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International Urogynecology Journal Nov 2022Chronic pelvic pain (CPP) is a common multifactorial condition affecting 6 to 27% of women aged 18-50 years worldwide. This study was conducted to review and... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION AND HYPOTHESIS
Chronic pelvic pain (CPP) is a common multifactorial condition affecting 6 to 27% of women aged 18-50 years worldwide. This study was conducted to review and meta-analyse the current literature on the reduction of chronic pelvic pain after botulinum toxin A (BTA) injection.
METHOD
In July 2021 we performed a systematic search in PubMed and EMBASE to assess the benefits of BTA injection in pelvic floor muscles in women with chronic pelvic pain. Primary outcome was reduction in visual analogue scale (VAS) after treatment. Secondary outcomes evaluated were: reduction of dyspareunia, pelvic floor resting pressure and quality of life. Identified reports were assessed on quality of reporting and risk of bias. Standardized mean difference (SMD) was used to combine and analyse outcomes of the included studies.
RESULTS
Eight studies with 289 participants were considered eligible to be included in this systematic review and meta-analysis. After recalculating SMD into VAS scores (0-100), long-term follow-up (24-26 weeks) showed a significant 15-point improvement in VAS scores (95% CI: 8.8-21.5) for non-menstrual pelvic pain and a 13-point improvement (95% CI: 2.1-24.0) for dyspareunia. BTA injection had a significant effect on pelvic floor resting pressure and quality of life.
CONCLUSION
There is limited scientific evidence on the effectiveness of BTA injections in pelvic floor muscles in women with chronic pelvic pain. The available studies show that BTA injections significantly reduce pain levels and improve quality of life at 6 months follow-up.
PROSPERO ID
CRD42018105204.
Topics: Botulinum Toxins, Type A; Chronic Pain; Dyspareunia; Female; Humans; Neuromuscular Agents; Pelvic Floor; Pelvic Pain; Quality of Life
PubMed: 35362767
DOI: 10.1007/s00192-022-05115-7 -
International Urogynecology Journal Sep 2022Myofascial pain arising from pelvic floor muscles occurs in women with vaginismus, interstitial cystitis and endometriosis but is often overlooked. The aim is to examine... (Review)
Review
INTRODUCTION AND HYPOTHESIS
Myofascial pain arising from pelvic floor muscles occurs in women with vaginismus, interstitial cystitis and endometriosis but is often overlooked. The aim is to examine alternative diagnostic tests to detect pelvic floor myofascial pain compared with standardized vaginal palpation of pelvic floor muscles as the reference test.
METHODS
A systematic review was prospectively conducted (PROSPERO-CRD42020183092) according to PRISMA guidelines. Databases searched included Ovid Medline 1946-, Embase 1957-, Scopus 1960-, Cochrane Combined, Clinical trials, Google Scholar (top 200 articles), Web of Science, TRIP, BIOSIS, DARE, CINHAL, EmCare, PEDro, ProQuest and EBSCOhost up to July 2020. Articles were independently screened by two authors and assessed for bias using QUASDAS-2 tool.
RESULTS
A total of 26,778 articles were screened and 177 were selected for full text review, of which 5 were selected for final analysis. Five studies included 9694 participants of which 1628 had pelvic floor myofascial pain. Only one study reported data to calculate sensitivities and specificities of the index test, which utilized a score of > 40 on the Central Sensitization Inventory to detect women with pelvic floor myofascial pain and revealed a sensitivity of 34.8% and a specificity of 84.9% compared to the reference test.
CONCLUSIONS
This systematic review did not reveal any diagnostic test superior to the pre-defined reference test. There is a lack of consensus on the definition of pelvic floor myofascial pain and a lack of a validated diagnostic criteria which must be addressed to progress with meaningful research in this field.
