Is Chinese herbal medicine effective in treating chronic kidney disease stage 3?
Date of publication of the randomized controlled trial: July 2012
Design
Randomized controlled trial (RCT).
Participants
578 Chinese patients with primary glomerulonephritis in chronic kidney disease stage 3 (mean age: 47.33 years in traditional Chinese medicine (TCM) group, 49.04 years in benazepril group, 49.32 years in TCM plus benazepril group; 49.8% male).
Intervention
TCM granules were given twice per day, followed by a 24-week follow-up period.
Comparator
Comparison 1: TCM versus benazepril (10mg/day);
Comparison 2: TCM versus TCM plus benazepril (10mg/day).
Major Outcomes
Outcome 1: Estimated glomerular filtration rate (MDRD formula) as measured at week 24 (ml/min);
Outcome 2: 24h proteinuria (UP) excretion as measured at week 24 (mg/24h);
Outcome 3: Urinary albumin/ creatinine (UAlb/Cr) as measured at week 24 (mg/gcr).
Settings
This study was performed in an outpatient setting.
Comparison    TCM versus benazepril
Main Results
Compared to baseline, TCM significantly improved renal function by increasing estimated glomerular filtration rate to 48.46ml/min at week 24 (p<0.05). However, 24h UP excretion was increased to 990.00mg/24h at week 24 (p<0.05) and UAlb/Cr was increased to 0.48mg/gcr (p>0.05) at week 24 for TCM group as compared to baseline.
Comparison 1: TCM versus benazepril among patients with primary glomerulonephritis in CKD stage 3
Outcomes (unit) No. of studies (Total no. of participants) Mean value(SD) / No. of participants Heterogeneity test (I2) MD (95% CI) Overall quality of evidence*
Intervention Comparator
1 (ml/min) 1 (381) 48.46 (15.90)/192 43.00 (12.37)/189 Not applicable as there is only 1 study. Not reported Moderate
2 (mg/24h) 1 (381) 990.00 (not reported) /192 510 (not reported) /189 Not applicable as there is only 1 study. Not reported Moderate
3 (mg/gcr) 1 (381) 0.48 (not reported)/192 0.26 (not reported)/189 Not applicable as there is only 1 study. Not reported Moderate
Keys: SD= standard deviation, MD = mean difference, CI = confidence interval.
Comparison    TCM versus TCM plus benazepril
Main Results
For the TCM plus benazepril group, estimated glomerular filtration rate was increased to 48.31ml/min at week 24 as compared to baseline (p<0.05). Besides, 24h UP excretion and UAlb/Cr were decreased to 453.50mg/24h (p<0.05) and 0.22mg/gcr (p<0.05) respectively in the TCM plus benazepril group at week 24.
Comparison 2: TCM versus TCM plus benazepril among patients with primary glomerulonephritis in CKD stage 3
Outcomes (units) No. of studies (Total no. of participants) Mean value (SD) / No. of participants Heterogeneity test (I2) MD (95% CI) Overall quality of evidence*
Intervention Comparator
1 (ml/min) 1 (383) 48.46 (15.90)/192 48.31 (17.50)/191 Not applicable as there is only 1 study. Not reported Moderate
2 (mg/24h) 1 (383) 990.00 (not reported) /192 453.50 (not reported) /191 Not applicable as there is only 1 study. Not reported Moderate
3 (mg/gcr) 1 (383) 0.48 (not reported)/192 0.22 (not reported)/191 Not applicable as there is only 1 study. Not reported Moderate
Keys: SD= standard deviation, MD = mean difference, CI = confidence interval.
Comparison    TCM versus benazepril
Main Results
Compared to baseline, TCM significantly improved renal function by increasing estimated glomerular filtration rate to 48.46ml/min at week 24 (p<0.05). However, 24h UP excretion was increased to 990.00mg/24h at week 24 (p<0.05) and UAlb/Cr was increased to 0.48mg/gcr (p>0.05) at week 24 for TCM group as compared to baseline.
