Advice
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. |
|||
|
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'. |
|||
|
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. |
|||
|
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. |
|||