Gastric Antral Injections of Botulinum Toxin Delay Gastric Emptying but Do Not Reduce Body Weight

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 U, 300 U, 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, using endoscopic ultrasound guidance. Gastric emptying of solids (GES) 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 psychologic aspects of eating behavior (by rating scale). Results Compared with baseline values, 2 weeks after injections, the mean t1/2 for GES increased by 0.8, 14, 24, and 14 minutes among subjects given placebo, 100 U, 300 U, or 500 U of 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

Inyección Intragástrica De Toxina Botulínica Mediante Endoscopia, ¿una Alternativa Para El Tratamiento Para La Obesidad? Una Revisión Sistemática.

“…La mayor parte de los estudios realizados incluyen técnicas que miden el vaciamiento gástrico, y varios de ellos concluyen que se produce un enlentecimiento significativo del mismo (24)(25)(26).…”

“…Esto resulta coherente, teniendo en cuenta que el efecto de la toxina botulínica comprende entre las 2 y las 24 semanas, si bien algunos de los estudios demuestran escaso efecto en el peso más allá de los tres meses (24,25).…”

Gastrointestinal traits: individualizing therapy for obesity with drugs and devices

“…63 A recently published meta-analysis and meta-regression of 4 randomized, controlled trials evaluating antral BOTOX injection suggested overall benefit (Hedges’ g −0.521; 95% CI, −0.845 to −0.040, P = .031), but 3 of the 4 trials were individually nonsignificant. In addition, wide-area injection was associated with weight loss (Hedges’ g, −0.890; 95% CI, −1.522 to −0.258; P = .006), though antrum only injection did not show significant efficacy (Hedges’ g, −0.192; 95% CI, −0.788 to 0.404; P = .528).…”

Botulinum Toxin A for Controlling Obesity

“…Gastric emptying times were longer, and a decrease in fasting ghrelin levels was appreciated. However, a larger randomized placebo controlled trial by Topazian et al [70], who enrolled 60 obese patients in a six-month trial, demonstrated a delay in gastric emptying without the effects of early satiety, in altered eating behaviors, or in weight loss. In this study, only antral injections were performed as opposed to both antral and fundal injections.…”