Nonresorbable copolymer implantation for gastroesophageal reflux disease: A randomized sham-controlled multicenter trial

Devière, Jacques; Costamagna, Guido; Neuhaus, Horst; Voderholzer, Winfried A.; Louis, Hubert; Tringali, Andrea; Marchese, Michele; Fiedler, Thomas; Darb-Esfahani, Patrick; Schumacher, Brigitte

doi:10.1053/j.gastro.2004.12.005

Cited by 116 publications

(87 citation statements)

References 23 publications

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“…A sham-controlled study showed a moderate effect on symptoms and PPI use, however the product was withdrawn after several reports of severe adverse events related to the injection of the substance. 32,33 The Stretta device (Curon Medical, Sunnyvale, CA, USA) delivers radiofrequency energy to the LES muscle, inducing fibrosis of the LES muscle and thereby augmenting its function. Although a mild subjective improvement was shown in a sham-controlled trial, it failed to improve objective reflux parameters.…”

Section: Discussionmentioning

confidence: 99%

“…Currently, 18 patients have completed 3-month follow-up and 14 patients 6-month follow-up. Interim results showed a positive ef- fect on symptoms: GERD-HRQL median (IQR) score was 4 (2-11) at 3 months and 5 (4-9) at 6 months, respectively with P < 0.001 and P < 0.01 when compared to baseline score off PPI (31 [25][26][27][28][29][30][31][32][33][34][35][36][37]). Furthermore, acid exposure time decreased from 11.3% (9.0-15.5%) at baseline to 3.3% (2.5-9.1%) at 3 months and to 2.6% (1.8-5.4%) at 6 months (Fig.…”

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confidence: 99%

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Electrical Stimulation Therapy for Gastroesophageal Reflux Disease

Rinsma

Bouvy

Masclee

et al. 2014

J Neurogastroenterol Motil

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Electrical stimulation therapy (EST) of the lower esophageal sphincter is a relatively new technique for the treatment of gastroesophageal reflux disease (GERD) that may address the need of GERD patients, unsatisfied with acid suppressive medication and concerned with the potential risks of surgical fundoplication. In this paper we review available data about EST for GERD, including the development of the technique, implant procedure, safety and results from open-label trials. Two short-term temporary stimulation and long-term open-label human trials each were initiated to investigate the safety and efficacy of EST for the treatment of GERD and currently up to 2 years follow-up results are available. The results of EST are promising as the open-label studies have shown that EST is a safe technique with a significant improvement in both subjective outcomes of symptoms and objective outcomes of esophageal acid exposure in patients with GERD. However, long-term data from larger number of patients and a sham-controlled trial are required before EST can be conclusively advised as a viable treatment option for GERD patients.

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

Electrical Stimulation Therapy for Gastroesophageal Reflux Disease

Rinsma

Bouvy

Masclee

et al. 2014

J Neurogastroenterol Motil

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“…For example, in the trial by Deviere and colleagues there were concerns that patients could have known the allocation because the copolymer used in the active arm had a distinct smell 55 . In trials on vertebroplasty, a container with cement was opened during placebo procedure to help with blinding 42, 56 .…”

Section: Strategies Used To Maintain Blinding In Interventional Placementioning

confidence: 99%

“…However, in some trials, the placebo procedure was shortened in comparison to the actual surgery because it was believed it would have been ethically unacceptable to prolong the placebo intervention 49, 55 .…”

Section: Strategies Used To Maintain Blinding In Interventional Placementioning

confidence: 99%

Blinding in trials of interventional procedures is possible and worthwhile

2017

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In this paper, we have used evidence from our earlier review of surgical randomised controlled trials with a placebo arm to show that blinding in trials of interventional procedures is feasible, and that many creative methods can be used to make the active and the placebo procedure as similar as possible. We give examples of ingenious strategies used to simulate the active procedure and make the placebo control indistinguishable from the active treatment. We discuss why it is important to blind of patients, assessors, and caregivers and the types of bias that may occur in interventional trials. Finally, we describe the benefits of blinding, from the obvious ones such as avoiding bias, as well as less evident benefits such as avoiding patient drop out in the control arm.

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“…This paper is an interesting and comprehensive overview of the published literature on the diagnostic and therapeutic capabilities of TBNI, with special emphasis on its role in the management of various pathological conditions using specifi c injectable agents. Surprisingly, TBNI has not gained much popularity amongst bronchoscopists, resulting in no randomized controlled trials that can effectively demonstrate its potential value as an armament in the pulmonologists' fi ght against various respiratory diseases.In contrast, this technique is widely used effectively by our gastroenterology colleagues as a management modality for a variety of digestive tract diseases: ethoxysclerol [2] , human thrombin [3] , histoacryl [4] or polidocanol [5] for bleeding peptic ulcers, botulinum for achalasia [6] , Nbutyl-2-cyanoacrylate for pancreatic fi stulas [7] , inert implantable materials and non-resorbable copolymers for gastroesophageal refl ux disease [8,9] , enbucrilate for mycotic aneurysms [10] , hydroxypropyl methylcellulose or photocrosslinkable chitosan for cancer or polyp resection [11,12] , or alcohol, various anticancer agents and local immunotherapy for digestive tract cancers [13] , to mention a few.The reason for this disparity between gastroenterologists and pulmonologists is unclear. One may postulate that there are more gastroenterologists with expertise in…”

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confidence: 99%