Abstract

Aim of the studyThis study was conducted to assess the efficacy of Gami Guibitang (GGBT), a mixture of Korean traditional medicinal herb extracts, in the treatment of patients suffering from moderate depression. MethodologyA randomized, double-blind, placebo-controlled clinical trial was conducted. A total of 164 male and female patients, between 19 and 80 years of age, who suffered from moderate depression and fulfilled the condition of >13 of the Hamilton depression (HAM-D17) rating scales and the diagnostic criteria for major depressive disorder or dysthymic disorder according to Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV), were selected for the present study. Patients were randomized into either GGBT (n=82) or placebo (n=82) groups. Subjects in the GGBT group were given 3 capsules of GGBT daily (4000mg extracts/day), whereas the placebo group received 3 placebo capsules daily. The effects of GGBT were evaluated on day 1 and at week 8 of treatment by assessing depression (HAM-D17 scale), quality of life (SF-36 questionnaires) and morning salivary cortisol levels. ResultsNo serious side effects that could be attributed to the herb extract were reported. Considerable reductions in HAM-D17 scales were observed in both groups but without any significant difference between them (placebo effect). However, increases in the score of subscale Bodily Pain in SF-36 questionnaire was significantly higher in placebo group compared to GGBT group, indicating more intense Bodily Pain in the placebo group after 8-weeks. Change in mean morning salivary cortisol level was significantly higher in GGBT group than that in the placebo group. ConclusionsThere was no significant difference in the reduction of HAM-D17 scales between the placebo and GGBT groups. However, compared to placebo, GGBT treatment increased morning cortisol level which could be associated with the improvement in Bodily Pain in these patients suffering from moderate depression.

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