Comparison of safety and efficacy of intragastric botulinum toxin-A versus gastric balloon.

Abstract

Background: A prospective case-matched study was conducted to compare the safety and efficacy of endoscopic intragastric botulinum toxin-A (EIBT) versus endoscopically planned gastric balloon (EPGB), as a treatment for obesity.

Methods: A total of 176 patients (matched for age and sex) were equally divided to undergo EIBT (n = 88) or EPGB (n = 88). Patients who received EIBT were restricted to a body mass index (BMI) of 25 to 35 kg/m², whereas a BMI >25 kg/m² was allowed in the EPGB group. The main measured outcomes were weight loss, procedure duration, complications, early satiety, and quality of life (QoL).

Results: The patients were followed up for a mean of 6 months. The mean weight loss was greater in the EPGB group than in the EIBT group (15.6 kg vs. 9.3 kg, P < 0.001). However, the percentage excess weight loss and the satiety score were greater in the EIBT group (59.1% vs. 42.2%, P < 0.001; and 3.5 vs. 2.3, P < 0.001) respectively. The procedure duration was shorter for EIBT patients (10 min vs. 15 min, P < 0.001). The postoperative complication rate recorded in the EPGB group was significantly higher (30% vs. 9%, P = 0.001). Adverse symptoms lasted longer in EPGB (5.2 days vs. 0.7 days, P < 0.001). Both groups enjoyed similar improvements in QoL.

Conclusion: EIBT is a safe and effective treatment for mild obesity. Although the weight loss was greater in the EPGB group, the percentage excess weight loss, procedure duration, postoperative complications, and symptom duration were significantly better in the EIBT group. QoL improvement was comparable between the two groups.