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. week 16, 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.