Evaluating the safety of high-intensity focused ultrasound treatment for rectal endometriosis: results from a French prospective multicentre study including 60 patients.

STUDY QUESTION: Is increasing the intensity of high-intensity focused ultrasound (HIFU) by 30% in the treatment of rectal endometriosis a safe procedure? SUMMARY ANSWER: This study demonstrates the safety of a 30% increase in the intensity of HIFU in the treatment of rectal endometriosis, with no Clavien-Dindo Grade III complications overall, and namely no rectovaginal fistulae. WHAT IS KNOWN ALREADY: A feasibility study including 20 patients with rectal endometriosis demonstrated, with no severe complications, a significant improvement in digestive disorders, dysmenorrhoea, dyspareunia, and health status, although the volume of the endometriosis nodule did not appear to be reduced. STUDY DESIGN, SIZE, DURATION: A prospective multicentre cohort study was conducted between 2020 and 2022 with 60 patients with symptomatic rectal endometriosis. Following the failure of medical treatment, HIFU treatment was offered as an alternative to surgery. PARTICIPANTS/MATERIALS, SETTING, METHODS: As the main objective of this study was to examine safety, all adverse events observed during the 6 months of follow-up were analysed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) and Clavien-Dindo classifications. Secondary objectives included evaluating the evolution of symptoms using validated questionnaires: gynaecological and digestive pain symptoms with a visual analogue scale, health status with the Medical Outcomes Study 36-item Short Form (SF-36) questionnaire, average post-operative daily pain level, and analgesic medication required in the 10 days following treatment. MRI was also performed at Day 1 to detect early complications. Finally, we performed a blinded MRI review of the evolution of the nodule at 6 months post-treatment. MAIN RESULTS AND THE ROLE OF CHANCE: The procedure was performed under spinal anaesthesia for 30% of the patients. The median duration of treatment was 32 min. Fifty-five patients left the hospital on Day 1. MRI scans performed on Day 1 did not highlight any early-onset post-operative complication. Using the Clavien-Dindo classification, we listed 56.7% Grade I events, 3.4% Grade II events, and no events Grade III or higher. At 1, 3, and 6 months, all gynaecologic, digestive and general symptoms, as well as health status, had significantly improved. The evolution of the nodule was also significant (P < 0.001) with a 28% decrease in volume. LIMITATIONS, REASONS FOR CAUTION: The main objective was safety and not effectiveness. The study was not randomized and there was no control group. WIDER IMPLICATIONS OF THE FINDINGS: HIFU treatment for rectal endometriosis results in an improvement of symptoms with low morbidity; as such, for selected patients, it could be a valuable alternative to surgical approaches following the failure of medical treatment. STUDY FUNDING/COMPETING INTEREST(S): The study was funded by the company EDAP TMS. Professors Dubernard and Rousset are consultants for EDAP TMS. Dubernard received travel support from EDAP-TMS. Dr F. Chavrier received industrial grants from EDAP-TMS. He has developed a device for generating focused ultrasonic waves with reduced treatment time. This device has been patented by EDAP-TMS. Dr Lafon received industrial grants from EDAP-TMS; he declares that EDAP-TMS provided funding directly to INSERM to support a young researcher chair in therapeutic ultrasound, which is unrelated to the current study. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier NCT04494568.

Alternative treatments of adenomyosis - an update in procedural management and clinical outcomes.

PURPOSE OF REVIEW: Adenomyosis is a common cause of abnormal uterine bleeding (AUB), dysmenorrhea, and pelvic pain. Definitive diagnosis and treatment have historically been by uterine histopathology at time of hysterectomy; however, advances in imaging have supported earlier diagnosis and subsequent conservative treatment. This review aims to update the evidence supporting the uterine-sparing, procedural management options with a focus on clinical outcomes. RECENT FINDINGS: Uterine artery embolization (UAE), radiofrequency ablation (RFA), high-intensity focused ultrasound (HIFU), percutaneous microwave ablation (PMWA), and adenomyomectomy are minimally invasive interventions proven to be effective in reducing AUB and dysmenorrhea due to adenomyosis. Symptom improvement is associated with a decrease in uterine volume. Studies support the use of alternative treatment options given the overall low rates of symptom recurrence and reintervention. Combination therapy may be more effective than monotherapy. SUMMARY: This review provides the current evidence for use of alternative treatment options for adenomyosis. Access to ablative therapies in the USA is limited and primarily off label, given lack of FDA approval. High-quality prospective and randomized controlled trials are needed in order to further delineate treatment comparisons, efficacy, safety, and ideal patient selection for these treatments. More data are needed to assess safety and utility in those desiring future fertility.

Transcutaneous electrical nerve stimulation (TENS) for pain control in women with primary dysmenorrhoea.

