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Management of Disorders of the Ductal System and Infections
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MASTALGIA AND BREAST CANCER RISK
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Webber and Boyd carried out a critical analysis of the 36 published papers that were available in English before 1984. They set 16 standards, including a description of the study population, a definition of benign disease, follow-up, and a description of the risk analysis. Of the 22 studies reporting an increase in risk, all met more of the standards than the 11 sug- gesting no increase in risk and the 3 drawing no conclusions. Since then, a few studies have specifically examined the relation between cyclic mastalgia and breast cancer risk. A French case-control study among premenopausal women— 210 younger than 45 years of age with breast cancer, and 210 neighborhood control subjects—matched on year of birth, education level, and age at first full-term pregnancy gave an unadjusted relative risk (RR) for cancer in cyclic mastalgia of 2.66, and after adjustment for family history, prior benign breast disease, and age at menarche, the RR was still signifi-
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Management of Disorders of the Ductal System and Infections
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MASTALGIA AND BREAST CANCER RISK
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cantly elevated at 2.12.
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MASTALGIA AND BREAST CANCER RISK
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Goodwin et al. (14) recruited 192 women with premeno- pausal node-negative breast cancer and 192 age-matched premenopausal control subjects. Significant risk variables for breast cancer in the model were marital status, family history, number of years of smoking, prior breast biopsy (before cancer diagnosis), and mean cyclic change in breast tenderness. The odds ratio of cancer for cyclic mastalgia was 1.35, rising to 3.32 in those with severe pain.
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Management of Disorders of the Ductal System and Infections
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MASTALGIA AND BREAST CANCER RISK
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Another indication of a possible link between mastalgia and cancer is the relationship between Wolfe grade of mam- mograms and breast pain. Deschamps et al. (15) determined the Wolfe grades of 1,394 women in the Canadian National Breast Screening Study. All completed a questionnaire, with mastalgia reported by 46%. The extent of dysplasia on mam- mograms was categorized as Dy2 (25% to 49%), Dy3 (50% to 74%), and Dy4 (75%). The odds ratio for a Dy3/4 rating was
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Management of Disorders of the Ductal System and Infections
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MASTALGIA AND BREAST CANCER RISK
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1.0 for those who never had breast swelling and mastalgia, whereas it was 2.7 in those reporting both symptoms.
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Management of Disorders of the Ductal System and Infections
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MASTALGIA AND BREAST CANCER RISK
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These epidemiologic studies have the problems of recall biases and unknown extent of histologic atypia in the patients who have not had biopsies. In most studies assess- ing risk using established algorithms, the presence of breast pain is not used as an independent variable in the calcula- tions, unlike prior breast biopsy. That women attend a phy- sician for breast pain, itself results in a higher rate of breast biopsy as noted in the study by Ader et al. (3).
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TREATMENT TRIALS
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Multiple treatments have been used in women with “benign breast disease,” some of whom had nothing more than nodu- larity without tenderness. Patients with diffusely nodular breasts that are painless require nothing other than exclusion of significant pathology and can be discharged if no other indications for follow-up exist.
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Management of Disorders of the Ductal System and Infections
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TREATMENT TRIALS
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Treatment trials for breast pain should have well- documented breast pain classified into cyclic or not, measured with a visual analog scale (VAS) or other rating scales, and ideally using each patient as her own control. Pain should have been present for a minimum of 6 months. Assessment of nodularity should be assessed separately from pain, and has been validated in a study of two experi- enced blinded physicians assessing 784 women using a VAS giving a highly significant interobserver correlation with a kappa value of 0.865 (16). The overall quality of most pub- lished studies has been poor with low numbers of patients recruited, and varying methodologies used. Trials should be of double-blinded, placebo-controlled, randomized design and include a minimum of 20 patients in each arm. Some trials have met these criteria and defined effective drugs or interventions; results are summarized in Table 6-1. The initial approach by most physicians is to advise reduction in alleged dietary factors associated with breast pain, such as caffeine or saturated fat intake, but the evi- dence for these interventions is poor. Diuretics are widely used by family physicians to reduce supposed water reten-
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TREATMENT TRIALS
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tion in the luteal phase of the cycle, but are ineffective.
