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. 2015 Feb 17;2015(2):CD007259. doi: 10.1002/14651858.CD007259.pub2

Chu 2012.

Study characteristics
Methods Randomised controlled crossover trial of G lucidum vs placebo
Participants Inclusion criteria
  • Pre‐hypertension or stage 1 hypertension (classified by JNC7; systolic BP 130‐150 mmHg or diastolic BP 85‐100 mmHg) or being treated with antihypertensive

  • Mild to moderate elevation of plasma total cholesterol (total cholesterol ≥ 6.0 mmol/L) and/or triglyceride (≥ 1.7 mmol/L and ≤ 5.0 mmol/L) with or without lipid lowering treatment.*

  • Type 2 diabetes, but only well controlled (HbA1c < 8.5)


Exclusion criteria
  • Recent cardiovascular events (last 6 months)

  • Liver enzymes (> 2 x upper normal limit)


Setting was an outpatient clinic of teaching hospital (Prince of Wales Hospital, Hong Kong)
Interventions G lucidum polysaccharide extract 1.44 g/day (360 mg/capsule) equal to 13.2 g of mushroom/day taken as 2 capsules twice/day
Duration was 12 weeks. Placebo and cross‐over run in periods of 4 weeks
Intervention provided by Vita‐Green Health Product Company Limited, Hong Kong
Outcomes
  • Anthropometry

  • BP

  • Urine electrolytes

  • Lipid profile

  • Plasma glucose

  • Apolipoprotein B

  • Anti‐oxidant enzymes

  • Allantoin

  • Uric acid

  • Lymphocyte subsets

  • Catecholamines

  • Cortisol

  • Cortisone


Adverse events
  • Any side effect or change in activity or well‐being

Notes *Authors provided additional data for first stage of cross‐over trial. Many variables had baseline values within normal ranges and were therefore not included in meta‐analysis
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote “This was a randomised, double‐blind, cross‐over study”
Authors were contacted and provided information that the randomisation sequence was conducted by personnel independent to the study using a computer‐generated program
Allocation concealment (selection bias) Low risk No information provided in the paper.
Authors were contacted and provided information that the randomisation sequence was conducted by personnel independent to the study using a computer‐generated program. The interventions were "labelled (A or B) by external personnel.*
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Quote “From twenty‐six eligible subjects enrolled in the study, one withdrew due to personal reasons, one subject had poor compliance (80% compliance from capsule counting) with therapy and one subject had intercurrent illness; so their data were not included in the per‐protocol analysis”. No intention‐to‐treat analysis was performed. It is unclear whether the effect of missing data might induce clinically relevant bias in observed effect size
*Complete data could not be obtained from authors
Selective reporting (reporting bias) Unclear risk No primary outcome measure was specified. The authors aimed to determine whether the intervention had “…beneficial effects on a wide range of cardiovascular and metabolic parameters.” There was an extensive description of outcome measures, but no protocol is available. Data were provided for all outcome measures described in the methods section. However some conclusions of treatment effect were made without between‐group treatment effect sizes, though these can be determined from table data
Further data were provided by authors to measure between‐group effects of the first stage only
Other bias Low risk None noted
No funding issues apparent
Blinding of participants and personnel (performance bias) Low risk Insufficient information provided in the paper. Authors were contacted and provided information that placebo and intervention were identical and provided in bottles labelled (A or B) blindly at an external site
Blinding of outcome assessment (detection bias) Unclear risk No assessor blinding details are outlined. As most outcome measures are pathology‐based, outcome bias might not be greatly affected