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Message from one of the participants of the public and patient involvement consultation of service user perspectives on tardive dyskinesia research.
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Figure 1

Message from one of the participants of the public and patient involvement consultation of service user perspectives on tardive dyskinesia research.

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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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Study flow diagram.
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Figure 4

Study flow diagram.

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Reference for the AMS scale used in Xiang 1997
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Figure 5

Reference for the AMS scale used in Xiang 1997

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Comparison 1 Benzodiazepines versus placebo/treatment as usual (TAU), Outcome 1 Tardive dyskinesia (TD) symptoms: no clinically important improvement (> 50% improvement on any TD scale).
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Analysis 1.1

Comparison 1 Benzodiazepines versus placebo/treatment as usual (TAU), Outcome 1 Tardive dyskinesia (TD) symptoms: no clinically important improvement (> 50% improvement on any TD scale).

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Comparison 1 Benzodiazepines versus placebo/treatment as usual (TAU), Outcome 2 TD symptoms: not any improvement.
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Analysis 1.2

Comparison 1 Benzodiazepines versus placebo/treatment as usual (TAU), Outcome 2 TD symptoms: not any improvement.

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Comparison 1 Benzodiazepines versus placebo/treatment as usual (TAU), Outcome 3 TD symptoms: deterioration.
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Analysis 1.3

Comparison 1 Benzodiazepines versus placebo/treatment as usual (TAU), Outcome 3 TD symptoms: deterioration.

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Comparison 1 Benzodiazepines versus placebo/treatment as usual (TAU), Outcome 4 TD symptoms: mean TD score at the end of treatment.
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Analysis 1.4

Comparison 1 Benzodiazepines versus placebo/treatment as usual (TAU), Outcome 4 TD symptoms: mean TD score at the end of treatment.

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Comparison 1 Benzodiazepines versus placebo/treatment as usual (TAU), Outcome 5 Mental state: mean score at the end of treatment (Brief Psychiatric Rating Scale (BPRS), low = best).
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Analysis 1.5

Comparison 1 Benzodiazepines versus placebo/treatment as usual (TAU), Outcome 5 Mental state: mean score at the end of treatment (Brief Psychiatric Rating Scale (BPRS), low = best).

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Comparison 1 Benzodiazepines versus placebo/treatment as usual (TAU), Outcome 6 Leaving the study early.
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Analysis 1.6

Comparison 1 Benzodiazepines versus placebo/treatment as usual (TAU), Outcome 6 Leaving the study early.

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Comparison 2 Benzodiazepines vs other compounds, Outcome 1 Tardive dyskinesia (TD) symptoms: no clinically important improvement (> 50% improvement on any TD scale) ‐ short term.
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Analysis 2.1

Comparison 2 Benzodiazepines vs other compounds, Outcome 1 Tardive dyskinesia (TD) symptoms: no clinically important improvement (> 50% improvement on any TD scale) ‐ short term.

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Comparison 2 Benzodiazepines vs other compounds, Outcome 2 TD symptoms: not any improvement ‐ short term.
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Analysis 2.2

Comparison 2 Benzodiazepines vs other compounds, Outcome 2 TD symptoms: not any improvement ‐ short term.

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Comparison 2 Benzodiazepines vs other compounds, Outcome 3 Adverse events: any adverse events ‐ short term.
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Analysis 2.3

Comparison 2 Benzodiazepines vs other compounds, Outcome 3 Adverse events: any adverse events ‐ short term.

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Comparison 2 Benzodiazepines vs other compounds, Outcome 4 Leaving the study early ‐ short term.
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Analysis 2.4

Comparison 2 Benzodiazepines vs other compounds, Outcome 4 Leaving the study early ‐ short term.

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Table 2. Reviews suggested by excluded studies

Study tag

Participants

Comparison

Review

Petit 1994

Antipsychotic‐induced akathisia

Clonazepam vs placebo

Benzodiazepines for neuroleptic‐induced acute akathisia.

Sachdev 1993

Benztropine vs propranolol

Anticholinergics for neuroleptic‐induced acute akathisia; Central action beta‐blockers versus placebo for neuroleptic‐induced acute akathisia.

Wang 2000

Benzodiazepines vs artane (trihexyphenidyl hydrochloride).

Benzodiazepines for neuroleptic‐induced acute akathisia; Anticholinergics for neuroleptic‐induced acute akathisia.

Wonodi 2004

Antipsychotic‐induced tardive dyskinesia

Naltrexone vs placebo

Miscellaneous treatments for neuroleptic‐induced tardive dyskinesia.

Naltrexone + clonazepam vs clonazepam + placebo
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Table 2. Reviews suggested by excluded studies
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Table 3. PICO table

Methods

Allocation: randomised.
Blinding: double.
Duration: minimum 6 months.
Setting: hospital/community, high‐/middle‐/low‐income country.

Participants

Diagnosis: serious mental illness treated by antipsychotic drugs for a protracted period. Tardive dyskinesia.a
n > 300 (sufficient power to highlight 10% difference between groups).
Age: 18‐65 years.
Sex: men and women.

