Effect of a Psidii guajavae folium extract in the treatment of primary dysmenorrhea: A randomized clinical trial

To assess the efficacy of two different doses of a Psidii guajavae folium extract in the management of primary dysmenorrhea. 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); ibu...

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Bibliographic Details
Published in:Journal of ethnopharmacology 2007-03, Vol.110 (2), p.305-310
Main Authors: Doubova, Svetlana Vladislavovna, Morales, Hortensia Reyes, Hernández, Sergio Flores, Martínez-García, María del Carmen, Ortiz, Marcela González de Cossío, Soto, Marco A. Chávez, Arce, Erika Rivera, Lozoya, Xavier
Format: Article
Language:English
Subjects:
Adolescent
Adult
analgesic effect
Analgesics, Non-Narcotic - therapeutic use
Biological and medical sciences
chemical constituents of plants
clinical trials
Double-Blind Method
Dysmenorrhea - drug therapy
Female
General pharmacology
Humans
Ibuprofen - therapeutic use
leaves
Medical sciences
medicinal plants
medicinal properties
menstrual cycle
Myrtaceae
Pain Measurement
Pharmacognosy. Homeopathy. Health food
Pharmacology. Drug treatments
Phytodrug
Phytotherapy
plant extracts
Plant Extracts - administration & dosage
Plant Extracts - adverse effects
Plant Extracts - therapeutic use
Plants, Medicinal
Primary dysmenorrhea
Psidii guajavae folium
Psidium guajava
Randomized Controlled Trials as Topic
Regression Analysis
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Summary:To assess the efficacy of two different doses of a Psidii guajavae folium extract in the management of primary dysmenorrhea. 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 (3 mg/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). 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 3 mg/day extract did not show a consistent effect throughout the three cycles. 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.
ISSN:0378-8741
1872-7573
DOI:10.1016/j.jep.2006.09.033