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.

Menstrual disturbances and its association with sleep disturbances: a systematic review.

BACKGROUND: Menstrual disturbances harm women's health, and general well-being. As growing evidence highlights the relationship between sleep and menstrual disturbances, it is imperative to comprehensively examine the association between sleep and menstrual disturbance considering the multiple dimensions of sleep. This systematic review aims to identify the association between sleep and menstrual disturbances by evaluating using Buysse's sleep health framework. METHODS: A comprehensive search of the literature was conducted in PubMed, EMBASE, psychINFO, and CINAHL to identify publications describing any types of menstrual disturbances, and their associations with sleep published between January 1, 1988 to June 2, 2022. Quality assessment was conducted using the Joanna Briggs Institute Critical Appraisal Checklist for Analytical Cross-Sectional Studies. The findings were iteratively evaluated menstrual disturbances and their association with sleep using Buysse's sleep health framework. This framework understands sleep as multidimensional concept and provides a holistic framing of sleep including Satisfaction, Alertness during waking hours, Timing of sleep, Efficiency, and Sleep duration. Menstrual disturbances were grouped into three categories: premenstrual syndrome, dysmenorrhea, and abnormal menstrual cycle/heavy bleeding during periods. RESULTS: Thirty-five studies were reviewed to examine the association between sleep and menstrual disturbances. Premenstrual syndrome and dysmenorrhea were associated with sleep disturbances in sleep health domains of Satisfaction (e.g., poor sleep quality), Alertness during waking hours (e.g., daytime sleepiness), Efficiency (e.g., difficulty initiating/maintaining sleep), and Duration (e.g., short sleep duration). Abnormal menstrual cycle and heavy bleeding during the period were related to Satisfaction, Efficiency, and Duration. There were no studies which investigated the timing of sleep. CONCLUSIONS/IMPLICATIONS: Sleep disturbances within most dimensions of the sleep health framework negatively impact on menstrual disturbances. Future research should longitudinally examine the effects of sleep disturbances in all dimensions of sleep health with the additional objective sleep measure on menstrual disturbances. This review gives insight in that it can be recommended to provide interventions for improving sleep disturbances in women with menstrual disturbance.

Adjuvant use of melatonin for pain management in endometriosis-associated pelvic pain-A randomized double-blinded, placebo-controlled trial.

Considering the pharmacological treatment options for endometriosis-associated pain are confined to hormonal therapy and analgesics, we studied the analgesic effect of 20 mg melatonin as an adjuvant therapy in women with endometriosis-associated pain. This randomized double-blinded, placebo-controlled trial was conducted at the Research Center for Womens' Health at Södersjukhuset, a university hospital in Stockholm, Sweden. Forty women from 18 to 50 years of age with endometriosis and severe dysmenorrhea with or without chronic pelvic pain were given 20 mg Melatonin or placebo orally daily for two consecutive menstrual cycles or months. The level of pain was recorded daily on the 11-point numeric rating scale, a difference of 1.3 units was considered clinically significant. Clincaltrials.gov nr NCT03782740. Sixteen participants completed the study in the placebo group and 18 in the melatonin group. The difference in endometriosis-associated pain between the groups showed to be non-significant statistically as well as clinically, 2.9 (SD 1.9) in the melatonin group and 3.3 (SD 2.0) in the placebo group, p = 0.45. This randomized, double-blinded, placebo-controlled trial could not show that 20 mg of melatonin given orally at bedtime had better analgesic effect on endometriosis-associated pain compared with placebo. No adverse effects were observed.

Advances in the medical treatment of adolescent endometriosis.

Endometriosis is defined as the presence of endometrial glands and stroma outside the uterus. Adolescent endometriosis is often confined to the pelvic cavity and is a common cause of secondary dysmenorrhea in adolescents. Adolescent endometriosis is often with delayed diagnosis. Early diagnosis and intervention can prevent the damage of pelvic structure and ovarian tissue and reduce the incidence of adhesion and infertility. Adolescent endometriosis can be diagnosed and treated by laparoscopic biopsy. There are many kinds of drugs to treat endometriosis, such as NSAIDs, progesterone, selective progesterone receptor antagonists, GnRH-a, gonadotropin-releasing hormone antagonists, aromatase inhibitors, dopamine agonists, angiogenesis inhibitors, vegetable drugs, traditional Chinese medicine prescriptions. Future treatment options, including Future treatment options include CTZ, vitamin D3, oxytocin receptor inhibitors, melatonin, doxycycline, bevacizumab, curcumin, isotretinoin, and rosiglitazone, etc., can inhibit ectopic lesions. This article mainly summarizes advances in medical treatment underlying adolescent endometriosis and provides guidance for the early clinical diagnosis and intervention of adolescent endometriosis, to improve the quality of life of patients and reduce adverse outcomes.

