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The Cochrane Database of Systematic... Mar 2015Uterine fibroids (also known as leiomyomas) are the most common benign pelvic tumours among women. They may be asymptomatic, or may be associated with pelvic symptoms... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Uterine fibroids (also known as leiomyomas) are the most common benign pelvic tumours among women. They may be asymptomatic, or may be associated with pelvic symptoms such as bleeding and pain. Medical treatment of this condition is limited and gonadotropin-releasing hormone (GnRH) analogues are the most effective agents. Long-term treatment with such agents, however, is restricted due to their adverse effects. The addition of other medications during treatment with GnRH analogues, a strategy known as add-back therapy, may limit these side effects. There is concern, however, that add-back therapy may also limit the efficacy of the GnRH analogues and that it may not be able to completely prevent their adverse effects.
OBJECTIVES
To assess the short-term (within 12 months) effectiveness and safety of add-back therapy for women using GnRH analogues for uterine fibroids associated with excessive uterine bleeding, pelvic pain, or urinary symptoms.
SEARCH METHODS
We searched electronic databases including the Cochrane Menstrual Disorders and Subfertility Group (MDSG) Specialised Register, CENTRAL, MEDLINE, PubMed, EMBASE, LILACS, CINAHL, PsycINFO; and electronic registries of ongoing trials including ClinicalTrials.gov, Current Controlled Trials, World Health Organization (WHO) International Clinical Trials Registry Platform. All searches were from database inception to 16 June 2014.
SELECTION CRITERIA
Randomized controlled trials (RCTs) that included women with uterine fibroids experiencing irregular or intense uterine bleeding, cyclic or non-cyclic pelvic pain, or urinary symptoms, and that compared treatment with a GnRH analogue plus add-back therapy versus a GnRH analogue alone or combined with placebo were eligible for inclusion.
DATA COLLECTION AND ANALYSIS
Two authors independently reviewed the identified titles and abstracts for potentially eligible records. Two review authors reviewed eligible studies and independently extracted data. Two authors independently assessed the studies' risk of bias. They assessed the quality of the evidence using GRADE criteria.
MAIN RESULTS
Fourteen RCTs were included in the review. Data were extracted from 12 studies (622 women). The primary outcome was quality of life (QoL).Add-back therapy with medroxyprogesterone (MPA): no studies reported QoL or uterine bleeding. There was no evidence of effect in relation to bone mass (standardized mean difference (SMD) 0.38, 95% confidence interval (CI) -0.62 to 1.38, 1 study, 16 women, P = 0.45, low quality evidence) and MPA was associated with a larger uterine volume (mean difference (MD) 342.19 cm(3), 95% CI 77.58 to 606.80, 2 studies, 32 women, I(2) = 0%, low quality evidence).Tibolone: this was associated with a higher QoL but the estimate was imprecise and the effect could be clinically insignificant, small or large (SMD 0.47, 95% CI 0.09 to 0.85, 1 study, 110 women, P = 0.02, low quality evidence). It was also associated with a decreased loss of bone mass, which could be insignificant, small or moderate (SMD 0.36, 95% CI 0.03 to 0.7, 3 studies, 160 women, I(2) = 7%, moderate quality evidence). Tibolone may, however, have been associated with larger uterine volumes (MD 23.89 cm(3), 95% CI= 8.13 to 39.66, 6 studies, 365 women, I(2) = 0%, moderate quality evidence) and more uterine bleeding (results were not combined but three studies demonstrated greater bleeding with tibolone while two other studies demonstrated no bleeding in either group). Four studies (268 women; not pooled owing to extreme heterogeneity) reported a large benefit on vasomotor symptoms in the tibolone group.Raloxifene: there was no evidence of an effect on QoL (SMD 0.11, 95% CI -0.57 to 0.34, 1 study, 74 women, P = 0.62, low quality evidence), while there was a beneficial impact on bone mass (SMD 1.01, 95% CI 0.57 to 1.45, 1 study, 91 women, P < 0.00001, low quality evidence). There was no clear evidence of effect on uterine volume (MD 27.1 cm(3), 95% CI -17.94 to 72.14, 1 study, 91 women, P = 0.24, low quality evidence), uterine bleeding or severity of vasomotor symptoms (MD 0.2 hot flushes/day, 95% CI -0.34 to 0.74, 1 study, 91 women, P = 0.46, low quality evidence).Estriol: no studies reported QoL, uterine size, uterine bleeding or vasomotor symptoms. Add-back with estriol may have led to decreased loss of bone mass, from results of a single study (SMD 3.93, 95% CI 1.7 to 6.16, 1 study, 12 women, P = 0.0005, low quality evidence).Ipriflavone: no studies reported QoL, uterine size or uterine bleeding. Iproflavone was associated with decreased loss of bone mass in a single study (SMD 2.71, 95% CI 2.14 to 3.27, 1 study, 95 women, P < 0.00001, low quality evidence); there was no evidence of an effect on the rate of vasomotor symptoms (RR 0.67, 95% Cl 0.44 to 1.02, 1 study, 95 women, P = 0.06, low quality evidence).Conjugated estrogens: no studies reported QoL, uterine size, uterine bleeding or vasomotor symptoms. One study suggested that adding conjugated estrogens to GnRH analogues resulted in a larger decrease in uterine volume in the placebo group (MD 105.2 cm(3), 95% CI 27.65 to 182.75, 1 study, 27 women, P = 0.008, very low quality evidence).Nine of 12 studies were at high risk of bias in at least one domain, most commonly lack of blinding. All studies followed participants for a maximum of six months. This short-term follow-up is usually insufficient to observe any significant effect of the treatment on bone health (such as the occurrence of fractures), limiting the findings.
