Is correspondence of herbal prescriptions and traditional Chinese medicine (TCM) syndrome effective in treating ischemic stroke?
Date of publication of the randomized controlled trial: September 2012
Design
Randomized controlled trial (RCT).
Participants
252 patients with ischemic stroke (mean age: 62 years in complete correspondence of prescriptions and TCM syndrome group, 63 years in incomplete correspondence of prescriptions and TCM syndrome group).
Intervention
A series of TCM syndrome-oriented formulas during 21 days after stroke onset. Formulas were changes daily according to the TCM syndrome.
Comparator
Comparison: Complete (series of formulas) versus incomplete (only 1 formula) correspondence of prescriptions and TCM syndrome. 1 formula that was disease-oriented, Hua Tan Tong Luo formula.
Major Outcomes
Outcome 1: Rate of disappearance of common symptoms of stroke after treatment for 1 week.
Settings
This trial was conducted in an outpatient setting.
Comparison    Complete (series of formulas) versus incomplete (only 1 formula) correspondence of prescriptions and TCM syndrome
Main Results
Compared to incomplete (only 1 formula) correspondence of prescriptions and TCM syndrome, complete correspondence significantly reduced frequency of micturition or urinary incontinence after treatment for 1 week. However, incomplete (only 1 formula) correspondence of prescriptions and TCM syndrome significantly reduced night sweating and dyspepsia after treatment for 1 week.
Comparison: Complete (series of formulas) versus incomplete (only 1 formula) correspondence of prescriptions and TCM syndrome among patients with ischemic stroke
Outcomes No. of studies (Total no. of participants) No. of patients with disappearance of common symptoms of stroke/ No. of participants Heterogeneity test (I2) MD (95% CI) p value Overall quality of evidence*
Intervention Comparator
1a) Frequency of micturition or urinary incontinence 1/45 10/24 2/21 Not applicable as there is only 1 study. Not reported 0.015 Low
1b) Night sweating 1/37 4/18 13/19 Not applicable as there is only 1 study. Not reported 0.005 Low
1c) Dyspepsia 1/64 4/30 17/34 Not applicable as there is only 1 study. Not reported 0.002 Low
Keys: MD = mean difference, CI = confidence interval.
Comparison    Complete (series of formulas) versus incomplete (only 1 formula) correspondence of prescriptions and TCM syndrome
Main Results
Compared to incomplete (only 1 formula) correspondence of prescriptions and TCM syndrome, complete correspondence significantly reduced frequency of micturition or urinary incontinence after treatment for 1 week. However, incomplete (only 1 formula) correspondence of prescriptions and TCM syndrome significantly reduced night sweating and dyspepsia after treatment for 1 week.
Comparison: Complete (series of formulas) versus incomplete (only 1 formula) correspondence of prescriptions and TCM syndrome among patients with ischemic stroke
Outcomes 1a) Frequency of micturition or urinary incontinence 1b) Night sweating 1c) Dyspepsia
No. of studies (Total no. of participants) 1/45 1/37 1/64
No. of patients with disappearance of common symptoms of stroke/ No. of participants Intervention 10/24 4/18 4/30
Comparator 2/21 13/19 17/34
MD (95% CI) Not reported Not reported Not reported
p value 0.015 0.005 0.002
Overall quality of evidence* Low Low Low
Keys: MD = mean difference, CI = confidence interval.
Conclusion
Benefits
Compared to incomplete (only 1 formula) correspondence of prescriptions and TCM syndrome, complete correspondence had similar effects on the central clinical manifestation of ischemic stroke. However, complete correspondence of prescriptions and TCM syndrome showed a better effect on some subjective symptoms of stroke. For all outcomes, the overall quality of evidence is low. Further research is likely to have an important impact on our confidence in this estimate of effect.
Harms
12 adverse events occurred in this study, including gout attack, allergic dermatitis and transient ischemic attack. 3 patients in the intervention group had diarrhea, which may have been related to a large dose of Mang Xiao in the stroke No.2 formula. No other adverse events related to the formulas were found, suggesting that the formulas adopted in this trial were safe.
Link to Original Article
https://www.ncbi.nlm.nih.gov/pubmed/23297552
The synopsis is based on the following article:
Gao Y, Zhong H, Ma B, Huang Y. Randomized, double-blind, parallel-controlled clinical trial on correspondence of prescriptions and traditional Chinese medicine syndrome of ischemic stroke. Journal of Traditional Chinese Medicine. 2012 Sep; 32(3), 335-342.


* 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.