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TREATMENT TRIALS
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Several agents have been found in controlled trials to be no better than placebo: vitamin E, lynestrenol, mefenamic acid, and caffeine reduction. This is perhaps not surprising because placebo-controlled trials report placebo response rates from 10% to 50%.
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TREATMENT TRIALS
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As an alternative, more complex approach, reduction in dietary fat can significantly reduce cyclic breast pain. Boyd et al. (17) entered 21 women with a minimum of 5 years of breast pain into a trial in which 11 were shown how to reduce their dietary fat content to 15% of total calories and 10 received general dietary advice. Those in the fat- reduction group had a significant reduction in breast pain. Although a nondrug intervention appeals to many patients, long-term dietary change is a difficult intervention to main- tain in premenopausal women with busy lives.
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Management of Disorders of the Ductal System and Infections
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TREATMENT TRIALS
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A similar dietary approach of adding the long-chain unsaturated fatty acid gamma-linolenic acid, present in eve- ning primrose oil and starflower oil, provides a nonendo- crine approach, but with an efficacy that is questionable. One study entered 103 women with mastalgia into a double- blinded, crossover study comparing evening primrose oil with placebo for 3 months, after which both groups received evening primrose oil capsules for a further 3 months. Cyclic pain was significantly diminished in those given evening primrose oil, but had no effect on noncyclic mastalgia.
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TREATMENT TRIALS
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However, a systematic literature search by Budeiri to determine the efficacy of evening primrose oil for premen- strual syndrome found no evidence of benefit (18). A more recent Dutch trial also failed to show an advantage for eve- ning primrose oil (19).
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Management of Disorders of the Ductal System and Infections
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TREATMENT TRIALS
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In an attempt to resolve this question, one of the larg- est studies ever performed in both community and hos- pital patients involving a total of 555 patients was carried out, but with a different placebo arm to the previous trials. This trial failed to show any advantage of the active arms containing gamma-linoleic acid, principally owing to the very large response of 40% reduction in symptoms in the placebo group (20). Despite this, many physicians advise their patients to try this product, which is widely available in nonprescription format, as an initial treatment of breast pain because the incidence of side effects was very low in all the trials. In practical terms it is likely that the patients feel better due to the large placebo effect.
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TREATMENT TRIALS
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In cyclic mastalgia, most treatments have focused on reduction in estrogen or prolactin drive to the breast cells in the belief that hormonal overstimulation is the predominant
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TREATMENT TRIALS
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factor in severe breast pain, although as noted above little evidence exists for this hypothesis.
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TREATMENT TRIALS
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Danazol, an impeded androgen, may relieve pain in up to 93% of patients, but with side effects that include nausea, depression, menstrual irregularity, and headaches in up to two-thirds of patients, sometimes leading to discontinuation of treatment. To reduce side effects, O’Brien and Abukhali
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Management of Disorders of the Ductal System and Infections
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TREATMENT TRIALS
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(21) conducted a double-blinded, placebo-controlled trial of luteal-phase danazol in 100 women with premenstrual syn- drome, including cyclic mastalgia. Danazol or placebo was given during the luteal phase for three cycles, with a signifi- cant pain reduction in those treated and similar side effects in both groups.
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Management of Disorders of the Ductal System and Infections
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TREATMENT TRIALS
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As an alternative to drugs, some physicians recommend a more supportive brassiere to relieve mastalgia. In a non- randomized study of 200 Saudi women with mastalgia, 100 were given danazol 200 mg/day and 100 instructed to wear a sports brassiere. Pain was relieved in 85% of those who wore sports brassieres and in 58% of those given danazol, but of the latter group 42% had side effects and 15% stopped treatment. The results of this trial are difficult to interpret due to its nonblinded, nonrandomized structure.
