Antidepressants compared to placebo for inflammatory bowel disease

Patient or population: participants with active and inactive inflammatory bowel disease
Setting: Outpatient
Intervention: Antidepressants
Comparison: Placebo

Anxiety at 12 weeks

‐

44
(1 study)

⊕⊕⊝⊝
low^{1, 2}

Anxiety was assessed using the HADS

Anxiety at 12 months

‐

26
(1 study)

⊕⊕⊝⊝
low³

Anxiety was assessed using the HADS

A second non‐randomised study using the HARS reported a mean score of 12.65 + 3.76 in the antidepressant group (n = 30) compared to 17.85 + 3.33 in the placebo group (n = 30) (MD ‐5.20, 95% CI ‐7 to ‐3.40; very low certainty evidence)

Depression at 12 weeks

‐

44
(1 study)

⊕⊕⊝⊝
low^{1, 2}

Depression was assessed using the HADS

Depression at 12 months

‐

26
(1 study)

⊕⊕⊝⊝
low³

Depression was assessed using the HADS

A second non‐randomised study using the Beck Depression Inventory reported a mean score of 9.6 + 2.76 in the antidepressant group (n = 30) compared to 16.35 + 5.41 in the placebo group (n = 30) (MD ‐6.75, 95% CI ‐8.92 to ‐4.58; very low certainty evidence)

Adverse events at 12 months

RR 2.29
(0.78 to 6.73)

26
(1 study)

⊕⊕⊝⊝
low⁴

Commonly reported adverse events include nausea, headache, dizziness, drowsiness, sexual problems, insomnia, fatigue, low mood/anxiety, dry mouth muscle spasms and hot flushes

None of the included studies reported any serious adverse events

Quality of life

See comment

70
(2 studies)

⊕⊕⊝⊝
low^{1, 2, 3}

Quality of life was assessed using the WHO‐QOL‐BREF

We were unable to pool data as the outcome was reported at 12 weeks in 1 trial (44 participants) and 12 months in 1 trial (26 participants). Physical, Psychological, Social and Environmental QoL were improved only at 12 weeks with no group difference at 12 months

Pain

No studies reported this outcome

Maintenance of remission at 12 months

RR 0.96
(0.55 to 1.69)

26
(1 study)

⊕⊕⊝⊝
low⁵

Maintenance of remission was measured by the CDAI (< 150) and fecal calprotectin levels

Endoscopic relapse at 12 months

RR 0.14
(0.01 to 2.65)

60
(1 study)

⊕⊝⊝⊝
very low⁶

Non‐randomised study. We were unable to calculate absolute effects. Endoscopic relapse occurred in 0% (0/30) of participants in the antidepressants group compared to 10% (3/30) in the placebo group

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: Confidence interval; CMD: Common mental disorders; MD: Mean Difference; HADS: Hospital Anxiety and Depression Scale; HARS: Hamilton Anxiety Rating Scale; RR: Risk Ratio; WHO‐QOL‐BREF: World Health Organization Quality of Life abbreviated questionnaire

GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect