Achalasia Treatment Trials: POEM, Heller Myotomy and Balloon Dilation


In achalasia, the muscle ring at the bottom of the food pipe (the lower esophageal sphincter) does not open properly when a person swallows, and the food pipe itself loses its normal squeezing waves. No treatment brings the lost nerve cells back. Every procedure in this page works the same way in principle: it weakens or cuts the tight muscle ring so that food can fall into the stomach by gravity. This page sets out what the head-to-head randomized trials, their long-term follow-ups, and the meta-analyses that pooled them actually found, with the numbers as the papers report them.

Three procedures dominate the trials. Pneumatic dilation (balloon dilation) stretches and tears the muscle ring from the inside with a balloon passed through an endoscope. Laparoscopic Heller myotomy is keyhole surgery through the abdomen that cuts the muscle ring from the outside, usually with a partial wrap of stomach (a Dor fundoplication) added to limit reflux. Peroral endoscopic myotomy (POEM) cuts the same muscle from the inside, through a tunnel made under the lining of the food pipe with an endoscope passed through the mouth, with no skin incision and no anti-reflux wrap. A fourth option, botulinum toxin injection into the muscle ring, relaxes it chemically for a time.


Table of Contents

  1. How the Trials Measure Success
  2. Balloon Dilation Versus Heller Myotomy
  3. Peroral Endoscopic Myotomy Versus Balloon Dilation
  4. Peroral Endoscopic Myotomy Versus Heller Myotomy
  5. Botulinum Toxin Versus Balloon Dilation
  6. Results by Chicago Classification Subtype
  7. Reflux After Each Treatment
  8. Perforation and Other Harms
  9. Repeat Treatment and Treatment After Failure
  10. What the Network Meta-Analyses Found
  11. What the 2020 American College of Gastroenterology Guideline States
  12. Limits of the Evidence
  13. Key Research Papers
  14. Connections
  15. Featured Videos

How the Trials Measure Success

Almost every trial on this page uses the same yardstick, the Eckardt score. It adds up four symptoms — trouble swallowing, food coming back up (regurgitation), chest pain behind the breastbone, and weight loss — on a scale from 0 to 12, where higher means worse. A trial usually counts a patient as a success when the score falls to 3 or less.

The small print matters, because the trials do not all define success the same way:

So a "success rate" for balloon dilation in one trial is not the same measurement as in another. Where this page puts numbers from different trials side by side, it says so: those are cross-trial comparisons, not head-to-head results.

Besides symptoms, trials measure the pressure in the muscle ring when it is meant to relax on swallowing (the integrated relaxation pressure, read on high-resolution manometry), and how fast a column of barium drains out of the food pipe on a timed X-ray (the timed barium esophagram).

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Balloon Dilation Versus Heller Myotomy

The European Achalasia Trial is the largest randomized trial of balloon dilation against laparoscopic Heller myotomy with a Dor fundoplication. It enrolled 201 newly diagnosed adults at centres in several European countries.

The 2-year results (Boeckxstaens 2011, New England Journal of Medicine)

The 5-year results (Moonen 2016, Gut)

This trial is the main evidence against the older belief that Heller myotomy gives clearly better long-term symptom control than balloon dilation. In this trial it did not, as long as repeat dilation was allowed.

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Peroral Endoscopic Myotomy Versus Balloon Dilation

The first randomized trial of peroral endoscopic myotomy against balloon dilation in people who had never been treated ran at six hospitals in the Netherlands, Germany, Italy, Hong Kong and the United States.

The 2-year results (Ponds 2019, JAMA)

The 5-year results (Kuipers 2022, Lancet Gastroenterology and Hepatology)

The gap between this trial's dilation success (54% at 2 years, 40% at 5 years) and the European Achalasia Trial's (86% at 2 years, 82% at 5 years) is a cross-trial comparison. It largely reflects the different rules: the European trial allowed repeat dilation inside the dilation strategy, while this trial counted a repeat dilation as failure.

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Peroral Endoscopic Myotomy Versus Heller Myotomy

The main head-to-head trial of the two myotomies ran at eight centres in six European countries and compared peroral endoscopic myotomy with laparoscopic Heller myotomy plus Dor fundoplication.

The 2-year results (Werner 2019, New England Journal of Medicine)

The 5-year results (Hugova 2025, Lancet Gastroenterology and Hepatology)

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Botulinum Toxin Versus Balloon Dilation

Botulinum toxin blocks the nerve signal that keeps the muscle ring tight. A Cochrane systematic review (Leyden 2014) pooled seven randomized trials with 178 participants comparing it with balloon dilation.

Two network meta-analyses (below) reached the same conclusion from a larger set of trials: at one year, botulinum toxin gave lower success than each of the other treatments.

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Results by Chicago Classification Subtype

High-resolution manometry, which reads pressure all along the food pipe, splits achalasia into three subtypes (the Chicago Classification, described on the main achalasia page): type I, with almost no pressure in the food pipe body; type II, where the whole food pipe pressurizes at once; and type III, with spastic, premature contractions.

