Wang 2008.
Study characteristics | ||
Methods | Randomised controlled trial of Ganopoly capsules versus placebo | |
Participants |
Inclusion criteria 50 outpatients with type 2 diabetes who had received an 8‐week diet control and an exercise advice and whose blood glucose level was still maintained at 150 mg/dL‐250 mg/dL Exclusion criteria Liver, kidney or gastrointestinal dysfunction Participants, baseline data presented as mean (SD) for intervention (I) and control (C) groups: Average age, years: I 58.6 (2.3); C 61.8 (2.4) Duration of disease, years: I 6.5 (0.8); C 8.5 (0.8) BMI, kg/m2: I 26.5 (1.0); C 25.3 (0.7) Systolic BP, mmHg: I 127.3 (2.9); C 131.1 (2.6) Diastolic BP, mmHg: I 74.2 (2.0); C 75.6 (1.9) FPG, mg/dL: I 180.1 (6.5); C 184.7 (3.2) 2hPPG, mg/dL: I 282.9 (8.5); C 264.6 (4.7) HbA1c, %: I 8.2 (1.3); C 8.5 (1.4) |
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Interventions |
Intervention: lingzhi was produced by the Guo‐Ren‐Shun‐Tian‐Tang Pharmaceutical Company. Lingzhi came from Nantou County Puli Town. The strain was authenticated by the Food Industry Research and Development Institute (FIRDI). Raw mushroom was made into powder through decoction, concentration, drying and then into capsules after quantity and quality approval. Dose: 1000 mg 3 times daily for 12 weeks Control: placebos were prepared by Guo‐Ren‐Shun‐Tian‐Tang Pharmaceutical Company as well; these consisted of starch and had the same appearance as the lingzhi capsules Additional treatments: prior co‐comitant hypoglycaemic agents were maintained through the study in both groups |
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Outcomes |
Meal tolerance test Participants were given nutritional advice for 2 days' diet of 30 Kcal/kg/day. On the day of receiving the meal tolerance test, participants had a fasting blood test and were then provided with breakfast containing 1/5 of the whole day's energy intake, comprising 55% carbohydrate, 30% fat and 15% protein. Blood was taken 1 h, 2 h, 3 h and 4 h after the breakfast to test blood glucose levels and calculate plasma glucose under the curve |
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Notes | Reported that the endpoint mean of the placebo group was 187.9 (49) mg/dL. Our comparisons and calculations suggest this standard deviation value was not 49 mg/dL, but rather, 4.9 mg/dL | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information provided. Quote ". . .eligible patients were randomly assigned" |
Allocation concealment (selection bias) | Unclear risk | Insufficient information provided |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | There were 50 participants, it is not certain that the 4 withdrawals occurred prior to randomisation. The wording that "46 were allocated" sounds as if random allocation occurred for only these participants, but it could mean that they had already been allocated Insufficient reporting of attrition/exclusions to permit judgement of 'low' or 'high risk of bias' |
Selective reporting (reporting bias) | Unclear risk | Primary outcome measures were not clearly specified but could be inferred as FPG, HbA1c, glucose area under‐the‐curve and 2h PPG. Without access to the protocol it is unclear whether these have been selected from a larger number of outcomes e.g. plasma glucose under the curve at 1st, 2nd, and 3rd hour of meal tolerance test were not reported in both groups. No aims were provided regarding adverse events and only partial adverse event results appeared to be provided. It is unclear whether these data are affected by reporting bias |
Other bias | Low risk | None noted No funding issues apparent |
Blinding of participants and personnel (performance bias) | Unclear risk | It was stated that placebo was used as 1000 mg three times daily for 12 weeks. No participant or study personnel blinding details were outlined With placebo statements, it could be implied that participants were blinded Insufficient information about the sequence generation process to permit judgement of 'low' or 'high risk of bias' |
Blinding of outcome assessment (detection bias) | Unclear risk | Insufficient information about the sequence generation process to permit judgement of 'low' or 'high risk of bias' |
Abbreviations
PPG: post prandial glucose
2hPPG: 2‐hour post prandial glucose
2hPC: 2‐hour post prandial glucose BMI: body mass index BP: blood pressure FPG: fasting plasma glucose h: hour(s) HbA1c: fasting and stimulated glycosylated haemoglobin HDL: high density lipoprotein LDL: low density lipoprotein NCEP: National Cholesterol Education Program w/w: weight to weight ULN: upper limit of normal