| Methods |
Design: three group parallel trial
Purpose: examine the effect of sulfonylurea therapy on patients with increased fasting plasma glucose |
| Participants |
Patients: out‐patients with increased but not diabetic fasting plasma glucose
Baseline comparability: yes |
| Interventions |
Placebo: tablets containing no sulfonylurea
Untreated: no tablets
Experimental: tablets containing sulfonylurea
(Co‐intervention: reinforced or basic health advice in a factorial design) |
| Outcomes |
Fasting plasma glucose (mmol/l)
Haemoglobin A1c
Plasma insulin
Beta‐cell function
Weight
Blood lipids
Arterial blood pressure |
| Notes |
Data from placebo and no‐treatment groups pooled in the original trial report. Contact with researchers provided unpooled data. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'... double‐blind placebo...' |
| Blinding?
Outcome assessor |
Unclear risk |
NS |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
High risk |
Data from placebo and no‐treatment groups pooled in the original trial report. Contact with researchers provided unpooled data. |
| Free of other bias? |
High risk |
See notes |
| No signs of variance inequality or skewness? |
High risk |
Either variance inequality (F‐test statistically significant) or skewness (1.64 standard deviations exceeds the mean) |
| Trial size > 49? |
Low risk |
N = 115 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Drop‐out > 15% or NS |
