Ascorbic acid for the treatment of Charcot‐Marie‐Tooth disease

Burkhard Gess; Jonathan Baets; Peter De Jonghe; Mary M Reilly; Davide Pareyson; Peter Young

doi:10.1002/14651858.CD011952

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study. Green (+) = low risk of bias; yellow (?) = unclear risk of bias; red (‐) = high risk of bias.

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Figure 3

Forest plot of comparison: 1 Ascorbic acid versus placebo 12 months, outcome: 1.1 CMTNS.

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Figure 4

Forest plot of comparison: 1 Ascorbic acid versus placebo 12 months (adults), outcome: 1.21 9‐hole peg test [s].

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Figure 5

Forest plot of comparison: 2 Ascorbic acid versus placebo 24 months (adults), outcome: 2.1 Impairment ‐ CMTNS.

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Figure 6

Forest plot of comparison: 2 Ascorbic acid versus placebo 24 months (adults), outcome: 2.11 Impairment ‐ 9‐hole peg test [s].

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Analysis 1.1

Comparison 1 Ascorbic acid versus placebo 12 months (adults), Outcome 1 Impairment ‐ CMTNS (scale 0 to 36 points).

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Analysis 1.2

Comparison 1 Ascorbic acid versus placebo 12 months (adults), Outcome 2 Impairment ‐ CMTES (scale 0 to 28 points).

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Analysis 1.3

Comparison 1 Ascorbic acid versus placebo 12 months (adults), Outcome 3 Impairment ‐ NIS (scale ‐26 to 26 points).

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Analysis 1.4

Comparison 1 Ascorbic acid versus placebo 12 months (adults), Outcome 4 Disability ‐ ODSS (scale 0 to 12 points).

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Analysis 1.5

Comparison 1 Ascorbic acid versus placebo 12 months (adults), Outcome 5 Disability ‐ ONLS (scale 0 to 12 points).

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Analysis 1.6

Comparison 1 Ascorbic acid versus placebo 12 months (adults), Outcome 6 Disability ‐ ALDS (scale 0 to 100 points).

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Analysis 1.7

Comparison 1 Ascorbic acid versus placebo 12 months (adults), Outcome 7 CMAP, ulnar nerve (abductor digiti minimi).

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Analysis 1.8

Comparison 1 Ascorbic acid versus placebo 12 months (adults), Outcome 8 CMAP, median nerve (abductor pollicis brevis).

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Analysis 1.9

Comparison 1 Ascorbic acid versus placebo 12 months (adults), Outcome 9 CMAP summatory from ulnar, median and peroneal nerves.

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Analysis 1.10

Comparison 1 Ascorbic acid versus placebo 12 months (adults), Outcome 10 Sensation ‐ INCAT Sensory Sum score (scale 0 to 20 points).

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Analysis 1.11

Comparison 1 Ascorbic acid versus placebo 12 months (adults), Outcome 11 SNAP amplitude.

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Analysis 1.12

Comparison 1 Ascorbic acid versus placebo 12 months (adults), Outcome 12 Hand grip.

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Analysis 1.13

Comparison 1 Ascorbic acid versus placebo 12 months (adults), Outcome 13 Three‐point pinch.

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Analysis 1.14

Comparison 1 Ascorbic acid versus placebo 12 months (adults), Outcome 14 Foot dorsiflexion.

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Analysis 1.15

Comparison 1 Ascorbic acid versus placebo 12 months (adults), Outcome 15 Quality of life ‐ SF36 ‐ physical functioning.

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Analysis 1.16

Comparison 1 Ascorbic acid versus placebo 12 months (adults), Outcome 16 Quality of life ‐ SF36 ‐ bodily pain.

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Analysis 1.17

Comparison 1 Ascorbic acid versus placebo 12 months (adults), Outcome 17 Quality of life ‐ SF36 ‐ energy.

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Analysis 1.18

Comparison 1 Ascorbic acid versus placebo 12 months (adults), Outcome 18 Quality of life ‐ SF36 ‐ psychological.

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Analysis 1.19

Comparison 1 Ascorbic acid versus placebo 12 months (adults), Outcome 19 Quality of life ‐ SF36 ‐ MCS.