Topics: Diagnostic Tests, Routine; Endometriosis; Female; Humans; Myofascial Pain Syndromes; Pain; Pelvic Floor
PubMed: 35796787
DOI: 10.1007/s00192-022-05258-7 -
The Cochrane Database of Systematic... Jun 2023Endometriosis is a common gynaecological condition affecting 6 to 11% of reproductive-age women and may cause dyspareunia, dysmenorrhoea, and infertility. One treatment... (Review)
Review
BACKGROUND
Endometriosis is a common gynaecological condition affecting 6 to 11% of reproductive-age women and may cause dyspareunia, dysmenorrhoea, and infertility. One treatment strategy is medical therapy with gonadotrophin-releasing hormone analogues (GnRHas) to reduce pain due to endometriosis. One of the adverse effects of GnRHas is a decreased bone mineral density. In addition to assessing the effect on pain, quality of life, most troublesome symptom and patients' satisfaction, the current review also evaluated the effect on bone mineral density and risk of adverse effects in women with endometriosis who use GnRHas versus other treatment options.
OBJECTIVES
To assess the effectiveness and safety of GnRH analogues (GnRHas) in the treatment of painful symptoms associated with endometriosis and to determine the effects of GnRHas on bone mineral density of women with endometriosis.
SEARCH METHODS
We searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO and the trial registries in May 2022 together with reference checking and contact with study authors and experts in the field to identify additional studies.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) which compared GnRHas with other hormonal treatment options, including analgesics, danazol, intra-uterine progestogens, oral or injectable progestogens, gestrinone and also GnRHas compared with no treatment or placebo. Trials comparing GnRHas versus GnRHas in conjunction with add-back therapy (hormonal or non-hormonal) or calcium-regulation agents were also included in this review. DATA COLLECTION AND ANALYSIS: We used standard methodology as recommended by Cochrane. Primary outcomes are relief of overall pain and the objective measurement of bone mineral density. Secondary outcomes include adverse effects, quality of life, improvement in the most troublesome symptoms and patient satisfaction. Due to high risk of bias associated with some of the studies, primary analyses of all review outcomes were restricted to studies at low risk of selection bias. Sensitivity analysis including all studies was then performed.
MAIN RESULTS
Seventy-two studies involving 7355 patients were included. The evidence was very low to low quality: the main limitations of all studies were serious risk of bias due to poor reporting of study methods, and serious imprecision. Trials comparing GnRHas versus no treatment We did not identify any studies. Trials comparing GnRHas versus placebo There may be a decrease in overall pain, reported as pelvic pain scores (RR 2.14; 95% CI 1.41 to 3.24, 1 RCT, n = 87, low-certainty evidence), dysmenorrhoea scores (RR 2.25; 95% CI 1.59 to 3.16, 1 RCT, n = 85, low-certainty evidence), dyspareunia scores (RR 2.21; 95% CI 1.39 to 3.54, 1 RCT, n = 59, low-certainty evidence), and pelvic tenderness scores (RR 2.28; 95% CI 1.48 to 3.50, 1 RCT, n = 85, low-certainty evidence) after three months of treatment. We are uncertain of the effect for pelvic induration, based on the results found after three months of treatment (RR 1.07; 95% CI 0.64 to 1.79, 1 RCT, n = 81, low-certainty evidence). Besides, treatment with GnRHas may be associated with a greater incidence of hot flushes at three months of treatment (RR 3.08; 95% CI 1.89 to 5.01, 1 RCT, n = 100, low-certainty evidence). Trials comparing GnRHas versus danazol For overall pain, for women treated with either GnRHas or danazol, a subdivision was made between pelvic tenderness, partly resolved and completely resolved. We are uncertain about the effect on relief of overall pain, when a subdivision was made for overall pain (MD -0.30; 95% CI -1.66 to 1.06, 1 RCT, n = 41, very low-certainty evidence), pelvic pain (MD 0.20; 95% CI -0.26 to 0.66, 1 RCT, n = 41, very low-certainty evidence), dysmenorrhoea (MD 0.10; 95% CI -0.49 to 0.69, 1 