BACKGROUND: Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacological treatment that works by delivering electrical currents via electrodes attached to the skin at the site of pain. It can be an alternative to pharmacological treatments. The mechanism of action of TENS for pain relief is related to the inhibition of the transmission of painful stimuli, release of endogenous opioids, and reduced muscle ischaemia of the uterus. Although it has been used for primary dysmenorrhoea ((PD); period pain or menstrual cramps), evidence of the efficacy and safety of high-frequency TENS, low-frequency TENS, or other treatments for PD is limited. OBJECTIVES: To evaluate the effectiveness and safety of transcutaneous electrical nerve stimulation (TENS) in comparison with placebo, no treatment, and other treatments for primary dysmenorrhoea (PD). SEARCH METHODS: We searched the Gynaecology and Fertility Group's Specialized Register of controlled trials, CENTRAL, MEDLINE, Embase, PsycINFO, AMED, CINAHL, and the Korean and Chinese language databases up to 9 April 2024. We also searched for ongoing trials in trials registries and the reference lists of relevant studies for additional trials. Language restrictions were not applied. SELECTION CRITERIA: We included randomized controlled trials (RCTs) that included women (aged 12 to 49 years) with PD. Included trials compared low-frequency TENS or high-frequency TENS with other TENS, placebo, or other treatment. DATA COLLECTION AND ANALYSIS: Four review authors screened the trials, extracted the data according to the protocol, assessed the risk of bias using RoB 2, and assessed the certainty of evidence for all review comparisons and primary outcomes (i.e. pain relief and adverse effects) using the GRADE approach. MAIN RESULTS: This review replaces the current review, published in 2009. We included 20 RCTs involving 585 randomized women with high-frequency TENS, low-frequency TENS, placebo or no treatment, or other treatment. We included five comparisons: high-frequency TENS versus placebo or no treatment, low-frequency TENS versus placebo or no treatment, high-frequency TENS versus low-frequency TENS, high-frequency TENS versus other treatments, and low-frequency TENS versus other treatments. High-frequency TENS versus placebo or no treatment High-frequency TENS may reduce pain compared with placebo or no treatment (mean difference (MD) -1.39, 95% confidence interval (CI) -2.51 to -0.28; 10 RCTs, 345 women; low-certainty evidence; I2 = 88%). Two out of three RCTs reported no adverse effects and hence we were unable to estimate the effect of high-frequency TENS on adverse effects. Low-frequency TENS versus placebo or no treatment Low-frequency TENS may reduce pain compared with placebo or no treatment (MD -2.04, 95% CI -2.95 to -1.14; 3 RCTs, 645 women; low-certainty evidence; I2 = 0%). No trials reported adverse effects for this comparison. High-frequency TENS versus low-frequency TENS It is uncertain whether high-frequency TENS had an effect on pain relief compared with low-frequency TENS (MD 0.89, 95% CI -0.19 to 1.96; 3 RCTs, 54 women; low-certainty evidence; I2 = 0%). One trial contributed data on adverse effects but no adverse events occurred. High-frequency TENS versus other treatments It is uncertain whether high-frequency TENS had an effect on pain relief compared to acupressure (MD -0.66, 95% CI -1.72 to 0.40; 1 RCT, 18 women; very low-certainty evidence), acetaminophen (paracetamol) (MD -0.98, 95% CI -3.30 to 1.34; 1 RCT, 20 women; very low-certainty evidence), and interferential current therapy (MD -0.03, 95% CI -1.04 to 0.98; 2 RCTs, 62 women; low-certainty evidence; I2 = 0%). The occurrence of adverse effects did not differ significantly between high-frequency TENS and NSAIDs (OR 12.06, 95% CI 0.26 to 570.62; 2 RCTs, 88 women; low-certainty evidence; I2 = 78%). Low-frequency TENS versus other treatments It is uncertain whether low-frequency TENS had an effect on pain relief compared with acetaminophen (MD -1.48, 95% CI -3.61 to 0.65; 1 RCT, 20 women; very low-certainty evidence). No trials reported adverse effects for this comparison. AUTHORS' CONCLUSIONS: High-frequency TENS and low-frequency TENS may reduce pain compared with placebo or no treatment. We downgraded the certainty of the evidence because of the risk of bias. Future RCTs should focus more on secondary outcomes of this review (e.g. requirement for additional analgesics, limitation of daily activities, or health-related quality of life) and should be designed to ensure a low risk of bias.

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

BACKGROUND: 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. METHODS: 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. DISCUSSION: 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).

Endometriosis is a chronic inflammatory disorder that negatively impacts reproductive health via endometriosis-related pain, infertility, and endometriosis-associated ovarian cancer. Although current therapeutic options for endometriosis are effective for the endometriosis-related 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. This is the first randomized controlled trial to investigate the efficacy and safety of a novel portable pain management device, AT-04, that incorporates a combination of mixed alternating magnetic fields, for endometriosis-related pain. This is a multicenter, prospective, sham device-controlled, double-blind, parallel study. Enrolled women will have undergone standard hormonal treatment for endometriosis at baseline, and this allows for assessing whether the device remains effective when used in conjunction with existing treatment methods. The study also will explore the impact of AT-04 on reducing the size of ovarian endometriotic cysts that reflect the activity of endometriosis. The study reflects the strong desire by physicians to liberate women from the unbearable pain associated with endometriosis. The sole efficacy of AT-04 in treating endometriosis-related pain is difficult to evaluate as there is a possibility that menstrual cycles may influence the assessment of pain and quality of life. However, the study findings regarding the effectiveness of AT-04 for the treatment of endometriosis-related pain may benefit women with endometriosis who have pain that is not effectively relieved by other treatments. Consequently, it may contribute to the improvement of reproductive health within society.

