[Purposes] Evidence-based medicine (EBM) is now the established standard for selecting appropriate treatment, the basic ideas of which cannot be ignored even in the field of Kampo medicines. With this in mind, we conducted a meta-analysis (MA) for those Kampo medicines which had been administered in randomized clinical trials, as a method of establishing the evidence for Kampo medicines, and then examined the resulting data obtained for the present study. Here, we focused on the assessing the usefulness in postpartum control, using Kyukichoketsuin (KCI), with methylergometrine maleate (MME) as control.
[Methods] We searched and collected articles published before September 2004 in Igaku Chuo Zasshi (Japana Centra Revuno Medicina) and Medline using keywords such as “Kyukichoketsuin”, etc. First we selected target articles for analysis in accordance with our inclusion criteria and examined the quality of those articles using a score system adopted by Chalmers, in 1981. Then we extracted target data from the articles in accordance with meta-analytic methods, integrated the resulting data using the DerSimonian-Laird method, and implemented sensitivity analysis to them.
[Results and Discussion] We selected four articles for our target analysis. All four were of similar quality. When we set post-labor pains as an assessment item, and integrated three of the four articles, KCI showed that it more significantly decreased those pains compared to MME, with an integrated odds ratio of 0.32 (95%CI, 0.17-0.60). The one remaining independent article, however, in which KCI exerted statistically significant effect in height of day-five uterine fundus, indicated no higher significance through integration with the first three articles. Also, even integrating the height of the uterine fundus shown in the articles, on day four as well as the height before integration, had no significance. These results indicate that the effect of KCI for the involution of the uterus may be the same as that of MME. Regarding the volume of breast-milk lactation on day four in comparison between two test drugs, some articles showed more volume in both the KCI and MME. groups, despite reaching no significant decreases in volume, with an integrated odds ratio of -8.20 (95%CI, -16.17--0.23). However, contrary to this, results for the integration of day-five breast-milk lactation volume showed an increase in the KCI group, although without reaching significant difference. Therefore, the effectiveness of KCI for breast-milk lactation could not be generally categorized as less than that of MME.
[Conclusion] MA demonstrated that KCI was more effective in decreasing post-labor pains than was MME. We could not implement the comparable study in safety at this time. Therefore, further analysis on KCI including safety may be required to argue total effectiveness on postpartum control.