Randomized trial of medical treatment versus hysterectomy for abnormal uterine bleeding: Resource use in the Medicine or Surgery (Ms) trial

doi:10.1016/j.ajog.2005.08.014

American Journal of Obstetrics and Gynecology

Volume 194, Issue 2, February 2006, Pages 332-338

https://doi.org/10.1016/j.ajog.2005.08.014 Get rights and content

Objective

This study was undertaken to compare resource use outcomes for participants in the Medicine or Surgery (Ms) randomized trial.

Study design

In a randomized controlled trial, we compared resources used during a 24-month follow-up period by women with abnormal uterine bleeding who were randomly assigned to either expanded medical treatment or hysterectomy.

Results

Women randomly assigned to hysterectomy used significantly more resources (medicine = $4479, hysterectomy = $6777; P = .03), with almost all the difference caused by the hysterectomy procedure. Fifty-three percent of women randomly assigned to medicine had a hysterectomy during the follow-up period; women who were able to continue on medical therapy had mean total resource use of $2595 compared with $6128 for medicine patients who eventually had surgery.

Conclusion

For women with abnormal uterine bleeding refractory to cyclic medroxyprogesterone acetate, compared with expanded medical treatment, hysterectomy increases resource use significantly and results in better clinical and 6-month quality-of-life outcomes.

Section snippets

Material and methods

The null hypothesis was that there would be no difference between randomly assigned groups in the amount or type of resources used during the 24 months after the date of randomization. The perspective of this analysis was relative resource use (not “costs” or “charges” to insurers, providers, or individual patients). The recruitment methods and study design,⁸ and clinical⁹ and quality-of-life¹⁰ outcomes, of the Ms trial have been reported, including a diagram of the flow of participants through

Results

The demographic characteristics, bleeding patterns, and preoperative diagnoses of subjects included in the analyses reported here are shown in Table I. Average age was 40.4 for medicine patients and 42.2 for hysterectomy patients (P = .19). Sixty-three percent of medicine patients and 50% of hysterectomy patients were black (P = .31); 37% of medicine patients and 39% of hysterectomy patients were high school graduates (P = .84); and having private insurance or belonging to an HMO was reported

Comment

We previously reported clinical and health-related quality-of-life outcomes for participants in the Ms trial.9, 10 In summary, for symptom improvement in patients with abnormal uterine bleeding refractory to MPA, hysterectomy was superior to continued efforts with expanded medical treatment at 6 months. Approximately half of the women randomly assigned to medicine chose to undergo a hysterectomy during the 2-year follow-up; they, too, experienced improvements as did the women who elected to

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Cited by (14)