Comparative Effects of Exercises Combined With Kinesio Taping and Electrotherapy in Women with Primary Dysmenorrhea: A Randomized Controlled Clinical Trial.

Background: Primary dysmenorrhea is a common gynecological problem characterized by menstrual pain without any pelvic pathology. It affects a significant portion of women of reproductive age, impacting their quality of life and daily activities. Physiotherapy interventions such as therapeutic exercise, manual therapy, electrotherapy, and kinesio taping reduce menstrual pain and symptoms. However, there is no study investigating the effects of combined physiotherapy interventions. Primary Study Objective: This study aimed to evaluate and compare the effects of exercises combined with either kinesio taping or electrotherapy on reducing menstrual pain and associated symptoms in women suffering from primary dysmenorrhea. Methods: The randomized controlled clinical trial. Setting: Biruni University Department of Physiotherapy and Rehabilitation Laboratory. Participants: Thirty-six women diagnosed with primary dysmenorrhea by a Gynecologist and Obstetrician were randomized into the kinesio-taping group (n=19) and the electrotherapy group (n=17). Intervention: A similar exercise program was carried out in both groups for eight weeks, two days a week and 40 minutes a day. To increase blood flow in the pelvic region and reduce pain mediators, taping was applied to the sacral and pubic regions using the ligament technique in the kinesio taping group, and a vacuum interferential current was applied to the lumbar and gluteal regions in the electrotherapy group. Primary Outcome Measures: The menstrual pain intensity and menstrual symptoms were assessed with valid and reliable the Visual Analogue Scale (VAS) and the Menstrual Symptom Questionnaire (MSQ). Results: The VAS (kinesio taping and electrotherapy group: P < .001), MSQ-pain symptoms (kinesio taping group: P = .014, electrotherapy group: P = .032), and MSQ-coping methods scores (kinesio taping group: P = .001, electrotherapy group: P = .005) decreased both statistically and clinically in both groups. In addition, a statistically significant improvement in MSQ-negative effects/somatic complaints (P = .047) and MSQ total scores (P = .030) was observed in the electrotherapy group. There was no statistically significant difference between the two groups regarding substantial changes (P > .05). Conclusion: The exercises combined with either kinesio taping or electrotherapy effectively reduced menstrual pain intensity and menstrual symptoms related to pain and coping methods in women with primary dysmenorrhea. Notably, exercises combined with electrotherapy also improved menstrual symptoms related to negative effects and somatic complaints. These findings suggest that both kinesio taping and electrotherapy, when combined with exercises, are viable options for managing primary dysmenorrhea, potentially offering clinicians flexible treatment approaches.

Impact of government-issued financial incentive to medical facilities on management of secondary dysmenorrhea.

AIM: In April 2020, the Japanese government introduced a Specific Medical Fee for managing secondary dysmenorrhea (SD). This initiative provided financial incentives to medical facilities that provide appropriate management of SD with hormonal therapies. We aimed to assess how this policy affects the management processes and outcomes of patients with SD. METHODS: Using a large Japanese administrative claims database, we identified outpatient visits of patients diagnosed with SD from April 2018 to March 2022. We used an interrupted time-series analysis and defined before April 2020 as the pre-introduction period and after April 2020 as the post-introduction period. Outcomes were the monthly proportions of outpatient visits due to SD and hormonal therapy among women in the database and the proportions of outpatient visits for hormonal therapy and continuous outpatient visits among patients with SD. RESULTS: We identified 815 477 outpatient visits of patients diagnosed with SD during the pre-introduction period and 920 183 outpatient visits during the post-introduction period. There were significant upward slope changes after the introduction of financial incentives in the outpatient visits due to SD (+0.29% yearly; 95% confidence interval, +0.20% to +0.38%) and hormonal therapies (+0.038% yearly; 95% confidence interval, +0.030% to +0.045%) among the women in the database. Similarly, a significant level change was observed after the introduction of continuous outpatient visits among patients with SD (+2.68% monthly; 95% confidence interval, +0.87% to +4.49%). CONCLUSIONS: Government-issued financial incentives were associated with an increase in the number of patients diagnosed with SD, hormonal therapies, and continuous outpatient visits.

Analysis of related factors influencing postoperative recurrence of adenomyosis treated with HIFU.

