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مداخلاتی برای مدیریت بالینی هیپرتانسیون داخل جمجمه‌ای ایدیوپاتیک

Appendices

Appendix 1. CENTRAL search strategy

#1 MeSH descriptor Pseudotumor Cerebri
#2 MeSH descriptor Sinus Thrombosis, Intracranial
#3 MeSH descriptor Intracranial Hypertension
#4 MeSH descriptor Papilledema
#5 (#1 OR #2 OR #3 OR #4)
#6 intracranial
#7 intra cranial
#8 intercranial
#9 inter cranial
#10 (#6 OR #7 OR #8 OR #9)
#11 hypertens* or pressur*
#12 increas* or elevat* or high*
#13 benign* or idiopathic* or secondary
#14 (#10 AND #11 AND #12 AND #13)
#15 pseudotumor or pseudo tumor* near cerebr*
#16 pseudoabscess* or pseudo abscess*
#17 otitic or toxic* near hydroceph*
#18 sinus near thrombosis
#19 meningeal near hydrop*
#20 (#15 OR #16 OR #17 OR #18 OR #19)
#21 (#5 OR #14 OR #20)

Appendix 2. MEDLINE (Ovid) search strategy

1 randomized controlled trial.pt.
2 (randomized or randomised).ab,ti.
3 placebo.ab,ti.
4 dt.fs.
5 randomly.ab,ti.
6 trial.ab,ti.
7 groups.ab,ti.
8 or/1‐7
9 exp animals/
10 exp humans/
11 9 not (9 and 10)
12 8 not 11
13 exp pseudotumor cerebri/
14 exp sinus thrombosis intracranial/
15 exp intracranial hypertension/
16 exp papilledema/
17 or/13‐16
18 intra?cranial.tw.
19 intra cranial.tw.
20 inter?cranial.tw.
21 inter cranial.tw.
22 or/18‐21
23 (hypertens$ or pressur$).tw.
24 (increas$ or elevat$ or high$).tw.
25 (benign$ or idiopathic$ or secondary).tw.
26 22 and 23 and 24 and 25
27 ((pseudotumor or pseudo tumor$) adj3 cerebr$).tw.
28 (pseudoabscess$ or pseudo abscess$).tw.
29 ((otitic or toxic$) adj5 hydroceph$).tw.
30 (sinus adj3 thrombosis).tw.
31 (meningeal adj3 hydrop$).tw.
32 or/13‐15
33 or/26‐32
34 12 and 33

The search filter for trials at the beginning of the MEDLINE strategy is from the published paper by Glanville et al (Glanville 2006).

Appendix 3. EMBASE (Ovid) search strategy

1 exp randomized controlled trial/
2 exp randomization/
3 exp double blind procedure/
4 exp single blind procedure/
5 random$.tw.
6 or/1‐5
7 (animal or animal experiment).sh.
8 human.sh.
9 7 and 8
10 7 not 9
11 6 not 10
12 exp clinical trial/
13 (clin$ adj3 trial$).tw.
14 ((singl$ or doubl$ or trebl$ or tripl$) adj3 (blind$ or mask$)).tw.
15 exp placebo/
16 placebo$.tw.
17 random$.tw.
18 exp experimental design/
19 exp crossover procedure/
20 exp control group/
21 exp latin square design/
22 or/12‐21
23 22 not 10
24 23 not 11
25 exp comparative study/
26 exp evaluation/
27 exp prospective study/
28 (control$ or prospectiv$ or volunteer$).tw.
29 or/25‐28
30 29 not 10
31 30 not (11 or 23)
32 11 or 24 or 31
33 exp brain pseudotumor/
34 exp cerebral sinus thrombosis/
35 exp intracranial hypertension/
36 exp papilledema/
37 or/33‐36
38 intra?cranial.tw.
39 intra cranial.tw.
40 inter?cranial.tw.
41 inter cranial.tw.
42 or/38‐41
43 (hypertens$ or pressur$).tw.
44 (increas$ or elevat$ or high$).tw.
45 (benign$ or idiopathic$ or secondary).tw.
46 42 and 43 and 44 and 45
47 ((pseudotumor or pseudo tumor$) adj3 cerebr$).tw.
48 (pseudoabscess$ or pseudo abscess$).tw.
49 ((otitic or toxic$) adj5 hydroceph$).tw.
50 (sinus adj3 thrombosis).tw.
51 (meningeal adj3 hydrop$).tw.
52 or/47‐51
53 37 or 46 or 52
54 32 and 53

Appendix 4. ISRCTN search strategy

(benign or idiopathic) and intracranial hypertension

Appendix 5. Clinicaltrials.gov search strategy

(Benign OR Idiopathic) AND Intracranial Hypertension

Appendix 6. ICTRP search strategy

Idiopathic Intracranial Hypertension

Benign Intracranial Hypertension

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

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

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

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.

Figuras y tablas -
Table 1. Reduction in vision according to change in perimetric mean deviation
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.

Figuras y tablas -
Table 2. Reduction in vision according to change in logMAR acuity
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.

Figuras y tablas -
Table 3. Reduction in patients with visual loss according to change in logMAR acuity
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)

Figuras y tablas -
Table 4. Reduction in cerebrospinal fluid pressure
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.

Figuras y tablas -
Table 5. Resolution of papilloedema or oculomotor disorder or both
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.

Figuras y tablas -
Table 6. Improvement in headache
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.

Figuras y tablas -
Table 7. Resolution of headache
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.

Figuras y tablas -
Table 8. Remission rate
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.

Figuras y tablas -
Table 9. Side effects
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.

Figuras y tablas -
Table 10. Quality of life