Primary objective: To evaluate the effectiveness of Neptune Krill Oil (NKO) for the management of premenstrual syndrome and dysmenorrhea.
Secondary objective: To compare the effectiveness of NKO for the management of premenstrual syndrome and dysmenorrhea with that of omega-3 fish oil.
Methods/design: Double-blind, randomized clinical trial.
Setting: Outpatient clinic.
Participants: Seventy patients of reproductive age diagnosed with premenstrual syndrome according to the Diagnostic and Statistical Manual of Mental Disorders, Third Edition, Revised (DSM-III-R).
Interventions: Treatment period of three months with either NKO or omega-3 fish oil.
Outcome measures: Self-Assessment Questionnaire based on the American College of Obstetricians and Gynecologists (ACOG) diagnostic criteria for premenstrual syndrome and dysmenorrhea and number of analgesics used for dysmenorrhea.
Results: In 70 patients with complete data, a statistically significant improvement was demonstrated among baseline, interim, and final evaluations in the self assessment questionnaire (P < 0.001) within the NKO group as well as between-group comparison to fish oil, after three cycles or 45 and 90 days of treatment. Data analysis showed a significant reduction of the number of analgesics used for dysmenorrhea within the NKO group (comparing baseline vs. 45- vs. 90-day visit). The between-groups analysis illustrated that women taking NKO consumed significantly fewer analgesics during the 10-day treatment period than women receiving omega-3 fish oil (P < 0.03).
Conclusion: Neptune Krill Oil can significantly reduce dysmenorrhea and the emotional symptoms of premenstrual syndrome and is shown to be significantly more effective for the complete management of premenstrual symptoms compared to omega-3 fish oil.