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Archives of Gynecology and Obstetrics Jul 2015Recurrence of endometriosis after conservative surgery has been observed in 40-50 % of patients within the first 5 years. A variety of regimens such as combined oral... (Comparative Study)
Comparative Study Review
PURPOSE
Recurrence of endometriosis after conservative surgery has been observed in 40-50 % of patients within the first 5 years. A variety of regimens such as combined oral contraceptives, GnRH agonists, danazol, and progestins have been used postoperatively to reduce recurrence rates. Oral contraceptives (oCP) have been used either in a cyclic or in a continuous (no pill-free interval) fashion. The purpose of this article was to summarize the existing evidence on the efficacy and patient compliance for the use of oCP in a continuous versus cyclic fashion following conservative surgery for endometriosis.
METHODS
A systematic search of Medline identified four eligible studies. Studies were considered eligible, if they have evaluated oCP therapy, either in a cyclic or continuous regimen, after conservative surgery for endometriosis. Specifically, studies (1) reporting on women with endometriosis who were treated postoperatively with both continuous oCP and cyclic oCP, (2) written in English, (3) with minimum 6 months duration of medical treatment, and (4) with minimum 12 months duration of follow-up were considered eligible for our systematic review. Outcome measures of these eligible studies were tabulated and then analyzed cumulatively. A purely descriptive approach was adopted concerning all variables.
RESULTS
Postoperative use of continuous oCP was associated with a reduction in the recurrence rate of dysmenorrhea, delay in the presentation of dysmenorrhea, reduction in nonspecific pelvic pain, and reduction in the recurrence rate for endometrioma.
CONCLUSIONS
Use of oCP in a continuous fashion following conservative surgery for endometriosis is more beneficial to cyclic use.
Topics: Contraceptives, Oral; Contraceptives, Oral, Combined; Dysmenorrhea; Endometriosis; Female; Humans; Pelvic Pain; Postoperative Period; Recurrence
PubMed: 25644508
DOI: 10.1007/s00404-015-3641-1 -
The Indian Journal of Surgery Jun 2014Breast pain or mastalgia is the common symptom in the breast. The two most common concerns of patients presenting with mastalgia are: the fear that breast pain is a...
Breast pain or mastalgia is the common symptom in the breast. The two most common concerns of patients presenting with mastalgia are: the fear that breast pain is a symptom of breast cancer and the presence of severe pain that affects a woman's quality of life. Breast pain requires thorough assessment and should be investigated in the same manner as any other breast symptom. We conducted a systematic review of treatment for breast pain. We searched various reviews, randomized controlled trial, and observational studies over Pubmed and Medline via internet. Searches were carried out on MEDLINE (1950-present), EMBASE (1980-present), and CINAHL (1981-present) using the NHS Evidence Healthcare Databases Advanced Search interface. A further search was also carried out on Cochrane Database of Systematic Reviews (issue 12 of 12, Dec 2011) and Central Register of Controlled Trials (issue 4 of 4, Oct 2011). If no abnormality is found in the breast on assessment, then a combination of reassurance, breast support brassiere, and topical NSAID gel massage are usually effective. Antiestrogen (centchroman/tamoxifen) therapy for 3 to 6 months is the second-line treatment of choice. Danazol may be used in resistant cases. Gamma-linolenic acid or evening primrose oil though commonly prescribed is not effective.
PubMed: 25177120
DOI: 10.1007/s12262-013-0813-8 -
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 -
The Cochrane Database of Systematic... Mar 2014This overview reports on interventions for pain relief and for subfertility in pre-menopausal women with clinically diagnosed endometriosis. (Review)
Review
BACKGROUND
This overview reports on interventions for pain relief and for subfertility in pre-menopausal women with clinically diagnosed endometriosis.
OBJECTIVES
The objective of this overview was to summarise the evidence from Cochrane systematic reviews on treatment options for women with pain or subfertility associated with endometriosis.