Chinese herbal formula Xuefu Zhuyu for primary dysmenorrhea patients (CheruPDYS): a study protocol for a randomized placebo-controlled trial.

BACKGROUND: Epidemiological studies have shown that young women often suffer from primary dysmenorrhea (PD) which is a common cause that affects their routine work and quality of life. Chinese herbal medicine has been widely used for PD in China. A systematic review found that Xuefu Zhuyu (XFZY) has a promising effect on PD management, yet there is a dearth of high-quality evidence in support of this claim. We want to conduct a randomized controlled trial to evaluate the efficacy and safety of XFZY for PD patients. METHODS: This is a protocol for a multicenter, randomized, placebo-controlled trial. A total of 248 participants with PD will be recruited at 6 centers and randomized into two groups-a herbal treatment group and a placebo group. The participants will receive either XFZY or placebo, three times per day, for 3 menstrual cycles, with a 12-week follow-up. The primary outcome will be the mean change in pain intensity as measured by VAS, while the change in menstrual pain duration, the change in peak pain intensity as measured by VAS, the Cox Menstrual Symptom Scale (CMSS), quality of life EQ-5D-5L, cumulative painkiller consumption, and health economics will be included as secondary outcomes. Adverse events will also be reported. DISCUSSION: This protocol describes a multicenter, double-blind, randomized, placebo-controlled trial that investigates the efficacy and safety of XFZY for primary dysmenorrhea. Validated evaluation tools will assess dysmenorrhea severity. We believe that this research will provide important evidence regarding the use of XFZY to treat dysmenorrhea. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1900026819 . Registered on 23 October 2019.

Primary Dysmenorrhea: Assessment and Treatment.

Primary dysmenorrhea is defined as menstrual pain in the absence of pelvic disease. It is characterized by overproduction of prostaglandins by the endometrium, causing uterine hypercontractility that results in uterine muscle ischemia, hypoxia, and, subsequently, pain. It is the most common gynecological illness in women in their reproductive years and one of the most frequent causes of pelvic pain; however, it is underdiagnosed, undertreated, and even undervalued by women themselves, who accept it as part of the menstrual cycle. It has major implications for quality of life, such as limitation of daily activities and psychological stress, being one of the main causes of school and work absenteeism. Its diagnosis is essentially clinical, based on the clinical history and normal physical examination. It is important to exclude secondary causes of dysmenorrhea. The treatment may have different approaches (pharmacological, non-pharmacological and surgical), but the first line of treatment is the use of nonsteroidal anti-inflammatory drugs (NSAIDs), and, in cases of women who want contraception, the use of hormonal contraceptives. Alternative treatments, such as topical heat, lifestyle modification, transcutaneous electrical nerve stimulation, dietary supplements, acupuncture, and acupressure, may be an option in cases of conventional treatments' contraindication. Surgical treatment is only indicated in rare cases of women with severe dysmenorrhea refractory to treatment.

