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BJOG : An International Journal of... Jun 2021There are uncertainties about the benefit of routine cervical preparation and/or cervical dilatation before outpatient hysteroscopy. (Meta-Analysis)
Meta-Analysis
BACKGROUND
There are uncertainties about the benefit of routine cervical preparation and/or cervical dilatation before outpatient hysteroscopy.
OBJECTIVE
To determine if cervical preparation and/or routine mechanical dilatation reduces pain during outpatient hysteroscopy.
SEARCH STRATEGY
MEDLINE, EMBASE, CINAHL and CENTRAL were searched on 19 October 2020, using keywords 'hysteroscopy', 'cervical preparation', 'cervical ripening', 'cervical dilatation', 'outpatient', 'office' and/or 'ambulatory' and associated medical subject headings.
SELECTION CRITERIA
Randomised controlled trials investigating the benefit of cervical preparation and/or cervical dilatation on pain in women undergoing outpatient hysteroscopy were included.
DATA COLLECTION AND ANALYSIS
Two independent reviewers selected eligible trials and extracted data on pain, feasibility, adverse events and satisfaction/acceptability for meta-analysis.
MAIN RESULTS
The literature search yielded 807 records, of which 24 were included for review and 19 provided data for meta-analysis. No trials investigated the role of routine mechanical cervical dilatation. Cervical preparation significantly reduced pain during outpatient hysteroscopy; standard mean difference (SMD) -0.67, 95% confidence interval (CI) -1.05 to -0.29. Feasibility also improved as priming provided significantly easier hysteroscopic entry (SMD 0.89, 95% CI 0.32-1.46), greater cervical dilatation (SMD 0.81, 95% CI 0.08-1.53) and shorter procedural times (SMD -0.51, 95% CI -0.88 to -0.13). Cervical preparation, however, incurred significantly more adverse effects, mainly comprising genital tract bleeding, abdominal pain and gastrointestinal symptoms (odds ratio 2.94, 95% CI 1.58-5.47). There were limited data regarding satisfaction, acceptability and complications.
CONCLUSIONS
Cervical preparation reduces pain and improves feasibility associated with outpatient hysteroscopy but increases the risk of adverse effects.
TWEETABLE ABSTRACT
Cervical preparation before outpatient hysteroscopy reduces pain, enhances feasibility but increases adverse effects.
Topics: Abdominal Pain; Ambulatory Surgical Procedures; Cervix Uteri; Dilatation; Female; Humans; Hysteroscopy; Operative Time; Pain, Postoperative; Postoperative Hemorrhage; Preoperative Care
PubMed: 33219606
DOI: 10.1111/1471-0528.16604 -
American Journal of Obstetrics and... Mar 2024Several systematic reviews and meta-analyses have summarized the evidence on the efficacy and safety of various outpatient cervical ripening methods. However, the method... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Several systematic reviews and meta-analyses have summarized the evidence on the efficacy and safety of various outpatient cervical ripening methods. However, the method with the highest efficacy and safety profile has not been determined conclusively. We performed a systematic review and network meta-analysis of published randomized controlled trials to assess the efficacy and safety of cervical ripening methods currently employed in the outpatient setting.
DATA SOURCES
With the assistance of an experienced medical librarian, we performed a systematic search of the literature using MEDLINE, Embase, Scopus, Web of Science, Cochrane Library, and ClinicalTrials.gov. We systematically searched electronic databases from inception to January 14, 2020.
STUDY ELIGIBILITY CRITERIA
We considered randomized controlled trials comparing a variety of methods for outpatient cervical ripening.
METHODS
We conducted a frequentist random effects network meta-analysis employing data from randomized controlled trials. We performed a direct, pairwise meta-analysis to compare the efficacy of various outpatient cervical ripening methods, including placebo. We employed ranking strategies to determine the most efficacious method using the surface under the cumulative ranking curve; a higher surface under the cumulative ranking curve value implied a more efficacious method. We assessed the following outcomes: time from intervention to delivery, cesarean delivery rates, changes in the Bishop score, need for additional ripening methods, incidence of Apgar scores <7 at 5 minutes, and uterine hyperstimulation.
