A pilot study of the multiherb Kampo medicine bakumondoto for cough in patients with chronic obstructive pulmonary disease

Objectives: To evaluate the effect of bakumondoto. Kampo medicine, on cough in patients with chronic obstructive pulmonary disease (COPD). Design: A 16-week, randomized, open-labeled, cross-over design. Setting: Outpatient clinics at one university hospital and two general hospitals in Japan from May 2007 to March 2009. Participants: Twenty-four elderly patients (14 men and 9 women aged over 65) with COPD. Intervention: Treatment with or without bakumondoto for 8 weeks in a cross-over design. Measurements: The primary outcome measurements were the frequency and intensity of cough assessed by a visual analogue scale (VAS) and a daily cough diary. Secondary outcome measurements were quality of life (QOL) assessed using St. George's Respiratory Questionnaire (SGRQ) and lung functions measured using spirometry. Results: Treatment with bakumondoto significantly improved cough severity during the first treatment period (week 0 vs. week 8, p = 0.004) and showed a trend to decrease during the second treatment period (week 8 vs. week16, p=0.129) assessed by the VAS. Neither QOL nor lung function was affected by the treatment with bakumondoto. Conclusion: Bakumondoto may be effective in suppressing cough in elderly patients with COPD. To further confirm the efficacy, a larger and placebo-controlled study with objective cough assessment is necessary