RCT, n = 41, very low-certainty evidence), dyspareunia (MD -0.20; 95% CI -0.77 to 0.37, 1 RCT, n = 41, very low-certainty evidence), pelvic induration (MD -0.10; 95% CI -0.59 to 0.39, 1 RCT, n = 41, very low-certainty evidence), and pelvic tenderness (MD -0.20; 95% CI -0.78 to 0.38, 1 RCT, n = 41, very low-certainty evidence) after three months of treatment. For pelvic pain (MD 0.50; 95% CI 0.10 to 0.90, 1 RCT, n = 41, very low-certainty evidence) and pelvic induration (MD 0.70; 95% CI 0.21 to 1.19, 1 RCT, n = 41, very low-certainty evidence), the complaints may decrease slightly after treatment with GnRHas, compared to danazol, for six months of treatment. Trials comparing GnRHas versus analgesics We did not identify any studies. Trials comparing GnRHas versus intra-uterine progestogens We did not identify any low risk of bias studies. Trials comparing GnRHas versus GnRHas in conjunction with calcium-regulating agents There may be a slight decrease in bone mineral density (BMD) after 12 months treatment with GnRHas, compared to GnRHas in conjunction with calcium-regulating agents for anterior-posterior spine (MD -7.00; 95% CI -7.53 to -6.47, 1 RCT, n = 41, very low-certainty evidence) and lateral spine (MD -12.40; 95% CI -13.31 to -11.49, 1 RCT, n = 41, very low-certainty evidence). AUTHORS' CONCLUSIONS: For relief of overall pain, there may be a slight decrease in favour of treatment with GnRHas compared to placebo or oral or injectable progestogens. We are uncertain about the effect when comparing GnRHas with danazol, intra-uterine progestogens or gestrinone. For BMD, there may be a slight decrease when women are treated with GnRHas, compared to gestrinone. There was a bigger decrease of BMD in favour of GnRHas, compared to GnRHas in conjunction with calcium-regulating agents. However, there may be a slight increase in adverse effects when women are treated with GnRHas, compared to placebo or gestrinone. Due to a very low to low certainty of the evidence, a wide range of outcome measures and a wide range of outcome measurement instruments, the results should be interpreted with caution.
Topics: Female; Humans; Endometriosis; Danazol; Progestins; Gestrinone; Dysmenorrhea; Calcium; Dyspareunia; Pelvic Pain; Calcium, Dietary; Drug-Related Side Effects and Adverse Reactions; Gonadotropin-Releasing Hormone
PubMed: 37341141
DOI: 10.1002/14651858.CD014788.pub2 -
Human Reproduction Update 2014Chronic pelvic pain (CPP) is a significant public health problem with 1 million affected women in the UK. Although many pathologies are associated with CPP, the pain... (Review)
Review
BACKGROUND
Chronic pelvic pain (CPP) is a significant public health problem with 1 million affected women in the UK. Although many pathologies are associated with CPP, the pain experienced is often disproportionate to the extent of disease identified and frequently no pathology is found (chronic pelvic pain syndrome). The central nervous system (CNS) is central to the experience of pain and chronic pain conditions in general are associated with alterations in both the structure and function of the CNS. This review describes the available evidence for central changes in association with conditions presenting with CPP.
METHODS
A detailed literature search was performed to identify relevant papers, however, this is not a systematic review.
RESULTS
CPP is associated with central changes similar to those identified in other pain conditions. Specifically these include, alterations in the behavioural and central response to noxious stimulation, changes in brain structure (both increases and decreases in the volume of specific brain regions), altered activity of both the hypothalamic-pituitary-adrenal axis and the autonomic nervous system (ANS) and psychological distress.
CONCLUSIONS
The evidence reviewed in this paper demonstrates that CPP is associated with significant central changes when compared with healthy pain-free women. Moreover, the presence of these changes has the potential to both exacerbate symptoms and to predispose these women to the development of additional chronic conditions. These findings support the use of adjunctive medication targeting the CNS in these women.