OBJECTIVE: To analyze the efficacy of high-intensity focused ultrasound (HIFU) for adenomyosis and postoperative recurrence and its influencing factors. METHODS: Clinical and follow-up data of 308 patients with adenomyosis who were treated with HIFU in Haifu Center, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine from September 2017 to January 2022 were retrospectively analyzed. The recurrence of adenomyosis and the efficacy of HIFU at 6 months after surgery were followed up. To explore factors influencing postoperative prognosis and recurrence, the following variables were analyzed: patients' age, course of disease, gravidity and parity, size of the uterus, duration of HIFU, duration of irradiation, treatment intensity, dysmenorrhea score, time of follow-up, combined treatment of traditional Chinese medicine (TCM), western medicine adjuvant treatment, lesion location and type, and menorrhagia. RESULTS: Among the 308 patients, 238 (77%) were followed up from 6 to 36 months, with an average follow-up time of 15.24 ± 9.97 months. The other 70 (23%) were lost to follow-up. At 6-month after surgery, efficacy rates of dysmenorrhea and menorrhagia management were 86.7% and 89.3%, respectively. Postoperative recurrence rates were 4.8% (1-12 months), 9.0% (12-24 months), and 17.0% (24-36 months) for dysmenorrhea; and 6.3% (1-12 months), 2.4% (12-24 months), and 12.2% (24-36 months) for menorrhagia. Multivariate logistic regression analyses showed that parity (P = 0.043, OR = 1.773, 95% CI 1.018-3.087), uterine size (P = 0.019, OR = 1.004, 95% CI 1.001-1.007), combined treatment of TCM (P = 0.047, OR = 1.846, 95% CI 1.008-3.381), diffuse lesion type (P = 0.013, OR = 0.464, 95% CI 0.254-0.848) and ablation rate (P = 0.015, OR = 0.481, 95%CI 0.267-0.868) were prognostic factors (P < 0.05). Age, course of disease, gravidity, duration of HIFU, duration of irradiation, treatment intensity, preoperative dysmenorrhea score, time of follow-up, western medicine adjuvant therapy, lesion location, and preoperative menstrual volume had no effect on prognosis (P > 0.05). CONCLUSION: HIFU can effectively relieve dysmenorrhea and reduce menstrual volume in patients with adenomyosis. Parity, uterine size, lesion type (diffuse), and ablation rate are risk factors for symptom recurrence after HIFU, while the combination of TCM therapy is a protective factor for relapse. We, therefore, recommend TCM in the adjuvant setting after HIFU according to patient condition.

The Effect of Psychoeducation Based on Leventhal's Self-Regulation Model on Dysmenorrhoea in Nursing Students: A Single-Blind Randomised Controlled Study.

BACKGROUND: The use of self-analgesics among women for dysmenorrhoea is common. Non-pharmacological methods can be employed to effectively cope with dysmenorrhoea. Psychoeducation based on Leventhal's Self-Regulation Model (SRM) is an affordable, easy, and non-pharmacological way that clinics can use to cope with dysmenorrhoea. METHOD: This study aimed to investigate how psychoeducation affected dysmenorrhoea for nursing students using SRM. The sample consisted of 66 female students suffering from moderate-to-severe menstrual pain. A three-session psychoeducation based on SRM was applied to the intervention group. An 'Introductory Information Form', 'Visual Analogue Scale', 'Functional and Emotional Measure of Dysmenorrhoea (FEMD)', and 'Menstrual Symptom Questionnaire (MSQ)' were used to collect the data. All the measurements were carried out over three consecutive menstrual cycles. RESULTS: A generalised linear model was used to analyse the data. After receiving psychoeducation, the pain and functional and emotional symptoms of dysmenorrhoea mean scores significantly decreased in the intervention group compared to the control group (p < .05), whereas there was no significant difference between the groups' MSQ mean scores (p > .05). CONCLUSION: The psychoeducation reduced the severity of dysmenorrhoea pain and the functional and emotional impact levels of dysmenorrhoea and it was proved to be effective at helping the subjects cope with pain in the long term.

Factors associated with dysmenorrhoea and menorrhagia improvement in patients with adenomyosis after uterine artery embolisation.

BACKGROUND: This study examined the improvement of dysmenorrhoea and menorrhagia after uterine artery embolisation (UAE) in women with symptomatic adenomyosis and identified factors that could predict the improvement of dysmenorrhoea and menorrhagia. METHODS: This retrospective study included women with adenomyosis who underwent bilateral UAE between December 2014 and December 2016. The percentage of the volume of the absence of contrast enhancement on T1-weighted images was evaluated 5-7 days after UAE. A receiver operating characteristic (ROC) analysis was used to determine a cut-off point and predict the improvement of dysmenorrhoea and menorrhagia. RESULTS: Forty-eight patients were included. At 24 and 36 months after UAE, the improvement rates for dysmenorrhoea and menorrhagia were 60.4% (29/48) and 85.7% (30/35), and the recurrence rates were 19.4% (7/36) and 9.1% (3/33), respectively. Only the percentage of the volume of the absence of contrast enhancement on T1-weighted images was associated with the improvement of dysmenorrhoea (p = 0.001, OR = 1.051; 95% CI: 1.02-1.08) and menorrhagia (p = 0.006, OR = 1.077; 95% CI: 1.021-1.136). When the cut-off value of the ROC analysis was 73.1%, sensitivity, specificity, positive predictive value, and negative predictive value for the improvement of dysmenorrhoea were 58.6%, 94.7%, 94.4%, and 60%, while they were 58.9%, 80%, 100%, 100%, and 45.5% for the improvement of dysmenorrhoea. CONCLUSION: Bilateral UAE for symptomatic adenomyosis led to good improvement of dysmenorrhoea and menorrhagia. The percentage of the volume of the absence of contrast enhancement on T1-weighted images of the uterus in postoperative magnetic resonance imaging might be associated with the improvement of dysmenorrhoea and menorrhagia.

