Indole-3-Carbinol I3C - 200 mg by NOW

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Breast cancer. Although there has been interest in using oral indole-3-carbinol for breast cancer, there is insufficient reliable information about the clinical effects of indole-3-carbinol for this purpose.
• Cervical dysplasia. It is unclear if oral indole-3-carbinol is beneficial in patients with cervical dysplasia. Details: Preliminary clinical research shows that taking indole-3-carbinol 200-400 mg orally daily for 12 weeks is associated with complete regression of precancerous lesions in 45% to 50% of women with grade II or III, biopsy-proven cervical intraepithelial neoplasia (CIN, cervical dysplasia), the majority of whom are positive for human papilloma virus (HPV) infection (7173).
• Colorectal cancer. Although there has been interest in using oral indole-3-carbinol for colorectal cancer, there is insufficient reliable information about the clinical effects of indole-3-carbinol for this purpose.
• Fibromyalgia. Although there has been interest in using oral indole-3-carbinol for fibromyalgia, there is insufficient reliable information about the clinical effects of indole-3-carbinol for this purpose.
• Liver disease. Although there has been interest in using oral indole-3-carbinol for liver disease, there is insufficient reliable information about the clinical effects of indole-3-carbinol for this purpose.
• Nonmelanoma skin cancer. It is unclear if oral indole-3-carbinol is beneficial in patients with nonmelanoma skin cancer. Details: Preliminary clinical research in patients with vulvar intraepithelial neoplasia (VIN), a precancerous condition that can progress to squamous cell carcinoma, shows that taking indole-3-carbinol 200 mg or 400 mg daily for 6 months improves symptoms and reduces lesion size and severity when compared with baseline. However, tissue biopsies taken from the women with the most severely affected areas did not show any improvement in grade of VIN (93241). The validity of this finding is limited by the small study size and lack of a comparator group. Additionally, it is unclear if treatment with indole-3-carbinol reduces the risk of progression to cancer.
• Ovarian cancer. It is unclear if oral indole-3-carbinol is beneficial in patients with ovarian cancer. Details: Preliminary clinical research in patients with previously untreated stage III-IV ovarian cancer shows that taking indole-3-carbinol 200 mg orally twice daily with or without epigallocatechechin-3-gallate (EGCG) 200 mg twice daily, in conjunction with neoadjuvant chemotherapy and surgery, increases median overall survival and progression-free survival by 16 and 18 months, respectively, when compared with chemotherapy and surgery alone. The addition of indole-3-carbonol with or without EGCG also reduced the tumor recurrence rate by about 16% when compared with chemotherapy and surgery alone (98610).
• Recurrent respiratory papillomatosis. It is unclear if oral indole-3-carbinol is beneficial in patients with recurrent respiratory papillomatosis. Details: Preliminary clinical evidence shows that taking indole-3-carbinol 200 mg twice daily for a mean of 57.6 months (range 31 months to 76 months) after complete surgical removal of respiratory papillomas stops regrowth in about a third of patients and slows regrowth, reducing the need for repeated surgery, in another third (7172,47645,93239).
• Systemic lupus erythematosus (SLE). It is unclear if oral indole-3-carbinol is beneficial in patients with SLE. Details: Preliminary clinical research shows that taking indole-3-carbinol 125 mg orally three times daily for 3 months does not significantly decrease disease activity when compared with baseline in women aged 20-49 years with SLE (93240). More evidence is needed to rate indole-3-carbinol for these uses.

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POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts. Doses up to 400 mg daily have been used safely for 3-76 months (7173,93239,93240,93241). There is also some evidence that 400 mg twice daily can be used safely for 4 weeks (93242).

CHILDREN: POSSIBLY SAFE
when used orally and appropriately in medicinal amounts. There is limited evidence from 9 children with recurrent respiratory papillomatosis that indole-3-carbinol can be safely used in children ages 1.2-16 years for 12-76 months at doses of 6-17 mg/kg of body weight daily (7172,93239).

PREGNANCY AND LACTATION:
There is insufficient reliable information available about the safety of indole-3-carbinol when used during pregnancy and lactation; avoid using.

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, indole-3-carbinol might increase the risk of bleeding when used with antiplatelet or anticoagulant drugs.  Details In vitro research shows that indole-3-carbinol inhibits platelet aggregation (98611).

CYTOCHROME P450 1A2 (CYP1A2) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, indole-3-carbinol might increase the metabolism of CYP1A2 substrates and lower serum concentrations.  Details Animal research shows that indole-3-carbinol induces CYP1A2 enzymes (7187).

ESTROGENS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Indole-3-carbinol might interfere with the effects of estrogen therapy.  Details Preliminary clinical and in vitro evidence shows that indole-3-carbinol has antiestrogenic activity (7173,47621,93238,93240).

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General ...Orally, indole-3-carbinol seems to be well tolerated.
Most Common Adverse Effects:
Orally: Diarrhea, imbalance, nausea, rash, tremor, unsteadiness.

Dermatologic ...Orally, indole-3-carbinol has been associated with reports of rash (93242). A woman taking indole-3-carbinol 375 mg daily for treatment of systemic lupus erythematosus (SLE) developed a generalized maculopapular rash which resolved when indole-3-carbinol was discontinued and recurred when it was restarted (93240).

Gastrointestinal ...Orally, indole-3-carbinol increases gastrointestinal motility and has been associated with diarrhea (93242,93243).

Neurologic/CNS ...Indole-3-carbinol has been associated with reports of unsteadiness and imbalance, especially at higher doses (7172). An adult male taking 400 mg twice daily for treatment of recurrent respiratory papillomatosis developed imbalance and tremor after 10 days of treatment. This resolved when the dose was halved (93238). Two children who took 3 times the intended weight-based dose of indole-3-carbinol in one day developed unsteadiness and nausea (93238).

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