Topics: Brain; Chronic Pain; Endometriosis; Female; Humans; Hypothalamo-Hypophyseal System; Pelvic Pain; Pituitary-Adrenal System; Stress, Psychological
PubMed: 24920437
DOI: 10.1093/humupd/dmu025 -
The Journal of Pain Dec 2022This study provides evidence- and consensus-based recommendations for the instruments to measure the five Pelvic Girdle Pain Core Outcome Set (PGP-COS): pain frequency,... (Review)
Review
Outcome Measurement Instruments and Evidence-based Recommendations for Measurement of the Pelvic Girdle Pain Core Outcome Set (PGP-COS): A Systematic Review and Consensus Process.
This study provides evidence- and consensus-based recommendations for the instruments to measure the five Pelvic Girdle Pain Core Outcome Set (PGP-COS): pain frequency, pain intensity/severity, function/disability/activity limitation, health-related quality of life and fear avoidance. Studies evaluating measurement properties of instruments measuring any PGP-COS outcome in women with PGP were identified through a systematic search of MEDLINE, EMBASE and PEDro databases (inception-July 2021). The methodological quality of studies and quality of measurement properties were evaluated using the COnsensus-based Standards for the selection of health status Measurement Instruments (COSMIN) checklist. Quality criteria and the synthesized evidence were graded using the modified grading of recommendations, assessment, development, and evaluation (GRADE) approach. A consensus meeting with PGP stakeholders was then held to establish recommendations, based on the evidence, for the instruments that should be used to measure the PGP-COS. Ten instruments were identified from 17 studies. No instrument showed high quality evidence for all measurement properties and/or measured all PGP-COS outcomes. Based on current evidence and consensus, the Pelvic Girdle Questionnaire (PGQ), the Short Form-8 (SF-8) and the Fear Avoidance Beliefs Questionnaire (FABQ) are recommended for measuring the PGP-COS. Future research should establish additional measurement properties of instruments and to substantiate these recommendations.
Topics: Female; Humans; Pelvic Girdle Pain; Consensus; Quality of Life; Surveys and Questionnaires; Outcome Assessment, Health Care
PubMed: 36115519
DOI: 10.1016/j.jpain.2022.08.003 -
Wiener Klinische Wochenschrift Jan 2022Biofeedback is recognized as an effective additive method for treating certain phenotypes of chronic pelvic pain syndrome and is a therapeutic option in other pelvic... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Biofeedback is recognized as an effective additive method for treating certain phenotypes of chronic pelvic pain syndrome and is a therapeutic option in other pelvic pain conditions. This review aims to evaluate evidence from the literature with a focus on the effect of biofeedback on pain reduction, overall symptom relief, physiological parameters and quality of life.
METHODS
A systematic literature search was conducted using the databases PubMed, MEDLINE, Embase, Cochrane Library and PEDro from inception to July 2020. Data were tabulated and a narrative synthesis was carried out, since data heterogeneity did not allow a meta-analysis. The PEDro scale and the McMaster Critical Review Form-Quantitative Studies were applied to assess risk of bias.
RESULTS
Out of 651 studies, 37 quantitative studies of primary research evaluating pelvic pain conditions in male and female adults and children were included. They covered biofeedback interventions on anorectal disorders, chronic prostatitis, female chronic pelvic pain conditions, urologic phenotypes in children and adults and a single study on low back pain. For anorectal disorders, several landmark studies demonstrate the efficacy of biofeedback. For other subtypes of chronic pelvic pain conditions there is tentative evidence that biofeedback-assisted training has a positive effect on pain reduction, overall symptoms relief and quality of life. Certain factors have been identified that might be relevant in improving treatment success.
CONCLUSIONS
For certain indications, biofeedback has been confirmed to be an effective treatment. For other phenotypes, promising findings should be further investigated in robust and well-designed randomized controlled trials.
