Objective: To compare the effect of a GnRH-agonist, triptorelin, versus placebo on the symptoms of endometriosis.
Design: A prospective, randomized, double-blind study of 6 months of treatment followed by 12 months of follow-up.
Setting: Departments of Obstetrics and Gynecology at two universities and one general hospital.
Patient(s): Forty-nine women with symptoms of laparoscopically verified endometriosis.
Intervention(s): Triptorelin depot or placebo was given every 4 weeks. Clinical evaluation, including the Duration Intensity Behavior Scale and Visual Analogue Scale for pain, was performed before the injections and up to 12 months after treatment. A control laparoscopy was performed 4-6 weeks after the last injection.
Main outcome measure(s): Quantitation of pain.
Result(s): Twenty-four patients had active treatment and 25 received placebo. Pain symptoms according to both scales were significantly more reduced after 2 months of triptorelin treatment compared to placebo. The extent of endometriotic lesions was reduced 50% during triptorelin treatment and increased 17% during placebo. The average area of endometriotic lesions was reduced 45% during triptorelin treatment but was unchanged during placebo. Side effects, mainly hot flushes, were experienced by 80% of the actively treated group but also by 33% of patients in the placebo group. Because of recurrent symptoms, only five patients could be observed for 12 months after completion of treatment.
Conclusion(s): Triptorelin reduces endometriotic lesions and pain to a significantly higher degree than placebo.