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International Journal of Environmental... Jun 2021Mastalgia, or breast pain, is common among women which can lead to significant impairment in daily living. Hence, finding an effective treatment that can alleviate the... (Meta-Analysis)
Meta-Analysis Review
Mastalgia, or breast pain, is common among women which can lead to significant impairment in daily living. Hence, finding an effective treatment that can alleviate the symptom is very important. Thus, we carry out this study to determine the efficacy of evening primrose oil (EPO) for mastalgia treatment in women. The review included published randomised clinical trials that evaluated EPO used for treating mastalgia against a placebo or other treatments, irrespective of the blinding procedure, publication status, or sample size. Two independent authors screened the titles and abstracts of the identified trials; full texts of relevant trials were evaluated for eligibility. Two reviewers independently extracted data on the methods, interventions, outcomes, and risk of bias. The random-effects model was used for estimating the risk ratios and mean differences with 95% confidence intervals. Thirteen trials with 1752 randomised patients were included. The results showed that EPO has no difference to reduce breast pain compared to topical NSAIDS, danazol, or vitamin E. The number of patients who achieved pain relief was no different compared to the placebo or other treatments. The EPO does not increase adverse events, such as nausea, abdominal bloating, headache or giddiness, increase weight gain, and altered taste compared to a placebo or other treatments. EPO is a safe medication with similar efficacy for pain control in women with mastalgia compared to a placebo, topical NSAIDS, danazol, or vitamin E.
Topics: Female; Humans; Linoleic Acids; Mastodynia; Oenothera biennis; Plant Oils; Randomized Controlled Trials as Topic; gamma-Linolenic Acid
PubMed: 34200727
DOI: 10.3390/ijerph18126295 -
Medicine Sep 2017Corticosteroid sparing is required in 15% to 40% of adults with persistent or chronic primary immune thrombocytopenic purpura (ITP). Herein, the efficacy of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Corticosteroid sparing is required in 15% to 40% of adults with persistent or chronic primary immune thrombocytopenic purpura (ITP). Herein, the efficacy of immunomodulatory drugs (dapsone, interferon alpha, danazol, and hydroxychloroquine as second-third-line therapies in ITP is investigated.
METHODS
MEDLINE was searched for studies that included patients with persistent or chronic primary ITP and published before the end of December 2014. Two investigators independently extracted data regarding study design, patient characteristics, dosage schedule, time to response, and occurrence of adverse events. The pooled overall response rate (ORR; platelet count >30 × 10 L) and the complete response rate (CRR; platelet count >100 × 10 L) were evaluated to determine drug efficacy by calculating weighted mean proportion using a fixed or random-effects model according to heterogeneity (I > 50%). The study was performed following the MOOSE and PRISMA guidelines.
RESULTS
A total of 28 studies (415 patients) were included (dapsone: k = 7 studies, n = 80; danazol: k = 12, n = 224; interferon alpha: k = 8, n = 83; hydroxychloroquine: k = 1, n = 28). The mean patient age was 50 years (female sex 70%, splenectomy 47%). The ORR and CRR were 55% (95% CI: 44%-66%, I = 0%) and 21% (95% CI: 13%-31%, I = 0%), respectively, for dapsone; 42% (95% CI: 22%-65%, I = 63%) and 18% (95% CI: 10%-29%, I = 9%), respectively, for interferon alpha; and 58% (95% CI: 42%-72%, I = 67%) and 29% (95% CI: 19%-42%, I = 63%), respectively, for danazol. The ORR was 50% (95% CI: 32%-67%) for hydroxychloroquine (data not available for CRR). Meta-regression analysis found a correlation between the ORR for interferon alpha and the splenectomized status of the patient (P = .02) and between the CRR for danazol and disease duration (P < .001). In total, 73%, 51%, 30%, and 0% of patients who received danazol, dapsone, interferon alpha, and hydroxychloroquine experienced side effects, respectively.
CONCLUSION
The ORR was equivalent for hydroxychloroquine, danazol, and dapsone in ITP. Regarding their low CRR, patients at high risk of infection or at low risk of bleeding should benefit from these treatments. Thanks to their best efficacy and safety profiles, dapsone and hydroxychloroquine in patients with antinuclear antibodies should be preferred over danazol and interferon alpha.
