Evidence map›Paper›PMID 41120363›Full record

Trial reportScientific reports2025

Randomized trial of the effect of esomeprazole on functional dyspepsia during Ramadan fasting.

Safa Hadrich, Feten Lamti, Imen Trabelsi, Randa Dhaoui, Mehdi Ben Abdewahed, Adel Sekma, Fadoua Neffati, Lotfi Boukadida, Hajer Yaakoubi, Rahma Jaballah and 25 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05287633 (Proton Pump Inhibitors Effects on Dyspepsia During Ramadan Fasting), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

NCT05287633 phase1 / phase2completednot on this map

Proton Pump Inhibitors Effects on Dyspepsia During Ramadan Fasting

TypeinterventionalSponsorUniversity of MonastirRan2020 to 2024Enrolled500ConditionsDyspepsiaArmsEsomeprazole, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

35 authors.

Safa HadrichResearch Laboratory LR12SP18, Monastir University, 5000, Monastir, Tunisia.
Feten LamtiResearch Laboratory LR12SP18, Monastir University, 5000, Monastir, Tunisia.
Imen TrabelsiResearch Laboratory LR12SP18, Monastir University, 5000, Monastir, Tunisia.
Randa DhaouiEmergency Department, Fattouma Bourguiba University Hospital, University of Monastir, 5000, Monastir, Tunisia.
Mehdi Ben AbdewahedDepartment of Gastroenterology and Hepatology, Fattouma Bourguiba University Hospital, 5000, Monastir, Tunisia.
Adel SekmaResearch Laboratory LR12SP18, Monastir University, 5000, Monastir, Tunisia.
Fadoua NeffatiDepartment of Biochemistry and Toxicology, Fattouma Bourguiba University Hospital, 5000, Monastir, Tunisia.
Lotfi BoukadidaEmergency Department, Sahloul University Hospital, 4011, Sousse, Tunisia.
Hajer YaakoubiEmergency Department, Sahloul University Hospital, 4011, Sousse, Tunisia.
Rahma JaballahEmergency Department, Sahloul University Hospital, 4011, Sousse, Tunisia.
Arij BakirEmergency Department, Sahloul University Hospital, 4011, Sousse, Tunisia.
Rym YoussefEmergency Department, Sahloul University Hospital, 4011, Sousse, Tunisia.
Asma ZorgatiEmergency Department, Sahloul University Hospital, 4011, Sousse, Tunisia.
Khaoula Bel Haj AliResearch Laboratory LR12SP18, Monastir University, 5000, Monastir, Tunisia.
Kaouthar BeltaiefResearch Laboratory LR12SP18, Monastir University, 5000, Monastir, Tunisia.
Zohra DridiCardiology Department A, Fattouma Bourguiba University Hospital, 5000, Monastir, Tunisia.
Khaldoun Ben HamdaCardiology Department B, Fattouma Bourguiba University Hospital, 5000, Monastir, Tunisia.
Walid JomaaCardiology Department B, Fattouma Bourguiba University Hospital, 5000, Monastir, Tunisia.
Ikram ChamtouriCardiology Department B, Fattouma Bourguiba University Hospital, 5000, Monastir, Tunisia.
Yosra BendayaMedis Laboratories, 1053, Tunis, Tunisia.
Mohamed BouchouchaMedis Laboratories, 1053, Tunis, Tunisia.
Sonia Ben HafaeidhMedis Laboratories, 1053, Tunis, Tunisia.
Rabie RazgallahDACIMA Consulting, 1053, Tunis, Tunisia.
Wahid BouidaResearch Laboratory LR12SP18, Monastir University, 5000, Monastir, Tunisia.
Mohamed Habib GrissaResearch Laboratory LR12SP18, Monastir University, 5000, Monastir, Tunisia.
Asma SrihaDepartment of Preventive Medicine, Fattouma Bourguiba University Hospital, 5000, Monastir, Tunisia.
Sonia KhedherResearch Laboratory LR12SP18, Monastir University, 5000, Monastir, Tunisia.
Ines KhochtaliDepartment of Endocrinology, Fattouma Bourguiba University Hospital, 5000, Monastir, Tunisia.
Nabil SaklyDepartment of Immunology, Fattouma Bourguiba University Hospital, 5000, Monastir, Tunisia.
Houda Ben SoltaneEmergency Department, Farhat Hached University Hospital, 4000, Sousse, Tunisia.
Mohsen HassineResearch Laboratory LR12SP18, Monastir University, 5000, Monastir, Tunisia.
Hamdi BoubakerResearch Laboratory LR12SP18, Monastir University, 5000, Monastir, Tunisia.
Riadh BoukefResearch Laboratory LR12SP18, Monastir University, 5000, Monastir, Tunisia.
Mohamed Amine MsolliResearch Laboratory LR12SP18, Monastir University, 5000, Monastir, Tunisia.
Semir NouiraResearch Laboratory LR12SP18, Monastir University, 5000, Monastir, Tunisia. semir.nouira.urg@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Dyspeptic symptoms are frequently encountered during Ramadan and may be exacerbated by changes in eating habits. We assessed the efficacy of esomeprazole in patients with functional dyspepsia (FD) who fasted during Ramadan. In this randomized, double-blind controlled study, 245 patients diagnosed with FD who completed Ramadan fasting were randomly assigned (1:1 ratio) to receive either esomeprazole (n = 122) or placebo (n = 123) for 30 days. Dyspepsia was assessed using the Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ) at baseline (pre-Ramadan), day7, day 14, and at end of Ramadan (End-Ramadan). The primary endpoint was the rate of responders defined as a > 50% reduction from baseline in SF-LDQ score at End-Ramadan. Secondary endpoints were changes in SF-LDQ scores over time, improvement in quality of life assessed by the general health and physical function components of SF-12 score, and safety. At End-Ramadan, 95% of the patients receiving placebo and 98% receiving esomeprazole were responders (p = 0.5). The SF-LDQ score improved more significantly with esomeprazole than with placebo at day7 [(mean difference 0.71 (95% CI - 1.64 to 1.18)], and at day 14 [(mean difference 0.77 (95% CI - 1.7 to 4.7)]. Both treatments significantly improved quality of life from baseline. All adverse events were minor and similar in both groups. Our results showed that, in patients with FD fasting during Ramadan, esomeprazole was effective. Our findings also suggest that fasting itself may contribute to significant improvement in FD symptoms. The potential synergistic effects of fasting combined with PPIs warrant further investigation.Trial registration: The protocol was registered at www.clinicaltrials.gov in 09/10/2020 under the number NCT05287633.

Indexed as

DyspepsiaEsomeprazoleFastingIslamAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedProton Pump InhibitorsQuality of LifeSurveys and QuestionnairesTreatment OutcomeEsomeprazoleProton Pump InhibitorsEsomeprazoleFastingFunctional dyspepsiaProton pump inhibitorsRamadanShort-Form Leeds Dyspepsia Questionnaire

Identifiers

PMID41120363
PMCPMC12541033

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LicenceCC BY-NC-ND
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Registered trials

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.