Gastric antral injections of botulinum toxin delay gastric emptying but do not reduce body weight

Mark Topazian, Michael Camilleri, Felicity T Enders, Jonathan E Clain, Ferga C Gleeson, Michael J Levy, Elizabeth Rajan, Vandana Nehra, Ross A Dierkhising, Maria L Collazo-Clavell, Nicholas J Talley, Matthew M Clark, Mark Topazian, Michael Camilleri, Felicity T Enders, Jonathan E Clain, Ferga C Gleeson, Michael J Levy, Elizabeth Rajan, Vandana Nehra, Ross A Dierkhising, Maria L Collazo-Clavell, Nicholas J Talley, Matthew M Clark

Abstract

Background & aims: Gastric injections of botulinum toxin A (BTA) have been reported to delay gastric emptying, increase satiation, and reduce body weight, but there are few data from randomized, placebo-controlled studies.

Methods: We enrolled 60 obese participants in a 24-week, double-blind, randomized, placebo-controlled, concealed allocation trial to compare the effects of gastric antral injections of BTA (100, 300, or 500 U) and saline placebo. The study was conducted at an outpatient clinical research unit. Participants were given one set of injections of BTA or placebo into the gastric antral muscularis propria by using endoscopic ultrasound guidance. Gastric emptying of solids was measured by scintigraphy; we also measured body weight, satiation (maximum tolerated volume in a caloric liquid drink test), calorie intake (by food frequency questionnaire), gastrointestinal symptoms, and psychological aspects of eating behavior (by rating scale).

Results: Compared with baseline values, 2 weeks after injections, the mean half-time for gastric emptying of solids increased by 0.8, 14, 24, and 14 minutes among subjects given placebo, 100, 300, or 500 U BTA, respectively (P = .24 overall, P = .04 for the group given 300 U vs placebo); 16 weeks after the injections, mean body weights were reduced by 2.2, 0.2, 2.3, and 3.0 kg in these groups, respectively. There were no statistically significant differences in mean body weight change, satiation volume, caloric intake, gastrointestinal symptoms, or psychological aspects of eating behavior among groups.

Conclusions: Gastric antral injections of BTA may delay gastric emptying at a dose of 300 U but do not cause early satiety, altered eating behaviors, or loss of body weight. Clinicaltrials.gov identifier: NCT00976443.

Conflict of interest statement

Disclosures: The authors have no relevant disclosures or conflicts of interest.

Copyright © 2013 AGA Institute. Published by Elsevier Inc. All rights reserved.

Figures

Figure 1
Figure 1
Change in gastric emptying of solids (GES) T½ two weeks after gastric injections. Shaded boxes indicate the interquartile range (IQR); the lines and diamonds inside the boxes indicate median and mean values, respectively. p=.24, .04, and .24 for comparison of the 100 U, 300 U, and 500 U groups with placebo, respectively; overall p=0.23.
Figure 2
Figure 2
Change (compared to baseline) in maximum tolerated volume (MTV) 2 and 16 weeks after gastric injections. Shaded boxes indicate the interquartile range (IQR); the lines and diamonds inside the boxes indicate median and mean values, respectively, with outliers represented by open circles. There are no statistically significant differences between groups at either week 2 or week 16.
Figure 3
Figure 3
Body weight change after gastric injections. Lines represent mean body weight change over time for each treatment group. There are no statistically significant differences between groups at any time point.
Figure 4
Figure 4
GSRS (Gastrointestinal Symptom Rating Scale) scores over time. There are no statistically significant differences between groups at any time point.

Source: PubMed

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