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. |
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Outcomes | Symptoms, FBG, and adverse effects. No follow‐up was reported. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |