Estroprogestin vs. gonadotrophin agonists plus estroprogestin in the treatment of endometriosis-related pelvic pain: a randomized trial. Gruppo Italiano per lo Studio dell'Endometriosi.
OBJECTIVE
This is a randomized clinical trial comparing estroprogestin (E/P) pill given for 12 months vs. gonadotrophin releasing hormone agonist (GNRHa) given for 4 months followed by E/P pill treatment for 8 months in the relief of endometriosis-related pelvic pain.


METHODS
Eligible for the study were women with laparoscopically confirmed endometriosis and pelvic pain lasting 3-12 months after diagnosis. Eligible women were randomly assigned to treatment with E/P pill (gestroden 0.75 mg and ethynlestradiol 0.03 mg) for 12 months (47 patients) vs. tryptorelin 3.75 mg slow release every 28 days for 4 months followed by E/P pill for 8 months (55 patients).


RESULTS
At baseline, dysmenorrhea was reported in 46 women allocated to E/P pill only (97.9%), and in all the 55 women allocated to GNRHa+E/P pill. The corresponding value at the 12 months follow-up visit was 14 subjects (35.9%) and 16 subjects (34.8%). The baseline median values of the multidimensional and analog scale were for dysmenorrhea 4 and 6 in the EP only and 3 and 6 in the GNRHa+E/P group. The corresponding value at the 12 months follow-up visit were 2 and 6 and 0 and 5. Non-menstrual pain was reported, respectively, at baseline and 12 month visit by 46 (97.9%) and 15 (38.5%) subjects in the E/P pill group and 49 (89.1%) and 17 (37.0%) of the GNRHa+E/P pill one. The baseline median values of the multidimensional and analog scale were for non-menstrual pain 3 and 5 in the E/P only and 2 and 6 in the GNRHa+E/P group. The corresponding values at the 12 month follow-up visit were 0 and 4 and 0 and 4. These differences between the two groups were not statistically significant.


CONCLUSIONS
1 year after randomization, the two treatment schedules show similar relief of pelvic pain in women with endometriosis.
Parazzini
F
F
Prima Clinica Ostetrico Ginecologica, Università di Milano, Milan, Italy. garimoldi@irfmn.mnegri.it
Di Cintio
E
E
Chatenoud
L
L
Moroni
S
S
Ardovino
I
I
Struzziero
E
E
Falsetti
L
L
Bianchi
A
A
Bracco
G
G
Pellegrini
A
A
Bertulessi
C
C
Romanini
C
C
Zupi
E
E
Massobrio
M
M
Guidetti
D
D
Troiano
L
L
Beretta
P
P
Franchi
M
M
D000328:Adult; D004412:Dysmenorrhea / Q000188:drug therapy / Q000209:etiology; D004715:Endometriosis / Q000150:complications / Q000188:drug therapy*; D004958:Estradiol / Q000008:administration & dosage / Q000819:agonists*; D005260:Female; D005500:Follow-Up Studies; D007987:Gonadotropin-Releasing Hormone / Q000819:agonists*; D006801:Humans; D008186:Luteolytic Agents / Q000008:administration & dosage*; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010147:Pain Measurement; D011374:Progesterone / Q000008:administration & dosage / Q000819:agonists*; D017329:Triptorelin Pamoate / Q000008:administration & dosage*
D008186:Luteolytic Agents; D017329:Triptorelin Pamoate; D007987:Gonadotropin-Releasing Hormone; D011374:Progesterone; D004958:Estradiol