Injection of botulinum toxin before pneumatic dilatation in achalasia treatment: a randomized‐controlled trial

PreambleThe guidelines for the surgical treatment of esophageal achalasia are a series of systematically developed statements to assist surgeon (and patient) decisions about the appropriate use of minimally invasive techniques for the treatment of achalasia in specific clinical circumstances. It addresses the indications, risks, benefits, outcomes, alternatives, and controversies of the procedures used to treat this condition. The statements included in this guideline are the product of a systematic review of published work on the topic, and the recommendations are explicitly linked to the supporting evidence. The strengths and weaknesses of the available evidence are highlighted, and expert opinion is sought where published evidence lacks depth. DisclaimerClinical practice guidelines are intended to indicate the best available approach to medical conditions as established by a systematic review of available data and expert opinion. The approach suggested may not necessarily be the only acceptable approach given the complexity of the healthcare environment. These guidelines are intended to be flexible, because the surgeon must always choose the approach best suited to the individual patient and variables in existence at the moment of decision. These guidelines are applicable to all physicians who are appropriately credentialed and address the clinical situation in question, regardless of specialty.Guidelines are developed under the auspices of SAGES-the guidelines committee-and are approved by the Board of Governors. The recommendations of each guideline undergo multidisciplinary review and are considered valid at the time of production based on the data available. New developments in medical research and practice pertinent to each guideline are reviewed, and guidelines will be periodically updated. Literature review methodA systematic literature search was performed on MED-LINE in October 2010. The search strategy was limited to adult English language articles and is shown in Fig. 1.We identified 214 relevant articles. The abstracts were reviewed by four committee members (DS, WR, TMF, and GPK) and divided into the following categories:(a) Randomized studies, meta-analyses, and systematic reviews and Other Interventional Techniques (b) Prospective studies (c) Retrospective studies (d) Case reports (e) Review articlesRandomized controlled trials, meta-analyses, and systematic reviews were selected for further review along with prospective and retrospective studies that included at least 50 patients. Studies with smaller samples were considered when additional evidence was lacking. The most recent reviews also were included. All case reports, old reviews, and smaller studies were excluded. According to these exclusion criteria, 102 articles were selected for review. Whenever the available evidence from Level I studies was considered to be adequate, lower evidence level studies were not considered.The reviewers graded the level of evidence and manually searched the bibliography of each article for additional articl...

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“…One proposed technique is to inject with botulinum toxin before dilatation. This has been found to be ineffective [38].…”

Section: Combination Treatmentsmentioning

confidence: 98%

SAGES guidelines for the surgical treatment of esophageal achalasia

et al. 2011

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“…In one randomized controlled trial, Mikaeli et al [20] compared pneumatic dilation with botulinum toxin injectionpneumatic dilation in achalasia patients. One-year remission rate of patients was 77% in botulinum toxin injection-pneumatic dilation group and 62% in pneumatic dilation group (P = 0.1).…”

Section: Pneumatic Dilation Versus Botulinum Toxin Injection-pneumatimentioning

confidence: 98%

Meta-Analysis of Randomized and Controlled Treatment Trials for Achalasia

Wang

2008

Dig Dis Sci

133

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Pharmacological therapy, botulinum toxin injection, pneumatic dilatation, and surgical myotomy are the primary therapeutic modalities for achalasia, for which laparoscopic myotomy is recommended as state-of-the-art therapy. However, its efficacy and safety remain unclear compared with other approaches in the treatment of achalasia. We searched electronic databases (MEDLINE, EMBASE, Cochrane Central Registry of Controlled Trials, LILACS-Latin American, Caribbean health science literature, and Science Citation Index Expanded) for randomized controlled trials to evaluate which therapeutic measures are temporary and reversible and which measures are definitive and effective by pooling data including remission rate, relapse rate, complications, and adverse effects. Seventeen studies with 761 patients met our inclusion criteria. There was better remission rate in pneumatic dilation than in botulinum toxin injection for initial intervention [relative risk (RR) 2.20, 95% confidence interval (CI) 1.51-3.20], Pneumatic dilation had lower relapse rate than did botulinum toxin injection (RR 0.12, 95% CI 0.04-0.32). Compared with pneumatic dilation, laparoscopic myotomy further increased remission rate (RR 1.48, 95% CI 1.48-1.87), and reduced clinical relapse rate (RR 0.14, 95% CI 0.04-0.58), and there was no difference in complication rate (RR 1.48, 95% CI 0.37-5.99). Based on limited randomized and controlled trials, laparoscopic myotomy is the preferred method for patients with achalasia. Future trials should investigate whether laparoscopic myotomy combined with different modalities of fundoplication is superior to isolated laparoscopic myotomy.

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“…The botulinum toxin-pneumatic dilation group showed a significant reduction in barium height at both 1 mo and 1 year after treatment (P < 0.001). In the botulinum toxin-pneumatic dilation group, 91% of patients older than 40 years were in remission at 1 year, compared with only 55% of this age group in the pneumatic dilation group (P = 0.07) [94] . We found an abstract in English that reported a series of 9 patients with achalasia who were treated with application of 250 IU Dysport into the LES and balloon dilation 7 d later.…”

Section: Pneumatic Dilation After Botulinum Toxin Injectionmentioning

confidence: 99%

Achalasia: A review of Western and Iranian experiences

Mikaeli¹,

Islami²,

Malekzadeh³

2009

WJG

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Achalasia is a primary motor disorder of the eso phagus, in which esophageal emptying is impaired. Diagnosis of achalasia is based on clinical findings. The diagnosis is confirmed by radiographic, endoscopic, and manometric evaluations. Several treatments for achalasia have been introduced. We searched the PubMed Database for original articles and meta analyses about achalasia to summarize the current knowledge regarding this disease, with particular focus on different procedures that are used for treatment of achalasia. We also report the Iranian experience of treatment of this disease, since it could be considered as a model for mediumresource countries. Myotomy, particularly laparoscopic myotomy with fundoplication, i s t h e m o s t e ffe c t i ve t re a t m e n t fo r a c h a l a s i a . Compared to other treatments, however, the initial cost of myotomy is usually higher and the recovery period is longer. When performing myotomy is not indicated or not possible, graded pneumatic dilation with slow rate of balloon inflation seems to be an effective and safe initial alternative. Injection of botulinum toxin into the lower esophageal sphincter before pneumatic dilation may increase remission rates. However, this needs to be confirmed in further studies. Due to lack of adequate information regarding the role of expandable stents in the treatment of achalasia, insertion of stents does not currently seem to be a recommended treatment. In summary, laparoscopic myotomy can be considered as the procedure of choice for treatment of achalasia. Graded pneumatic dilation is an effective alternative when the performance of myotomy is not possible for any reason.

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Injection of botulinum toxin before pneumatic dilatation in achalasia treatment: a randomized‐controlled trial

Abstract: Injection of botulinum toxin before pneumatic dilatation does not significantly enhance the efficacy of pneumatic dilatation.

Cited by 35 publications

References 20 publications

SAGES guidelines for the surgical treatment of esophageal achalasia

SAGES guidelines for the surgical treatment of esophageal achalasia

Meta-Analysis of Randomized and Controlled Treatment Trials for Achalasia

Achalasia: A review of Western and Iranian experiences

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