| . | MHT (FDA Approved) . | BIH (Unregulated) . |
|---|---|---|
| Goal of intervention | Treatment: clinicians prescribe estrogen to treat symptoms (primarily vasomotor) | Replacement: clinicians prescribe replacing multiple sex steroids with the goal of restoring levels to the premenopausal range |
| They add progestin only for women with a uterus to prevent endometrial hyperplasia | Progesterone is often recommended for all women, even those without a uterus | |
| Pretreatment testing | No pretreatment is required | Extensive salivary or blood testing is required |
| Baseline hormones do not predict dose requirements | ||
| Biochemical testing for monitoring | This is rarely needed | Routine salivary or blood testing to monitor and adjust doses is required |
| FDA-approval status and concerns | FDA-approved estrogens and progestins, including 17β-E2 and progesterone, are required to: 1. Demonstrate sufficient purity, potency, efficacy, and safety for approval 2. Have a failure rate <2% in quality and potency tests 3. Have indications (hot flashes, vaginal atrophy, prevention of bone loss) 4. Be supported by well-conducted RCTs 5. Have package inserts that provide extensive product information, which may include black box warnings 6. Have all adverse events reported to the FDA both before approval and after marketing 7. E3 not approved | Compounded bioidenticals have: 1. No requirement to prove efficacy or safety before use 2. No requirement for routine monitoring for purity or potency (sporadic assessments indicate high failure rates) 3. Unsupported claims that the approach is safer and more effective than conventional HT 4. No requirement for package inserts or black box warnings 5. No listed concerns about possible overdosing or underdosing or the risk of higher estrogen/inadequate progesterone exposure 6. No requirement for adverse event reporting 7. E3 is a commonly included agent |
| Timing and duration of treatment | Perimenopause, ages 50–59, or <10 y after menopause is recommended | There are no age or duration restrictions |
| Evidence for efficacy (relief of symptoms) | There is 80%–90% relief with appropriate estrogen doses | There is anecdotal evidence for efficacy |
| Other benefits | Alleviating adverse mood | Energy |
| Reduction in fracture | Vitality | |
| Increased attractiveness (these are only claims and not supported by RCTs) | ||
| Risks | 1. Breast cancer: E + P after 5 y of use 2. CVD: risk of CHD, stroke, particularly in older women (WHI), safer in younger menopausal women because of very low absolute risk (ages 50–59) 3. VTE: small excess at all ages but, absolute risk small in younger women ages 50–59 4. Gallbladder disease 5. Urinary incontinence | The lack of evidence for harm (due to overall lack of evidence of any sort) is suggested by some of these products as evidence of safety |
| . | MHT (FDA Approved) . | BIH (Unregulated) . |
|---|---|---|
| Goal of intervention | Treatment: clinicians prescribe estrogen to treat symptoms (primarily vasomotor) | Replacement: clinicians prescribe replacing multiple sex steroids with the goal of restoring levels to the premenopausal range |
| They add progestin only for women with a uterus to prevent endometrial hyperplasia | Progesterone is often recommended for all women, even those without a uterus | |
| Pretreatment testing | No pretreatment is required | Extensive salivary or blood testing is required |
| Baseline hormones do not predict dose requirements | ||
| Biochemical testing for monitoring | This is rarely needed | Routine salivary or blood testing to monitor and adjust doses is required |
| FDA-approval status and concerns | FDA-approved estrogens and progestins, including 17β-E2 and progesterone, are required to: 1. Demonstrate sufficient purity, potency, efficacy, and safety for approval 2. Have a failure rate <2% in quality and potency tests 3. Have indications (hot flashes, vaginal atrophy, prevention of bone loss) 4. Be supported by well-conducted RCTs 5. Have package inserts that provide extensive product information, which may include black box warnings 6. Have all adverse events reported to the FDA both before approval and after marketing 7. E3 not approved | Compounded bioidenticals have: 1. No requirement to prove efficacy or safety before use 2. No requirement for routine monitoring for purity or potency (sporadic assessments indicate high failure rates) 3. Unsupported claims that the approach is safer and more effective than conventional HT 4. No requirement for package inserts or black box warnings 5. No listed concerns about possible overdosing or underdosing or the risk of higher estrogen/inadequate progesterone exposure 6. No requirement for adverse event reporting 7. E3 is a commonly included agent |
| Timing and duration of treatment | Perimenopause, ages 50–59, or <10 y after menopause is recommended | There are no age or duration restrictions |
| Evidence for efficacy (relief of symptoms) | There is 80%–90% relief with appropriate estrogen doses | There is anecdotal evidence for efficacy |
| Other benefits | Alleviating adverse mood | Energy |
| Reduction in fracture | Vitality | |
| Increased attractiveness (these are only claims and not supported by RCTs) | ||
| Risks | 1. Breast cancer: E + P after 5 y of use 2. CVD: risk of CHD, stroke, particularly in older women (WHI), safer in younger menopausal women because of very low absolute risk (ages 50–59) 3. VTE: small excess at all ages but, absolute risk small in younger women ages 50–59 4. Gallbladder disease 5. Urinary incontinence | The lack of evidence for harm (due to overall lack of evidence of any sort) is suggested by some of these products as evidence of safety |
For FDA-approved MHT, see section V, part D, for more detail on the indications for MHT. CVD, cardiovascular disease; BIH, custom-compounded bioidentical HT; E+P, estrogen plus progestin MHT; E3, estriol.
