Pharmacological treatment for memory disorder in multiple sclerosis

Dian He; Yun Zhang; Shuai Dong; Dongfeng Wang; Xiangdong Gao; Hongyu Zhou

doi:10.1002/14651858.CD008876.pub3

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3

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

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Figure 4

Efficacy on the primary outcomes reported in each study.

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Analysis 1.1

Comparison 1 Subgroup analysis for donepezil versus placebo, Outcome 1 The mean change of total recall on the Selective Reminding Test (SRT) from baseline.

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Analysis 1.2

Comparison 1 Subgroup analysis for donepezil versus placebo, Outcome 2 The mean total recall on the Selective Reminding Test (SRT) at exit.

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Analysis 1.3

Comparison 1 Subgroup analysis for donepezil versus placebo, Outcome 3 The mean change of total correct score on the 10/36 Spatial Recall Test (10/36 SRT) from baseline.

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Analysis 1.4

Comparison 1 Subgroup analysis for donepezil versus placebo, Outcome 4 The mean total correct score on the 10/36 Spatial Recall Test (10/36 SRT) at exit.

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Analysis 1.5

Comparison 1 Subgroup analysis for donepezil versus placebo, Outcome 5 The mean change of total correct score on the Symbol Digit Modalities Test (SDMT) from baseline.

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Analysis 1.6

Comparison 1 Subgroup analysis for donepezil versus placebo, Outcome 6 The mean total correct score on the Symbol Digit Modalities Test (SDMT) at exit.

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Analysis 1.7

Comparison 1 Subgroup analysis for donepezil versus placebo, Outcome 7 The mean change of total correct score on the Paced Auditory Serial Addition Test (PASAT) (2+3 sec) from baseline.

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Analysis 1.8

Comparison 1 Subgroup analysis for donepezil versus placebo, Outcome 8 The mean total correct score on the Paced Auditory Serial Addition Test (PASAT) (2+3 sec) at exit.

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Analysis 1.9

Comparison 1 Subgroup analysis for donepezil versus placebo, Outcome 9 The number of patients experiencing diarrhoea.

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Analysis 1.10

Comparison 1 Subgroup analysis for donepezil versus placebo, Outcome 10 The number of patients experiencing diarrhoea.

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Analysis 1.11

Comparison 1 Subgroup analysis for donepezil versus placebo, Outcome 11 The number of patients experiencing nausea.

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Analysis 1.12

Comparison 1 Subgroup analysis for donepezil versus placebo, Outcome 12 The number of patients experiencing nausea.

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Analysis 1.13

Comparison 1 Subgroup analysis for donepezil versus placebo, Outcome 13 The number of patients experiencing abnormal dreams.

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Analysis 1.14

Comparison 1 Subgroup analysis for donepezil versus placebo, Outcome 14 The number of patients experiencing abnormal dreams.

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Summary of findings for the main comparison. Donepezil for memory disorder in multiple sclerosis

Donepezil for memory disorder in multiple sclerosis
Patient or population: Patients with memory disorder in multiple sclerosis Settings: USA Intervention: Donepezil
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Donepezil
The mean change of total recall on the SRT from baseline Scale from: 0 to 72 Follow‐up: median 24 weeks	The mean change of total recall on the SRT from baseline ranged across control groups from 0.7 to 1.7	The mean change of total recall on the SRT from baseline in the intervention groups was 1.68 higher (2.21 lower to 5.58 higher)	‐	189 (2 studies)	⊕⊕⊕⊝ moderate¹	‐
The mean change of total correct score on the 10/36 SRT from baseline Scale from: 0 to 40 Follow‐up: median 24 weeks	The mean change of total correct score on the 10/36 SRT from baseline ranged across control groups from 1.2 to 16	The mean change of total correct score on the 10/36 SRT from baseline in the intervention groups was 0.93 lower (3.18 lower to 1.32 higher)	‐	189 (2 studies)	⊕⊕⊕⊝ moderate¹	‐
The mean change of total correct score on the SDMT from baseline Scale from: 0 to infinity Follow‐up: median 24 weeks	The mean change of total correct score on the SDMT from baseline in the control groups was 2	The mean change of total correct score on the SDMT from baseline in the intervention groups was 1.27 lower (3.15 lower to 0.61 higher)	‐	189 (2 studies)	⊕⊕⊕⊝ moderate¹	‐
The mean change of total correct score on the PASAT (2+3 sec) from baseline Scale from: 0 to 120 Follow‐up: median 24 weeks	The mean change of total correct score on the PASAT (2+3 sec) from baseline ranged across control groups from 0.8 to 3.5	The mean change of total correct score on the PASAT (2+3 sec) from baseline in the intervention groups was 2.23 higher (1.87 lower to 6.33 higher)	‐	189 (2 studies)	⊕⊕⊕⊝ moderate¹	‐
The number of patients experiencing diarrhoea Follow‐up: median 24 weeks	Low		RR 3.88 (1.66 to 9.05)	189 (2 studies)	⊕⊕⊕⊝ moderate¹	‐
	65 per 1000	252 per 1000 (108 to 588)
The number of patients experiencing nausea Follow‐up: median 24 weeks	Low		RR 1.71 (0.93 to 3.18)	189 (2 studies)	⊕⊕⊕⊝ moderate¹	‐
	140 per 1000	239 per 1000 (130 to 445)
The number of patients experiencing abnormal dreams Follow‐up: median 24 weeks	Low		RR 2.91 (1.38 to 6.14)	189 (2 studies)	⊕⊕⊕⊝ moderate¹	‐
	86 per 1000	250 per 1000 (119 to 528)
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. 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). 10/36 SRT: 10/36 Spatial Recall Test;CI: confidence interval; PASAT: Paced Auditory Serial Addition Test;RR: risk ratio; SDMT: Symbol Digit Modalities Test; SRT: Selective Reminding Test;
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 Both studies had a small sample size and a power of test lower than 80%.