Topics: Humans; Immunomodulation; Purpura, Thrombocytopenic, Idiopathic
PubMed: 28906353
DOI: 10.1097/MD.0000000000007534 -
The Cochrane Database of Systematic... Jun 2023Endometriosis is a common gynaecological condition affecting 6 to 11% of reproductive-age women and may cause dyspareunia, dysmenorrhoea, and infertility. One treatment... (Review)
Review
BACKGROUND
Endometriosis is a common gynaecological condition affecting 6 to 11% of reproductive-age women and may cause dyspareunia, dysmenorrhoea, and infertility. One treatment strategy is medical therapy with gonadotrophin-releasing hormone analogues (GnRHas) to reduce pain due to endometriosis. One of the adverse effects of GnRHas is a decreased bone mineral density. In addition to assessing the effect on pain, quality of life, most troublesome symptom and patients' satisfaction, the current review also evaluated the effect on bone mineral density and risk of adverse effects in women with endometriosis who use GnRHas versus other treatment options.
OBJECTIVES
To assess the effectiveness and safety of GnRH analogues (GnRHas) in the treatment of painful symptoms associated with endometriosis and to determine the effects of GnRHas on bone mineral density of women with endometriosis.
SEARCH METHODS
We searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO and the trial registries in May 2022 together with reference checking and contact with study authors and experts in the field to identify additional studies.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) which compared GnRHas with other hormonal treatment options, including analgesics, danazol, intra-uterine progestogens, oral or injectable progestogens, gestrinone and also GnRHas compared with no treatment or placebo. Trials comparing GnRHas versus GnRHas in conjunction with add-back therapy (hormonal or non-hormonal) or calcium-regulation agents were also included in this review. DATA COLLECTION AND ANALYSIS: We used standard methodology as recommended by Cochrane. Primary outcomes are relief of overall pain and the objective measurement of bone mineral density. Secondary outcomes include adverse effects, quality of life, improvement in the most troublesome symptoms and patient satisfaction. Due to high risk of bias associated with some of the studies, primary analyses of all review outcomes were restricted to studies at low risk of selection bias. Sensitivity analysis including all studies was then performed.
MAIN RESULTS
Seventy-two studies involving 7355 patients were included. The evidence was very low to low quality: the main limitations of all studies were serious risk of bias due to poor reporting of study methods, and serious imprecision. Trials comparing GnRHas versus no treatment We did not identify any studies. Trials comparing GnRHas versus placebo There may be a decrease in overall pain, reported as pelvic pain scores (RR 2.14; 95% CI 1.41 to 3.24, 1 RCT, n = 87, low-certainty evidence), dysmenorrhoea scores (RR 2.25; 95% CI 1.59 to 3.16, 1 RCT, n = 85, low-certainty evidence), dyspareunia scores (RR 2.21; 95% CI 1.39 to 3.54, 1 RCT, n = 59, low-certainty evidence), and pelvic tenderness scores (RR 2.28; 95% CI 1.48 to 3.50, 1 RCT, n = 85, low-certainty evidence) after three months of treatment. We are uncertain of the effect for pelvic induration, based on the results found after three months of treatment (RR 1.07; 95% CI 0.64 to 1.79, 1 RCT, n = 81, low-certainty evidence). Besides, treatment with GnRHas may be associated with a greater incidence of hot flushes at three months of treatment (RR 3.08; 95% CI 1.89 to 5.01, 1 RCT, n = 100, low-certainty evidence). Trials comparing GnRHas versus danazol For overall pain, for women treated with either GnRHas or danazol, a subdivision was made between pelvic tenderness, partly resolved and completely resolved. We are uncertain about the effect on relief of overall pain, when a subdivision was made for overall pain (MD -0.30; 95% CI -1.66 to 1.06, 1 RCT, n = 41, very low-certainty evidence), pelvic pain (MD 0.20; 95% CI -0.26 to 0.66, 1 RCT, n = 41, very low-certainty evidence), dysmenorrhoea (MD 0.10; 95% CI -0.49 to 0.69, 1 RCT, n = 41, very low-certainty evidence), dyspareunia (MD -0.20; 95% CI -0.77 to 0.37, 1 RCT, n = 41, very low-certainty evidence), pelvic induration (MD -0.10; 95% CI -0.59 to 0.39, 1 RCT, n = 41, very low-certainty evidence), and pelvic tenderness (MD -0.20; 95% CI -0.78 to 0.38, 1 RCT, n = 41, very low-certainty evidence) after three months of treatment. For pelvic pain (MD 0.50; 95% CI 0.10 to 0.90, 1 RCT, n = 41, very low-certainty evidence) and pelvic induration (MD 0.70; 95% CI 0.21 to 1.19, 1 RCT, n = 41, very low-certainty evidence), the complaints may decrease slightly after treatment with GnRHas, compared to danazol, for six months of treatment. Trials comparing GnRHas versus analgesics We did not identify any studies. Trials comparing GnRHas versus intra-uterine progestogens We did not identify any low risk of bias studies. Trials comparing GnRHas versus GnRHas in conjunction with calcium-regulating agents There may be a slight decrease in bone mineral density (BMD) after 12 months treatment with GnRHas, compared to GnRHas in conjunction with calcium-regulating agents for anterior-posterior spine (MD -7.00; 95% CI -7.53 to -6.47, 1 RCT, n = 41, very low-certainty evidence) and lateral spine (MD -12.40; 95% CI -13.31 to -11.49, 1 RCT, n = 41, very low-certainty evidence). AUTHORS' CONCLUSIONS: For relief of overall pain, there may be a slight decrease in favour of treatment with GnRHas compared to placebo or oral or injectable progestogens. We are uncertain about the effect when comparing GnRHas with danazol, intra-uterine progestogens or gestrinone. For BMD, there may be a slight decrease when women are treated with GnRHas, compared to gestrinone. There was a bigger decrease of BMD in favour of GnRHas, compared to GnRHas in conjunction with calcium-regulating agents. However, there may be a slight increase in adverse effects when women are treated with GnRHas, compared to placebo or gestrinone. Due to a very low to low certainty of the evidence, a wide range of outcome measures and a wide range of outcome measurement instruments, the results should be interpreted with caution.
Topics: Female; Humans; Endometriosis; Danazol; Progestins; Gestrinone; Dysmenorrhea; Calcium; Dyspareunia; Pelvic Pain; Calcium, Dietary; Drug-Related Side Effects and Adverse Reactions; Gonadotropin-Releasing Hormone
PubMed: 37341141
DOI: 10.1002/14651858.CD014788.pub2 -
Gynecological Endocrinology : the... Sep 2016Adenomyosis is a heterogeneous gynaecologic condition with a range of clinical presentations, the most common being heavy menstrual bleeding and dysmenorrhoea; however,... (Review)
Review
Adenomyosis is a heterogeneous gynaecologic condition with a range of clinical presentations, the most common being heavy menstrual bleeding and dysmenorrhoea; however, patients can also be asymptomatic. Several studies support the theory that adenomyosis results from invasion of the endometrium into the myometrium, causing alterations in the junctional zone. These changes are commonly seen on imaging studies, such as transvaginal ultrasound and magnetic resonance imaging. The aim of this review is to discuss the medical approach to the management of adenomyosis symptoms, including pain and abnormal uterine bleeding. The standard treatment of adenomyosis is hysterectomy, but there is no medical therapy to treat the symptoms of adenomyosis while still allowing patients to conceive. Medical therapies using suppressive hormonal treatments, such as continuous use of oral contraceptive pills, high-dose progestins, selective oestrogen receptor modulators, selective progesterone receptor modulators, the levonorgestrel-releasing intrauterine device, aromatase inhibitors, danazol, and gonadotrophin receptor hormone agonists can temporarily induce regression of adenomyosis and improve the symptoms.
Topics: Adenomyosis; Female; Humans
PubMed: 27379972
DOI: 10.1080/09513590.2016.1197200 -
The Cochrane Database of Systematic... 2003Endometriosis is the finding of endometrial glands or stroma in sites other than the uterine cavity. Endometriosis appears to be an estrogen dependent condition. This... (Review)
Review
BACKGROUND
Endometriosis is the finding of endometrial glands or stroma in sites other than the uterine cavity. Endometriosis appears to be an estrogen dependent condition. This hormonal dependency has prompted the therapeutic use of ovulation suppression agents, in an effort to improve subsequent fertility.
