Dewell 2002.
| Methods | Parallel randomised controlled clinical trial, randomisation ratio intervention: control = 5 : 4 | |
| Participants |
Inclusion criteria: healthy moderately hypercholesterolaemic (mean TC 6.6 ± 1.3 mmol/L) postmenopausal women (mean age 69 ± 4 years) Exclusion criteria: receiving hormone replacement therapy, clinical or biochemical evidence of diabetes or renal, hepatic or cardiovascular disease Diagnostic criteria: not specified |
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| Interventions |
Number of study centres: 1 Treatment before study: two individuals were taking medication known to affect carbohydrate or lipid metabolism. 1 woman was taking simvastatin and 1 woman fluvastatin for hypercholesterolaemia. Both women had been on a stable dose for at least 1 year before the study, and medications were not altered during the study period Titration period: 6 months |
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| Outcomes | Outcomes reported in abstract of publication: triacylglycerol, TC and HDL‐C | |
| Study details |
Run‐in period: no Study terminated before regular end (for benefit/because of adverse events): no |
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| Publication details |
Language of publication: English Commercial funding: not reported Non‐commercial/other funding: yes; a small research grant from the College of Applied Sciences and Arts at San Jose State University and a research award from the Circle of Friends/Department of Nutrition and Food Science of San Jose State University Publication status: peer‐reviewed journal |
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| Stated aim of study | Quote from publication: "to investigate the effects of PE supplementation (150 mg) on serum lipids and lipoproteins in moderately hypercholesterolemic, elderly, postmenopausal women" | |
| Notes | The trial reported the outcomes of HDL‐C and non‐HDL‐C at baseline and at 2 months, but no data at 6 months Abbreviations: HDL: high‐density‐lipoprotein |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote from publication: "Thirty‐six subjects were randomized into two groups" Comment: no information about sequence generation |
| Allocation concealment (selection bias) | Unclear risk | Comment: no information about concealment |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote from publication: "Subjects were recruited initially as part of a larger randomized, double blind, placebo‐controlled trial with a parallel design to assess the role of PE supplementation on bone mineral health" Comment: no information about blinding |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: no information about blinding |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote from publication: "Because of the unavailability of serum, determinations of triacylglycerol and cholesterol concentrations at 6 months were performed only on 17 and 18 of the 20 subjects in the PE‐treated group, respectively" Comment: number of participants analyzed was less than number of participants randomized |
| Selective reporting (reporting bias) | Low risk | Comment: none detected |
| Other bias | Low risk | Comment: no other sources of bias were found in this study |