Chu 2012.
Study characteristics | ||
Methods | Randomised controlled crossover trial of G lucidum vs placebo | |
Participants |
Inclusion criteria
Exclusion criteria
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 |
Adverse events
|
|
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 |