Dismenorreia primária é definida como dor menstrual na ausência de patologia pélvica. Caracteriza-se pelo excesso de produção de prostaglandinas pelo endométrio que provocam hipercontractilidade uterina, resultando em isquemia e hipoxia do músculo uterino e, subsequentemente, dor. É a patologia ginecológica mais comum em mulheres em idade fértil e uma das causas mais frequentes de dor pélvica; contudo, é subdiagnosticada, subtratada, e até desvalorizada pelas próprias mulheres, que a aceitam como parte do ciclo menstrual. A dismenorreia tem grandes implicações na qualidade de vida, como limitação das atividades diárias e estresse psicológico, sendo uma das principais causas de absentismo escolar e laboral. O seu diagnóstico é essencialmente clínico, baseando-se na história clínica e num exame físico sem alterações. É importante excluir causas secundárias de dismenorreia. O tratamento pode ter diferentes abordagens (farmacológica, não farmacológica e cirúrgica), sendo que a primeira linha de tratamento consiste na utilização de anti-inflamatórios não esteroides (AINEs) e, em casos de mulheres que desejem contracepção, no uso de anticoncepcionais hormonais. Tratamentos alternativos, como a utilização de calor tópico, modificação do estilo de vida, estimulação elétrica nervosa transcutânea, suplementos alimentares, acupuntura e acupressão, podem ser uma opção nos casos de contraindicação da utilização dos tratamentos convencionais. O tratamento cirúrgico apenas se encontra indicado em casos raros de mulheres com dismenorreia grave e refratária aos tratamentos.

Viscero-visceral hyperalgesia in dysmenorrhoea plus previous urinary calculosis: Role of myofascial trigger points and their injection treatment in the referred area.

BACKGROUND: Women with dysmenorrhoea plus symptomatic urinary calculosis experience enhanced pain and referred muscle hyperalgesia from both conditions than women with one condition only (viscero-visceral hyperalgesia). The study aimed at verifying if enhanced dysmenorrhoea persists after urinary stone elimination in comorbid women and if local anaesthetic inactivation of myofascial trigger points (TrPs) in the lumbar area (of urinary pain referral) also relieves dysmenorrhoea. METHODS: Thirty-one women with dysmenorrhoea plus previous urinary calculosis (Dys+PrCal) and lumbar TrPs, and 33 women with dysmenorrhoea without calculosis (Dys) underwent a 1-year assessment of menstrual pain and muscle hyperalgesia in the uterus-referred area (electrical pain threshold measurement in rectus abdominis, compared with thresholds of 33 healthy controls). At the end of the year, 16 comorbid patients underwent inactivation of TrPs through anaesthetic injections, whereas the remaining 12 received no TrP treatment. Both groups were monitored for another year at the end of which thresholds were re-measured. RESULTS: In year1, Dys+PrCal presented significantly more painful menstrual cycles and lower abdominal thresholds than Dys, thresholds of both groups being significantly lower than normal (p < .001). Anaesthetic treatment versus no treatment of the lumbar TrP significantly reduced the number of painful cycles during year2 and significantly increased the abdominal thresholds (p < .0001). CONCLUSION: Viscero-visceral hyperalgesia between uterus and urinary tract may persist after stone elimination due to nociceptive inputs from TrPs in the referred urinary area, since TrPs treatment effectively reverses the enhanced menstrual symptoms. The procedure could represent an integral part of the management protocol in these conditions. SIGNIFICANCE: A past pain process from an internal organ can continue enhancing pain expression from a painful disease in another neuromerically connected organ (viscero-visceral hyperalgesia) if secondary myofascial trigger points (TrPs) developed in the referred area at the time of the previous visceral disease. Inactivation of these TrPs reverts the enhancement. Assessment and treatment of TrPs in referred areas from past visceral pain conditions should be systematically carried out to better control pain from current diseases in other viscera.

Primary dysmenorrhea: assessment and treatment / Dismenorreia primária: avaliação e tratamento

Abstract Primary dysmenorrhea is defined asmenstrual pain in the absence of pelvic disease. It is characterized by overproduction of prostaglandins by the endometrium, causing uterine hypercontractility that results in uterine muscle ischemia, hypoxia, and, subsequently, pain. It is the most common gynecological illness in women in their reproductive years and one of the most frequent causes of pelvic pain; however, it is underdiagnosed, undertreated, and even undervalued by women themselves, who accept it as part of themenstrual cycle. It hasmajor implications for quality of life, such as limitation of daily activities and psychological stress, being one of themain causes of school and work absenteeism. Its diagnosis is essentially clinical, based on the clinical history and normal physical examination. It is important to exclude secondary causes of dysmenorrhea. The treatment may have different approaches (pharmacological, nonpharmacological and surgical), but the first line of treatment is the use of nonsteroidal anti-inflammatory drugs (NSAIDs), and, in cases of women who want contraception, the use of hormonal contraceptives. Alternative treatments, such as topical heat, lifestyle modification, transcutaneous electrical nerve stimulation, dietary supplements, acupuncture, and acupressure, may be an option in cases of conventional treatments' contraindication. Surgical treatment is only indicated in rare cases of women with severe dysmenorrhea refractory to treatment.