Topics: Biofeedback, Psychology; Female; Humans; Male; Pelvic Floor; Pelvic Pain; Quality of Life; Treatment Outcome
PubMed: 33751183
DOI: 10.1007/s00508-021-01827-w -
Medicina (Kaunas, Lithuania) Dec 2023: To identify the most frequently reported predictive factors for the persistency of pregnancy-related pelvic girdle pain (PPGP) at 3-6 months after childbirth in women... (Meta-Analysis)
Meta-Analysis Review
: To identify the most frequently reported predictive factors for the persistency of pregnancy-related pelvic girdle pain (PPGP) at 3-6 months after childbirth in women with PPGP alone or PPGP in association with pregnancy-related lower back pain (PLBP). : Eligibility criteria: Two authors independently selected studies excluding PPGP determined by a specific, traumatic, gynecological/urological cause or isolated PLBP and studies that did not include the presence/absence of PPGP as the the primary outcome. We, instead, included studies with an initial assessment in pregnancy (within 1 month of delivery) and with a follow-up of at least 3 months after delivery. : The research was performed using the databases of Medline, Cochrane, Pedro, Scopus, Web of Science and Cinahl from December 2018 to January 2022, following the indications of the PRISMA statement 2021 and the MOOSE checklist. It includes observational cohort studies in which data were often collected through prospective questionnaires (all in English). : Two independent authors performed evaluations of the risk of bias (ROB) using the quality in prognostic studies (QUIPS) tool. : An in-depth qualitative analysis was conducted because, due to a high degree of heterogeneity in the data collection of the included studies and a lack of raw data suitable for quantitative analysis, it was not possible to carry out the originally planned meta-analyses for the subgroups. : The research process led to the inclusion of 10 articles which were evaluated using the QUIPS tool: 5 studies were evaluated as low ROB and 5 were evaluated as moderate ROB. High levels of pain in pregnancy, a large number of positive provocation tests, a history of lower back pain and lumbo-pelvic pain, high levels of disability in pregnancy, neurotic behavior and high levels of fear-avoidance belief were identified as strong predictors of long-term PPGP, while there was weak or contradictory evidence regarding predictions of emotional distress, catastrophizing and sleep disturbances. : The impossibility of carrying out the meta-analysis by subgroups suggests the need for further research with greater methodological rigor in the acquisition of measures based on an already existing PPGP core predictors/outcome sets.
Topics: Pregnancy; Humans; Female; Pelvic Girdle Pain; Low Back Pain; Prospective Studies; Pregnancy Complications; Surveys and Questionnaires
PubMed: 38138226
DOI: 10.3390/medicina59122123 -
PloS One 2012Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) has been treated with several different interventions with limited success. This meta-analysis aims to review... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) has been treated with several different interventions with limited success. This meta-analysis aims to review all trials reporting on therapeutic intervention for CP/CPPS using the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI).
METHODS
We searched Medline, PubMed, the Cochrane Pain, Palliative & Supportive Care Trials, the Cochrane Register of Controlled Trials, CINAHL, ClinicalTrials.gov, and the NIDDK website between 1947 and December 31, 2011 without language or study type restrictions. All RCTs for CP/CPPS lasting at least 6 weeks, with a minimum of 10 participants per arm, and using the NIH-CPSI score, the criterion standard for CP/CPPS, as an outcome measure were included. Data was extracted from each study by two independent reviewers. Gillbraith and I-squared plots were used for heterogeneity testing and Eggers and Peters methods for publication bias. Quality was assessed using a component approach and meta-regression was used to analyze sources of heterogeneity.
RESULTS
Mepartricin, percutaneous tibial nerve stimulation (PTNS), and triple therapy comprised of doxazosin + ibuprofen + thiocolchicoside (DIT) resulted in clinically and statistically significant reduction in NIH-CPSI total score. The same agents and aerobic exercise resulted in clinically and statistically significant NIH-CPSI pain domain score reduction. Acupuncture, DIT, and PTNS were found to produce statistically and clinically significant reductions in the NIH-CPSI voiding domain. A statistically significant placebo effect was found for all outcomes and time analysis showed that efficacy of all treatments increased over time. Alpha-blockers, antibiotics, and combinations of the two failed to show statistically or clinically significant NIH-CPSI reductions.
