title: Effect of a Psidii guajavae folium extract in the treatment of primary dysmenorrhea: a randomized clinical trial.
abstract: OBJECTIVE
  To assess the efficacy of two different doses of a Psidii guajavae folium extract in the management of primary dysmenorrhea.
  
  
  METHODS
  A double-blinded randomized clinical trial was conducted in 197 women with primary dysmenorrhea. Four intervention groups were defined: two extract doses (3 and 6 mg/day); ibuprofen (1200 mg/day); placebo (3mg/day). Participants were followed-up individually for 4 months. The main outcome variable was abdominal pain intensity measured according to a visual analogue scale (VAS).
  
  
  RESULTS
  The average age of participants was 19 years; menarche occurred around age 12 years. Participants had menstrual cycles of 28 or 29 days, with menstruation lasting 5 days and mean of pain intensity of 8.2 on the VAS. During each successive treatment cycle, participants experienced a lower pain intensity score. Multiple regression analysis, after adjusting each cycle for baseline pain, treatment compliance and other variables, showed that the group receiving 6 mg/day extract had significantly reduced pain intensity (p<0.001). This effect was maintained in cycles 2 and 3, although the reduction in the mean of pain intensity was lower. The group receiving the 3mg/day extract did not show a consistent effect throughout the three cycles.
  
  
  CONCLUSIONS
  At a dose of 6 mg/day, the standardized phyto-drug (Psidii guajavae folium extract) reduced menstrual pain significantly compared with conventional treatment and placebo.
authors.affiliation: Epidemiology and Health Services Research Unit "Centro Medico Nacional Siglo XXI", Mexican Institute of Social Security (IMSS), Mexico.
authors.forename: Svetlana Vladislavovna
authors.initials: SV
authors.lastname: Doubova
authors.forename: Hortensia Reyes
authors.initials: HR
authors.lastname: Morales
authors.forename: Sergio Flores
authors.initials: SF
authors.lastname: Hernández
authors.forename: María
authors.initials: M
authors.lastname: del Carmen Martínez-García
authors.forename: Marcela González
authors.initials: MG
authors.lastname: de Cossío Ortiz
authors.forename: Marco A Chávez
authors.initials: MA
authors.lastname: Soto
authors.forename: Erika Rivera
authors.initials: ER
authors.lastname: Arce
authors.forename: Xavier
authors.initials: X
authors.lastname: Lozoya
mesh_terms: D000293:Adolescent; D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use; D004311:Double-Blind Method; D004412:Dysmenorrhea / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use; D027822:Myrtaceae; D010147:Pain Measurement; D008517:Phytotherapy; D010936:Plant Extracts / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010946:Plants, Medicinal; D016032:Randomized Controlled Trials as Topic; D012044:Regression Analysis
chemical_list: D018712:Analgesics, Non-Narcotic; D010936:Plant Extracts; D007052:Ibuprofen