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Hartmann KE, Jerome RN, Lindegren ML, et al. Primary Care Management of Abnormal Uterine Bleeding [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Mar. (Comparative Effectiveness Reviews, No. 96.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

Appendix OSystematic Reviewsa

Review Title
Author, Year
Review Type
Intervention
Findings
Efficacy of tranexamic acid in the treatment of idiopathic and non-functional heavy menstrual bleeding: A systematic review.

Naoulou et al., 20121
Systematic review of 10 studies (5 double-blind RCTs; 2 RCTs; 1 prospective cohort; 1 comparative; 1 observational study)

Tranexamic acid
"Available evidence indicates that tranexamic acid therapy in women with idiopathic menorrhagia resulted in 34–54% reduction in menstrual blood loss. Following tranexamic acid treatment, patient's quality-of-life parameters improved by 46–83%, compared with 15–45% for norethisterone treatment. When compared with placebo, tranexamic acid use significantly decreased the blood loss by 70% in women with menorrhagia secondary to an intrauterine device (p<0.001). Limited evidence indicated potential benefit in fibroid patients with menorrhagia. No thromboembolic event was reported in all studies analyzed."
Tranexamic acid therapy for heavy menstrual bleeding.

Lumsden and Wedisinghe, 20112
Systematic review

Tranexamic acid
"Although several treatment options are available for HMB, tranexamic acid is particularly useful in women who either desire immediate pregnancy or for whom hormonal treatment is inappropriate. Tranexamic acid is a well-tolerated, cost-effective drug that reduces menstrual blood loss in the range of 34-59%. It improves the health-related quality of life in women in HMB."
Effective treatment of heavy and/or prolonged menstrual bleeding without organic cause: pooled analysis of two multinational, randomised, double-blind, placebo-controlled trials of oestradiol valerate and dienogest.

Fraser et al., 20113
Pooled analysis of 2 RCTs (421 women in ITT population)

Estradiol valerate / dienogest
Mean blood loss reduced in women with heavy and/or prolonged menstrual bleeding, and the effect is seen at the first withdrawal bleed after initiation of treatment. The effect is consistent across a larger and more diverse population of women.

"Although not directly comparable, the median decrease in MBL achieved by treatment cycle 7 with E2V/DNG treatment (88%) appears to approach that achieved with the LNG-IUS (median 95% and 96% reduction) over six cycles in two studies that also used the alkaline haematin method to objectively assess blood loss in women with heavy menstrual bleeding."
Cost-effectiveness and quality of life associated with heavy menstrual bleeding among women using the levonorgestrel-releasing intrauterine system.

Blumenthal et al., 20114
Review

LNG-IUS
"Treating heavy menstrual bleeding with the LNG-IUS was found to be cost-effective in various countries and settings. Moreover, irrespective of the measuring instrument used, health-related quality-of-life outcomes were found to be improved to a degree similar to that achieved with endometrial ablation or hysterectomy. In some cases, the LNG-IUS appeared to be more effective and less costly than the surgical options."
Systematic review highlights difficulty interpreting diverse clinical outcomes in abnormal uterine bleeding trials.

Rahn et al., 20115
Systematic review

Includes medical and surgical interventions
" Many interventions for abnormal uterine bleeding (AUB) are tested in clinical trials, but the large number and diversity of outcomes reported limit the ability to compare treatments across trials… There is a dearth of standardized outcome measures in AUB that identify symptoms of importance to patients. Further research is required to develop validated measures that capture patient-based outcomes, are responsive to change, yet feasible to use in future trials."
Clinical practice guidelines on menorrhagia: management of abnormal uterine bleeding before menopause.

Marret et al., 20106
Clinical practice guidelines"In idiopathic AUB, the first-line treatment is medical, with efficacy ranked as follows: levonorgestrel IUD, tranexamic acid, oral contraceptives, either estrogens and progestins or synthetic progestins only, 21 days a month, or NSAIDs. When hormone treatment is contraindicated or immediate pregnancy is desired, tranexamic acid is indicated. Iron must be included for patients with iron-deficiency anemia. For women who do not wish to become pregnant in the future and who have idiopathic AUB, the long-term efficacy of conservative surgical treatment is greater than that of oral medical treatment. Placement of a levonorgestrel IUD (or administration of tranexamic acid by default) is recommended for women with idiopathic AUB. If this fails, a conservative surgical technique must be proposed…"
Chinese Herbal Medicine for Dysfunctional Uterine Bleeding: a Meta-analysis.

Tu et al., 20097
Meta-analysis

Chinese herbal medicine (CHM) and conventional Western medicine (CWM)
"Trials of CHM treatments with CWM treatments were compared with CWM treatments alone. Jadad scale and allocation concealment were used to assess the quality of included studies. Four RCTs or quasi-RCTs involving 525 patients were included. The methodological quality was poor in all trials except one trial. No serious adverse events were reported in the included studies. With the lack of trials comparing CHM with no treatment or placebo, it is impossible to accurately evaluate the efficacy of CHM. However, CHM in these studies seem to show an encouraging comparative effectiveness with CWM. More RCTs with a higher quality are required."
The experience of heavy menstrual bleeding: a systematic review and meta-ethnography of qualitative studies.