METHODS
Published Cochrane systematic reviews reporting pain or fertility outcomes in women with clinically diagnosed endometriosis were eligible for inclusion in the overview. We also identified Cochrane reviews in preparation (protocols and titles) for future inclusion. The reviews, protocols and titles were identified by searching the Cochrane Database of Systematic Reviews and Archie (the Cochrane information management system) in March 2014.Pain-related outcomes of the overview were pain relief, clinical improvement or resolution and pain recurrence. Fertility-related outcomes were live birth, clinical pregnancy, ongoing pregnancy, miscarriage and adverse events.Selection of systematic reviews, data extraction and quality assessment were undertaken in duplicate. Review quality was assessed using the AMSTAR tool. The quality of the evidence for each outcome was assessed using GRADE methods. Review findings were summarised in the text and the data for each outcome were reported in 'Additional tables'.
MAIN RESULTS
Seventeen systematic reviews published in The Cochrane Library were included. All the reviews were high quality. The quality of the evidence for specific comparisons ranged from very low to moderate. Limitations in the evidence included risk of bias in the primary studies, inconsistency between the studies, and imprecision in effect estimates. Pain relief (14 reviews) Gonadotrophin-releasing hormone (GnRH) analogues One systematic review reported low quality evidence of an overall benefit for GnRH analogues compared with placebo or no treatment. Ovulation suppression Five systematic reviews reported on medical treatment using ovulation suppression. There was moderate quality evidence that the levonorgestrel-releasing intrauterine system (LNG-IUD) was more effective than expectant management, and very low quality evidence that danazol was more effective than placebo. There was no consistent evidence of a difference in effectiveness between oral contraceptives and goserelin, estrogen plus progestogen and placebo, or progestogens and placebo, though in all cases the relevant evidence was of low or very low quality. Non-steroidal anti-inflammatory drugs (NSAIDS)A review of NSAIDs reported inconclusive evidence of a benefit in symptom relief compared with placebo. Surgical interventions There were two reviews of surgical interventions. One reported moderate quality evidence of a benefit in pain relief following laparoscopic surgery compared to diagnostic laparoscopy only. The other reported very low quality evidence that recurrence rates of endometriomata were lower after excisional surgery than after ablative surgery. Post-surgical medical interventions Two reviews reported on post-surgical medical interventions. Neither found evidence of an effect on pain outcomes, though in both cases the evidence was of low or very low quality. Alternative medicine There were two systematic reviews of alternative medicine. One reported evidence of a benefit from auricular acupuncture compared to Chinese herbal medicine, and the other reported no evidence of a difference between Chinese herbal medicine and danazol. In both cases the evidence was of low or very low quality. Anti-TNF-α drugs One review found no evidence of a difference in effectiveness between anti-TNF-α drugs and placebo. However, the evidence was of low quality. Reviews reporting fertility outcomes (8 reviews) Medical interventions Four reviews reported on medical interventions for improving fertility in women with endometriosis. One compared three months of GnRH agonists with a control in women undergoing assisted reproduction and found very low quality evidence of an increase in clinical pregnancies in the treatment group. There was no evidence of a difference in effectiveness between the interventions in the other three reviews, which compared GnRH agonists versus antagonists, ovulation suppression versus placebo or no treatment, and pre-surgical medical therapy versus surgery alone. In all cases the evidence was of low or very low quality. Surgical interventions Three reviews reported on surgical interventions. There was moderate quality evidence that both live births or ongoing pregnancy rates and clinical pregnancy rates were higher after laparoscopic surgery than after diagnostic laparoscopy alone. There was low quality evidence of no difference in effectiveness between surgery and expectant management for endometrioma. One review found low quality evidence that excisional surgery resulted in higher clinical pregnancy rates than drainage or ablation of endometriomata. Post-surgical interventions Two reviews reported on post-surgical medical interventions. They found no evidence of an effect on clinical pregnancy rates. The evidence was of low or very low quality. Alternative medicine A review of Chinese herbal medicine in comparison with gestrinone found no evidence of a difference between the groups in clinical pregnancy rates. However, the evidence was of low quality. Adverse events Reviews of GnRH analogues and of danazol reported that the interventions were associated with higher rates of adverse effects than placebo; and depot progestagens were associated with higher rates of adverse events than other treatments. Chinese herbal medicine was associated with fewer side effects than gestrinone or danazol.Three reviews reported miscarriage as an outcome. No difference was found between surgical and diagnostic laparoscopy, between GnRH agonists and antagonists, or between aspiration of endometrioma and expectant management. However, in all cases the quality of the evidence was of low quality.
AUTHORS' CONCLUSIONS
For women with pain and endometriosis, suppression of menstrual cycles with gonadotrophin-releasing hormone (GnRH) analogues, the levonorgestrel-releasing intrauterine system (LNG-IUD) and danazol were beneficial interventions. Laparoscopic treatment of endometriosis and excision of endometriomata were also associated with improvements in pain. The evidence on NSAIDs was inconclusive. There was no evidence of benefit with post-surgical medical treatment.In women with endometriosis undergoing assisted reproduction, three months of treatment with GnRH agonist improved pregnancy rates. Excisional surgery improved spontaneous pregnancy rates in the nine to 12 months after surgery compared to ablative surgery. Laparoscopic surgery improved live birth and pregnancy rates compared to diagnostic laparoscopy alone. There was no evidence that medical treatment improved clinical pregnancy rates.Evidence on harms was scanty, but GnRH analogues, danazol and depot progestagens were associated with higher rates than other interventions.
Topics: Acupuncture, Ear; Anti-Inflammatory Agents, Non-Steroidal; Drugs, Chinese Herbal; Endometriosis; Female; Gonadotropin-Releasing Hormone; Humans; Infertility, Female; NM23 Nucleoside Diphosphate Kinases; Ovulation Inhibition; Pelvic Pain; Review Literature as Topic
PubMed: 24610050
DOI: 10.1002/14651858.CD009590.pub2 -
The Cochrane Database of Systematic... Nov 2013Heavy menstrual bleeding is one of the most common reasons for referral of premenopausal women to a gynaecologist. Although medical therapy is generally first line, many... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Heavy menstrual bleeding is one of the most common reasons for referral of premenopausal women to a gynaecologist. Although medical therapy is generally first line, many women eventually will require further treatment. Endometrial ablation by hysteroscopic and more recent "second-generation" devices such as balloon, radiofrequency or microwave ablation offers a day-case surgical alternative to hysterectomy. Complete endometrial destruction is one of the main determinants of treatment success. Surgery is most effective if undertaken when endometrial thickness is less than four millimeters. One option is to perform the surgery in the immediate postmenstrual phase, which is not always practical. The other option is to use hormonal agents that induce endometrial thinning pre-operatively. The most commonly evaluated agents are goserelin (a gonadotrophin-releasing hormone analogue, or GnRHa) and danazol. Other GnRH analogues and progestogens have also been studied, although fewer data are available. It has been suggested that these agents will reduce operating time, improve the intrauterine operating environment and reduce absorption of fluid used for intraoperative uterine cavity distension. They may also improve long-term outcomes, including menstrual loss and dysmenorrhoea.
OBJECTIVES
To investigate the effectiveness and safety of pre-operative endometrial thinning agents (GnRH agonists, danazol, estrogen-progestins and progestogens) versus another agent or placebo when given before endometrial destruction in premenopausal women with heavy menstrual bleeding.
SEARCH METHODS
The following electronic databases were searched to April 2013 for published and unpublished randomised controlled trials that met the inclusion criteria: the Menstrual Disorders and Subfertility Group (MDSG) Specialised Register of controlled trials, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL and PsycINFO.Other electronic sources of trials included trial registers for ongoing and registered trials; citation indexes; conference abstracts in the Web of Knowledge; the LILACS database for trials from the Portuguese- and Spanish-speaking world; PubMed; and the OpenSIGLE database and Google for grey literature.All searches were performed in consultation with the MDSG Trials Search Co-ordinator.
