In the first group, 70 percent noticed clinical improvement, but the rate of side effects was unacceptably high. Four percent had a change in thyroid indices; three percent developed symptoms of iodism (coryza and enlarged tender lymph nodes) and two percent occurrence of acne (quite apart from the vile taste of Lugol's solution).

In the second group, an excellent response was noted in 40 percent of the patients with 50 percent having marked improvement, and side effects involving 9.5 percent of the women.

In his next research project, Ghent took 145 patients from the first study who had not responded well to iodaminol and found that 74.5 percent of these then improved. Another group of 108 new patients had treatment initiated with elemental iodine, and this group had remarkable success with 98 percent of women having their breasts return to normal.

Next the original series of 233 women were enlarged to 1,365. In this larger group of women, within two years of treatment, 95 percent of women had excellent results with loss of pain and disappearance of cysts and scar tissue and complete return of the breast tissue to normal. This effect is time dependant. That is to say there is greater subjective and objective improvement noted after eighteen months than six months.

Six women fail to respond to any therapy including danazol, bromocriptine, tamoxifen and progesterone, and required subcutaneous mastectomy for definitive treatment. Ghent concluded that there may be a "point of no return", at which time surgery may be the only option.

In Seattle, a prospective double blind study was carried out and supervised by the FDA in collaboration with Dr. Donald Low and Dr. Lucius Hill at the Department of Surgery at Virginia Mason Clinic. It involved 23 patients receiving aqueous iodine and 33 receiving an aqueous mixture of brown vegetable dye with quinine added for flavour. The group was followed at two month intervals for an average of six months. The results showed the treatment group had 65 percent subjective and objective improvement and the control group a subjective improvement of 33 percent (the expected placebo response) and an objective worsening of three percent.

In October 1993, the results of Dr. Ghent and his colleagues research was published in the Canadian Journal of Surgery.

In an editorial in the same issue entitled Elemental Iodine- Relief for the Painful Breast? Dr. John MacFarlane, Chairman of the Department of Surgery, at St. Paul's Hospital in Vancouver congratulated Dr. Ghent and his colleagues "on an excellent and meaningful study... {which} seems to confirm the validity of the hypothesis that {elemental} iodine can be of significant benefit to patients with fibrocystic breasts. However, Dr. MacFarlane cautioned that although the study is an important one, the findings should be confirmed by another centre before elemental iodine is recommended as standard therapy for symptomatic cystic breast disease.

Although the elemental iodine capsules are still classified as an experimental drug, (approved by HPB in Canada and awaiting FDA approval in the States), it appears to be a very safe and effective treatment for FCBD. Further clinical trials of Dr. Ghent's capsules are in progress and more double blind studies are being organized.

Mechanism Of Action Of Elemental Iodine

The mechanism of action of elemental iodine is only partially understood, and more research needs to be done in this area.

Eskin's research in rats showed that there was a progressively better resolution of FCBD depending on the type of iodine used. Only elemental iodine corrected the entire disease process. Dr. Ghent's clinical studies paralleled these findings in humans.

When I-2 is replaced, it renders the breast duct cells less sensitive to estrogen, thus acting like a natural anti-estrogen.

In the Canadian Journal of Surgery, Ghent and Eskin speculated that the elemental iodine is essential for breast normality, and its absence seems to render the breast ducts more sensitive to estrogen stimulation and subsequent formation of cysts and scar tissue. They theorize that adequate amounts of elemental iodine in breasts tissue makes them less sensitive to circulating estrogens. As such the iodine could be classed as a natural "anti-estrogen", a sort of natural tamoxifen.