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The Cochrane Database of Systematic... Jul 2013Progestin-only contraceptives (POCs) are appropriate for many women who cannot or should not take estrogen. Many POCs are long-acting, cost-effective methods of... (Review)
Review
BACKGROUND
Progestin-only contraceptives (POCs) are appropriate for many women who cannot or should not take estrogen. Many POCs are long-acting, cost-effective methods of preventing pregnancy. However, concern about weight gain can deter the initiation of contraceptives and cause early discontinuation among users.
OBJECTIVES
The primary objective was to evaluate the association between progestin-only contraceptive use and changes in body weight.
SEARCH METHODS
Through May 2013, we searched MEDLINE, CENTRAL, POPLINE, LILACS, ClinicalTrials.gov, and ICTRP. The 2010 search also included EMBASE. For the initial review, we contacted investigators to identify other trials.
SELECTION CRITERIA
All comparative studies were eligible that examined a POC versus another contraceptive method or no contraceptive. The primary outcome was mean change in body weight or mean change in body composition. We also considered the dichotomous outcome of loss or gain of a specified amount of weight.
DATA COLLECTION AND ANALYSIS
Two authors extracted the data. We computed the mean difference (MD) with 95% confidence interval (CI) for continuous variables. For dichotomous outcomes, the Mantel-Haenszel odds ratio (OR) with 95% CI was calculated.
MAIN RESULTS
We found 16 studies; one examined progestin-only pills, one studied the levonorgestrel-releasing intrauterine system (LNG-IUS), four examined an implant, and 10 focused on depot medroxyprogesterone acetate (DMPA). Outcomes examined were changes in body weight only (14 studies), changes in both body weight and body composition (1 study), and changes in body composition only (1 study). We did not conduct meta-analysis due to the various contraceptive methods and weight change measures.Comparison groups did not differ significantly for weight change in 12 studies. However, three studies showed weight change differences for POC users compared to women not using a hormonal method. In one study, weight gain (kg) was greater for the DMPA group than the group using a non-hormonal IUD in years one through three [(MD 2.28; 95% CI 1.79 to 2.77), (MD 2.71, 95% CI 2.12 to 3.30), and (MD 3.17; 95% CI 2.51 to 3.83), respectively]. The differences were notable within the normal weight and overweight subgroups. Two implant studies also showed differences in weight change. The implant group (six-capsule) had greater weight gain (kg) compared to the group using a non-hormonal IUD in both studies [(MD 0.47 (95% CI 0.29 to 0.65); (MD 1.10; 95% CI 0.36 to 1.84)]. In one of those studies, the implant group also had greater weight gain than a group using a barrier method or no contraceptive (MD 0.74; 95% CI 0.52 to 0.96).The two studies that assessed body composition change showed differences between POC users and women not using a hormonal method. Adolescents using DMPA had a greater increase in body fat (%) compared to a group not using a hormonal method (MD 11.00; 95% CI 2.64 to 19.36). The DMPA group also had a greater decrease in lean body mass (%) (MD -4.00; 95% CI -6.93 to -1.07). The other study reported differences between an LNG-IUS group and a non-hormonal IUD group in percent change in body fat mass (2.5% versus -1.3%, respectively; reported P value = 0.029) and percent change in lean body mass (-1.4% versus 1.0%, respectively; reported P value = 0.027).
AUTHORS' CONCLUSIONS
The overall quality of evidence was moderate to low, given that the studies were evenly divided across the evidence quality groups (high, moderate, low, or very low quality). We found limited evidence of weight gain when using POCs. Mean gain was less than 2 kg for most studies up to 12 months. Weight change for the POC group generally did not differ significantly from that of the comparison group using another contraceptive. Two studies that assessed body composition showed that POC users had greater increases in body fat and decreases in lean body mass compared to users of non-hormonal methods. Appropriate counseling about typical weight gain may help reduce discontinuation of contraceptives due to perceptions of weight gain.
