Chiasson 1994.
| Methods |
Parallel randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design |
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| Participants |
Inclusion criteria: people with non‐insulin‐dependent diabetes of at least 6 months, HbA1c > 7%, normal renal and hepatic function Exclusion criteria: poor controlled hypertension, documented gastrointestinal disease, taking medication likely to alter gut motility or absorption, taking medications to lower lipid levels Diagnostic criteria: WHO 1985 |
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| Interventions |
Number of study centres: 7 Treatment before study: insulin, dose is not stated in the publication Titration period: 6 weeks |
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| Outcomes | Primary outcome(s) (as stated in the publication): glycaemic control (HbA1c, oral glucose tolerance test, fasting blood glucose), side effects, hypoglycaemia, C‐peptide, lipids, blood count, biochemistry, vitamins, minerals | |
| Study details |
Total study duration: 12 months Run‐in period: 6 weeks Study terminated early (for benefit/because of adverse events): no |
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| Publication details |
Language of publication: English Funding source: Miles Canada Publication status: peer‐reviewed journal |
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| Stated aim of study | Quote from publication: "to evaluate the long‐term efficacy of acarbose, an alpha‐glucosidase inhibitor, in improving glycaemic control in patients with non‐insulin‐dependent diabetes mellitus" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: not possible to judge whether the sequence generation was adequate |
| Allocation concealment (selection bias) | Unclear risk | Comment: not possible to judge whether the allocation to the intervention and control group was concealed |
| Blinding of participants and personnel (performance bias) Adverse events | Unclear risk | Comment: it is not clear whether the physician or the outcome assessor is besides the participants blinded |
| Blinding of participants and personnel (performance bias) HbA1c, FPG, lipids | Unclear risk |
Quote from publication: (from the abstract) " Design: a 1‐year, multicenter, randomised, double‐blind, placebo‐controlled study" (from the main text) "Acarbose or placebo was taken with the first sip of the liquid meal" Comment: it is not clear whether the physician or the outcome assessor is besides the participants blinded |
| Blinding of participants and personnel (performance bias) Insulin dose | Unclear risk |
Quote from publication: (from the abstract) " Design: a 1‐year, multicenter, randomised, double‐blind, placebo‐controlled study" (from the main text) "Acarbose or placebo was taken with the first sip of the liquid meal" Comment: it is not clear whether the physician or the outcome assessor is besides the participants blinded |
| Blinding of outcome assessment (detection bias) Adverse events | Unclear risk | Comment: it is not clear whether the physician or the outcome assessor is besides the participants blinded |
| Blinding of outcome assessment (detection bias) HbA1c, FPG, lipids | Unclear risk | Comment: it is not clear whether the physician or the outcome assessor is besides the participants blinded |
| Blinding of outcome assessment (detection bias) Insulin dose | Unclear risk | Comment: it is not clear whether the physician or the outcome assessor is besides the participants blinded |
| Incomplete outcome data (attrition bias) Adverse events | Low risk | Comment: none |
| Incomplete outcome data (attrition bias) HbA1c, FPG, lipids | High risk | Comment: data on lipids is only mentioned, no analyses is performed or shown |
| Incomplete outcome data (attrition bias) Insulin dose | Low risk | Comment: data were presented for both groups |
| Selective reporting (reporting bias) | Unclear risk | Comment: more figures than tables, that causes unclear reporting |
| Other bias | Unclear risk | Comment: funded in part by a pharmaceutical company |