Efficacy of Vitex agnus castus L. extract Ze 440 in patients with pre-menstrual syndrome (PMS)
Efficacy of Vitex agnus castus L. extract Ze 440 in patients with pre-menstrual syndrome (PMS)
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DOI：
10.1007/s004040000123
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发表时间：
2000-11-01
影响因子：
2.6
通讯作者：
Brattström, A
中科院分区：
文献类型：
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作者：
Berger, D;Schaffner, W;Brattström, A
在一项前瞻性、多中心试验中，研究了50例经前综合征（PMS）患者中Vitex agnus castus L提取物Ze 440的疗效。患者在三个月经周期内每天服用一片（20 mg天然提取物）。43例患者完成了研究方案，包括8个月经周期（2个基线、3个治疗和3个治疗后），13/43例患者接受了合并口服避孕药。6例患者因与研究药物无关的原因未完成研究，1例患者主诉可能与研究药物相关的疲乏。所有接受评估的患者均服用了至少85%的处方药物。主要效应参数是经验证的Moos月经困扰问卷（MMDQ），次要参数是视觉模拟量表（VAS;自我评估）和总体印象量表（GI，自我评估）。研究人群在年龄（31.3 ± 7.7岁）、体重（58.9 ± 6.9 kg）和周期长度（28.4 ± 0.3 d）方面具有同质性。诊断依据DMS-III。在研究结束时，治疗减轻了PMS相关症状。作为主要效应参数的MMDQ评分显著降低（42.5%）（p <0.001）。停止治疗后症状逐渐恢复。然而，与基线的差异保持（20%; p <0.001），直至3个周期后。43例患者中有20例被视为"应答者"，MMDQ评分相对于基线降低至少50%。基线时，VAS评分在黄体晚期升高，在卵泡期降低，与预期一致。治疗期间，黄体晚期VAS评分下降（47.2%; p <0.01），停止治疗后3个周期后仍低于基线21.7%（p <0.001）。在鲸鱼观察期间，卵泡期内的低VAS评分保持不变。38例患者评价总体疗效为中至优，5例患者表示无总体疗效。患者持续PMS症状的天数略有减少，从7.5天减少到6天。静息状态下的血催乳素水平始终保持在生理范围内。服用或不服用口服避孕药的患者之间没有差异。20例患者报告了37起不良事件（AE）。未报告严重AE。1例患者在治疗4天后因疲劳和头痛退出治疗。实验室安全性控制参数未受影响。总之，经前综合征患者可以成功地治疗与荆条agnus-castus提取物Ze 440，在治疗过程中的主要效果参数的明显改善和治疗停止后逐渐恢复。对治疗的主要反应似乎与症状缓解有关，而不是与综合征的持续时间有关。
In a prospective, multicentre trial the efficacy of an Vitex agnus castus L extract Ze 440 was investigated in 50 patients with pre-menstrual syndrome (PMS). The patients were treated daily with one tablet (20 mg native extract) during three menstrual cycles. 43 patients completed the study protocol which encompassed 8 menstrual cycles (2 baseline, 3 treatment and 3 post-treatment), 13/43 patients were receiving concomitant oral contraceptives. 6 patients did not complete the study for reasons not related to study medication, and one patient complained of fatigue possibly related to study medication. All evaluated patients took at least 85% of the prescribed medication. The main effect parameter was the validated Moos' menstrual distress questionnaire (MMDQ), and secondary parameters were a visual analogue scale (VAS; self-assessment) and a global impression scale (GI, self-assessment). The study population was homogenous in age (31.3 +/- 7.7 years) weight (58.9 +/- 6.9 kg) and cycle length (28.4 +/- 0.3 d). The diagnosis was according to DMS-III. At the end of the study, PMS-related symptoms were reduced by treatment. There was a significant score reduction (42.5%) of the MMDQ as the main effect parameter (p < 0.001). Symptoms gradually returned after treatment cessation. However, a difference from baseline remained (20%; p < 0.001) up to 3 cycles thereafter. 20/43 patients were considered "responders", with a reduction in MMDQ score by at least 50% relative to baseline. At baseline, the VAS score was elevated in the late luteal phase and low at the follicular phase, as expected. During treatment, VAS score decreased in the late luteal phase (47.2%; p < 0.01) and remained 21.7% (p < 0.001) below baseline after 3 cycles post-cessation of treatment. The low VAS score within the follicular phase remained unchanged over the whale observation period. 38 patients judged the global efficacy moderate to excellent, 5 patients indicated no global efficacy. The number of days patients sustained PMS symptoms was reduced slightly From 7.5 to 6. Resting levels of blood prolactin remained within the physiological range throughout. No differences were seen between patients on or off oral contraceptives. 20 patients reported 37 adverse events (AE). No serious AE were reported. One patint withdrew after four days of treatment due to fatigue and headache. Laboratory safety control parameters were not affected. In conclusion, patients with PMS can be treated successfully with Vitex agnus-castus extract Ze 440, as indicated by clear improvement in the main effect parameter during treatment and the gradual return after cessation of treatment. The main response to treatment seems related to symptomatic relief rather than to the duration of the syndrome.