Efficacy of acupuncture on pelvic pain in patients with endometriosis: study protocol for a randomized, single-blind, multi-center, placebo-controlled trial.

Liang R ，Li P ，Peng X ，Xu L ，Fan P ，Peng J ，Zhou X ，Xiao C ，Jiang M ... -  《Trials》

Efficacy of acupuncture for endometriosis-associated pain: a multicenter randomized single-blind placebo-controlled trial.

To evaluate the efficacy and safety of acupuncture in the treatment of endometriosis-associated pain. A multicenter, randomized, single-blind, placebo-controlled trial. Four tertiary hospitals in Jiangxi and Hainan Provinces. Women with endometriosis-associated pain aged between 20 and 40 years. Subjects were assigned randomly to receive either acupuncture or sham acupuncture treatment for 12 weeks, starting one week before each expected menstruation and administered as a 30-minute session once per day, 3 times a week. During the menstruation period, acupuncture was administered daily when pelvic pain associated with endometriosis occurred. After acupuncture or sham acupuncture treatment, the subjects were followed for another 12 weeks. Changes in maximum pain as assessed with the visual analog scale (VAS) for various pelvic pain, duration of dysmenorrhea, and scores on the Multidimensional Pain Inventory, Beck Depression Inventory, Profile of Mood States, and Endometriosis Health Profile from baseline to week 12 and week 24. A total of 106 women were assigned randomly to the acupuncture and sham groups. In the acupuncture group, the reduction in the dysmenorrhea VAS score was significantly greater after treatment, but not at the end of the trial, compared to the sham group. The duration of pain was significantly shorter in the acupuncture group. All test scores were improved to a significantly greater extent in the acupuncture group than in the sham group at week 12 but not at week 24. Changes in nonmenstrual pelvic pain and dyspareunia VAS scores were not different between the groups. No severe adverse events or differences in adverse events were recorded. Acupuncture is an effective and safe method of relieving dysmenorrhea, shortening the pain duration, and improving wellbeing and quality of life in women with endometriosis-associated pain, although its efficacy fades after treatment is discontinued. NCT03125304.

Li PS ，Peng XM ，Niu XX ，Xu L ，Hung Yu Ng E ，Wang CC ，Dai JF ，Lu J ，Liang RN ... -  《-》

Efficacy and safety of a novel pain management device, AT-04, for endometriosis-related pain: study protocol for a phase III randomized controlled trial.

Endometriosis-related pain encompassing dysmenorrhea, dyspareunia, and chronic pelvic pain, reduces the quality of life in premenopausal women. Although treatment options for endometriosis alleviate this pain, approximately one-third of women still experience pain even after receiving treatment, indicating the need for novel approaches to pain relief in those women. The Angel Touch device (AT-04) is a portable magnetic fields irradiation device that incorporates a combination of mixed alternative magnetic fields at 2 kHz and 83.3 MHz. A phase III trial confirmed the efficacy and safety of AT-02, a prototype of AT-04, for pain relief in patients with fibromyalgia. This is a phase III, multicenter, prospective, randomized, sham device-controlled, double-blind, parallel study. The participants will be premenopausal women aged > 18 years who have endometriosis-related pain with at least moderate severity. Considering dropouts, 50 participants have been deemed appropriate. Eligible women will be centrally registered, and the data center will randomly allocate them in a 1:1 ratio to the intervention and control groups. Women in the intervention group will receive electromagnetic wave irradiation generated by AT-04 and those who in the control group will wear a sham device for 16 weeks, and both groups will wear AT-04 for another 4 weeks. The primary outcome measure is the change in the Numeric Rating Scale score at 16 weeks compared with the baseline. Secondary outcome measures are efficacy for pelvic pain including dysmenorrhea and non-menstrual pain, and chronic pelvic pain not related to menstruation, dysmenorrhea, and dyspareunia, and improvement of quality of life during the study period. Safety will be evaluated by device defects and the frequency of adverse events. The study protocol has been approved by the Clinical Study Review Board of Chiba University Hospital, Chiba, Japan, and will be conducted in accordance with the principles of the Declaration of Helsinki and the Japanese Clinical Trials Act and relevant notifications. This study aims to develop a novel method of managing endometriosis-related pain. The AT-04 is an ultralow-invasive device that can be used without inhibiting ovulation, suggesting potential benefits to women of reproductive-age. Trial registration number Japan Registry of Clinical Trials (jRCTs032230278).

Ishikawa H ，Yoshino O ，Taniguchi F ，Harada T ，Momoeda M ，Osuga Y ，Hikake T ，Hattori Y ，Hanawa M ，Inaba Y ，Hanaoka H ，Koga K ... -  《Reproductive Health》

Acupuncture for clinical improvement of endometriosis-related pain: a systematic review and meta-analysis.

