Berks County Medical Society Medical Record Fall 2018 - 26

Reading Hospital/Tower Health

Student Sum mer Research Projects
Incidence of Abnormal
Uterine Bleeding and
Endometrial Hyperplasia
in Postmenopausal Women
by Xuezhi Jiang, Nathalia Arias-Alzate,
Cassandra Mitchell, Brian D. Novi, Gregory Bolton,
Kristine Leaman, Shahab Minassian, Peter F. Schnatz,
Mark B. Woodland
OBJECTIVE:
The objective of this study was to assess the incidence of
abnormal uterine bleeding (AUB) and endometrial hyperplasia in
postmenopausal women treated with non-FDA approved Pellet
Hormonal Therapy (PHT) while compared with FDA approved
Hormonal Therapy (FHT).

METHODS:
A retrospective cohort study was designed to compare two
cohorts (PHT vs. FHT). A total of 522 postmenopausal women
with menopausal symptoms were identified from the Reading
Hospital Electronic Medical Record System through pharmacy
coding, including 367 on PHT (estradiol [E2, 6-37.5mg] and/or
testosterone [T,12-137.5 mg] pellets) and 155 on FHT. Data on
demographics, initial menopausal symptoms (i.e. hot flash, vaginal
dryness, decreased libido), side effects (i.e. AUB, mood swing,
anxiety, breast tenderness, change in hair pattern, acne, weight
gain), and treatment duration were extracted from medical records.
Chi-Square test was applied to assess the difference in incidence
of side effects between the two cohorts, and a multiple logistic
regression was fit with covariates (HT cohort, age at the initiation
of HT, Body Mass Index, duration of HT), to assess risk profile of
the individual covariate.

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RESULTS:
Women on PHT (n=367) were significantly younger than those
on FHT (n=155), with mean age (SD) of 51.04 (7.52) and 60.61
(9.56) years, respectively (p<.0001). The incidence of side effects
was significantly higher in PHT while compared with FHT (179
[49.5%] vs. 23 [15.3%], p<.0001, odds ratio [95% CI] =5.92[3.4210.25]). A total of 91 (58.7%) women on FHT had a hysterectomy
prior to the initiation of HT, which was significantly higher than the
151 (41.4%) on PHT (p=0.0003). When examining 276 women
with an intact uterus prior to HT initiation, mean (SD) duration
of HT treatment in years were significantly longer in PHT group
(3.11 [1.64] vs. 2.15 [2.22], p=.0023). During the treatment,
59.4% (127/214) on PHT vs. 19.4% (12/62) on FHT had at least
one episode of AUB (p<.0001, odds ratio [95% CI] =7.15[3.0017.04]). Of those, 54 (27%) and 5 (7.8%) had a hysterectomy
while on PHT and FHT respectively (p=.0013, odds ratio [95%
CI] =3.49[1.22-9.99]), and 87(41.8%) in PHT vs. 10 (16.4%) in
FHT had endometrial pathology available either from endometrial
biopsy or hysterectomy. No endometrial cancer was identified in
either group. There was no significant difference in incidence of
endometrial hyperplasia between the two cohorts (22[25.9%] vs.
4[40.0%]), with 3(14%) in PHT vs. 0 in FHT being diagnosed with
endometrial hyperplasia with atypia. A total of 201 women on PHT
had lab monitoring data available, abnormal E2 and T level were
detected in 52 (25.9%) and 133 (66.2%) women, respectively, who
subsequently required dose adjustment.

CONCLUSION:
When compared with women on FHT, women on PHT had a
significantly higher incidence of AUB and hysterectomy. It may be
difficult to assess difference in incidence of endometrial hyperplasia
due to relatively rare outcome and short durations of HT treatment
in our study. Large scale prospective clinical trials are warranted
to further investigate the safety of PHT for treating menopausal
symptoms.

Nathalia Arias-Alzate is currently a first-year
medical student at Rutgers Robert Wood Johnson
Medical School.
http://www.berkscms.org
Berks County Medical Society Medical Record Fall 2018

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