Ludvik 2004.
| Methods | Parallel RCT Randomisation ratio: 1:1 Superiority design |
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| Participants |
Inclusion criteria: clinically stable T2DM on diet only Exclusion criteria: renal, hepatic, cardiovascular, hematological, respiratory, autoimmune, neurological diseases or other endocrine dysfunction that could interfere with the study Diagnostic criteria: authors' criteria |
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| Interventions |
Number of study centres: no information Treatment before study: oral hypoglycaemic agents withdrawn 2 weeks before trial Titration period: nil Intervention group: 4 g of Caiopo (Ipomoea batatas) once daily Control intervention: Placebo tablets; no information provided regarding the content of these tablets All participants were on diet regimen during the study |
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| Outcomes |
Outcomes reported in abstract of publication: Primary outcome(s): (as stated in the publication) change in fasting blood glucose and 2‐hour postprandial blood glucose; change in HbA1c Seondary outcome(s): (as stated in the publication) change in cholesterol and triglyceride levels Additional outcome(s): incidence of adverse events |
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| Study details |
Run‐in period: 5 participants on antidiabetic medication (metformin and/or glibenclamide) had their medications withdrawn 2 weeks before the start of the study Was s tudy terminated early (for benefit/because of adverse events): no |
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| Publication details |
Language of publication: English Commercial funding: grant from manufacturer Non‐commercial funding: nil Publication status: peer review journal |
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| Stated aim of study | Quote from publication: "... assessment of the efficacy and tolerability of Caiapo (4 g/day) compared with placebo when administered for 12 consecutive weeks for type 2 diabetic patients ..." | |
| Notes | Original research journal article | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote from publication: "randomly divided into two groups" Comment: the process of randomisation was not specified |
| Allocation concealment (selection bias) | Unclear risk | Comment: there was no information about the adequacy of allocation concealment |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote from publication: "double‐blind" Comment: there was no other information available about blinding |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: fasting blood glucose and HbA1c were specifically measured |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: all participants completed the study, no treatment withdrawals or major adverse events reported |
| Selective reporting (reporting bias) | Low risk | Comment: primary outcome measures were stated |
| Other bias | Low risk | Comment: none detected |