SELECTION CRITERIA
Randomised controlled trials (RCTs) were included if they compared the effects of these agents with one other, or with placebo or no treatment, on relevant intraoperative and postoperative treatment outcomes. Selection of trials was carried out independently by two review authors.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed studies for risk of bias and extracted data on surgical outcomes, effectiveness outcomes, proportion of women requiring further surgical therapy during follow-up, endometrial outcome measures, acceptability of use outcomes and quality of life. Data were analysed on an intention-to-treat basis. Dichotomous data were combined for meta-analysis with RevMan software using the Mantel-Haenszel method to estimate pooled risk ratios (RRs). Continuous data were combined for meta-analysis with RevMan software using an inverse variance method to estimate the pooled mean difference (MD) with 95% confidence interval (CI). The overall quality of evidence for the main findings was assessed with the use of GRADE working group methods.
MAIN RESULTS
Twenty studies with 1969 women were included in this review. These studies compared GnRHa, danazol and progestogens versus placebo or no treatment; GnRHa versus danazol, progestogens, GnRH antagonists or dilatation & curettage; and danazol versus progestogens. Four studies performed more than one comparison.When compared with no treatment, GnRHa used before hysteroscopic resection were associated with a higher rate of postoperative amenorrhoea at 12 months (RR 1.6, 95% CI 1.2 to 2.0, 7 RCTs, 605 women, moderate heterogeneity; I(2) = 40%) and at 24 months (RR 1.62, 95% CI 1.04 to 2.52, 2 RCTs, 357 women, no heterogeneity; I(2) = 0%), a slightly shorter duration of surgery (-3.5 minutes, 95% CI -4.7 to -2.3, 5 RCTs, 156 women, substantial heterogeneity; I(2) = 72%) and greater ease of surgery (RR 0.32, 95% CI 0.22 to 0.46, 2 RCTs, 415 women, low heterogeneity; I(2) = 4%). Postoperative dysmenorrhoea was reduced (RR 0.59, 95% CI 0.40 to 0.87, 2 RCTs, 133 women, no heterogeneity; I(2) = 0%). The use of GnRHa had no effect on intraoperative complication rates (RR 1.47, 95% CI 0.35 to 6.06, 5 RCTs, 592 women, no heterogeneity; I(2) = 0%), and participant satisfaction with this surgery was high irrespective of the use of pre-operative endometrial thinning agents (RR 0.99, 95% CI 0.93 to 1.05, 6 RCTs, 599 women, low heterogeneity; I(2) = 11%). GnRHa produced more consistent endometrial atrophy than was produced by danazol (RR 1.84, 95% CI 1.23 to 2.75, 2 RCTs, 142 women, no heterogeneity; I(2) = 0%). For other intraoperative and postoperative outcomes, any differences were minimal, and no benefits of GnRHa pretreatment were noted in studies in which women underwent second-generation ablation techniques. Both GnRHa and danazol produced side effects in a significant proportion of women, although few studies reported these in detail. Few randomised data were available to allow assessment of the effectiveness of progestogens as endometrial thinning agents. When reported, the long-term effects of endometrial thinning agents on benefits such as postoperative amenorrhoea were reduced with time.The main study weaknesses were that most participants received no follow-up beyond 24 months and that the studies used a small sample size. Heterogeneity for outcomes reported ranged from none to substantial. More than half the trials had no blinding of participants or outcome assessment. Most of the trials were determined to have uncertain selection and reporting bias, as they did not report allocation concealment and evidence of selective reporting was noted. The quality of reporting of adverse events was generally poor, but, when described in the studies, they included menopausal symptoms such as hot flushes, vaginal dryness, hirsutism, decreased libido and voice changes, as well as other side effects such as headache and weight gain.
