unclear in all the analyses.
4.3 In a systematic review of 364 patients, a meta-analysis of 4 studies including 75 patients with gastroparesis treated by gastroelectrical stimulation reported no statistically significant change in weight (weighted mean difference 3.7 [95% CI −0.2 to 7.6]; I2=0%). Length of follow-up was not reported but 12-month outcomes were preferred.
4.4 In the systematic review of 364 patients, a meta-analysis of 8 studies including 184 patients with gastroparesis treated by gastroelectrical stimulation reported a reduction in need for nutritional support from 44% (96/216) of patients at baseline to 11% (21/184) at follow-up (odds ratio 5.5 [95% CI 2.8 to 11.1]; p<0.00001; I2=27%). Length of follow-up was not reported but 12-month outcomes were preferred.
4.5 A randomised controlled trial (RCT) of 32 patients with gastroparesis of idiopathic origin reported that there was a significant reduction in weekly vomiting frequency from 61 to 87% (p<0.001) and improvements in gastroparesis symptoms, gastric emptying and days of hospitalisation (all p<0.05) at 1-year follow-up.
4.6 The systematic review of 364 patients reported a significant improvement in Short Form-36 physical component score (weighted mean difference 8.1 [95% CI 5.0 to 11.1]) and the mental component score (weighted mean difference 8.16 [95% CI 4.9 to 11.5]), based on meta-analyses of 4 studies with 78 patients. The difference was statistically significant (p<0.00001) for both outcomes with no heterogeneity. Length of follow-up was not reported but 12-month outcomes were preferred.
4.7 The specialist advisers listed key efficacy outcomes as reduced symptoms, reduced need for nutritional support, improved nutritional status and reduced frequency of hospital admissions.