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TREATMENT TRIALS
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Bromocriptine, a prolactin inhibitor, was also effective in breast pain in several small preliminary studies. In a multi- center European study of 272 women comparing bromocrip- tine, 2.5 mg twice daily, with placebo, significant symptom relief occurred in the treated group but 29% dropped out because of side effects, mostly nausea and dizziness (22). A double-blinded comparison study in 47 women with severe breast pain treated with bromocriptine and danazol had significantly better pain relief than the placebo group, but the best response was recorded in the danazol group.
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Management of Disorders of the Ductal System and Infections
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TREATMENT TRIALS
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A study using the dopamine agonist lisuride maleate for 2 months in a double-blinded, placebo-controlled trial treated 60 women in a 1:1 ratio. Severity of mastalgia was monitored by VAS, but there was neither run-in period nor any pain severity threshold for trial entry. In patients with
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Management of Disorders of the Ductal System and Infections
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TREATMENT TRIALS
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less pain, the response rate was 8 of 11 (73%) in the treated and 2 of 15 (13%) in the placebo arm. Among those with more severe pain, the respective response rates were 19 of 19 (100%) and 5 of 15 (33%). The main side effect was nausea, experienced by 17% of the treated and 10% of the control subjects. However, the use of dopamine agents has been limited owing to problematic side effects, and they are currently not being used in breast pain.
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TREATMENT TRIALS
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The efficacy of progesterone vaginal cream has been investigated in two small randomized trials. In a small study, McFadyen reported a minor, nonsignificant benefit for those women given placebo cream. In a larger trial with 80 participants, a greater than 50% reduction in pain was recorded in 22% of the placebo group and in 65% of those given progesterone-containing cream.
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Management of Disorders of the Ductal System and Infections
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TREATMENT TRIALS
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A study of 26 women compared medroxyprogesterone acetate tablets, 20 mg/day in the luteal phase of the cycle, with placebo and found no difference in response rate or side effects. In a multicenter, double-blinded, randomized trial, Peters (23) administered the synthetic 19-norsteroid gestrinone to 73 women and placebo to 72 control subjects. A significantly greater reduction in pain was seen in the gestrinone group, with side effects reported by 44% of the treated cases and 14% of the control subjects.
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Management of Disorders of the Ductal System and Infections
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TREATMENT TRIALS
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Tamoxifen, a partial estrogen antagonist and agonist, is effective in treating breast pain. In the first double-blinded, crossover, randomized trial, conducted at Guy’s Hospital, pain relief occurred in 71% of those given tamoxifen and 38% of control subjects (24). After 3 months, nonresponders switched to the alternative treatment arm, and pain control was achieved in 75% of the tamoxifen group and 33% of the placebo group. The most common side effect of tamoxifen was hot flashes, occurring in 27%.
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Management of Disorders of the Ductal System and Infections
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TREATMENT TRIALS
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A similar placebo response was seen in a more recent trial comparing tamoxifen with danazol, but in the group that received tamoxifen 10 mg, a higher response rate was seen and breast pain was controlled in 89%. In two trials that compared
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Management of Disorders of the Ductal System and Infections
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TREATMENT TRIALS
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tamoxifen 10 mg with 20 mg, similar response rates were seen but side effects with the lower dose were substantially reduced (21% vs. 64%). When tamoxifen was compared with danazol, similar response rates were seen, but significantly more side effects occurred in those given danazol (90% vs. 50%). When tamoxifen 10 mg was compared with bromocrip- tine 7.5 mg daily, pain relief was achieved in 18 of 20 (90%) of the tamoxifen group and in 17 of 20 (85%) of those given bromocriptine. Tamoxifen is now being used extensively in the management of breast pain, as an off-label drug because it is not currently licensed for use in benign breast conditions. The safety of this drug in patients without breast cancer is, however, well documented in the prevention trials involving large numbers of normal high-risk women (25). Furthermore, this review of the prevention trials confirms the reduction in benign breast conditions on the drug, which is consistent with the reduction in symptoms seen in the breast pain tri- als. Patients who are prescribed tamoxifen should be given a careful explanation that the drug is being used to reduce estrogen drive and is not being used for breast cancer.