The original subtype study (Pandolfino 2008)

In this study of 99 newly diagnosed patients, found among 1,000 manometry studies (21 type I, 49 type II, 29 type III; 83 with enough follow-up), type II patients were significantly more likely to respond to any therapy: 71% to botulinum toxin, 91% to balloon dilation and 100% to Heller myotomy. Overall response was 56% in type I and 29% in type III. Type III and a widened food pipe before treatment predicted a poorer response. This was an observational study, not a trial.

Subtypes inside the European Achalasia Trial (Rohof 2013)

These are subgroup analyses of a randomized trial; the trial was not designed to compare treatments within each subtype.

Pooled subtype data

The claim that peroral endoscopic myotomy works better than Heller myotomy in type III rests on these observational comparisons and the ability of the endoscopic cut to run further up the food pipe; it has not been tested in a randomized trial limited to type III.

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Reflux After Each Treatment

Opening the muscle ring lets food down, but it also lets stomach acid up. Peroral endoscopic myotomy adds no anti-reflux wrap, and the trials consistently find more reflux after it.

Reflux esophagitis on endoscopy, as each trial reports it

Pooled data

A meta-analysis of prospective studies (Repici 2018), covering 1,542 peroral endoscopic myotomy patients and 2,581 Heller myotomy patients with fundoplication, reported:

The long-term peroral endoscopic myotomy meta-analysis (Zhang 2023) put symptomatic reflux at 23.9% and reflux esophagitis at 16.7%.

Most esophagitis in these trials was graded mild (Los Angeles grade A or B). The gap between measured acid and symptoms is worth knowing: at 5 years after peroral endoscopic myotomy, abnormal acid exposure was found in 62% of those tested, yet reflux symptom scores were similar to the surgery group. Reflux damage can therefore be present without heartburn. Long-term reflux damage of the food pipe is the background to Barrett's esophagus; the 5-year trial found no cases of it, but 5 years is short for that question.

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Perforation and Other Harms

The guideline describes the signs that teams watch for after dilation: pain, crepitus (a crackling feel under the skin) and fever. It notes that a perforation can show up later, after discharge, with severe chest pain with or without fever, and that every patient undergoing dilation is meant to be a candidate for surgery in case a perforation needs repair. A perforation of the food pipe is treated by hospitals as an emergency.

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Repeat Treatment and Treatment After Failure

When Heller myotomy fails (Wessels 2026)

A randomized trial in the Netherlands, Belgium and Italy enrolled 90 people whose symptoms had come back after Heller myotomy, and assigned them to balloon dilation (30 to 35 mm) or peroral endoscopic myotomy. At 5 years, treatment success was 11% after dilation (5 of 45) and 40% after peroral endoscopic myotomy (18 of 45); put the other way, 89% and 60% had failed. Median time to failure was 12 months after dilation and 60 months after peroral endoscopic myotomy. Grade B to D reflux esophagitis was found in 11% and 9%. No procedure-related serious adverse events occurred between years 1 and 5.

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What the Network Meta-Analyses Found

A network meta-analysis combines direct trial comparisons (A against B) with indirect ones (A against C and B against C) to rank several treatments at once. Its results are only as good as the small trials feeding it.

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What the 2020 American College of Gastroenterology Guideline States

The American College of Gastroenterology clinical guideline on achalasia (Vaezi 2020) graded its statements with the GRADE system. The statements below are quoted as the guideline words them in its summary table, with the quality of evidence and strength it assigned (taken from the full text of the guideline). In the quotes, PD is pneumatic dilation, LHM laparoscopic Heller myotomy, POEM peroral endoscopic myotomy, LES the lower esophageal sphincter and GERD gastroesophageal reflux disease.

The guideline was written before the 5-year results of the two peroral endoscopic myotomy trials and the trial after failed Heller myotomy were published. In its text it notes that people who undergo peroral endoscopic myotomy may need lifelong acid suppression, and that screening for erosive esophagitis or Barrett's esophagus after the procedure may be prudent.

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Limits of the Evidence

Decisions about which procedure fits a given person, with their subtype, age and other illnesses, belong with the treating team.