Resumo Dismenorreia primária é definida como dormenstrual na ausência de patologia pélvica. Caracteriza-se pelo excesso de produção de prostaglandinas pelo endométrio que provocam hipercontractilidade uterina, resultando em isquemia e hipoxia do músculo uterino e, subsequentemente, dor. É a patologia ginecológica mais comum em mulheres em idade fértil e uma das causas mais frequentes de dor pélvica; contudo, é subdiagnosticada, subtratada, e até desvalorizada pelas próprias mulheres, que a aceitam como parte do ciclo menstrual. A dismenorreia tem grandes implicações na qualidade de vida, como limitação das atividades diárias e estresse psicológico, sendo uma das principais causas de absentismo escolar e laboral. O seu diagnóstico é essencialmente clínico, baseando-se na história clínica e num exame físico sem alterações. É importante excluir causas secundárias de dismenorreia. O tratamento pode ter diferentes abordagens (farmacológica, não farmacológica e cirúrgica), sendo que a primeira linha de tratamento consiste na utilização de anti-inflamatórios não esteroides (AINEs) e, em casos de mulheres que desejem contracepção, no uso de anticoncepcionais hormonais. Tratamentos alternativos, como a utilização de calor tópico, modificação do estilo de vida, estimulação elétrica nervosa transcutânea, suplementos alimentares, acupuntura e acupressão, podem ser uma opção nos casos de contraindicação da utilização dos tratamentos convencionais. O tratamento cirúrgico apenas se encontra indicado em casos raros de mulheres com dismenorreia grave e refratária aos tratamentos.

Effect of alpha-lipoic acid at the combination with mefenamic acid in girls with primary dysmenorrhea: randomized, double-blind, placebo-controlled clinical trial.

Primary dysmenorrhea is a common gynecologic disorder and is one of the main causes for referral to the gynecology clinic. This study aimed to determine the effects of alpha-lipoic acid (ALA) and mefenamic acid and a combination compared with placebo on the girls with primary dysmenorrhea. This double-blind, placebo-controlled clinical trial done on population consisted of female students living in dormitories of Qazvin University of Medical Sciences who had moderate to severe dysmenorrhea using the Visual Analog Scale (VAS) questionnaire. Participants were randomly divided into four groups (n = 100): ALA, mefenamic acid, ALA + mefenamic acid and placebo groups. ALA and mefenamic acid were administrated in 600 mg and 250 mg, respectively. The severity of the pain was measured in the beginning and the end of the study. Statistical analysis was performed using SPSS software (SPSS Inc., Chicago, IL). Our final results suggested that, although mefenamic acid significantly decreased the menstrual pain, ALA supplementation, 600 mg, would be more efficient than mefenamic acid in 250 mg. Also, the combination of ALA and mefenamic acid significantly has been far. Considering the ALA supplementation effect on pain relief in patients with primary dysmenorrhea, this antioxidant can be recommended for the healing of symptoms of these patients.

Yoga and Quality of Life in Women with Primary Dysmenorrhea: A Systematic Review.

INTRODUCTION: Primary dysmenorrhea is a prevalent condition causing quality of life (QOL) reduction for many women, resulting from pain as well as parallel social and psychological distress. Yoga reduces pain and sympathetic reactivity, thus promoting QOL. This article reports a systematic review of the evidence for the effectiveness of yoga as a QOL improvement method for women with primary dysmenorrhea. METHODS: The PRISMA guidelines were used in preparation of this review. Ovid MEDLINE, PsycINFO, CINAHL, Scopus, PubMed, ScienceDirect, Cochrane Database of Systematic Reviews (CDSR), and Cochrane Central Register of Controlled Trials (CENTRAL) were screened through January 2017 using the keywords yoga, meditation, menstrual cycle, dysmenorrhea, pelvic pain, and prostaglandins. English-language randomized controlled trials (RCTs) and quasi-experimental studies regarding yoga, primary dysmenorrhea, and QOL were eligible; all yoga styles were included. Two independent reviewers rated the methodological quality of each study selected for review using the Downs and Black checklist; possible scores ranged from 0 to 32. Ratings were established through consensus. RESULTS: The search yielded a total of 378 articles, of which 14 (age range 13-45 years, N = 1409) met the criteria for final review: 8 RCTs and 6 quasi-experimental studies. Downs and Black ratings were predominantly moderate in quality with moderate risk of bias, ranging from 15 to 23 (RCTs) and 10 to 17 (quasi-experimental studies). Statistically significant improvements along most QOL domains, including physical pain, sleep, concentration, negative feelings, social relationships, work capacity, and overall QOL, were identified after a yoga intervention. Results indicate preliminary evidence for yoga as a safe and effective QOL improvement method for women with primary dysmenorrhea. DISCUSSION: Practitioners may consider yoga for management of primary dysmenorrhea. However, future research using larger RCTs of high methodological quality is needed to ascertain the magnitude of yoga's clinical significance.

