Gao 2004b.

Study characteristics
Methods	Randomised controlled trial of Ganopoly capsules versus placebo
Participants	Inclusion criteria Men and women 18‐75 years of age Coronary heart disease, confirmed by a comprehensive medical and physical examination including history, blood biochemistry and heart ultrasound scanning. Exclusion criteria Severe disease of another vital organ Clinically significant haematologic, hepatic, metabolic, renal, rheumatologic, neurological or psychiatric disease Anaphylactic reactions Clinically significant cardiac or cardiovascular anomalies other than coronary heart disease Chronic obstructive pulmonary disease Abnormal carbon monoxide diffusion capacity Organ grafts Severe or disabling illnesses Systemic bacterial or fungal infection Clinically significant bleeding disorders Evidence of malignant neoplastic disease within 5 years Average daily intake of alcohol exceeding 50 g of ethanol Drug abuse within the previous year Participants, baseline data presented as mean (SD) for intervention (GL) and control (C) groups unless indicated otherwise: Average age, years: GL 54.2 (9.8); C 55.4 (11.1) Duration of disease, years: GL 5.2 (1.5); C 5.5 (1.7) Cholesterol, xULN: GL 2.1 (1.2); C 2.2 (1.1) Systolic BP, mmHg: GL 142.5 (13.2); C 141.4 (14.2) Diastolic BP, mmHg: GL 96.4 (7.2); C 94.3 (8.9) > 50% narrowing of one major coronary artery, number: GL 28; C 25 ECG abnormality, %:GL 74; C 76
Interventions	Intervention: Ganopoly capsules each containing 600 mg extract of G lucidum, with 25% (w/w) crude polysaccharides, equivalent to 9 g fruiting body of G lucidum (provided by Encore International Co. Auckland, NZ). Dose: 5400 mg/day (9 capsules), dose adjusted within first 4 weeks. 3 capsules taken orally, 3 times per day before meals for 12 weeks Control: placebo (provided by Encore International, Auckland, NZ)
Outcomes	Body weight BP Concomitant medication or illness Clinical chemistry Haematological profile Triglycerides Total cholesterol HDL cholesterol LDL cholesterol Urinalysis ECG changes Vital symptoms and signs, graded as –lack, +minor (1‐2 symptoms without impact on work and life), ++mild (3‐5 symptoms, some impact on life and work), and +++severe (> 5 symptoms, stop work) Adverse events, categorised as events reported before treatment that were exacerbated during treatment; during treatment; or within 7 days after the study drug was stopped Serious adverse event: any event, whether treatment‐related or not, that posed a medically significant hazard to the participant, i.e. was fatal, life threatening, permanently disabling or required hospitalisation
Notes	Did not report data suitable for use in between‐group comparisons in Review Manager 5. Authors did not respond to requests for additional information
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information. Quote ". . . eligible patients were randomly assigned" Insufficient information about the sequence generation process to permit judgement of 'low' or 'high risk of bias'
Allocation concealment (selection bias)	Unclear risk	Insufficient information about the sequence generation process to permit judgement of 'low' or 'high risk of bias'.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	There were 170 participants, 10 were lost to follow‐up but they were not included in the analysis. 8 out of 10 were in the intervention group, which indicated that the drop‐out may have been relevant to the treatment. There was no indication analysis was by intention‐to‐treat. Quote "Changes between baseline and the last treatment were evaluated for all efficacy variables with the last observation carried forward". This seems to describe how missing data was handled, but that the data for participants who dropped‐out was not included Overall it appears the data of drop‐outs has not been included, and this may affect the assessment of effect and safety of intervention therapy. There is a potential risk of bias due to incomplete outcome data Insufficient information to permit judgement of 'low' or 'high risk of bias'
Selective reporting (reporting bias)	High risk	No primary outcome measure specified. The overall strategy for analysis was unclear. There was selective reporting as baseline for BP and cholesterol level are provided, but only BP of intervention group has post‐treatment mean result. Both may be regarded as within‐group differences. Basic data for adverse events were provided for the intervention group only For between‐group differences significance was found for symptom and electrocardiographic improvement but standard deviation of data was not provided Overall, the primary outcomes were not specified, descriptions of statistical significance between groups were vague and insufficient data were provided. No effect sizes could be determined due to no provision of control group means or between‐group standard deviations. There was a high risk of bias due to selective outcome reporting
Other bias	Low risk	None noted No funding issues apparent The study appears to be free of other sources of bias
Blinding of participants and personnel (performance bias)	Unclear risk	Quote "This double blind. . .". It is stated that 1800 mg of placebo were taken 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. However there is insufficient information to permit judgement of 'low' or 'high risk of bias'
Blinding of outcome assessment (detection bias)	Unclear risk	Insufficient information to permit judgement of 'low' or 'high risk of bias'