Topics: Body Composition; Body Weight; Contraceptives, Oral, Hormonal; Female; Humans; Levonorgestrel; Medroxyprogesterone Acetate; Progestins; Weight Gain
PubMed: 23821307
DOI: 10.1002/14651858.CD008815.pub3 -
The Cochrane Database of Systematic... Dec 2012Health care providers often tell women to wait until the next menses to begin hormonal contraception. The intent is to avoid contraceptive use during an undetected... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Health care providers often tell women to wait until the next menses to begin hormonal contraception. The intent is to avoid contraceptive use during an undetected pregnancy. An alternative is to start hormonal contraception immediately with back-up birth control for the first seven days. Immediate initiation was introduced with combined oral contraceptives (COCs), and has expanded to other hormonal contraceptives. At the time of the initial review, how immediate start compared to conventional menses-dependent start was unclear regarding effectiveness, continuation, and acceptability. The immediate-start approach may improve women's access to, and continuation of, hormonal contraception.
OBJECTIVES
This review examined randomized controlled trials (RCTs) of immediate-start hormonal contraception for differences in effectiveness, continuation, and acceptability.
SEARCH METHODS
In August 2012, we searched MEDLINE, CENTRAL, POPLINE, LILACS, ClinicalTrials.gov, and ICTRP for trials of immediate-start hormonal contraceptives. We contacted researchers to find other studies. Earlier searches also included EMBASE.
SELECTION CRITERIA
We included RCTs that compared immediate start to conventional start of hormonal contraception. Also included were trials that compared immediate start of different hormonal contraceptive methods with each other.
DATA COLLECTION AND ANALYSIS
Data were abstracted by two authors and entered into RevMan. The Peto odds ratio (OR) with 95% confidence interval (CI) was calculated.
MAIN RESULTS
Five studies were included. No new eligible studies have been found since the review was initially conducted. Method discontinuation was similar between groups in all trials. Bleeding patterns and side effects were similar in trials that compared immediate with conventional start. In a study of depot medroxyprogesterone acetate (DMPA), immediate start of DMPA showed fewer pregnancies than a 'bridge' method before DMPA (OR 0.36; 95% CI 0.16 to 0.84). Further, more women in the immediate-DMPA group were very satisfied versus those with a 'bridge' method (OR 1.99; 95% CI 1.05 to 3.77). A trial of two immediate-start methods showed the vaginal ring group had less prolonged bleeding (OR 0.42; 95% CI 0.20 to 0.89) and less frequent bleeding (OR 0.23; 95% CI 0.05 to 1.03) than COC users. The ring group also reported fewer side effects. Also, more immediate ring users were very satisfied than immediate COC users (OR 2.88; 95% CI 1.59 to 5.22).
AUTHORS' CONCLUSIONS
We found limited evidence that immediate start of hormonal contraception reduces unintended pregnancies or increases method continuation. However, the pregnancy rate was lower with immediate start of DMPA versus another method. Some differences were associated with contraceptive type rather than initiation method, i.e., immediate ring versus immediate COC. More studies are needed of immediate versus conventional start of the same hormonal contraceptive.
Topics: Contraception; Contraceptives, Oral, Hormonal; Drug Chronotherapy; Female; Humans; Intrauterine Devices; Medroxyprogesterone Acetate; Menstruation; Pregnancy; Pregnancy, Unplanned; Randomized Controlled Trials as Topic
PubMed: 23235628
DOI: 10.1002/14651858.CD006260.pub3 -
The Cochrane Database of Systematic... Aug 2012Reduced circulating estrogen levels around the time of the menopause can induce unacceptable symptoms that affect the health and well-being of women. Hormone therapy... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Reduced circulating estrogen levels around the time of the menopause can induce unacceptable symptoms that affect the health and well-being of women. Hormone therapy (both unopposed estrogen and estrogen/progestogen combinations) is an effective treatment for these symptoms, but is associated with risk of harms. Guidelines recommend that hormone therapy be given at the lowest effective dose and treatment should be reviewed regularly. The aim of this review is to identify the minimum dose(s) of progestogen required to be added to estrogen so that the rate of endometrial hyperplasia is not increased compared to placebo.
OBJECTIVES
The objective of this review is to assess which hormone therapy regimens provide effective protection against the development of endometrial hyperplasia or carcinoma.
SEARCH METHODS
We searched the Cochrane Menstrual Disorders and Subfertility Group trials register (searched January 2012), The Cochrane Library (Issue 1, 2012), MEDLINE (1966 to January 2012), EMBASE (1980 to January 2012), Current Contents (1993 to May 2008), Biological Abstracts (1969 to 2008), Social Sciences Index (1980 to May 2008), PsycINFO (1972 to January 2012) and CINAHL (1982 to May 2008). Attempts were made to identify trials from citation lists of reviews and studies retrieved, and drug companies were contacted for unpublished data.
