Systematic review and meta-analysis of controlled and prospective cohort efficacy studies of endoscopic radiofrequency for treatment of gastroesophageal reflux disease

Abstract

Background

The endoscopic radiofrequency procedure (Stretta) has been used for more than a decade to treat patients with gastroesophageal reflux disease (GERD). However, the efficacy of the procedure in improving objective and subjective clinical endpoints needs to be further established.

Aim

To determine the efficacy of the Stretta procedure in treating patients with GERD, using a systematic review and meta-analysis of controlled and cohort studies.

Methods

We conducted a systematic search of the PubMed and Cochrane databases for English language clinical studies of the Stretta procedure, published from inception until May 2016. Randomized controlled trials (RCTs) and cohort studies that included the use of the Stretta procedure in GERD patients were included. A generalized inverse weighting was used for all outcomes. Results were calculated by both fixed effects and random effects model.

Results

Twenty-eight studies (4 RCTs, 23 cohort studies, and 1 registry) representing 2468 unique Stretta patients were included in the meta-analysis. The (unweighted) mean follow-up time for the 28 studies was 25.4 [14.0, 36.7] months. The pooled results showed that the Stretta reduced (improved) the health-related quality of life score by −14.6 [−16.48, −12.73] (P < 0.001). Stretta also reduced (improved) the pooled heartburn standardized score by −1.53 [−1.97, −1.09] (P < 0.001). After Stretta treatment, only 49% of the patients using proton pump inhibitors (PPIs) at baseline required PPIs at follow-up (P < 0.001). The Stretta treatment reduced the incidence of erosive esophagitis by 24% (P < 0.001) and reduced esophageal acid exposure by a mean of −3.01 [−3.72, −2.30] (P < 0.001). Lower esophageal sphincter (LES) basal pressure was increased post Stretta therapy by a mean of 1.73 [−0.29, 3.74] mmHg (P = NS).

Conclusions

The Stretta procedure significantly improves subjective and objective clinical endpoints, except LES basal pressure, and therefore should be considered as a viable alternative in managing GERD.

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Authors

Corresponding author

Correspondence to Ronnie Fass.

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Disclosures

Dennis J. Scotti is a Part-time Consultant with Baker Tilly Virchow Krause, LLC. Baker Tilly Virchow Krause, LLC is a Business Advisor to Mederi Therapeutics, Inc. David A. Gregory is a principal with Baker Tilly, a Business Advisor to Mederi Therapeutics. Frederick Cahn is a principal with BioMedical Strategies, a Business Advisor to Baker Tilly. Ronnie Fass is an Advisor to Ironwood and Mederi Therapeutics, Speaker for AstraZeneca, Dr. Reddy, Mederi Therapeutics and Takeda and receives Research Grant from Ironwood.

Appendices

Appendix 1: Modified Newcastle–Ottawa scoring system

We used the modified Newcastle–Ottawa scale to evaluate the following study characteristics, with the definition of exposure being Stretta treatment, and the measures of interest are the self-reported outcomes:

  • Representativeness of exposed cohort A = truly representative of the average patient with GERD, B = somewhat representative of the average patient with GERD, C = selected group and D = no description of the derivation of the cohort.

  • Selection of non-exposed cohort A = drawn from the same community as the exposed cohort, B = drawn from a different source and C = no description of the derivation of the non-exposed cohort.

  • Ascertainment of exposure A = secure record (e.g. surgical records), B = structured interview, C = written self-report and D = no description.

  • Demonstration that outcome of interest was not present at start of study (with respect to PPI use) A = yes, B = no, C = not applicable because outcome was not assessed at follow-up.

  • Comparability of cohorts on the basis of the design or analysis A = study controls for comorbidities, B = study controls for additional risk factors (such as age and severity of illness) and C = not done.

  • Assessment of outcome A = independent blind assessment, B = record linkage, C = self-report and D = no description.

  • Was follow-up long enough for outcomes to occur A = yes, and B = no.

  • Adequacy of follow-up of cohorts A = complete follow-up—all subjects accounted for, B = subjects lost to follow-up unlikely to introduce bias (small number lost), follow-up rate higher than 90% or description provided of those lost, C = follow-up rate 90% or lower and no description of those lost and D = no statement.

Appendix 2: Assessment of studies using the PICOTS framework

  1. 1.

    The patient population (“P”) in all trials were GERD patients. GERD is a common chronic and stable condition with a clinical context and natural history that is consistent with the criteria of Glasziou et al. [50] for the validity of non-randomized studies.

  2. 2.

    The intervention (“I”) is in all included studies a single physician-administered outpatient procedure using one specific device. Patient compliance was not a factor affecting treatment effectiveness.

  3. 3.

    In both RCT and cohort studies, the comparison (“C”) is a pre–post-treatment difference that directly measures a treatment effect. This design also reduces the risk of bias from confounding variables. Also, because of the stable natural history of GERD there is a low risk of bias due to regression-to-the-mean or spontaneous improvement. None of the studies use historical controls, which is known to have substantial risk of bias [24].

  4. 4.

    Both RCT and cohort studies report the same patient-reported effectiveness outcomes (“O”) (HRQL, heartburn score, PPI use) and in the case of erosive esophagitis an objective physician-measured effectiveness outcome.

  5. 5.

    The timeframe (“T”) of the treatment is short and the timeframe of follow-up is significant in terms of natural history of GERD. The follow-up times for the cohort studies overlap those of the RCT studies.

  6. 6.

    The setting (“S”) for the treatment in all studies is the outpatient clinic and the evaluation of HRQL, heartburn and PPI use is by the patient in the course of their normal activities. This setting matches that of normal clinical practice.

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Fass, R., Cahn, F., Scotti, D.J. et al. Systematic review and meta-analysis of controlled and prospective cohort efficacy studies of endoscopic radiofrequency for treatment of gastroesophageal reflux disease. Surg Endosc 31, 4865–4882 (2017). https://doi.org/10.1007/s00464-017-5431-2

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Keywords

  • GERD
  • Heartburn
  • PPI
  • Endoscopy
  • Radiofrequency ablation
  • pH test