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Annals of Allergy, Asthma & Immunology... Apr 2015To provide an objective basis for evaluating the risk-benefit ratio of long-term androgen use in patients with hereditary angioedema (HAE). (Review)
Review
OBJECTIVE
To provide an objective basis for evaluating the risk-benefit ratio of long-term androgen use in patients with hereditary angioedema (HAE).
DATA SOURCES
PubMed was searched with no time limitations using the keywords hereditary angioedema or angio-oedema combined with danazol, stanozolol, and androgen.
STUDY SELECTION
Qualifying articles were English-language reports of androgen use in patients with HAE, with relevant safety and/or efficacy information. Reports were categorized according to level of evidence (LOE).
RESULTS
The search process identified 153 citations, 63 of which contained relevant information; 2 additional publications were identified while other citations were being reviewed. Fifteen LOE 2 studies and multiple LOE 4 reports provided efficacy data, confirming a high level of prophylactic efficacy for androgen therapy in HAE, with occasional reports of poor prophylactic response. Common adverse events include weight gain, menstrual irregularities, virilization, headaches, myalgias or cramps, mood changes, and elevations in creatine phosphokinase level, liver function test results, and serum lipid level. The risk of adverse events is often correlated with dose and/or treatment duration. Rare cases of hepatic adenomas and hepatocellular carcinoma associated with long-term androgen use often had no preceding changes in liver function test results.
CONCLUSION
Androgen therapy may be effective for most patients with HAE; however, potential risks and adverse effects must be carefully considered and discussed with patients when considering options for long-term HAE prophylaxis.
Topics: Androgens; Angioedemas, Hereditary; Animals; Danazol; Drug Dosage Calculations; Female; Humans; Lipid Metabolism; Menstruation Disturbances; Obesity; Risk Assessment; Stanozolol; Time Factors; Virilism
PubMed: 25707325
DOI: 10.1016/j.anai.2015.01.003 -
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... Sep 2019Heavy 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...
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
To determine the effectiveness, safety and tolerability of NSAIDs in achieving a reduction in menstrual blood loss (MBL) in women of reproductive years with HMB.
SEARCH METHODS
We searched, in April 2019, the Cochrane Gynaecology and Fertility specialised register, Cochrane Central Register of Studies Online (CENTRAL CRSO), MEDLINE, Embase, PsycINFO, the clinical trial registries and reference lists of articles.
SELECTION CRITERIA
The inclusion criteria were randomised comparisons of individual NSAIDs or combined with other medical therapy with 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 HMB.
DATA COLLECTION AND ANALYSIS
We identified 19 randomised controlled trials (RCTs) (759 women) that fulfilled the inclusion criteria for this review and two review authors independently extracted data. We estimated odds ratios (ORs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes from the data of nine trials. We described in data tables 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. One trial had no data available for analysis.
MAIN RESULTS
As a group, NSAIDs were more effective than placebo at reducing HMB but less effective than 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, based on trials from 1980 to 1990. However, currently danazol is not a usual or recommended treatment for HMB. There was no clear evidence of difference between NSAIDs and the other treatments (oral luteal progestogen, ethamsylate, an older progesterone-releasing intrauterine system and the oral contraceptive pill (OCP), but most studies were underpowered. There was no evidence of a difference between the individual NSAIDs (naproxen and mefenamic acid) in reducing HMB. The evidence quality ranged from low to moderate, the main limitations being risk of bias and imprecision.
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, there was no clear evidence of a difference in efficacy between NSAIDs and other medical treatments such as oral luteal progestogen, ethamsylate, OCP or the older progesterone-releasing intrauterine system.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Contraceptives, Oral, Combined; Dysmenorrhea; Female; Humans; Menorrhagia; Naproxen; Progesterone; Randomized Controlled Trials as Topic
PubMed: 31535715
DOI: 10.1002/14651858.CD000400.pub4 -
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 -
Journal of Primary Health Care Dec 2018INTRODUCTION Idiopathic mastalgia (benign breast pain of unknown origin) is often poorly managed because of its subjective nature and unclear aetiology. Mastalgia is a...
