-
The Cochrane Database of Systematic... Oct 2007Endometriosis is defined as the presence of endometrial tissue (stromal and glandular) outside the normal uterine cavity. Conventional medical and surgical treatments... (Review)
Review
BACKGROUND
Endometriosis is defined as the presence of endometrial tissue (stromal and glandular) outside the normal uterine cavity. Conventional medical and surgical treatments for endometriosis aim to remove or decrease the deposits of ectopic endometrium. The observation that hyper androgenic states (an excess of male hormone) induce atrophy of the endometrium has led to the use of androgens in the treatment of endometriosis. Danazol is one of these treatments. The efficacy of danazol is based on its ability to produce a high androgen and low oestrogen environment (a pseudo menopause) which results in atrophy of the endometriotic implants and thus an improvement in painful symptoms.
OBJECTIVES
To determine the effectiveness of danazol compared to placebo or no treatment in the treatment of the symptoms and signs, other than infertility, of endometriosis in women of reproductive age.
SEARCH STRATEGY
We searched the Cochrane Menstrual Disorders and Subfertility Group Specialised Register of trials (searched April 2007), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2007), and MEDLINE (1966 to April 2007). In addition, all reference lists of included trials were searched, and relevant drug companies were contacted for details of unpublished trials.
SELECTION CRITERIA
Randomised controlled trials in which danazol (alone or as adjunctive therapy) was compared to placebo or no therapy. Trials which only reported infertility outcomes were excluded.
DATA COLLECTION AND ANALYSIS
Only five trials met the inclusion criteria and two authors independently extracted data from these trials. All trials compared danazol to placebo. Three trials used danazol as sole therapy and three trials used danazol as an adjunct to surgery. Although the main outcome was pain improvement other data relating to laparoscopic scores and hormonal parameters were also collected.
MAIN RESULTS
Treatment with danazol (including adjunctive to surgical therapy) was effective in relieving painful symptoms related to endometriosis when compared to placebo. Laparoscopic scores were improved with danazol treatment (including as adjunctive therapy) when compared with either placebo or no treatment. Side effects were more commonly reported in those patients receiving danazol than for placebo.
AUTHORS' CONCLUSIONS
Danazol is effective in treating the symptoms and signs of endometriosis. However, its use is limited by the occurrence of androgenic side effects.
Topics: Danazol; Endometriosis; Estrogen Antagonists; Female; Humans; Pelvic Pain; Randomized Controlled Trials as Topic
PubMed: 17943735
DOI: 10.1002/14651858.CD000068.pub2 -
The Cochrane Database of Systematic... 2001Endometriosis is defined as the presence of endometrial tissue (stromal and glandular) outside the normal uterine cavity. Conventional medical and surgical treatments... (Review)
Review
BACKGROUND
Endometriosis is defined as the presence of endometrial tissue (stromal and glandular) outside the normal uterine cavity. Conventional medical and surgical treatments for endometriosis aim to remove or decrease deposits of ectopic endometrium. The observation that hyperandrogenic states (an excess of male hormone) induce atrophy of the endometrium has led to the use of androgens in the treatment of endometriosis. Danazol is one of these treatments used. The efficacy of danazol is based on its ability to produce a high androgen/low estrogen environment (a pseudo menopause) which results in the atrophy of endometriotic implants and thus an improvement in painful symptoms.
OBJECTIVES
To determine the effectiveness of danazol compared to placebo or no treatment in the treatment of the symptoms and signs, other than infertility, of endometriosis in women of reproductive age.
SEARCH STRATEGY
The Menstrual Disorders Group search strategy was used to identify randomised controlled trials of the use of danazol in endometriosis. In addition, all reference lists of included trials were searched, and relevant drug companies were contacted for details of unpublished trials
SELECTION CRITERIA
Randomised controlled trials in which danazol (alone or as adjunctive therapy) was compared to placebo or no therapy. Trials which only reported infertility outcomes were excluded.
DATA COLLECTION AND ANALYSIS
Only four trials met the inclusion criteria and two authors extracted data independently from these trials. All four trials compared danazol to placebo. Two trials used danazol as sole therapy and two trials used danazol as an adjunct to surgery. Although the main outcome was pain improvement other data relating to laparoscopic scores and hormonal parameters were also collected.
