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. 2002 Jul 22;2002(3):CD003642. doi: 10.1002/14651858.CD003642.pub2

Chen YB 1995.

Methods Generation of allocation sequence: not stated. 
 Blinding: single blind, but not mentioned who was blinded. 
 Sample size estimation: 
 no information. 
 Withdrawal/drop‐out: unstated.
Participants Ethnic: Chinese; 
 68 patients (M/F 32/36, mean age 54 years (39‐68), mean disease duration 6 years (1‐25 years). 34 in Bushen Huoxue group and 34 in placebo group). 
 Setting: outpatients. 
 Inclusion criteria: type 2 diabetes diagnosed by WHO criteria (WHO 1985), TCM diagnosis belonged to syndrome of 'kidney deficiency and blood stasis'; mean levels of fasting blood glucose > or = 6.05 mmol/L by two measurements prior the treatment; without ketoacidosis, recent infection, tuberculosis, and with normal functions of heart, liver, kidneys. 
 Exclusion criteria: unstated.
Interventions Experimental intervention: 
 Bushen Huoxue No. I (composed of more than 8 herbs) tablet, 10 tablets (1 g/tab) orally, t.i.d., for two months.
Control intervention: 
 placebo (starch, named as Bushen Huoxue No. II), 3 tablets (0.75 g/tab), t.i.d., orally, for two months.
All patients had a run‐in period of 4 weeks prior to the interventions, but kept their original treatments (12 continued dietary therapy, 56 continued oral hypoglycaemic drugs during the trial.
Outcomes Symptoms, FBG, and adverse effects.
No follow‐up was reported.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear