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Endoscopic pneumatic dilation versus botulinum toxin injection in the management of primary achalasia

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Abstract

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Background

Achalasia is an oesophageal motility disorder, of unknown cause, which results in increased lower oesophageal sphincter (LOS) tone and symptoms of difficulty swallowing. Treatments are aimed at reducing the LOS tone. Current endoscopic therapeutic options include pneumatic dilation (PD) or botulinum toxin injection (BTX).

Objectives

The objective of this review was to compare the efficacy and safety of two endoscopic treatments, pneumatic dilatation and intrasphincteric botulinum toxin injection, in the treatment of oesophageal achalasia.

Search methods

Trials were identified by searching MEDLINE 1966 to August 2008, EMBASE 1980 to September 2008, ISI Web of Science 1955 to September 2008, The Cochrane Library Issue 3, 2008.  Searches in all databases were conducted in October 2005 and updated in September 2008. The Cochrane Highly Sensitive Search Strategy for identifying randomized trials in MEDLINE, sensitivity maximising version, Ovid format, was combined with specific search terms to identify randomized controlled trials in MEDLINE. The MEDLINE search strategy was adapted for use in the other databases searched.

Selection criteria

Randomised controlled trials comparing PD to BTX injection in patients with primary achalasia.

Data collection and analysis

Two review authors independently performed quality assessment and data extraction.

Main results

Six studies involving 178 participants were included. Two studies were excluded from the meta‐analysis of remission rates on the basis of clinical heterogeneity of the initial endoscopic protocols. There was no significant difference in remission between PD or BTX treatment within four weeks of the initial intervention, with a relative risk of remission of 1.15 (95% CI 0.95 to 1.38, P = 0.39) for PD compared to BTX. There was also no significant difference in the mean oesophageal pressures between the treatment groups; weighted mean difference for PD of ‐0.77 (95% CI ‐2.44 to 0.91, P = 0.37). Data on remission rates following the initial endoscopic treatment was available for two studies at six months and three studies at 12 months. At six months 22 of 29 PD participants were in remission compared to 7 of 27 in the BTX group, giving a relative risk of 2.90 (95% CI 1.48 to 5.67, P = 0.002); whilst at 12 months 33 of 47 PD participants were in remission compared to 11 of 43 BTX participants, relative risk of 2.67 (95% CI 1.58 to 4.52, P = 0.0002). No serious adverse outcomes occurred in participants receiving BTX, whilst PD was complicated by perforation in three cases.

Authors' conclusions

The results of this meta‐analysis would suggest that PD is the more effective endoscopic treatment in the long term (greater than six months) for patients with achalasia.

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Plain language summary

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Endoscopic balloon dilation versus Botox injection for managing achalasia (a condition causing difficulty in swallowing)

Achalasia is an oesophageal motility disorder which results in increased lower oesophageal sphincter (LOS) tone and symptoms of difficulty swallowing. Treatments are aimed at reducing the tone of the LOS and include the endoscopic options of pneumatic dilation (PD) or botulinum toxin (BTX) injection. We set out to undertake a systematic review comparing randomised controlled trials that examined the efficacy and safety of PD and BTX injection in patients with achalasia. Six randomised controlled trials were reviewed, and four were suitable for meta‐analysis. Meta‐analysis suggested that, although both interventions have similar initial response rates, the remission rates at 6 and 12 months were significantly greater with PD.