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Journal of Chinese Integrative Medicine ›› 2012, Vol. 10 ›› Issue (9): 991-996.doi: 10.3736/jcim20120907

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Using nested case-control study to appraise the effectiveness of Chinese medicines in the treatment of diabetic nephropathy

Zhao-lan Liu1, Qing Li1, Yu-jie Mu1, Ying Gao2, Jian-ping Liu1()   

  1. 1. Centre for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China
    2. Department of Neurology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China
  • Received:2012-03-27 Accepted:2012-04-27 Online:2012-09-20 Published:2018-09-15
  • Contact: Jian-ping Liu

Objective: A nested case-control study was carried out to assess the effectiveness of Chinese medicines in the treatment of diabetic nephropathy, so as to explore the feasibility of using nested case-control study on effect assessment of Chinese medicine

Methods: Nested case-control study was applied and the participants were enrolled from the subjects recruited in a cohort study. The cases and the controls were matched by 1 to 4 in age, gender, nationality and the stage of diabetic nephropathy when recruited in the cohort study. The EpiData 3.1 software was used for inputting data and SAS system was used for data analysis. Conditional logistic regress was applied to analyze the relationship between treatment and the progression of diabetic nephropathy. The study power was estimated and the sample sizes for case-control study and cohort study were recalculated based on the data from the cohort study

Results: Eight cases and 32 controls were recruited in this study. The education level, ratio of drug withdrawal, change of therapy, syndrome differentiation and treatment were not significantly different in case and control groups. The progression of diabetic nephropathy was not significantly related with the treatment and the odds ratio (OR) value was 0.725 with a 95% confidence interval from 0.174 to 3.030. The statistical power of the study was 5%. To achieve the statistical power of 80%, 1 350 (270∶1 080) participants were needed for 1∶4 matched case-control study, 880 (440∶440) for 1∶1 paired case-control study, and 1 020 (510∶510) for 1∶1 control study

Conclusion: The treatment method is not significantly related with the progress of diabetic nephropathy. The nested case-control study is applicable in the therapeutic effect evaluation of Chinese medicine. Basic studies such as cross-sectional studies should be carried out to supply fundamental information for other types of studies including case-control study, cohort study and randomized clinical trials. Large sample size studies were needed to appraise the effect of Chinese medicine.

Key words: case-control studies, diabetic nephropathies, logistic models, traditional Chinese medicine, treatment outcome

Table 1

Characteristics of progressed diabetic nephropathy cases"

Item n Proportion (%)
Time of progression (months)
24 3 37.5
12 3 37.5
6 2 25.0
Recruitment stage of diabetic nephropathy
5 62.5
3 37.5

Table 2

Basic characteristics of cases and controls"

Item Case group (n=8) Control group (n=32) χ2/Zvalue Pvalue
Age ($\overline{x}$±s, years) 58.63±11.07 59.28±9.42
Duration (Median (P25, P75), months) 7 (1.00, 20.75) 1 (0, 11.00) 1.036 0.300
Male 5 20
Female 3 12
Education degree*
Primary school (≤6 years) 1 3 0.719a
Junior high school (6 to 9 years) 2 4
Senior high school or technical secondary school (9 to 12 years) 2 13
Senior high school above (>12 years) 2 10
Recruitment stage of diabetic nephropathy
5 20
3 12
Drug withdrawal during follow-up
Yes 0 5 0.563a
No 8 27
Treatment based on syndrome differentiation
Yes 4 19 0.702a
No 4 13
Therapy adjustment
Yes 3 6 0.348a
No 5 26

Table 3

Distribution of treatment way in cases and controls"

Matching No Case group Control group χ2 OR (95% CI)
1 1 0 2/4 2/4 0.194 0.725 (0.174, 3.030)
2 1 0 3/4 1/4
3 1 0 2/4 2/4
4 0 1 2/4 2/4
5 0 1 3/4 1/4
6 0 1 3/4 1/4
7 1 0 1/4 3/4
8 0 1 3/4 1/4
Total 4 (50.0%) 4 (50.0%) 19 (59.4%) 13 (40.6%)
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