MAIN RESULTS
Treatment with danazol (including adjunctive surgical therapy) was effective in relieving painful symptoms related to endometriosis when compared to placebo. Laparoscopic scores were improved with danazol treatment (including adjunctive therapy) when compared with either placebo or no treatment. Side effects were more commonly reported in those patients receiving danazol than placebo.
REVIEWER'S CONCLUSIONS
Danazol is effective in treating the symptoms and signs of endometriosis. However, its use is limited by the occurrence of androgenic side effects.
Topics: Danazol; Endometriosis; Estrogen Antagonists; Female; Humans; Pelvic Pain; Randomized Controlled Trials as Topic
PubMed: 11687066
DOI: 10.1002/14651858.CD000068 -
The Cochrane Database of Systematic... 2000Endometriosis is defined as the presence of endometrial tissue (stromal and glandular) outside the normal uterine cavity. Conventional medical and surgical treatments... (Review)
Review
BACKGROUND
Endometriosis is defined as the presence of endometrial tissue (stromal and glandular) outside the normal uterine cavity. Conventional medical and surgical treatments for endometriosis aim to remove or decrease deposits of ectopic endometrium. The observation that hyperandrogenic states (an excess of male hormone) induce atrophy of the endometrium has led to the use of androgens in the treatment of endometriosis. Danazol is one of these treatments used. The efficacy of danazol is based on its ability to produce a high androgen/low estrogen environment (a pseudo menopause) which results in the atrophy of endometriotic implants and thus an improvement in painful symptoms.
OBJECTIVES
To determine the effectiveness of danazol compared to placebo or no treatment in the treatment of the symptoms and signs, other than infertility, of endometriosis in women of reproductive age.
SEARCH STRATEGY
The Menstrual Disorders Group search strategy was used to identify randomised controlled trials of the use of danazol in endometriosis. In addition, all reference lists of included trials were searched, and relevant drug companies were contacted for details of unpublished trials
SELECTION CRITERIA
Randomised controlled trials in which danazol (alone or as adjunctive therapy) was compared to placebo or no therapy. Trials which only reported infertility outcomes were excluded.
DATA COLLECTION AND ANALYSIS
Only four trials met the inclusion criteria and two authors extracted data independently from these trials. All four trials compared danazol to placebo. Two trials used danazol as sole therapy and two trials used danazol as an adjunct to surgery. Although the main outcome was pain improvement other data relating to laparoscopic scores and hormonal parameters were also collected.
MAIN RESULTS
Treatment with danazol (including adjunctive surgical therapy) was effective in relieving painful symptoms related to endometriosis when compared to placebo. Laparoscopic scores were improved with danazol treatment (including adjunctive therapy) when compared with either placebo or no treatment. Side effects were more commonly reported in those patients receiving danazol than placebo.
REVIEWER'S CONCLUSIONS
Danazol is effective in treating the symptoms and signs of endometriosis. However, its use is limited by the occurrence of androgenic side effects.
Topics: Danazol; Endometriosis; Estrogen Antagonists; Female; Humans; Pelvic Pain
PubMed: 10796483
DOI: 10.1002/14651858.CD000068 -
The Cochrane Database of Systematic... 2002Heavy menstrual bleeding (HMB) is an important cause of ill health in pre menopausal women. Medical therapy, with the avoidance of possibly unnecessary surgery is an... (Review)
Review
BACKGROUND
Heavy menstrual bleeding (HMB) is an important cause of ill health in pre menopausal women. Medical therapy, with the avoidance of possibly unnecessary surgery is an attractive treatment option, but there is considerable variation in practice and uncertainty about the most effective therapy. Danazol is a synthetic steroid with anti-oestrogenic and anti progestogenic activity, and weak androgenic properties. Danazol suppresses oestrogen and progesterone receptors in the endometrium, leading to endometrial atrophy (thinning of the lining of the uterus) and reduced menstrual loss and to amenorrhoea in some women.
OBJECTIVES
To determine the effectiveness and tolerability of danazol when used for heavy menstrual bleeding in women of reproductive years.
SEARCH STRATEGY
All studies which might describe randomised controlled trials of danazol for the treatment of heavy menstrual bleeding were obtained by electronic searches of MEDLINE, EMBASE, Current Contents, CINAHL, National Research Register and the Menstrual Disorders and Subfertility Group's Specialist Register of controlled trials (on 6 November 2001). Attempts were also made to identify trials from citation lists of included trials and relevant review articles. In most cases the first author of each included trial was contacted for unpublished additional information.