RESULTS
We included data from 42 randomized controlled trials including 6093 participants. When assessing the efficacy of all methods, 25 μg vaginal misoprostol was the most efficacious in reducing the time from intervention to delivery (surface under the cumulative ranking curve of 1.0) without increasing the odds of cesarean delivery, the need for additional ripening methods, the incidence of a low Apgar score, or uterine hyperstimulation. Acupressure (surface under the cumulative ranking curve of 0.3) and primrose oil (surface under the cumulative ranking curve of 0.2) were the least effective methods in reducing the time to delivery interval. Among effective methods, 50 mg oral mifepristone was associated with the lowest odds of cesarean delivery (surface under the cumulative ranking curve of 0.9).
CONCLUSION
When balancing efficacy and safety, vaginal misoprostol 25 μg represents the best method for outpatient cervical ripening.
Topics: Pregnancy; Female; Humans; Misoprostol; Oxytocics; Cervical Ripening; Network Meta-Analysis; Outpatients; Labor, Induced
PubMed: 38462254
DOI: 10.1016/j.ajog.2022.09.043 -
Neurology India 2019Surgery is challenging in patients with multiple or recurrent meningiomas. With the discovery of progesterone receptors (PR) on meningioma cells, there is an increased...
BACKGROUND
Surgery is challenging in patients with multiple or recurrent meningiomas. With the discovery of progesterone receptors (PR) on meningioma cells, there is an increased interest in the hormonal treatment using mifepristone, a PR blocker.
MATERIALS AND METHODS
A systematic review of clinical studies evaluating the efficacy and side effects of mifepristone in recurrent, unresectable, or multiple meningiomas was done. The primary outcome of this review was to study the efficacy in terms of tumor regression and clinical symptoms. Secondarily, we also reviewed the frequency and severity of different side effects reported by various studies.
RESULTS
A total of 7 studies, including one Phase III randomized controlled trial, were found relevant to the topic. Though a few studies showed some response in terms of clinical improvement and tumor size reduction, the response was either minimal or temporary. The only subset showing a good response was the "diffuse meningiomatosis" group. None of the studies evaluated the relation of the PR isoform with mifepristone responsiveness. However, long-term mifepristone administration was well tolerated in most of the patients.
CONCLUSIONS
Use of mifepristone as a hormonal agent for meningiomas has produced mixed results. We propose that the possible mechanisms of action of mifepristone on meningioma cells must be studied in further detail by in-vitro studies. This may help in the identification of a mifepristone responsive subset of meningioma. This must be followed up with appropriately designed clinical studies with detailed baseline evaluation and standardized clinical and radiological follow-up.
Topics: Humans; Meningeal Neoplasms; Meningioma; Mifepristone; Neoplasm Recurrence, Local; Receptors, Progesterone; Treatment Outcome
PubMed: 31347538
DOI: 10.4103/0028-3886.263232 -
Contraception Apr 2010The administration interval between mifepristone and misoprostol is usually about 36-48 h, which might affect a woman's choice of method of termination. Unwanted... (Review)
Review
BACKGROUND
The administration interval between mifepristone and misoprostol is usually about 36-48 h, which might affect a woman's choice of method of termination. Unwanted outcomes such as uterine bleeding, painful cramps and psychosocial issues which may occur during this long interval can be altered by a shorter administration interval. A shorter interval will be cost-effective as it saves both women's and clinician's time and other resources. If the waiting time interval between therapeutic interventions could be reduced without compromising efficacy, it will potentially improve compliance, patient acceptability and quality of care.
STUDY DESIGN
A systematic review of randomized controlled trials published from 1999 to 2008 was conducted to assess the evidence for a shorter mifepristone and misoprostol administration interval at first trimester medical termination. Searching strategy included MEDLINE, EMBASE, CLINAHL and Cochrane Library. The primary outcome measure was complete abortion without the need for a surgical procedure.
RESULTS
Five randomized controlled trials (RCT) compared the efficacy of mifepristone and misoprostol administration intervals between 0 and 72 h in 5139 participants. The complete abortion rates varied between 90% and 98%. Although the meta-analysis of pooled data of all RCTs shows no statistically significant difference in efficacy between the shorter and longer dosing intervals, there is a trend toward slightly lower success rates with administration intervals earlier than 8 h.
CONCLUSIONS
Overall efficacy of complete abortion is not statistically different between the longer and shorter administration intervals. This might encourage the clinician to adopt a 'flexible policy' with fully informed consent and consideration of all circumstances.