Comparison of the effect of honey and mefenamic acid on the severity of pain in women with primary dysmenorrhea.

BACKGROUND AND OBJECTIVE: Primary dysmenorrhea starts simultaneously with menstruation or before it and usually continues for 48-72 h. As a prevalence disorder, it affects about 80-97% of women in the reproductive age. The conventional treatment modalities of primary dysmenorrhea are associated with complications and side effects. In addition, there is a lack of knowledge of the effect of honey on the treatment of primary dysmenorrhea. The objective of this study is to investigate the effect of honey on the severity of pain in women with dysmenorrhea. METHODS: A randomized crossover clinical trial was conducted on 56 female students. Subjects were randomly assigned to two groups. Groups I and II received honey and mefenamic acid in the 'first treatment period', respectively. In the 'second treatment period', the intervention methods were reversed between the groups. Samples recorded the severity of pain during the first 3 days of menstruation. RESULTS: There were no significant differences in the most severe level of pain in the first and second months of the first treatment period, and the first and second months of the second treatment period between the groups. CONCLUSIONS: Honey and the mefenamic acid capsules led to the same amount of pain relief in women with primary dysmenorrhea. Honey is suggested to be used for pain relief due to its lower side effects and pharmacological complications.

Moxibustion for pain relief in patients with primary dysmenorrhea: A randomized controlled trial.

BACKGROUND: Though moxibustion is frequently used to treat primary dysmenorrhea in China, relevant evidence supporting its effectiveness is still scanty. METHODS: This study was a pragmatic randomized, conventional drug controlled, open-labeled clinical trial. After initial screen, 152 eligible participants were averagely randomized to receive two different treatment strategies: Moxibustion and conventional drugs. Participants and practitioners were not blinded in this study. The duration of each treatment was 3 months. The primary outcome was pain relief measured by the Visual Analogue Scale. The menstrual pain severity was recorded in a menstrual pain diary. RESULTS: 152 eligible patients were included but only 133 of them eventually completed the whole treatment course. The results showed that the menstrual pain intensity in experimental group and control group was reduced from 6.38±1.28 and 6.41±1.29, respectively, at baseline, to 2.54±1.41 and 2.47±1.29 after treatment. The pain reduction was not significantly different between these two groups (P = 0.76), however; the pain intensity was significantly reduced relative to baseline for each group (P<0.01). Three months after treatment, the effectiveness of moxibustion sustained and started to be superior to the drug's effect (-0.87, 95%CI -1.32 to -0.42, P<0.01). Secondary outcome analyses showed that moxibustion was as effective as drugs in alleviating menstrual pain-related symptoms. The serum levels of pain mediators, such as PGF2α, OT, vWF, ß-EP, PGE2, were significantly improved after treatment in both groups (P<0.05). No adverse events were reported in this trial. CONCLUSIONS: Both moxibustion and conventional drug showed desirable merits in managing menstrual pain, given their treatment effects and economic costs. This study as a pragmatic trial only demonstrates the effectiveness, not the efficacy, of moxibustion for menstrual pain. It can't rule out the effect of psychological factors during treatment process, because no blind procedure or sham control was used due to availability. In clinical practice, moxibustion should be used at the discretion of patients and their physicians. TRIAL REGISTRATION: ClinialTrials.gov NCT01972906.

