This is the current release of the guideline.

Mastalgia (cyclical and non-cyclical breast pain)

Counseling
Management
Treatment

Family Practice
Obstetrics and Gynecology
Oncology
Psychiatry
Psychology

Patients
Physicians
Psychologists/Non-physician Behavioral Health Clinicians

To review the current management of women with breast pain

Women with mastalgia (cyclical and non-cyclical breast pain)

1. Patient education and reassurance
2. Use of a well-fitting support bra
3. Discontinuation or changes in dose, formation, or scheduling of hormone replacement therapy (HRT)
4. Flaxseed
5. Non-steroidal anti-inflammatory gel, such as diclofenac 2% in pluronic lethicin organogel (PLO)
6. Tamoxifen
7. Danazol

Note: The following interventions were discussed but not recommended: reduction in caffeine intake, vitamin E, evening primrose oil, mastectomy or partial mastectomy.

The following interventions were discussed, but no recommendation for or against was made: use of oral contraceptives, vitamin B6, low-fat diet, isoflavones, herbs such as ginseng and chasteberry, progesterone cream, and bromocriptine.

• Effective and timely management of women with breast pain
• Quality of life

Searches of Electronic Databases

A literature search was performed to identify reports published in English between 1975 and July 2003 using MEDLINE and Cochrane Database of Systematic Reviews.

Not stated

Weighting According to a Rating Scheme (Scheme Given)

Level of Evidence*

I: Evidence obtained from at least one properly designed randomized controlled trial.

II-1: Evidence from well-designed controlled trials without randomization.

II-2: Evidence from well-designed cohort (prospective or retrospective) or case–control studies, preferably from more than one centre or research group.

II-3: Evidence from comparisons between times or places with or without the intervention. Dramatic results from uncontrolled experiments (such as the results of treatment with penicillin in the 1940s) could also be included in this category.

III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.

*Adapted from the Evaluation of Evidence criteria described in the Canadian Task Force on the Periodic Health Exam.

Systematic Review

Not stated

Expert Consensus

Not stated

Classification of Recommendations*

1. There is good evidence to support the recommendation that the condition be specifically considered in a periodic health examination.
2. There is fair evidence to support the recommendation that the condition be specifically considered in a periodic health examination.
3. There is poor evidence regarding the inclusion or exclusion of the condition in a periodic health examination.
4. There is fair evidence to support the recommendation that the condition not be considered in a periodic health examination.
5. There is good evidence to support the recommendation that the condition be excluded from consideration in a periodic health examination.

*Adapted from the Classification of Recommendations criteria described in the Canadian Task Force on the Periodic Health Exam.

A formal cost analysis was not performed and published cost analyses were not reviewed.

Internal Peer Review

Comparison has been made with management protocols in the literature, but no clinical guidelines have been located. No formal clinical testing has taken place.

This guideline has been reviewed by the Breast Disease Committee and approved by the Executive and Council of the Society of Obstetricians and Gynecologists of Canada. This guideline has also been developed in collaboration with the Breast Health Centre, Winnipeg Regional Health Authority.

The level of evidence (I-III) and classification of recommendations (A-E) are defined at the end of the "Major Recommendations" field.

Mastalgia and Breast Cancer

Psychological Factors

1. Education and reassurance is an integral part of the management of mastalgia and should be the first-line treatment. (II-1 A)

Well-Fitting Support Bra

2. The use of a well-fitting bra that provides good support should be considered for the relief of cyclical and noncyclical mastalgia. (II-3 B)

Hormones

Hormone Replacement Therapy (HRT)

3. A change in dose, formulation, or scheduling should be considered for women on HRT. HRT may be discontinued if appropriate. (III C)

Caffeine

4. Women with breast pain should not be advised to reduce caffeine intake. (1 E)

Vitamins

Vitamin E

5. Vitamin E should not be considered for the treatment of mastalgia. (1 E)

Fat

Evening Primrose Oil (EPO)

