Objectives: To evaluate whether the traditional Chinese herbal medicine banxia houpu tang (BHT, formula magnolia et pinelliae) prevents aspiration pneumonia and pneumonia-related mortality in elderly people.
Design: A prospective, observer-blinded, randomized, controlled trial.
Setting: Two long-term care hospitals for handicapped elderly patients in Japan from March 2005 to February 2006.
Participants: One hundred four elderly patients (31 men and 73 women; mean age+/-standard deviation 83.5+/-7.8) with dementia and cerebrovascular disease, Alzheimer's disease, or Parkinson's disease.
Intervention: Ninety-five participants (mean age 84.0, M:F=28:67) were randomly assigned to the BHT treatment group (n=47) or the control group (n=48) and took BHT or placebo for 12 months.
Measurements: The occurrence of pneumonia, mortality due to pneumonia, and the daily amount of self-feeding.
Results: Complete data were available for analysis on 92 of the 95 subjects randomized. Four patients in the BHT group developed pneumonia, and one of them died as a result. Fourteen patients in the control group developed pneumonia, and six of them died as a result. There was a significant difference between the two groups in pneumonia onset (P=.008), and a tendency toward significance in pneumonia-related mortality (P=.05). The relative risk of pneumonia in the BHT group compared with the control group was 0.51 (95% confidence interval (CI)=0.27-0.84, P=.008) and that of death from pneumonia was 0.41 (95% CI=0.10-1.03, P=.06) according to the Cox proportional hazards model. No adverse events were observed from treatment with BHT. The BHT group was able to maintain self-feeding better than the control group (P=.006).
Conclusion: Treatment with BHT reduced the risk of pneumonia and pneumonia-related mortality in elderly patients with dementia.