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

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