6. There is presently insufficient evidence to recommend the use of EPO in the treatment of breast pain. (II-2 C)

Phytoestrogens

Flaxseed

7. Flaxseed should be considered as a first-line treatment for cyclical mastalgia. (I A)

Medications

Topical Non-Steroidal Anti-inflammatory Drugs

8. Topical, non-steroidal anti-inflammatory gel, such as diclofenac 2% in pluronic lethicin organogel (PLO), should be considered for pain control for localized treatment of mastalgia. (I A)

Tamoxifen and Danazol

9. Tamoxifen 10 mg daily or danazol 200 mg daily should be considered when first-line treatments are ineffective. (I A)

Mastectomy

10. Mastectomy or partial mastectomy should not be considered an effective treatment for mastalgia. (III E)

Definitions:

Level of Evidence*

I: Evidence obtained from at least one properly designed randomized controlled trial.

II-1: Evidence from well-designed controlled trials without randomization.

II-2: Evidence from well-designed cohort (prospective or retrospective) or case–control analytic studies, preferably from more than one centre or research group.

II-3: Evidence from comparisons between times or places with or without the intervention. Dramatic results in uncontrolled experiments (such as the results of treatment with penicillin in the 1940s) could also be included in this category.

III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.

Classification of Recommendations**

1. There is good evidence to support the recommendation that the condition be specifically considered in a periodic health examination.
2. There is fair evidence to support the recommendation that the condition be specifically considered in a periodic health examination.
3. There is poor evidence regarding the inclusion or exclusion of the condition in a periodic health examination.
4. There is fair evidence to support the recommendation that the condition not be considered in a periodic health examination.
5. There is good evidence to support the recommendation that the condition be excluded from consideration in a periodic health examination.

*The quality of evidence reported in these guidelines has been adapted from the Evaluation of Evidence criteria described in the Canadian Task Force on the Periodic Health Exam.

**Recommendations included in these guidelines have been adapted from the Classification of Recommendations criteria described in the Canadian Task Force on the Periodic Health Exam.

None provided

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

Utilizing the information will increase knowledge, enabling a consistent approach, which will reduce the number of ineffective interventions and ensure appropriate use of medications.

• Side effects of tamoxifen commonly observed in short-term treatment for mastalgia include hot flashes (10%), menstrual irregularity/amenorrhea (10%), weight gain, nausea, vaginal dryness, and bloating (5% or less). Thromboembolic events, endometrial cancer, and cataracts are rare but serious side effects of tamoxifen; their incidence in short-term, low-dose treatment regimens for mastalgia is not known.
• Side effects of danazol at the 200 mg dose include weight gain (30%), menstrual irregularity/amenorrhea or menorrhagia (50%), deepening of the voice (10%), and hot flashes (10%).

This guideline reflects emerging clinical and scientific advances as of the date issued and are subject to change. The information should not be construed as dictating an exclusive course of treatment or procedure to be followed. Local institutions can dictate amendments to these opinions. They should be well documented if modified at the local level. None of these contents may be reproduced in any form without prior written permission of the Society of Obstetricians and Gynaecologists of Canada (SOGC).

An implementation strategy was not provided.

Getting Better

Effectiveness
Patient-centeredness

Not applicable: The guideline was not adapted from another source.

2006 Jan

Society of Obstetricians and Gynaecologists of Canada - Medical Specialty Society

Society of Obstetricians and Gynaecologists of Canada

Breast Disease Committee of the Society of Obstetricians and Gynaecologists of Canada

Principal Authors: Vera Rosolowich, RN, SCM, IBCLC, Winnipeg MB; Elizabeth Saettler, MD, FRCSC, Winnipeg MB; Beth Szuck, BA, HEc, CACE, RD, Winnipeg MB

Committee Members: Robert H. Lea, MD, FRCSC, Glen Haven NS; Pierre Levesque, MD, FRCSC, Rimouski QC; Fay Weisberg, MD, FRCSC, Toronto ON; James Graham, MD, FRCSC, Halifax NS; Lynne McLeod, MD, FRCSC, Halifax NS; Vera Rosolowich, RN, SCM, IBCLC, Winnipeg MB

Not stated

This is the current release of the guideline.

None available

None available

This NGC summary was completed by ECRI Institute on February 4, 2009. The information was verified by the guideline developer on March 4, 2009.

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.