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Clinical Trial
. 2004 Mar;239(3):364-70.
doi: 10.1097/01.sla.0000114217.52941.c5.

Randomized Controlled Trial of Botulinum Toxin Versus Laparoscopic Heller Myotomy for Esophageal Achalasia

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Free PMC article
Clinical Trial

Randomized Controlled Trial of Botulinum Toxin Versus Laparoscopic Heller Myotomy for Esophageal Achalasia

Giovanni Zaninotto et al. Ann Surg. .
Free PMC article

Abstract

Objective: To compare laparoscopic cardia myotomy and fundoplication with botulinum toxin (BoTx) injection in patients with esophageal achalasia.

Summary background data: Although myotomy is thought to offer better results, recent studies have reported 80% success rates after 2 BoTx injections a month apart. No randomized controlled trials comparing the 2 treatments have been published so far.

Materials and methods: Newly diagnosed achalasia patients were randomly assigned to BoTx injection or laparoscopic myotomy. Symptoms were scored; lower esophageal sphincter resting and nadir pressures were measured by manometry; barium swallow was used to assess esophageal diameter pre- and post-treatment. Eight to one hundred units of BoTx were injected twice, a month apart, at the esophagogastric junction. Myotomy included anterior partial (Dor) or Nissen fundoplication.

Results: Eighty patients were involved in the study: 40 received BoTx and 40 underwent myotomy. Mortality was nil. One surgical patient bled from the trocar site. Median hospital stay was 6 days for surgery; BoTox patients were treated as day-hospital admissions. All patients completed the follow-up. After 6 months, the results in the 2 groups were comparable, although symptom scores improved more in surgical patients (82% confidence interval [CI] 76-89 vs. 66% CI 57-75, P < 0.05). The drop in lower esophageal sphincter pressure was similar in the 2 groups; the reduction in esophageal diameter was greater after surgery (19% CI 13-26 vs. 5% CI 2-11, P < 0.05). Later on, symptoms recurred in 65% of the BoTx-treated patients and the probability of being symptom-free at 2 years was 87.5% after surgery and 34% after BoTx (P < 0.05).

Conclusion: Laparoscopic myotomy is as safe as BoTx treatment and is a 1-shot treatment that cures achalasia in most patients. BoTx should be reserved for patients who are unfit for surgery or as a bridge to more effective therapies, such as surgery or endoscopic dilation.

Figures

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FIGURE 1. Flow-chart illustrating the study protocol.
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FIGURE 2. Probability of remaining asymptomatic after treatment (patients at risk for each interval in brackets). The 2 curves differ significantly (P < 0.01).
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FIGURE 3. LES resting pressure in patients before and 6 months after myotomy or BoTx injection. White column = pretreatment values; black column = post-treatment. In both groups the pressure decreased significantly; from 27 mm Hg (11–51) to 14.50 mm Hg (3.5–35) for surgery (P < 0.05), and from 36 mm Hg (13–65) to 22 mm Hg (12–50) for BoTx (P < 0.05), respectively. Values are expressed as median and (ranges). Pretreatment values were higher for BoTx compared with surgery, but no difference was observed between myotomy and BoTx post-treatment values.
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FIGURE 4. Lowest LES pressure at swallowing (nadir pressure) in patients before and 6 months after myotomy or BoTx injection. White column = pretreatment values; black column = post-treatment. In both groups, the pressure dropped significantly: from 10.1 mm Hg (2.3–24) to 3.2 mm Hg (0–11.2) for surgery (P < 0.05) and from 13 mm Hg (1.1–65) to 5.5 mm Hg (0–40) for BoTx (P < 0.05), respectively. Values are expressed as median and (ranges).
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FIGURE 5. Lowest LES pressure at swallowing (nadir pressure) in responders and nonresponders to both treatments. Nadir pressure in responders (white column) was 3.5 mm Hg (0–40); in nonresponders it was 6 mm Hg (0–12; P = n.s.). Values are expressed as median and (ranges).
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FIGURE 6. Largest esophageal diameter at barium swallow before and after myotomy or BoTx injection. White column = pretreatment; black column = post-treatment. The values (cm) are: premyotomy 4.1 (2.5–7) post 3.1 (1.7–4.5); pre Botox 3.5 (2.5–7); post 3.4 (1.8–5.1). Values are expressed as median and (ranges). The difference between before and after treatment was only significant for surgery (P < 0.05).

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