Assessment of effects of traditional herbal medicines on elderly patients with weakness using a self-controlled trial

Abstract

Background: The objectives of this study were to evaluate the effects of traditional herbal medicine on elderly patients with weakness, and to devise a suitable study design for assessing the clinical effectiveness of traditional herbal medicines. Methods: Twenty-one elderly patients with weakness (mean age, 78.2 ± 7.5; male : female, 8 : 13) were studied using a self-controlled design with a run-in period. The observation term was 3 months, and quality of life (short form-36 and profile of mood status) were adopted as evaluation endpoints. In addition, natural killing activity and surface antigens (CD19, CD3, CD4, CD16, CD56, CD158a, CD158b) on lymphocytes obtained from peripheral blood were analyzed to evaluate patients’ immune status. Results: EK-41 (Hochu-ekki-to), EK-48 (Juzen-taiho-to) and EK-98 (Ogi-kenchu-to) were administered to 10, 10 and one patients, respectively. There were no dropouts due to side-effects. Results of the short form-36 were significantly improved after 3 months, with the patients in the EK-48 group showing greater improvement than those in the EK-41 group. Each component of the profile of mood status was improved by the treatment, and the improvement of V, D and F was especially significant. D and A-H were considerably improved in the patients of the EK-48 group. In contrast, the improvement of D and T-A was most marked in the EK-41 group. Some augmentation of NK activity was observed after 3 months, but the effect was not significant. Although neither the CD4/8 ratio nor the percentages of CD3+, CD19+ or CD16+ CD158a + cells was changed significantly, the percentage of CD56+, CD56+ CD16+ and CD16+ CD158b + cells were significantly increased. Conclusion: A preliminary clinical trial for elderly patients with weakness was carried out to assess the efficacy of traditional medicines, resulting in evidence of their clinical and immunomodulating effects, although this evidence had some limitations. In addition, we obtained some insights into the elements of designing studies suitable for assessing the clinical efficacy of traditional herbal medicines.