Polyunsaturated Fatty Acids and Chronic Pain: A Systematic Review and Meta-analysis.

BACKGROUND: Chronic pain is one of the most frequent disease symptoms and represents a global health problem with a considerable economic burden. The role of polyunsaturated fatty acids (PUFA) in chronic pain conditions was debated during the last decade with conflicting results. OBJECTIVE: To assess whether polyunsaturated fatty acids intake is useful as a preventive or curative tool in chronic pain. STUDY DESIGN: Systematic review and meta-analysis. SETTING: This study examined all published studies, either preventive or curative, on PUFA supplementation and chronic pain. METHODS: We retrieved studies published in any language by searching systematically Medline, Embase, Conference Proceedings Citation Index, dissertations databases, and the 5 regional bibliographic databases of the World Health Organization until May 2015. We included both observational and intervention studies reporting effect measures and their confidence intervals of polyunsaturated fatty acids intake in the regular diet or supplementation and pain. Two investigators selected studies; extracted data independently on baseline characteristics, exposure, and outcomes; and rated the quality of interventional studies using Jadad score. We calculated pooled standardized mean differences (SMDs) of pain indexes such as the Visual Analogue Score. We further carried out subgroup analyses by disease, type of PUFA, outcome scale, quality index, dose, and time of supplementation. RESULTS: We retrieved 5 observational and 46 intervention studies. Only one observational study showed a protective effect of PUFA. On the contrary, the interventional studies yielded a pooled random effects SMD of -0.40 (95% CI -0.58, -0.22), which indicates improvement, as 0 is the value that indicates absence of effect. The largest effect was found for dysmenorrhea (SMD -0.82, 95% CI -1.21, -0.43), Ω-3 supplementation (-0.47, 95% CI -0.68, -0.26) and composite scores (-0.58, 95% CI -1.07, -0.09). Mitigation of pain was stronger for low doses (-0.55, 95% CI -0.79, -0.30) and short supplementation periods (-0.56, 95% CI -0.86, -0.25). LIMITATIONS: While the number of curative studies was large, that of preventive studies available was limited. CONCLUSION: Our results suggest that Ω-3 PUFA supplementation moderately improves chronic pain, mainly that due to dysmenorrhea. Further investigation on the preventive potential of PUFA supplementation is needed, as the amount of evidence is scarce. Key words: Meta-analysis, systematic review, chronic pain, PUFA, supplementation, Ω-3, dysmenorrhea.

The New Portable Transcutaneous Electrical Nerve Stimulation Device Was Efficacious in the Control of Primary Dysmenorrhea Cramp Pain.

INTRODUCTION: Transcutaneous electrical nerve stimulation (TENS) is an established method for pain relief in dysmenorrhea. A feasible advantage would be the study of a portable device. The purpose of the study was to evaluate the effectiveness and safety of a new portable TENS device (TANYX®) for menstruation cramps. MATERIALS AND METHODS: Forty women were evaluated in a double-blind, prospective, randomized fashion, divided into sham and active groups. TENS was applied medially at the suprapubic region, for 30-min duration at eight-hour intervals, up to seven days. The placebo group (PG) received sham device. The TENS group (TG) applied an active 85 Hz frequency TENS. Efficacy measures were pain relief evaluated on a visual analog scale (VAS) and diclofenac intake, and quality of life represented by: 1) capacity to get out of the bed, 2) food or drink intake, 3) missing routine daily activities such as work or school, and 4) quality of sleep. RESULTS: The active TENS device induced a prompt onset of pain relief in a strictly segmental manner nearby the dermatomes where the TENS was applied at the skin, and there was a drop in mean pain score from 8 to 2 cm (p < 0.001). Diclofenac consumption was also significantly reduced (p < 0.01), compared with the PG. Quality of life improved significantly in TG when compared with PG (p < 0.05). Three months after the beginning of the study, 14/20 of the women were still using the active device regularly. No adverse effects were observed. CONCLUSIONS: The portable, disposable, active TENS device induced a prompt onset of pain relief and improved the quality of life, without adverse effects, in patients with painful cramps associated with dysmenorrhea.

Effects of acupressure on menstrual distress and low back pain in dysmenorrheic young adult women: an experimental study.