Garside et al., 20088
Systematic review and meta-ethnography"These provided support for the fourth paper's conceptual framework of a lay model of heavy menstrual bleeding which shows little overlap with the traditional clinical definition. Details of physical, practical and emotional elements of this model were identified. A matrix of uncertainties were identified suggesting reasons why women may or may not seek medical help for heavy menstrual bleeding. Women and healthcare professionals may conspire to privilege blood loss over other symptoms and the disease model of heavy menstrual bleeding is little help to either."
Abnormal uterine bleeding: a review of patient-based outcome measures.

Matteson et al., 20099
Systematic review of patient-based outcome measures (983 studies, 80 eligible)"Fifty different instruments were used to evaluate amount of bleeding, bleeding-related symptoms, or menstrual bleeding-specific quality of life. The quality of each of these instruments was evaluated on eight psychometric properties. The majority of instruments had no documentation of reliability, precision, or feasibility. There was no satisfactory evidence that any one instrument completely addressed all eight psychometric properties."
A systematic review evaluating health-related quality of life, work impairment, and health-care costs and utilization in abnormal uterine bleeding.

Liu et al., 200710
Systematic review to evaluate the impact of AUB on health-related quality of life and to quantify the economic burden from a societal perspective"The prevalence of AUB among women of reproductive age ranged from 10% to 30%. The HRQoL scores from the 36-item Short-Form Health Survey Questionnaire (SF-36) suggested that women with AUB have HRQoL below the 25th percentile of that for the general female population within a similar age range. The conservatively estimated annual direct and indirect economic costs of AUB were approximately $1 billion and $12 billion, respectively. These figures do not account for intangible costs and productivity loss due to presenteeism."
Current treatment of dysfunctional uterine bleeding.

Bongers et al., 200411
Review"Antifibrinolytic tranexamic acid is the most effective medical therapy to treat dysfunctional uterine bleeding. In general medical therapy is not as effective as endometrial resection in terms of patient satisfaction and health related quality of life. The levonorgestrel releasing intra uterine device is an effective treatment for dysfunctional uterine bleeding. No difference in quality of life was observed in patients treated with a levonorgestrel releasing intra uterine device as compared to hysterectomy."
Quality of life instruments in studies of menorrhagia: a systematic review.

Clark et al., 200212
Systematic review

Quality of life instruments
"A total of 19 articles, 8 on instrument development and 11 on application, were included in the review. The generic Short Form 36 Health Survey Questionnaire (SF36) was used in 12/19 (63%) studies. Only two studies developed new specific QoL instruments for menorrhagia but they complied with 7/17 (41%) and 10/17 (59%) of the quality criteria. Quality assessment showed that only 7/19 (37%) studies complied with more than half the criteria for face validity whereas 17/19 (90%) studies complied with more than half of the criteria for measurement properties (P = 0.0001)."
ACOG practice bulletin: management of anovulatory bleeding (2001)

American College of Obstetricians and Gynecologists13
"The treatment of choice for anovulatory uterine bleeding is medical therapy with oral contraceptives. Cyclic progestins also are effective. (Level A evidence)"
The effectiveness of the levonorgestrel-releasing intrauterine system in menorrhagia: a systematic review.

Stewart et al., 200114
Systematic review (5 controlled trials and 5 case series)

LNG-IUS
"Small studies of moderate quality indicate the LNG-IUS is an effective treatment for menorrhagia. Costs may be less than for tranexamic acid in primary and secondary care. Although its use may reduce surgical waiting lists, cost effectiveness assessment requires longer follow up."
Thrombotic risks of oral contraceptives.


Rott, 201215
Review

Contraceptive vaginal ring
“The venous thromboembolism risk for transdermal COCs like vaginal ring (Nuvaring) or patch (Evra) is as high as for COCs of third or fourth generation.” “Second-generation COCs should be first choice when prescribing hormonal contraception”
Contraceptive vaginal rings: a review.

Brache and Faundes, 201016
Systematic review“The incidence of estrogen-related adverse events such as breast tenderness, headache and nausea was similar between the NuvaRing and COC users. The only difference… was the higher incidences of loca events such as leucorrhea, vaginitis, vaginal discomfort and ring-related events (foreign body sensation, coital problems, expulsions).” (In Ring users)
Combined hormonal contraception and bone health: a systematic review.


Martins et al., 200617
Systematic review (one vaginal ring cohort study)

Contraceptive vaginal ring
“…measured changes in BMD among 105 users of a combined CRV (Nuvaring, 15 μg EE/120 μg etongestrel daily)and 39 nonhormonal contraceptive users aged 18-35 years. Over 24 months, BMD at the spine and femoral neck did not change significantly in the ring group but increases in the control group (NuvaRing vs control, p<0.0001). Because differences in BMD between the two groups were within 1 S.D. of each other, the study authors did not consider them to be clinically relevant.”