Topics: Abortifacient Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Abortion, Induced; Administration, Intravaginal; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Meta-Analysis as Topic; Mifepristone; Misoprostol; Pregnancy; Pregnancy Trimester, First; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 20227541
DOI: 10.1016/j.contraception.2009.09.007 -
American Journal of Obstetrics &... Nov 2020This study aimed to determine the optimal cervical priming regimen before surgical abortion up to and including 13 weeks' gestation. (Meta-Analysis)
Meta-Analysis Review
Cervical priming before surgical abortion up to 13 weeks' gestation: a systematic review and metaanalyses for the National Institute for Health and Care Excellence-new clinical guidelines for England.
OBJECTIVE
This study aimed to determine the optimal cervical priming regimen before surgical abortion up to and including 13 weeks' gestation.
DATA SOURCES
Embase, MEDLINE, and the Cochrane Library were searched for publications up to February 2020. Experts were consulted for any ongoing or missed trials.
STUDY ELIGIBILITY CRITERIA
This study included randomized controlled trials published in English after 2000 that compared the following: (1) mifepristone and misoprostol against each other, placebo, or no priming; (2) different doses of mifepristone or misoprostol; (3) different intervals between priming and abortion; or (4) different routes of misoprostol administration.
STUDY APPRAISAL AND SYNTHESIS METHODS
Risk of bias was assessed using the Cochrane Collaboration checklist for randomized controlled trials, and data were metaanalyzed in Review Manager 5.3. Dichotomous outcomes were analyzed as risk ratios using the Mantel-Haenszel method, and continuous outcomes were analyzed as mean differences using the inverse variance method. Fixed effects models were used when there was no substantial heterogeneity (I<50%), random effects models were used for moderate heterogeneity (I≤50% and <80%), and evidence was not pooled when there was high heterogeneity (I≥80%). Subgroup analyses were undertaken based on parity where available. The overall quality of the evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation.
RESULTS
A total of 18 randomized controlled trials (n=8538) were included and showed the following: decreased incomplete abortion rate (risk ratio=0.44; 95% confidence interval, 0.21-0.9) and force required to dilate the cervix (mean difference= -7.08 N; 95% confidence interval, -11.67 to -2.49) and increased preoperative bleeding (risk ratio=5.90; 95% confidence interval, 5.08-6.86) with misoprostol compared with no priming; decreased preoperative bleeding when sublingual misoprostol was given 1 hour before abortion compared with 3 hours before (risk ratio=0.14; 95% confidence interval, 0.03-0.56); and increased force required to dilate the cervix (mean difference=14.3 N; 95% confidence interval, 2.13-26.47) when mifepristone was given 24 hours before abortion compared with 48 hours before. The quality of the evidence base was limited by low event rates and risk of bias in included studies.
CONCLUSION
Cervical priming with misoprostol decreases the force needed to dilate the cervix for first trimester surgical abortion and reduces the risk of incomplete abortion. Considered alongside clinical expertise, this evidence supports the use of routine cervical priming before first trimester surgical abortion with 400 µg misoprostol or, if misoprostol cannot be used, 200 mg oral mifepristone.
Topics: Abortion, Induced; Cervix Uteri; England; Female; Humans; Mifepristone; Misoprostol; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 33345928
DOI: 10.1016/j.ajogmf.2020.100220 -
Human Reproduction Update May 2019First-trimester miscarriage affects up to a quarter of women worldwide. With many competing treatment options available, there is a need for a comprehensive evidence... (Meta-Analysis)
Meta-Analysis
BACKGROUND
First-trimester miscarriage affects up to a quarter of women worldwide. With many competing treatment options available, there is a need for a comprehensive evidence synthesis.
OBJECTIVES AND RATIONALE
We conducted a systematic review and network meta-analysis to assess the effectiveness and safety of treatment options for first-trimester miscarriage: expectant management (EXP), sharp dilation and curettage (D+C), electric vacuum aspiration (EVAC), manual vacuum aspiration (MVA), misoprostol alone (MISO), mifepristone+misoprostol (MIFE+MISO) and misoprostol plus electric vacuum aspiration (MISO+EVAC).
SEARCH METHODS
We searched MEDLINE, Embase, CINAHL, AMED and Cochrane Library from inception till June 2018. We included randomized trials of women with first-trimester miscarriage (<14 weeks gestation) and conducted a network meta-analysis generating both direct and mixed evidence on the effectiveness and side effects of available treatment options. The primary outcome was complete evacuation of products of conception. We assessed the risk of bias and the global network inconsistency. We compared the surface under the cumulative ranking curve (SUCRA) for each treatment.
