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Contraception Sep 2016This study aims to systematically review evidence published on the safety of Sino-implant (II) [SI (II)] among women with medical conditions or characteristics... (Review)
Review
OBJECTIVES
This study aims to systematically review evidence published on the safety of Sino-implant (II) [SI (II)] among women with medical conditions or characteristics identified by the World Health Organization for eligibility for contraceptive use.
STUDY DESIGN
We searched PubMed, WEIPU, CNKI and Wanfang to identify all relevant evidence published in peer-reviewed journals from 1991 through 2014 regarding the safety of SI (II). We considered studies among women with medical conditions or other characteristics, such as age and parity, as direct evidence and studies among healthy women or a general population of women as indirect evidence.
RESULTS
We identified 108 articles of which 9 met our inclusion criteria. Among women with medical conditions, no evidence was identified for the outcomes of interest, including serious adverse events or outcomes related to medical conditions. Among healthy women, evidence regarding efficacy of SI (II) for women weighing ≥70 kg was conflicting; one study showed an increased pregnancy rate and another showed no relationship. Women with menorrhagia did not experience worsened symptoms and may benefit from SI (II) use. Healthy women using SI (II) were no more likely than users of other methods to gain weight, develop elevated blood pressure, have abnormal liver or bone density tests or develop ovarian cysts or uterine myomas.
CONCLUSIONS
Evidence among healthy women suggests SI (II) is safe and had health outcomes similar to those of other levonorgestrel implants. Studies were limited and conflicting regarding efficacy for women ≥70 kg. All included studies were conducted in China, limiting generalizability.
Topics: Bone Density; China; Contraception Behavior; Contraceptive Agents, Female; Drug Implants; Female; Humans; Leiomyoma; Levonorgestrel; Ovarian Cysts; Patient Satisfaction; Randomized Controlled Trials as Topic; Weight Gain
PubMed: 27217053
DOI: 10.1016/j.contraception.2016.05.004 -
The Cochrane Database of Systematic... Jan 2016Heavy menstrual bleeding significantly impairs the quality of life of many otherwise healthy women. Perception of heavy menstrual bleeding is subjective and management... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Heavy menstrual bleeding significantly impairs the quality of life of many otherwise healthy women. Perception of heavy menstrual bleeding is subjective and management usually depends upon what symptoms are acceptable to the individual. Surgical options include conservative surgery (uterine resection or ablation) and hysterectomy. Medical treatment options include oral medication and a hormone-releasing intrauterine device (LNG-IUS).
OBJECTIVES
To compare the effectiveness, safety and acceptability of surgery versus medical therapy for heavy menstrual bleeding.
SEARCH METHODS
We searched the following databases from inception to January 2016: Cochrane Gynaecology and Fertility Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO and clinical trials registers (clinical trials.gov and ICTRP). We also searched the reference lists of retrieved articles.
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing conservative surgery or hysterectomy versus medical therapy (oral or intrauterine) for heavy menstrual bleeding.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected the studies, assessed their risk of bias and extracted the data. Our primary outcomes were menstrual bleeding, satisfaction rate and adverse events. Where appropriate we pooled the data to calculate pooled risk ratios (RRs) or mean differences, with 95% confidence intervals (CIs), using a fixed-effect model. We assessed heterogeneity with the I(2) statistic and evaluated the quality of the evidence using GRADE methods.
