May B, Kuntz H D, Kieser M, Köhler S
University Medical Clinic and Outpatient Clinic, Bochum, Germany.
Arzneimittelforschung. 1996 Dec;46(12):1149-53.
The efficacy and safety of the standardized herbal combination preparation of Enteroplant, consisting of peppermint oil (90 mg) and caraway (50 mg) in an enteric coated capsule, have been studied in a double-blind, placebo-controlled multicentre trial in patients with non-ulcer dyspepsia. A total of 45 patients were included in the trial after thorough physical and gastro-enterological examination. The primary outcome variables were the change in the intensity of pain and the global clinical impression (Clinical Global Impression [CGI], Item 2), which were evaluated for 39 patients (test preparation: 19, placebo: 20). After four weeks of treatment both target parameters were significantly improved for the group of patients treated with the peppermint oil/caraway oil combination compared to the placebo group (p = 0.015 and 0.008, respectively). Before the start of treatment all patients in the test preparation group reported moderate to severe pain, while by the end of the study 63.2% of these patients were free of pain. The pain symptoms had improved in a total of 89.5% of the patients in the active treatment group. After 4 weeks the Clinical Global Impressions were improved for 94.5% of the patients treated with the peppermint oil/caraway oil combination. The trial medication was also superior to placebo with respect to pain frequency, medical prognosis, the severity of the disorder and the efficacy index (CGI, Items 1 and 3), which were adopted as secondary end-points for evaluation of efficacy. There were similarly favourable findings for the herbal combination, compared with placebo, with respect to the reduction of other gastrointestinal symptoms. The combination preparation was found to be excellently tolerated. There was a total of 7 adverse events (test preparation: 4, placebo: 3), with a causal association with the treatment being ascribed in one case for the test preparation group and one case for the placebo group.
对一种标准化草药复方制剂Enteroplant进行了疗效和安全性研究，该制剂由90毫克薄荷油和50毫克葛缕子制成肠溶胶囊。研究采用双盲、安慰剂对照的多中心试验，受试对象为非溃疡性消化不良患者。经过全面的体格检查和胃肠检查后，共有45名患者纳入试验。主要结局变量为疼痛强度变化和整体临床印象（临床整体印象量表[CGI]，第2项），对39名患者（试验制剂组：19名，安慰剂组：20名）进行了评估。与安慰剂组相比，薄荷油/葛缕子油复方制剂治疗组患者在治疗四周后，两个目标参数均有显著改善（p值分别为0.015和0.008）。治疗开始前，试验制剂组所有患者均报告有中度至重度疼痛，而到研究结束时，该组63.2%的患者已无疼痛。活性治疗组共有89.5%的患者疼痛症状得到改善。四周后，接受薄荷油/葛缕子油复方制剂治疗的患者中，94.5%的患者临床整体印象得到改善。在疼痛频率、医学预后、疾病严重程度和疗效指数（CGI，第1项和第3项）方面，试验药物也优于安慰剂，这些指标被用作评估疗效的次要终点。与安慰剂相比，该草药复方制剂在减轻其他胃肠道症状方面也有类似的良好效果。该复方制剂耐受性良好。总共发生了7起不良事件（试验制剂组：4起，安慰剂组：3起），试验制剂组和安慰剂组各有1例不良事件被归因于与治疗有因果关系。
