Comparing the effect of aromatase

inhibitor (letrozole) + cabergoline

(Dostinex) and letrozole alone on
uterine myoma regression, a
randomized clinical trial
 Introduction
• Uterine myomas are the most common benign
gynecological tumours.
• The risk factors include increasing age, black
ethnicity, early menarche, nulliparity, obesity,
inactivity, alcohol consumption, caffeine use,
stress, family history and environmen- tal
factors
Introduction

Most common solid pelvic

tumors
Develop in 20-25% of women
during reproductive years

30-50 years old

Approximately 40% of
patients need medical/surgical
intervention
 Fibroids

Uterine [99%] Extrauterine [1%]

Corporeal [95%] Cervical [4%] Genital Extragenital

Interstitial [60%] Parasitic Fibroid

Submucous [ 20%] Others

Subserous [15%]
 Introduction
GnRH agonist Antiprogrestin
and progestin
antagonist

Dopamine Aromatase
Uterine Inhibitor
agonist
(letrozole)
(cabergoline) Myoma

Herbal
Danazol Gestrinone agents
 Introduction

Letrozole +
Cabergoline Letrozole
 Methods

Location Time
Alzahra April
Teaching
Hospital, 2015 to
Tabriz March
2016
University of
Medical
Sciences, Iran
 Methods
Exclusion criteria Exclusion criteria
• Age >45 years • Pregnancy-related toxae- mia
• Fibroids >10 cm • Cardiovascular disease
• More than five fibroids • Peptic ulcer
• Fibroids with subserosal • Use of antipsychotic
location medications
• A positive history of • Receipt of oestrogen and
abnormal endometrial or progesterone in the last month
cervical pathology • A hormone-based implant in
• Uterine infection the last 3 months
• Renal disease • Previous history of
• Hepatic disease medical/surgical treatment for
uterine myomas.
Methods
 Methods
12 weeks of
Group 1 (n = 38) treatment
Letrozole 2.5
mg/day) +
cabergoline 0.5
mg/week 80
patients

Group 2 (n = 38)
Letrozole 2,5 mg/ 2 Patients excluded due
day to side effects and loss
to follow up
 Statistical Analysis
Categorical data
Chi-squared or
Fisher’s
exact test

Numerical data : Presented as

the independent Statistical mean (SD)
samples t-test or and
Mann–Whitney Analysis Frequency
U test (%)

Normal
distribution :
Kolmogorov-
Smirnov test
 Results
Characteristics of patients in both groups
Results
Results
Results
 Results
Percentage of volume changes in uterine
myomas after treatment
Results

Percentage of
overall
satisfaction
after
completion of
treatment
 Discussion
Gurates et al., :
Letrozole led to a
decrease in the volume
of uterine myomas
(46.7%) and uterine size
(21.7%)
Parsanezhad et al., :
Letrozole and triptorelin
were found to be similarly
effective in reducing the
volume of uterine myomas
(45.6% vs 33.2%)

Badawy et al :
Letrozole did not decrease the uterine
volume, but it led to a greater decrease in
the volume of uterine myomas than the
present study (49.1% in letrozole group)
 Discussion

Song et al. : Duhan et al. :

Letrozole was not Found a significant
associated with major side decrease in myoma
effects volume after 12 weeks of
treatment with letrozole
2.5 mg/day (52.5% on
Leone Roberti Maggiore et
average).
al.:
Administration of presurgical
letrozole 2.5 mg/day +
norethindrone for 3 months
improved the quality of surgical
intervention in patients with large
myomas ( 8 cm)
 Discussion

Bizzarri et al. : Elbareg et al. :

Letrozole 2.5 mg/day before Cabergoline 0.5 mg/week
surgical treatment for reduced large uterine
uterine myomas and myomas significantly.
observed a significant Side effects,were less
decrease (34.5%) in the common in the cabergoline
volume of uterine myomas group. The decrease in
after treatment myoma size was 39–58% in
the cabergoline group.
 Discussion

Author’s previous study :

In cabergoline group, the Comparison between author’s
degree of myoma present and previous study :
regression ranged Headache was more common
between 46% and 53%, in the present study (23.7%),
whereas the rates of nausea
the side effects were less
and vomiting were
frequent, and the drug comparable (28.9% and 5.3%,
was better tolerated than respectively).
diphereline
 Conclusion

This study found that 12 weeks of treatment

with letrozole +/- cabergoline induced
regression of uterine myomas, led to
symptomatic improvement, and could be used
for short-term treatment prior to surgery or
fertility programmes.
 Conclusion

There was no significant difference between

the two groups in terms of the degree of
reduction in the volume of uterine myomas,
the number of uterine myomas and changes
in uterine volume.
Headache was more common with
cabergoline.