Management of women with abnormal uterine bleeding: Clinical practice guidelines of the French National College of Gynaecologists and Obstetricians (CNGOF)
2023, European Journal of Obstetrics and Gynecology and Reproductive Biology
To provide French guidelines for the management of women with abnormal uterine bleeding (AUB).
A consensus committee of 26 experts was formed. A formal conflict-of-interest policy was developed at the beginning of the process and enforced throughout. The entire guidelines process was conducted independently of any industry funding (i.e. pharmaceutical or medical device companies). The authors were advised to follow the rules of the Grading of Recommendations Assessment, Development and Evaluation (GRADE®) system to guide assessment of quality of evidence. The potential drawbacks of making strong recommendations in the presence of low-quality evidence were emphasized.
The last guidelines from the Collège National des Gynécologues et Obstétriciens Français on the management of women with AUB were published in 2008. The literature seems now sufficient for an update. The committee studied questions within 7 fields (diagnosis; adolescents; idiopathic AUB; endometrial hyperplasia and polyps; type 0–2 fibroids; type 3 or higher fibroids; and adenomyosis). Each question was formulated in a PICO (Patients, Intervention, Comparison, Outcome) format and evidence profiles were compiled. The GRADE® methodology was applied to the literature review and the formulation of recommendations.
The experts' synthesis work and the application of the GRADE method resulted in 36 recommendations. Among the formalized recommendations, 19 are strong and 17 weak. No response was found in the literature for 14 questions. We chose to abstain from recommendations rather than providing advice based solely on expert clinical experience.
The 36 recommendations make it possible to specify the diagnostic and therapeutic strategies for various clinical situations practitioners encounter, from the simplest to the most complex.
Management of women with abnormal uterine bleeding: Clinical practice guidelines of the French National College of Gynecologists and Obstetricians (CNGOF)
2022, Gynecologie Obstetrique Fertilite et Senologie
Émettre des recommandations pour la prise en charge des femmes ayant des ménorragies.
Un comité de 26 experts a été constitué. Une politique de déclaration et de suivi des liens d’intérêts a été appliquée et respectée durant tout le processus de réalisation du référentiel. De même, celui-ci n’a bénéficié d’aucun financement provenant d’une entreprise commercialisant un produit de santé (médicament ou dispositif médical). Le comité devait respecter et suivre la méthode GRADE® (Grading of Recommendations Assessment, Development and Evaluation) pour évaluer la qualité des données factuelles sur lesquelles étaient fondées les recommandations.
Les dernières recommandations du Collège national des gynécologues et obstétriciens français (CNGOF) sur la prise en charge des femmes ayant des ménorragies ont été publiées en 2008. Nous avons souhaité réactualiser ces recommandations selon la méthodologie GRADE® en identifiant 7 champs différents (diagnostic ; adolescente ; ménorragies idiopathiques ; hyperplasie et polype de l’endomètre ; myomes de type 0 à 2 ; myomes de type 3 et plus ; adénomyose). Chaque question a été formulée selon le format PICO (Patients, Intervention, Comparison, Outcome). L’analyse de la littérature et les recommandations ont été formulées selon la méthodologie GRADE®.
Le travail de synthèse des experts et l’application de la méthode GRADE ont abouti à 36 recommandations. Parmi les recommandations, 19 ont été établies avec un accord fort et 17 avec un accord faible. Il n’a pas été possible de statuer pour 14 questions pour lesquelles nous avons préféré nous abstenir plutôt que de fournir des avis d’experts.
Les 36 recommandations ont permis de préciser les stratégies diagnostiques et thérapeutiques des différentes situations cliniques des plus simples au plus complexes rencontrées par le praticien.
To provide French guidelines for the management of women with abnormal uterine bleeding (AUB).
A consensus committee of 26 experts was formed. A formal conflict-of-interest (COI) policy was developed at the beginning of the process and enforced throughout. The entire guidelines process was conducted independently of any industrial funding (i.e. pharmaceutical, or medical devices). The authors were advised to follow the rules of the Grading of Recommendations Assessment, Development and Evaluation (GRADE®) system to guide assessment of quality of evidence. The potential drawbacks of making strong recommendations in the presence of low-quality evidence were emphasized.
The last guidelines from the Collège national des gynécologues et obstétriciens français (CNGOF) on the management of women with AUB was published in 2008. The literature seems now sufficient for an update. The committee studied questions within 7 fields (diagnosis; adolescent; idiopathic AUB; endometrial hyperplasia and polyps; fibroids type 0 to 2; fibroids type 3 and more; adenomyosis). Each question was formulated in a PICO (Patients, Intervention, Comparison, Outcome) format and the evidence profiles were produced. The literature review and recommendations were made according to the GRADE® methodology.
The experts’ synthesis work and the application of the GRADE method resulted in 36 recommendations. Among the formalized recommendations, 19 present a strong agreement and 17 a weak agreement. Fourteen questions did not find any response in the literature. We preferred to abstain from recommending instead of providing expert advice.
The 36 recommendations made it possible to specify the diagnostic and therapeutic strategies of various clinical situations managed by the practitioner, from the simplest to the most complex.
Evaluation and Management of Abnormal Uterine Bleeding
2019, Mayo Clinic Proceedings
Abnormal uterine bleeding (AUB) is a common condition that leads to increased health care costs and decreased quality of life. A systematic approach to AUB evaluation can simplify management and enhance women’s well-being. Abnormal uterine bleeding describes any variation from normal bleeding patterns in nonpregnant, reproductive-aged women beyond menarche lasting for at least 6 months. Ambiguous and inconsistent use of terminology and definitions to characterize AUB in the past decades necessitated a new, consensus-based approach to nomenclature and AUB evaluation. This led to the International Federation of Gynecology and Obstetrics (FIGO) System 1 in 2007, which standardized nomenclature, set parameters, and defined normal and abnormal bleeding based on the 5th to 95th percentile data from available large-scale epidemiologic studies. FIGO System 1, endorsed by several national and international societies, improved worldwide communication among educators, clinicians, and researchers. FIGO System 2, published in 2011, focused on classifications of AUB etiology into structural and nonstructural entities using the PALM-COEIN (polyp[s], adenomyosis, leiomyoma, malignancy, coagulopathy, ovulatory dysfunction, endometrial disorders, iatrogenic, and not yet classified) classification system. The PALM-COEIN classification is facilitated by a complete patient history combined with appropriate imaging, histopathologic analysis, or laboratory evaluation to ensure accurate diagnostic and treatment approaches to AUB. Herein we present the systematic evaluation of AUB.
Epidural corticosteroid injections as a possible cause of menorrhagia: A case report
2010, Pain Medicine
A 47-year-old female was referred for evaluation of chronic lower back pain. A magnetic resonance imaging of her lumbar spine revealed a broad-based disc herniation at L4–L5 with bilateral neural foraminal narrowing. A decision was made to treat her with bilateral L4–5 transforaminal epidural steroid injections. Following moderate pain relief, the procedure was repeated. Several days after each injection, the patient experienced unusually heavy and painful menstrual bleeding. We postulate that the introduction of exogenous corticosteroids directly into the neuraxial space can initiate a negative feedback loop on the hypothalamic–pituitary–ovarian axis. As a result, this may lead to decreased levels of circulating hormones, resulting in episodes of menorrhagia in the premenopausal population.
Surgery versus medical therapy for heavy menstrual bleeding
2016, Cochrane Database of Systematic Reviews
Abnormal uterine bleeding: Taking the stress out of controlling the flow
2015, Canadian Family Physician