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TREATMENT TRIALS
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Alternative routes of delivery of tamoxifen or selective estrogen receptor modulators (SERMS) may be possible by the transcutaneous route to reduce side effects by avoiding transhepatic passage. This approach has shown some prom- ise using a gel containing 4-hydroxy tamoxifen applied to the breast morning and night (26). A placebo-controlled trial of this gel showed efficacy in cyclic mastalgia, particularly in the late luteal phase of the cycle, and showed a clear blunting of the luteal peak of cyclic breast pain (Fig. 6-1). It is clear that these series of studies of SERMS and the prevention studies
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TREATMENT TRIALS
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confirm the active therapeutic role of these agents in benign conditions of the breast. These new agents are currently not licensed in the treatment of breast pain, and are awaiting fur- ther safety data as it is a novel formulation of tamoxifen.
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Management of Disorders of the Ductal System and Infections
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TREATMENT TRIALS
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A recent randomized study compared a novel anties- trogen ormeloxifine with danazol and showed that the new agent, which has predominantly antagonist actions, was as effective as danazol but with fewer side effects (27). Pain was assessed by VAS pain scores and ormeloxifine (Centchroman) produced a reduction in median pain scores from 7 at baseline to 2 at 12 weeks.
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TREATMENT TRIALS
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The relationship of the menstrual cycle in cyclic breast pain was further demonstrated by a randomized trial of the luteinizing hormone-releasing hormone (LHRH) agonist gos- erelin (Zoladex), which abolishes the menstrual cycle and thus removes the normal fluctuation in estradiol and pro- gesterone. This large placebo-controlled trial of women with cyclic mastalgia treated with Zoladex for 6 months showed significant reduction in breast pain (28). The patients were then followed off treatment for 6 months and the breast pain gradually returned as did menstruation.
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Management of Disorders of the Ductal System and Infections
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TREATMENT TRIALS
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In a different approach, Ingram et al. (29) studied iso- flavones derived from red clover to determine whether this phytoestrogen could relieve mastalgia. The 18 patients in the trial underwent a 2-month, single-blinded, placebo run-in phase, after which they received either pla- cebo, isoflavone 40 mg, or isoflavone 80 mg. Pain scores for the final single-blinded month and the final double-blinded month were compared. In the placebo group, there was a 13% reduction, for the 40 mg/day group it was 44%, and for
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100
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90
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80
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70
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60
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50
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40
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30
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20
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10
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0
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0 10
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20 30 0 10 20 30 0 10 20 30
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Cycle 1
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Cycle 2
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Day of Cycle
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Cycle 4
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FIGURE 6-1 Effect of topical 4-hydroxy tamoxifen gel on cyclical mastalgia. Randomized trial of 4-hydroxy tamoxifen gel (2 and 4 mg vs. placebo gel) applied to the breast for breast pain. Note the clear cyclical pattern of pain and the reduction of the peak luteal pain in cycle 4 by the 4-mg preparation. (From Mansel R, Goyal A, Nestour EL, et al. and the Afimoxifene [4-OHT] Breast Pain Research Group. A phase II trial of Afimoxifene [4-hydroxytamoxifen gel] for cyclical mastalgia in premenopausal women. Breast Cancer Res Treat 2007;106[3]:389–397, with permission.)
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the 80 mg/day group it was 31%. No major side effects were reported, but the study needs repeating with larger num- bers to determine the true efficacy of isoflavones.