OBJECTIVES
To determine the effectiveness of a) ovulation suppression with danazol, medroxy progesterone acetate, gestrinone, combined oral contraceptive pills and GnRH analogues versus placebo or no treatment and b) any of the above agents versus danazol, for the treatment of endometriosis-associated subfertility.
SEARCH STRATEGY
We searched the Cochrane Menstrual Disorders and Subfertility Group trial register (searched 30 April 2002), the Cochrane Central Register of Controlled Trials (Cochrane Library, Issue 2, 2002), MEDLINE (January 1966 to December 1998), EMBASE (January 1985 to December 1997) and reference lists of articles. We also contacted manufacturers and researchers in the field.
SELECTION CRITERIA
Trials comparing the interventions described above, were included if allocation to treatment was based on a random process. Six RCTs with seven treatment arms compared an ovulation suppression agent with placebo or no treatment. Ten trials were identified comparing a suppressive agent with danazol.
DATA COLLECTION AND ANALYSIS
Relevant data were extracted independently by two reviewers using the standardised data extraction sheet. Validity was assessed in terms of method of randomisation, completeness of follow-up, presence or absence of crossover and co-intervention. 2 x 2 tables were generated for all relevant outcomes. Odds ratios were generated using the Peto modified Mantel-Haenszel technique. Statistical heterogeneity was assessed using Breslow-Day X2.
MAIN RESULTS
The odds ratio for pregnancy following ovulation suppression versus placebo or no treatment was 0.74 (95%CI 0.48 to 1.15). These data were statistically homogeneous, despite the use of a variety of suppression agents. They suggest no statistically significant benefit from treatment. The odds ratio for pregnancy following all agents versus danazol, the most commonly used agent prior to the advent of gonadotropin releasing hormone agonists (GnRHa), was 1.3 (95% CI 0.97 to 1.76). When GnRHa and danazol were directly compared, the odds ratio for pregnancy across six trials, was similar to the summary statistic for all ten studies: 1.29 (95% CI 0.9 to 1.85). Again, this suggests no statistically significant difference between these interventions.
REVIEWER'S CONCLUSIONS
These results rule out a benefit of more than a 15% increase in odds, and do not justify the risk of side effects when used as therapy for endometriosis-associated subfertility.
Topics: Danazol; Endometriosis; Estrogen Antagonists; Female; Fertility Agents, Female; Humans; Infertility, Female; Ovulation; Randomized Controlled Trials as Topic
PubMed: 12917884
DOI: 10.1002/14651858.CD000155 -
The Cochrane Database of Systematic... Jan 2007The synthetic androgen Danazol, was developed in the 1970's as a treatment for endometriosis. Its use was soon advocated in women with unexplained subfertility. Two... (Review)
Review
BACKGROUND
The synthetic androgen Danazol, was developed in the 1970's as a treatment for endometriosis. Its use was soon advocated in women with unexplained subfertility. Two randomised trials were subsequently conducted to assess the effectiveness of danazol in this population.
OBJECTIVES
The objective of this review was to assess the effect of danazol on live birth rate in women with unexplained subfertility.
SEARCH STRATEGY
We searched the Cochrane Menstrual Disorders and Sub-fertility Group's specialised register of trials (searched November , 2006) the Cochrane Register of Controlled Trials (The Cochrane Library, Issue 4, 2006), MEDLINE (1966-November 2006), EMBASE (1980 - November 2006) and reference lists of articles.
SELECTION CRITERIA
Randomised trials of danazol compared with placebo or no treatment in women with unexplained subfertility.
DATA COLLECTION AND ANALYSIS
Data were extracted by two reviewers EH and GT.
