The authors reported that 43 studies were included in the review, although 46 studies were presented in the results section.
Radiofrequency energy: Fifteen trials, 14 were non-randomised, open-label, pre-post studies and one was blinded and sham-controlled. Sample sizes ranged from 18 to 118 participants. Follow-up periods ranged from three to 48 months. Significant improvement in the median heartburn score, GORD score, satisfaction, mental SF-36 and physical SF-36 were found in most studies. The most common side effects were fever, odynophagia, mucosal injury and gastroparesis. Proton pump inhibitor use was the primary endpoint in half the studies and 43% to 87% of patients discontined usage.
Implant methods: Eight trials, one sham-controlled and the rest pre-post studies. Sample sizes ranged from 15 to 144 participants. Follow-up periods ranged from six to 24 months. The proportion of patients off proton pump inhibitors at the end of follow-up ranged from 53% to 80%. Significant improvements in symptoms, quality of life and heartburn scores were found. The most common side effects were chest pain, dysphagia, fever and pneumonitis.
Suturing and plication devices: There appeared to be 23 trials, all single-group except for one randomised and sham-controlled and two open-label and non-randomised. Where stated, sample sizes ranged from 15 to 85 participants and follow up periods ranged from three to 24 months. Symptomatic improvement was found in most studies, but median oesophageal acid exposure did not always show a significant difference. Studies with follow-ups of up to 24 months showed the efficacy of suturing devices decreased over time. The most common side effects were fever, abdominal pain, pharyngitis and sore throat.
All three types of treatment could lead to mild and severe complications (such as perforation and abscess), some of which resulted in death.