1. In this multicenter randomized trial, peroral endoscopic myotomy (POEM) generated clinical success in controlling symptoms of achalasia similar to the current gold standard treatment, laparoscopic Heller’s myotomy (LHM) with fundoplication.
2. Patients in the POEM group were more likely to experience gastroesophageal reflux and reflux esophagitis versus LHM, most likely due to the absence of a concomitant antireflux measure.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Current treatments for achalasia include endoscopic botulinum toxin injection, pneumatic dilation, and laparoscopic Heller’s myotomy (LHM) with fundoplication. Compared to LHM, peroral endoscopic myotomy (POEM) is a less invasive procedure that has demonstrated promising safety and efficacy in retrospective studies. This prospective trial involving patients with idiopathic achalasia found POEM to be noninferior to LHM with regard to clinical success as measured by Eckardt score. Improvement in esophageal function measured through manometry also appeared similar between groups. However, because no adjunct antireflux procedure is added to the POEM procedure, patients are more vulnerable to gastroesophageal reflux. As expected, a greater percentage of patients in the treatment group had developed reflux esophagitis at 3 months despite a higher prevalence of proton pump-inhibitor use. Additionally, the overall rate of clinical success at 2 years was lower than in existing literature, potentially due to the inclusion of previously unsuccessfully treated patients. This study was limited by a number of factors including an unblinded design, physician inexperience, and insufficient power to detect differences in adverse events. These results support the role of POEM as a treatment alternative, especially for patients who desire a shorter procedure time or require a longer incision for more advanced achalasia.
In-Depth [randomized controlled trial]: In this European multicenter trial, 221 patients with symptomatic achalasia were randomized in a 1:1 ratio to undergo either LHM with Dor fundoplication or POEM. The primary endpoint of clinical success was defined as an Eckardt symptom score of 3/12 or less without the use of additional treatments at the 2 year follow-up. The four components of the questionnaire are dysphagia, regurgitation, chest pain, and weight loss, and all patients self-reported scores higher than 3 at baseline. In the per protocol population, 82.4% of patients in the POEM group had clinical success at 2 years, compared to 80.6% of patients in the LHM group (odds ratio, 1.28; 95% CI, 0.85 to 1.92). No interactions were found in exploratory analyses of subgroups established according to age, sex, achalasia subtype, and previous treatment. Improvement in esophageal function as indicated by integrated relaxation pressure was similar between groups (difference, −0.75 mm Hg; 95% CI, −2.26 to 0.76), but reflux esophagitis was more common in the POEM group than in the LHM group, both at 3 months (57% vs. 20%; odds ratio, 5.74; 95% CI, 2.99 to 11.00) and at 24 months (44% vs. 29%; odds ratio, 2.00; 95% CI, 1.03 to 3.85). The average procedure time was shorter by 13.81 minutes in the POEM group, but the average length of hospital stay remained similar between groups (difference, 0.26 days; 95% CI, −0.12 to 0.63).
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