Hopfenmüller W
Institut für Medizinische Statistik und Informationsverarbeitung, Freien Universität Berlin, Klinikum Steglitz.
Arzneimittelforschung. 1994 Sep;44(9):1005-13.
Eleven controlled clinical trials were evaluated in a meta-analysis in order to proof the effectiveness of the ginkgo biloba special extract LI 1370 (Kaveri forte). All included studies were placebo controlled randomized double blind studies, using in most of the cases a daily dosage of 150 mg extract. The requirements for the quality of the studies were the basic criteria for the performance of clinical drug tests analysed from the biometrical scope. The analysis of the individual studies revealed that three studies had to be excluded from the meta-analysis according to methodological or objective reasons. In two further studies the evaluation of the physician or the patients was missing, therefore the studies could not be used for the analysis of the "global effectiveness". All other studies were comparable with regard to diagnoses, inclusion and exclusion criteria as well as methodology. Therefore a statistical meta-analysis could be performed for them, analysing the parameters "single symptoms", total score of clinical symptoms and "global effectiveness". For all analyzed single symptoms significant differences could be concluded, indicating the superiority of ginkgo biloba in comparison to placebo. The analysis of the total score of clinical symptoms from all relevant studies indicated that 7 studies confirmed the effectiveness (Ginkgo biloba being better compared to placebo) while only one study was inconclusive (the medications were not different). This relation confirms the therapeutical effectiveness of ginkgo biloba regarding the clinical symptom complex. Finally the parameter "global effectiveness" was evaluated.(ABSTRACT TRUNCATED AT 250 WORDS)
为证明银杏叶特殊提取物LI 1370(凯维力 forte)的有效性,在一项荟萃分析中对11项对照临床试验进行了评估。所有纳入研究均为安慰剂对照随机双盲研究,多数情况下每日提取物剂量为150毫克。研究质量要求是从生物统计学角度分析临床药物试验执行的基本标准。对各单项研究的分析表明,根据方法学或客观原因,有3项研究必须从荟萃分析中排除。在另外两项研究中,缺少医生或患者的评估,因此这些研究不能用于“总体有效性”分析。所有其他研究在诊断、纳入和排除标准以及方法学方面具有可比性。因此可以对它们进行统计荟萃分析,分析“单一症状”、临床症状总分和“总体有效性”等参数。对于所有分析的单一症状,可以得出显著差异,表明银杏叶相对于安慰剂具有优越性。对所有相关研究的临床症状总分分析表明,7项研究证实了有效性(银杏叶比安慰剂更好),而只有1项研究无定论(药物无差异)。这种关系证实了银杏叶对临床症状复合体的治疗有效性。最后对“总体有效性”参数进行了评估。(摘要截选至250字)