Evidence map›Paper›PMID 22361121›Full record

Trial reportBMC gastroenterology2012

Gaviscon® vs. omeprazole in symptomatic treatment of moderate gastroesophageal reflux. a direct comparative randomised trial.

Denis Pouchain, Marc-André Bigard, François Liard, Marc Childs, Annick Decaudin, Donna McVey

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC gastroenterology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 3 pooled it
3.3field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 3 syntheses or guidelines pooled it, 52 citations in OpenAlex.

  1. Pooled it
  2. Alginate therapy is effective treatment for GERD symptoms: a systematic review and meta-analysis.Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus · 2017
    Pooled it
  3. Guideline
  4. Magnesium alginate versus proton pump inhibitors for the treatment of laryngopharyngeal reflux: a non-inferiority randomized controlled trial.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2022
    Trial
  5. Trial
  6. Review
  7. Article
  8. Article
  9. Review
  10. Article
  11. Alginates: From the ocean to gastroesophageal reflux disease treatment.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2019
    Article
  12. Review
  13. Review
  14. Review
  15. Article
  16. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 2 countries.

Denis PouchainDépartement de Médecine Générale, Université François Rabelais, Faculté de Médecine, 10 Boulevard Tonnellé, BP 3223, 6 Rue du Docteur Lebel 94300, Vincennes 37032, Tours Cedex 1, France. denis.pouchain@univ-tours.fr
Marc-André Bigard
François Liard
Marc Childs
Annick Decaudin
Donna McVey
Centre Hospitalier Régional et Universitaire de Nancy · FRDermscan Group (France) · FRReckitt Benckiser (United Kingdom) · GBUniversité de Tours · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMedical management of GERD mainly uses proton pump inhibitors. Alginates also have proven efficacy. The aim of this trial was to compare short-term efficacy of an alginate (Gaviscon®, 4 × 10 mL/day) and omeprazole (20 mg/day) on GERD symptoms in general practice.

methodsA 14-day multicentre randomised double-blind double-dummy non-inferiority trial compared Gaviscon® (4 × 10 mL/day) and omeprazole (20 mg/day) in patients with 2-6 day heartburn episodes weekly without alarm signals. The primary outcome was the mean time to onset of the first 24-h heartburn-free period after initial dosing. Secondary outcomes were the proportion of patients without heartburn by D7, pain relief by D7, and reduction in pain intensity by D7 and D14.

results278 patients were recruited; 120 were included in the Gaviscon® group and 121 in the omeprazole group for the per protocol non-inferiority analysis. The mean time to onset of the first 24-h heartburn-free period after initial dosing was 2.0 (± 2.2) days for Gaviscon® and 2.0 (± 2.3) days for omeprazole (p = 0.93); mean intergroup difference was 0.01 ± 1.55 days (95% CI = -0.41 to 0.43): i.e., less than the lower limit of the 95% CI of -0.5 days predetermined to demonstrate non-inferiority. The mean number of heartburn-free days by D7 was significantly greater in the omeprazole group: 3.7 ± 2.3 days vs. 3.1 ± 2.1 (p = 0.02). On D7, overall quality of pain relief was slightly in favour of omeprazole (p = 0.049). There was no significant difference in the reduction in pain intensity between groups by D7 (p = 0.11) or D14 (p = 0.08). Tolerance and safety were good and comparable in both groups.

conclusionGaviscon® was non-inferior to omeprazole in achieving a 24-h heartburn-free period in moderate episodic heartburn, and is a relevant effective alternative treatment in moderate GERD in primary care.

trial registrationISRCTN62203233.

Indexed as

Severity of Illness IndexAdolescentAdultAlginatesAluminum HydroxideDouble-Blind MethodDrug CombinationsFemaleGastroesophageal RefluxHumansMaleMiddle AgedOmeprazoleProton Pump InhibitorsSilicic AcidSodium Bicarbonatealginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combinationAlginatesAluminum HydroxideDrug CombinationsOmeprazoleProton Pump InhibitorsSilicic AcidSodium Bicarbonate

Identifiers

PMID22361121
PMCPMC3298711
OpenAlexW2152601459

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.