Endometriosis is a common chronic gynecological condition characterized by the presence of endometrial tissue outside the uterine cavity, leading to chronic inflammation, pelvic nodules and masses, pelvic pain, and infertility. Acupuncture has been shown to improve pain associated with endometriosis by modulating abnormal levels of prostaglandins, β-endorphins, dynorphins, electrolytes, and substance P. This review aims to evaluate the clinical efficacy of acupuncture in treating endometriosis, specifically focusing on its efficacy in relieving pain associated with endometriosis. A comprehensive search was conducted in eight databases (PubMed, EMBASE, Cochrane, Web of Science, China National Knowledge Infrastructure (CNKI), the China Biology Medicine (CBM), Wanfang, and Weipu database) to identify randomized controlled trials (RCTs) published from database inception to December 16, 2022, which investigated the use of acupuncture for endometriosis-related pain. Two researchers independently screened articles, extracted data, and assessed methodological quality using the Cochrane Collaboration's risk of bias tool. Meta-analysis was performed using Stata statistical software. A total of 1991 articles were identified, and ultimately, 14 studies involving 793 patients (387 in the acupuncture group and 359 in the control group) were included. The control interventions in the included studies included placebo, traditional Chinese medicine (TCM), and Western medicine treatments. Meta-analysis results showed that compared to the control group, acupuncture treatment for pain associated with endometriosis demonstrated significant reductions in pain severity [SMD = - 1.10, 95% CI (- 1.45, - 0.75), P < 0.001], improved response rate [RR = 1.25, 95% CI (1.09, 1.44), P = 0.02], and decreased serum CA-125 levels [SMD = - 0.62, 95% CI (- 1.15, - 0.08), P = 0.024]. Furthermore, subgroup analysis revealed that electroacupuncture and auricular acupuncture were superior to the control group in reducing pain severity, while auricular acupuncture and warm needling showed greater clinical efficacy compared to the control group. However, there were no significant differences between electroacupuncture or fire needling and the control group in terms of pain relief. The findings suggest that acupuncture is effective in improving pain associated with endometriosis. In conclusion, acupuncture is effective in alleviating dysmenorrhea and pelvic pain associated with endometriosis, reducing serum CA-125 levels, decreasing the size of nodules, improving patients' quality of life, and lowering the recurrence rate. However, it should be noted that the current evidence is limited by the design and quality flaws of the original studies, as well as a lack of research specifically focusing on subtypes of acupuncture. Therefore, caution should be exercised when interpreting the results.

Chen C ，Li X ，Lu S ，Yang J ，Liu Y ... -  《-》

Potentized estrogen in homeopathic treatment of endometriosis-associated pelvic pain: A 24-week, randomized, double-blind, placebo-controlled study.

To evaluate the efficacy and safety of potentized estrogen compared to placebo in homeopathic treatment of endometriosis-associated pelvic pain (EAPP). The present was a 24-week, randomized, double-blind, placebo-controlled trial that included 50 women aged 18-45 years old with diagnosis of deeply infiltrating endometriosis based on magnetic resonance imaging or transvaginal ultrasound after bowel preparation, and score≥5 on a visual analogue scale (VAS: range 0 to 10) for endometriosis-associated pelvic pain. Potentized estrogen (12cH, 18cH and 24cH) or placebo was administered twice daily per oral route. The primary outcome measure was change in the severity of EAPP global and partial scores (VAS) from baseline to week 24, determined as the difference in the mean score of five modalities of chronic pelvic pain (dysmenorrhea, deep dyspareunia, non-cyclic pelvic pain, cyclic bowel pain and/or cyclic urinary pain). The secondary outcome measures were mean score difference for quality of life assessed with SF-36 Health Survey Questionnaire, depression symptoms on Beck Depression Inventory (BDI), and anxiety symptoms on Beck Anxiety Inventory (BAI). The EAPP global score (VAS: range 0 to 50) decreased by 12.82 (P<0.001) in the group treated with potentized estrogen from baseline to week 24. Group that used potentized estrogen also exhibited partial score (VAS: range 0 to 10) reduction in three EAPP modalities: dysmenorrhea (3.28; P<0.001), non-cyclic pelvic pain (2.71; P=0.009), and cyclic bowel pain (3.40; P<0.001). Placebo group did not show any significant changes in EAPP global or partial scores. In addition, the potentized estrogen group showed significant improvement in three of eight SF-36 domains (bodily pain, vitality and mental health) and depression symptoms (BDI). Placebo group showed no significant improvement in this regard. These results demonstrate superiority of potentized estrogen over placebo. Few adverse events were associated with potentized estrogen. Potentized estrogen (12cH, 18cH and 24cH) at a dose of 3 drops twice daily for 24 weeks was significantly more effective than placebo for reducing endometriosis-associated pelvic pain. ClinicalTrials.gov Identifier: NCT02427386.

Teixeira MZ ，Podgaec S ，Baracat EC 《-》