CONCLUSION
Results from this meta-analysis reflect our current inability to effectively manage CP/CPPS. Clinicians and researchers must consider placebo effect and treatment efficacy over time and design studies creatively so we can more fully elucidate the etiology and role of therapeutic intervention in CP/CPPS.
Topics: Anti-Bacterial Agents; Chronic Disease; Chronic Pain; Colchicine; Humans; MEDLINE; Male; Mepartricin; Pelvic Pain; Prostatitis; Randomized Controlled Trials as Topic; Transcutaneous Electric Nerve Stimulation
PubMed: 22870266
DOI: 10.1371/journal.pone.0041941 -
Medicine Mar 2016Acupuncture is a promising therapy for relieving symptoms in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), which affects >15% of adult men worldwide. The... (Review)
Review
Acupuncture is a promising therapy for relieving symptoms in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), which affects >15% of adult men worldwide. The aim of the study was to assess the effects and safety of the use of acupuncture for CP/CPPS. MEDLINE, EMBASE, CENTRAL, Web of Science, CBM, CNKI, Wang-Fang Database, JCRM, and CiNii were searched from their inception through 30 November 2015. Grey literature databases and websites were also searched. No language limits were applied. Only randomized controlled trials (RCTs) with CP/CPPS treated by acupuncture were included. Two reviewers extracted data and assessed the risk of bias of RCTs using the Cochrane Risk of Bias Tools, respectively. Seven trials were included, involving 471 participants. The result of meta-analysis indicated that compared with sham acupuncture (MD: -6.09 [95%CI: -8.12 to -5.68]) and medicine (Levofloxacinand, Ibuprofen, and Tamsulosin) (MD: -4.57 [95%CI: -7.58 to -1.56]), acupuncture was more effective at decreasing the total NIH-CPSI score. Real acupuncture was superior to sham acupuncture in improving symptoms (pain, voiding) and quality of life (Qof) domain subscores. Compared to sham acupuncture and medicine, acupuncture appears to be more effective at improving the global assessment. Two trials found that there is no significant difference between acupuncture and sham acupuncture in decreasing the IPSS score. Acupuncture failed to show more favorable effects in improving both symptoms and the Qof domain compared with medicine. Overall, current evidence supports acupuncture as an effective treatment for CP/CPPS-induced symptoms, particularly in relieving pain. Based on the meta-analysis, acupuncture is superior to sham acupuncture in improving symptoms and Qof. Acupuncture might be similar to medicine (Levofloxacinand, Ibuprofen, and Tamsulosin) in its long-term effects, but evidence was limited due to high ROB among included trials as well as potential heterogeneity. Acupuncture is associated with rare and slightly adverse events. Protocol registration PROSPERO CRD42015027522.
Topics: Acupuncture Therapy; Chronic Disease; Humans; Male; Pelvic Pain; Prostatitis
PubMed: 26986148
DOI: 10.1097/MD.0000000000003095 -
The Cochrane Database of Systematic... Dec 2021Dysmenorrhoea (period pain) is a common condition with a substantial impact on the well-being and productivity of women. Primary dysmenorrhoea is defined as recurrent,... (Review)
Review
BACKGROUND
Dysmenorrhoea (period pain) is a common condition with a substantial impact on the well-being and productivity of women. Primary dysmenorrhoea is defined as recurrent, cramping pelvic pain that occurs with periods, in the presence of a normal uterus, ovaries and fallopian tubes. It is thought to be caused by uterine contractions (cramps) associated with a high level of production of local chemicals such as prostaglandins. The muscle of the uterus (the myometrium) responds to these high levels of prostaglandins by contracting forcefully, causing low oxygen levels and consequently pain. Nifedipine is a calcium channel blocker in widespread clinical use for preterm labour due to its ability to inhibit uterine contractions in that setting. This review addresses whether this effect of nifedipine also helps with relief of the uterine contractions during menstruation OBJECTIVES: To assess the effectiveness and safety of nifedipine for primary dysmenorrhoea.
