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EvidenceUpdates
BACKGROUND:
Various hormone therapies (HT) are available to treat menopausal
vasomotor symptoms. Bioidentical hormones are chemically identical to
those produced by the human body, and several types are well-tested and
available on prescription. Many women have opted for bioidentical
hormone therapy (BHT) on the assumption that it is safer than other
forms of HT. We evaluated the evidence.
OBJECTIVES:
To determine the effectiveness and safety of bioidentical hormones
compared to placebo or non-bioidentical hormones for the relief of
vasomotor symptoms.
SEARCH METHODS:
In July 2015 we searched the Cochrane Central Register of Controlled
Trials, PubMed, Embase, Literatura Latino-Americana e do Caribe em
Ciências da Saúde (LILACS), registers of ongoing trials and the
reference lists of articles retrieved.
SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing bioidentical hormone therapy (BHT) versus placebo or non-bioidentical hormones.
DATA COLLECTION AND ANALYSIS:
We used standard methodological procedures expected by the Cochrane
Collaboration. Our primary outcome was vasomotor symptoms (hot flushes
and night sweats). We evaluated the overall quality of the evidence
using Grading of Recommendations Assessment, Development and Evaluation
criteria (GRADE).
MAIN RESULTS:
We included 23 RCTs (5779 participants). Most studies (20/23) included
only women with moderate to severe hot flushes. All studies compared
unopposed 17 beta-estradiol (beta-estradiol) versus placebo or
conjugated equine estrogens (CEE). None of the studies reported night
sweats as a separate outcome. BHT patch versus placebo Frequency of hot
flushesFour RCTs reported data suitable for analysis. There were fewer
hot flushes in the BHT group, with a moderate to large effect size (SMD
-0.68, 95% CI -0.83 to -0.53, four RCTs, 793 women, I(2) = 67%, low
quality evidence). There was moderate heterogeneity, but a consistent
direction of effect. Seven RCTs reported data unsuitable for analysis;
all reported a benefit in the intervention group. Symptom intensityTwo
RCTs reported analysable data. Measured on a 0-100 visual analogue scale
(VAS), hot flush intensity was lower in the BHT group (MD -19.94
points, 95% CI -24.86 to -15.02, two RCTs, 393 women, I(2) = 54%, low
quality evidence). There was moderate heterogeneity, but a consistent
direction of effect. Adverse effectsAdverse events (such as headache,
vaginal bleeding, breast tenderness and skin reactions) were more common
in the intervention group (odds ratio (OR) 2.14, 95% CI 1.29 to 3.54, 9
RCTs, 1822 women, I(2) = 73%, low quality evidence). There was moderate
heterogeneity, but a consistent direction of effect. In one study, five
women in the intervention group developed endometrial hyperplasia. BHT
gel versus placebo Hot flush frequencyThree RCTs reported this outcome,
but the data were unsuitable for analysis. All reported a benefit in the
BHT group. Adverse effectsAdverse events were more common in the BHT
group (OR 1.41, 95% CI 1.09 to 1.83, 3 RCTs, 1086 women, I(2) = 0%,
moderate quality evidence). Oral BHT versus placebo Hot flush
frequencyTwo studies reported analysable data. There were fewer hot
flushes in the BHT group, with a moderate to large effect size (SMD
-0.80, 95% CI -1.03 to -0.57, two RCTs, 356 women, I(2) = 14%, low
quality evidence). Adverse effectsThere was no evidence of a difference
between the groups (OR 1.28, 95% CI 0.84 to 1.96, 3 RCTs, 433 women,
I(2) = 0%, low quality evidence). Topical BHT emulsion versus placebo
Hot flush frequencyOne study with data unsuitable for analysis reported a
benefit in the intervention group. Adverse effectsThere was no evidence
of a difference between the groups (OR 1.46, 95% CI 0.80 to 2.66, one
RCT, 200 women, low quality evidence). Intranasal BHT versus placebo Hot
flush frequencyOnly one study reported analysable data. There were
fewer hot flushes per day in the BHT group (MD -3.04 95% CI -4.05 to
-2.03, one study, 458 women, moderate quality evidence) Adverse
effectsAdverse events (such as headache, breast tenderness, arthralgia
and nausea) were more common in the intervention group (OR 1.96, 95% CI
1.26 to 3.03, one RCT, 458 women, moderate quality evidence). Subgroup
analysesSubgroup analyses by dose of BHT suggested that higher doses of
BHT may be associated with more effectiveness but also higher risk of
adverse effects. BHT patch versus 0.625 mg CEETwo RCTs reported this
comparison, but the data were unsuitable for analysis. Hot flush
frequencyBoth RCTs reported no evidence of a difference between the
groups. Adverse effectsFindings were inconsistent. In one comparison
(0.1 mg BHT versus CEE), breast pain and vaginal bleeding were more
frequent in the BHT group. Oral BHT versus 0.625 mg CEE Hot flush
frequencyOne study with data unsuitable for analysis reported no
evidence of a difference between the groups. Adverse effectsThere was no
evidence of a difference between the groups (OR 1.20, 95% CI 0.50 to
2.87, one RCT, 103 women, very low quality evidence).
AUTHORS' CONCLUSIONS:
There was low to moderate quality evidence that BHT in various forms
and doses is more effective than placebo for treating moderate to severe
menopausal hot flushes. There was low to moderate quality evidence of
higher rates of adverse effects such as headache, vaginal bleeding,
breast tenderness and skin reactions in the BHT group. There was some
evidence to suggest that higher doses of BHT are associated with greater
effectiveness but also with higher risk of adverse effects. Although
all the included studies used unopposed estrogen, it is recommended best
practice to use progestogen therapy in women with a uterus taking
estrogen in order to avoid endometrial hyperplasia, regardless of the
source of the estrogen. No data are yet available about the safety of
BHT with regard to long-term outcomes such as heart attack, stroke and
breast cancer.There was no good evidence of a difference in
effectiveness between BHT and CEE, and findings with regard to adverse
effects were inconsistent. The quality of the evidence was too low to
reach any firm conclusions.The main limitations in the quality of the
evidence were study risk of bias (mainly due to poor reporting of
methods), imprecision and lack of data suitable for analysis.
Comments from Clinical Raters |
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General Internal Medicine-Primary Care(US)Supports the idea of not using untested stuff. Since this study indicates lack of useful testing of BHT, I'll continue to advise against. |
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