Department of Obstetrics and Gynaecology, Faculty of Medicine, National University of Malaysia, Kuala Lumpur, Malaysia.
Department of Community Health, Faculty of Medicine, National University of Malaysia, Kuala Lumpur, Malaysia.
Womens Health (Lond). 2024 Jan-Dec;20:17455057241234524. doi: 10.1177/17455057241234524.
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).
原发性痛经与生活质量较差相关；然而，其因果机制仍不清楚。大量文献支持使用口服益生菌来缓解子宫内膜异位症的症状；然而，据我们所知，尚无研究将益生菌用于原发性痛经。
本研究旨在探讨口服益生菌补充 3 个月对原发性痛经患者生活质量和炎症标志物的影响。
随机安慰剂对照试验。
共纳入 72 例患者（每组 36 例），随机分为两组，分别每日口服含有 50 亿个菌落形成单位的益生菌或安慰剂，共 3 个月。主要观察指标为视觉模拟评分、口头评分、使用 SF-12 简表第 2 版评估的身体和心理健康评分、非甾体抗炎药的使用频率，以及治疗前后炎症标志物（白细胞介素 6、白细胞介素 8 和肿瘤坏死因子-α）的变化。
益生菌组和安慰剂组的生活质量评分无显著差异。两组的疼痛（视觉模拟评分）和严重程度（口头评分）均有显著改善，但益生菌组的非甾体抗炎药使用率较低（比值比：0.69，95%置信区间：0.26-1.83），心理健康评分较高（平均变化：6.5，=0.03 与 6.1，=0.08）。非甾体抗炎药的使用对生活质量评分有显著的混杂影响。两组的炎症细胞因子无显著差异。
经测试的口服益生菌改善了心理健康，并可能减少了非甾体抗炎药的使用；然而，炎症标志物无显著变化。需要更大样本量的进一步研究来证实这些发现。
本研究在 ClinicalTrials.gov 注册（NCT04119011）。
