Therapeutic effects of Chiljehyangbuhwan on primary dysmenorrhea: a randomized, double blind, placebo-controlled study.

Objective: This clinical study was conducted to investigate the efficacy and safety of an oriental herbal medicine native to Korea, Chiljehyangbuhwan, in treating primary dysmenorrhea.

Design And Setting: A total of 100 primary dysmenorrhea patients who visited Kyung Hee University Korean Oriental Medicine Hospital between July 19 2004 and August 27 2004 were recruited. Secondary or drug-related dysmenorrhea was screened out through interviews and examination. The patients were grouped by fixed blocked randomization and administered either Chiljehyangbuhwan or placebo for one menstrual period in a double blind model. Visual Analogue Scale (VAS), Verbal Rating Scale (VRS), and Multidimensional Verbal Rating Scale (MVRS) were used to evaluate dysmenorrhea severity. A total of 71 patients who passed the screening test and remained to the last were divided into either placebo or Chiljehyangbuhwan group, and each were further split into smaller subsets (indication, non-indication, and unspecified group) according to Korean Oriental medical diagnosis.

Results: In the non-indication group, the placebo and Chiljehyangbuhwan group did not show significant difference in VAS, VRS, and MVRS scores before medication (1st VAS, 1st VRS, 1st MVRS), after medication (2nd VAS, 2nd VRS, 2nd MVRS), and in changes in scores before and after (DeltaVAS, DeltaVRS, DeltaMVRS). In the indication group, the placebo and Chiljehyangbuhwan group showed significant difference in change in VAS and MVRS scores (DeltaVAS and DeltaMVRS). No evidence of toxicity could be found, and no serious adverse reactions to Chiljehyangbuhwan were reported.

Conclusion: The results suggest that Chiljehyangbuhwan is effective and safe in treating primary dysmenorrhea when prescribed appropriately under Korean Oriental medical diagnosis.