Summary of findings for the main comparison. Donepezil for memory disorder in multiple sclerosis

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Table 1. Data of the primary outcomes reported in each study

Study	Primary outcomes	Groups	Number	Pre mean values at baseline	Post mean values at exit	The mean change from baseline	Mean difference (95% CI) between groups	P value	Notes
Krupp 2004	Total recall on SRT	Donepezil	35	42.3 ± 9.0	46.8 ± 9.3	4.6 ± 9.1	3.9 (0.13 to 7.66)*	0.043	Mean ± SD *exit‐baseline difference
Krupp 2004	Total recall on SRT	Placebo	34	42.7 ± 8.8	43.2 ± 9.2	0.7 ± 6.3	3.9 (0.13 to 7.66)*	0.043	Mean ± SD *exit‐baseline difference
Krupp 2011	Total recall on SRT	Donepezil	61	38.0 ± 8.7 (35.7 to 40.2)	39.6 ± 8.7 (37.4 to 41.8)	1.6 ± 7.5 (0.3 to 3.6)	0.54*	‐	Mean ± SD (95% CI) *exit‐baseline difference
Krupp 2011	Total recall on SRT	Placebo	59	36.0 ± 9.8 (33.5 to 38.6)	37.7 ± 11.5 (34.7 to 40.7)	1.7 ± 7.2 (0.2 to 3.6)	0.54*	‐	Mean ± SD (95% CI) *exit‐baseline difference
Lovera 2007	LDFR on CVLT‐II	GB	20	9.4 ± 1.0	8.9 ± 0.7	‐	‐1.2 (‐3.2 to 0.8)*	‐	Mean ± SEM *Exit group difference
	LDFR on CVLT‐II	Placebo	19	10.2 ± 0.7	10.1 ± 0.7	‐	‐1.2 (‐3.2 to 0.8)*	‐
	SDMT	GB	20	47.7 ± 2.8	43.4 ± 1.3	‐	‐0.8 (‐3.0 to 4.6)*	‐
	SDMT	Placebo	19	45.4 ± 2.8	44.1 ± 1.3	‐	‐0.8 (‐3.0 to 4.6)*	‐
	PASAT	GB	20	42.4 ± 3.1	48.9 ± 1.1	‐	1.1 (‐3.1 to 4.2)*	‐
	PASAT	Placebo	19	43.9 ± 3.0	47.8 ± 1.1	‐	1.1 (‐3.1 to 4.2)*	‐
Lovera 2010	LDFR on CVLT‐II	Memantine	54	‐	‐	0.9 (‐0.3 to 2)	‐0.6 (‐2 to 0.8)*	0.4	Mean change (95% CI) *Exit‐baseline difference
	LDFR on CVLT‐II	Placebo	65	‐	‐	0.2 (‐0.9 to 1.3)	‐0.6 (‐2 to 0.8)*	0.4
	PASAT	Memantine	54	‐	‐	3.6 (0.7 to 6.4)	‐0.0 (‐3.3 to 3.4)*	0.9
	PASAT	Placebo	65	‐	‐	3.6 (0.9 to 6.3)	‐0.0 (‐3.3 to 3.4)*	0.9
Lovera 2012	LDFR on CVLT‐II	GB	61	‐0.5 ± 1.2	‐0.4 ± 1.2	‐	0.0 (‐0.3 to 0.3)*	‐	z‐scores, mean ± SD *Exit group difference, mean (95% CI)
	LDFR on CVLT‐II	Placebo	59	‐0.5 ± 1.2	‐0.4 ± 1.2	‐	0.0 (‐0.3 to 0.3)*	‐
	PASAT	GB	61	‐1.4 ± 0.8	‐1.3 ± 0.9	‐	‐0.2 (‐0.5 to 0.1)*	‐
	PASAT	Placebo	59	‐1.2 ± 0.9	‐1.0 ± 1.1	‐	‐0.2 (‐0.5 to 0.1)*	‐
Mäurer 2013	Total recall on SRT	Rivastigmine	43	43.93 ± 10.67	‐	1.35*	(‐5.8 to 1.6)	0.2576	**Exit‐baseline difference of adjusted LS‐means
Mäurer 2013	Total recall on SRT	Placebo	38	48.21 ± 10.32	‐	‐0.76*	(‐5.8 to 1.6)	0.2576	**Exit‐baseline difference of adjusted LS‐means
Shaygannejad 2008	WMS	Rivastigmine	30	60.0 ± 4.2	64.9 ± 5.3	4.9 (3.8 to 6.0)	0.4 (‐0.2 to 2.8)*	‐	Mean ± SD *Exit group difference
	WMS	Placebo	30	60.5 ± 4.9	64.5 ± 3.7	4.0 (3.0 to 5.0)	0.4 (‐0.2 to 2.8)*	‐
	Logical Memory	Rivastigmine	30	16.1 ± 1.8	18.0 ± 2.0	1.9 (1.4 to 2.4)	1.6 (0.4 to 2.8)*	‐
	Logical Memory	Placebo	30	15.2 ± 2.5	16.4 ± 2.5	1.2 (0.7 to 1.7)	1.6 (0.4 to 2.8)*	‐
	Digit Span	Rivastigmine	30	4.6 ± 0.7	4.6 ± 0.7	0.0 (‐0.3 to 0.3)	‐1.3 (‐1.7 to ‐0.9)*	‐
	Digit Span	Placebo	30	5.5 ± 1.0	5.9 ± 0.9	0.4 (0.2 to 0.5)	‐1.3 (‐1.7 to ‐0.9)*	‐
CI: confidence interval; CVLT‐II: California Verbal Learning Test II; GB: Ginkgo biloba; LDFR: Long Delay Free Recall; LS: least square; PASAT: Paced Auditory Serial Addition Test; SD: standard deviation; SDMT: Symbol‐Digit Modalities Test; SEM: standard error of the mean; SRT: Selective Reminding Test; WMS: Wechsler Memory Scale.