SELECTION CRITERIA
Randomised comparisons of unopposed estrogen therapy, combined continuous estrogen-progestogen therapy, sequential estrogen-progestogen therapy with each other or placebo, administered over a minimum period of 12 months. Incidence of endometrial hyperplasia/carcinoma assessed by a biopsy at the end of treatment was a required outcome. Data on adherence to therapy, rates of additional interventions, and withdrawals owing to adverse events were also extracted.
DATA COLLECTION AND ANALYSIS
In this update, 46 studies were included. Odds ratios (ORs) were calculated for dichotomous outcomes. The small numbers of studies in each comparison and the clinical heterogeneity precluded meta-analysis for many outcomes.
MAIN RESULTS
Unopposed estrogen is associated with increased risk of endometrial hyperplasia at all doses, and durations of therapy between one and three years. For women with a uterus the risk of endometrial hyperplasia with hormone therapy comprising low-dose estrogen continuously combined with a minimum of 1 mg norethisterone acetate (NETA) or 1.5 mg medroxyprogesterone acetate (MPA) is not significantly different from placebo at two years (1 mg NETA: OR 0.04; 95% confidence interval (CI) 0 to 2.8; 1.5 mg MPA: no hyperplasia events).
AUTHORS' CONCLUSIONS
Hormone therapy for postmenopausal women with an intact uterus should comprise both estrogen and progestogen to reduce the risk of endometrial hyperplasia.
Topics: Drug Therapy, Combination; Endometrial Hyperplasia; Endometrial Neoplasms; Estrogen Replacement Therapy; Estrogens; Female; Humans; Postmenopause; Progestins; Randomized Controlled Trials as Topic; Uterine Hemorrhage
PubMed: 22895916
DOI: 10.1002/14651858.CD000402.pub4 -
The Cochrane Database of Systematic... Mar 2012Endometriosis is a chronic inflammatory condition defined by the presence of glands and stroma outside the uterine cavity. It occurs in 7% to 10% of all women of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Endometriosis is a chronic inflammatory condition defined by the presence of glands and stroma outside the uterine cavity. It occurs in 7% to 10% of all women of reproductive age and may present as pain or infertility. The pelvic pain may be in the form of dysmenorrhoea, dyspareunia or pelvic pain. Initially a combination of estrogens and progestagens was used to create a pseudopregnancy and alleviate the symptoms associated with endometriosis. Progestagens alone or anti-progestagens have been considered as alternatives because they are inexpensive and may have a better side effect profile than other choices.
OBJECTIVES
To determine the effectiveness of both the progestagens and anti-progestagens in the treatment of painful symptoms ascribed to the diagnosis of endometriosis.
SEARCH METHODS
We used the search strategy of the Menstrual Disorders and Subfertility Group to identify all publications which described or might have described randomised controlled trials (RCTs) of any progestagen or any anti-progestagen in the treatment of symptomatic endometriosis. We updated the review in 2011.
SELECTION CRITERIA
We considered only RCTs which compared the use of progestagens and anti-progestagens with other interventions, placebo or no treatment for the alleviation of symptomatic endometriosis.
DATA COLLECTION AND ANALYSIS
We have added six new studies, bringing the total of included studies to 13 in the update of this review. The six newly included studies evaluated progestagens (comparisons with placebo, danazol, oral or subdermal contraceptive, oral contraceptive pill and danazol, gonadotrophin-releasing hormone (GnRH) analogue and other drugs). The remaining studies compared the anti-progestagen gestrinone with danazol, GnRH analogues or itself.
MAIN RESULTS
The progestagen medroxyprogesterone acetate (100 mg daily) appeared to be more effective at reducing all symptoms up to 12 months of follow-up (MD -0.70, 95% CI -8.61 to -5.39; P < 0.00001) compared with placebo. There was evidence of significantly more cases of acne (six versus one) and oedema (11 versus one) in the medroxyprogesterone acetate group compared with placebo. There was no evidence of a difference in objective efficacy between dydrogesterone and placebo.There was no evidence of a benefit with depot administration of progestagens versus other treatments (low dose oral contraceptive or leuprolide acetate) for reduced symptoms. The depot progestagen group experienced significantly more adverse effects.There was no overall evidence of a benefit of oral progestagens over other medical treatment at six months of follow-up for self-reported efficacy. Amenorrhoea and bleeding were more frequently reported in the progestagen group compared with other treatment groups.There was no evidence of a benefit of anti-progestagens (gestrinone) compared with danazol. GnRH analogue (leuprorelin) was found to significantly improve dysmenorrhoea compared with gestrinone (MD 0.82, 95% CI 0.15 to 1.49; P = 0.02) although it was also associated with increased hot flushes (OR 0.20, 95% CI 0.06 to -0.63; P = 0.006).
