ABSTRACT
[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.<br>[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.<br>[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.<br>[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.
ABSTRACT
[<b>Purpose</b>]<br>The purpose of this study was to demonstrate the effectiveness of Kampo medicines, from the aspect of cost effectiveness. We obtained judgment criteria by analyzing past published papers and implemented our study according to criteria about the kinds of formulations and diseases that were suitable for pharmacoeconomic analysis.<br>[<b>Method</b>]<br>First, we extracted the original, clinical, and NHI price listed formulations (EA) from each published paper, by searching for Japanese key words such as “_??__??_ (Kampo)” or “_??__??_ (economic)” in the databases of “Igaku Chuo Zasshi” and “Institute for Health Economics and Policy.” Considering the importance establishing a controlled treatment method in pharmacoeconomic analysis, we defined papers with a comparative control (Comp) as one judgment criterion (1), then extracted these data; and analyzed how target (diseases and formulations), controlled formulation, measurement outcomes, and “Sho” (patterns or syndromes) were handled in each paper. Secondly, we defined those formulations which had been referred to many times in the EA as our second judgment criterion (2), because we thought they had abundant and clear outcomes, and then implemented an outcome analysis of them.<br>[<b>Results and Discussion</b>]<br>Judgment criterion (1): The number of formulations, and the total number of papers referring to a Comp (38 articles) were 25 and 41 (Shoseiryuto [4], Shosaikoto [4], Kyukichoketsuin [3] in descending order) respectively. Approximately two-thirds of target illnesses covered in these papers were gastrointestinal diseases, infectious diseases, ear nose and throat diseases; and in women, pregnancy or delivery-related diseases. Concerning outcomes, only 10.5% of the papers measured human outcomes such as quality of life (QOL), which might suggest that the implementation of cost effectiveness analysis was difficult. The results of analyzing how to handle “Sho” suggested that Kyo-sho or Vacuity-sho patient formulations tended to exert their treatment effects relatively, even without consideration for “Sho”.<br>Judgment criterion (2): Using EA prices, we expedientially defined frequently referred formulations as those referred to in 15 or more of the total research paper number, and then extracted them. As the result of this extraction, 6 formulations (Hochuekkito, Keishibukuryogan, Shishihakuhito, and etc.) were obtained. Among these formulations, Shishihakuhito had high rates (88.2%) for achieving treatment goals, including the improvement of skin symptoms such as erythema and pruritus.<br>[<b>In Conclusion</b>]<br>A comparison between Kampo and Western medicines was not simply applicable, due to large differences between their mechanisms of action, and the ways they exert their effect, even if their ultimate effects are the same. We would need to create a study plan which would cover human outcomes when making a further pharmacoeconomic study, because Kampo medicines do have a good chance of improving QOL. We would even say that Vacuity-sho formulations given to patients could easily work, without consideration for “Sho”.
