Wu HM 1996.

Methods	Generation of allocation sequence: unstated. Blinding: not used. Sample size estimation: no information. Withdrawal/drop‐out: unstated.
Participants	Ethnic: Chinese; 164 patients (104 in treatment group, M/F 60/44, mean age 46 years (5‐75), disease duration from 0.5‐26 years; 60 in control group, no details on gender, age, and disease duration). Setting: outpatients and inpatients. Inclusion criteria: type 2 diabetes mellitus, diagnosed by WHO criteria (WHO 1980), and classified into two syndromes by a diagnostic criteria of Chinese Medicine: deficiency of Qi‐Yin, and deficiency of Spleen and Kidney. Exclusion criteria: unstated.
Interventions	Experimental intervention: Two herbal mixtures: either Yiqi Yangyin Qingre recipe or Jianpi Zhuyun Yishen Huayu (use based on differentiation of the syndrome) decoction, one dosage daily, divided into two times orally; plus D860 (tolbutamide), 500 mg orally, t.i.d., both for two months. Control intervention: D860, 500 mg orally, t.i.d., for two months. The dosage of D860 would be adjusted based on the levels of fasting blood glucose to avoid hypoglycaemic event.
Outcomes	FBG and PBG. No follow‐up was reported.
Notes	There was a skew distribution numbers of participants in 2 groups. The author did not give reason for that. Letter sent to request (Aug. 2002).
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear