Results tables

Results tables

Table 8 Schollhammer et al. 2015

Oxybutynin

Placebo

Analysis

n

30

28 a

Primary outcome

Proportion of participants with an improvement in HDSS score of 1 point or more at week 6

60% (18/30)

29% (8/28)

p<0.01

Selected secondary outcomes

Level of improvement in HDSS score

0 points: 12/30

1 point: 5/30

2 points: 11/30

3 points: 2/30

(from a mean baseline score of 3.2)

0 points: 20/28

1 point: 6/28

2 points: 2/28

3 points: 0/28

(from a mean baseline score of 3.3)

No statistical analyses reported

Level of improvement in DLQI score from baseline to week 6

−6.9 (from a mean baseline score of 11.4)

−2.3 (from a mean baseline score of 10.8)

p<0.01

Safety and tolerability outcomes

n

30

28

Dry mouth

13/30 (43%)

[6/13 slight intensity, 5/13 mild intensity, 2/13 severe intensity]

3/28 (11%)

[intensity not reported]

p<0.01

Blurred vision

4/30 (13%)

0/28 (0%)

No statistical analysis reported

a The authors state that the ITT analysis included 30 people in the placebo group, although results are only provided for 28 people.

Abbreviations: DLQI, Dermatology Life Quality Index; HDSS, Hyperhidrosis Disease Severity Scale; ITT, intention to treat.

Table 9 Wolosker et al. 2012

Oxybutynin

Placebo

Analysis

n

23

22

Efficacy outcomes

Patient assessment of improvement in palmar or axillary hyperhidrosisa

0–4: 6/23

5–7: 6/23

8–10: 11/23

0–4: 16/22

5–7: 6/22

8–10: 0/22

p<0.001

More people in the oxybutynin group had an improvement of 5–7 or 8–10 points compared with placebo (statistically significant difference)

Patient assessment of improvement in quality of lifeb

20–35: 8/23

36–51: 9/23

52–67: 6/23

68–83: 0/23

84–100: 0/23

20–35: 0/22

36–51: 3/22

52–67: 19/22

68–83: 0/22

84–100: 0/22

p<0.001

More people in the oxybutynin had an improvement of 36–51 or 52–67 points compared with placebo (statistically significant difference)

n

12

15

Patient assessment of improvement in plantar hyperhidrosisa

0–4: 1/12

5–7: 7/12

8–10: 4/12

0–4: 13/15

5–7: 2/15

8–10: 0/15

p<0.001

Safety and tolerability outcomes

n

30

28

Dry mouth: moderate and severe

5 mg: 6/23

10 mg: 8/23

5 mg: 7/22

10 mg: 2/22

No statistical analysis reported

Dry mouth: absent and mild

5 mg: 17/23

10 mg: 15/23

5 mg: 15/22

10 mg: 20/22

No statistical analysis reported

a A score of 0–4 corresponds to a 'null or slight' improvement; 5–7 a 'moderate' improvement and 8–10 a 'great' improvement.

b Improvements of 20–35 points correspond to the person feeling 'much better'; 36–51 'a little better'; 52–67 'the same'; 69–83'a little worse'; and 84–100 'much worse'.

Table 10 Costa Jr et al. 2014

Oxybutynin

Placebo

Analysis

n

16

16

Efficacy outcomes

Mean adjusted quality of life score (SD)a

Before treatment

40.4 (14.4)

'Very good'

Before treatment

34.8 (16.3)

'Very good'

Oxybutynin: p=0.001

Placebo: p=0.099

Statistically significant difference in oxybutynin group only

After treatment

17.5 (11.9)

'Excellent'

After treatment

33.2 (15.3)

'Very good'

Right foot – mean transepidermal water loss (SD), g/m2/hour

Before treatment

140.3 (40.3)

Before treatment

112.6 (49.3)

Oxybutynin: p=0.008

Placebo: p=0.796

Statistically significant difference in oxybutynin group only

After treatment

87.6 (70.2)

After treatment

102.2 (55.9)

Right hand – mean transepidermal water loss (SD), g/m2/hour

Before treatment

61.7 (43.9)

Before treatment

58.3 (39.3)

Oxybutynin: p=0.001

Placebo: p=0.245

Statistically significant difference in oxybutynin group only

After treatment

28.6 (20.5)

After treatment

50.4 (37.8)

Back – mean transepidermal water loss (SD), g/m2/hour

Before treatment

38.2 (64.3)

Before treatment

18.2 (19.0)

Oxybutynin: p=0.004

Placebo: p=0.959

Statistically significant difference in oxybutynin group only

After treatment

10.8 (8.7)

After treatment

19.0 (27.9)

Abdomen – mean transepidermal water loss (SD), g/m2/hour

Before treatment

39.7 (46.0)

Before treatment

24.0 (18.1)

Oxybutynin: p=0.004

Placebo: p=0.501

Statistically significant difference in oxybutynin group only

After treatment

16.5 (19.2)

After treatment

26.8 (31.4)

Safety and tolerability outcomes

n

16

16

Dry mouth

100.0% (16/16)

43.8% (7/16)

p=0.001

Constipation

31.0% (5/16)

6.3% (1/16)

p=0.172

Drowsiness

18.0% (3/16)

6.3% (1/16)

p=0.600

a Scored from 0 to 100, with lower scores indicating better quality of life. 0–20= 'excellent' ; 21–40= 'very good'; 41–60= 'good'; 61–80= 'poor'; 81–100= 'very poor'.

Abbreviations: g, gram; m, metre; SD, standard deviation.

Table 11 Ghaleiha et al. 2012

Oxybutynin

Placebo

Analysis

n

66

74

Efficacy outcomes

HDSS score at week 2

1.546, from a baseline score of 2.864

1.961 from a baseline score of 2.648

p=0.03

Safety and tolerability outcomes

n

66

74

Gastrointestinal complications

7/66 (10.6%)

6/74 (8.1%)

p=0.61

Sedation

0/66 (0.0%)

0/74 (0.0%)

NA

Dry mouth

3/66 (4.4%)

0/74 (0.0%)

p=0.10

Urinary complications

3/66 (4.4%)

0/74 (0.0%)

p=0.10

Abbreviations: HDSS, Hyperhidrosis Disease Severity Scale; NA, not applicable.