Edoardo Tartaglia1, Mario Armentano2, Brunella Giugliano3, Teresa Sena4, Piero Giuliano5, Castrese Loffredo6, Pasquale Mastrantonio5. 1. Department of Medicine and Health Sciences, University of Molise, Campobasso, Italy. Electronic address: edo.tartaglia@libero.it. 2. Department of Gynecology and Obstetrics, San Paolo Hospital, Naples, Italy. 3. Department of Paediatrics, ASL NA1/C, Napoli, Italy. 4. Department of Gynecology and Obstetrics, San Giovanni Bosco Hospital, Naples, Italy. 5. Department of Medicine and Health Sciences, University of Molise, Campobasso, Italy. 6. Department of Gynecology and Obstetrics, Villa Cinzia Clinic, Naples, Italy.
Abstract
STUDY OBJECTIVE: To evaluate the effectiveness and safety of the combination of N-palmitoylethanolamine (PEA) and transpolydatin vs placebo in the treatment of primary dysmenorrhea in adolescents and young women. DESIGN, SETTING, AND PARTICIPANTS: Randomized treatment and follow-up of 220 cases of primary dysmenorrhea in the Department of Medicine and Health Sciences, Institute of Gynecology and Obstetrics, University of Molise, Italy. METHODS:Between February 2013 and February 2014, we treated 220 young women aged 16 to 24 years who had primary dysmenorrhea: 110 patients were treated with the oral combination of PEA-transpolydatin: 400 mg + 40 mg (1 tablet a day for 10 days from the 24th day of cycle) and 110 patients with placebo (1 tablet a day for 10 days from the 24th day of cycle). A follow-up was performed after treatment, and all girls were seen at this time. A 10-point visual analog scale was used to measure the improvement of pelvic pain. For categorical variables, the χ(2) test and analysis of variance were performed to value the significance of differences between groups. A value of P < .05 was considered statistically significant. RESULTS: An improvement of pelvic pain was seen in 98.18% (95% confidence interval 97.64% to 98.60%) of cases in group 1 vs 56.36% (95% confidence interval 48.62% to 63.81%) in group 2 (P < .001). The combination of PEA and transpolydatin was more effective than placebo (P < .001). CONCLUSION: The combination of PEA and transpolydatin shows promise as a valid adjuvant therapy in the medical treatment of primary dysmenorrhea in adolescents and young women.
RCT Entities:
STUDY OBJECTIVE: To evaluate the effectiveness and safety of the combination of N-palmitoylethanolamine (PEA) and transpolydatin vs placebo in the treatment of primary dysmenorrhea in adolescents and young women. DESIGN, SETTING, AND PARTICIPANTS: Randomized treatment and follow-up of 220 cases of primary dysmenorrhea in the Department of Medicine and Health Sciences, Institute of Gynecology and Obstetrics, University of Molise, Italy. METHODS: Between February 2013 and February 2014, we treated 220 young women aged 16 to 24 years who had primary dysmenorrhea: 110 patients were treated with the oral combination of PEA-transpolydatin: 400 mg + 40 mg (1 tablet a day for 10 days from the 24th day of cycle) and 110 patients with placebo (1 tablet a day for 10 days from the 24th day of cycle). A follow-up was performed after treatment, and all girls were seen at this time. A 10-point visual analog scale was used to measure the improvement of pelvic pain. For categorical variables, the χ(2) test and analysis of variance were performed to value the significance of differences between groups. A value of P < .05 was considered statistically significant. RESULTS: An improvement of pelvic pain was seen in 98.18% (95% confidence interval 97.64% to 98.60%) of cases in group 1 vs 56.36% (95% confidence interval 48.62% to 63.81%) in group 2 (P < .001). The combination of PEA and transpolydatin was more effective than placebo (P < .001). CONCLUSION: The combination of PEA and transpolydatin shows promise as a valid adjuvant therapy in the medical treatment of primary dysmenorrhea in adolescents and young women.