INTRODUCTION Idiopathic mastalgia (benign breast pain of unknown origin) is often poorly managed because of its subjective nature and unclear aetiology. Mastalgia is a reason for up to 50% of breast outpatient referrals. Existing systematic reviews discuss dated treatment options that provide limited symptomatic relief. METHODS A systematic review was conducted for aetiology and treatment of idiopathic mastalgia in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidance. Databases such as PubMed, MEDLINE, Cochrane Database and the Clinical Trial Registry were searched (February 2016). RESULTS Reassurance plus bra-fitting advice provides relief for most women. If symptoms persist, addition of topical non-steroidal anti-inflammatory drugs (NSAIDs) provides relief in 70-92% of women. There is some benefit in reducing dietary coffee and fat intake. Medical treatments have serious side-effects (often androgenic or menopausal) and should be considered only in cases resistant to simpler measures. Dopamine agonists are useful, but less effective than endocrine treatments such as Danazol or Tamoxifen. Of the Selective Oestrogen Receptor Modulator drugs, Ormeloxifene appears most effective, but is not licenced in the United Kingdom. Relaxation therapy, acupuncture and kinesiology may be useful but currently lack good evidence of effectiveness. DISCUSSION First-line management of breast pain should be explanation, reassurance and a bra-fitting advice. Subsequent drug therapy should be balanced against its side-effects; topical NSAIDs and Ormeloxifene show greatest benefit with least side-effects. Newer agents (Ormeloxifene) currently being used for mastalgia in India could be considered in the developed world.
Topics: Female; Humans; Mastodynia; Risk Factors
PubMed: 31039960
DOI: 10.1071/HC18026 -
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 -
Revista Brasileira de Ginecologia E... Oct 2022Different drugs are used to treat mastalgia, such as danazol and bromocriptine, and both are associated with side effects, due to which most of women and healthcare... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Different drugs are used to treat mastalgia, such as danazol and bromocriptine, and both are associated with side effects, due to which most of women and healthcare providers are interested in herbal medicines. Therefore we aim to study the effectiveness of phytoestrogens on the severity of cyclic mastalgia.
METHODS
To carry out the present study, English electronic resources such as the Cochrane Library, ISI Web of Science, Scopus, and PubMed were used systematically and with no time limitation up to February 10, 2020.
RESULTS
In total, 20 studies were included in the present meta-analysis. The results of the meta-analysis showed that herbal medicines versus the control group (standard mean difference [SMD] = - 0.585; 95% confidence interval [CI]: - 0.728-- 0.44; heterogeneity; = 0.02; I2 = 42%), herbal medicines versus the B group (SMD = - 0.59; 95%CI: - 0.75-- 0.44; heterogeneity; = 0.03; I2 = 42%), and its subgroups, such as phytoestrogen (SMD = - 0.691; 95%CI: - 0.82-- 0.55; heterogeneity; = 0.669; I2 = 0%), Vitex-agnus-castus (SMD = - 0.642; 95%CI: - 0.84-- 0.44; < 0.001; = 203; I2 = 32%), flaxseed (SMD = - 0.63; 95%CI: - 0.901-- 0.367; = 0.871; I2 = 0%), and evening primrose (SMD= - 0.485; 95%CI:- 0.84-- 0.12; = 0.008; heterogeneity; = 0.06; I2 = 56%] may have effective and helpful effects on improving cyclic breast mastalgia. Also, chamomile, isoflavone, cinnamon, and nigella sativa significantly reduced mastalgia symptoms.
CONCLUSION
Herbal medicines and their subgroups may have effective and helpful effects on improving cyclic breast mastalgia. The findings of our meta-analysis must be done cautiously because low methodological quality in some evaluated studies of this systematic review.
Topics: Female; Humans; Mastodynia; Plants, Medicinal; Breast; Plant Extracts
PubMed: 36446563
DOI: 10.1055/s-0042-1755456 -
The Cochrane Database of Systematic... Feb 2019Menorrhagia or heavy menstrual bleeding (HMB) is an excessive blood loss that impairs a woman's quality of life, either physical, emotional, social or material. It is... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Menorrhagia or heavy menstrual bleeding (HMB) is an excessive blood loss that impairs a woman's quality of life, either physical, emotional, social or material. It is benign and not associated with pregnancy or any other gynaecological or systemic disease. Medical treatments used to reduce excessive menstrual blood loss (MBL) include prostaglandin synthetase inhibitors, antifibrinolytics, oral contraceptive pills, and other hormones. The combined oral contraceptive pill (COCP) is claimed to have a variety of beneficial effects, inducing a regular shedding of a thinner endometrium and inhibiting ovulation, thus having the effect of both treating HMB and providing contraception. More recently, a contraceptive vaginal ring (CVR) has been trialled to investigate whether this treatment can provide similar benefits to COCP while lessening hormonal systemic exposure. This review is an update of a review which originally focused on COCP alone. The scope of the review has been widened to consider other types of delivery of combined hormonal contraceptives for reduction of MBL.
