Weikl A, Assmus K D, Neukum-Schmidt A, Schmitz J, Zapfe G, Noh H S, Siegrist J
Hauptkrankenhaus Deggendorf.
Fortschr Med. 1996 Aug 30;114(24):291-6.
In a multicenter, placebo-controlled double-blind study, the efficacy of the Crataegus-Specialextrakt WS 1442 in patients with NYHA stage II cardiac insufficiency was investigated. A total of 136 patients with this diagnosis were admitted to the study and, following a 2-week run-in phase, treated with Crataegus-Specialextract or placebo over a period of 8 weeks. The primary target parameter was the change in the difference of the pressure, heart rate product (systolic blood pressure x heart rate/100) (PHRP 50 W load vs. rest) measured at the beginning and end of treatment.
On the basis of this variable, a clear improvement in the performance of the heart was shown in the group receiving the test substance, while the condition of the placebo group progressively worsened. The therapeutic difference between the groups was statistically significant. The positive result for the objective efficacy parameter was confirmed by a statistically obvious superiority of Crataegus in the patient's own assessment of improvement in the main symptoms (reduced performance, shortness of breath, ankle edema etc.). In addition, active treatment led, in comparison with placebo, to a considerably better quality of life for the patient, in particular with respect to mental well-being. The tolerability of the active substance proved to be very good-as shown by comprehensive laboratory investigations and the recording of undesirable events.
All in all, the results of the present clinical investigation confirm those of previous studies showing that Crataegus-Specialextrakt WS 1442 is an effective and low-risk phytotherapeutic form of treatment in patients with NYHA II cardiac insufficiency.
在一项多中心、安慰剂对照的双盲研究中，对山楂叶提取物WS 1442治疗纽约心脏协会（NYHA）II级心功能不全患者的疗效进行了研究。共有136例诊断为此病的患者纳入研究，经过2周的导入期后，接受山楂叶提取物或安慰剂治疗8周。主要目标参数是治疗开始和结束时测量的压力-心率乘积（收缩压×心率/100）（PHRP 50 W负荷与静息状态相比）差值的变化。
基于该变量，接受受试药物的组心脏功能有明显改善，而安慰剂组的病情逐渐恶化。两组间的治疗差异具有统计学意义。山楂叶提取物在患者对主要症状改善（体力下降、呼吸急促、脚踝水肿等）的自我评估方面具有统计学上明显的优势，从而证实了客观疗效参数的阳性结果。此外，与安慰剂相比，积极治疗使患者的生活质量有了显著提高，尤其是在精神健康方面。综合实验室检查和不良事件记录显示，活性物质的耐受性非常好。
总的来说，本临床研究结果证实了先前研究的结果，表明山楂叶提取物WS 1442是治疗NYHA II级心功能不全患者的一种有效且低风险的植物疗法。
