• FemBalance™ is an ideal nutrient and herbal formula to assist healthy menstrual function and for the relief of symptoms associated with premenstrual syndrome (PMS).^[1],[2]
• FemBalance™ is indicated in female health conditions associated with oestrogen dominance. FemBalance™ features Indolplex^®, a unique and highly absorbable diindolylmethane as found in cruciferous sources with demonstrated clinical activity.^[3],[4]
• Indolplex^® assists the favourable metabolism of oestrogen down the 2-hydroxylation pathway.^[1],[3],[5] A beneficial shift in metabolism can help maintain healthy oestrogen ratios and reduce the symptoms of oestrogen dominance.
• The active 2-hydroxyoestrone metabolites are considered the ‘good’ oestrogens.^[6] Whereas the 4-hydroxyoestrone and 16-alpha-hydroxyoestrone metabolites are often termed the ‘bad’ oestrogens. The common symptoms of oestrogen dominance are often due to underactive oestrogen metabolism and the overproduction of unfavourable oestrogen metabolites. For this reason bioavailable DIM is indicated to assist health of the reproductive tract^{[3],[7],[8],[9]} and breast.^{[1],[10],[11]}
• Vitex agnus castus (Chaste berry) helps maintain normal physiology in women. It is effective for the relief of symptoms of PMS.^[12],[13]
• Fucus vesiculosus (Bladderwrack) is a rich source of iodine. Iodine is an essential element for the synthesis of triiodothyronine (T3) and thyroxine (T4), and is therefore required for normal thyroid function. Mild iodine deficiency is common in Australia.^[14],[15]
• Iodine deficiency leads to an increased sensitivity of breast tissue to oestrogen.^[16] Iodine can help relieve the symptoms of fibrocystic breast disease.^[17],[18] Iodine may also have a protective effect on the breast tissue by modulating oestrogen pathways.^[19]
• Selenium is an essential micronutrient fundamental to health. It is a necessary component of several major metabolic pathways, including thyroid hormone metabolism, antioxidant defence systems and immune function.^{[20],[21],[22]}
• A combination of selenium and iodine deficiency exacerbates hypothyroidism.^[23] Selenium dependent enzymes are required for conversion of T4 to the biologically active T3.  Iodine together with selenium can help support normal metabolism of thyroid hormones.
• Vitamin D3 (cholecalciferol) is the naturally occurring form of vitamin D. The biological effects extend far beyond controlling mineral metabolism. Vitamin D3 is now considered a ‘repair and maintenance’ pro-hormone that targets a wide variety of tissue.^[24]
• Vitamin D3 (cholecalciferol) supports overall health, including a healthy immune system.^[24],[25] In Australia, the prevalence of vitamin D deficiency is widespread despite the abundance of sunshine.^[26]

• This product contains selenium which is toxic in high doses.  A daily dose of 150µg for adults of selenium from dietary supplements should not be exceeded.
• Do not use Indolplex^® if you are pregnant, may become pregnant or are lactating.  

Precautions & Considerations

• FemBalance™ contains iodine which can affect metabolism of thyroid hormones. Monitoring of individuals taking prescribed thyroid medication is recommended.
• Harmless changes in urine colour may occur with Indolplex®. Increased water consumption can reduce this side effect.
• Symptoms of nausea and/or headaches may occur with Indolplex^®. Indolplex^® assists activity of hepatic cytochrome P450 enzymes (CYP1A1/2) pathways. Nutrients required to support phase 2 liver detoxification pathways can assist in reducing these symptoms.
• A short term increase in symptoms with Indolplex^® may be due to increased metabolism of available oestrogen.
• Indolplex^® does not contain goitrogenic compounds which could affect thyroid function.
• Indolplex^® is not phytoestrogenic and has no inherent oestrogenic activity. FemBalance™ can be used in used in conjunction with phytoestrogenic herbs.
• Indolplex^® may assist hormone health when taken with Hormone Replacement Therapy (HRT).
• Indolplex^® may assist hormone health when taken with the oral contraceptive pill (OCP).  Indolplex® has no inducing action on CYP3A4, the enzyme that metabolises the OCP. Therefore, Indolplex^® does not affect efficacy of the OCP.
• Indolplex^® may assist effective metabolism of increased available oestrogen when taken with bioidentical hormone replacement therapy (BHRT).
• Safety studies support concomitant use of Indolplex^® with Tamoxifen.^[27]
• Combined use of Indolplex^® and Zoladex is supported.
• Concomitant use of Indolplex^® with aromatase inhibitors is not recommended. This includes drugs such as Arimidex and Femara.
• Indolplex^® should be used with caution in patients taking anticoagulation medications.

References

[1] Zeligs MA, Brownstone PK, Sharp ME, et al. Managing Cyclical Mastalgia with Absorbable Diindolylmethane: A Randomized, Placebo-controlled Trial. JANA. Vol. 8, No.1 2005. Pages 10-20.

[2] Kessler JH. The effect of supraphysiologic levels of iodine on patients with cyclic mastalgia. Breast J. 2004;10(4):328-336.