AUTHORS' CONCLUSIONS
There was low or moderate quality evidence that tibolone, raloxifene, estriol and ipriflavone help to preserve bone density and that MPA and tibolone may reduce vasomotor symptoms. Larger uterine volume was an adverse effect associated with some add-back therapies (MPA, tibolone and conjugated estrogens). For other comparisons, outcomes of interest were not reported or study findings were inconclusive.
Topics: Antineoplastic Agents, Hormonal; Bone Density; Bone Density Conservation Agents; Drug Therapy, Combination; Estriol; Female; Gonadotropin-Releasing Hormone; Humans; Isoflavones; Leiomyoma; Medroxyprogesterone; Norpregnenes; Quality of Life; Raloxifene Hydrochloride; Randomized Controlled Trials as Topic; Uterine Hemorrhage; Uterine Neoplasms
PubMed: 25793972
DOI: 10.1002/14651858.CD010854.pub2 -
PloS One 2015To identify non-invasive tools for diagnosis of the major potentially life-threatening gynaecological emergencies (G-PLEs) reported in previous studies, and to assess... (Review)
Review
OBJECTIVE
To identify non-invasive tools for diagnosis of the major potentially life-threatening gynaecological emergencies (G-PLEs) reported in previous studies, and to assess their diagnostic accuracy.
METHODS
MEDLINE; EMBASE; Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library) were searched to identify all eligible studies published in English or French between January 1990 and December 2012. Studies were considered eligible if they were primary diagnostic studies of any designs, with a gold standard and with sufficient information for construction of a 2 × 2 contingency table, concerning at least one of the following G-PLEs: complicated ectopic pregnancy, complicated pelvic inflammatory disease, adnexal torsion and haemoperitoneum of any gynaecological origin. Extraction of data and assessment of study quality were conducted by two independent reviewers. We set the thresholds for the diagnostic value of signs retrieved at Sensibility ≥ 95% and LR-≤ 0.25, or Specificity ≥ 90% and LR+ ≥ 4.
RESULTS
We identified 8288 reports of diagnostic studies for the selected G-PLEs, 45 of which met the inclusion criteria. The methodological quality of the included studies was generally low. The most common diagnostic tools evaluated were transvaginal ultrasound (20/45), followed by medical history (18/45), clinical examination (15/45) and laboratory tests (14/45). Standardised questioning about symptoms, systolic blood pressure<110 mmHg, shock index>0.85, identification of a mass by abdominal palpation or vaginal examination, haemoglobin concentration <10 g/dl and six ultrasound and Doppler signs presented high performances for the diagnosis of G-PLEs. Transvaginal ultrasound was the diagnostic tool with the best individual performance for the diagnosis of all G-PLEs.
CONCLUSION
This systematic review suggests that blood pressure measurement, haemoglobin tests and transvaginal ultrasound are cornerstone examinations for the diagnosis of G-PLEs that should be available in all gynaecological emergency care services. Standardised questioning about symptoms could be used for triage of patients.