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Key Research Papers

  1. Boeckxstaens GE, Annese V, des Varannes SB, Chaussade S, Costantini M, Cuttitta A, et al. Pneumatic dilation versus laparoscopic Heller's myotomy for idiopathic achalasia. N Engl J Med. 2011;364(19):1807-16. PubMed PMID: 21561346
  2. Moonen A, Annese V, Belmans A, Bredenoord AJ, Bruley des Varannes S, Costantini M, et al. Long-term results of the European achalasia trial: a multicentre randomised controlled trial comparing pneumatic dilation versus laparoscopic Heller myotomy. Gut. 2016;65(5):732-9. PubMed PMID: 26614104
  3. Rohof WO, Salvador R, Annese V, Bruley des Varannes S, Chaussade S, Costantini M, et al. Outcomes of treatment for achalasia depend on manometric subtype. Gastroenterology. 2013;144(4):718-25. PubMed PMID: 23277105
  4. Pandolfino JE, Kwiatek MA, Nealis T, Bulsiewicz W, Post J, Kahrilas PJ. Achalasia: a new clinically relevant classification by high-resolution manometry. Gastroenterology. 2008;135(5):1526-33. PubMed PMID: 18722376
  5. Ponds FA, Fockens P, Lei A, Neuhaus H, Beyna T, Kandler J, et al. Effect of Peroral Endoscopic Myotomy vs Pneumatic Dilation on Symptom Severity and Treatment Outcomes Among Treatment-Naive Patients With Achalasia: A Randomized Clinical Trial. JAMA. 2019;322(2):134-144. PubMed PMID: 31287522
  6. Kuipers T, Ponds FA, Fockens P, Bastiaansen BAJ, Lei A, Oude Nijhuis RAB, et al. Peroral endoscopic myotomy versus pneumatic dilation in treatment-naive patients with achalasia: 5-year follow-up of a randomised controlled trial. Lancet Gastroenterol Hepatol. 2022;7(12):1103-1111. PubMed PMID: 36206786
  7. Werner YB, Hakanson B, Martinek J, Repici A, von Rahden BHA, Bredenoord AJ, et al. Endoscopic or Surgical Myotomy in Patients with Idiopathic Achalasia. N Engl J Med. 2019;381(23):2219-2229. PubMed PMID: 31800987
  8. Hugova K, Mares J, Hakanson B, Repici A, von Rahden BHA, Bredenoord AJ, et al. Per-oral endoscopic myotomy versus laparoscopic Heller's myotomy plus Dor fundoplication in patients with idiopathic achalasia: 5-year follow-up of a multicentre, randomised, open-label, non-inferiority trial. Lancet Gastroenterol Hepatol. 2025;10(5):431-441. PubMed PMID: 40112837
  9. Wessels EM, Masclee GMC, Bastiaansen BAJ, Saleh CMC, Tack J, Boeckxstaens G, et al. Long-Term Outcomes of Peroral Endoscopic Myotomy vs Pneumatic Dilation After Prior Laparoscopic Heller Myotomy for Achalasia. Clin Gastroenterol Hepatol. 2026;24(7):1812-1822. PubMed PMID: 41932531
  10. Leyden JE, Moss AC, MacMathuna P. Endoscopic pneumatic dilation versus botulinum toxin injection in the management of primary achalasia. Cochrane Database Syst Rev. 2014;2014(12):CD005046. PubMed PMID: 25485740
  11. Repici A, Fuccio L, Maselli R, Mazza F, Correale L, Mandolesi D, et al. GERD after per-oral endoscopic myotomy as compared with Heller's myotomy with fundoplication: a systematic review with meta-analysis. Gastrointest Endosc. 2018;87(4):934-943.e18. PubMed PMID: 29102729
  12. Andolfi C, Fisichella PM. Meta-analysis of clinical outcome after treatment for achalasia based on manometric subtypes. Br J Surg. 2019;106(4):332-341. PubMed PMID: 30690706
  13. Kumbhari V, Tieu AH, Onimaru M, El Zein MH, Teitelbaum EN, Ujiki MB, et al. Peroral endoscopic myotomy (POEM) vs laparoscopic Heller myotomy (LHM) for the treatment of Type III achalasia in 75 patients: a multicenter comparative study. Endosc Int Open. 2015;3(3):E195-201. PubMed PMID: 26171430
  14. Zhang H, Zeng X, Huang S, Shi L, Xia H, Jiang J, et al. Mid-Term and Long-Term Outcomes of Peroral Endoscopic Myotomy for the Treatment of Achalasia: A Systematic Review and Meta-Analysis. Dig Dis Sci. 2023;68(4):1386-1396. PubMed PMID: 36260203
  15. Beshr MS, Hayek MA, Nounou MV, Elhadi M, Mori Y, Facciorusso A, et al. Comparative Effectiveness of Peroral Endoscopic Myotomy, Laparoscopic Heller Myotomy, Pneumatic Dilation, and Botulinum Toxin for Achalasia: A Network Meta-Analysis. J Clin Gastroenterol. 2026 (online ahead of print). PubMed PMID: 42296412
  16. Morrison JP, Davey MG, Donlon NE. Evaluating surgical management of primary achalasia-a systematic review and network meta-analysis of randomized clinical trials. J Gastrointest Surg. 2026;30(10):102558. PubMed PMID: 42617727
  17. Gong F, Li Y, Ye S. Effectiveness and complication of achalasia treatment: A systematic review and network meta-analysis of randomized controlled trials. Asian J Surg. 2023;46(1):24-34. PubMed PMID: 35484068
  18. Vaezi MF, Pandolfino JE, Yadlapati RH, Greer KB, Kavitt RT. ACG Clinical Guidelines: Diagnosis and Management of Achalasia. Am J Gastroenterol. 2020;115(9):1393-1411. PubMed PMID: 32773454

PubMed Topic Searches

  1. PubMed: peroral endoscopic myotomy randomized trials in achalasia
  2. PubMed: balloon dilation versus Heller myotomy trials
  3. PubMed: achalasia subtype and treatment outcome
  4. PubMed: reflux after achalasia myotomy

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Connections

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