SELECTION CRITERIA
Randomised controlled trials of danazol versus placebo, any other medical (non-surgical) therapy or danazol in different dosages for heavy menstrual bleeding in women of reproductive age with regular HMB measured either subjectively or objectively. Trials that included women with post menopausal bleeding, intermenstrual bleeding and pathological causes of heavy menstrual bleeding were excluded.
DATA COLLECTION AND ANALYSIS
Nine RCTs, with 353 women, were identified that fulfilled the inclusion criteria for this review. Quality assessment and data extraction were performed independently by two reviewers. The main outcomes were menstrual blood loss, the number of women experiencing adverse effects, weight gain, withdrawals due to adverse effects and dysmenorrhoea. If data could not be extracted in a form suitable for meta-analysis, they were presented in a descriptive format.
MAIN RESULTS
Most data were not in a form suitable for meta analysis, and the results are based on a small number of trials, all of which are under-powered. Danazol appears to be more effective than placebo, progestogens, NSAIDs and the OCP at reducing MBL, but confidence intervals were wide. Treatment with danazol caused more adverse events than NSAIDs (OR 7.0; 95% CI 1.7, 28.2) and progestogens (OR 4.05, 95% CI 1.6, 10.2), but this did not appear to affect adherence to treatment. Danazol was shown to significantly lower the duration of menses when compared with NSAIDs (WMD -1.0; 95% CI -1.8, -0.3) and a progesterone releasing IUD (WMD -6.0; 95% CI -7.3, -4.8). There were no randomised trials comparing danazol with tranexamic acid or the levonorgestrel-releasing intrauterine system.
REVIEWER'S CONCLUSIONS
Danazol appears to be an effective treatment for heavy menstrual bleeding compared to other medical treatments, though it is uncertain whether it is acceptable to women. The use of danazol may be limited by its side effect profile, its acceptability to women and the need for continuing treatment. Overall no strong recommendations can be made due to the small number of trials, and the small sample sizes of the included trials.
Topics: Danazol; Estrogen Antagonists; Female; Humans; Menorrhagia; Randomized Controlled Trials as Topic
PubMed: 12076401
DOI: 10.1002/14651858.CD001017 -
The Journal of the American Osteopathic... Apr 1980
Review
Topics: Danazol; Depression, Chemical; Endometriosis; Female; Gonadotropins, Pituitary; Gynecomastia; Humans; Male; Ovary; Pregnadienes; Priapism; Puberty, Precocious
PubMed: 6988373
DOI: No ID Found -
Seminars in Arthritis and Rheumatism Feb 2011To review and summarize published information on the use, effectiveness, and adverse effects of danazol in patients with systemic lupus erythematosus (SLE). (Review)
Review
OBJECTIVES
To review and summarize published information on the use, effectiveness, and adverse effects of danazol in patients with systemic lupus erythematosus (SLE).
METHODS
A MEDLINE search from January 1950 to July 2009 was conducted using 2 search strategies retrieving 51 and 62 references, respectively. We also searched 2 standard reference textbooks and bibliographies of the 38 articles selected.
RESULTS
Of the 38 articles selected, there were 19 case series/reports with a total of 153 patients, including 2 prospective trials of 7 and 16 patients, respectively, and 1 randomized controlled trial of 40 patients. Danazol has been used successfully in the treatment of hematologic manifestations of SLE such as thrombocytopenia, Evan's syndrome, autoimmune hemolytic anemia, and a case of red cell aplasia. Thirteen patients responded to danazol after failing splenectomy. There is limited information on the use of danazol in nonhematologic manifestations of SLE. Adverse effects were generally tolerable but high doses may produce undesirable side effects for female patients.
CONCLUSIONS
Danazol is a useful drug in the treatment of SLE patients, especially in patients with refractory thrombocytopenia, autoimmune hemolytic anemia, and premenstrual flares, and in some mild nonhematologic manifestations of SLE. It appears to be relatively well tolerated, safe, and efficacious.
