YU Dajun, WENG Weiliang, LU Fang, et al. Randomized Controlled Trials in Individual Patient of the Third Stage of Chronic Kidney Disease[J]. Journal of Traditional Chinese Medicine2012, 53(3): 222-224.
YU Dajun, WENG Weiliang, LU Fang, et al. Randomized Controlled Trials in Individual Patient of the Third Stage of Chronic Kidney Disease[J]. Journal of Traditional Chinese Medicine2012, 53(3): 222-224.DOI: 10.13288/j.11-2166/r.2012.03.016.
Randomized Controlled Trials in Individual Patient of the Third Stage of Chronic Kidney Disease
Objective To study on the feasibility and advantages of randomized controlled trials in individual patient through the TCM individual treatment for chronic kidney disease (CKD) of the third stage. Methods The patients were enrolled according to the staging criterion of CKD. The randomized controlled design was adopted in the trial. Each of these patients was studied in 3 rounds
each round was divided into 2 phases
namely the treatment phase and control phase
each phase was of 4 weeks
and the first week of each phase was taken as the elution time. In each round
the randomized list was given by the computer for grouping the patients and the randomized plan was made. For the treatment phase
the Chinese medicinal decoctions based on the syndrome differentiation and the routine basic treatment were applied
whilst for the control phase
only the routine basic treatment was performed. The indices of efficacy included the scores of main symptoms
serum creatinine (SCr)
and creatinine clearance rate (Ccr). The patient recorded the symptom score at the same time each day. Before and after each phase
the SCr and Ccr were tested and recorded as well. Results Three CKD patients of the third stage were enrolled. Their TCM symptom scores were improved to different degrees in three rounds. Of them
one was partially improved and two completely improved. In the comparison of each treatment and control phase of the 3 patients
SCr was decreased to different degrees
while Ccr was increased to different degrees
the treatment phase was better than the control phase. After the data of SCr and Ccr of all 3 rounds of the patients were summed up
there showed the statistical difference. Conclusion The studying method of randomized controlled trials in individual patient is able to embody the advantages of TCM individual treatment
and application of this design to the clinical studies of Chinese medicine is useful and feasible.