OBJECTIVETo evaluate the therapeutic effect of Chaipo Granule (CPG) combined with routine treatment on refractory asthma.

METHODSSixty patient with refractory asthma were assigned equally in a double-blind, randomized way to the treatment group and the control group. Routine treatment (including regular inhalation of salmeterol and fluticasone propionate 50/250 microg, and if necessary, inhalation of salbutamol + ipratropium bromide) were given to all patients. CPG (3 pouches every time, twice a day) were administered to the treatment group in addition, while to the control group, placebo with similar appearance in equal volume was given. The therapeutic course for all was 24 weeks. Asthma control test (ACT) scoring and lung function tests (FEV1 and PEF) were performed before treatment and at the end of the 4th, 12th and 24th week; daily records of asthma, dose of hormone used, withdrawal reaction and adverse reaction occurred were monitored, and serum levels of cortisol, total IgE and cytokines (IL-4, IL-5, IL-13 and IFN-gamma) were measured before treatment and at terminating the 24-week treatment.

RESULTSSymptoms and lung function were significantly improved after treatment in both groups, but the improvements were better in the treatment group than the control group at all time points, the difference between groups was statistically significant (P < 0.05). Levels of IL-5, IL-13, total IgE decreased, IFN-gamma and Cor increased in all patients after 24-week treatment, but the improvements in the treatment group was more significant, with statistical difference between groups (P < 0.05); the mean hormone withdrawal time in the treatment group was (14.6 +/- 5.1) days, with the incidence of systemic withdrawal reactions of 20%, while those in the control group was (22.1 +/- 6.8) days and 36.7% correspondingly, the difference between groups was statistically significant (P < 0.05). However, one patient in the treatment group quit the trial due to a severe seizure of asthma. No obvious treatment-related side effects appeared in the treatment group, except that 3 patients suffered from slight abdominal pain.

CONCLUSIONSCPG could improve the clinical symptoms and lung function, facilitate to Th1/Th2 balance and enhance the secretion of adrenal cortex. It is an effective and safe Chinese herbal remedy for treatment of refractory asthma.