Topics: Adult; Diagnostic Techniques and Procedures; Emergencies; Female; Female Urogenital Diseases; Humans; Pregnancy; Pregnancy Complications; Sensitivity and Specificity
PubMed: 25723401
DOI: 10.1371/journal.pone.0114189 -
BMC Women's Health Jan 2015Uterine leiomyoma is the most common gynecological tumor in the reproductive years. However, it is extremely rare in adolescence (<1%), with few reports found in the... (Review)
Review
BACKGROUND
Uterine leiomyoma is the most common gynecological tumor in the reproductive years. However, it is extremely rare in adolescence (<1%), with few reports found in the literature. The biological behavior of such tumors in this age group is unknown, as well as the best possible treatment for this population. We aimed to analyze all available reports of uterine leiomyoma in adolescence.
METHODS
A systematic review was performed at PubMed/MEDLINE and EMBASE. Between 1965 and 2014, 19 reports were found on uterine leiomyoma in patients under 18 years. The following parameters were discussed: age, tumor diameter, symptoms, clinical treatments, surgical treatments, hemodynamic changes.
RESULTS
Mean age was 15.35 (14-17) years. Mean tumor diameter was 12.28 cm (3-30) and median diameter was 10 cm. Most patients presented with symptoms (87.5%), including abnormal uterine bleeding (10/18) and pelvic/abdominal pain (6/18). A pelvic mass was the most common finding. Two patients required transfusion due to anemia. One patient underwent abdominal hysterectomy, and the others underwent myomectomy. Mean follow-up was 1 year and 8 months, and only case recurred, after 6 months.
CONCLUSION
Leiomyomas' biologic behavior in adolescents may be different from that of older women, but their molecular characteristics still haven't been analyzed. Optimal treatment is still not defined, but myomectomy has several advantages in this population. Leiomyomas must be remembered as an important differential diagnosis of pelvic mass in adolescents.
Topics: Adolescent; Diagnosis, Differential; Disease Management; Female; Humans; Leiomyoma; Uterine Myomectomy; Uterine Neoplasms
PubMed: 25609056
DOI: 10.1186/s12905-015-0162-9 -
Annals of Internal Medicine Dec 2014Previous research has supported screening for gonorrhea and chlamydia in asymptomatic, sexually active women (including pregnant women) who are younger than 25 years or... (Review)
Review
BACKGROUND
Previous research has supported screening for gonorrhea and chlamydia in asymptomatic, sexually active women (including pregnant women) who are younger than 25 years or at increased risk but not in other patient populations.
PURPOSE
To update the 2005 and 2007 systematic reviews for the U.S. Preventive Services Task Force on screening for gonorrhea and chlamydia in men and women, including pregnant women and adolescents.
DATA SOURCES
MEDLINE (1 January 2004 to 13 June 2014), Cochrane databases (May 2014), ClinicalTrials.gov, and reference lists.
STUDY SELECTION
English-language trials and observational studies about screening effectiveness, test accuracy, and screening harms.
DATA EXTRACTION
Extracted study data were confirmed by a second investigator, and study quality and applicability were dual-rated using prespecified criteria.
DATA SYNTHESIS
Screening a subset of asymptomatic young women for chlamydia in a good-quality trial did not significantly reduce the incidence of pelvic inflammatory disease over the following year (relative risk, 0.39 [95% CI, 0.14 to 1.08]); however, 1 previous trial reported a reduction. An observational study evaluating a risk prediction tool to identify persons with chlamydia in high-risk populations had low predictive ability and applicability. In 10 new studies of asymptomatic patients, nucleic acid amplification tests demonstrated sensitivity of 86% or greater and specificity of 97% or greater for diagnosing gonorrhea and chlamydia, regardless of specimen type or test.
LIMITATIONS
There were few relevant studies of screening benefits and harms. Only screening tests and methods cleared by the U.S. Food and Drug Administration for current clinical practice were included to determine diagnostic accuracy.
CONCLUSION
Chlamydia screening in young women may reduce the incidence of pelvic inflammatory disease. Nucleic acid amplification tests are accurate for diagnosing gonorrhea and chlamydia in asymptomatic persons.
PRIMARY FUNDING SOURCE
Agency for Healthcare Research and Quality.
Topics: Asymptomatic Diseases; Bacteriological Techniques; Chlamydia Infections; Female; Gonorrhea; Humans; Male; Mass Screening; Nucleic Acid Amplification Techniques; Risk Factors
PubMed: 25244000
DOI: 10.7326/M14-1022