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

Primary 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 dysmen...

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Published in:	Women's health (London, England) Vol. 20; p. 17455057241234524
Main Authors:	Zakaria, Izyan Atiqah, Mohammed Zain, Nur Aini, Teik, Chew Kah, Abu, Muhammad Azrai, Zainuddin, Ani Amelia, Abdul Aziz, Nor Haslinda, Safian, Nazarudin, Mohd Mokhtar, Norfilza, Raja Ali, Raja Affendi, Beng Kwang, Ng, Mohamed Ismail, Nor Azlin, Hamizan, Muhammad Rafiuddin, Ab Razak, Wira Sorfan, Nur Azurah, Abdul Ghani
Format:	Journal Article
Language:	English
Published:	United States SAGE Publications 01-01-2024 SAGE Publishing
Subjects:	Anti-Inflammatory Agents, Non-Steroidal - therapeutic use Double-Blind Method Dysmenorrhea - drug therapy Endometriosis Female Humans Improving Menstrual Health Throughout the Reproductive Life Course Quality of Life inflammatory markers primary dysmenorrheal menstrual disorders quality of life probiotics
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Summary:	Primary 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. The 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. Randomized placebo-controlled trial. A total of 72 patients (36 patients in each arm) were randomized to receive either oral sachets containing 5 billion colony-forming units each of each or placebo twice daily for 3 months. Main outcome measures were visual analog scale, verbal rating scale, physical and mental health scores using Short-Form 12-Item version 2 questionnaire, frequency of nonsteroidal anti-inflammatory drug use, and changes in inflammatory markers (interleukin-6, interleukin-8, and tumor necrosis factor alpha) before and after treatment. There 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, = 0.03 versus 6.1, = 0.08) than the placebo group. There was a significant confounding effect of nonsteroidal anti-inflammatory drug use on quality of life scores. No significant difference was found in inflammatory cytokines. Tested 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. This study is registered under ClinicalTrials.gov (NCT04119011).
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3
ISSN:	1745-5057 1745-5065
DOI:	10.1177/17455057241234524