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. 2015 May 1;2015(5):CD011681. doi: 10.1002/14651858.CD011681

Summary of findings for the main comparison. SSRIs or SNRIs versus placebo for tension‐type headache.

SSRIs or SNRIs compared to placebo for tension‐type headache
Patient or population: patients with tension‐type headache
 Intervention: SSRIs or SNRIs
 Comparison: placebo
Outcomes Illustrative comparative risks* (95% CI) Relative effect
 (95% CI) No. of Participants
 (studies) Quality of the evidence
 (GRADE) Comments
Assumed risk Corresponding risk
Placebo SSRIs or SNRIs
Headache frequency
 (number of days with headache)
Follow‐up: 2 months
The mean headache frequency ranged across control groups from
 13.8 to 21.7 days with headache The mean headache frequency in the intervention groups was
 0.96 lower
 (3.95 lower to 2.03 higher)   127
 (2 studies) ⊕⊕⊝⊝
 low1  
Headache intensity
 (score)
Follow‐up: 2 months
The mean headache severity in the control groups was
 3.9 The mean headache severity in the intervention groups was
 0.30 lower
 (1.13 lower to 0.53 higher)   40
 (1 study) ⊕⊕⊝⊝
 low1  
Headache duration
 (hours)
Follow‐up: 2 months
The mean headache duration in the control groups was
 6.57 The mean headache duration in the intervention groups was
 0.07 lower
 (2.69 lower to 2.55 higher)   40
 (1 study) ⊕⊕⊝⊝
 low1  
Symptomatic/analgesic medication for acute headache attacks 
 (doses/month)
Follow‐up: 2 months
The mean symptomatic/analgesic medication for acute headache attacks ranged across control groups from
 1.07 to 34.8 doses The mean symptomatic/analgesic medication for acute headache attacks in the intervention groups was
 1.87 lower
 (2.09 to 1.65 lower)   118
 (2 studies) ⊕⊕⊝⊝
 low1 This finding is largely driven by the results reported by a study at high risk of sponsorship bias
             
Headache index
Follow‐up: 2 months
The mean headache index ranged across control groups from
 18.3 to 877 The mean headache index in the intervention groups was 0.24 SDs lower
 (0.59 lower to 0.11 higher)   128
 (2 studies) ⊕⊝⊝⊝
 very low2 As a rule of thumb, 0.2 SDs represents a small difference, 0.5 moderate and 0.8 large (Cohen 1988)
Quality of life See comment See comment Not estimable See comment Not measured
Withdrawals due to adverse events
Follow‐up: 2 months
Study population OR 3.72 
 (0.79 to 17.53) 190
 (3 studies) ⊕⊝⊝⊝
 very low3  
11 per 1000 40 per 1000
 (9 to 163)
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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; OR: Odds ratio; SD: Standard deviation; SNRI: Serotonin‐norepinephrine reuptake inhibitor; SSRI: selective serotonin reuptake inhibitor
GRADE Working Group grades of evidence
 High quality: Further research is very unlikely to change our confidence in the estimate of effect.
 Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
 Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
 Very low quality: We are very uncertain about the estimate.

1 Limitations in study design, imprecision (insufficient data).
 2 Limitations in study design, imprecision (insufficient data), indirectness (lack of generalisability).
 3 Limitations in study design, imprecision (insufficient data), inconsistency (heterogeneity).