Table 2 Primary and secondary clinical outcomes at final visit: single vs. combination (intention-to-treat population)

From: Single versus combination treatment in tinnitus: an international, multicentre, parallel-arm, superiority, randomised controlled trial

 

All treatments

Cognitive Behavioural Therapy

Hearing Aid

Structured Counselling

Sound Therapy

 

Single

Combination

Single

Combination

Single

Combination

Single

Combination

Single

Combination

Primary outcome

          

THI

          

Change from baseline

−11.7

−14.9

−16.9

−15.6

−14.4

−15.7

−12.0

−15.5

−3.8

−13.2

(95% CI)

(−14.4 to −9.0)

(−17.7 to −12.1)

(−22.8 to −10.9)

(−19.5 to −11.7)

(−19.5 to −9.4)

(−20.7 to −10.7)

(−17.5 to −6.5)

(−19.3 to −11.7)

(−9.3 to 1.6)

(−16.7 to −9.8)

Secondary Outcome

          

TFI

          

Change from baseline

−11.0

−11.6

−16.1

−12.1

−14.5

−13.9

−9.7

−10.1

−3.7

−11.7

(95% CI)

(−13.9 to −8.0)

(−14.7 to −8.5)

(−22.1 to −10.1)

(−16.3 to −7.9)

(−20.2 to −8.9)

(−19.4 to −8.4)

(−15.5 to −3.9)

(−14.0 to −6.2)

(−9.6 to 2.1)

(−15.5 to −7.9)

Mini-TQ

          

Change from baseline

−2.9

−3.4

−4.1

−3.8

−3.5

−3.0

−2.9

−3.4

−1.2

−3.0

(95% CI)

(−3.6 to −2.2)

(−4.1 to −2.7)

(−5.5 to −2.6)

(−4.8 to −2.8)

(−4.7 to −2.4)

(−4.2 to −1.9)

(−4.3 to −1.4)

(−4.3 to −2.5)

(−2.6 to 0.2)

(−3.9 to −2.2)

NRS-tinnitus loudness

          

Change from baseline

−0.8

−0.8

−0.5

−0.8

−1.4

−0.8

−0.8

−0.7

−0.3

−0.8

(95% CI)

(−1.2 to −0.4)

(−1.2 to −0.4)

(−1.4 to 0.3)

(−1.4 to −0.2)

(−2.2 to −0.6)

(−1.6 to −0.1)

(−1.6 to 0.0)

(−1.2 to −0.2)

(−1.0 to 0.5)

(−1.3 to −0.3)

PHQ-9

          

Change from baseline

−1.7

−1.4

−1.7

−1.7

−2.3

−1.5

−1.7

−1.3

−0.8

−1.3

(95% CI)

(−2.3 to −1.0)

(−2.1 to −0.8)

(−3.0 to −0.3)

(−2.6 to −0.8)

(−3.5 to −1.2)

(−2.6 to −0.4)

(−3.1 to −0.4)

(−2.2 to −0.5)

(−2.2 to 0.6)

(−2.2 to −0.4)

  1. Values depict least-squares mean changes at week 12 for primary and secondary outcomes with 95% confidence intervals. Higher total scores on the THI, TFI and Mini-TQ indicate greater severity of tinnitus. Higher total scores on the NRS - tinnitus loudness indicate greater loudness of tinnitus. Higher total scores on the PHQ-9 indicate greater severity of depression. Further objectives and secondary clinical outcomes not reported in this table can be seen in the Supplementary Appendix.
  2. NRS numeric rating scale, PHQ-9 Patient Health Questionnaire for Depression, TFI Tinnitus Functional Index, THI Tinnitus Handicap Inventory, TQ Tinnitus Questionnaire.
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