Ref (type) | Population | Outcome, Interventions | Results and statistical analysis | Effect size | Favours |
General well-being | |||||
RCT |
75 people with tinnitus, considered to be at high risk of developing severe and disabling tinnitus Further report of reference |
Change in Psychological General Well-Being Index (PGWB)
16 weeks
+20.83 with sertraline 50 mg daily +2.79 with placebo |
P = 0.001 The RCT reported no significant correlation between visual analogue scale and tinnitus loudness The RCT may have been underpowered to detect a clinically meaningful difference between groups |
Effect size not calculated | sertraline 50 mg daily |
Annoyance | |||||
RCT |
76 people with tinnitus, considered to be at high risk of developing severe and disabling tinnitus |
Reduction in tinnitus annoyance score (measured by visual analogue scale; scale of 0–100 mm; higher score denotes higher level of annoyance)
16 weeks
15.76 with sertraline (25 mg/day for 1 week followed by 50 mg/day for 15 weeks) 5.15 with placebo |
Reported as not significant P value not reported The RCT may have been underpowered to detect a clinically meaningful difference between groups |
Not significant | |
Anxiety | |||||
RCT |
76 people with tinnitus, considered to be at high risk of developing severe and disabling tinnitus |
Reduction in clinician-rated anxiety score (measured by Hamilton Anxiety Rating Scale; scale of 0–56; higher score denotes higher level of anxiety)
16 weeks
8.51 with sertraline (25 mg/day for 1 week followed by 50 mg/day for 15 weeks) 4.09 with placebo |
P = 0.037 The RCT may have been underpowered to detect a clinically meaningful difference between groups |
Effect size not calculated | sertraline |
RCT |
76 people with tinnitus, considered to be at high risk of developing severe and disabling tinnitus |
Reduction in participant-rated anxiety score (measured by Comprehensive Psychopathological Rating Scale [CPRS-S-A] for anxiety; scale of 0–54; higher score denotes higher level of anxiety)
16 weeks
4.38 with sertraline (25 mg/day for 1 week followed by 50 mg/day for 15 weeks) 0.73 with placebo |
P = 0.013 The RCT may have been underpowered to detect a clinically meaningful difference between groups |
Effect size not calculated | sertraline |
Depression | |||||
RCT |
76 people with tinnitus, considered to be at high risk of developing severe and disabling tinnitus |
Reduction in participant-rated depression score (measured by CPRS-S-A for depression; scale of 0–60; higher score denotes higher level of depression)
16 weeks
5.93 with sertraline (25 mg/day for 1 week followed by 50 mg/day for 15 weeks) 0.05 with placebo |
P = 0.002 The RCT may have been underpowered to detect a clinically meaningful difference between groups |
Effect size not calculated | sertraline |
RCT |
76 people with tinnitus, considered to be at high risk of developing severe and disabling tinnitus |
Reduction in clinician-rated depression score (measured by Hamilton Depression Rating Scale; scale 0–62; higher score denotes higher level of depression)
16 weeks
9.79 with sertraline (25 mg/day for 1 week followed by 50 mg/day for 15 weeks) 5.87 with placebo |
Reported as not significant P value not reported The RCT may have been underpowered to detect a clinically meaningful difference between groups |
Not significant |