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Analysis 1.20

Comparison 1 Ascorbic acid versus placebo 12 months (adults), Outcome 20 Quality of life ‐ SF36 ‐ PCS.

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Analysis 1.21

Comparison 1 Ascorbic acid versus placebo 12 months (adults), Outcome 21 9‐hole peg test.

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Analysis 1.22

Comparison 1 Ascorbic acid versus placebo 12 months (adults), Outcome 22 Timed 10 m walk.

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Analysis 1.23

Comparison 1 Ascorbic acid versus placebo 12 months (adults), Outcome 23 50 m walk.

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Analysis 2.1

Comparison 2 Ascorbic acid versus placebo 24 months (adults), Outcome 1 Impairment ‐ CMTNS (scale 0 to 36 points).

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Analysis 2.2

Comparison 2 Ascorbic acid versus placebo 24 months (adults), Outcome 2 Impairment ‐ CMTES (scale 0 to 28 points).

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Analysis 2.3

Comparison 2 Ascorbic acid versus placebo 24 months (adults), Outcome 3 Disability ‐ ONLS (scale 0 to 12 points).

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Analysis 2.4

Comparison 2 Ascorbic acid versus placebo 24 months (adults), Outcome 4 CMAP, ulnar nerve (abductor digiti minimi).

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Analysis 2.5

Comparison 2 Ascorbic acid versus placebo 24 months (adults), Outcome 5 Hand grip.

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Analysis 2.6

Comparison 2 Ascorbic acid versus placebo 24 months (adults), Outcome 6 Three‐point pinch.

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Analysis 2.7

Comparison 2 Ascorbic acid versus placebo 24 months (adults), Outcome 7 Foot dorsiflexion.

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Analysis 2.8

Comparison 2 Ascorbic acid versus placebo 24 months (adults), Outcome 8 Quality of life ‐ SF36 ‐ physical functioning.

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Analysis 2.9

Comparison 2 Ascorbic acid versus placebo 24 months (adults), Outcome 9 Quality of life ‐ SF36 ‐ bodily pain.

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Analysis 2.10

Comparison 2 Ascorbic acid versus placebo 24 months (adults), Outcome 10 Quality of life ‐ SF36 ‐ energy.

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Analysis 2.11

Comparison 2 Ascorbic acid versus placebo 24 months (adults), Outcome 11 9‐hole peg test.

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Analysis 2.12

Comparison 2 Ascorbic acid versus placebo 24 months (adults), Outcome 12 Timed 10 m walk.

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Analysis 2.13

Comparison 2 Ascorbic acid versus placebo 24 months (adults), Outcome 13 PMP22 mRNA (skin biopsy).

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Analysis 3.1

Comparison 3 Ascorbic acid vs placebo (children), Outcome 1 CMAP amplitude (M. abductor pollicis brevis).

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Analysis 3.2

Comparison 3 Ascorbic acid vs placebo (children), Outcome 2 Hand grip.

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Analysis 3.3

Comparison 3 Ascorbic acid vs placebo (children), Outcome 3 Finger pinch.

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Analysis 3.4

Comparison 3 Ascorbic acid vs placebo (children), Outcome 4 Foot dorsiflexion.

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Analysis 3.5

Comparison 3 Ascorbic acid vs placebo (children), Outcome 5 Foot plantar flexion.

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Analysis 3.6

Comparison 3 Ascorbic acid vs placebo (children), Outcome 6 Median nerve motor conduction velocity.

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Analysis 3.7

Comparison 3 Ascorbic acid vs placebo (children), Outcome 7 9‐hole peg test.

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Analysis 3.8

Comparison 3 Ascorbic acid vs placebo (children), Outcome 8 6 min walk.

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Analysis 3.9

Comparison 3 Ascorbic acid vs placebo (children), Outcome 9 Balance.

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Analysis 3.10

Comparison 3 Ascorbic acid vs placebo (children), Outcome 10 Agility.

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Analysis 3.11

Comparison 3 Ascorbic acid vs placebo (children), Outcome 11 Long jump.

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Analysis 3.12

Comparison 3 Ascorbic acid vs placebo (children), Outcome 12 Speed.

