ACHALASIA - OUTCOME OF PATIENTS TREATED WITH INTRASPHINCTERIC INJECTION OF BOTULINUM TOXIN

Background - To evaluate the safety and clinical efficacy of botulinum toxin (BT) in patients with achalasia followed up for six months. Met hods - Fifty five symptomatic patients with manometrically proven acha lasia were included in a multicentre prospective trial. Before and two weeks and two months after intrasphincteric injection of BT, symptoms of dysphagia, regurgitation, and chest pain were scored on a 0-3 scal e, and lower oesophageal sphincter pressure (LOSP) was assessed. The s ymptom score was determined again at six months, clinical improvement being defined by less than or equal to 3, relapse by >3, and failure a s a relapse after two injections or loss to follow up. Results - Excep t for transient chest or epigastric pain (22%), no side effects were o bserved. There was a significant decrease in LOSP after treatment. Sym ptom scores were significantly improved at two weeks (2.0 (SD 1.6)), t wo months (1.7 (1.8)), and six months (1.9 (2.0)) compared with pretre atment values (5.1 (1.8), p<0.001). At six months, 33 patients had cli nical improvement (27 after one injection), 17 were considered failure s, and five had just relapsed. Although there was a trend for age (old er patients being more responsive), age, sex, prior duration of sympto ms, initial symptom score, weight loss, LOSP, magnitude of oesophageal contractions, vigorous or non-vigorous achalasia, previous dilatation s, and radiological features were not predictive of results. Conclusio ns - This multicentre series confirms that intrasphincteric injection of BT is a safe procedure, resulting in clinical improvement in 60% of patients with achalasia at six months. The therapeutic role of BT in achalasia needs further evaluation with regard to other alternatives.