This study examined the improvement of dysmenorrhoea and menorrhagia after uterine artery embolisation in women with symptomatic adenomyosis and identified factors that could predict the improvement of dysmenorrhoea and menorrhagia. This retrospective study included women with adenomyosis who underwent uterine artery embolisation. A total of 48 patients were included. Only the percentage of the volume of the absence of contrast enhancement on T1-weighted images was associated with improvement of dysmenorrhoea and menorrhagia. Bilateral uterine artery embolisation for symptomatic adenomyosis led to good improvement. The percentage of the volume of the absence of contrast enhancement on images in postoperative T1-weighted magnetic resonance imaging of the uterus might be associated with the improvement of dysmenorrhoea and menorrhagia.

The Effect of Aviva Exercise Intervention on Pain Level and Body Awareness in Women with Primary Dysmenorrhea.

Background and Objective: Primary dysmenorrhea (PD) is one of the most common clinical disorders in women of reproductive age. Our aim was to examine whether a twice-weekly thirty-minute Aviva exercise intervention could result in improvements in pain level and body awareness in patients with PD. Materials and Methods: In our prospective observational trial, the observation period included two consecutive menstrual cycles and the period of the next menstrual bleeding. The first menstrual bleeding period was the first measurement time (T1), the second was the second measurement time (T2), and the third was the third measurement time (T3) in a total of 78 volunteers. The primary endpoint was the change in the level of menstrual pain according to the Numeric Rating Scale (NRS) questionnaire between the intervention group (IG) and the control group (CG) at T1, T2, and T3. In this study, the secondary outcomes were the differences between the IG and CG regarding the different subscales of the Hungarian version of the Body Awareness Questionnaire (BAQ-H) at T1, T2, and T3; the Borg scale results of the IG; and adherence to the intervention. Statistical tests such as independent-sample t-tests, chi-square tests, Pearson's linear correlation coefficient, and repeated-measure ANCOVA were used for the analyses. Results: In total, 78 volunteers were enrolled: 40 persons in the IG and 38 in the CG. There was a significant change in the level of menstruation pain according to the NRS questionnaire between the IG and CG (p < 0.001). There was no significant difference between the IG and CG regarding the different subscales of the BAQ-H. Only in the case of the "Note responses or changes in body process" subscale of the BAQ-H was there a trend-like effect from the Aviva exercises (p = 0.086). Conclusions: The Aviva exercise could contribute to pain relief from PD. Regarding body awareness, no significant difference was found between the two groups. Due to the short detection period and prospective observational design, our results are preliminary and need to be confirmed in larger clinical trials.

Efficacy of non-pharmacological interventions for primary dysmenorrhoea: a systematic review and Bayesian network meta-analysis.

OBJECTIVES: To assess the relative benefits of various non-pharmacological interventions on treating primary dysmenorrhoea within a network meta-analysis. STUDY DESIGN: Systematic review and Bayesian network meta-analysis. INCLUSION CRITERIA: Randomised controlled trial involving patient with primary dysmenorrhoea and received non-pharmacological interventions. DATA SOURCES: Four databases (Medline, Embase, Cochrane Library and Web of Science) were searched from inception to October first, 2022. RISK-OF-BIAS ROB ASSESSMENT: RoB 2.0 assessment tools was used to assess the risk of bias in the included studies. SYNTHESIS OF RESULTS: Conventional meta-analysis was conducted by pairwise comparison between non-pharmacological therapy and control treatment. The Bayesian network meta-analysis was conducted by the Aggregate Data Drug Information System Software based on the consistency or inconsistency model, and rank probability was used to indicate the priority of non-pharmacological therapy. RESULTS: 33 studies involving eight non-pharmacological interventions were included. With regard to conventional meta-analysis, we selected Visual Analogue Scale (VAS) as primary outcome to evaluate the pain intensity. The result showed that eight interventions (Exercise, Herb, Acupuncture, Aromatherapy, Transcutaneous Electrical Nerve Stimulation, Topical heat, Acupressure, Yoga) displayed positive effect on reduction of menstrual pain compared with placebo or no treatment. A Bayesian network meta-analysis revealed that exercise -3.20 (95% CI -4.01 to -2.34), acupuncture -2.90 (95% CI -3.97 to -2.85) and topical heat -2.97 (95% CI -4.66 to -1.29) probably resulted in a reduction in pain intensity (VAS) . CONCLUSIONS: Non-pharmacological interventions may result in a reduction or slight reduction in pain intensity compared with no treatment or placebo. Specifically, exercise and acupuncture are considered as potentially effective non-pharmacological treatments in short-term treatment. Indeed, larger and better methodological quality research is needed. TRIAL REGISTRATION NUMBER: CRD42022351021.