OBJECTIVES
To determine the efficacy of combined hormonal contraceptives (pills, vaginal ring or patch) compared with other medical therapies, placebo, or no therapy in the treatment of HMB. A secondary objective was to compare the COCP with the CVR.
SEARCH METHODS
We searched the Gynecology and Fertility Group trials register, MEDLINE, Embase, CENTRAL, CINAHL and PsycINFO (search dates: Oct 1996, May 2002, June 2004, April 2006, June 2009, July 2017 and September 2018) for all randomised controlled trials (RCTs) of COCP and CVR for the treatment of HMB. We also searched trial registers and the reference lists of retrieved studies for additional trials.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) of the use of COCP or CVR compared with no treatment, placebo, or other medical therapies for women with HMB and regular menstrual cycles.
DATA COLLECTION AND ANALYSIS
All assessments of trial quality and data extraction were performed unblinded by at least two review authors. Our primary review outcomes were treatment success, menstrual bleeding (assessed objectively, semi-objectively or subjectively), and participant satisfaction with treatment. Secondary outcomes were adverse events, quality of life, and haemoglobin level.
MAIN RESULTS
We identified eight RCTs involving 805 participants. Two trials comparing COCP with placebo were considered to be moderate quality and the remaining studies were low to very low quality, mainly because of serious risk of bias from lack of blinding and concerns over precision.COCP versus placeboCOCP, with a step-down oestrogen and step-up progestogen regimen, improved response to treatment (return to menstrual 'normality') (OR 22.12, 95% CI 4.40 to 111.12; 2 trials; 363 participants; I = 50%; moderate-quality evidence), and lowered MBL (OR 5.15, 95% CI 3.16 to 8.40; 2 trials; 339 participants; I = 0%; moderate-quality evidence) when compared to placebo. The results suggested that, if the chance of 'successful' treatment was 3% in women taking placebo, then COCP increased this chance from 12% to 77% in women with unacceptable HMB. Minor adverse events, in particular breast pain, were more common with COCP. No study in this comparison reported semi-objectively assessed MBL or participant satisfaction with treatment.COCP versus other medical treatmentsNon-steroidal anti-inflammatory drugs (NSAIDs)There was insufficient evidence to determine whether the COCP reduced MBL when compared to NSAIDs (mefenamic acid and naproxen). No study in this comparison reported semi-objectively assessed MBL, subjectively assessed MBL, participant satisfaction with treatment or adverse events.Levonorgestrel-releasing intrauterine system (LNG IUS)The LNG IUS was more effective than COCP in reducing MBL (OR 0.21, 95% CI 0.09 to 0.48; 2 trials; 151 participants; I = 0%; low-quality evidence) but it was not clear whether satisfaction with treatment or adverse effects varied according to which treatment was used. No study in this comparison reported semi-objectively assessed MBL or subjectively assessed MBL.Contraceptive vaginal ring (CVR) versus other medical treatmentsCOCP COCP was compared with CVR in two trials. There were discrepancies between some of the findings and there was no evidence of a benefit for one treatment compared to the other for response to treatment, MBL or participant satisfaction with treatment. There was a greater likelihood of nausea with COCP. No study in this comparison reported objectively assessed MBL or subjectively assessed MBL.ProgestogensCVR was compared to long course progestogens in one trial. It is possible that CVR increased the odds of satisfaction; but we are uncertain whether CVR improved MBL. The evidence was based on small numbers of participants and was very low quality, so definitive conclusions could not be reached. No study in this comparison reported objectively assessed MBL, subjectively assessed MBL, or adverse events.
AUTHORS' CONCLUSIONS
Moderate-quality evidence suggests that the combined oral contraceptive pill over six months reduces HMB in women with unacceptable HMB from 12% to 77% (compared to 3% in women taking placebo). When compared with other medical options for HMB, COCP was less effective than the LNG IUS. Limited evidence suggested that COCP and CVR had similar effects. There was insufficient evidence to determine comparative efficacy of combined hormonal contraceptives with NSAIDs, or long course progestogens.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Contraceptive Agents, Female; Contraceptives, Oral, Combined; Danazol; Drug Therapy, Combination; Female; Humans; Intrauterine Devices, Medicated; Levonorgestrel; Mefenamic Acid; Menorrhagia; Naproxen; Nausea; Placebos; Progestins; Randomized Controlled Trials as Topic
PubMed: 30742315
DOI: 10.1002/14651858.CD000154.pub3 -
La Revue de Medecine Interne Aug 2019Ten to 15% of common variable immunodeficiencies (CVID) develop auto-immune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP). Treatment is based on...