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ALTERNATIVE APPROACHES
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Acupuncture has been used for the treatment of premen- strual syndrome with some improvement of symptoms, but a recent study from the Mayo Clinic showed that pain scores measured on a 10-point brief inventory scale showed a clini- cally meaningful improvement in 67% of patients with the worst pain (30). The authors have suggested a randomized trial is required to confirm the findings, but this would be dif- ficult to blind from the patient and placebo responses would be difficult to evaluate. At Guy’s Hospital in an open pilot study, applied kinesiology was used in 88 women with self- rated moderate or severe mastalgia present for more than 6 months. This technique uses a type of pressure massage and is a hands-on technique based on improving lymphatic flow. Using self-rated pain scores, there was improvement in 60% and complete resolution in 18%, but as with the acu- puncture trials, this trial was not blinded, and the response may have been due to placebo effects.
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Management of Disorders of the Ductal System and Infections
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ALTERNATIVE APPROACHES
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A randomized trial of Vitus agnus-castus extract (castor oil, Mastodynon) showed a modest fall in VAS scores on the plant extract (54% compared with 40% on placebo), with few side effects (Mastodynon).
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Management of Disorders of the Ductal System and Infections
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ALTERNATIVE APPROACHES
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Ghent et al. (31) investigated the effect of iodine replace- ment in women with breast pain in three different studies, one of which was a randomized, double-blinded, placebo- controlled trial. The rationale was that iodine deficiency in Sprague-Dawley rats led to mammary epithelial hyperplasia and carcinoma. Participants were treated for 6 months with aqueous molecular iodine 0.07 to 0.09 mg/kg daily, or pla- cebo composed of an aqueous mixture of brown vegetable dye and quinine. Pain improvement occurred in 11 of 33 (33%) of the placebo group and 15 of 23 (65%) of those given iodine. No side effects were reported. More recently Kessler
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Management of Disorders of the Ductal System and Infections
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ALTERNATIVE APPROACHES
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(32) studied supraphysiologic doses of iodine in cyclic mastalgia and reported that approximately 40% of patients obtained more than 50% reduction in breast pain on 3 to 6 mg iodine daily compared with 8% on placebo.
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Management of Disorders of the Ductal System and Infections
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EXTRA MAMMARY PAIN
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Pain originating within the thorax or abdomen and referred to the breast area is managed by treatment of the under- lying condition. Pain that originates from the thoracic wall (Tietze’s syndrome or costochondritis) and localized specific tender areas in the breast (trigger spots) can be managed by injection of steroid and local anesthetic. More recently, nonsteroidal analgesics have been used as topi- cal gel applications and their use is supported by a large randomized trial of 108 women with both cyclic and non- cyclic pain, which showed significant reduction in breast pain by diclofenac gel at 6 months compared with placebo gel (reduction in pain measured on visual analog scale from 0 = no pain to 10 = intolerable pain; cyclic 5.87 with diclofenac vs. 1.30 placebo; noncyclic 6.33 diclofenac vs.
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EXTRA MAMMARY PAIN
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1.12 placebo, p < .001) (33).
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ROLE OF SURGERY
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Severely distressed nonresponders to drug therapy may ask for mastectomy. This drastic step should not be undertaken before a full psychiatric assessment has been sought because
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Management of Disorders of the Ductal System and Infections
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ROLE OF SURGERY
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without careful selection, surgical intervention will damage body image without achieving pain relief. Even after careful psychiatric assessment, excisional surgery should very rarely be undertaken because clinical experience has shown that pain reduction is achieved in only a small number of patients. This is not surprising because the etiology of breast pain is poorly understood, and there are causes of pain that lie out- side the breast tissue. In the author’s experience the focus on pain will often move to body image after mastectomy and this leaves an unhappy patient who still complains of breast pain, which is clearly therapeutic failure.