SEARCH METHODS
We searched for all published and unpublished randomised controlled trials (RCTs) of nifedipine for dysmenorrhoea, without language restriction and in consultation with the Cochrane Gynaecology and Fertility Group (CGF) Information Specialist. The following databases were searched to 25 November 2021: the Cochrane Gynaecology and Fertility Group (CGF) Specialised Register of Controlled Trials, CENTRAL, MEDLINE, Embase, PsycINFO, and CINAHL. Also searched were the international trial registers: ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal, the Web of Science, OpenGrey, LILACS database, PubMed and Google Scholar. We checked the reference lists of relevant articles.
SELECTION CRITERIA
We included RCTs comparing nifedipine with placebo for the treatment of primary dysmenorrhoea.
DATA COLLECTION AND ANALYSIS
The primary outcomes to be assessed were pain, and health-related quality of life. Secondary outcomes were adverse effects, satisfaction, and need for additional medication. The two review authors independently assessed the included trials. There were insufficient data to allow meaningful meta-analysis.
MAIN RESULTS
The evidence assessed was of very low quality overall. We examined three small RCTs, with a total of 106 participants. Data for analysis could be extracted from only two of these trials (with a total of 66 participants); two trials were published in the 1980s, and the third in 1993. Nifedipine may be effective for "any pain relief" compared to placebo in women with primary dysmenorrhoea (odds ratio (OR) 9.04, 95% confidence interval (CI) 2.61 to 31.31; 2 studies, 66 participants; very low-quality evidence). The evidence suggests that if the rate of pain relief using placebo is 40%, the rate using nifedipine would be between 64% and 95%. For the outcome of "good" or "excellent" pain relief, nifedipine may be more effective than placebo; the confidence interval was very wide (OR 43.78, 95% CI 5.34 to 259.01; 2 studies, 66 participants; very low-quality evidence). We are uncertain if the use of nifedipine was associated with less requirement for additional analgesia use than placebo (OR 0.54, 95% CI 0.07 to 4.20, 1 study, 42 participants; very low-quality evidence). Participants indicated that they would choose to use nifedipine over their previous analgesic if the option was available. There were similar levels of adverse effects and menstruation-related symptoms in the placebo and intervention groups (OR 0.94, 95% CI 0.08 to 10.90; 1 study, 24 participants; very low-quality evidence); if the chance of adverse effects with placebo is 80%, the rate using nifedipine would be between 24% and 98%. There were no results regarding formal assessment of health-related quality of life.
AUTHORS' CONCLUSIONS
The evidence is insufficient to confirm whether nifedipine is a possible medical treatment for primary dysmenorrhoea. The trials included in this review had very low numbers and were of low quality. Notably, there was a large imbalance in numbers randomised between placebo and treatment groups in one of the two trials with data available for analysis. While there was no evidence of a difference noted in adverse effects between groups, more data from larger participant numbers are needed for this outcome. Larger, more well-conducted trials are required to elucidate the potential role of nifedipine in the treatment of this common condition, as it could be a useful addition to the therapeutic options available if shown to be well tolerated and effective. The safety of nifedipine in women of reproductive age is well established from trials of its use in preterm labour, and clinicians are accustomed to off-label use for this indication. The drug is inexpensive and readily available. Other options for relief of primary dysmenorrhoea are not suitable for all women; NSAIDs and the oral contraceptive pill (OCP) are contraindicated for some women, and the OCP is not suitable for women who are trying to conceive. In addition, the trials examined suggest there may be a participant preference for nifedipine.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Dysmenorrhea; Female; Humans; Infant, Newborn; Menstruation; Nifedipine; Pelvic Pain; Pregnancy
PubMed: 34921554
DOI: 10.1002/14651858.CD012912.pub2