MAIN RESULTS
Two trials involving seventy-one women were included. There was no statistically significant difference in the live birth/ ongoing pregnancy rate between danazol and placebo at the end of treatment (OR 1.16, 95% CI 0.0 to 8.29; P=0.36) or at the end of follow-up (OR 2.41; 95% CI 0.59, 9.82; P=0.22). There was no significant difference in clinical pregnancies following treatment (OR 0.14, 95% CI 0.01, 2.26; P=0.17), however there were significantly more clinical pregnancies during the follow-up period in the danazol group compared with the placebo group (OR 3.15, 95%CI 0.98, 10.10; P<0.05). Multiple side effects were reported.
AUTHORS' CONCLUSIONS
Available data demonstrate no evidence of the benefit of danazol for unexplained subfertility. Although there is insufficient evidence to be certain of this, the need for contraception during treatment and the adverse effects and costs of danazol, make its use for this problem unwarranted. The increased pregnancy rate in the long term follow-up data may be attributable to additional therapies and did not influence the live birth/ongoing pregnancy data.
Topics: Danazol; Estrogen Antagonists; Female; Humans; Infertility, Female
PubMed: 17253444
DOI: 10.1002/14651858.CD000069.pub2 -
The Cochrane Database of Systematic... 2000The androgen, Danazol, was developed in the 1970's as a treatment for endometriosis. Its use was soon advocated in women with unexplained infertility. Two randomized... (Review)
Review
BACKGROUND
The androgen, Danazol, was developed in the 1970's as a treatment for endometriosis. Its use was soon advocated in women with unexplained infertility. Two randomized trials were subsequently conducted to assess the effectiveness of danazol in this population.
OBJECTIVES
The objective of this review was to assess the effects of danazol on pregnancy rates in women with unexplained subfertility.
SEARCH STRATEGY
The Cochrane Subfertility Review Group specialised register of controlled trials was searched.
SELECTION CRITERIA
Randomised trials of danazol compared with placebo or no treatment in women with unexplained subfertility.
DATA COLLECTION AND ANALYSIS
Data were extracted by two reviewers.
MAIN RESULTS
Two trials involving 68 women were involved. There was no difference found in pregnancy rate between danazol and placebo (odds ratio 2.57, 95% confidence 0.53 to 12.46).
REVIEWER'S CONCLUSIONS
There is not enough evidence to evaluate the effect of danazol on pregnancy rates in women with unexplained subfertility. The need to use contraception during danazol treatment, adverse effects and costs are additional considerations.
Topics: Danazol; Estrogen Antagonists; Female; Humans; Infertility, Female
PubMed: 10796484
DOI: 10.1002/14651858.CD000069 -
Current Problems in Cardiology Nov 2021Recurrent gastrointestinal bleeding (GIB) is a common complication following left ventricular assist device (LVAD) implantation. Our study aimed to estimate the... (Meta-Analysis)
Meta-Analysis Review
Recurrent gastrointestinal bleeding (GIB) is a common complication following left ventricular assist device (LVAD) implantation. Our study aimed to estimate the comparative efficacy of different pharmacologic interventions for the prevention of GIB, through a network meta-analysis (NMA). A total of 13 observational studies comparing six strategies. Among those, 4 were for primary, and 9 were for secondary prevention of GIB. On NMA, thalidomide (Hazard ratio [HR]: 0.016, Credible interval [CrI]I: 0.00053-0.12), omega-3-fatty acid (HR:0.088, CrI: 0.026-0.77), octreotide (HR: 0.17, CrI: 0.0589-0.41) and danazol (HR:0.17, CrI: 0.059-0.41) reduced the risk of GIB. The use of angiotensin-converting enzyme inhibitors/angiotensin II receptor blocker (ACEi/ARB) and digoxin were not associated with any significant reduction. Based on NMA, combining indirect treatment comparisons, thalidomide, danazol, and octreotide treatments were associated with decreased risk of recurrent GIB. Additionally, Omega 3 fatty acids were associated with a lower risk of the primary episode of GIB in the LVAD patient population.
Topics: Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Gastrointestinal Hemorrhage; Heart Failure; Heart-Assist Devices; Humans; Network Meta-Analysis; Retrospective Studies; Secondary Prevention
PubMed: 33992428
DOI: 10.1016/j.cpcardiol.2021.100835 -
Obstetrics and Gynecology Feb 2023To assess which interventions are effective in reducing fluid absorption at the time of hysteroscopy. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To assess which interventions are effective in reducing fluid absorption at the time of hysteroscopy.