AUTHORS' CONCLUSIONS
There is only limited evidence to support the use of progestagens and anti-progestagens for pain associated with endometriosis.
Topics: Danazol; Dydrogesterone; Endometriosis; Female; Gestrinone; Gonadotropin-Releasing Hormone; Humans; Leuprolide; Medroxyprogesterone Acetate; Pelvic Pain; Progesterone Congeners; Progestins
PubMed: 22419284
DOI: 10.1002/14651858.CD002122.pub2 -
Breastfeeding Medicine : the Official... Feb 2012Breastfeeding has numerous maternal and infant benefits. Progesterone contraception after birth is frequently recommended, but because a decrease in progesterone is... (Review)
Review
BACKGROUND
Breastfeeding has numerous maternal and infant benefits. Progesterone contraception after birth is frequently recommended, but because a decrease in progesterone is required to initiate lactation, early postpartum progesterone contraception use could inhibit lactation. The purpose of this article is to critically evaluate the scientific basis for conflicting clinical recommendations related to postpartum medroxyprogesterone use among breastfeeding women.
METHODS
Relevant peer-reviewed literature was identified through a comprehensive search of PubMed through December 2010. The search was restricted to clinical trials, randomized clinical trials, or comparative studies written in English and conducted among humans. The studies included in this review addressed the effect of medroxyprogesterone administration at <6 weeks postpartum on breastfeeding exclusivity and/or duration and measured breastfeeding outcomes at ≥ 6 weeks postpartum.
RESULTS
Of the 20 articles identified, only three studies satisfied the inclusion criteria. However, all three studies were of low-quality methodological rigor, and none accounted for potential confounders.
CONCLUSION
Current evidence is methodologically weak and provides an inadequate basis for inference about a possible causal relationship between early postpartum medroxyprogesterone use and poor breastfeeding outcomes. However, given the presence of a strong biological model describing the potential deleterious effect of postpartum medroxyprogesterone use on lactation, further research that improves on current literature is warranted. Meanwhile, we recommend that potential breastfeeding risks associated with early (<6 weeks) postpartum medroxyprogesterone use be disclosed to allow for a fully informed consent and decision-making process.
Topics: Breast Feeding; Contraceptives, Oral, Hormonal; Contraceptives, Oral, Synthetic; Decision Making; Evidence-Based Practice; Female; Humans; Infant, Newborn; Informed Consent; Lactation; Medroxyprogesterone Acetate; Mothers; Postpartum Period; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 22085201
DOI: 10.1089/bfm.2011.0105 -
The Cochrane Database of Systematic... Jun 2011Endometrial cancer is the most common genital tract carcinoma among women in developed countries, with most women presenting with stage 1 disease. Adjuvant progestagen... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Endometrial cancer is the most common genital tract carcinoma among women in developed countries, with most women presenting with stage 1 disease. Adjuvant progestagen therapy has been advocated following primary surgery to reduce the risk of recurrence of disease.
OBJECTIVES
To evaluate the effectiveness and safety of adjuvant progestagen therapy for the treatment of endometrial cancer.
SEARCH STRATEGY
We searched the Cochrane Gynaecological Cancer Group Trials Specilaised Register, Cochrane Central Register of Controlled Trials (CENTRAL) Issue 2, 2009. MEDLINE and EMBASE up to April 2009.
SELECTION CRITERIA
Randomised controlled trials (RCTs) of progestagen therapy in women who have had surgery for endometrial cancer.
DATA COLLECTION AND ANALYSIS
Two review authors independently abstracted data and assessed risk of bias. Risk ratios (RRs) comparing survival in women who did and did not receive progestagen were pooled in random effects meta-analyses. .