OUTCOMES
A total of 46 trials (9250 women) were included. The quality of included studies was overall moderate with some studies demonstrating a high risk of bias. We detected unexplained inconsistency in evidence loops involving MIFE+MISO and adjusted for it. EXP had lower effectiveness compared to other treatment options. The effectiveness of medical treatments was similar compared to surgery. Mixed evidence of low confidence suggests increased effectiveness for MIFE+MISO compared to MISO alone (RR 1.49, 95% CI: 1.09-2.03). Side effects were similar among all options. Fewer women needed analgesia following EVAC compared to MISO (RR for MISO 0.43, 95% CI: 0.27-0.68) and in the EXP group compared to EVAC (RR 2.07, 95% CI: 1.25-3.41). MVA had higher ranking (low likelihood) for post-treatment infection and serious complications (SUCRA 87.6 and 79.2%, respectively) with the highest likelihood for post-treatment satisfaction (SUCRA 98%).
WIDER IMPLICATIONS
Medical treatments for first-trimester miscarriage have similar effectiveness and side effects compared to surgery. The addition of MIFE could increase the effectiveness of MISO and reduce side effects, although evidence is limited due to inconsistency. EXP has lower effectiveness compared to other treatment options.Systematic review registration: Prospero CRD42016048920.
Topics: Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Abortion, Spontaneous; Female; Gestational Age; Humans; Mifepristone; Misoprostol; Network Meta-Analysis; Pregnancy; Pregnancy Trimester, First; Vacuum Curettage
PubMed: 30753490
DOI: 10.1093/humupd/dmz002 -
The Cochrane Database of Systematic... Aug 2017Emergency contraception (EC) is using a drug or copper intrauterine device (Cu-IUD) to prevent pregnancy shortly after unprotected intercourse. Several interventions are... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Emergency contraception (EC) is using a drug or copper intrauterine device (Cu-IUD) to prevent pregnancy shortly after unprotected intercourse. Several interventions are available for EC. Information on the comparative effectiveness, safety and convenience of these methods is crucial for reproductive healthcare providers and the women they serve. This is an update of a review previously published in 2009 and 2012.
OBJECTIVES
To determine which EC method following unprotected intercourse is the most effective, safe and convenient to prevent pregnancy.
SEARCH METHODS
In February 2017 we searched CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, Popline and PubMed, The Chinese biomedical databases and UNDP/UNFPA/WHO/World Bank Special Programme on Human Reproduction (HRP) emergency contraception database. We also searched ICTRP and ClinicalTrials.gov as well as contacting content experts and pharmaceutical companies, and searching reference lists of appropriate papers.
SELECTION CRITERIA
Randomised controlled trials including women attending services for EC following a single act of unprotected intercourse were eligible.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures recommended by Cochrane. The primary review outcome was observed number of pregnancies. Side effects and changes of menses were secondary outcomes.
MAIN RESULTS
We included 115 trials with 60,479 women in this review. The quality of the evidence for the primary outcome ranged from moderate to high, and for other outcomes ranged from very low to high. The main limitations were risk of bias (associated with poor reporting of methods), imprecision and inconsistency. Comparative effectiveness of different emergency contraceptive pills (ECP)Levonorgestrel was associated with fewer pregnancies than Yuzpe (estradiol-levonorgestrel combination) (RR 0.57, 95% CI 0.39 to 0.84, 6 RCTs, n = 4750, I = 23%, high-quality evidence). This suggests that if the chance of pregnancy using Yuzpe is assumed to be 29 women per 1000, the chance of pregnancy using levonorgestrel would be between 11 and 24 women per 1000.Mifepristone (all doses) was associated with fewer pregnancies than Yuzpe (RR 0.14, 95% CI 0.05 to 0.41, 3 RCTs, n = 2144, I = 0%, high-quality evidence). This suggests that if the chance of pregnancy following Yuzpe is assumed to be 25 women per 1000 women, the chance following mifepristone would be between 1 and 10 women per 1000.Both low-dose mifepristone (less than 25 mg) and mid-dose mifepristone (25 mg to 50 mg) were probably associated with fewer pregnancies than levonorgestrel (RR 0.72, 95% CI 0.52 to 0.99, 14 RCTs, n = 8752, I = 0%, high-quality