References

1.
Naoulou B, Tsai MC. Efficacy of tranexamic acid in the treatment of idiopathic and non-functional heavy menstrual bleeding: A systematic review. Acta Obstet Gynecol Scand. 2012 May;91(5):529–37. [PubMed: 22229782]
2.
Lumsden MA, Wedisinghe L. Tranexamic acid therapy for heavy menstrual bleeding. Expert Opin Pharmacother. 2011 Sep;12(13):2089–95. [PubMed: 21767224]
3.
Fraser IS, Parke S, Mellinger U, et al. Effective treatment of heavy and/or prolonged menstrual bleeding without organic cause: pooled analysis of two multinational, randomised, double-blind, placebo-controlled trials of oestradiol valerate and dienogest. Eur J Contracept Reprod Health Care. 2011 Aug;16(4):258–69. [PMC free article: PMC3154543] [PubMed: 21774563]
4.
Blumenthal PD, Dawson L, Hurskainen R. Cost-effectiveness and quality of life associated with heavy menstrual bleeding among women using the levonorgestrel-releasing intrauterine system. Int J Gynaecol Obstet. 2011 Mar;112(3):171–8. [PubMed: 21269626]
5.
Rahn DD, Abed H, Sung VW, et al. Society of Gynecologic Surgeons Systematic Review Group. Systematic review highlights difficulty interpreting diverse clinical outcomes in abnormal uterine bleeding trials. J Clin Epidemiol. 2011 Mar;64(3):293–300. [PMC free article: PMC3057176] [PubMed: 20705427]
6.
Marret H, Fauconnier A, Chabbert-Buffet N, et al. Clinical practice guidelines on menorrhagia: management of abnormal uterine bleeding before menopause. Eur J Obstet Gynecol Reprod Bio. 2010 Oct;152(2):133–7. [PubMed: 20688424]
7.
Tu X, Huang G, Tan S. Chinese Herbal Medicine for Dysfunctional Uterine Bleeding: a Meta-analysis. Evid Based Complement Alternat Med. 2009 Mar;6(1):99–105. [PMC free article: PMC2644269] [PubMed: 18955223]
8.
Garside R, Britten N, Stein K. The experience of heavy menstrual bleeding: a systematic review and meta-ethnography of qualitative studies. J Adv Nurs. 2008 Sep;63(6):550–62. [PubMed: 18808575]
9.
Matteson KA, Boardman LA, Munro MG, et al. Abnormal uterine bleeding: a review of patient-based outcome measures. Fertil Steril. 2009 Jul;92(1):205–16. [PMC free article: PMC2746391] [PubMed: 18635169]
10.
Liu Z, Doan QV, Blumenthal P, et al. A systematic review evaluating health-related quality of life, work impairment, and health-care costs and utilization in abnormal uterine bleeding. Value Health. 2007 May-Jun;10(3):183–94. [PubMed: 17532811]
11.
Bongers MY, Mol BW, Brolmann HA. Current treatment of dysfunctional uterine bleeding. Maturitas. 2004 Mar 15;47(3):159–74. [PubMed: 15036486]
12.
Clark TJ, Khan KS, Foon R, et al. Quality of life instruments in studies of menorrhagia: a systematic review. Eur J Obstet Gynecol Reprod Biol. 2002 Sep 10;104(2):96–104. [PubMed: 12206918]
13.
ACOG Committee on Practice Bulletins--Gynecology. ACOG Practice Bulletin No. 14: management of anovulatory bleeding. Int J Gynaecol Obstet. 2001 Mar;72(3):263–71. [PubMed: 11296797]
14.
Stewart A, Cummins C, Gold L, et al. The effectiveness of the levonorgestrel-releasing intrauterine system in menorrhagia: a systematic review. BJOG. 2001 Jan;108(1):74–86. [PubMed: 11213008]
15.
Rott H. Thrombotic risks of oral contraceptives. Curr Opin Obstet Gynecol. 2012 Aug;24(4):235–40. [PubMed: 22729096]
16.
Brache V, Faundes A. Contraceptive vaginal rings: a review. Contraception. 2010 Nov;82(5):418–27. [PubMed: 20933115]
17.
Martins SL, Curtis KM, Glasier AF. Combined hormonal contraception and bone health: a systematic review. Contraception. 2006 May;73(5):445–69. [PubMed: 16627030]

Footnotes

a

Does not include systematic reviews published by the Cochrane Collaboration or reviews of interventions (e.g., surgical intervention, medical treatments not used in primary care) or populations (e.g., women with bleeding due to fibroids or systemic disease, post-menopausal women, acute bleeding, etc.) outside the scope of this review.

Cover of Primary Care Management of Abnormal Uterine Bleeding
Primary Care Management of Abnormal Uterine Bleeding [Internet].
Comparative Effectiveness Reviews, No. 96.
Hartmann KE, Jerome RN, Lindegren ML, et al.

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