Primary Dysmenorrhea Clinical Trial
Official title:
Which do You Think is the Best Treatment Choice in Primary Dysmenorrhea?
Our aim is to evaluate and compare the pain relief of estradiol valerate/dienogest and
ethinylestradiol/ drospirenone by using doppler indices.
100 nullipara patients with symptoms of severe primary dysmenorrhea (PD) requesting
contraception aged from 18 to 35 were included to the study. Visual analog scale (VAS), the
uterine artery doppler indices including systole/diastole rates ( S/D), pulsatility index
(PI) and resistance index (RI) values were evaluated and recorded in both uterine vessels
before treatment. The 66 PD patients who met the inclusion criteria were divided into 2
groups and 33 healthy controls created Group 1. Group 2 were administered estradiol
valerate/dienogest while Group 3 were administered 0.03 mg ethinylestradiol and 3 mg
drospirenone. Both VAS scores and doppler indices were repeated after 3 months treatment.
The changes in values were recorded.
This prospective, randomized, controlled clinical trial was conducted in Kayseri Education
and Research Hospital, in Turkey between 2015 and 2016. Nullipara patients with symptoms of
severe primary dysmenorrhea (PD) requesting contraception aged from 18 to 35 were included
to the study. Afterwards, based on computer generated random numbers the patients were
allocated to one of the two study arms; Group2 (Qlarista group) and Group3 (yasmin group),
equally.
The PD was diagnosed clinically. The characteristic of pain was periodic (at least following
3 menstrual cycles), midline, lower abdominal cramps or pelvic colic like pain that starts
up to one day before menses, lasts for the 3 days of bleeding, gradually diminishes over 12
to 72 hours and ends after period. The pain starts generally in 2 to 3 years after menarche
with regular menses (25-31 day). Also absence of pelvic pathology was important in these
patients for diagnosis.
Patients with history of pelvic inflammatory diseases, endometriosis, ovarian cysts, chronic
abdominal pain, fibroids, obstructive endometrial polyps, cervical stenosis, inflammatory
bowel syndrome, irritable bowel syndrome, major abdominal or pelvic surgery, intrauterine
device and congenital obstructive müllerian malformations were excluded. Smoking,
overweighted (body mass index (BMI) ≥ 30) patients that oral contraceptive pills (OCP)
treatment was contraindicated were also excluded. Additionally, patients enrolled
simultaneously into other studies that require drug intake or otherwise prevent compliance
with protocol were out of the study.
Visual analog scale (VAS) from 0 (no pain) to 10 (maximum pain, 'worst pain I have ever
felt') was applied to patients on the first day of menstrual cycle. Patients with VAS score
of between 7 to10 and PD accompanied with vomiting, nausea, dizziness, headache,
nervousness, diarrhea and fatigue were classified as severe PD. The ages (years), BMI
(kg/m2), length of menstrual cycle (days) and length of bleeding (days) and demographic data
of patients were recorded.
Before treatment during menstruation period all ultrasound examinations were carried out
trans abdominally with Toshiba Xario machine ( Shimoishigami, Otawara-shi, Tochigi 324-8550,
Japan) equipped with a 2.8-7 megahertz (MHz) transducer by a single radiologist (Ş.T.) The
uterine artery blood flows were measured at the lateral level of uterine artery neighbour to
cervicocorporeal junction in both sides (right and left). Doppler indices including
systole/diastole rates ( S/D), pulsatility index (PI) and resistance index (RI) values were
evaluated and recorded in both uterine vessels. Both VAS scores and doppler indices were
repeated after 3 months treatment. The changes in values were recorded.
According to previously published studies and after power analyses, when α error and β error
were considered, respectively, as 0.05 and 0.20, with 80% power number of patients for each
group were determined as minimum 30. Power Analysis and Sample Size Software (PASS) 11
software (NCSS, Kaysville, USA) was used to perform these analyses. Regarding dropout rates
(40 % -50 %) in similar studies over the treatment period we planned to include 100 patients
with PD and 40 healthy controls. The PD patients who met the inclusion criteria were divided
into 2 groups. Patients in Group 2 were administered estradiol valerate/dienogest (Qlarista;
Bayer HealthCare Berlin, Germany). Qlarista consists of 28 tablets (including 2 tablets of
3mg estradiol valerate, 5 tablets of 2mg estradiol valerate plus 2mg dienogest, 17 tablets
of 2mg estradiol valerate plus 3mg dienogest, 2 tablets of 1mg estradiol valerate and 2 non
hormonal tablets as placebo, respectively). Patients in Group 3 were administered 0.03 mg
ethinylestradiol and 3 mg drospirenone (21 tablets) (Yasmin; Bayer HealthCare Berlin,
Germany). Patients were randomly administered to the 2 treatments in a 1:1 ratio. Instead of
relieving, patients were not allowed to use rescue medication (NSAI drugs) to prevent
menstruation related pelvic pain.
All procedures performed in studies involving human participants were in accordance with the
ethical standards of the institutional and/or national research committee and with the 1964
Helsinki declaration and its later amendments or comparable ethical standards. Ethics
approval for the study was obtained from Erciyes University Hospital (protocol
number:2014/290). Informed consent was obtained from all patients who included in our study.
All analyses were performed using the SPSS for Windows 21.0 (SPSS Inc. USA) software
package. The normality of distribution for variables was assessed using the Shapiro Wilk
test. Data was presented as means ± standart deviation (SD) for continuous variables. To
assess the differences in variables between groups, the independent t test was used. As the
results did not have a normal distribution, Kruskal-Wallis, Mann-Whitney U-test and
Bonferroni correction was used in the comparisons between the groups. For comparison, the
Wilcoxon test was applied to the results (VAS scores, Doppler flow parameters) before and
after receiving therapy. For all comparisons, the P < 0.05 value was determined as
statistically significant.
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