MAIN RESULTS
We included 15 parallel-group RCTs (1289 women). Surgical interventions included hysterectomy and endometrial resection or ablation. Medical interventions included oral medication and the levonorgestrel-releasing intrauterine device (LNG-IUS). The overall quality of the evidence for different comparisons ranged from very low to moderate. The main limitations were lack of blinding, attrition and imprecision. Moreover, it was difficult to interpret long-term study findings as many women randomised to medical interventions subsequently underwent surgery. Surgery versus oral medicationSurgery (endometrial resection) was more effective in controlling bleeding at four months (RR 2.66, 95% CI 1.94 to 3.64, one RCT, 186 women, moderate quality evidence) and also at two years (RR 1.29, 95% CI 1.06 to 1.57, one RCT, 173 women, low quality evidence). There was no evidence of a difference between the groups at five years (RR 1.14, 95% CI 0.97 to 1.34, one RCT, 140 women, very low quality evidence).Satisfaction with treatment was higher in the surgical group at two years (RR 1.40, 95% CI 1.13 to 1.74, one RCT, 173 women, moderate quality evidence), but there was no evidence of a difference between the groups at five years (RR 1.13, 95% CI 0.94 to 1.37, one RCT, 114 women, very low quality evidence). There were fewer adverse events in the surgical group at four months (RR 0.26, 95 CI 0.15 to 0.46, one RCT, 186 women). These findings require cautious interpretation, as 59% of women randomised to the oral medication group had had surgery within two years and 77% within five years. Surgery versus LNG-IUSWhen hysterectomy was compared with LNG-IUS, the hysterectomy group were more likely to have objective control of bleeding at one year (RR 1.11, 95% CI 1.05 to 1.19, one RCT, 223 women, moderate quality evidence). There was no evidence of a difference in quality of life between the groups at five or 10 years, but by 10 years 46% of women originally assigned to LNG-IUS had undergone hysterectomy. Adverse effects associated with hysterectomy included surgical complications such as bladder or bowel perforation and vesicovaginal fistula. Adverse effects associated with LNG-IUS were ongoing bleeding and hormonal symptoms.When conservative surgery was compared with LNG-IUS, at one year the surgical group were more likely to have subjective control of bleeding (RR 1.19, 95% CI 1.07 to 1.32, five RCTs, 281 women, low quality evidence, I(2) = 15%). Satisfaction rates were higher in the surgical group at one year (RR 1.16, 95% CI 1.04, to 1.28, six RCTs, 442 women, I(2) = 27%), but this finding was sensitive to the choice of statistical model and use of a random-effects model showed no conclusive evidence of a difference between the groups. There was no evidence of a difference between the groups in satisfaction rates at two years (RR 0.93, 95% CI 0.81 to 1.08, two RCTs, 117 women, I(2) = 1%).At one year there were fewer adverse events (such as bleeding and spotting) in the surgical group (RR 0.36, 95% CI 0.15 to 0.82, three RCTs, moderate quality evidence). It was unclear what proportion of women assigned to LNG-IUS underwent surgery over long-term follow-up, as there were few data beyond one year.
AUTHORS' CONCLUSIONS
Surgery, especially hysterectomy, reduces menstrual bleeding more than medical treatment at one year. There is no conclusive evidence of a difference in satisfaction rates between surgery and LNG-IUS, though adverse effects such as bleeding and spotting are more likely to occur with LNG-IUS. Oral medication suits a minority of women in the long term, and the LNG-IUS device provides a better alternative to surgery in most cases. Although hysterectomy is a definitive treatment for heavy menstrual bleeding, it can cause serious complications for a minority of women. Most women may be well advised to try a less radical treatment as first-line therapy. Both LNG-IUS and conservative surgery appear to be safe, acceptable and effective.
Topics: Adult; Antifibrinolytic Agents; Contraceptives, Oral, Hormonal; Endometrium; Female; Humans; Hysterectomy; Intrauterine Devices, Medicated; Menorrhagia; Middle Aged; Quality of Life; Randomized Controlled Trials as Topic
PubMed: 26820670
DOI: 10.1002/14651858.CD003855.pub3 -
BMJ Clinical Evidence Jun 2015Between 50% and 77% of women may have fibroids, depending on the method of diagnosis used. Fibroids may be asymptomatic, or may present with menorrhagia, pain, mass and... (Review)
Review
INTRODUCTION
Between 50% and 77% of women may have fibroids, depending on the method of diagnosis used. Fibroids may be asymptomatic, or may present with menorrhagia, pain, mass and pressure effects, infertility, or recurrent pregnancy loss. Risk factors for fibroids include obesity, having no children, and no long-term use of the oral contraceptive pill. Fibroids tend to shrink or fibrose after the menopause.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of surgical/interventional radiological treatments in women with fibroids? We searched: Medline, Embase, The Cochrane Library, and other important databases up to May 2014 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
Five studies were included. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: magnetic resonance-guided focused ultrasound surgery versus no/sham treatment; magnetic resonance-guided focused ultrasound surgery versus other interventions (hysterectomy, myomectomy, hysteroscopic resection, rollerball endometrial ablation, thermal balloon ablation, thermal myolysis with laser); uterine artery embolisation versus no/sham treatment; uterine artery embolisation versus hysterectomy; uterine artery embolisation versus myomectomy; uterine artery embolisation versus other interventions (magnetic resonance-guided focused ultrasound surgery, hysteroscopic resection, rollerball endometrial ablation, thermal balloon ablation, thermal myolysis with laser).
