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Health Protocols

Fibrocystic Breast Changes

Novel and Emerging Strategies

Ormeloxifene (Centchroman)

Ormeloxifene, also known as centchroman, belongs to a class of drugs known as selective estrogen receptor modulators (SERMs). Ormeloxifene is a nonsteroidal compound that is manufactured and currently available in India as an oral contraceptive; some research on the drug is ongoing in the United States (de Barros 2015). A paper published in 2015 reported on a trial that compared ormeloxifene to tamoxifen for the treatment of breast pain. The effectiveness of the two medications after 12 weeks was similar, though side effects such as dizziness, menstrual irregularities and development of ovarian cysts were greater in the ormeloxifene group (Jain 2015). A three-month randomized controlled trial in 121 women aged 20–50 compared 30 mg ormeloxifene twice per week to placebo for the treatment of breast pain and lumps. Compared with placebo, both breast pain and breast lumps were significantly reduced by ormeloxifene treatment (Kumar 2013).

In another trial ormeloxifene significantly reduced breast pain to a greater degree than danazol; nearly 90% of women had relief in the ormeloxifene group, while 69% taking danazol experienced pain relief (Tejwani 2011). In another study, 86% of women taking ormeloxifene for 24 weeks had complete resolution of breast pain (Sharma 2012).

As some researchers have expressed concern with ormeloxifene’s side-effect profile (Jain 2015), women interested in this drug should consult closely with their health care provider to weigh the risks and benefits.

Near-Infrared Imaging with Contrast

The primary concern in the assessment of breast symptoms is to correctly differentiate between benign breast changes and serious breast diseases such as breast cancer. An experimental procedure, near-infrared imaging with the use of contrast, has shown an ability to increase diagnostic accuracy when combined with mammography and ultrasound. Multiple studies have shown that cancerous breast tissue tends to absorb more contrast media than benign tissue. This difference can be detected using a scanner that detects near-infrared energy. Preliminary evidence is promising, but this innovative diagnostic approach is still in development. Like other imaging methods, this approach is minimally invasive, though the contrast material must be injected into a vein (Hawrysz 2000; Poellinger 2012). More research is needed to determine the true utility of near-infrared imaging in detecting fibrocystic changes and differentiating them from breast cancer.