To test whether the kampo herbal medicine, Saiboku-to (Cha-Po-Tang : CPT) prevents asthma exacebation during reducted medium-dose corticosteroid beclomethasone dipropionate (BDI), inhalation, we conducted a well-controlled randomized comparative study in 94 asthma patients requiring doses (800 μg/day) of inhaled BDI for clinical control. After BDI doses were halved, patients were assigned to inhale either CPT at 500μg/capsule, 1 capsule/1 time×4 times/days (CPT group) or sodium cromoglycate (DSCG) 20 mg/capsule, 1 capusle/1 time×4 times/day (DSCG group) for 12 months. In the CPT group, FEV
1.0 increased after 12 months and morning and evening PEF increased. In contrast, these variables decreased to below the baseline in the DSCG group (p <0.01 vs CPT group). The number of daytime and nighttime asthma symptoms and the use of β
2-agonist decreased in the CPT group, whereas they incredsed in the DSCG group (p<0.01 vs DSCG group). In the CPT group, concentrations of leukotriens and other chemical mediators decreased, as did exhaled nitric oxide, the number of eosinophils, and other asthmatic releated substances, compared to a significant low in the DSCG group (p<0.01). In the CPT group, endothelin-1, TXA
2, IL-3, IL-5 and IL-8 decreased during the 12 months, but not in the DSCG group (endotheline-1, IL-3, IL-5, IL-8 : p<0.01 vs CPT group, TAX
2 : p<0.05 vs CPT group). CPT thus prevents the asthma deterioration provoked by a 12-month halving of inhaled BDI administration.
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