MAIN RESULTS
Seven trials assessing 4556 women were identified. Three trials included women with stage one disease only, whereas four included women with more advanced disease. Meta-analysis of four trials showed that there was no significant difference in the risk of death at five years between adjuvant progestagen therapy and no further treatment (RR = 1.00, 95% CI 0.85 to 1.18). This conclusion is also robust to single trial analyses at 4 and 7 years and in one trial across all points in time using a hazard ratio (HR). There was also no significant difference between progestagen therapy and control in terms of the risk of death from endometrial cancer, cardiovascular disease and intercurrent disease. Relapse of disease appeared to be reduced by progestagen therapy in one trial (HR = 0.71, 95% CI 0.52 to 0.97 and 5 year RR = 0.74, 95% CI 0.58 to 0.96), but there was no evidence of a difference in disease recurrence in another trial at 7 years (RR = 1.34, 95% CI 0.79 to 2.27).
AUTHORS' CONCLUSIONS
There is no evidence to support the use of adjuvant progestagen therapy in the primary treatment of endometrial cancer.
Topics: Antineoplastic Agents, Hormonal; Cause of Death; Chemotherapy, Adjuvant; Endometrial Neoplasms; Female; Humans; Hydroxyprogesterones; Medroxyprogesterone Acetate; Progestins; Randomized Controlled Trials as Topic
PubMed: 21678331
DOI: 10.1002/14651858.CD001040.pub2 -
The Cochrane Database of Systematic... Apr 2011Progestin-only contraceptives (POCs) are appropriate for many women who cannot or should not take estrogen. Many POCs are long-acting, cost-effective methods of... (Review)
Review
BACKGROUND
Progestin-only contraceptives (POCs) are appropriate for many women who cannot or should not take estrogen. Many POCs are long-acting, cost-effective methods of preventing pregnancy. However, concern about weight gain can deter the initiation of contraceptives and cause early discontinuation among users.
OBJECTIVES
The primary objective was to evaluate the association between progestin-only contraceptive use and changes in body weight.
SEARCH STRATEGY
We searched MEDLINE, CENTRAL, POPLINE, EMBASE, LILACS, ClinicalTrials.gov, and ICTRP, and contacted investigators to identify other trials.
SELECTION CRITERIA
All comparative studies were eligible that examined a POC versus another method or no contraceptive. The primary outcome was mean change in body weight or body composition.
DATA COLLECTION AND ANALYSIS
Two authors extracted the data. We computed the mean difference with 95% confidence interval (CI) for continuous variables and odds ratio with 95% CI for dichotomous variables.
MAIN RESULTS
We did not conduct meta-analysis due to the various contraceptive methods and weight change measures. Fifteen studies examined progestin-only pills (N=1), Norplant (N=4), and depot medroxyprogesterone acetate (DMPA) (N=10). Comparison groups were similar for weight change in 11 studies. Four studies showed differences in weight or body composition change for POCs compared to no hormonal method. Adolescents using DMPA had a greater increase in body fat (%) versus a group using no hormonal method (mean difference 11.00; 95% CI 2.64 to 19.36). The DMPA group also had a greater decrease in lean body mass (%) (mean difference -4.00; 95% CI -6.93 to -1.07). In another study, weight gain (kg) was greater for the DMPA group than an IUD group (mean difference 2.28, 2.71, 3.17, respectively). The differences were notable within the normal weight and overweight subgroups. One study showed the Norplant (six-capsule) group had greater weight gain (kg) than a non-hormonal IUD group (mean difference 0.47 (95% CI 0.29 to 0.65) and a group using non-hormonal or no method (mean difference 0.74; 95% CI 0.52 to 0.96). Another study also showed a Norplant group also had greater weight gain (kg) than an IUD group (mean difference 1.10; 95% CI 0.36 to 1.84).
AUTHORS' CONCLUSIONS
We found little evidence of weight gain when using POCs. Mean gain was less than 2 kg for most studies up to 12 months, and usually similar for the comparison group using another contraceptive. Appropriate counseling about typical weight gain may help reduce discontinuation of contraceptives due to perceptions of weight gain.
