Quality of life and metabolic status in mildly depressed women with type 2 diabetes treated with paroxetine: A single-blind randomised placebo controlled trial
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Key result
Paroxetine shows a non-significant trend toward improved glycemic control versus placebo in mildly depressed diabetic women.
- 95% CI -0.05 to 0.80
- P=0.08
- n=15
Why the study?
Does paroxetine improve glycemic control and quality of life in mildly depressed women with type 2 diabetes?
Population
15 mildly depressed women with non-optimally controlled type 2 diabetes
Comparison
Paroxetine 20 mg oral per day for 10 weeks vs Placebo for 10 weeks
Design
RCT, randomised, single-blind
Follow-up
10 weeks
Authors
Discussion
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Implication
Paroxetine shows only a nonsignificant trend for glycemic improvement; leaves open its role in mildly depressed women with type 2 diabetes.
Study Design
Type
RCT (n=15)
Blinding
Single-blind
Randomization
Computerised
Multicenter
No
Structured PICO
Does paroxetine improve glycemic control and quality of life in mildly depressed women with type 2 diabetes?
P
Population
15 postmenopausal women over 50 years of age with non-optimally controlled type 2 diabetes and mild depression, followed for 10 weeks.
I
Intervention
Paroxetine 20 mg oral per day for 10 weeks
C
Comparator
Placebo for 10 weeks
O
Outcome
Glycemic control (measured by GHbA1c) and quality of life (evaluated using RAND-36)surrogate
Main Result
Absolute Event Rate: -0.44% vs -0.07%
p-value: p=0.08
Paroxetine may improve insulin sensitivity and glycemic control in mildly depressed women with type 2 diabetes, though it did not significantly improve quality of life in this small trial.
Limitations
- Small sample size resulting in low statistical power
- Short study duration of 10 weeks
- Relatively good glycemic control at baseline (average GHbA1c 7.5%) may have limited the ability to demonstrate full treatment effect
- Single-blind design may have influenced investigator-rated mental state scales
- small sample size
- short duration
Cite This Study
Paile‐Hyvärinen et al. (2003) conducted an RCT in Type 2 diabetes and mild depression (n=15). Paroxetine vs. Placebo was evaluated on Change in glycosylated hemoglobin A1c (GHbA1c) (95% CI -0.05 to 0.80, p=0.08). Paroxetine showed a trend towards superior improvement in glycemic control compared to placebo in mildly depressed women with type 2 diabetes, reducing GHbA1c by 0.44% versus 0.07% (p=0.08).
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