Topics: Danazol; Estrogen Antagonists; Humans; Lupus Erythematosus, Systemic; Treatment Outcome
PubMed: 20541792
DOI: 10.1016/j.semarthrit.2010.03.005 -
American Journal of Hematology Feb 1997Paroxysmal nocturnal hemoglobinuria (PNH) is a rare clonal stem-cell disorder in which blood cells lack complement inhibiting membrane proteins, and become susceptible... (Review)
Review
Paroxysmal nocturnal hemoglobinuria (PNH) is a rare clonal stem-cell disorder in which blood cells lack complement inhibiting membrane proteins, and become susceptible to complement-mediated injury, leading to chronic intravascular hemolysis and pancytopenia. Glucocorticoids have been a mainstay of therapy. For patients refractory to glucocorticoids and requiring blood transfusions, an alternative therapy is needed. We studied danazol therapy in 5 patients refractory to other treatments. Four of the 5 benefited, showing rise in hematocrit and eventual cessation of transfusion requirements. Remissions lasted > or =2 years in 3 and 10 years in 1 patient. Danazol was well-tolerated without serious side effects. Danazol appears to be a good alternative treatment in PNH.
Topics: Adolescent; Adult; Circadian Rhythm; Danazol; Female; Hemoglobinuria, Paroxysmal; Humans; Male; Middle Aged; Remission Induction
PubMed: 9034290
DOI: 10.1002/(sici)1096-8652(199702)54:2<149::aid-ajh9>3.0.co;2-x -
Acta Haematologica 1990Danazol, an attenuated androgen developed for the treatment of endometriosis, has recently been found useful in the treatment of several hematologic disorders, including... (Review)
Review
Danazol, an attenuated androgen developed for the treatment of endometriosis, has recently been found useful in the treatment of several hematologic disorders, including idiopathic thrombocytopenic purpura (ITP), autoimmune hemolytic anemia (AIHA), paroxysmal nocturnal hemoglobinuria, myelodysplastic syndrome, and others. Our studies of the past 6 years have demonstrated that danazol is advantageous in the treatment of AIHA, and in specifically defined populations of ITP patients. Of 96 ITP patients treated with danazol 61% overall had excellent/good responses, but this rate varied markedly with prognostic factors, e.g. 82% in older women versus only 18% in younger women. Of 28 AIHA patients, 77% with idiopathic type and 60% with secondary type were excellent/good responders. When the drug was discontinued after 1 year or more of therapy, lasting unmaintained remissions of up to 5 years were often observed in both ITP and AIHA, a notably important benefit. The side-effects of danazol are generally much less serious than with glucocorticoids. Glucocorticoids can be tapered off and in most cases discontinued completely with danazol therapy in AIHA and chronic ITP. Approximately one third of ITP patients who failed on glucocorticoids are successfully maintained on danazol. Its mechanism of action in these disorders is currently under study in our laboratory, stimulated by new findings. Tentatively, danazol appears to modify cell membranes in a manner leading to specific immune modulations, as discussed. Further study is warranted to explore its application to other autoimmune and membrane-related disorders, and to clarify its mechanism of therapy.
Topics: Adjuvants, Immunologic; Adult; Aged; Anemia, Hemolytic; Autoimmune Diseases; Cell Membrane; Danazol; Female; Hematologic Diseases; Humans; Male; Middle Aged; Purpura, Thrombocytopenic
PubMed: 2123061
DOI: 10.1159/000205048 -
Annals of Internal Medicine Aug 1982
Topics: Danazol; Humans; Pregnadienes
PubMed: 7103299
DOI: 10.7326/0003-4819-97-2-286_1 -
Vaginally Administered Danazol: An Overlooked Option in the Treatment of Rectovaginal Endometriosis?Journal of Obstetrics and Gynaecology... Dec 2015Danazol has been used in the treatment of endometriosis and heavy menstrual bleeding for more than 40 years. This medication has both central antigonadotropic actions... (Review)
Review
Danazol has been used in the treatment of endometriosis and heavy menstrual bleeding for more than 40 years. This medication has both central antigonadotropic actions and direct atrophic effects on endometriotic tissue. Although it demonstrates a high-efficacy profile, the associated side effects have resulted in limited usage. Vaginal administration of the drug may prove favourable specifically in rectovaginal endometriosis. This targeted mode of delivery is associated with a significant reduction in both pain symptoms and nodule size. The relative persistence of these therapeutic benefits is likely related to the direct tissue effects after absorption through the vaginal mucosa. Vaginal administration would also limit systemic propagation of danazol and thus should minimize androgenic side effects. Use of vaginal danazol also improves heavy menstrual bleeding and may even restore fertility in some patients. In this review we provide a critical analysis of the existing literature on the use of vaginal danazol.
Topics: Administration, Intravaginal; Danazol; Endometriosis; Estrogen Antagonists; Female; Humans
PubMed: 26637082
DOI: 10.1016/s1701-2163(16)30075-5