Table 1. Data of the primary outcomes reported in each study

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Comparison 1. Subgroup analysis for donepezil versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 The mean change of total recall on the Selective Reminding Test (SRT) from baseline Show forest plot	2	189	Mean Difference (IV, Random, 95% CI)	1.68 [‐2.21, 5.58]

2 The mean total recall on the Selective Reminding Test (SRT) at exit Show forest plot	2	189	Mean Difference (IV, Random, 95% CI)	1.23 [‐3.07, 5.53]

3 The mean change of total correct score on the 10/36 Spatial Recall Test (10/36 SRT) from baseline Show forest plot	2	189	Mean Difference (IV, Random, 95% CI)	‐0.93 [‐3.18, 1.32]

4 The mean total correct score on the 10/36 Spatial Recall Test (10/36 SRT) at exit Show forest plot	2	189	Mean Difference (IV, Random, 95% CI)	0.29 [‐2.64, 3.23]

5 The mean change of total correct score on the Symbol Digit Modalities Test (SDMT) from baseline Show forest plot	2	189	Mean Difference (IV, Fixed, 95% CI)	‐1.27 [‐3.15, 0.61]

6 The mean total correct score on the Symbol Digit Modalities Test (SDMT) at exit Show forest plot	2	189	Mean Difference (IV, Fixed, 95% CI)	1.15 [‐2.71, 5.01]

7 The mean change of total correct score on the Paced Auditory Serial Addition Test (PASAT) (2+3 sec) from baseline Show forest plot	2	189	Mean Difference (IV, Random, 95% CI)	2.23 [‐1.87, 6.33]

8 The mean total correct score on the Paced Auditory Serial Addition Test (PASAT) (2+3 sec) at exit Show forest plot	2	189	Mean Difference (IV, Fixed, 95% CI)	5.41 [‐1.42, 12.23]

9 The number of patients experiencing diarrhoea Show forest plot	2	189	Risk Ratio (M‐H, Fixed, 95% CI)	3.88 [1.66, 9.05]

10 The number of patients experiencing diarrhoea Show forest plot	2	189	Odds Ratio (M‐H, Fixed, 95% CI)	4.84 [1.87, 12.51]

11 The number of patients experiencing nausea Show forest plot	2	189	Risk Ratio (M‐H, Fixed, 95% CI)	1.71 [0.93, 3.18]

12 The number of patients experiencing nausea Show forest plot	2	189	Odds Ratio (M‐H, Fixed, 95% CI)	1.94 [0.92, 4.12]

13 The number of patients experiencing abnormal dreams Show forest plot	2	189	Risk Ratio (M‐H, Fixed, 95% CI)	2.91 [1.38, 6.14]

14 The number of patients experiencing abnormal dreams Show forest plot	2	189	Odds Ratio (M‐H, Fixed, 95% CI)	3.55 [1.50, 8.37]

Comparison 1. Subgroup analysis for donepezil versus placebo

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