Effects of the Chinese herbal medicine ‘Ba Wei Di Huang Wan’ in the treatment of dementia: A SPECT cerebral blood flow examination and a randomized, double‐blind, placebo‐controlled clinical trial for cognitive function and ADL

Abstract

Context: Traditional Chinese herbal medicine has a long history as a remedy for dementia among East Asian countries. This study clarifies its benefits through current scientific designs.Objective: Study 1: To evaluate the effects of Ba Wei Di Huang Wan (BDW), a Chinese herbal drug on cerebral blood flow (CBF) by tecnetium‐99 m‐ethyl cysteinate dimer brain single photon emission computed tomography (99mTc ECD SPECT).Study 2: To evaluate whether BDW improves cognitive and physical functioning in dementia patients.Design: Study 1: An 8‐week case series for the SPECT examination.Study 2: An 8‐week randomized, double‐blind, placebo‐controlled trial for cognitive and physical functioning in dementia patients.Setting and Participants: Study 1: Ten patients with multiple brain infarctions (5 men and 5 women; mean age 73 years) were recruited.Study 2: Thirty‐three patients with mild‐to‐severe dementia (7 men and 26 women; age 84.4 ± 7.8 [mean ± SD] years) admitted to a long‐term care facility in Japan, were recruited and enrolled from May 2002 through September 2002.Interventions: Study 1: Participants took BDW extract 7.5 g/day for 8 weeks, and CBF in whole brain and regional CBFs were compared before and after the administration.Study 2: Participants were randomly assigned to the active drug (BDW) group (n = 16) or the placebo group (n = 17), and treated by BDW or placebo for 8 weeks.Main outcome measures: Study 1: CBF in whole brain and rCBF in each Regions of interest (ROIs)Study 2: Cognitive function and the activities of daily living (ADL)Results: Study 1: CBF in whole brain were increased from 38.2 ± 3.0 mL/100 mg/min to 40.5 ± 3.1 mL/100 mg/min (P = 0.007). rCBFs in bilateral temporal lobes, area Broca, and lt. thalamus were also increased significantly (P < 0.05).Study 2: After the trial, cognitive function as assessed by Mini‐Mental State Examination (MMSE) significantly improved from 13.5 ± 8.5 to 16.3 ± 7.7 (mean ± SD, P < 0.01, − 4.1 < 95% C.I. < −1.4) in the BDW group. The ADL score in the Barthel index also significantly went from 61.8 ± 34.6 to 78.9 ± 21.1 (P < 0.01, − 26.2 < 95% C.I. < −7.9). Eight weeks after the end of the administration, both MMSE and Barthel index score of the BDW group declined to the baseline level.Conclusions: Our results argue the benefits of BDW in the treatment of dementia.