evidence; RR 0.61, 95% CI 0.45 to 0.83, 27 RCTs, n = 6052, I = 0%, moderate-quality evidence; respectively). This suggests that if the chance of pregnancy following levonorgestrel is assumed to be 20 women per 1000, the chance of pregnancy following low-dose mifepristone would be between 10 and 20 women per 1000; and that if the chance of pregnancy following levonorgestrel is assumed to be 35 women per 1000, the chance of pregnancy following mid-dose mifepristone would be between 16 and 29 women per 1000.Ulipristal acetate (UPA) was associated with fewer pregnancies than levonorgestrel (RR 0.59; 95% CI 0.35 to 0.99, 2 RCTs, n = 3448, I = 0%, high-quality evidence). Comparative effectiveness of different ECP dosesIt was unclear whether there was any difference in pregnancy rate between single-dose levonorgestrel (1.5 mg) and the standard two-dose regimen (0.75 mg 12 hours apart) (RR 0.84, 95% CI 0.53 to 1.33, 3 RCTs, n = 6653, I = 0%, moderate-quality evidence).Mid-dose mifepristone was associated with fewer pregnancies than low-dose mifepristone (RR 0.73; 95% CI 0.55 to 0.97, 25 RCTs, n = 11,914, I = 0%, high-quality evidence). Comparative effectiveness of Cu-IUD versus mifepristoneThere was no conclusive evidence of a difference in the risk of pregnancy between the Cu-IUD and mifepristone (RR 0.33, 95% CI 0.04 to 2.74, 2 RCTs, n = 395, low-quality evidence). Adverse effectsNausea and vomiting were the main adverse effects associated with emergency contraception. There is probably a lower risk of nausea (RR 0.63, 95% CI 0.53 to 0.76, 3 RCTs, n = 2186 , I = 59%, moderate-quality evidence) or vomiting (RR 0.12, 95% CI 0.07 to 0.20, 3 RCTs, n = 2186, I = 0%, high-quality evidence) associated with mifepristone than with Yuzpe. levonorgestrel is probably associated with a lower risk of nausea (RR 0.40, 95% CI 0.36 to 0.44, 6 RCTs, n = 4750, I = 82%, moderate-quality evidence), or vomiting (RR 0.29, 95% CI 0.24 to 0.35, 5 RCTs, n = 3640, I = 78%, moderate-quality evidence) than Yuzpe. Levonorgestrel users were less likely to have any side effects than Yuzpe users (RR 0.80, 95% CI 0.75 to 0.86; 1 RCT, n = 1955, high-quality evidence). UPA users were more likely than levonorgestrel users to have resumption of menstruation after the expected date (RR 1.65, 95% CI 1.42 to 1.92, 2 RCTs, n = 3593, I = 0%, high-quality evidence). Menstrual delay was more common with mifepristone than with any other intervention and appeared to be dose-related. Cu-IUD may be associated with higher risks of abdominal pain than mifepristone (18 events in 95 women using Cu-IUD versus no events in 190 women using mifepristone, low-quality evidence).
AUTHORS' CONCLUSIONS
Levonorgestrel and mid-dose mifepristone (25 mg to 50 mg) were more effective than Yuzpe regimen. Both mid-dose (25 mg to 50 mg) and low-dose mifepristone(less than 25 mg) were probably more effective than levonorgestrel (1.5 mg). Mifepristone low dose (less than 25 mg) was less effective than mid-dose mifepristone. UPA was more effective than levonorgestrel.Levonorgestrel users had fewer side effects than Yuzpe users, and appeared to be more likely to have a menstrual return before the expected date. UPA users were probably more likely to have a menstrual return after the expected date. Menstrual delay was probably the main adverse effect of mifepristone and seemed to be dose-related. Cu-IUD may be associated with higher risks of abdominal pain than ECPs.
Topics: Contraception, Postcoital; Contraceptives, Postcoital; Drug Administration Schedule; Estradiol; Female; Humans; Intrauterine Devices, Copper; Intrauterine Devices, Medicated; Levonorgestrel; Mifepristone; Norpregnadienes; Pregnancy; Pregnancy Rate; Randomized Controlled Trials as Topic; Unsafe Sex
PubMed: 28766313
DOI: 10.1002/14651858.CD001324.pub5 -
BMJ Sexual & Reproductive Health Oct 2020Medical abortion with mifepristone and misoprostol usually involves an interval of 36-48 hours between administering these drugs; however, it is possible that the... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Medical abortion with mifepristone and misoprostol usually involves an interval of 36-48 hours between administering these drugs; however, it is possible that the clinical efficacy at early gestations may be maintained when the drugs are taken simultaneously. The objective of this systematic review was to determine the safety and effectiveness of simultaneous compared with interval administration of mifepristone and misoprostol for abortion up to 10 weeks' gestation.
