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Study flow diagram.
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Figure 1

Study flow diagram.

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Table 1. Reduction in vision according to change in perimetric mean deviation

Outcome

Acetalomazide

Placebo

MD (95% CI) adjusted for centre, baseline value of outcome and baseline papilloedema grade, with multiple imputation for missing data

Mean

SD

N

Mean

SD

N

Wall 2014: Change in perimetric mean deviation (decibels) between baseline and 6 months

1.43

2.23

86

0.71

2.49

69

0.71 (0 to 1.43)

Abbreviations: MD = mean difference; SD = standard deviation; CI = confidence interval.
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Table 1. Reduction in vision according to change in perimetric mean deviation
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Table 2. Reduction in vision according to change in logMAR acuity

Outcome

Acetalomazide

Placebo

MD (95% CI)

Mean

SD

N

Mean

SD

N

Ball 2011: Change in logMAR acuity in the right eye between baseline and 12 months

Not reported

Not reported

21

Not reported

Not reported

20

0.04 (‐0.08, 0.16)

Ball 2011: Change in logMAR acuity in the left eye between baseline and 12 months

Not reported

Not reported

21

Not reported

Not reported

20

0.03 (‐0.09, 0.15)

Wall 2014a: Change in visual acuity (number of correct letters) between baseline and 6 months

2.65

Not reported (SE 0.49)

b

2.64

Not reported (SE 0.51)

b

0.01 (‐1.45, 1.46)

aIn Wall 2014 MD adjusted for centre, baseline value of outcome and baseline papilloedema grade.
bIt is unclear how many patients were included in these analyses.
Abbreviations: MD = mean difference; SD = standard deviation; CI = confidence interval; SE = standard error.

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Table 2. Reduction in vision according to change in logMAR acuity
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Table 3. Reduction in patients with visual loss according to change in logMAR acuity

Outcome

Acetalomazide

Placebo

OR (95% CI)

n

N

n

N

Ball 2011: Visual loss (logMAR 0.2 or more) at 12 months

0

21

2

20

0.17 (0.01, 3.82)

Abbreviations: MD = mean difference; SD = standard deviation; CI = confidence interval; n = number of events; N = number of participants; OR = odds ratio.

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Table 3. Reduction in patients with visual loss according to change in logMAR acuity
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Table 4. Reduction in cerebrospinal fluid pressure

Outcome

Acetalomazide

Placebo

MD (95% CI) adjusted for centre, baseline value of outcome and baseline papilloedema grade

Mean

SD

N

Mean

SD

N

Wall 2014: Change in CSF pressure (mmH20) between baseline and 6 months

‐112.3

Not reported

47

‐52.4

Not reported

38

‐59.9 (‐96.4 to ‐23.4)
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Table 4. Reduction in cerebrospinal fluid pressure
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Table 5. Resolution of papilloedema or oculomotor disorder or both

Outcome

Acetalomazide

Placebo

MD (95% CI) adjusted for centre and baseline papilloedema grade

Mean

SD

N

Mean

SD

N

Wall 2014: Change in papilloedema grade between baseline and 6 months, graded by fundus photographs

‐1.31

SE 0.11a

a

‐0.61

SE 0.11a

a

‐0.70 (‐1.00 to ‐0.40)

Wall 2014: Change in papilloedema grade between baseline and 6 months, clinical grading

‐1.75

SE 0.13a

a

‐0.85

SE 0.14a

a

‐0.91 (‐1.27 to ‐0.54)

aIt is unclear how many patients were included in these analyses.
Abbreviations: MD = mean difference; SD = standard deviation; SE = standard error; CI = confidence interval; N = number of participants.