View all citing articles on Scopus

This project was supported by grant number UO1 HS09478 from the Agency for Healthcare Research and Quality.

Reprints not available from the authors.

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General Obstetrics and Gynecology: GynecologyRandomized trial of medical treatment versus hysterectomy for abnormal uterine bleeding: Resource use in the Medicine or Surgery (Ms) trial

Objective

Study design

Results

Conclusion

Section snippets

Material and methods

Results

Comment

Hysterectomy rates in the United States 1990-1997

Obstet Gynecol

Hysterectomy surveillance—United States, 1994-1999

MMWR CDC Surveill Summ

Dysfunctional uterine bleeding: advances in diagnosis and treatment

Curr Opin Obstet Gynecol

Treatment of ovulatory and anovulatory dysfunctional uterine bleeding with oral progestogens

Aust N Z J Obstet Gynaecol

Triphasic norgestimate-ethinyl estradiol for treating dysfunctional uterine bleeding

Obstet Gynecol

Treatment of menorrhagia during menstruation: randomised controlled trial of ethamsylate, mefenamic acid, and tranexamic acid

BMJ

Reduction of menstrual blood loss in women suffering from idiopathic menorrhagia with a novel antifibrinolytic drug (Kabi 2161)

BJOG

Medicine or Surgery (Ms): a randomized clinical trial comparing hysterectomy and medical treatment in premenopausal women with abnormal uterine bleeding

Controlled Clin Trials

Hysterectomy versus expanded medical treatment for abnormal uterine bleeding: clinical outcomes in the Medicine or Surgery trial

Obstet Gynecol

Effect of hysterectomy versus medical treatment on health-related quality of life and sexual functioning: the Medicine or Surgery (Ms) randomized trial

JAMA

Methods to estimate and analyze medical care resource use: an example from liver transplantation

Int J Technol Assess Health Care

Physician ICD-9-CM 2004: International Classification of Diseases, Clinical Modification

General Obstetrics and Gynecology: Gynecology
Randomized trial of medical treatment versus hysterectomy for abnormal uterine bleeding: Resource use in the Medicine or Surgery (Ms) trial