title: Electrical stimulation therapy of the lower oesophageal sphincter for refractory gastro-oesophageal reflux disease - interim results of an international multicentre trial.
abstract: BACKGROUND
  A previous single-centre study showed that lower oesophageal sphincter electrical stimulation therapy (LES-EST) in gastro-oesophageal reflux disease (GERD) patients improves reflux symptoms and decreases oesophageal acid exposure.
  
  
  OBJECTIVE
  To evaluate safety and efficacy of LES-EST in GERD patients with incomplete response to proton pump inhibitors (PPIs) in a prospective, international, multicentre, open-label study.
  
  
  METHODS
  GERD patients, partially responsive to PPIs, received LES-EST. GERD health-related quality of life (GERD-HRQL), daily symptom diaries, quality of life scores, oesophageal acid exposure, and LES resting and residual pressure were measured before and after initiation of LES-EST. Stimulation sessions were optimised based on residual symptoms and oesophageal acid exposure.
  
  
  RESULTS
  Forty-four patients were enrolled and 6-month data from 41 patients are available. Hiatal repair was performed in 16 patients. One device-related, one procedure-related and one unrelated severe adverse event were reported. GERD-HRQL improved from 31.0 (IQR 26.2-36.8) off-PPI and 16.5 (IQR 9.0-22.8) on-PPI to 4 (IQR 1-8) at 3-month and 5 (IQR 3-9) at 6-month follow-up (P < 0.0001 vs. on- and off-PPI). Oesophageal acid exposure (pH < 4.0) improved from 10.0% (IQR 7.5-12.9) to 3.8% (IQR 1.9-12.3) at 3 months (P = 0.0027) and 4.4% (IQR 2.2-7.2) at 6 months (P < 0.0001).
  
  
  CONCLUSIONS
  These interim results show an acceptable safety record of LES-EST to date, combined with good short-term efficacy in GERD patients who are partially responsive to PPI therapy. A remarkable reduction in regurgitation symptoms, without the risk of intervention-requiring dysphagia may prove to be an advantage compared with other anti-reflux procedures. ClinicalTrials.gov Identifier: NCT01574339.
authors.affiliation: University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: W F W
authors.initials: WF
authors.lastname: Kappelle
authors.affiliation: Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: A J
authors.initials: AJ
authors.lastname: Bredenoord
authors.affiliation: Maastricht University Medical Center, Maastricht, The Netherlands.
authors.forename: J M
authors.initials: JM
authors.lastname: Conchillo
authors.affiliation: University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: J P
authors.initials: JP
authors.lastname: Ruurda
authors.affiliation: Maastricht University Medical Center, Maastricht, The Netherlands.
authors.forename: N D
authors.initials: ND
authors.lastname: Bouvy
authors.affiliation: Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: M I
authors.initials: MI
authors.lastname: van Berge Henegouwen
authors.affiliation: Chinese University of Hong Kong, Hong Kong.
authors.forename: P W
authors.initials: PW
authors.lastname: Chiu
authors.affiliation: Waitemata Specialist Centre, Auckland, The New Zealand.
authors.forename: M
authors.initials: M
authors.lastname: Booth
authors.affiliation: Pontificia Universidad Javeriana - Hospital San Ignacio, Bogota, Colombia.
authors.forename: A
authors.initials: A
authors.lastname: Hani
authors.affiliation: Asian Institute of Gastroenterology, Hyderabad, India.
authors.forename: D N
authors.initials: DN
authors.lastname: Reddy
authors.affiliation: University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: A
authors.initials: A
authors.lastname: Bogte
authors.affiliation: Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: A J P M
authors.initials: AJ
authors.lastname: Smout
authors.affiliation: Chinese University of Hong Kong, Hong Kong.
authors.forename: J C
authors.initials: JC
authors.lastname: Wu
authors.affiliation: Pontificia Universidad Catolica de Chile, Santiago, Chile.
authors.forename: A
authors.initials: A
authors.lastname: Escalona
authors.affiliation: Instituto Nacional de Ciencias Médicas y Nutrición, Salvador Zubirán, Mexico City, Mexico.
authors.forename: M A
authors.initials: MA
authors.lastname: Valdovinos
authors.affiliation: Instituto Nacional de Ciencias Médicas y Nutrición, Salvador Zubirán, Mexico City, Mexico.
authors.forename: G
authors.initials: G
authors.lastname: Torres-Villalobos
authors.affiliation: University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: P D
authors.initials: PD
authors.lastname: Siersema
mesh_terms: D000328:Adult; D000368:Aged; D004599:Electric Stimulation Therapy / Q000009:adverse effects / Q000379:methods*; D049630:Esophageal Sphincter, Lower; D005260:Female; D005764:Gastroesophageal Reflux / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D054328:Proton Pump Inhibitors