本態性高血圧に対する紅麹の臨床評価　プラセボを対照とした多施設二重盲検群間比較試験

DOI PubMed 被引用文献6件 参考文献17件

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  • Clinical effects of beni-koji in mild essential hypertension. A multi-center double-blind comparison with placebo.

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Antihypertensive effects of beni-koji were studied using 29 outpatients with mild hypertension in a placebo-controlled double-blind comparative fashion. After a 4-week vehicle (apple juice) run-in period, 13 patients were assigned to receive beni-koji aqueous extracts containing juice once daily (27 g of beni-koji eq. per day) for 8 weeks and 16 were assigned to vehicle. Two patients assigned to the vehicle group did not complete the study. In addition to casual blood pressure, 24-hr non-invasive ambulatory blood pressure (ABP) was monitored in 6 patients given the beni-koji drink and 5 patients given the vehicle. 1) In the beni-koji group, both casual systolic and diastolic pressure decreased significantly during the treatment period (from 150±10/96±6 mmHg to 140±0/89±10 mmHg, p<0.01). The averages of the 24-hr blood pressure recorded in ABP (24-BP) also significantly decreased (from 141± 17/95±13 mmHg to 132±21 / 86±10 mmHg, p<0.05) when compared with those of the control period. Casual pressure normalized (less than 140/90 mmHg) in 4 patients who received beni-koji. Circadian variation of the blood pressure by ABP showed a significant decrease during the daytime. 2) In the vehicle group, casual systolic pressure did not change significantly (from 155±8 mmHg to 151±12 mmHg), but diastolic pressure decreased significantly (98±7 mmHg to 93±6 mmHg). Casual blood pressure did not normalize in any of the patients and 24-BP did not change significantly. 3) Summative evaluation of safety showed that no problems appeared in the beni-koji group. In conclusion, beni-koji appears to be an effective and safe food material for mild essential hypertension. The mechanism of the antihypertensive effect of beni-koji still remains to be investigated.

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