The purpose of this study was to examine the effects of acupressure on menstrual distress and low back pain (LBP) in dysmenorrheic young adult women. In all, 129 female students, who had been experiencing dysmenorrhea with LBP during menstruation and who scored more than 4 points on the visual analog scale for pain, were randomly assigned to an experimental group and a control group. The experimental group (n = 65) received acupressure massage three times a week for 30 minutes on the sanyinjiao (SP6), ciliao (BL32), and taichong (Liver 3) acupoints. The control group (n = 64) received only a manual of menstrual health education without acupressure intervention. Data were collected at five time points: at baseline, 30 minutes, and 4, 8, and 12 months after the intervention. During the 12-month follow-up, the experimental group had significantly lower menstrual distress and LBP scores than the control group. Among 65 participants in the experimental group, 53 (82%) reported a moderate to high levels of menstrual distress, 51 (78%) reported moderate to high levels of LBP relief, and 49 (75%) reported moderate to high levels of satisfaction with acupressure. Our findings may serve as a reference for health care professionals and young women to improve self-care during menstruation and help further understand the therapeutic effects of acupressure on menstrual distress and LBP.

Effect of rhubarb (Rheum emodi) in primary dysmenorrhoea: a single-blind randomized controlled trial.

BACKGROUND: The aim of this study was to investigate and evaluate the efficacy of Rheum emodi in the management of primary dysmenorrhoea. METHODS: A randomized, single-blind, standard controlled trial compared efficacy of R. emodi against mefenamic acid on diagnosed subjects of primary dysmenorrhoea for three consecutive cycles. Experimental group (n=30) received capsules of R. emodi powder two times a day, two days before the expected date of menstruation, and continued first three days of menstruation, while control group (n=15) participants received mefenamic acid capsules three times a day on the same protocol. The primary outcome measures were reduced in severity and duration of pain, assessed by visual analogue scale (VAS) and verbal multidimensional scoring system (VMSS), and secondary outcome measures were overall improvement of dysmenorrhoea and improved in quality of life (QOL). Statistical analysis was done by repeated measures analysis of variance and Chi-square/Fisher Exact test. RESULTS: The menstrual pain was significantly decreased in both groups after three-cycle intervention. Significant changes were observed in VAS (p<0.001) and VMSS (p<0.001) in the experimental group. There is a significant (p<0.001) reduction in duration of pain in both the groups. Associated symptoms and QOL were markedly improved after treatment (p<0.001). CONCLUSIONS: It has been clear from the above result that R. emodi is an effective herb in alleviating symptoms of primary dysmenorrhoea. It can serve as an alternative treatment without any apparent side effects. These results deserve further investigations.

Changes in pain perception after pelvis manipulation in women with primary dysmenorrhea: a randomized controlled trial.

OBJECTIVE: This study aims to evaluate the immediate effect of a global pelvic manipulation (GPM) technique, bilaterally applied, on low back pelvic pain in women with primary dysmenorrhea (PD). DESIGN: A prospective, randomized, double-blind, controlled trial. SETTING: Faculty of Nursing, Physiotherapy and Podiatry. University of Sevilla, Spain. METHODS: The sample group included 40 women (30 ± 6.10 years) that were divided into an experimental group (EG) (N = 20) who underwent a bilateral GPM technique and a control group (CG) (N = 20) who underwent a sham (placebo) intervention. Evaluations were made of self-reported low back pelvic pain (visual analog scale), pressure pain threshold (PPT) in sacroiliac joints (SIJs), and the endogenous response of the organism to pain following catecholamines and serotonin release in blood levels. RESULTS: The intragroup comparison showed a significant improvement in the EG in the self-perceived low back pelvic pain (P = 0.003) and in the mechanosensitivity in both SIJs (P = 0.001). In the between-group comparison, there was a decrease in pain perception (P = 0.004; F(1,38) = 9.62; R(2) = 0.20) and an increase in the PPT of both SIJs, in the right side (P = 0.001; F(1,38) = 21.29; R(2) = 0.35) and in the left side (P = 0.001; F(1,38) = 20.63; R(2) = 0.35). There were no intergroup differences for catecholamines plasma levels (adrenaline P = 0.123; noradrenaline P = 0.281; dopamine P = 0.173), but there were for serotonin levels (P = 0.045; F(1,38) = 4.296; R(2) = 0.10). CONCLUSION: The bilateral GPM technique improves in a short term the self-perceived low back pelvic pain, the PPT in both SIJs, and the serotonin levels in women with PD. It shows no significant differences with a sham intervention in catecholamines plasma levels.