DATA SOURCE
Ovid MEDLINE, Ovid EMBASE, PubMed (non-MEDLINE records only), EBM Reviews-Cochrane Central Register of Controlled Trials (CENTRAL), ClinicalTrials.gov , and Web of Science were searched from inception to February 2022 without restriction on language or geographic origin.
METHODS OF STUDY SELECTION
Following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, all English-language, full-text articles reporting fluid balance, with an intervention and comparator arm, were included. Title and abstract screening and full-text review were completed independently by two authors. Conflicts were resolved through discussion and consensus. Studies' risk of bias was assessed using the Cochrane Risk of Bias Tool for RCTs and the Newcastle-Ottawa Scale for observational studies.
TABULATION, INTEGRATION, AND RESULTS
The search identified 906 studies, 28 of which were eligible for inclusion, examining the following interventions: gonadotropin-releasing hormone (GnRH) agonist; ulipristal acetate; vasopressin; danazol; oxytocin; and local, general, and regional anesthesia. A significant reduction in mean fluid absorption was seen in patients preoperatively treated with danazol (-175.7 mL, 95% CI -325.4 to -26.0) and a GnRH agonist (-139.68 mL, 95% CI -203.2, -76.2) compared with patients in a control group. Ulipristal acetate and type of anesthesia showed no difference. Data on type of anesthesia and vasopressin use were not amenable to meta-analysis; however, four studies favored vasopressin over control regarding fluid absorption. Mean operative time was reduced after preoperative treatment with ulipristal acetate (-7.1 min, 95% CI -11.31 to -2.9), danazol (-7.5 min, 95% CI -8.7 to -6.3), and a GnRH agonist (-3.3 min, 95% CI -5.6 to -0.98).
CONCLUSION
Preoperative treatment with a GnRH agonist and danazol were both found to be effective in reducing fluid absorption and operative time across a range of hysteroscopic procedures. High-quality research aimed at evaluating other interventions, such as combined hormonal contraception, progestin therapy, and vasopressin, are still lacking in the literature.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO, CRD42021233804.
Topics: Pregnancy; Female; Humans; Danazol; Gonadotropin-Releasing Hormone; Hysteroscopy
PubMed: 36649319
DOI: 10.1097/AOG.0000000000005051 -
The Cochrane Database of Systematic... Jul 2009Uterine fibroids (myomas, fibromyomas, leiomyomas) are the most common benign tumours of the female genital tract. Danazol, a synthetic isoxazole derivative chemically... (Review)
Review
BACKGROUND
Uterine fibroids (myomas, fibromyomas, leiomyomas) are the most common benign tumours of the female genital tract. Danazol, a synthetic isoxazole derivative chemically related to 17-ethinyl testosterone, has been used for many years for the treatment of women with uterine fibroids.
OBJECTIVES
To evaluate the effectiveness and safety of danazol in women with uterine fibroids.
SEARCH STRATEGY
We searched the Cochrane Menstrual Disorders and Subfertility Review Group Specialised Register; Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2008, Issue 4); MEDLINE; EMBASE; Chinese Biomedical Disc; and the China National Knowledge Infrastructure for relevant trials (to December 2008). Attempts were made to identify trials from references in published studies. We also searched for ongoing trials in the five major clinical trials registries.
SELECTION CRITERIA
Randomised controlled trials of danazol versus placebo or any other medical therapy in women with uterine fibroids confirmed by medical procedures, regardless of the women's symptoms or age. Women with malignancies were excluded.
DATA COLLECTION AND ANALYSIS
Data extraction and risk of bias assessment were not been performed because there were no identified studies.
MAIN RESULTS
We did not identify any studies which met our full inclusion criteria.
AUTHORS' CONCLUSIONS
There is no reliable evidence available from randomised controlled trials regarding the benefits and or harms of the use of danazol for treating uterine fibroids.
Topics: Danazol; Estrogen Antagonists; Female; Humans; Leiomyoma; Uterine Neoplasms
PubMed: 19588442
DOI: 10.1002/14651858.CD007692.pub2