Objective To evaluate the anti-tussive effect of a total alkaloid agent extracted from Papaver Somniferum L. on simple chronic bronchitis of which the syndrome was counterflow ascent of lung qi according to traditional Chinese medicine (TCM). Methods Randomised, double blind method, placebo control and add on design were applied. Forty-five patients with counterflow ascent of lung qi of simple chronic bronchitis were randomly divided into two groups: treatment group (n=21) with alkaloid agent and control group (n=24) with placebo. Results The incidences of obvious coughing in treatment and control groups were 66.67% and 70.83% (P=0.763 3) respectively. The cough alleviation time of patients was 14.64±16.30 h and 15.12±15.28 h (P=0.795 6) respectively. The loss of cough rates on the third day was 28.57%, 16.67% (P=0.337 7) respectively. The average scores decreased were 4.29 and 2.88 (P=0.054 8) respectively. Conclusions The study indicates that total alkaloid agent extracted from Papaver somniferum L. has no significant anti-tussive effect on patients with counterflow ascent of lung qi of simple chronic bronchitis treated with cefaclor sustained release capsules simultaneously. The trial was interrupted by the advice from experts who disagreed with the selection of drug indication.
Objective To evaluate the safety of Rongbisu capsule used for treating benign prostatic hyperplasia. Methods A total of 218 patients (average age 63.73±7.50 years old) with phase Ⅰor Ⅱ benign prostatic hyperplasia were treated with oral Rongbisu capsule at a dose of 3 granules twice daily. The therapeutic course was 6 weeks and hepatic function was determined every 2 weeks. Results The median value of ALT in 218 patients rose significantly after the patients took Rongbishu capsule for 6 weeks (P=0.001 7). There were 17 patients whose ALT level rose from normal to abnormal, the incidence was 7.80%. There were 3 patients whose hepatic function was seriously impaired (ALT＞200 IU/L). Conclusions The essential component of Rongbishu capsule is edible tulip which has been recorded in the medical literature as being toxic. Airpotato yam of which the alias is also edible tulip is easily mistaken for edible tulip. Airpotato yam is the tuber of dioscorea bulbifera L. (family dioscoreaceae) which has confirmed hepatotoxcity. Our study result indicates that in order to insure the safety of Chinese crude drug, the origin of Chinese crude drug should be defined in the formulation according to the standard of Chinese drugs preparation. Pharmaceutical enterprises should strictly abide by the standards to identify the origin of Chinese crude drugs when approving the raw materials, especially for species which are poisonous and easily mistaken.
In phase II clinical trial of Compound Prescription of Huangyaozi (Dioscorea bulbifera L.), 7 cases out of 37 developed (18.92%) impairment of liver function. As a result, the ethic committee required researchers to report all data of safety of the drug and have all subjects rechecked about their liver function so as to provided reasonable evidence for the scientifical evaluation of the relationship between the drug and the adverse event and the succedent suspending of the clinical trial.