Berks County Medical Society Medical Record Fall 2017 - 23

Pellet vs. FDA Approved Hormonal Therapy
in Postmenopausal Women: Preliminary Safety Findings
from a Retrospective Cohort Study
by Kellie A. Matson, Xuezhi Jiang, Peter F. Schnatz, Biren Desai, Sydney Walker, Sarah Corcoran,
Phoenix Lau, Ashley Cochran, Larryl Damon Jr., Jennifer Larkin, Mark Woodland
The Reading Hospital, Department of Obstetrics and Gynecolog
Objective: Pellet Therapy (PT) is a non-FDA approved Hormonal
Therapy (HT) method of treating menopausal symptoms with
limited research on safety and efficacy. The objective of this study
was to assess the safety of PT vs. FDA approved HT (FDA-HT).
Design: A retrospective cohort study was designed to compare two
cohorts: women treated with PT and women treated with FDAHT. A total of 11,862 postmenopausal women were identified
through the Reading Hospital Electronic Medical Record System
by pharmacy coding, including 10,801 in FDA-HT and 1,061 in
PT (estradiol and/or testosterone pellets). Of 11,862 women, 337
were randomly selected for further investigation. Data on patient
histories, demographics, initial symptoms (e.g. hot flash, vaginal
dryness, decreased libido), side effects (e.g. abnormal uterine
bleeding [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 logistic regression model was fit with covariates,
including age at the initiation of HT, Body Mass Index, duration of
HT treatment, and HT type (FDA-HT vs. PT), to assess risk profile
of individual covariate. All statistical analyses were conducted with
SAS 9.3 at the 0.05 significance level.

Conclusion: When compared with women on FDA-HT, women
on PT had a significantly higher incidence of side effects including
AUB and subsequent hysterectomy. These preliminary findings raise
concern about the safety of PT. Further clinical research is warranted
to investigate utilization of PT for treating menopausal symptoms.

Kellie Matson is in her final year at West Chester
University of Pennsylvania, with a major in
Cell and Molecular Biology. She has worked
with Senior Helpers of Exton, PA and served as
a Patient Volunteer with the Chester County
Hospital Inpatient Hospice Unit.

continued on next page >

Results: Women on PT (n=183) were significantly younger than
those in FDA-HT group (n=154), with mean age (SD) of 51.03
(7.30) and 60.62 (9.26), respectively (p<.0001). Mean (SD)
duration of HT treatment in years was significantly longer in PT
group (3.60 [2.67] vs. 2.37 [1.60], p<.0001). The incidence of side
effects was significantly higher in PT group while compared with
FDA-HT (117 [63.9%] vs. 15 [10.6%], p<.0001, odds ratio [95%
CI] =14.7[7.93-27.25]). A total of 81 (53.6%) women on FDAHT had a hysterectomy prior to the initiation of HT, which was
significantly higher than the 75 (41.2%) on PT (p=0.024). When
examining women with an intact uterus prior to HT initiation,
62.6% (67/107) on PT vs. 17.7% (12/68) on FDA-HT had at least
one episode of AUB (p<.0001, odds ratio [95% CI]=5.46[2.4911.98]). Furthermore, significantly higher proportion of women on
HT (38.1% [40/107]), compared with 10% (7/70) on FDA-HT,
had a hysterectomy even though HT in both cohorts included
a variety of progestational agents for endometrial protection
(p<.0001, odds ratio [95% CI] =3.20[1.26-8.15]).
FALL 2017

|

23


http://www.intouchbysah.com/

Berks County Medical Society Medical Record Fall 2017

Table of Contents for the Digital Edition of Berks County Medical Society Medical Record Fall 2017