Topics: Body Weight; Contraceptives, Oral, Hormonal; Female; Humans; Levonorgestrel; Medroxyprogesterone Acetate; Progestins; Weight Gain
PubMed: 21491411
DOI: 10.1002/14651858.CD008815.pub2 -
The Cochrane Database of Systematic... Dec 2010Endometrial cancer is a cancer of the lining of the womb and worldwide is the seventh most common cancer in women. Treatment with hormones is thought to be beneficial in... (Review)
Review
BACKGROUND
Endometrial cancer is a cancer of the lining of the womb and worldwide is the seventh most common cancer in women. Treatment with hormones is thought to be beneficial in patients with endometrial cancer.
OBJECTIVES
To assess the indications, effectiveness and safety of hormone therapy for advanced or recurrent epithelial endometrial cancer.
SEARCH STRATEGY
We searched the Cochrane Gynaecological Cancer Group Trials Register, MEDLINE, EMBASE up to May 2009 and and CENTRAL (Issue 2, 2009). We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of included studies, and contacted experts in the field.
SELECTION CRITERIA
Randomised controlled trials (RCTs) that studied hormonal therapy in adult women diagnosed with advanced or recurrent endometrial cancer.
DATA COLLECTION AND ANALYSIS
Two review authors independently abstracted data and assessed risk of bias. Comparisons were restricted to single-trial analyses so we did not synthesise data in meta-analyses.
MAIN RESULTS
We found six trials (542 participants) that met our inclusion criteria. These trials assessed the effectiveness of hormonal therapy in women with advanced or recurrent endometrial cancer as a single agent, as part of combination therapy and as low versus high dose. All comparisons were restricted to single-trial analyses, where we found no evidence that hormonal therapy as a single agent or as a combination treatment prolonged overall or five-year disease-free survival of women with advanced or recurrent endometrial cancer. However, low-dose hormonal therapy may have had a benefit in terms of overall and progression-free survival (PFS) compared to high-dose hormonal therapy (HR 1.31, 95% CI 1.04 to 1.66 and HR 1.35, 95% CI 1.07 to 1.71 for overall and PFS, respectively).
AUTHORS' CONCLUSIONS
We found insufficient evidence that hormonal treatment in any form, dose or as part of combination therapy improves the survival of patients with advanced or recurrent endometrial cancer. However, a large number of patients would be needed to demonstrate an effect on survival and none of the included RCTs had a sufficient number of patients to demonstrate a significant difference. In the absence of a proven survival advantage and the heterogeneity of patient populations, the decision to use any type of hormonal therapy should be individualised and with the intent to palliate the disease. It is debatable whether outcomes such as quality of life, treatment response or palliative measures such as relieving symptoms should take preference over overall and PFS as the major objectives of future trials.
Topics: 17 alpha-Hydroxyprogesterone Caproate; Adult; Antineoplastic Agents, Hormonal; Disease-Free Survival; Drug Therapy, Combination; Endometrial Neoplasms; Female; Humans; Hydroxyprogesterones; Medroxyprogesterone Acetate; Megestrol; Neoplasm Recurrence, Local; Neoplasm Staging; Progestins
PubMed: 21154390
DOI: 10.1002/14651858.CD007926.pub2 -
The Cochrane Database of Systematic... Jun 2010Highly effective contraception is essential to reduce unintended pregnancies and the effect these have on individuals, society and public health resources. Intrauterine... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Highly effective contraception is essential to reduce unintended pregnancies and the effect these have on individuals, society and public health resources. Intrauterine devices (IUDs) and depot progestogens are two commonly used long-acting, reversible contraceptive methods with different risk and benefit profiles.
OBJECTIVES
To compare the contraceptive and non-contraceptive benefits and risks of using the copper-containing IUD versus depot progestogens for contraception.
SEARCH STRATEGY
In June 2009 we searched the Cochrane Pregnancy and Childbirth Group Trials Register, the Cochrane Central Register of Controlled Trials, Pubmed, Popline, Clinical Trials.gov, the Current Controlled Trials metaRegister, EMBASE and LILACS, and contacted study authors.
SELECTION CRITERIA
Randomized trials comparing women using copper-containing IUDs with women using depot progestogens.
DATA COLLECTION AND ANALYSIS
We assessed eligibility and trial quality, extracted and double-entered data.
