Evidence map›Paper›PMID 35704960›Full record

Trial reportPloS one2022

Efficacy and safety of a food supplement with standardized menthol, limonene, and gingerol content in patients with irritable bowel syndrome: A double-blind, randomized, placebo-controlled trial.

Vladimir T Ivashkin, Anna V Kudryavtseva, George S Krasnov, Yuri M Poluektov, Margarita A Morozova, Oleg S Shifrin, Allan G Beniashvili, Zarina A Mamieva, Alexandra L Kovaleva, Anatoly I Ulyanin and 3 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04484467 (Efficacy and Safety of a Food Supplement With Standardized Menthol, Limonene, and Gingerol Content in Patients With Irritable Bowel Syndrome), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 14% 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.

NCT04484467 nacompletednot on this map

Efficacy and Safety of a Food Supplement With Standardized Menthol, Limonene, and Gingerol Content in Patients With Irritable Bowel Syndrome: a Double-blind, Randomized, Placebo-controlled Trial

TypeinterventionalSponsorFederal Stare Budgetary Scientific Institution, Mental Health Research CenterRan2018 to 2019Enrolled56ConditionsIrritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea, Irritable Bowel Syndrome With Constipation, Irritable Bowel Syndrome MixedArmsFood Supplement With Standardized Menthol, Limonene, and Ginger, Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Non-Chinese herbal medicines for functional dyspepsia.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Review
  3. Review
  4. Review
  5. Review
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

13 authors at 4 institutions in 1 country.

Vladimir T IvashkinI.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation.
Anna V KudryavtsevaEngelhardt Institute of Molecular Biology, Russian Academy of Sciences, Moscow, Russian Federation.
George S KrasnovEngelhardt Institute of Molecular Biology, Russian Academy of Sciences, Moscow, Russian Federation.
Yuri M PoluektovEngelhardt Institute of Molecular Biology, Russian Academy of Sciences, Moscow, Russian Federation.ORCID 0000-0002-9710-7490
Margarita A MorozovaMental Health Research Center, Moscow, Russian Federation.ORCID 0000-0002-7847-2716
Oleg S ShifrinI.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation.
Allan G BeniashviliEngelhardt Institute of Molecular Biology, Russian Academy of Sciences, Moscow, Russian Federation.
Zarina A MamievaI.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation.
Alexandra L KovalevaI.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation.
Anatoly I UlyaninI.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation.ORCID 0000-0001-5506-5555
Elizaveta A TrushI.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation.
Alexander G ErlykinMoscow State Linguistic University, Moscow, Russian Federation.
Elena A PoluektovaI.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation.ORCID 0000-0003-1312-120X
Sechenov University · RUEngelhardt Institute of Molecular Biology · RUMental Health Research Center of Russian Academy of Medical Sciences · RUMoscow State Linguistic University · RU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIrritable bowel syndrome (IBS) affects 9,2% of the global population and places a considerable burden on healthcare systems. Most medications for treating IBS, including spasmolytics, laxatives, and antidiarrheals, have low efficacy. Effective and safe therapeutic treatments have yet to be developed for IBS. PURPOSE: This study assessed the efficacy and safety of a food supplement containing standardized menthol, limonene, and gingerol in human participants with IBS or IBS/functional dyspepsia (FD).

designA double-blind, randomized, placebo-controlled trial.

methodsWe randomly assigned 56 patients with IBS or IBS/FD to an intervention group (Group 1) or control group (Group 2) that were given supplement or placebo, respectively, in addition to the standard treatment regimen for 30 d. Three outpatient visits were conducted during the study. Symptom severity was measured at each visit using a 7×7 questionnaire. Qualitative and quantitative composition of the intestinal microbiota were assessed at visits 1 and 3 based on 16S rRNA gene sequencing.

resultsAt visit 1 (before treatment), the median total 7×7 questionnaire score was in the moderately ill range for both groups, with no difference between the groups (p = 0.1). At visit 2, the total 7×7 score decreased to mildly ill, with no difference between the groups (p = 0.4). At visit 3, the total score for group 1 indicated borderline illness and for group 2 remained indicated mild illness (p = 0.009). Even though we observed some variations in gut microbiota between the groups, we did not find any statistically significant changes.

conclusionThe food supplement with standardized menthol, limonene, and gingerol content increased the efficacy of standard therapy in IBS and FD patients. The use of the supplement did not cause any obvious side effects. REGISTRATION: ClinicalTrials.gov Identifier: NCT04484467.

Indexed as

DyspepsiaIrritable Bowel SyndromeCatecholsDietary SupplementsDouble-Blind MethodFatty AlcoholsHumansLimoneneMentholRNA, Ribosomal, 16STreatment OutcomeCatecholsFatty AlcoholsgingerolLimoneneMentholRNA, Ribosomal, 16S

Identifiers

PMID35704960
PMCPMC9200470
OpenAlexW4282963165

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

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 Socratic graph.