Evidence map›Paper›PMID 38444064›Full record

Trial reportWomen's health (London, England)

The role of probiotics in improving menstrual health in women with primary dysmenorrhoea: A randomized, double-blind, placebo-controlled trial (the PERIOD study).

Izyan Atiqah Zakaria, Nur Aini Mohammed Zain, Chew Kah Teik, Muhammad Azrai Abu, Ani Amelia Zainuddin, Nor Haslinda Abdul Aziz, Nazarudin Safian, Norfilza Mohd Mokhtar, Raja Affendi Raja Ali, Ng Beng Kwang and 4 more

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

Trial report in Women's health (London, England). The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04119011 (A Novel Approach to Manipulate Intestinal Homeostasis in Primary Dysmenorrhoea Women), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
3.8field-weighted citation impact, top 7% 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.

NCT04119011 phase1 / phase2completednot on this map

A Novel Approach to Manipulate Intestinal Homeostasis in Primary Dysmenorrhoea Women: a Randomised Controlled Trial

TypeinterventionalSponsorNational University of MalaysiaRan2019 to 2020Enrolled72ConditionsPrimary DysmenorrheaArmsProbiotic, Placebo
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Review
  7. Review
  8. Article
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

14 authors at 1 institution in 1 country.

Izyan Atiqah ZakariaDepartment of Obstetrics and Gynaecology, Faculty of Medicine, National University of Malaysia, Kuala Lumpur, Malaysia.ORCID 0000-0003-3816-7589
Nur Aini Mohammed ZainDepartment of Obstetrics and Gynaecology, Faculty of Medicine, National University of Malaysia, Kuala Lumpur, Malaysia.
Chew Kah TeikDepartment of Obstetrics and Gynaecology, Faculty of Medicine, National University of Malaysia, Kuala Lumpur, Malaysia.
Muhammad Azrai AbuDepartment of Obstetrics and Gynaecology, Faculty of Medicine, National University of Malaysia, Kuala Lumpur, Malaysia.
Ani Amelia ZainuddinDepartment of Obstetrics and Gynaecology, Faculty of Medicine, National University of Malaysia, Kuala Lumpur, Malaysia.
Nor Haslinda Abdul AzizDepartment of Obstetrics and Gynaecology, Faculty of Medicine, National University of Malaysia, Kuala Lumpur, Malaysia.
Nazarudin SafianDepartment of Community Health, Faculty of Medicine, National University of Malaysia, Kuala Lumpur, Malaysia.
Norfilza Mohd MokhtarDepartment of Physiology, Faculty of Medicine, National University of Malaysia, Kuala Lumpur, Malaysia.
Raja Affendi Raja AliDepartment of Medicine, Faculty of Medicine, National University of Malaysia, Kuala Lumpur, Malaysia.
Ng Beng KwangDepartment of Obstetrics and Gynaecology, Faculty of Medicine, National University of Malaysia, Kuala Lumpur, Malaysia.
Nor Azlin Mohamed IsmailDepartment of Obstetrics and Gynaecology, Faculty of Medicine, National University of Malaysia, Kuala Lumpur, Malaysia.
Muhammad Rafiuddin HamizanDepartment of Obstetrics and Gynaecology, Faculty of Medicine, National University of Malaysia, Kuala Lumpur, Malaysia.
Wira Sorfan Ab RazakDepartment of Obstetrics and Gynaecology, Faculty of Medicine, National University of Malaysia, Kuala Lumpur, Malaysia.
Abdul Ghani Nur AzurahDepartment of Obstetrics and Gynaecology, Faculty of Medicine, National University of Malaysia, Kuala Lumpur, Malaysia.
National University of Malaysia · MY

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrimary dysmenorrhea is associated with poorer quality of life; however, the causal mechanism remains unclear. A vast body of literature supports the use of oral probiotics for relief from the symptoms of endometriosis; however, to our knowledge, no study has prescribed probiotics for primary dysmenorrhea.

objectiveThe aim of this study is to investigate the effects of 3-month supplementation with oral probiotics on quality of life and inflammatory markers in women with primary dysmenorrhea.

designRandomized placebo-controlled trial.

methodsA total of 72 patients (36 patients in each arm) were randomized to receive either oral sachets containing 5 billion colony-forming units each of

resultsThere was no significant difference in the quality of life scores between the probiotic and placebo groups. Both groups showed significant improvement in pain (visual analog scale) and severity (verbal rating scale) scores but the probiotic group had much lower nonsteroidal anti-inflammatory drug use (odds ratio: 0.69, 95% confidence interval: 0.26-1.83) and better mental health scores (mean change: 6.5,

conclusionTested oral probiotics improved mental health and potentially reduced the use of nonsteroidal anti-inflammatory drugs; however, there was no significant change in inflammatory markers. Further research with a larger sample size is needed to confirm the findings. REGISTRATION: This study is registered under ClinicalTrials.gov (NCT04119011).

Indexed as

DysmenorrheaEndometriosisAnti-Inflammatory Agents, Non-SteroidalDouble-Blind MethodFemaleHumansQuality of LifeAnti-Inflammatory Agents, Non-Steroidalinflammatory markersmenstrual disordersprimary dysmenorrhealprobioticsquality of life

Identifiers

PMID38444064
PMCPMC10916465
OpenAlexW4392513934

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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 OpenQuestion graph.