METHODS
We searched Embase Classic, Embase; Ovid MEDLINE(R) including Daily, and Epub Ahead-of-Print, In-Process & Other Non-Indexed Citations; and Cochrane Library on 11 December 2019. We included randomised controlled trials (RCTs), published in English from 1985, comparing simultaneous to interval administration of mifepristone and misoprostol for early abortion. Risk of bias was assessed using the Cochrane Collaboration checklist for RCTs. Meta-analysis of risk ratios (RRs) using the Mantel-Haenszel method were performed. The quality of the evidence was assessed using GRADE.
RESULTS
Meta-analyses of three RCTs (n=1280) showed no differences in 'ongoing pregnancy' (RR 1.78, 95% CI 0.38 to 8.36), 'haemorrhage requiring transfusion or ≥500 mL blood loss' (RR 0.11, 95% CI 0.01 to 2.03) and 'incomplete abortion with the need for surgical intervention' (RR 1.30, 95% CI 0.76 to 2.25) between the interventions. Individual study results showed no difference in patient satisfaction, or 'need for repeat misoprostol', although 'time to onset of bleeding or cramping' was longer after simultaneous than interval administration. The quality of evidence was very low to moderate.
CONCLUSION
The published data support the use of simultaneous mifepristone and misoprostol for medical abortion up to 9 weeks in women who prefer this method of administration.
Topics: Abortifacient Agents, Steroidal; Abortion, Induced; Female; Gestational Age; Humans; Mifepristone; Misoprostol; Pregnancy
PubMed: 32079651
DOI: 10.1136/bmjsrh-2019-200448 -
The Cochrane Database of Systematic... Aug 2012Uterine fibroids are the most common benign uterine tumours present in women of reproductive age. Mifepristone (RU-486) competitively binds and inhibits progesterone... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Uterine fibroids are the most common benign uterine tumours present in women of reproductive age. Mifepristone (RU-486) competitively binds and inhibits progesterone receptors. Studies have suggested that fibroid growth depends on the sexual steroids. Mifepristone has been shown to decrease fibroid size. This review summarises the effects of mifepristone treatment on fibroids and the associated adverse effects as described in randomised controlled trials.
OBJECTIVES
To determine the efficacy and safety of mifepristone for the management of uterine fibroids in pre-menopausal women.
SEARCH METHODS
We searched the specialised register of the Cochrane Menstrual Disorders and Subfertility (Cochrane Menstrual Disorders and subfertility Review Group), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 4), MEDLINE, EMBASE, PsycINFO, and CINAHL (to November 2011). We handsearched a number of journals, and searched reference lists, databases of ongoing trials and the Internet. There were no language restrictions.
SELECTION CRITERIA
Only truly randomised controlled trials of mifepristone versus other forms of medical therapy or placebo in pre-menopausal women with confirmed uterine fibroids were included.
DATA COLLECTION AND ANALYSIS
Four authors independently extracted data and assessed trial quality. Data were analysed using the Peto odds ratios (OR) for dichotomous data and the weighted mean differences for continuous data, with 95% confidence intervals (CI). Meta-analyses were performed using the fixed-effect model.
MAIN RESULTS
Three studies involving 112 participants were included. Comparison interventions included different dosages of mifepristone, placebo and vitamin B tablets. There is evidence that treatment with mifepristone relieves heavy menstrual bleeding compared with placebo (Peto OR 17.84; 95% CI 6.72 to 47.38; 2 RCTs, 77 women, I(2) = 0%). Three studies (Bagaria 2009; Engman 2009; Fiscella 2006) were included in the meta-analysis of this comparison. There was no evidence of an effect of mifepristone on the fibroid volume (standardised mean difference (SMD) -0.02; 95% CI -0.38 to 0.41; 99 women). Two studies (Bagaria 2009; Fiscella 2006) were included in the meta-analysis of this comparison. There was no evidence of an effect of mifepristone on uterine volume (mean difference (MD) -77.24; 95% CI -240.62 to 86.14; 72 women). The pooled data suggest an increased adverse event (abnormal endometrial histology) in the mifepristone group compared to placebo (OR 31.65; 95% CI 4.83 to 207.35; 2 RCTs; 54 women; I(2) = 0%). Only one study (Bagaria 2009) reported endometrial hyperplasia at the end of the therapy (12/19 women in the mifepristone group versus 0/16 in the placebo group; OR 55.0; 95% CI 2.86 to 105.67). Engman 2009 found a significantly higher rate of cystic glandular dilatation in women in the mifepristone group (5/8 women biopsied) compared with the placebo group (1/11 women biopsied) (OR 16.67; 95% CI 1.36 to 204.03). One study (Fiscella 2006) suggested significant improvements (P < 0.001) for specific quality of life outcomes.
