A Randomized, Double‐Blind, Placebo‐Controlled Clinical Trial of the Chinese Herbal Medicine “Ba Wei Di Huang Wan” in the Treatment of Dementia

Abstract

Objectives: To evaluate whether a traditional Chinese herbal medicine, ba wei di huang wan (BDW), improves cognitive and physical functioning in dementia patients. Design: An 8‐week randomized, double‐blind, placebo‐controlled trial. Setting: Long‐term‐care facility in Japan. Participants: Thirty‐three patients with mild to severe dementia (7 men and 26 women; mean age±standard deviation=84.4±7.8) were recruited and enrolled from May 2002 through September 2002. Intervention: Participants were randomly assigned to the active drug (BDW) group (n=16) or the placebo group (n=17) and treated for 8 weeks. Measurement: Cognitive function and activities of daily living (ADLs); palsatility index. Results: After the trial, cognitive function as assessed using the Mini‐Mental State Examination (MMSE) significantly improved from 13.5±8.5 to 16.3±7.7 (P<.01, 95% confidence interval (CI)=−4.1 to −1.4) in the BDW group. The ADL score in the Barthel Index also significantly changed, from 61.8±34.6 to 78.9±21.1 (P<.01, 95% CI=−26.2 to −7.9). In contrast, MMSE and Barthel Index scores of the placebo group showed no significant change. Eight weeks after the end of the administration, MMSE and Barthel Index scores of the BDW group declined to the baseline level. The pulsatility index in the internal carotid artery as measured using Doppler sonography significantly decreased in the BDW group (2.5±1.7 to 1.9±0.5, P<.05) but not in the placebo group. Conclusion: These results argue the benefits of BDW in the treatment of dementia.