Clinical Study on Combined Therapy of Botulinum Toxin Injection and Small Balloon Dilation in Patients with Esophageal Achalasia

Abstract

Background and Study Aims: To compare the efficiency of pneumatic balloon dilation, botulinum toxin (BT) injection, and the combination of the two modalities in the management of esophageal achalasia. Patients and Methods: Ninety patients with esophageal achalasia were randomly divided into three groups according to different interventions, i.e. patients in group A received 100 U BT injection; patients in group B were given balloon dilation, and patients in group C were subjected to balloon dilation plus 100 U BT injection 15 days after the dilation. Clinical assessment and esophageal manometry were performed by experienced gastroenterologists. All patients were followed-up for more than 2 years. Results: At any time after the treatment, the lower esophageal sphincter pressure and symptom score in group C were lower compared with those in group A or group B (p < 0.05). At 2 years after treatment, the response rate in group C remained 56.67%, still higher than those in the other groups (p < 0.05); the response rate in group B was only 35.71% (10/28); the response rate in group A was 13.79%, the lowest among the three groups. Conclusions: The efficiency of the combination of 100 U BT administration and small balloon dilation is superior to the single modality approach.

2019 Seoul Consensus on Esophageal Achalasia Guidelines

“…50,51 However, although multiple trials have demonstrated short-term benefits of botulinum toxin injection, a single injection of botulinum toxin has only short-duration clinical effects with relapses within several months occurring frequently. [51][52][53][54][55][56][57][58][59] Typically, 100 U of botulinum toxin is injected into 4 quadrant of LES each as 4 divided doses. There is wide variability in the timing of the botulinum toxin injections.…”

The Kagoshima consensus on esophageal achalasia

“…When PD is performed after myotomy, it has only a 50% response but no higher risk for complications. PD after BoTox injection is safe and feasible but there is no added benefit to combination therapy of BoTox injection before pneumatic dilation 24 …”

“…11 and 12). Randomized studies of the two procedures have tended to favor the surgical treatment also, although the largest trial mounted to date at very early follow‐up suggests there is not a lot to choose between the two therapies 24 …”

“…PD after BoTox injection is safe and feasible but there is no added benefit to combination therapy of BoTox injection before pneumatic dilation. 24 In a long-term study of 77 patients, 69 achieved stable remission and were followed for 5.6 years; six patients had myotomy and two perforated. Twelve patients relapsed after 2.6 years and 9 of them had 1-2 PD.…”

“…Randomized studies of the two procedures have tended to favor the surgical treatment also, although the largest trial mounted to date at very early follow-up suggests there is not a lot to choose between the two therapies. 24 The principle underlying the lower esophageal myotomy is for all the muscle fibers of the lower esophageal sphincter to be divided, therefore diminishing the resistance to esophageal outflow and allow food to pass through into the stomach under gravity. Although regarded as one of the more challenging laparoscopic esophagogastric operations, with appropriate mentoring the learning curve for the procedure is probably in the range of 10-20 operations.…”