Table 1 Demographic and clinical characteristics

Age at randomisation (years)

 Mean [SD]

61.1 [10.8]

55.4 [15.6]

58.2 [13.6]

Duration of tinnitus (years)

 Mean [SD]

7.0 [8.3]

8.7 [10.4]

7.8 [9.4]

Gender

 Male

24 (59%)

27 (64%)

51 (61%)

 Female

17 (41%)

15 (36%)

32 (39%)

Ethnicity

 White

40 (98%)

39 (93%)

79 (95%)

 Black Caribbean

0

3 (7%)

3 (4%)

 Sikh

1 (2%)

0

1 (1%)

Degree of hearing loss^a

 Mean [SD]

41.2 [17.3]

39.2 [13.4]

40.2 [15.4]

Severity of tinnitus (Tinnitus Functional Index score)^b

 Mean [SD]

57.1 [21.9]

57 [22]

57.1 [21.8]

Initial onset of tinnitus related to^c

 Change in hearing

3 (7%)

0

3 (4%)

 Whiplash

0

1 (2%)

1 (1%)

 Stress

2 (5%)

2 (5%)

4 (5%)

 Head trauma

0

1 (2%)

1 (1%)

 Loud sound

0

2 (5%)

2 (2%)

 Other cause

13 (32%)

7 (17%)

20 (24%)

 Unknown

23 (56%)

29 (69%)

52 (63%)

Location of tinnitus

 Bilateral

25 (61%)

28 (67%)

53 (64%)

 Unilateral

9 (22%)

11 (26%)

20 (24%)

 Inside the head

7 (17%)

3 (7%)

10 (12%)

Tinnitus sound over time

 Intermittent

9 (22%)

7 (17%)

16 (19%)

 Constant

32 (78%)

35 (83%)

67 (81%)

Sounds of tinnitus^c

 Hissing

6 (15%)

13 (31%)

19 (23%)

 Ringing

10 (24%)

9 (21%)

19 (23%)

 Pulsing

1 (2%)

2 (5%)

3 (4%)

 Buzzing

11 (27%)

11 (26%)

22 (27%)

 Clicking

2 (5%)

1 (2%)

3 (4%)

 Cracking

0

2 (5%)

2 (2%)

 Tonal

9 (22%)

5 (12%)

14 (17%)

 Humming

5 (12%)

5 (12%)

10 (12%)

 Popping

1 (2%)

1 (2%)

2 (2%)

 Roaring

0

3 (7%)

3 (4%)

 Rushing

2 (5%)

1 (2%)

3 (4%)

 Whistling

5 (12%)

8 (19%)

13 (16%)

 Whooshing

6 (15%)

9 (21%)

15 (18%)

 Other

7 (17%)

11 (26%)

18 (22%)

Tinnitus seem to pulsate

 Pulsatile

4 (9%)

5 (12%)

9 (11%)

 Non-pulsatile

37 (90%)

35 (83%)

72 (87%)

 Do not know

0

2 (5%)

2 (2%)