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Table 5. Resolution of papilloedema or oculomotor disorder or both
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Table 6. Improvement in headache

Outcome

Acetalomazide

Placebo

MD (95% CI) adjusted for centre, baseline value of outcome and baseline papilloedema grade

Mean

SD

N

Mean

SD

N

Ball 2011: Change in headache score as measured on a 10‐point visual analogue score at 12 months

Not reported

Not reported

21

Not reported

Not reported

20

1.0 (‐1.80 to 3.70)

Wall 2014: Change in HIT‐6 total score between baseline and 6 months

‐9.56

Not reporteda

a

‐9.11

Not reporteda

a

‐0.45 (‐3.50 to 2.60)

aIt is unclear how many patients were included in these analyses.
Abbreviations: MD = mean difference; SD = standard deviation; CI = confidence interval; N = number of participants.

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Table 6. Improvement in headache
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Table 7. Resolution of headache

Outcome

Acetalomazide

Placebo

OR (95% CI)

n

N

n

N

Ball 2011: Number of people with headache at 12 months

9

21

13

20

0.42 (0.12 to 1.41)

Abbreviations: CI = confidence interval; n = number of events; N = number of participants; OR = odds ratio.

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Table 7. Resolution of headache
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Table 8. Remission rate

Outcome

Acetalomazide

Placebo

OR (95% CI)

n

N

n

N

Ball 2011: Number of people in remission at 12 months

9

21

8

20

1.13 (0.32 to 3.90)

Abbreviations: CI = confidence interval; n = number of events; N = number of participants; OR = odds ratio.

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Table 8. Remission rate
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Table 9. Side effects

Outcome

Acetalomazide

Placebo

OR (95% CI)

n

N

n

N

Elevated ALT

6

69

3

79

1.90 (0.46 to 7.87)

Decreased CO2

9

69

0

79

19.49 (1.12 to 340.66)

Diarrhea

12

69

3

79

4.11 (1.11 to 15.15)

Dizziness

8

69

3

79

2.60 (0.66 to 10.16)

Dysgeusia

13

69

0

79

29.20 (1.71 to 500.07)

Dyspepsia

7

69

1

79

6.91 (0.83 to 57.49)

Dyspnea

7

69

2

79

3.41 (0.69 to 16.94)

Fatigue

14

69

1

79

15.17 (1.94 to 118.27)

Headache

13

69

11

79

1.10 (0.46 to 2.62)

Nasopharyngitis

5

69

8

79

0.55 (0.17 to 1.75)

Nausea

26

69

10

79

2.99 (1.33 to 6.70)

Paresthesia

41

69

5

79

13.48 (4.96 to 36.64)

Post‐LP syndrome

5

69

6

79

0.75 (0.22 to 2.56)

Rash

7

69

2

79

3.41 (0.69 to 16.94)

Sinusitis

3

69

6

79

0.44 (0.11 to 1.82)

Tinnitus

11

69

3

79

3.72 (1.00 to 13.85)

Vomiting

12

69

3

79

4.11 (1.11 to 15.15)

This data is from one study (Wall 2014).

Abbreviations: CI = confidence interval; n = number of events; N = number of participants; OR = odds ratio.

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Table 9. Side effects
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Table 10. Quality of life

Outcome

Acetalomazide

Placebo

MD (95% CI) adjusted for centre, baseline value of outcome and baseline papilloedema grade

Mean

SD

N

Mean

SD

N

Wall 2014: Change in VFQ‐25 total score between baseline and 6 months

8.33

SE 1.47a

a

1.98

SE 1.53a

a

6.35 (2.22 to 10.47)

Wall 2014: Change in VFQ‐25 10‐item neuro‐ophthalmic supplement between baseline and 6 months

9.82

SE 1.55a

a

1.59

SE 1.62a

a

8.23 (3.89 to 12.56)

Wall 2014: Change in SF‐36 Physical Component Summary between baseline and 6 months

5.84

SE 1.01a

a

2.82

SE 1.03a

a

3.02 (0.34 to 5.70)

Wall 2014: Change in SF‐36 Mental Component Summary between baseline and 6 months

5.62

SE 1.16a

a

2.17

SE 1.17a

a

3.45 (0.35 to 6.55)

aIt is unclear how many patients were included in these analyses.
Abbreviations: CI = confidence interval; N = number of participants; SE = standard error; SD = standard deviation.

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Table 10. Quality of life
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