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Analysis 3.13

Comparison 3 Ascorbic acid vs placebo (children), Outcome 13 Cadence.

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Analysis 3.14

Comparison 3 Ascorbic acid vs placebo (children), Outcome 14 Step time.

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Analysis 3.15

Comparison 3 Ascorbic acid vs placebo (children), Outcome 15 Step length.

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Analysis 3.16

Comparison 3 Ascorbic acid vs placebo (children), Outcome 16 Stride length.

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Ascorbic acid treatment compared with placebo for CMT1A in adults
Participants or population: adults with CMT1A Intervention: oral ascorbic acid (1 g to 4 g/day) Comparison: placebo
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Placebo	Ascorbic acid
Impairment ‐ change in CMTNS at 24 months (0 to 36 points)	The mean change in CMTNS ranged across control groups from ‐0.92 to 1 point	The mean change in CMTNS in the intervention groups was 0.21 lower (0.81 lower to 0.39 higher)	‐0.21 (‐0.81 to 0.39)	388 (3)	⊕⊕⊕⊕ high
Impairment ‐ change in CMTES at 24 months (0 to 28 points)	The mean change in CMTES ranged across control groups from ‐0.64 to 0.5 point	The mean change in CMTES in the intervention groups was 0.12 lower (0.67 lower to 0.42 higher)	‐0.12 (‐0.67 to 0.42)	337 (2)	⊕⊕⊕⊝ moderate¹
Change in timed 10‐m walk at 12 months (seconds (s))	The mean change in timed 10‐m walk ranged across control groups from ‐0.15 to 0.56 s	The mean change in timed 10‐m walk in the intervention groups was 0.02 lower (0.32 lower to 0.29 lower)	‐0.02 (‐0.32 to 0.29)	401 (3)	⊕⊕⊕⊕ high
Change in foot dorsiflexion at 12 months (N)	The mean change in foot dorsiflexion force ranged across control groups from ‐5.1 to 3 N	The mean change in foot dorsiflexion force in the intervention groups was 1.1 higher (3.47 lower to 5.67 higher)	1.1 (‐3.47 to 5.67)	423 (4)	⊕⊕⊕⊕ high
Change in 9‐hole peg test (HPT) at 12 months (seconds)	The mean change in 9‐HPT ranged across control groups from ‐3.5 to 0.43 s	The mean change in 9‐HPT in the intervention groups was 0.39 lower (0.76 lower to 0.02 lower)	‐0.39 (‐0.76 to ‐0.02)	286 (3)	⊕⊕⊕⊝ moderate¹
Serious adverse events (SAE; %)	The relative abundance of SAE was 12% in the placebo group ((number of SAE/number of participants)*100)	The relative abundance of SAE was 11.7% in the intervention groups ((number of SAE/number of participants)*100)	Not estimable	702 (6, including 1 study in children)	⊕⊕⊕⊕ high
The assumed risk* is based on the mean change or the range of mean change) across control groups in included studies.. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). Key: 10‐m walk: 10‐metre walk; 9‐HPT: 9‐hole‐peg test; CMTES: CMT examination scale; CMTNS: CMT neuropathy scale; CI: confidence interval; RR: risk ratio; N: Newton; SAE: Serious adverse event
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ Evidence downgraded because of number of studies and participants, which was lower than for other outcomes. Further research may thus have an impact on our confidence in the estimate of effect and may change the estimate.

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Comparison 1. Ascorbic acid versus placebo 12 months (adults)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Impairment ‐ CMTNS (scale 0 to 36 points) Show forest plot	5	533	Mean Difference (IV, Fixed, 95% CI)	‐0.37 [‐0.83, 0.09]

2 Impairment ‐ CMTES (scale 0 to 28 points) Show forest plot	3	460	Mean Difference (IV, Fixed, 95% CI)	‐0.15 [‐0.57, 0.27]

3 Impairment ‐ NIS (scale ‐26 to 26 points) Show forest plot	1	110	Mean Difference (IV, Fixed, 95% CI)	1.91 [‐2.24, 6.06]

4 Disability ‐ ODSS (scale 0 to 12 points) Show forest plot	2	134	Mean Difference (IV, Fixed, 95% CI)	‐0.09 [‐0.36, 0.18]

