Systematic review: endoluminal therapy for gastro-oesophageal reflux disease: evidence from clinical trials.

During the last few decades many endoscopic interventions have been developed as an alternative for the treatment of gastro-oesophageal reflux disease (GORD). In many countries, these interventions are thus being performed in the general clinical setting. The aim of this study is to systematically review the evidence on the effect of endoscopic therapies for GORD. A systematic search of the literature on this subject in English, indexed in MEDLINE (1966 to May 2007) and in the Cochrane Library, was carried out. For the study selection, retrospective and prospective open-label and randomized, sham-controlled trials were taken into account. The exclusion criteria included the following: case series that included fewer than 10 patients, abstracts, studies involving children or those with a follow-up shorter than 3 months. For data extraction, two reviewers, using standardized forms, independently abstracted data on study design and methods, population, sample size, function studies (e.g. pH-metry), type of endoscopic treatment, follow-up, health-related and quality of life scores, outcomes and complications. Data synthesis involved the following: 43 studies, including four randomized, sham-controlled trials that met the inclusion criteria, out of 4182 citations. The primary end point in most studies was the reduction of the use of proton pump inhibitors (PPIs) by more than 50%. In view of these findings, the majority of studies suggested the efficacy of endoluminal therapies for the control of symptoms in GORD. In the sham-controlled studies, the effect of placebo was, nevertheless, as high as 50%. Most studies were small feasibility studies, with follow-ups of less than 1 year. No study comparing endoscopic techniques with other established treatment options such as PPIs existed. All endoscopic therapies were associated with a small but important percentage of mild to severe complications, which included perforation, abscess and death. In conclusion, the data from most of the short-term follow-up and the few sham-controlled studies demonstrate that subgroups of patients experienced improvement or resolution of typical GORD symptoms and decreased PPI usage. Currently, however, there are not enough scientific and clinical data on safety, efficacy and durability to support the use of endoluminal therapies for GORD in routine clinical practice.