Comparison 1: TCM versus benazepril among patients with primary glomerulonephritis in CKD stage 3
Outcomes (unit) 1 (ml/min) 2 (mg/24h) 3 (mg/gcr)
No. of studies (Total no. of participants) 1 (381) 1 (381) 1 (381)
Mean value(SD) / No. of participants Intervention 48.46 (15.90)/192 990.00 (not reported) /192 0.48 (not reported)/192
Comparator 43.00 (12.37)/189 510 (not reported) /189 0.26 (not reported)/189
MD (95% CI) Not reported Not reported Not reported
Overall quality of evidence* Moderate Moderate Moderate
Keys: SD= standard deviation, MD = mean difference, CI = confidence interval.
Comparison    TCM versus TCM plus benazepril
Main Results
For the TCM plus benazepril group, estimated glomerular filtration rate was increased to 48.31ml/min at week 24 as compared to baseline (p<0.05). Besides, 24h UP excretion and UAlb/Cr were decreased to 453.50mg/24h (p<0.05) and 0.22mg/gcr (p<0.05) respectively in the TCM plus benazepril group at week 24.
Comparison 2: TCM versus TCM plus benazepril among patients with primary glomerulonephritis in CKD stage 3
Outcomes (units) 1 (ml/min) 2 (mg/24h) 3 (mg/gcr)
No. of studies (Total no. of participants) 1 (383) 1 (383) 1 (383)
Mean value (SD) / No. of participants Intervention 48.46 (15.90)/192 990.00 (not reported) /192 0.48 (not reported)/192
Comparator 48.31 (17.50)/191 453.50 (not reported) /191 0.22 (not reported)/191
MD (95% CI) Not reported Not reported Not reported
Overall quality of evidence* Moderate Moderate Moderate
Keys: SD= standard deviation, MD = mean difference, CI = confidence interval.
Conclusion
Benefits
TCM and TCM plus benazepril showed significant effect in improving renal function by increasing estimated glomerular filtration rate as compared to baseline. Besides, benazepril and TCM plus benazepril significantly decreased proteinuria and urinary albumin/ creatinine as measured to baseline. For all outcomes, the overall quality of evidence is moderate. Further research is fairly likely to have an important impact on our confidence in this estimate of effect.
Harms
Adverse events were not reported in this trial. Side effects events were lowest in the TCM group as compared with the other two groups. Dry cough occurred in 5 patients in benazepril group versus 6 patients in TCM plus benazepril group and no one in the TCM group. Hyperkalemia occurred in 18 patients in TCM plus benazepril group compared with 10 patients in benazepril group and 7 patients in TCM group.
Link to Original Article
https://www.ncbi.nlm.nih.gov/pubmed/22178174
The synopsis is based on the following article:
Wang YJ, He LQ, Sun W, Lu Y, Wang XQ, Zhang PQ, et al. Optimized project of traditional Chinese medicine in treating chronic kidney disease stage 3: a multicenter double-blinded randomized controlled trial. Journal of Ethnopharmacology. 2012 Jul; 139(3), 757-764.


* Interpretation of quality assessment results:
• Very low: Further research is most likely to have an important impact on our confidence in this estimate of effect.
• Low: Further research is likely to have an important impact on our confidence in this estimate of effect.
• Moderate: Further research is fairly likely to have an important impact on our confidence in this estimate of effect.
• High: Further research is unlikely to have an important impact on our confidence in this estimate of effect.
• Very high: Further research is most unlikely to have an important impact on our confidence in this estimate of effect.

Details of assessment method can be found at Chung VC, Wu XY, Ziea ET, Ng BF, Wong SY, Wu JC. Assessing internal validity of clinical evidence on effectiveness of CHinese and integrative medicine: Proposed framework for a CHinese and Integrative Medicine Evidence RAting System (CHIMERAS). European Journal of Integrative Medicine. 2015 Aug 31;7(4):332-41.