5 Disability ‐ ONLS (scale 0 to 12 points) Show forest plot	2	289	Mean Difference (IV, Fixed, 95% CI)	0.07 [‐0.02, 0.17]

6 Disability ‐ ALDS (scale 0 to 100 points) Show forest plot	1	11	Mean Difference (IV, Fixed, 95% CI)	‐1.3 [‐4.28, 1.68]

7 CMAP, ulnar nerve (abductor digiti minimi) Show forest plot	2	161	Mean Difference (IV, Fixed, 95% CI)	0.13 [‐0.34, 0.59]

8 CMAP, median nerve (abductor pollicis brevis) Show forest plot	1	11	Mean Difference (IV, Fixed, 95% CI)	‐0.18 [‐1.19, 0.83]

9 CMAP summatory from ulnar, median and peroneal nerves Show forest plot	1	217	Mean Difference (IV, Fixed, 95% CI)	0.23 [‐0.48, 0.94]

10 Sensation ‐ INCAT Sensory Sum score (scale 0 to 20 points) Show forest plot	1	10	Mean Difference (IV, Fixed, 95% CI)	‐2.0 [‐5.53, 1.53]

11 SNAP amplitude Show forest plot	1	123	Mean Difference (IV, Fixed, 95% CI)	0.0 [‐0.42, 0.42]

12 Hand grip Show forest plot	3	412	Mean Difference (IV, Fixed, 95% CI)	1.39 [‐4.17, 6.95]

13 Three‐point pinch Show forest plot	3	300	Mean Difference (IV, Fixed, 95% CI)	0.60 [‐1.53, 2.73]

14 Foot dorsiflexion Show forest plot	4	423	Mean Difference (IV, Fixed, 95% CI)	1.10 [‐3.47, 5.67]

15 Quality of life ‐ SF36 ‐ physical functioning Show forest plot	4	522	Mean Difference (IV, Fixed, 95% CI)	‐0.05 [‐1.32, 1.22]

16 Quality of life ‐ SF36 ‐ bodily pain Show forest plot	3	401	Mean Difference (IV, Fixed, 95% CI)	‐0.53 [‐2.69, 1.62]

17 Quality of life ‐ SF36 ‐ energy Show forest plot	2	291	Mean Difference (IV, Fixed, 95% CI)	0.45 [‐2.84, 3.74]

18 Quality of life ‐ SF36 ‐ psychological Show forest plot	1	123	Mean Difference (IV, Fixed, 95% CI)	0.90 [‐2.65, 4.45]

19 Quality of life ‐ SF36 ‐ MCS Show forest plot	1	110	Mean Difference (IV, Fixed, 95% CI)	0.46 [‐3.80, 4.72]

20 Quality of life ‐ SF36 ‐ PCS Show forest plot	1	110	Mean Difference (IV, Fixed, 95% CI)	0.39 [‐2.98, 3.76]

21 9‐hole peg test Show forest plot	3	286	Mean Difference (IV, Fixed, 95% CI)	‐0.39 [‐0.76, ‐0.02]

22 Timed 10 m walk Show forest plot	3	401	Mean Difference (IV, Fixed, 95% CI)	‐0.02 [‐0.32, 0.29]

23 50 m walk Show forest plot	1	11	Mean Difference (IV, Fixed, 95% CI)	‐0.30 [‐2.49, 1.89]

Comparison 1. Ascorbic acid versus placebo 12 months (adults)

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Comparison 2. Ascorbic acid versus placebo 24 months (adults)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Impairment ‐ CMTNS (scale 0 to 36 points) Show forest plot	3	388	Mean Difference (IV, Fixed, 95% CI)	‐0.21 [‐0.81, 0.39]

2 Impairment ‐ CMTES (scale 0 to 28 points) Show forest plot	2	337	Mean Difference (IV, Fixed, 95% CI)	‐0.12 [‐0.67, 0.42]

3 Disability ‐ ONLS (scale 0 to 12 points) Show forest plot	2	276	Mean Difference (IV, Fixed, 95% CI)	0.14 [‐0.05, 0.34]

4 CMAP, ulnar nerve (abductor digiti minimi) Show forest plot	2	161	Mean Difference (IV, Fixed, 95% CI)	0.06 [‐0.10, 0.23]

