Heller cardiomyotomy and endoscopic PD are the two main treatments for achalasia and disrupt the circular muscle of the LES. Peroral endoscopic myotomy is a new endoscopic technique that is gaining popularity in treating achalasia and other GI disorders, but it lacks reproducibility and long-term results assessing its efficacy; moreover, it needs training expertise and specialized centers that are not widely available. It is difficult to assess the superiority of one method to another because of the low disease prevalence. A few studies have compared both techniques in the management of achalasia and found similar efficacy and varying complications. The European Achalasia Trial group showed that the therapeutic success rate for LHM was similar to that of PD after 2 years of follow-up [13]. Some physicians consider PD to be the first-line management option because it can be performed on an outpatient basis with fewer complications, and LHCM is considered to be the second-line option after PD failure [14, 15]. Hence, the main objective of this study was to use a randomized study design to evaluate the two state-of-the-art treatments, PD and LHCM.
We conducted this study in a sample of 50 patients diagnosed with achalasia and who had an Eckardt symptom score > 3. The patients were randomly assigned to group A, which was treated by LHCM, and group B, which was treated by endoscopic PD. The patients’ age, sex, and BMI were comparable between the two groups with no statistically significant differences shown. The symptom durations in groups A and B were 46.12 ± 27.187 and 52.84 ± 30.449 months, respectively, and there were no significant differences in occupation, comorbidity, and smoking habits between the groups. Our results are consistent with those of Boeckxstaens et al., [16], who conducted a study in 201 patients with idiopathic achalasia.
The current study showed a significant difference in the height of the barium-contrast column after 5 min at 16 months between the two groups, with lower height among patients in the LHCM group. Vela et al. demonstrated that the post-procedure reduction in the height of the barium column at 5 min is considered to be a predictor of success, especially in men, and lack of improvement carries a risk for repeating the surgical procedure [17] in contrast to a study by An Moonen et al. [6] that found no significant differences in the height of the barium-contrast column after 5 min at 1, 2, and 5 years between the LHCM group and PD group. Another study reported by Boeckxstaens et al. [16] showed no significant differences in the height of the barium-contrast column after 5 min at 1 and 2 years between the two groups.
However, for the other parameters of the primary and secondary outcomes at 8 and 16 months of follow-up, our study has shown no significant difference in Eckardt scores between the studied groups. In contrast to our findings, the study of Boeckxstaensa et al. [16] found that the success rates after 1 and 2 years of follow-up were 93% and 90%, respectively, for LHCM and were 90% and 86%, respectively, for PD, when the cutoff point in the study was a decrease in the Eckardt scale scores to ≤ 3 as the criterion for successful treatment.
Regarding quality of life, the current study showed no significant differences in the physical or mental component after 8 and 16 months of follow-up between the PD and LHM groups, which agrees with the findings of a study reported by An Moonen et al. [6] that showed no significant difference in the quality of life after 1, 2, and 5 years of follow-up between the two groups. Another study reported by Boeckxstaens et al. [16] using the same SF-36 survey showed no significant difference in quality of life after 1 and 2 years of follow-up between the two groups. A study reported by Jan Persson et al. [7] using the Psychological General Well-being (PGWB) questionnaire showed that the total PGWB score was significantly higher in the LHM group than in the PD group after 3 years. The difference was evident in all domains, particularly for anxiety and self-control, but after 5 years, the difference was diminished.
The present study showed a significant difference in the LES pressure of 10.20 ± 1.3 and 14.00 ± 1.6 in the LHCM and PD groups, respectively, after 8 months of follow-up between the groups, which is consistent with the results of a study reported by Boeckxstaens et al. [16] that showed a significant difference after 1 year of follow-up between the two groups, with a higher LES pressure in the PD than in the LHCM group.Another study reported by An Moonen et al. [6] showed a significant difference in the LES pressure after 1 year of follow-up between the two groups, with a higher pressure in the PD group than in the LHCM group. In contrast to a study reported by Borges et al. [18] that showed no significant difference in the decrease in the LES pressure < 50% after 3 months of follow-up between the two groups, with 60.7% for the PD group and 85.7% for the LHCM group.
Effectiveness, durability of response, and procedure-related complications affect the choice of treatment. Among the entire surgical community, mucosal tears that immediately healed during surgery occur in 4% of patients. Esophageal perforation complications in PD were noted in 8% of patients, a rate that is comparable to that previously reported by Boeckxstaens et al. [16]. Esophageal perforation appeared in four (4%) of the 95 patients in the PD group, which is comparable to that reported by Emad Hamdy et al. [9]. Esophageal perforation occurred in two (8%) of the 50 patients, mucosal tears occurred in 12% in the LHCM group, and abnormal gastric acid toxicity occurred in 15% of the PD patients and 23% of the LHCM patients. On the other hand, symptom improvement for PD and LHCM patients who experienced gastroesophageal reflux events was higher but transient in the PD group than in the LHM group, which may be explained by the combination of the DOR fundoplication technique with Heller myotomy to minimize postoperative acid reflux in the LHCM group. Twenty-six percent of the patients included in the study by Vela MF et al. were on proton-pump inhibitors at the last follow-up evaluation, and complicated GERD was rare (4%); however, an anti-reflux procedure was performed in only 33% of those patients [17]. In a study by Emad Hamdy et al., 16% and 28% of patients developed reflux symptoms after PD and laparoscopic Heller myotomy, respectively [9].
The current study showed no significant difference in recurrence of symptoms after 1 month between the two groups, which were 24% and 32% in the LHCM and PD groups, respectively. These findings were comparable to those reported by Emad Hamdy et al. who found that the rates of recurrent symptoms after 1 year were 26.3% and 8.3% in the PD and LHCM groups, respectively [9].
The Kaplan–Meier curve analyses in the present study showed no significant difference in the treatment success rates between the two groups, although the numerical results were higher for the LHM group than for the PD group at 7, 10, and 15 months. Those findings agree with those of a study reported by An Moonen et al. [6] that showed no significant differences in the success rates of 94% for LHM and 90% for PD after 1 year, 89% (LHCM) and 86% (PD) after 2 years, and 84% (LHM) and 82% (PD) after 5 years of follow-up between the two groups. In contrast, another study reported by Jan Persson et al. [7] showed significant differences in the success rates of 96%, 96%, 92% and 88% for LHCM and of 79%, 68%, 64%, and 61% for PD after 1, 3, 5, and 6.5 years of follow-up, respectively, between the groups.
There were some study limitations that should be considered when interpreting the results. We performed our study in a single center, and the results could have been affected by the degree of operator experience. Other limitations included the small sample sizes of the studied groups and the lack of post-procedure motility studies.