INTRODUCTION
Ten to 15% of common variable immunodeficiencies (CVID) develop auto-immune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP). Treatment is based on immunosuppressants, which produce blocking effects in the CVID. Our objective was to assess their risk-benefit ratio in these immunocompromised patients.
METHODS
We identified 17 articles detailing the treatment of AIHA and/or ITP in patients suffering from CVID through a systematic review of the MEDLINE database.
RESULTS
The increased infectious risk with corticosteroids does not call into question their place in the first line of treatment of ITP and AIHA in CVID. High-doses immunoglobulin therapy remain reserved for ITP with a high risk of bleeding. In second-line treatment, rituximab appears to be effective, with a lower infectious risk than the splenectomy. Immunosuppressants (azathioprine, methotrexate, mycophenolate, cyclophosphamide, vincristine, ciclosporine) are moderately effective and often lead to severe infections, meaning that their use is justified only in resistant cases and steroid-sparing. Dapsone, danazol and anti-D immunoglobulins have an unfavorable risk-benefit ratio. The place of TPO receptor agonists is still to be defined. The establishment of immunoglobulin replacement in the place of immunosuppressants (except for short-term corticotherapy) or splenectomy appears to be essential to limit the risk of infections, including in the absence of previous infections.
CONCLUSION
The presence of CVID does not mean that it is necessary to give up on corticosteroids as a first-line treatment and rituximab as a second-line treatment for AIHA and ITP, but it should be in addition to immunoglobulin replacement. A splenectomy should be reserved as a third-line treatment.
Topics: Anemia, Hemolytic, Autoimmune; Common Variable Immunodeficiency; Danazol; Glucocorticoids; Humans; Immunoglobulins, Intravenous; Immunologic Factors; Immunosuppressive Agents; Purpura, Thrombocytopenic, Idiopathic; Receptors, Thrombopoietin; Rituximab; Splenectomy
PubMed: 31101329
DOI: 10.1016/j.revmed.2019.02.006 -
European Journal of Obstetrics,... Dec 2018To compare the efficacy of levonorgestrel releasing intrauterine system (LNG-IUS) with other treatments as a postoperative maintenance therapy for endometriosis in terms... (Comparative Study)
Comparative Study Meta-Analysis
OBJECTIVE
To compare the efficacy of levonorgestrel releasing intrauterine system (LNG-IUS) with other treatments as a postoperative maintenance therapy for endometriosis in terms of pain reduction, recurrence prevention, side effects and patients' satisfaction.
STUDY DESIGN
We searched MEDLINE, EMBASE, and the Cochrane Library from January 1986 until February 2018. Two evaluators independently extracted and reviewed prospective and retrospective articles based on pre-determined selection criteria. Outcomes were expressed as mean difference (MD), risk ratios (RR) or odds ratios (OR) in a meta-analysis model, using Revman software.
RESULTS
Among the 962 studies, 7 studies were selected: 7 studies included 4 randomized controlled trials with 212 patients, 1 prospective cohort study with 88 patients, and 2 retrospective studies with 191 patients. A meta-analysis showed that LNG-IUS was significantly effective in reducing pain after surgery (MD = 12.97, 95% confidence interval (CI): 5.55-20.39), with a comparable effect to gonadotropin-releasing hormone analogues (MD = -0.16, 95% CI: -2.02 to 1.70). LNG-IUS was also effective in decreasing the recurrence rate (RR = 0.40, 95% CI: 0.26-0.64), with an effect comparable to OC (OR = 1.00, 95% CI: 0.25-4.02) and danazol (RR = 0.30, 95% CI: 0.03-2.81). Furthermore, patients' satisfaction with LNG-IUS was significantly higher than that with OC (OR = 8.60, 95% CI: 1.03-71.86). However, vaginal bleeding was significantly higher in the LNG-IUS group than in the gonadotropin-releasing hormone analogue group (RR = 27.0, 95% CI: 1.71-425.36).
CONCLUSION
Our meta-analysis found a positive effect of LNG-IUS as a postoperative maintenance therapy for endometriosis on pain relief, prevention of dysmenorrhea recurrence, and patients' satisfaction.
Topics: Dysmenorrhea; Endometriosis; Female; Humans; Intrauterine Devices, Medicated; Levonorgestrel; MEDLINE; Pain Management; Patient Satisfaction; Postoperative Care; Prospective Studies; Randomized Controlled Trials as Topic; Recurrence; Retrospective Studies; Secondary Prevention; Uterine Hemorrhage
PubMed: 30336309
DOI: 10.1016/j.ejogrb.2018.10.014