Endometriosis rectosigmoidea infiltrante profunda. Claves para su diagnóstico / Deep infiltrating rectosigmoid endometriosis. Diagnostic keys

No disponible

Evaluación del dolor lumbo-pélvico tras la aplicación de la manipulación global de la pelvis en pacientes con dismenorrea primaria: estudio piloto / Assessment of low back and pelvic pain after applying the pelvis global manipulation technique in patients with primary dysmenorrhea: a pilot study

Introducción: La dismenorrea primaria (DP) es un desorden ginecológico común en mujeres en edad reproductiva. Se define como el conjunto de síntomas que preceden a la menstruación, siendo el más característico de ellos el dolor en la zona baja del abdomen seguido del dolor lumbo-pélvico. Objetivos: Valorar el efecto de la manipulación global de la pelvis (MGP) sobre el dolor lumbar en pacientes con DP a través de: (i) el dolor lumbo-pélvico percibido; (ii) el umbral del dolor a la presión (UDP) en las articulaciones sacroilíacas (ASIS); (iii) la respuesta endógena del cuerpo frente al dolor con la liberación de catecolaminas y serotonina. Material y Métodos: Estudio experimental, controlado, aleatorizado, doble ciego. Han participado 20 pacientes con DP, 10 formaron parte del Grupo Experimental (GE) y 10 del Grupo Control (GC). Se midió el dolor lumbo-pélvico con una escala visual analógica (EVA), el UDP con un dinamómetro digital y los niveles de catecolaminas/serotonina con una analítica sanguínea. Resultados: El GE obtuvo una mejoría significativa en el UDP de ambas ASIS (p=0.001), no así en el dolor lumbo-pélvico percibido (p=0.129). Asimismo, aumentaron los niveles de serotonina y dopamina en el GE aunque no de manera significativa (p=0.447) y (p=0.255) respectivamente, mientras que disminuyó la concentración en plasma de adrenalina (p=0.819) y noradrenalina (p=0.218). Conclusiones: La MGP mejora el UDP en ambas ASIS en pacientes con DP, no así el dolor lumbo-pélvico medido con EVA. La MGP también aumenta los niveles de serotonina, aunque no de manera significativa, mientras que no produce ningún cambio en los niveles plasmáticos de catecolaminas (AU)

Introduction: Primary Dysmenorrhea (PD) is a common gynaecological disorder in women of childbearing age. The most common premenstrual symptom is pain in the lower abdomen, followed by low back and pelvic pain. Objectives: We aim to assess the effect of global pelvic manipulation (GPM) on low back pain in subjects with PD through the evaluation of the: (i) self-perceived low back-pelvic pain; (ii) pressure pain threshold (PPT) in right and left sacroiliac joints (SIJ), and (iii) endogenous response of the organism to pain following catecholamines and serotonin release. Material and Methods: A randomized, double-blind, controlled clinical trial was performed to evaluated the efficacy of the GPM in the treatment of women with PD. Twenty patients (n=20) with PD were screened, ten (n=10) belonged to the control group (CG) and ten (n=10) to the experimental group (EG). The low back-pelvic pain was measured using Visual Analogue Scale (VAS) scores, the PPT was determined with a digital algometer, and a blood test was performed to determine catecholamines (adrenaline, noradrenalin, and dopamine) and serotonin levels. Results: A significant improvement of the PPT of both SIJ (p = 0.001) was observed in the EG, although there were no differences in the self-perceived low back-pelvic pain (p = 0.129). There was a nonstatistically significant increase in serotonin (p=0.447) and dopamine (p = 0.255) levels, as well as a nonsignificantly decrease in plasma levels of adrenaline (p = 0.819) and noradrenalin (p=0.218) in the EG. Conclusions: The bilateral GPM technique improves the PPT in both SIJ in patients with PD, but it does not affect the self-perceived low back-pelvic pain. The GPM also increases serotonin levels, but not significantly, although no changes are detected in the catecholamines plasma levels(AU)