| . | MHT (FDA Approved) . | BIH (Unregulated) . |
|---|---|---|
| Goal of intervention | Treatment: clinicians prescribe estrogen to treat symptoms (primarily vasomotor) | Replacement: clinicians prescribe replacing multiple sex steroids with the goal of restoring levels to the premenopausal range |
| They add progestin only for women with a uterus to prevent endometrial hyperplasia | Progesterone is often recommended for all women, even those without a uterus | |
| Pretreatment testing | No pretreatment is required | Extensive salivary or blood testing is required |
| Baseline hormones do not predict dose requirements | ||
| Biochemical testing for monitoring | This is rarely needed | Routine salivary or blood testing to monitor and adjust doses is required |
| FDA-approval status and concerns | FDA-approved estrogens and progestins, including 17β-E2 and progesterone, are required to: 1. Demonstrate sufficient purity, potency, efficacy, and safety for approval 2. Have a failure rate <2% in quality and potency tests 3. Have indications (hot flashes, vaginal atrophy, prevention of bone loss) 4. Be supported by well-conducted RCTs 5. Have package inserts that provide extensive product information, which may include black box warnings 6. Have all adverse events reported to the FDA both before approval and after marketing 7. E3 not approved | Compounded bioidenticals have: 1. No requirement to prove efficacy or safety before use 2. No requirement for routine monitoring for purity or potency (sporadic assessments indicate high failure rates) 3. Unsupported claims that the approach is safer and more effective than conventional HT 4. No requirement for package inserts or black box warnings 5. No listed concerns about possible overdosing or underdosing or the risk of higher estrogen/inadequate progesterone exposure 6. No requirement for adverse event reporting 7. E3 is a commonly included agent |
| Timing and duration of treatment | Perimenopause, ages 50–59, or <10 y after menopause is recommended | There are no age or duration restrictions |
| Evidence for efficacy (relief of symptoms) | There is 80%–90% relief with appropriate estrogen doses | There is anecdotal evidence for efficacy |
| Other benefits | Alleviating adverse mood | Energy |
| Reduction in fracture | Vitality | |
| Increased attractiveness (these are only claims and not supported by RCTs) | ||
| Risks | 1. Breast cancer: E + P after 5 y of use 2. CVD: risk of CHD, stroke, particularly in older women (WHI), safer in younger menopausal women because of very low absolute risk (ages 50–59) 3. VTE: small excess at all ages but, absolute risk small in younger women ages 50–59 4. Gallbladder disease 5. Urinary incontinence | The lack of evidence for harm (due to overall lack of evidence of any sort) is suggested by some of these products as evidence of safety |
| . | MHT (FDA Approved) . | BIH (Unregulated) . |
|---|---|---|
| Goal of intervention | Treatment: clinicians prescribe estrogen to treat symptoms (primarily vasomotor) | Replacement: clinicians prescribe replacing multiple sex steroids with the goal of restoring levels to the premenopausal range |
| They add progestin only for women with a uterus to prevent endometrial hyperplasia | Progesterone is often recommended for all women, even those without a uterus | |
| Pretreatment testing | No pretreatment is required | Extensive salivary or blood testing is required |
| Baseline hormones do not predict dose requirements | ||
| Biochemical testing for monitoring | This is rarely needed | Routine salivary or blood testing to monitor and adjust doses is required |
| FDA-approval status and concerns | FDA-approved estrogens and progestins, including 17β-E2 and progesterone, are required to: 1. Demonstrate sufficient purity, potency, efficacy, and safety for approval 2. Have a failure rate <2% in quality and potency tests 3. Have indications (hot flashes, vaginal atrophy, prevention of bone loss) 4. Be supported by well-conducted RCTs 5. Have package inserts that provide extensive product information, which may include black box warnings 6. Have all adverse events reported to the FDA both before approval and after marketing 7. E3 not approved | Compounded bioidenticals have: 1. No requirement to prove efficacy or safety before use 2. No requirement for routine monitoring for purity or potency (sporadic assessments indicate high failure rates) 3. Unsupported claims that the approach is safer and more effective than conventional HT 4. No requirement for package inserts or black box warnings 5. No listed concerns about possible overdosing or underdosing or the risk of higher estrogen/inadequate progesterone exposure 6. No requirement for adverse event reporting 7. E3 is a commonly included agent |
| Timing and duration of treatment | Perimenopause, ages 50–59, or <10 y after menopause is recommended | There are no age or duration restrictions |
| Evidence for efficacy (relief of symptoms) | There is 80%–90% relief with appropriate estrogen doses | There is anecdotal evidence for efficacy |
| Other benefits | Alleviating adverse mood | Energy |
| Reduction in fracture | Vitality | |
| Increased attractiveness (these are only claims and not supported by RCTs) | ||
| Risks | 1. Breast cancer: E + P after 5 y of use 2. CVD: risk of CHD, stroke, particularly in older women (WHI), safer in younger menopausal women because of very low absolute risk (ages 50–59) 3. VTE: small excess at all ages but, absolute risk small in younger women ages 50–59 4. Gallbladder disease 5. Urinary incontinence | The lack of evidence for harm (due to overall lack of evidence of any sort) is suggested by some of these products as evidence of safety |
For FDA-approved MHT, see section V, part D, for more detail on the indications for MHT. CVD, cardiovascular disease; BIH, custom-compounded bioidentical HT; E+P, estrogen plus progestin MHT; E3, estriol.
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