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Study flow diagram.
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Figure 1

Study flow diagram.

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'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 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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'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
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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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Comparison 1 Pyridoxal 5 phosphate (Vitamin B6) versus placebo, Outcome 1 Global: Clinical efficacy ‐ significant reduction in ESRS scores from baseline.
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Analysis 1.1

Comparison 1 Pyridoxal 5 phosphate (Vitamin B6) versus placebo, Outcome 1 Global: Clinical efficacy ‐ significant reduction in ESRS scores from baseline.

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Study

Lerner 2001

400 mg daily

Lerner 2007

1200 mg daily

Miodownik 2003

400 mg daily

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Analysis 1.2

Comparison 1 Pyridoxal 5 phosphate (Vitamin B6) versus placebo, Outcome 2 Global 1. Average endpoint dose of pyridoxal 5 phosphate.

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Comparison 1 Pyridoxal 5 phosphate (Vitamin B6) versus placebo, Outcome 3 Global: 2. Other adverse effects than tardive dyskinesia.
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Analysis 1.3

Comparison 1 Pyridoxal 5 phosphate (Vitamin B6) versus placebo, Outcome 3 Global: 2. Other adverse effects than tardive dyskinesia.

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Comparison 1 Pyridoxal 5 phosphate (Vitamin B6) versus placebo, Outcome 4 Global: 3. Discontinuation of Vitamin B6.
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Analysis 1.4

Comparison 1 Pyridoxal 5 phosphate (Vitamin B6) versus placebo, Outcome 4 Global: 3. Discontinuation of Vitamin B6.

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Comparison 1 Pyridoxal 5 phosphate (Vitamin B6) versus placebo, Outcome 5 Tardive dyskinesia: 1. Deterioration in tardive dyskinesia symptoms.
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Analysis 1.5

Comparison 1 Pyridoxal 5 phosphate (Vitamin B6) versus placebo, Outcome 5 Tardive dyskinesia: 1. Deterioration in tardive dyskinesia symptoms.

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Comparison 1 Pyridoxal 5 phosphate (Vitamin B6) versus placebo, Outcome 6 Tardive dyskinesia: 2. Average endpoint ESRS tardive dyskinesia scores.
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Analysis 1.6

Comparison 1 Pyridoxal 5 phosphate (Vitamin B6) versus placebo, Outcome 6 Tardive dyskinesia: 2. Average endpoint ESRS tardive dyskinesia scores.

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Comparison 1 Pyridoxal 5 phosphate (Vitamin B6) versus placebo, Outcome 7 General Mental State: Average endpoint positive psychiatric symptoms score.
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Analysis 1.7

Comparison 1 Pyridoxal 5 phosphate (Vitamin B6) versus placebo, Outcome 7 General Mental State: Average endpoint positive psychiatric symptoms score.

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Comparison 1 Pyridoxal 5 phosphate (Vitamin B6) versus placebo, Outcome 8 General mental state: Average endpoint negative psychiatric symptoms score.
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Analysis 1.8

Comparison 1 Pyridoxal 5 phosphate (Vitamin B6) versus placebo, Outcome 8 General mental state: Average endpoint negative psychiatric symptoms score.

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Table 1. Possible design for a future study

Method

Allocation: randomised ‐ clearly described generation of sequence and concealment of allocation.
Blinding: double ‐ described and tested.
Duration: long term.
Setting: Inpatients and outpatients

Design: Single phase, longer study duration.

Participants

People with schizophrenia or schizophrenia‐like disorder.
N = Sample size obtained through power calculation.
Age: any
Sex: both

History: History of tardive dyskinesia, fulfilling diagnostic criteria for tardive dyskinesia, stable on antipsychotic medication for at least 3 months.

Intervention

1.Pyridoxal Phosphate (vitamin B6), any dose

2. Placebo

Outcomes

Tardive dyskinesia scores measured using AIMS (primary outcome)

Deterioration of tardive dyskinesia symptoms

Any other adverse effects

Discontinuation of pyridoxal phosphate (with reasons)

Psychiatric symptoms score using a standardised rating scale (PANSS, BPRS)

Pyridoxal phosphate dose

Plasma pyridoxal phosphate level

Quality of life

Satisfaction with care

AIMS: Abnormal Involuntary Movement Scale
BPRS: Brief Psychiatric Rating Scale
PANSS: Positve and Negative Scale of Schizophrenia

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Table 1. Possible design for a future study
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Summary of findings for the main comparison. Pyridoxal 5 phosphate (vitamin B6) compared with Placebo for neuroleptic‐induced tardive dyskinesia

Pyridoxal 5 phosphate (vitamin B6) compared with Placebo for neuroleptic‐induced tardive dyskinesia

