口服乳酸杆菌对子宫内膜异位症女性疼痛严重程度的有益影响：一项安慰剂对照的随机临床试验初步研究
Beneficial Effects of Oral Lactobacillus on Pain Severity in Women Suffering from Endometriosis: A Pilot Placebo-Controlled Randomized Clinical Trial.
作者信息
Khodaverdi Sepideh, Mohammadbeigi Robabeh, Khaledi Mojdeh, Mesdaghinia Leila, Sharifzadeh Fatemeh, Nasiripour Somayyeh, Gorginzadeh Mansoureh
机构信息
Fellowship in Minimally Invasive Gynecologic Surgery (FMIG), Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.
Fellowship in Infertility, Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.
出版信息
Int J Fertil Steril. 2019 Oct;13(3):178-183. doi: 10.22074/ijfs.2019.5584. Epub 2019 Jul 14.
BACKGROUND
This study assessed the effects of a lactobacillus-based medication on pain intensity scores in women with endometriosis.
MATERIALS AND METHODS
The present randomized pilot placebo-controlled trial was done on eligible women who were surgically and pathologically diagnosed with endometriosis. Thirty-seven participants who had not received hormonal treatment in the last three months, were enrolled and randomized into LactoFem® and placebo groups. Lactobacillus capsules or placebo were administrated orally once a day for 8 weeks. Patients were assessed for pain severity using Visual Analogue Scale (VAS) scores for dysmenorrhea, dyspareunia and chronic pelvic pain at baseline and after 8 and 12 weeks post-intervention.
RESULTS
Mean age of participants and mean body mass index (BMI) for the LactoFem® and control groups were comparable. All patients had stage 3 and 4 of the disease based on revised American fertility society (AFS) classification of endometriosis. Mean initial pain scores for dysmenorrhea, dyspareunia and chronic pelvic pain were 6.53 ± 2.88, 4.82 ± 3.76 and 4.19 ± 3.53, respectively in the LactoFem® group and 5.60 ± 2.06, 3.67 ± 2.64 and 2.88 ± 2.80, respectively for the control group; the two groups had comparable scores in this regard. There was more decrease in pain scores for both dysmenorrhea and the overall pain after 8 weeks of treatment in LactoFem® group compared to the control group. The scores for dysmenorrhea were 6.53 ± 2.88 and 5.60 ± 2.06 in the LactoFem® and control groups, respectively, before intervention but, after 8-week treatment, these values were 3.07 ± 2.49 and 4.47 ± 2.13 (P=0.018), respectively. The changes in overall pain score in the LactoFem® and control group during this period were 7.33 ± 7.00 and 4.11 ± 1.68, respectively (P=0.017).
CONCLUSION
This study showed some beneficial effects of lactobacillus administration on endometriosis-related pain (Registration number: IRCT20150819023684N5).
背景
本研究评估了一种基于乳酸菌的药物对子宫内膜异位症女性疼痛强度评分的影响。
材料与方法
本随机对照试验纳入了经手术和病理诊断为子宫内膜异位症的合格女性。37名在过去三个月内未接受激素治疗的参与者被纳入研究，并随机分为LactoFem®组和安慰剂组。乳酸菌胶囊或安慰剂每天口服一次，持续8周。在基线以及干预后8周和12周，使用视觉模拟量表（VAS）对痛经、性交痛和慢性盆腔疼痛的严重程度进行评估。
结果
LactoFem®组和对照组参与者的平均年龄和平均体重指数（BMI）具有可比性。根据修订后的美国生育协会（AFS）子宫内膜异位症分类，所有患者均为疾病3期和4期。LactoFem®组痛经、性交痛和慢性盆腔疼痛的初始平均疼痛评分分别为6.53±2.88、4.82±3.76和4.19±3.53，对照组分别为5.60±2.06、3.67±2.64和2.88±2.80；两组在这方面的评分具有可比性。与对照组相比，LactoFem®组治疗8周后痛经和总体疼痛的评分下降更多。干预前，LactoFem®组和对照组的痛经评分分别为6.53±2.88和5.60±2.06，但在8周治疗后，这些值分别为3.07±2.49和4.47±2.13（P = 0.018）。在此期间，LactoFem®组和对照组总体疼痛评分的变化分别为7.33±7.00和4.11±1.68（P = 0.017）。
结论
本研究表明服用乳酸菌对子宫内膜异位症相关疼痛有一定益处（注册号：IRCT20150819023684N5）。
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