Effect of a Psidii guajavae folium extract in the treatment of primary dysmenorrhea: a randomized clinical trial.
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.
Doubova
Svetlana Vladislavovna
SV
Epidemiology and Health Services Research Unit "Centro Medico Nacional Siglo XXI", Mexican Institute of Social Security (IMSS), Mexico.
Morales
Hortensia Reyes
HR
Hernández
Sergio Flores
SF
del Carmen Martínez-García
María
M
de Cossío Ortiz
Marcela González
MG
Soto
Marco A Chávez
MA
Arce
Erika Rivera
ER
Lozoya
Xavier
X
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
D018712:Analgesics, Non-Narcotic; D010936:Plant Extracts; D007052:Ibuprofen