Topics: Female; Humans; Leiomyoma; Pregnancy; Safety; Treatment Outcome
PubMed: 26032466
DOI: No ID Found -
World Journal of Clinical Cases Dec 2014To conduct a detailed systematic review of the current evidence on the administration and efficacy of tranexamic acid in patients with menorrhagia due to uterine...
AIM
To conduct a detailed systematic review of the current evidence on the administration and efficacy of tranexamic acid in patients with menorrhagia due to uterine fibroids.
METHODS
We conducted an electronic search on the following databases PubMed and Medline (1950-2013); (1980-2013); Cochrane library (1993-2013).
RESULTS
A total of 36 articles were retrieved after the initial electronic search. Careful assessment of the retrieved studies led to the final selection of 5 articles for inclusion in the review.
CONCLUSION
Tranexamic acid may reduce blood loss perioperatively in myomectomies. It may reduce the menorrhagia in patients with fibroids, however a stratification of fibroids by size and location is required to define the responses. It is safe in general, with mild adverse effects observed in some cases. More studies with a double-blind randomized design and larger numbers of participants are necessary to reach more precise and safe conclusions.
PubMed: 25516866
DOI: 10.12998/wjcc.v2.i12.893 -
Medical Science Monitor : International... Sep 2014The aim of this study was to compare the effects of the levonorgestrel-releasing intrauterine system (LNG-IUS) with conventional medical treatment in reducing heavy... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The aim of this study was to compare the effects of the levonorgestrel-releasing intrauterine system (LNG-IUS) with conventional medical treatment in reducing heavy menstrual bleeding.
MATERIAL AND METHODS
Relevant studies were identified by a search of MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and clinical trials registries (from inception to April 2014). Randomized controlled trials comparing the LNG-IUS with conventional medical treatment (mefenamic acid, tranexamic acid, norethindrone, medroxyprogesterone acetate injection, or combined oral contraceptive pills) in patients with menorrhagia were included.
RESULTS
Eight randomized controlled trials that included 1170 women (LNG-IUS, n=562; conventional medical treatment, n=608) met inclusion criteria. The LNG-IUS was superior to conventional medical treatment in reducing menstrual blood loss (as measured by the alkaline hematin method or estimated by pictorial bleeding assessment chart scores). More women were satisfied with the LNG-IUS than with the use of conventional medical treatment (odds ratio [OR] 5.19, 95% confidence interval [CI] 2.73-9.86). Compared with conventional medical treatment, the LNG-IUS was associated with a lower rate of discontinuation (14.6% vs. 28.9%, OR 0.39, 95% CI 0.20-0.74) and fewer treatment failures (9.2% vs. 31.0%, OR 0.18, 95% CI 0.10-0.34). Furthermore, quality of life assessment favored LNG-IUS over conventional medical treatment, although use of various measurements limited our ability to pool the data for more powerful evidence. Serious adverse events were statistically comparable between treatments.
CONCLUSIONS
The LNG-IUS was the more effective first choice for management of menorrhagia compared with conventional medical treatment. Long-term, randomized trials are required to further investigate patient-based outcomes and evaluate the cost-effectiveness of the LNG-IUS and other medical treatments.
Topics: Contraceptive Agents, Female; Drug Administration Routes; Female; Humans; Levonorgestrel; Menorrhagia; Uterus
PubMed: 25245843
DOI: 10.12659/MSM.892126 -
The Cochrane Database of Systematic... Jul 2014This review has been replaced by a new full review with the same title 'Pre‐operative endometrial thinning agents before endometrial destruction for heavy menstrual... (Review)
Review
This review has been replaced by a new full review with the same title 'Pre‐operative endometrial thinning agents before endometrial destruction for heavy menstrual bleeding' published in issue 11 of The Cochrane Library 2013; authors are Yu Hwee Tan and Anne Lethaby. The editorial group responsible for this previously published document have withdrawn it from publication.
Topics: Danazol; Endometrium; Estrogen Antagonists; Female; Gonadotropin-Releasing Hormone; Goserelin; Humans; Hysteroscopy; Menorrhagia; Progestins
PubMed: 25070909
DOI: 10.1002/14651858.CD001124.pub2