AUTHORS' CONCLUSIONS
Low-quality evidence suggests that endometrial thinning with GnRHa and danazol before hysteroscopic surgery improves operating conditions and short-term postoperative outcomes. GnRHa produced slightly more consistent endometrial thinning than was produced by danazol, although both achieved satisfactory results. The effect of these agents on longer-term postoperative outcomes was reduced with time. No benefits of GnRHa pretreatment were apparent with second-generation ablation techniques. Also, side effects were more common when these agents were used.
Topics: Danazol; Dilatation and Curettage; Dysmenorrhea; Endometrium; Female; Gonadotropin-Releasing Hormone; Humans; Menorrhagia; Preoperative Care; Progestins; Randomized Controlled Trials as Topic
PubMed: 24234875
DOI: 10.1002/14651858.CD010241.pub2 -
European Journal of Medical Research Jun 2013A variety of pharmacological and surgical treatments have been developed for heavy menstrual bleeding (HMB), which can have negative physical, social, psychological, and... (Meta-Analysis)
Meta-Analysis
BACKGROUND
A variety of pharmacological and surgical treatments have been developed for heavy menstrual bleeding (HMB), which can have negative physical, social, psychological, and economic consequences. We conducted a systematic literature review and mixed-treatment-comparison (MTC) meta-analysis of available data from randomized controlled trials (RCTs) to derive estimates of efficacy for 8 classes of treatments for HMB, to inform health-economic analysis and future studies.
METHODS
A systematic review identified RCTs that reported data on menstrual blood loss (MBL) at baseline and one or more follow-up times. Eight treatment classes were considered: COCs, danazol, endometrial ablation, LNG-IUS, placebo, progestogens given for less than 2 weeks out of 4 during the menstrual cycle, progestogens given for close to 3 weeks out of 4, and TXA. The primary measure of efficacy was the proportion of women who achieved MBL < 80 mL per cycle (month), as measured by the alkaline hematin method. A score less than 100 on an established pictorial blood-loss assessment chart (PBAC) was considered an acceptable substitute for MBL < 80 mL. Estimates of efficacy by treatment class and time were obtained from a Bayesian MTC model. The model also included effects for treatment class, study, and the combination of treatment class and study and an adjustment for baseline mean MBL. Several methodological challenges complicated the analysis. Some trials reported various summary statistics for MBL or PBAC, requiring estimation (with less precision) of % MBL < 80 mL or % PBAC < 100. Also, reported follow-up times varied substantially.
RESULTS
The evidence network involved 34 RCTs, with follow-up times from 1 to 36 months. Efficacy at 3 months of follow-up (estimated as the posterior median) ranged from 87.5% for the levonorgestrel-releasing intrauterine system (LNG-IUS) to 14.2% for progestogens administered for less than 2 weeks out of 4 in the menstrual cycle. The 95% credible intervals for most estimates were quite wide, mainly because of the limited evidence for many combinations of treatment class and follow-up time and the uncertainty from estimating % MBL < 80 mL or % PBAC < 100 from summary statistics.
CONCLUSIONS
LNG-IUS and endometrial ablation are very efficacious in treating HMB. The study yielded useful insights on using MTC in sparse evidence networks. Diversity of outcome measures and follow-up times in the HMB literature presented considerable challenges. The Bayesian credible intervals reflected the various sources of uncertainty.
Topics: Bayes Theorem; Danazol; Endometrial Ablation Techniques; Female; Humans; Intrauterine Devices, Medicated; Levonorgestrel; Menorrhagia; Menstruation; Progestins; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 23786677
DOI: 10.1186/2047-783X-18-17 -
Obstetrics and Gynecology Mar 2013To compare the effectiveness of nonsurgical abnormal uterine bleeding treatments for bleeding control, quality of life (QOL), pain, sexual health, patient satisfaction,... (Comparative Study)
Comparative Study Review
OBJECTIVE
To compare the effectiveness of nonsurgical abnormal uterine bleeding treatments for bleeding control, quality of life (QOL), pain, sexual health, patient satisfaction, additional treatments needed, and adverse events.
