title: Effectiveness of the Association N-Palmitoylethanolamine and Transpolydatin in the Treatment of Primary Dysmenorrhea.
abstract: 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.
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Medicine and Health Sciences, University of Molise, Campobasso, Italy. Electronic address: edo.tartaglia@libero.it.
authors.forename: Edoardo
authors.initials: E
authors.lastname: Tartaglia
authors.affiliation: Department of Gynecology and Obstetrics, San Paolo Hospital, Naples, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Armentano
authors.affiliation: Department of Paediatrics, ASL NA1/C, Napoli, Italy.
authors.forename: Brunella
authors.initials: B
authors.lastname: Giugliano
authors.affiliation: Department of Gynecology and Obstetrics, San Giovanni Bosco Hospital, Naples, Italy.
authors.forename: Teresa
authors.initials: T
authors.lastname: Sena
authors.affiliation: Department of Medicine and Health Sciences, University of Molise, Campobasso, Italy.
authors.forename: Piero
authors.initials: P
authors.lastname: Giuliano
authors.affiliation: Department of Gynecology and Obstetrics, Villa Cinzia Clinic, Naples, Italy.
authors.forename: Castrese
authors.initials: C
authors.lastname: Loffredo
authors.affiliation: Department of Medicine and Health Sciences, University of Molise, Campobasso, Italy.
authors.forename: Pasquale
authors.initials: P
authors.lastname: Mastrantonio
mesh_terms: D000293:Adolescent; D000328:Adult; D000577:Amides; D000700:Analgesics / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004412:Dysmenorrhea / Q000188:drug therapy*; D004983:Ethanolamines / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D005960:Glucosides / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007558:Italy; D010147:Pain Measurement; D010169:Palmitic Acids / Q000008:administration & dosage / Q000627:therapeutic use*; D017699:Pelvic Pain / Q000188:drug therapy; D011247:Pregnancy; D013267:Stilbenes / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000577:Amides; D000700:Analgesics; D004983:Ethanolamines; D005960:Glucosides; D010169:Palmitic Acids; D013267:Stilbenes; C005958:palmidrol; C058229:polydatin
keywords: N-Palmitoylethanolamine; Primary dysmenorrhea; Transpolydatin