[3] Zeligs MA. Safer Estrogen With Phytonutrition. Townsend Letter for Doctors and Patients. 1999; 189:83-88.

[4] Zeligs, MA. The Cruciferous Choice: Diindolylmethane or I3C? Phytonutrient Supplements For Cancer Prevention and Health Promotion. Townsend Letter for Doctors and Patients. August, 2001.

[5] Dalessandri KM, Firestone KM, Firestone GL, Fitch MD, et al. Pilot study: effect of 3,3'-diindolylmethane supplements on urinary hormone metabolites in postmenopausal women with a history of early-stage breast cancer. Nutrition and Cancer. 2004;50(2):161-7.

[6] Bradlow HL, Telang NT, Sepkovic DW, Osborne MP. 2-Hydroxyestrone: the 'good' estrogen. J Endocrinol. 1996;150 Suppl:S259-265.

[7] Zeligs MA, Sepkovic DW, Manrique C, et al. Absorption-enhanced 3,3’-Diindolylmethane: Human Use in HPV-related, Benign and Pre-cancerous Conditions. Proc. Am. Assoc. Cancer Res. 2003, Apr; 44.

[8] Chen DZ, Qi M, Auborn KJ, et al. Indole-3-Carbinol and Diindolylmethane Induce Apoptosis of Human Cervical Cancer Cells and in Murine HPV16-Transgenic Preneoplastic Cervical Epithelium. J Nutr. 2001 Dec;131(12):3294-3302.

[9] Leong H, Firestone GL, Bjeldanes LF. Cytostatic effects of 3,3'-diindolylmethane in human endometrial cancer cells result from an estrogen receptor-mediated increase in transforming growth factor-alpha expression. Carcinogenesis. 2001 Nov;22(11):1809-17.

[10] Rahman KW, Sarkar FH. Inhibition of nuclear translocation of nuclear factor-{kappa}B contributes to 3,3'-diindolylmethane-induced apoptosis in breast cancer cells. Cancer Research 65. 2005 Jan 1;65(1):364-71.

[11] Rahman KW, Li Y, Wang Z, et al. Gene expression profiling revealed survivin as a target of 3,3'-diindolylmethane-induced cell growth inhibition and apoptosis in breast cancer cells. Cancer Research 6. 2006 May 1;66(9):4952-60.

[12] Schellenberg R. Treatment for the premenstrual syndrome with agnus castus fruit extract: prospective, randomized, placebo controlled study. BMJ 2001;20:134–7.

[13] Bone K. Vitex agnus-castus: Scientific studies and clinical applications. Eur J Herbal Med 1994;1:12–5.

[14] Travers CA, Guttikonda K, Norton CA, et al. Iodine status in pregnant women and their newborns: are our babies at risk of iodine deficiency? Med J Aust. 2006 Jun 19;184(12):617-20.

[15] Li M, Eastman, CJ, et al. Are Australian children iodine deficient? Results from the Australian National Iodine Nutritional Study. Med J Aust. 2006 Feb 20;184(4):165-9.

[16] Brownstein, D. Iodine: Why You Need It, Why You Can't Live Without It (3^rd Edition). Medical Alternative Press. West Bloomfield, Michigan. USA. 2008: Page 76.

[17] Ghent WR, et al. Iodine replacement in fibrocystic disease of the breast. Can J Surg 1993;36:453-460.

[18] Gaby, AR. Iodine treatment of fibrocystic breast disease. Townsend Letter for Doctors and Patients. 2004; 256: 24.

[19] Stoddard FR 2nd, Brooks AD, Eskin BA, et al. Iodine Alters Gene Expression in the MCF7 Breast Cancer Cell Line: Evidence for an Anti-Estrogen Effect of Iodine. Int J Med Sci. 2008 Jul 8;5(4):189-96.

[20] Rayman MP. The importance of selenium to human health. Lancet. 2000;356(9225):233-241.

[21] Ganther HE. Selenium metabolism, selenoproteins and mechanisms of cancer prevention: complexities with thioredoxin reductase. Carcinogenesis. 1999 Sep;20(9):1657-66.

[22] Brown KM, Arthur JR. Selenium, selenoproteins and human health: a review. Public Health Nutr. 2001 Apr;4(2B):593-9.

[23] Rayman MP. The importance of selenium to human health. Lancet. 2000;356(9225):233-241.

[24] Cannell JJ, Hollis BW, Zasloff M, et al. Diagnosis and treatment of vitamin D deficiency. Expert Opin Pharmacother. 2008 Jan;9(1):107-18.

[25] Cannell JJ, Hollis BW. Use of Vitamin D in Clinical Practice. Altern Med Rev. 2008 Mar;13(1):6-20.

[26] Nowson CA, Margerison C. Vitamin D intake and vitamin D status of Australians. Med J Aust. 2002 Aug 5;177(3):149-52.

[27] Zeligs MA, Fulfs JC, Peterson R, et al. In vivo, uterine-protective activity of absorption-enhanced diindolylmethane: Animal and preliminary human use in combination with Tamoxifen. Proc Am Assoc Cancer Res. 2003. 44:1268.

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