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J Psychiatr Res. 2006 Sep 28; [Epub ahead of print]

 

The beneficial effects of the herbal medicine Free and Easy

Wanderer Plus (FEWP) for mood disorders: Double-blind,

placebo-controlled studies.

 

Zhang ZJ, Kang WH, Li Q, Tan QR.

 

School of , The University of Hong Kong, 10

Sassoon Road, Pokfulam, Hong Kong, SAR, China.

 

Our previous study has shown the beneficial effects of the herbal

medicine called Free and Easy Wanderer Plus (FEWP) as adjunctive

therapy with carbamazepine (CBZ) in the 12-week treatment of bipolar

disorders (Zhang ZJ, Kang WH, Tan QR, Li Q, Gao CG, Zhang FG, et al.,

Adjunctive herbal medicine with carbamazepine for bipolar disorders: a

double-blind, randomized, placebo-controlled study. J Psychiatr Res;

2005). Here, we present follow-up data obtained from a continuation of

the previously reported study. Treatment and clinical evaluation of

bipolar patients (n=188) who had randomly received 12-week CBZ plus

placebo (n=92) or CBZ plus FEWP (n=96) were extended to 26 weeks under

double-blind condition. Patients in adjunctive FEWP showed a

significantly lower overall discontinuation rate (31%) at endpoint

compared to placebo (51%, p=0.009), and of 15% in adjunctive FEWP

discontinued due to intolerable side effects, markedly lower than

those in placebo (28%, p=0.019). No difference in discontinuation for

lack of efficacy and exacerbation was observed in the two groups.

Patients receiving adjunctive FEWP had significantly fewer adverse

side effects and lower serum levels of CBZ than those in placebo. A

separate study was further conducted to evaluate the effectiveness of

FEWP as monotherapy in depressed patients. A total of 87 unipolar and

62 bipolar depressed patients were randomly assigned to treatment with

36g/day FEWP (n=86) or placebo (n=63) for 12 weeks under double-blind

condition. Efficacy was measured using the Hamilton Rating Scale for

Depression (HAMD), Montgomery-Asberg Depression Rating Scale (MADRS),

and Clinical Global Impression-Severity (CGI-S). Both unipolar and

bipolar patients assigned to FEWP displayed significantly greater

improvement on the three efficacy indices and significantly higher

clinical response rate (74%) than those treated with placebo (42%,

p<0.001) at endpoint. These results suggest that adjunctive FEWP

improves tolerability of CBZ in the long-term use, which may be

associated with the suppression of blood CBZ concentrations via

herb-drug interactions. FEWP monotherapy may be also an effective

alternative treatment for depressed conditions.

 

PMID: 17010995 [PubMed - as supplied by publisher]