DATA SOURCES
MEDLINE, Cochrane databases, and Clinicaltrials.gov were searched from inception to May 2012. We included randomized controlled trials of nonsurgical treatments for abnormal uterine bleeding presumed secondary to endometrial dysfunction and abnormal uterine bleeding presumed secondary to ovulatory dysfunction. Interventions included the levonorgestrel intrauterine system, combined oral contraceptive pills (OCPs), progestins, nonsteroidal anti-inflammatory drugs (NSAIDs), and antifibrinolytics. Gonadotropin-releasing hormone agonists, danazol, and placebo were allowed as comparators.
METHODS OF STUDY SELECTION
Two reviewers independently screened 5,848 citations and extracted eligible trials. Studies were assessed for quality and strength of evidence.
TABULATION, INTEGRATION, AND RESULTS
Twenty-six articles met inclusion criteria. For reduction of menstrual bleeding in women with abnormal uterine bleeding presumed secondary to endometrial dysfunction, the levonorgestrel intrauterine system (71-95% reduction), combined OCPs (35-69% reduction), extended cycle oral progestins (87% reduction), tranexamic acid (26-54% reduction), and NSAIDs (10-52% reduction) were all effective treatments. The levonorgestrel intrauterine system, combined OCPs, and antifibrinolytics were all superior to luteal-phase progestins (20% increase in bleeding to 67% reduction). The levonorgestrel intrauterine system was superior to combined OCPs and NSAIDs. Antifibrinolytics were superior to NSAIDs for menstrual bleeding reduction. Data were limited on other important outcomes such as QOL for women with abnormal uterine bleeding presumed secondary to endometrial dysfunction and for all outcomes for women with abnormal uterine bleeding presumed secondary to ovulatory dysfunction.
CONCLUSION
For the reduction in mean blood loss in women with heavy menstrual bleeding presumed secondary to abnormal uterine bleeding presumed secondary to endometrial dysfunction, we recommend the use of the levonorgestrel intrauterine system over OCPs, luteal-phase progestins, and NSAIDs. For other outcomes (QOL, pain, sexual health, patient satisfaction, additional treatments needed, and adverse events) and for treatment of abnormal uterine bleeding presumed secondary to ovulatory dysfunction, we were unable to make recommendations based on the limited available data.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Antifibrinolytic Agents; Contraceptives, Oral, Combined; Dysmenorrhea; Female; Humans; Intrauterine Devices, Medicated; Menorrhagia; Patient Satisfaction; Quality of Life; Randomized Controlled Trials as Topic; Reproductive Health; Tranexamic Acid
PubMed: 23635628
DOI: 10.1097/AOG.0b013e3182839e0e -
The Cochrane Database of Systematic... Jan 2013Heavy menstrual bleeding (HMB) is an important cause of ill health in premenopausal women. Although surgery is often used as a treatment, a range of medical therapies... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Heavy menstrual bleeding (HMB) is an important cause of ill health in premenopausal women. Although surgery is often used as a treatment, a range of medical therapies are also available. Non-steroidal anti-inflammatory drugs (NSAIDs) reduce prostaglandin levels, which are elevated in women with excessive menstrual bleeding and also may have a beneficial effect on dysmenorrhoea.
OBJECTIVES
The primary objective of this review was to investigate the effectiveness of NSAIDs in achieving a reduction in menstrual blood loss in women of reproductive years with HMB.
SEARCH METHODS
We searched the Cochrane Menstrual Disorders & Subfertility Group trials register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and CINAHL in July 2012 and reference lists of articles. We also contacted manufacturers and researchers in the field.
SELECTION CRITERIA
The inclusion criteria were randomised comparisons of individual NSAIDs or combined with other medical therapy with either each other, placebo or other medical treatments in women with regular heavy periods measured either objectively or subjectively and with no pathological or iatrogenic (treatment-induced) causes for their heavy menstrual blood loss.
