Quality of life and metabolic status in mildly depressed patients with type 2 diabetes treated with paroxetine: A double-blind randomised placebo controlled 6-month trial
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Key result
Paroxetine fails to improve HbA1c or quality of life versus placebo in mildly depressed diabetics.
- MD 0.13
- 95% CI -0.52 to 0.78
- P=0.693
- n=49
Why the study?
Does paroxetine improve quality of life and glycaemic control in mildly depressed patients with type 2 diabetes?
Population
n=49 mildly depressed primary care outpatients with non-optimally controlled type 2 diabetes, aged 50-70…
Comparison
Paroxetine 20 mg oral once daily for 6 months. vs Matching placebo for 6 months.
Design
RCT, randomised, double-blind
Follow-up
6 months
Authors
Discussion
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Implication
Paroxetine does not support routine use for glycaemic control or quality of life; challenges assumptions of SSRI benefit in mildly depressed type 2 diabetes.
Study Design
Type
RCT (n=49)
Blinding
Double-blind
Randomization
Computerised and concealed
Multicenter
No
Structured PICO
Does paroxetine improve quality of life and glycaemic control in mildly depressed patients with type 2 diabetes?
P
Population
49 mildly depressed primary care outpatients aged 50-70 years with non-optimally controlled type 2 diabetes followed for 6 months.
I
Intervention
Paroxetine 20 mg oral once daily for 6 months.
C
Comparator
Matching placebo for 6 months.
O
Outcome
Quality of life (defined as a 10 points improvement in the SF-36 score) and glycaemic control (defined as a 0.8%-units decrease in GHbA1c).patient reported
Main Result
Mean Difference: 0.13 (95% CI -0.52–0.78)
Absolute Event Rate: 8.3% vs 8.4%
p-value: p=0.693
Paroxetine does not provide sustained improvements in glycaemic control or quality of life in mildly depressed patients with type 2 diabetes, indicating routine prescription is not warranted for this indication.
Limitations
- Small sample size
- High dropout rate in the placebo group (6 out of 25)
- Patients had sub-threshold depression rather than major depression, which may have limited the potential for observable benefit
Cite This Study
Paile‐Hyvärinen et al. (2007) conducted an RCT in Type 2 diabetes with mild depression (n=49). Paroxetine vs. Placebo was evaluated on Glycosylated haemoglobin A1c (GHbA1c) at 6 months (MD 0.13, 95% CI -0.52 to 0.78, p=0.693). Paroxetine did not significantly improve glycosylated haemoglobin A1c (mean difference 0.13%-units, p=0.693) or quality of life compared to placebo at 6 months in mildly depressed patients with type 2 diabetes.
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