Comparative study of different dosages of grain-sized moxibustion on uterine artery blood flow in patients with cold and dampness primary dysmenorrhea. / ä¸åŒå‰‚é‡éº¦ç²’ç¸å¯¹å¯’æ¹¿å‡æ»žåž‹åŽŸå‘æ€§ç—›ç»æ‚£è€ å­å®«åŠ¨è„‰è¡€æµå½±å“çš„æ¯”è¾ƒç ”ç©¶.

OBJECTIVES: To observe the differences in the effects of different dosages of grain-sized moxibustion on uterine artery blood flow in patients with cold and dampness primary dysmenorrhea (PD). METHODS: A total of 60 patients with PD were randomly divided into 3 groups with 20 cases in each group. Acupoints Sanyinjiao (SP6), Diji (SP8) and Xuehai (SP10) were selected in all the 3 groups, and different dosages of grain-sized moxibustion were used (3 moxa cones, 6 moxa cones, 9 moxa cones) respectively. Treatment started 7 days before menstruation for 3 times, lasting for a total of 3 menstrual cycles. The values of uterine artery blood flow parameters including pulsatility index (PI), resistance index (RI), and systolic/diastolic ratio (S/D) were recorded before and after treatment. The visual analog scale (VAS) score and cox menstrual symptom scale (CMSS) score (including severity ［CMSS-S］ and time of duration ［CMSS-T］) were evaluated before treatment, at the end of each menstrual cycle, and one menstrual cycle after treatment. RESULTS: The values of uterine artery blood flow parameters (PI, RI, S/D) after treatment in the 9 moxa cones group were lower than those before treatment, as well as lower than those in the 3 and 6 moxa cones groups after treatment (P<0.05). The VAS scores of the 3 moxa cones group were lower than those before treatment in the first and second cycle (P<0.05). The VAS scores of the 6 and 9 moxa cones groups were lower than those before treatment at each observation point (P<0.05), and were lower than those of the 3 moxa cones group in the third cycle of treatment and follow-up period (P<0.05). And the VAS score of the 9 moxa cones group was lower than that of the 6 moxa cones group during the follow-up period (P<0.05). Compared with the scores before treatment, the CMSS-T scores at each observation point after treatment were lower in the 9 moxa cones group (P<0.05)；the CMSS-T scores in the second and third cycle after treatment, and follow-up period were lower in the 6 moxa cones group (P<0.05), with the CMSS-S scores in the second and third cycle after treatment, and follow-up period lower in the 6 and 9 moxa cones groups (P<0.05). The CMSS-T and CMSS-S scores of the 6 and 9 moxa cones groups were lower than those of the 3 moxa cones group in the third cycle and follow-up period (P<0.05). The CMSS-T and CMSS-S scores of the 9 moxa cones group were lower than those of the 6 moxa cones group during the follow-up period (P<0.05). CONCLUSIONS: Grain-Sized moxibustion has dose-effect relationship in the treatment of PD. Compared with 3 and 6 moxa cones groups, 9 moxa cones group has advantages in improving uterine artery blood flow parameters and alleviating dysmenorrhea symptoms in PD patients.

Clinical observation on 90 cases of primary dysmenorrhea treated by buccal acupuncture therapy: a randomized controlled study.

OBJECTIVE: To explore the short-term and long-term efficacy of buccal acupuncture therapy in the treatment of patients with primary dysmenorrhea (PD). METHODS: A total of 90 patients with PD who were admitted to the Second Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine from January 2020 to December 2021 were included in this study and randomly divided into three groups, including the observation group, the control group, and the placebo group, with 30 patients in each group. Patients in the observation group were treated according to the syndrome types of Traditional Chinese Medicine, those in the control group were treated with Saridon, and those in the placebo group received a placebo. The visual analog scale (VAS) scores of these patients were evaluated at different time points (before treatment, 5 min after needle retention, 30 min after needle retention, 1 h after treatment, 2 h after treatment, 1 d after treatment, and 2 d after treatment). The Cox Menstrual Symptom Scale (CMSS) scores were assessed before the treatment and after three courses of treatment. Besides, these two scales were also evaluated during follow-up. Moreover, the pain score and adverse reactions of these patients were assessed during treatment. RESULTS: After treatment, the VAS and CMSS scores in the observation group decreased significantly (P < 0.05) 5 and 30 min after needle retention and after treatment. CONCLUSION: Buccal acupuncture therapy is verified to have short-term efficacy in the treatment of PD. In addition, this therapy has an immediate analgesic effect and long-term efficacy in reducing the severity and frequency of PD.