DATA COLLECTION AND ANALYSIS
Eighteen RCTs were identified that fulfilled the inclusion criteria for this review and data were extracted independently. Odds ratios for dichotomous outcomes and weighted mean differences for continuous outcomes were estimated from the data of nine trials. The results of the remaining seven cross-over trials with data unsuitable for pooling, one trial with skewed data and one trial with missing variances were described in data tables.
MAIN RESULTS
As a group, NSAIDs were more effective than placebo at reducing HMB but less effective than either tranexamic acid, danazol or the levonorgestrel-releasing intrauterine system (LNG IUS). Treatment with danazol caused a shorter duration of menstruation and more adverse events than NSAIDs but this did not appear to affect the acceptability of treatment. There were no statistically significant differences between NSAIDs and the other treatments (oral luteal progestogen, ethamsylate, an older progesterone-releasing intrauterine system (Progestasert), oral contraceptive pill (OCC)) but most studies were underpowered. There was no evidence of a difference between the individual NSAIDs (naproxen and mefenamic acid) in reducing HMB.
AUTHORS' CONCLUSIONS
NSAIDs reduce HMB when compared with placebo but are less effective than tranexamic acid, danazol or LNG IUS. However, adverse events are more severe with danazol therapy. In the limited number of small studies suitable for evaluation, no significant difference in efficacy was demonstrated between NSAIDs and other medical treatments such as oral luteal progestogen, ethamsylate, OCC or another type of intrauterine system, Progestasert.
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Dysmenorrhea; Female; Humans; Menorrhagia; Randomized Controlled Trials as Topic
PubMed: 23440779
DOI: 10.1002/14651858.CD000400.pub3 -
BMJ Open 2012To systematically review the evidence regarding long-term prophylaxis in the prevention or reduction of attacks in hereditary angio-oedema (HAE).
OBJECTIVE
To systematically review the evidence regarding long-term prophylaxis in the prevention or reduction of attacks in hereditary angio-oedema (HAE).
DESIGN
Systematic review and meta-analysis.
DATA SOURCES
Electronic databases were searched up to April 2011. Two reviewers selected the studies and extracted the study data, patient characteristics and outcomes of interest.
ELIGIBILITY CRITERIA FOR SELECTED STUDIES
Controlled trials for HAE prophylaxis.
RESULTS
7 studies were included, for a total of 73 patients and 587 HAE attacks. Due to the paucity of studies, a meta-analysis was not possible. Since two studies did not report the number of HAE attacks, five studies (52 patients) were finally included in the summary analysis. Four classes of drugs with at least one controlled trial have been proposed for HAE prophylaxis. All those drugs, except heparin, were found to be more effective than placebo. In the absence of direct comparisons, the relative efficacies of these drugs were determined by calculating a RR of attacks (drug vs placebo). The results were as follows: danazol (RR=0.023, 95% CI 0.003 to 0.162), methyltestosterone (RR=0.054, 95% CI 0.013 to 0.163), ε-aminocaproic acid (RR=0.095, 95% CI 0.025 to 0.356), tranexamic acid (RR=0.308, 95% CI 0.195 to 0.479) and C1-INH 0.491 (95% CI 0.395 to 0.607).
CONCLUSIONS
Few trials have evaluated the benefits of HAE prophylaxis, and all drugs but heparin seem to be effective in this setting. Since there are no direct comparisons of HAE drugs, it was not possible to draw definitive conclusions on the most effective one. Thus, to accumulate evidence for HAE prophylaxis, further studies are needed that consider the dose-efficacy relationship and include a head-to-head comparison between drugs, with the active group, rather than placebo, as the control.