Patient or population: patients with neuroleptic‐induced tardive dyskinesia
Settings: Inpatients
Intervention: Pyridoxal 5 phosphate (vitamin B6)
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

Pyridoxal 5 phosphate (vitamin B6)

Clinical efficacy ‐ improvement (> 40%) in ESRS scores from baseline
ESRS1
Follow‐up: mean 17.5 weeks2

Study population

RR 19.97
(2.87 to 139.19)

65
(2 studies)

⊕⊕⊝⊝
low3,4

0 per 1000

0 per 1000
(0 to 0)

Moderate

0 per 1000

0 per 1000
(0 to 0)

Global: Other adverse effects than tardive dyskinesia
Self‐report by participants
Follow‐up: mean 17.5 weeks2

Study population

RR 3.97
(0.2 to 78.59)

65
(2 studies)

⊕⊕⊝⊝
low3,4

0 per 1000

0 per 1000
(0 to 0)

Moderate

0 per 1000

0 per 1000
(0 to 0)

Global: Discontinuation of Vitamin B6
Follow‐up: mean 17.5 weeks2

Study population

RR 8.72
(0.51 to 149.75)

65
(2 studies)

⊕⊕⊝⊝
low3,4

0 per 1000

0 per 1000
(0 to 0)

Moderate

0 per 1000

0 per 1000
(0 to 0)

Tardive dyskinesia: Deterioration in tardive dyskinesia symptoms
ESRS1
Follow‐up: mean 17.5 weeks2

Study population

RR 0.16
(0.01 to 3.14)

65
(2 studies)

⊕⊕⊝⊝
low3,4

69 per 1000

11 per 1000
(1 to 217)

Moderate

46 per 1000

7 per 1000
(0 to 144)

General mental state: Positive psychiatric symptom score
PANSS5. Scale from: 7 to 49.
Follow‐up: 9 weeks

The mean general mental state: positive psychiatric symptom score in the control groups was
15.6

The mean general mental state: positive psychiatric symptom score in the intervention groups was
1.50 lower
(4.80 lower to 1.80 higher)

15
(1 study)

⊕⊕⊝⊝
low3,6

General mental state: Negative psychiatric symptoms
PANSS5. Scale from: 7 to 49.
Follow‐up: 9 weeks

The mean general mental state: negative psychiatric symptoms in the control groups was
14.6

The mean general mental state: negative psychiatric symptoms in the intervention groups was
1.10 lower
(5.92 lower to 3.72 higher)

15
(1 study)

⊕⊕⊝⊝
low3,6

*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).
CI: Confidence interval; RR: Risk ratio;

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 Extrapyramidal Symptom Rating Scale (high scores = worse)
2 Study duration: 9 weeks and 26 weeks respectively for the two included studies
3 Adequate description of randomisation methods was not provided. Methods for allocation concealment and blinding were not described.
4 The included studies have small sample sizes
5 Positive and Negative Symptoms Scale (high scores = worse)
6 Study has a small sample size

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Summary of findings for the main comparison. Pyridoxal 5 phosphate (vitamin B6) compared with Placebo for neuroleptic‐induced tardive dyskinesia
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Comparison 1. Pyridoxal 5 phosphate (Vitamin B6) versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Global: Clinical efficacy ‐ significant reduction in ESRS scores from baseline Show forest plot

2

65

Risk Ratio (M‐H, Fixed, 95% CI)

19.97 [2.87, 139.19]

2 Global 1. Average endpoint dose of pyridoxal 5 phosphate Show forest plot

Other data

No numeric data

3 Global: 2. Other adverse effects than tardive dyskinesia Show forest plot

2

65

Risk Ratio (M‐H, Fixed, 95% CI)

3.97 [0.20, 78.59]

4 Global: 3. Discontinuation of Vitamin B6 Show forest plot

2

65

Risk Ratio (M‐H, Fixed, 95% CI)

8.72 [0.51, 149.75]

5 Tardive dyskinesia: 1. Deterioration in tardive dyskinesia symptoms Show forest plot

2

65

Risk Ratio (M‐H, Fixed, 95% CI)

0.16 [0.01, 3.14]

6 Tardive dyskinesia: 2. Average endpoint ESRS tardive dyskinesia scores Show forest plot

2

60

Mean Difference (IV, Fixed, 95% CI)

‐4.07 [‐6.36, ‐1.79]

7 General Mental State: Average endpoint positive psychiatric symptoms score Show forest plot

1

15

Mean Difference (IV, Fixed, 95% CI)

‐1.50 [‐4.80, 1.80]

8 General mental state: Average endpoint negative psychiatric symptoms score Show forest plot

1

15

Mean Difference (IV, Fixed, 95% CI)

‐1.10 [‐5.92, 3.72]
Figures and Tables -
Comparison 1. Pyridoxal 5 phosphate (Vitamin B6) versus placebo
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