The effects of taping in the management of primary dysmenorrhoea: A systematic review with meta-analysis.

In this systematic review and meta-analysis, we explored the efficacy of taping as a non-pharmacological intervention for pain reduction in primary dysmenorrhoea (PD), a prevalent condition causing significant quality of life impairment. We conducted a comprehensive search across databases including PubMed, PEDro, and Web of Science to identify randomized controlled trials assessing taping's effectiveness in PD for pain relief. Our criteria focused on studies comparing taping to no intervention or alternatives, with pain outcomes primarily measured using the Visual Analogue Scale (VAS). The quality assessment utilized the PEDro scale, with scores ranging from 4 to 8, indicating a spectrum of moderate to high-quality evidence. The results indicate that both kinesiotaping (SMD = -1.22; 95 % CI: -2.15, -0.29; p = 0.01) and other tapes (SMD = -1.61, 95 % CI: -2.15, -0.65; p = 0.001) significantly reduces pain intensity in women with PD. However, the certainty of evidence was very low according to GRADE criteria. This underscores the necessity for further research to understand taping's analgesic mechanisms, its long-term effects, and its influence on related symptoms and overall quality of life. Our findings advocate for the inclusion of taping in PD management, offering a promising direction for enhancing care in affected women.

Delayed diagnosis and treatment of adolescents and young women with suspected endometriosis.

STUDY OBJECTIVE: Early diagnosis and treatment of endometriosis in adolescents and young women is considered essential for improving their quality of life and for prevention of long-term complications. In adult women with endometriosis, significant delays in diagnosis and medical or surgical treatment have been described. Our study aimed to investigate the delay in diagnosis and treatment of adolescents and young women with suspected endometriosis. METHODS: A retrospective study of adolescents and young women (12-22 years-old) who were evaluated for suspected endometriosis at the endometriosis clinic in the Shamir medical center between January 2017 and December 2022. All patients were referred by their primary care gynecologists. The evaluation in the endometriosis clinic included targeted history, physical exam and a focused ultrasound survey for endometriosis (performed trans-abdominally in all cases, and trans-vaginally in sexually active women). RESULTS: Out of 400 women with suspected endometriosis evaluated in our endometriosis clinic during the study period, 68 were adolescents and young women <22 years old. Their mean age at time of evaluation for endometriosis was 18 ± 2.5 years, and the mean time-period from onset of symptoms to the endometriosis evaluation was 4.0 ± 2.9 years. Their most common symptoms were dysmenorrhea (in 61 cases, 89.7 %), followed by gastrointestinal symptoms (in 32 cases, 47.1 %). In 30 (44.1 %) cases, hormonal treatment was prescribed by the primary care gynecologist prior to their appointment in the endometriosis clinic. On comparison of patients with delay of <4 years (N = 31) versus ≥4 years (N = 37) from symptom onset to the endometriosis evaluation, patients with shorter duration of symptoms were more likely to decline any hormonal treatment for endometriosis while patients with longer duration of symptoms were more likely to accept the recommendation for hormonal treatment (16.2 % versus 0 %, p = 0.02, and 83.8 % versus 100 %, p = 0.03, respectively). CONCLUSION: Adolescents and young women with suspected endometriosis may experience significant delays in diagnosis and medical care, similar to adult patients.

Effect of aquatic exercise versus aerobic exercise on primary dysmenorrhea and quality of life in adolescent females: A randomized controlled trial.

BACKGROUND: Primary dysmenorrhea leads to significant gynecological consultations, school absenteeism, disrupted daily activities, and adversely affects overall quality of life (QOL). PURPOSE: This study compared the effects of aquatic exercise versus aerobic exercise on primary dysmenorrhea and QOL in adolescent females. SUBJECTS AND METHODS: Sixty adolescent females suffering from primary dysmenorrhea with moderate to severe intensity were distributed randomly and equally into two groups was registered at ClinicalTrials.gov (NCT06129708) the Registration Date, November 13, 2023; group A was treated by aquatic exercise for 12 weeks, while group B was treated by aerobic exercise for 12 weeks. Assessment of both groups before and after treatment involved evaluating dysmenorrhea severity using the WaLIDD Score, measuring pain intensity with the numeric pain rating scale (NPRS), determining pressure pain threshold (PPT) with an algometry, and evaluating the QOL using EuroQol-5 Dimension-3 Level (EQ-5D-3L) and EuroQol-visual analog scale (EQ-VAS). RESULTS: Both groups, A and B, experienced significant reductions in the WaLIDD score, NPRS, and all domains of EQ-5D-3L (p < 0.05), coupled with significant increases in PPT and EQ-VAS (p < 0.05). Posttreatment comparisons between the groups showed insignificant differences in WaLIDD score, NPRS, and PPT (p > 0.05). However, there was a significant decrease in EQ-5D-3L and a significant increase in EQ-VAS, favoring group A (p < 0.05). CONCLUSION: Both aquatic and aerobic exercises are effective methods in primary dysmenorrhea management and QOL improvement in adolescent females, with a better effect of aquatic exercise in enhancing QOL.

