Advice
Clinical and technical evidence
Clinical and technical evidence
A literature search was carried out for this briefing in accordance with the published process and methods statement. This briefing includes the most relevant/best publicly-available evidence relating to the clinical and cost effectiveness of the technology. The literature search strategy, evidence selection methods and detailed data extraction tables are available on request by contacting medtech@nice.org.uk.
Published evidence
The results of 1 systematic review (which included 2 randomised controlled trials [RCTs] and 18 cohort series), 2 additional RCTs, 1 non‑randomised comparative study and 4 case series, all using the Stretta System, were assessed in the development of NICE interventional procedures guidance on endoscopic radiofrequency ablation for gastro-oesophageal reflux disease. The systematic review and meta-analysis by Perry et al. (2012) was the only one of these studies to report objective physiological measurements after Stretta Therapy.
Of the 14 interventional studies using Stretta Therapy that have been published since the NICE guidance, 1 systematic review (Lipka et al. 2015) and 5 non‑randomised comparator studies (Hu et al. 2015; Hu et al. 2014; Liang et al. 2015; Liang et al. 2014; Yan et al. 2015) have been included in this briefing.
Table 2 summarises the clinical evidence as well as its strengths and limitations.
Table 2: Summary of selected studies
|
Study |
Details of intervention and comparators |
Outcomes |
Strengths and limitations |
|
Systematic review: 4 RCTs; 153 patients with GORD; follow-up ranging from 6–12 months. Multi-centre (Belgium, Egypt, France, US). |
3 RCTs: Stretta Therapy versus sham. 1 RCT: Stretta versus PPI therapy. Stretta used in 81 patients. |
Study shows no significant difference in physiological parameters including time spent at pH less than 4 over 24 hours, mean lower oesophageal sphincter pressure, ability to stop PPI therapy, and health-related quality of life between Stretta Therapy and control arms. |
The Society of American Gastrointestinal and Endoscopic Surgeons formally disagreed with the methodology used and conclusions reached. The quality of evidence from RCTs on the efficacy of Stretta was very low. The studies included in the meta-analysis had different comparators and endpoints. The study states that its senior author is a consultant for Endostim, a competing technology. Each included study met its primary endpoint but the meta-analysis concluded that there were no significant improvements in patient outcomes. |
|
Non‑randomised comparative study: 137 patients with GORD and severe asthma; 5‑year follow-up. Single centre (China). |
Stretta Therapy (n=82) versus LNF (n=55). |
Significant improvement in symptom scores from baseline were seen in both groups. LNF resulted in significantly better improvements in digestive, respiratory and ENT symptom scores at 1‑year and 5‑year follow-up when compared with Stretta Therapy. |
Non‑randomised, uncontrolled, non‑blinded study based on a select patient group. No physiological measurements recorded. No statistical comparison of complications. |
|
Non‑randomised comparative study: 57 patients with GORD-related childhood-to-adult persistent asthma. Single centre (China). |
Stretta Therapy (n=24) versus LNF (n=33, 2 of whom previously had Stretta). |
Significant improvement in symptom scores from baseline across pooled results (not able to separate LNF from Stretta). LNF resulted in significantly better improvement in oesophageal symptoms when compared with Stretta Therapy. |
Non‑randomised, uncontrolled, non‑blinded study based on a select patient group. No physiological measurements recorded. No statistical comparison of complications or patient satisfaction between groups, unable to separate some pooled results. |
|
Non‑randomised comparative study: 125 patients with GORD completed 3‑year follow-up. Multi-centre (China). |
Stretta Therapy (n=60) versus LTF (n=65). |
Significant improvement in symptom scores from baseline seen in both groups. LTF resulted in significantly better improvements in typical symptoms and a lower revision rate than with Stretta Therapy. There was no significant difference between groups in the proportion of patients no longer needing PPI treatment. Complication rate at 1- and 3‑year follow-up was higher for LTF but did not reach significance. |
Non‑randomised, not controlled. No physiological measurements recorded. |
|
Non‑randomised comparative study: 179 patients with GORD completed 5‑year follow-up. Multi-centre (China). |
Stretta Therapy (n=92) versus LNF (n=87). |
Significant improvement seen in symptom scores from baseline in both groups. LNF resulted in significantly better symptom improvements than Stretta Therapy. Significantly more patients having LNF no longer needed PPI treatment than in the Stretta group. Significantly more abdominal distension complications were seen in the LNF group than in the Stretta group. |
Non‑randomised, not controlled. No physiological measurements recorded. |
|
Non‑randomised comparative study: 90 patients with GORD-related extra-oesophageal symptoms reaching 3‑year follow-up. Multi-centre (China). |
Stretta Therapy (n=47) versus LTF (n=51). |
There were significant improvements in symptom scores from baseline in both groups. Improvements in cough, sputum and wheezing symptom scores were not significantly different between groups, but the LTF group had a significantly lower globus score at 3 years. The LTF group reported higher quality-of-life scores than the Stretta group. There was no significant difference between the groups in the proportion of patients no longer needing PPI treatment. |
Non‑randomised, not controlled. No physiological measurements recorded. Only PPI drug use was recorded. |
|
Abbreviations: ENT, ear nose and throat; GORD, gastro-oesophageal reflux disease; LNF, laparoscopic Nissen fundoplication; LTF, laparoscopic Toupet fundoplication; PPI, proton pump inhibitor; RCT, randomised controlled trial. |
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Strengths and limitations of the evidence
None of the reviewed evidence was set in the UK, so this may limit the generalisability of the study findings to NHS settings.
None of the studies compared Stretta Therapy with other therapeutic endoscopic procedures. Five non‑randomised comparative studies compared Stretta Therapy with laparoscopic surgery, which could cause population bias because patients for whom surgery was not suitable may have had comorbidities that contributed to outcomes. The systematic review compared Stretta Therapy with either a sham device or PPI therapy and found no significant difference in results.
Four of the 6 reviewed studies focused on PPI therapy independence as an outcome measure, but none recorded the use of other acid reflux medications, such as H2-receptor antagonists or antacids. Only 1 study investigated the outcomes of single compared with multiple treatments using Stretta.
The 2 available meta-analyses of Stretta reached contradicting conclusions on the effectiveness of Stretta therapy. Both analyses included studies with a range of inclusion criteria and clinical end-points. The Lipka (2015) meta-analysis was smaller (4 studies; n=153), compared with the Perry (2012) meta-analysis (20 studies; n=1,441).
The most recent cost analysis by Gregory et al. (2016) found that Stretta Therapy was cost saving over medical and fundoplication treatment. This contradicts the findings from 3 previous economic studies, which all found that medical management was the most cost-effective treatment for GORD.
Recent and ongoing studies
Two ongoing trials on Stretta Therapy for GORD were identified in the preparation of this briefing:
The manufacturer also identified a meta-analysis that is currently in development (unpublished at the time of publication of this briefing). Specialist commentators also identified emerging data not yet in the public domain from recent or ongoing studies.