PubMed: 22786946
DOI: 10.1136/bmjopen-2011-000524 -
The Cochrane Database of Systematic... May 2012Endometriosis is characterized by the presence of tissue that is morphologically and biologically similar to normal endometrium in locations outside the uterus. Surgical... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Endometriosis is characterized by the presence of tissue that is morphologically and biologically similar to normal endometrium in locations outside the uterus. Surgical and hormonal treatment of endometriosis have unpleasant side effects and high rates of relapse. In China, treatment of endometriosis using Chinese herbal medicine (CHM) is routine and considerable research into the role of CHM in alleviating pain, promoting fertility, and preventing relapse has taken place.This review is an update of a previous review published in the Cochrane Database of Systematic Reviews 2009, issue No 3.
OBJECTIVES
To review the effectiveness and safety of CHM in alleviating endometriosis-related pain and infertility.
SEARCH METHODS
We searched the Menstrual Disorders and Subfertility Group Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library) and the following English language electronic databases (from their inception to 31/10/2011): MEDLINE, EMBASE, AMED, CINAHL, and NLH.We also searched Chinese language electronic databases: Chinese Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), Chinese Sci & Tech Journals (VIP), Traditional Chinese Medical Literature Analysis and Retrieval System (TCMLARS), and Chinese Medical Current Contents (CMCC).
SELECTION CRITERIA
Randomised controlled trials (RCTs) involving CHM versus placebo, biomedical treatment, another CHM intervention; or CHM plus biomedical treatment versus biomedical treatment were selected. Only trials with confirmed randomisation procedures and laparoscopic diagnosis of endometriosis were included.
DATA COLLECTION AND ANALYSIS
Risk of bias assessment, and data extraction and analysis were performed independently by three review authors. Data were combined for meta-analysis using relative risk (RR) for dichotomous data. A fixed-effect statistical model was used, where appropriate. Data not suitable for meta-analysis were presented as descriptive data.
MAIN RESULTS
Two Chinese RCTs involving 158 women were included in this review. Both these trials described adequate methodology. Neither trial compared CHM with placebo treatment.There was no evidence of a significant difference in rates of symptomatic relief between CHM and gestrinone administered subsequent to laparoscopic surgery (95.65% versus 93.87%; risk ratio (RR) 1.02, 95% confidence interval (CI) 0.93 to 1.12, one RCT). The intention-to-treat analysis also showed no significant difference between the groups (RR 1.04, 95% CI 0.91 to 1.18). There was no significant difference between the CHM and gestrinone groups with regard to the total pregnancy rate (69.6% versus 59.1%; RR 1.18, 95% CI 0.87 to 1.59, one RCT).CHM administered orally and then in conjunction with a herbal enema resulted in a greater proportion of women obtaining symptomatic relief than with danazol (RR 5.06, 95% CI 1.28 to 20.05; RR 5.63, 95% CI 1.47 to 21.54, respectively). Overall, 100% of women in all the groups showed some improvement in their symptoms.Oral plus enema administration of CHM showed a greater reduction in average dysmenorrhoea pain scores than did danazol (mean difference (MD) -2.90, 95% CI -4.55 to -1.25; P < 0.01). Combined oral and enema administration of CHM also showed a greater improvement measured as the disappearance or shrinkage of adnexal masses than with danazol (RR 1.70, 95% CI 1.04 to 2.78). For lumbosacral pain, rectal discomfort, or vaginal nodules tenderness, there was no significant difference between CHM and danazol.
AUTHORS' CONCLUSIONS
Post-surgical administration of CHM may have comparable benefits to gestrinone but with fewer side effects. Oral CHM may have a better overall treatment effect than danazol; it may be more effective in relieving dysmenorrhoea and shrinking adnexal masses when used in conjunction with a CHM enema. However, more rigorous research is required to accurately assess the potential role of CHM in treating endometriosis.
Topics: Danazol; Drugs, Chinese Herbal; Dysmenorrhea; Endometriosis; Enema; Estrogen Antagonists; Female; Gestrinone; Humans; Pelvic Pain; Progestins; Randomized Controlled Trials as Topic
PubMed: 22592712
DOI: 10.1002/14651858.CD006568.pub3