Efficacy of progressive muscle relaxation technique in primary dysmenorrhea: A randomized controlled trial.

OBJECTIVE: To examine the effects of Jacobson's Progressive Muscle Relaxation Technique (JPMRT) on menstrual pain and symptoms, anxiety, quality of life (QoL), social activity, and work/school performance in primary dysmenorrhea (PD). MATERIALS AND METHODS: Women with PD were randomly divided into two groups as relaxation and control groups. JPMRT was applied three times a week from the estimated date of ovulation to the onset of the next menstruation. No treatment was performed in the control group. Pain intensity, menstrual symptoms, anxiety, impacts on QoL, social activity, and work/school performance were assessed before and after the interventions. RESULTS: After the interventions, there was a further decrease in menstrual pain intensity, menstrual symptoms, anxiety level, the impact of QoL, and the work/school performance scores in the relaxation group than in the control group (p < 0.05). CONCLUSION: JPMRT might be used as an alternative method in the treatment of PD.

[Fu's subcutaneous needling combined with monkshood cake-separated moxibustion for primary dysmenorrhea with cold congealing and blood stasis: a randomized controlled trial].

OBJECTIVE: To observe the clinical efficacy of Fu's subcutaneous needling combined with monkshood cake-separated moxibustion for primary dysmenorrhea with cold congealing and blood stasis. METHODS: Sixty patients with primary dysmenorrhea of cold congealing and blood stasis were randomly divided into an observation group (30 cases, 1 case dropped out) and a control group (30 cases, 2 cases dropped out). The control group received monkshood cake-separated moxibustion at Shenque (CV 8) and bilateral Zigong (EX-CA 1), while the observation group received Fu's subcutaneous needling based on the control group. The muscles were palpated and the affected muscles were determined. Needles were inserted 5-10 cm away from the affected muscles and reperfusion activity was performed simultaneously. All the treatment started on the first day of menstrual cycle pain, once a day, for 3 days, totaling for 3 menstrual cycles. The visual analogue scale (VAS) score, Cox menstrual symptom scale (CMSS) score, and traditional Chinese medicine (TCM) syndrome score in the two groups were observed before treatment, after 2 treatment courses and after 3 treatment courses. The serum prostaglandin F2α(PGF2α) levels before and after 3 treatment courses were measured, and the clinical efficacy of the two groups was evaluated. RESULTS: After 2 and 3 treatment courses, the VAS scores, CMSS scores, and TCM syndrome scores in the two groups were lower than those before treatment (P<0.05), and the scores in the observation group were lower than those in the control group (P<0.05). After 3 treatment courses, the PGF2α level in the observation group was decreased (P<0.05), and were lower than that in the control group (P<0.05). The total effective rate was 96.6% (28/29) in the observation group, which was higher than 64.3% (18/28) in the control group (P<0.05). CONCLUSION: Fu's subcutaneous needling combined with monkshood cake-separated moxibustion could effectively reduce the pain intensity, improve clinical symptoms of dysmenorrhea, and lower PGF2α level in patients with primary dysmenorrhea of cold congealing and blood stasis.

Optimized treatment parameter by computer simulation for high-intensity focused ultrasound treatment of uterine adenomyosis: Short-term and long-term results.

This study aimed to investigate the efficacy and safety of using optimized parameters obtained by computer simulation for ultrasound-guided high-intensity focused ultrasound (HIFU) treatment of uterine adenomyosis in comparison with conventional parameters. We retrospectively assessed a single-institution, prospective study that was registered at Clinical Research Information Service (CRiS) of Republic of Korea (KCT0003586). Sixty-six female participants (median age: 44 years) with focal uterine adenomyosis were prospectively enrolled. All participants were treated with a HIFU system by using treatment parameters either for treating uterine fibroids (Group A, first 20 participants) or obtained via computer simulation (Group B, later 46 participants). To assess the treatment efficacy of HIFU, qualitative indices, including the clinically effective dysmenorrhea improvement index (DII), were evaluated up to 3 years after treatment, whereas quantitative indices, such as the nonperfused volume ratio and adenomyosis volume shrinkage ratio (AVSR), on MRI were evaluated up to 3 months after treatment. Quantitative/qualitative indices were compared between Groups A and B by using generalized linear mixed effect model. A safety assessment was also performed. Results showed that clinically effective DII was more frequently observed in Group B than in Group A (odds ratio, 3.69; P = 0.025), and AVSR were higher in Group B than in Group A (least-squares means, 21.61; P = 0.001). However, two participants in Group B developed skin burns at the buttock and sciatic nerve pain and required treatment. In conclusion, parameters obtained by computer simulation were more effective than the conventional parameters for treating uterine adenomyosis by using HIFU in terms of clinically effective DII and AVSR. However, care should be taken because of the risk of adverse events.