Zhang Zhang-Jin, Kang Wan-Hu, Li Qiang, Tan Qing-Rong
School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong, SAR, China.
J Psychiatr Res. 2007 Nov;41(10):828-36. doi: 10.1016/j.jpsychires.2006.08.002. Epub 2006 Sep 29.
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 36 g/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.
我们之前的研究表明，名为逍遥散加味方（FEWP）的草药作为卡马西平（CBZ）的辅助疗法，在双相情感障碍的12周治疗中具有有益效果（Zhang ZJ, Kang WH, Tan QR, Li Q, Gao CG, Zhang FG, 等人，卡马西平联合草药治疗双相情感障碍：一项双盲、随机、安慰剂对照研究。《精神疾病研究杂志》；2005年）。在此，我们展示了从先前报道研究的延续中获得的随访数据。对随机接受12周CBZ加安慰剂（n = 92）或CBZ加FEWP（n = 96）治疗的双相情感障碍患者（n = 188）的治疗和临床评估在双盲条件下延长至26周。与安慰剂组（51%，p = 0.009）相比，接受FEWP辅助治疗的患者在终点时的总体停药率显著更低（31%），且FEWP辅助治疗组中因无法耐受的副作用而停药的比例为15%，明显低于安慰剂组（28%，p = 0.019）。两组在因缺乏疗效和病情加重而停药方面未观察到差异。接受FEWP辅助治疗的患者的不良副作用显著少于安慰剂组患者，且其CBZ血清水平更低。还进一步开展了一项单独研究，以评估FEWP作为单一疗法治疗抑郁症患者的有效性。总共87名单相抑郁患者和62名双相抑郁患者在双盲条件下被随机分配接受每天36克FEWP（n = 86）或安慰剂（n = 63）治疗12周。使用汉密尔顿抑郁量表（HAMD）、蒙哥马利 - 阿斯伯格抑郁量表（MADRS）和临床总体印象 - 严重程度量表（CGI - S）来衡量疗效。在终点时，分配接受FEWP治疗的单相和双相患者在这三个疗效指标上均显示出显著更大的改善，且临床缓解率显著更高（74%），高于接受安慰剂治疗的患者（42%，p < 0.001）。这些结果表明，FEWP辅助治疗可提高CBZ长期使用的耐受性，这可能与通过草药 - 药物相互作用抑制血液中CBZ浓度有关。FEWP单一疗法也可能是治疗抑郁症的一种有效替代疗法。