MAIN RESULTS
Two studies were included in the review. In the one study in HIV infected women, the IUD was compared with depot progestogen or the oral contraceptive, according to the women's choice. As the majority of women chose depot progestogen, we have included this study in the review, within a mixed hormonal contraception sub-group.Overall, the copper IUD was more effective than depot progestogens/hormonal contraception at preventing pregnancy (risk ratio (RR) 0.45; 95% confidence interval (CI) 0.24 to 0.84). HIV disease progression was reduced in the IUD group (RR 0.58; 95% CI 0.39 to 0.87). There was no significant difference in pelvic inflammatory disease rates between the two groups. Discontinuation of the allocated method was less frequent with the IUD in one study, and less frequent with hormonal contraception in the other study (in which women were allowed to switch between various hormonal methods).
AUTHORS' CONCLUSIONS
In the populations studied, the IUD was more effective than hormonal contraception with respect to pregnancy prevention. High quality research is urgently needed to compare the effects, if any, of these two commonly used contraception methods on HIV acquisition/seroconversion and HIV/AIDS disease progression.
Topics: Contraception; Contraceptive Agents, Female; Disease Progression; Female; HIV Infections; Humans; Intrauterine Devices, Copper; Medroxyprogesterone Acetate; Pregnancy; Progestins; Randomized Controlled Trials as Topic
PubMed: 20556773
DOI: 10.1002/14651858.CD007043.pub2 -
The Cochrane Database of Systematic... Oct 2009Endocrine therapy removes the influence of oestrogen on breast cancer cells and so hormonal treatments such as tamoxifen, megestrol acetate and medroxyprogesterone... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Endocrine therapy removes the influence of oestrogen on breast cancer cells and so hormonal treatments such as tamoxifen, megestrol acetate and medroxyprogesterone acetate have been in use for many years for advanced breast cancer. Aromatase inhibitors (AIs) inhibit oestrogen synthesis in the peripheral tissues and have a similar tumour-regressing effect to other endocrine treatments. Aminoglutethimide was the first AI in clinical use and now the third generation AIs, anastrozole, exemestane and letrozole, are in current use. Randomised trial evidence on response rates and side effects of these drugs is still limited.
OBJECTIVES
To compare AIs to other endocrine therapy in the treatment of advanced breast cancer in postmenopausal women.
SEARCH STRATEGY
For this update, the Cochrane Breast Cancer Group Specialised Register and the Cochrane Central Register of Controlled Trials (CENTRAL) and relevant conference proceedings were searched (to 30 June 2008).
SELECTION CRITERIA
Randomised controlled trials in postmenopausal women comparing the effects of any AI versus other endocrine therapy, no endocrine therapy, or a different AI in the treatment of advanced (metastatic) breast cancer. Non-English language publications, comparisons of the same AI at different doses, AIs used as neoadjuvant treatment, or outcomes not related to tumour response were excluded.
DATA COLLECTION AND ANALYSIS
Data from published trials were extracted independently by two review authors and cross-checked by a third. Hazard ratios (HR) were derived for analysis of time-to-event outcomes (overall and progression-free survival). Odds ratios (OR) were derived for objective response, clinical benefit, and toxicity.
MAIN RESULTS
Thirty-seven trials were identified, 31 of which were included in the main analysis of any AI versus any other treatment (11,403 women). No trials were excluded due to inadequate allocation concealment. The pooled estimate showed a significant survival benefit for treatment with an AI over other endocrine therapies (HR 0.90, 95% CI 0.84 to 0.97). A subgroup analysis of the three commonly prescribed AIs (anastrozole, exemestane, letrozole) also showed a similar survival benefit (HR 0.88, 95% CI 0.80 to 0.96). There were very limited data to compare one AI with a different AI, but these suggested an advantage for letrozole over anastrozole.AIs have a different toxicity profile to other endocrine therapies. For those currently prescribed, and for all AIs combined, they had similar levels of hot flushes and arthralgia; increased risks of rash, nausea, diarrhoea and vomiting; but a 71% decreased risk of vaginal bleeding and 47% decrease in thromboembolic events compared with other endocrine therapies.
AUTHORS' CONCLUSIONS
In women with advanced (metastatic) breast cancer, aromatase inhibitors including those in current clinical use show a survival benefit when compared to other endocrine therapy.
Topics: Antineoplastic Agents, Hormonal; Aromatase Inhibitors; Breast Neoplasms; Female; Humans; Neoplasms, Hormone-Dependent; Postmenopause; Randomized Controlled Trials as Topic
PubMed: 19821307
DOI: 10.1002/14651858.CD003370.pub3