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ROLE OF SURGERY
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A recent overview has considered the role of drugs in the treatment of mastalgia. Srivastava et al. considered the range of drugs available but concluded that the only effec- tive drugs were tamoxifen, bromocriptine, and danazol
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ROLE OF SURGERY
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(34). Many of the studies considered were rejected for poor design or methodology.
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ROLE OF SURGERY
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The precise mechanisms behind many of the symptom- atic presentations of benign breast change remain unclear, but the various hypotheses have been summarized in a review by Santen and Mansel (35).
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ROLE OF SURGERY
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MANAGEMENT SUMMARY
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ROLE OF SURGERY
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REFERENCES
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Crandall CJ, Aragaki AK, Cauley JA, et al. Breast tenderness and breast cancer risk in the estrogen plus progestin and estrogen-alone women’s health initiative clinical trials. Breast Cancer Res Treat 2012;132:275–285.
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ROLE OF SURGERY
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Barros AC, Mottola J, Ruiz CA, et al. Reassurance in the treatment of mas- talgia. Breast J 1999;5:162.
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ROLE OF SURGERY
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Ader DN, South-Paul J, Adera T, et al. Cyclical mastalgia: prevalence and associated health behavioural factors. J Psychosom Obstet Gynaecol 2001;22:71–76.
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ROLE OF SURGERY
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Ader DN, Browne MW. Prevalence and impact of cyclical mastalgia in a United States clinic-based sample. Am J Obstet Gynecol 1997;177:126–132.
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ROLE OF SURGERY
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Wang DY, Fentiman IS. Epidemiology and endocrinology of benign breast disease. Breast Cancer Res Treat 1985;6:5.
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ROLE OF SURGERY
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Hughes LE, Mansel RE, Webster DJT. Aberrations of normal development and involution (ANDI): a new perspective on pathogenesis and nomencla- ture of benign breast disorders. Lancet 1987;2:1316.
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ROLE OF SURGERY
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Ecochard R, Marret H, Rabilloud M, et al. Gonadotropin level abnormali- ties in women with cyclic mastalgia. Eur J Obstet Gynecol 2001;94:92.
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ROLE OF SURGERY
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Preece PE, Hughes LE, Mansel RE, et al. Clinical syndromes of mastalgia.
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Lancet 1976;2:670.
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Maddox PR, Harrison BJ, Mansel RE, et al. Non-cyclical mastalgia: an improved classification and treatment. Br J Surg 1989;76:901.
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ROLE OF SURGERY
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Khan SA, Apkarian AV. The characteristics of cyclical and non cyclical mastalgia: a prospective study using a modified McGill Pain Questionnaire. Breast Cancer Res Treat 2002;75:147–157.
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Preece PE, Mansel RE, Hughes LE. Mastalgia: psychoneurosis or organic disease? BMJ 1978;1:29.
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Ramirez AJ, Jarrett SR, Hamed H, et al. Psychological adjustment of women with mastalgia. Breast 1995;4:48.
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Fox H, Walker LG, Heys SD, et al. Are patients with mastalgia anxious, and does relaxation help? Breast 1997;6:138.
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Goodwin PJ, DeBoer G, Clark RM, et al. Cyclical mastopathy and premeno- pausal breast cancer risk. Breast Cancer Res Treat 1994;33:63.
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Deschamps M, Band PR, Coldman AJ, et al. Clinical determinants of mam- mographic dysplasia patterns. Cancer Detect Prev 1996;20:610.
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ROLE OF SURGERY
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Kumar S, Rai R, Das V, et al. Visual analogue scale for assessing breast nodularity in non-discrete lumpy breasts: the Lucknow-Cardiff breast nodularity scale. Breast 2010;19:238–242.
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Boyd NF, Shannon P, Kriukov V, et al. Effect of a low-fat high-carbohydrate diet on symptoms of cyclical mastopathy. Lancet 1988;2:128.
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Budeiri D, Li Wan Po A, Dornan JC. Is evening primrose oil of value in the treatment of premenstrual syndrome? Control Clin Trials 1996;17:60.
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