Berks County Medical Society Medical Record Fall 2017 - 1
Berks County Medical Society Medical Record Fall 2017 - 2
Berks County Medical Society Medical Record Fall 2017 - 3
Berks County Medical Society Medical Record Fall 2017 - 4
Berks County Medical Society Medical Record Fall 2017 - 5
Berks County Medical Society Medical Record Fall 2017 - 6
Berks County Medical Society Medical Record Fall 2017 - 7
Berks County Medical Society Medical Record Fall 2017 - 8
Berks County Medical Society Medical Record Fall 2017 - 9
Berks County Medical Society Medical Record Fall 2017 - 10
Berks County Medical Society Medical Record Fall 2017 - 11
Berks County Medical Society Medical Record Fall 2017 - 12
Berks County Medical Society Medical Record Fall 2017 - 13
Berks County Medical Society Medical Record Fall 2017 - 14
Berks County Medical Society Medical Record Fall 2017 - 15
Berks County Medical Society Medical Record Fall 2017 - 16
Berks County Medical Society Medical Record Fall 2017 - 17
Berks County Medical Society Medical Record Fall 2017 - 18
Berks County Medical Society Medical Record Fall 2017 - 19
Berks County Medical Society Medical Record Fall 2017 - 20
Berks County Medical Society Medical Record Fall 2017 - 21
Berks County Medical Society Medical Record Fall 2017 - 22
Berks County Medical Society Medical Record Fall 2017 - 23
Berks County Medical Society Medical Record Fall 2017 - 24
Berks County Medical Society Medical Record Fall 2017 - 25
Berks County Medical Society Medical Record Fall 2017 - 26
Berks County Medical Society Medical Record Fall 2017 - 27
Berks County Medical Society Medical Record Fall 2017 - 28
Berks County Medical Society Medical Record Fall 2017 - 29
Berks County Medical Society Medical Record Fall 2017 - 30
Berks County Medical Society Medical Record Fall 2017 - 31
Berks County Medical Society Medical Record Fall 2017 - 32
Berks County Medical Society Medical Record Fall 2017 - 33
Berks County Medical Society Medical Record Fall 2017 - 34
Berks County Medical Society Medical Record Fall 2017 - 35
Berks County Medical Society Medical Record Fall 2017 - 36
https://www.nxtbook.com/hoffmann/BerksCountyMedicalSociety/BerksCountyMedicalSociety_MedicalRecord_Spring2021
https://www.nxtbook.com/hoffmann/BerksCountyMedicalSociety/BerksCountyMedicalSociety_MedicalRecord_Winter2021
https://www.nxtbook.com/hoffmann/BerksCountyMedicalSociety/BCMS_MedicalRecord_Fall2020
https://www.nxtbook.com/hoffmann/BerksCountyMedicalSociety/BerksCountyMedicalSociety_MedicalRecord_Summer2020
https://www.nxtbook.com/hoffmann/BerksCountyMedicalSociety/BerksCountyMedicalSociety_MedicalRecord_Spring2020
https://www.nxtbook.com/hoffmann/BerksCountyMedicalSociety/BerksCountyMedicalSociety_MedicalRecord_Winter2020
https://www.nxtbook.com/hoffmann/BerksCountyMedicalSociety/BerksCountyMedicalSociety_MedicalRecord_Fall2019
https://www.nxtbook.com/hoffmann/BerksCountyMedicalSociety/BerksCountyMedicalSociety_MedicalRecord_Summer2019
https://www.nxtbook.com/hoffmann/BerksCountyMedicalSociety/BerksMedicalSocietyHealthWellnessDirectory
https://www.nxtbook.com/hoffmann/BerksCountyMedicalSociety/BerksMedicalRecord_Spring2019
https://www.nxtbook.com/hoffmann/BerksCountyMedicalSociety/BerksMedicalRecord_Winter2019
https://www.nxtbook.com/hoffmann/BerksCountyMedicalSociety/BerksCountyMedicalSociety_MedicalRecord_Fall2018
https://www.nxtbook.com/hoffmann/BerksCountyMedicalSociety/BerksCountyMedicalSociety_MedicalRecord_Summer2018
https://www.nxtbook.com/hoffmann/BerksCountyMedicalSociety/BerksCountyMedicalSociety_MedicalRecord_Spring2018b
https://www.nxtbook.com/hoffmann/BerksCountyMedicalSociety/BerksCountyMedicalSociety_MedicalRecord_Winter2017-18
https://www.nxtbook.com/hoffmann/BerksCountyMedicalSociety/BerksCountyMedicalSociety_Physician_Fall2017
https://www.nxtbook.com/hoffmann/BerksCountyMedicalSociety/BerksCountyMedicalSociety_MedicalRecord_Summer2017
https://www.nxtbook.com/hoffmann/BerksCountyMedicalSociety/MedicalRecordSpring2017
https://www.nxtbookmedia.com