Comparison of the efficacy of esophageal balloon dilatation and Botox injection, with esophageal balloon dilatation alone, in children with achalasia referred to Mofid children hospital (2020-2023)

Background: Achalasia is an esophageal motility disorder with symptoms like regurgitation, dysphagia, anorexia, and chronic cough. Effective treatments include pneumatic dilatation and myotomy. This study evaluated the combined use of botulinum toxin (Botox) injection and esophageal balloon dilation versus balloon dilation alone, analyzing recovery rates for gastrointestinal and non-gastrointestinal symptoms. Study method: This clinical trial involved an intervention group and historical controls. Patients with symptomatic achalasia referred to Mofid Hospital (2020-2023) received balloon dilatation with Botox injection. Historical controls had balloon dilatation alone. Botox was injected at four points in the Lower Esophageal Sphincter (LES) before balloon dilatation. Symptoms and growth parameters were monitored every three months for a year, then every six months, with annual follow-ups for three years. The study included 37 intervention and 31 control patients, and data were analyzed using SPSS 24 software. Results: From the onset of the study to the 36th month, the intervention group showed greater symptom improvement than the control group: nausea or vomiting (19%), regurgitation (21%), dysphagia to liquids (37%), dysphagia to solids (10%), globus sensation (10%), anorexia (2.14%), weight loss (18%), halitosis (15%), cough (44%), aspiration (18%), and refusal to eat (7%). Exceptions were chest pain (same in both groups) and heartburn (14% better in the control group). At 6 and 12 months, the intervention group improved in abdominal tenderness (4.2%), wheezing (7.11%), and coarse rales (20.9%). Radiological signs improved more in the intervention group: esophageal dilatation (11.6%), rat tail/bird beak sign (31.7%), tertiary contractions (10.4%), and reduced air-fluid level in the esophagus (upper to middle third: 17%, middle to lower third: 35.8%), except for the sigmoid esophagus (same in both groups). At 36 months, growth criteria in the intervention group increased: weight (4 kg), length (5.35 cm), BMI (1.47 units), Z score (0.65 units), and percentile (5.65 units). Conclusion: The combined balloon and Botox treatment has shown effectiveness in improving disease symptoms, physical examination results, growth criteria, and radiological findings. Further studies are recommended to potentially establish this approach as a national protocol.