AUTHORS' CONCLUSIONS
Mifepristone reduced heavy menstrual bleeding and improved fibroid-specific quality of life. However, it was not found to reduce fibroid volume. Further well-designed, adequately powered RCTs are needed before a recommendation can be made on the use of mifepristone for the treatment of uterine fibroids.
Topics: Female; Humans; Leiomyoma; Menorrhagia; Mifepristone; Premenopause; Randomized Controlled Trials as Topic; Receptors, Progesterone; Tumor Burden; Uterine Neoplasms
PubMed: 22895965
DOI: 10.1002/14651858.CD007687.pub2 -
The Cochrane Database of Systematic... Apr 2013Uterine fibroids are the most common non-malignant growths in women of childbearing age. They are associated with heavy menstrual bleeding and subfertility. Herbal... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Uterine fibroids are the most common non-malignant growths in women of childbearing age. They are associated with heavy menstrual bleeding and subfertility. Herbal preparations are commonly used as alternatives to surgical procedures.
OBJECTIVES
To evaluate the effectiveness and safety of Chinese herbal medicine for treatment of uterine fibroids.
SEARCH METHODS
The authors with the guidance of the Trials Search Coordinator searched the following electronic databases: the Trials Registers of the Cochrane Menstrual Disorders and Subfertility Group and the Cochrane Complementary Medicine Field, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 4), MEDLINE, EMBASE, the Chinese Biomedical Database, the Traditional Chinese Medical Literature Analysis and Retrieval System (TCMLARS), AMED, and LILACS. The searches were up to 11 September 2012.
SELECTION CRITERIA
Randomised controlled trials comparing herbal preparations with no intervention, placebo, medical treatment, or surgical procedures in women with uterine fibroids. We included trials of herbal preparations with or without conventional therapy.
DATA COLLECTION AND ANALYSIS
Two review authors collected data independently. We assessed trial risk of bias according to our methodological criteria. We presented dichotomous data as risk ratios (RR) and continuous outcomes as mean differences (MD), both with 95% confidence intervals (CI).
MAIN RESULTS
We included 21 randomised trials (involving 2222 women) and the majority of them had unclear or high risk of bias. There were several different herbal preparations used within the included trials. The average treatment duration was three to six months. The primary outcome of uterine fibroid related symptoms was not reported in any of the included trials. The majority of the trials reported fibroid volume and size of the uterus.Compared with mifepristone, Tripterygium wilfordii extract was associated with a greater reduction in the fibroid volume (MD -23.03 cm(3), 95% CI -28.39 to -17.67; 2 trials) and in uterine size (MD -51.25 cm(3), 95% CI -77.70 to -24.80; 2 trials). There was no evidence of a significant difference between Nona Roguy herbal product and gonadotropin-releasing hormone (GnRH) agonist on the average fibroid volume or the uterine size. The combination of Guizhi Fuling formula and mifepristone was associated with a greater reduction in the fibroid volume (-1.72 [-2.42, -1.02] 7 trials) and in uterine size (MD -31.63 [95% CI -54.58, -8.68] 3 trials)) compared with mifepristone alone. Only 13/21 trials reported on adverse events and no serious adverse effects from herbal preparations were reported.
AUTHORS' CONCLUSIONS
Current evidence does not support or refute the use of herbal preparations for treatment of uterine fibroids due to insufficient studies with large sample sizes and of high quality. Further high quality trials evaluating clinically relevant outcomes are warranted.
Topics: Drugs, Chinese Herbal; Female; Gonadotropin-Releasing Hormone; Hormone Antagonists; Humans; Leiomyoma; Mifepristone; Phytotherapy; Plant Preparations; Randomized Controlled Trials as Topic; Uterine Neoplasms
PubMed: 23633329
DOI: 10.1002/14651858.CD005292.pub3