Comparing the Efficacy in Reducing Pelvic Pain Score at 3 Months after Treatment in Clinically Diagnosed Endometriotic Patients between Leuprolide Acetate and Depot Medroxyprogesterone Acetate: A randomized controlled trial

Abstract

Objectives: To compare the efficacy of 11.25 mg-leuprolide acetate (Enantone L.P.) and 150 mg-intramuscular depot medroxyprogesterone acetate (DMPA-IM) (Depo-Progesta) in the reduction of pelvic pain score, satisfaction of the patients after 3 months of treatment and associated side effects.
Materials and Methods: The study design was based on a randomized controlled trial, which was conducted in thirty-six patients who attended gynecologic outpatient department at Her Royal Highness Princess Maha Chakri Sirindhorn Medical Centre (MSMC). These patients were randomized into two groups, either the 11.25 mg-leuprolide acetate or the DMPA-IM group at their first visit. The pelvic pain scores were gathered by using the numerical rating scale at their first visit and 3 months after treatment. The satisfaction score was gathered by using rating scale 1-10. Side effects were collected data as yes or no. Mann-Whitney U test was used to evaluate both the efficacy through the improvements in pelvic pain score and patient’s satisfaction score. Finally, Chi-square test was used to evaluate side effects of both medications.
Results: The efficacy to reduce the pelvic pain score was similar between the 11.25 mg- leuprolide acetate and DMPA-IM group after 3 months of treatment. After the treatment, pain score was reduced from 7.00 (6.00, 8.00) [median (interquartile range)] to 2.00 (0.00, 2.00) in leuprolide acetate group and from 8.50 (6.00, 10.00) to 2.00 (2.00, 3.00) in the DMPA-IM group. The median (interquartile range) reduction in pain score was 73.21% (55.56, 100.00) in leuprolide acetate group and 71.43% (60.00, 80.00) in DMPA-IM group. However, this reduction did not show statistical significance between groups. Concerning the secondary objectives of this study, the median (interquartile range) of satisfaction score was 9.00 (7.00, 10.00) in leuprolide acetate group and 8.00 (8.00, 9.00) in DMPA-IM group at 3 months after treatment which were considered high but were not statistically significant between groups. In this study hot flashes were more commonly experienced by the patients in the leuprolide acetate group with statistical significance. In contrast, vaginal spotting was more common in patients of the DMPA-IM group. Other side effects such as night sweat, mood swing and vaginal dryness experienced by these patients were not statistically different between groups.
Conclusion: This double-blinded randomized controlled trial demonstrated that 11.25 mg-Leuprolide acetate was as effective as 150 mg-DMPA-IM in terms of reduction in endometriosis-related pain and patient satisfaction at 3 months after the initial treatment without significant differences.