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To evaluate the efficacy and safety of kihito for Alzheimertype dementia.

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Evidence Reports of Kampo Treatment

Task Force for Evidence Reports / Clinical Practice Guideline Committee for EBM, the Japan Society for Oriental Medicine

070005e

6. Nervous System Diseases (including Alzheimer's Disease) Reference

Higashi K, Rakugi H, Yu H, et al. Effect of kihito extract granules on cognitive function in patients with Alzheimer's-type dementia. Geriatrics & Gerontology International 2007; 7: 245-51. Ichushi Web ID: 2008113647

1. Objectives

To evaluate the efficacy and safety of kihito (帰脾湯) for Alzheimer-type dementia. 2. Design

Randomized controlled trial (RCT). 3. Setting

Hanwa Daini Senboku Hospital, Japan. 4. Participants

Seventy-five elderly patients diagnosed with Alzheimer’s disease according to DSM-IV criteria, with Hachinski ischemic score of ≤4 points and Mini-Mental State Examination (MMSE) score of 10–26 points. Patients with marked hypertension, diabetes, hypercholesterolemia, heart disease, renal failure, or depression, or MRI findings of marked cerebral infarction were excluded.

5. Intervention

Arm 1: no treatment, n=20.

Arm 2: oral administration of 2.5 g of TSUMURA Goshajinkigan (牛車腎気丸) Extract Granules t.i.d. after meals for 3 months, n=24.

Arm 3: Oral administration of 2.5 g of TSUMURA Kihito (帰脾湯) Extract Granules t.i.d. after meals for 3 months, n=20.

6. Main outcome measures

MMSE score, activities of daily living (ADL) evaluated in all patients at baseline and 3 months. Brain blood flow measured by single photon emission computed tomography (SPECT) in 6 patients in arm 2 and 4 patients in arm 3 at baseline and 3 months (selection criteria for performing SPECT not indicated). 7. Main results

Of 75 participants, 64 were included in the analysis population. MMSE score in arm 3 was significantly improved from baseline at 3 months and was also significantly improved compared with arm 1 and arm 2. In particular, disorientation and attentiveness were markedly improved. There were no among-arm differences in ADL and between baseline and 3 months. SPECT revealed no obvious changes in brain blood flow.

8. Conclusions

Kihito is an effective treatment for Alzheimer-type dementia. 9. From Kampo medicine perspective

None.

10. Safety assessment in the article

One patient in arm 2 experienced diarrhea and 1 patient in arm 3 increased blood pressure, leading to discontinuation of treatment.

11. Abstractor’s comments

This excellent clinical study investigated and demonstrated the efficacy of kihito for Alzheimer’s dementia using a non-Kampo-treatment and goshajinkigan as controls. The authors selected goshajinkigan as a control because of its onji-free composition and the lack of reports showing an effect on cognitive function. However, since the efficacy of hachimijiogan, containing goshajinkigan ingredients other than gohitsu and shazenshi, for elderly dementia has already been reported (Iwasaki K, Kanbayashi S, Chimura Y, et al. A randomized, double-blind, placebo-controlled clinical trial of the Chinese herbal medicine “Ba wei di huang wan” in the treatment of dementia. Journal of the American Geriatrics Society 2004; 52: 1518-21.), goshajinkigan was considered inappropriate for a control, although the results showed significantly improved MMSE score only with kihito. Furthermore, although they attribute, in the discussion, the absence of a difference in brain blood flow to the small sample size, information on selection criteria for performing SPECT would be necessary. The number of dropouts in arm 1 should be indicated. Although these details were omitted, this clinical research demonstrated the efficacy of kihito for treatment of dementia, and investigation of the mechanism of action and long-term effect using a larger sample size is expected.

12. Abstractor and date

参照

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