5 Hand grip Show forest plot	2	186	Mean Difference (IV, Fixed, 95% CI)	1.25 [‐3.86, 6.37]

6 Three‐point pinch Show forest plot	2	276	Mean Difference (IV, Fixed, 95% CI)	0.73 [‐3.62, 5.08]

7 Foot dorsiflexion Show forest plot	2	278	Mean Difference (IV, Fixed, 95% CI)	0.77 [‐7.21, 8.76]

8 Quality of life ‐ SF36 ‐ physical functioning Show forest plot	3	382	Mean Difference (IV, Fixed, 95% CI)	‐0.07 [‐2.41, 2.26]

9 Quality of life ‐ SF36 ‐ bodily pain Show forest plot	3	385	Mean Difference (IV, Fixed, 95% CI)	‐1.57 [‐4.93, 1.80]

10 Quality of life ‐ SF36 ‐ energy Show forest plot	2	267	Mean Difference (IV, Fixed, 95% CI)	0.71 [‐3.35, 4.77]

11 9‐hole peg test Show forest plot	2	275	Mean Difference (IV, Fixed, 95% CI)	‐1.16 [‐1.96, ‐0.37]

12 Timed 10 m walk Show forest plot	2	278	Mean Difference (IV, Fixed, 95% CI)	0.09 [‐0.64, 0.82]

13 PMP22 mRNA (skin biopsy) Show forest plot	2	114	Mean Difference (IV, Fixed, 95% CI)	‐0.05 [‐0.13, 0.03]

Comparison 2. Ascorbic acid versus placebo 24 months (adults)

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Comparison 3. Ascorbic acid vs placebo (children)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 CMAP amplitude (M. abductor pollicis brevis) Show forest plot	1	80	Mean Difference (IV, Fixed, 95% CI)	0.30 [‐0.75, 1.35]

2 Hand grip Show forest plot	1	80	Mean Difference (IV, Fixed, 95% CI)	9.80 [‐18.10, 37.70]

3 Finger pinch Show forest plot	1	80	Mean Difference (IV, Fixed, 95% CI)	1.60 [‐1.84, 5.04]

4 Foot dorsiflexion Show forest plot	1	80	Mean Difference (IV, Fixed, 95% CI)	‐1.0 [‐11.90, 9.90]

5 Foot plantar flexion Show forest plot	1	80	Mean Difference (IV, Fixed, 95% CI)	‐10.20 [‐36.29, 15.89]

6 Median nerve motor conduction velocity Show forest plot	1	80	Mean Difference (IV, Fixed, 95% CI)	2.0 [‐0.89, 4.89]

7 9‐hole peg test Show forest plot	1	78	Mean Difference (IV, Fixed, 95% CI)	‐0.80 [‐2.85, 1.25]

8 6 min walk Show forest plot	1	65	Mean Difference (IV, Fixed, 95% CI)	‐3.0 [‐32.34, 26.34]

9 Balance Show forest plot	1	74	Mean Difference (IV, Fixed, 95% CI)	‐1.30 [‐4.62, 2.02]

10 Agility Show forest plot	1	72	Mean Difference (IV, Fixed, 95% CI)	‐1.70 [‐5.43, 2.03]

11 Long jump Show forest plot	1	72	Mean Difference (IV, Fixed, 95% CI)	2.20 [‐11.10, 15.50]

12 Speed Show forest plot	1	53	Mean Difference (IV, Fixed, 95% CI)	‐0.20 [‐9.33, 8.93]

13 Cadence Show forest plot	1	53	Mean Difference (IV, Fixed, 95% CI)	0.80 [‐6.54, 8.14]

14 Step time Show forest plot	1	53	Mean Difference (IV, Fixed, 95% CI)	0.0 [‐0.05, 0.05]

15 Step length Show forest plot	1	53	Mean Difference (IV, Fixed, 95% CI)	‐0.90 [‐4.97, 3.17]

16 Stride length Show forest plot	1	53	Mean Difference (IV, Fixed, 95% CI)	‐1.80 [‐9.58, 5.98]

Comparison 3. Ascorbic acid vs placebo (children)

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