Short- and medium-term clinical efficacy of three endoscopic therapies for achalasia: a single-blinded prospective study
Caunedo, A.; Romero, R.; Hergueta, P.; Gómez, B.J.; Rodríguez-Téllez, M.; Linares, E.; Sánchez-Gey, S.; Pellicer, F.J.; Herrerías, J.M.
Revista Espanola de Enfermedades Digestivas Organo Oficial de la Sociedad Espanola de Patologia Digestiva 95(1): 13-21 22-9
2003
ISSN/ISBN: 1130-0108 PMID: 12760727 Document Number: 557785
Objective: to compare the efficacy of three endoscopic therapies for achalasia and to identify predictors of response. Design: prospective, single-blinded study at short and medium term. Material and methods: 22 patients (9 M/13 F; mean age: 47.45+-21.01 years) with confirmed clinical and manometric achalasia were randomised in three groups: intrasphincteric injections of botulinum toxin (group 1: 10 patients), injections of 1% polidocanol (group 2: 6 patients), and a combined therapy with both of them (group 3: 6 patients). Clinical response was evaluated by a score (0-5) of tested symptoms (dysphagia, regurgitation and chest pain) at 1 and 24 weeks post-treatment. Results: at 24 weeks post-treatment group 2 had the best complete response (CR) rate (33.33%), whereas CR in both the botulinum toxin and combined therapy groups was 10 and 0%, respectively. Groups 1 and 2 got an overall improvement in clinical score at 1 (p = 0.02) and 24 weeks (p = 0.04). Five patients (50%) in group 1, two patients (33.33%) in group 2, and three patients (50%) in group 3 needed other therapies (dilation or surgery) because of treatment failure. Separately, neither age nor sex, time from diagnosis or type of therapy could distinguish responders from non-responders in these three groups. However, absence of response within the first week, and an initial clinical score above 7 were predictive factors of poor response at six months. Conclusions: short- and medium-term clinical response to these endoscopic therapies was limited. The absence of response at seven days and a severe initial clinical score were predictive factors of poor medium-term response.