Interventions

1. Clonazepam 6‐12 mg oral daily dose.
2. Placebo.

Outcomes

Tardive dyskinesia: any clinically important improvement in tardive dyskinesia, any improvement, deterioration.b
Adverse effects: no clinically significant extrapyramidal adverse effects ‐ any time period,b use of any antiparkinsonism drugs, other important adverse events.
Leaving study early.
Service outcomes: admitted, number of admissions, length of hospitalisation, contacts with psychiatric services.
Compliance with drugs.
Economic evaluations: cost‐effectiveness, cost‐benefit.
General state: relapse, frequency, and intensity of minor and major exacerbations.
Social confidence, social inclusion, social networks, or personalised quality of life: binary measure.
Distress among relatives: binary measure.
Burden on family: binary measure.

aThis could be diagnosed by clinical decision. If funds were permitting all participants could be screened using operational criteria, otherwise a random sample should suffice.

bPrimary outcome. The same applies to the measure of primary outcome as for diagnosis. Not everyone may need to have operational criteria applied if clinical impression is proved to be accurate.

n: number of participants.
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Table 3. PICO table
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Summary of findings for the main comparison. Benzodiazepines compared with placebo for antipsychotic‐induced tardive dyskinesia

Benzodiazepines compared with placebo for antipsychotic‐induced tardive dyskinesia

Patient or population: psychiatric patients (mainly schizophrenia) with antipsychotic‐induced tardive dyskinesia
Setting: inpatients and outpatients in China (1 study) and the USA (3 studies)
Intervention: benzodiazepines (clonazepam, diazepam)
Comparison: placebo/no treatment

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with placebo/no treatment

Risk with benzodiazepines

Tardive dyskinesia: no clinically important improvement
Follow‐up: 5‐10 weeks

Study population

RR 1.12
(0.60 to 2.09)

32
(2 RCTs)

⊕⊝⊝⊝
Very low1,2

‐

545 per 1000

611 per 1000
(327 to 1000)

Tardive dyskinesia: deterioration in symptoms
Follow‐up: 5‐10 weeks

Study population

RR 1.48
(0.22 to 9.82)

30
(2 RCTs)

⊕⊝⊝⊝
Very low1,2

‐

91 per 1000

135 per 1000
(20 to 893)

Adverse effect: any adverse event

None of the included studies reported on these outcomes.

Adverse effect: no clinically significant extrapyramidal adverse effects

Acceptability of the treatment (measured by participants leaving the study early)
Follow‐up: 5‐10 weeks

Study population

RR 2.73
(0.15 to 48.04)

56
(3 RCTs)

⊕⊝⊝⊝
Very low1,2

‐

0 per 1000

0 per 1000
(0 to 0)

Social confidence, social inclusion, social networks, or personalised quality of life ‐ not reported

None of the included studies reported on this outcome.

*The risk in the intervention group (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; RCT: randomised controlled trial; RR: risk ratio.

GRADE Working Group grades of evidence
High quality: we are very confident that the true effect lies close to that of the estimate of the effect.
Moderate quality: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

1Downgraded one level for risk of bias: none of the studies adequately described randomisation procedure or allocation concealment, one study did not blind participants and personnel, and one study was a post hoc subgroup analysis of participants with tardive dyskinesia.

2Downgraded two levels for imprecision: small sample size, and 95% CI of effect estimate includes both appreciable benefit and appreciable harm for benzodiazepines.

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Summary of findings for the main comparison. Benzodiazepines compared with placebo for antipsychotic‐induced tardive dyskinesia
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Summary of findings 2. Benzodiazepines compared with phenobarbital (as active placebo) for antipsychotic‐induced tardive dyskinesia

Benzodiazepines compared with phenobarbital (as active placebo) for antipsychotic‐induced tardive dyskinesia

Patient or population: psychiatric patients (mainly schizophrenia) with antipsychotic‐induced tardive dyskinesia
Setting: inpatients and outpatients in the USA
Intervention: benzodiazepines (clonazepam)
Comparison: active placebo (phenobarbital)

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with phenobarbital (active placebo)

Risk with benzodiazepines

Tardive dyskinesia: no clinically important improvement
Follow‐up: 2 weeks

Study population

RR 0.44
(0.20 to 0.96)

21
(1 RCT)

⊕⊝⊝⊝
Very low1,2

‐

909 per 1000

400 per 1000
(182 to 873)

Tardive dyskinesia: deterioration in symptoms ‐ not measured

The included study did not report on this outcome.

Adverse events: any
Follow‐up: 2 weeks

Study population

RR 1.53
(0.97 to 2.41)

21
(1 RCT)

⊕⊝⊝⊝
Very low1,2

‐

636 per 1000

974 per 1000
(617 to 1000)

Adverse effect: extrapyramidal symptoms ‐ not reported

The included study did not report on this outcome.

Acceptability of the treatment (measured by participants leaving the study early)
Follow‐up: 2 weeks

Study population

Not estimable

21
(1 RCT)

⊕⊝⊝⊝
Very low1,2

No events were reported; no one left the study early.

0 per 1000

0 per 1000
(0 to 0)

Social confidence, social inclusion, social networks, or personalised quality of life ‐ not measured

The included study did not report on this outcome.

*The risk in the intervention group (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; RCT: randomised controlled trial; RR: risk ratio.

GRADE Working Group grades of evidence
High quality: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect
Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect

1Downgraded one level for risk of bias: the included study did not adequately describe randomisation procedure, allocation concealment, or blinding.

2Downgraded two levels for imprecision: only one study with a very small sample size.

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Summary of findings 2. Benzodiazepines compared with phenobarbital (as active placebo) for antipsychotic‐induced tardive dyskinesia
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Table 1. Other reviews in the series

Interventions

Reference

Anticholinergic medication

Soares‐Weiser 1997; Soares‐Weiser 2000; 2016 update to be published.

Benzodiazepines

This review.

Calcium channel blockers

Essali 2011; 2016 update to be published.

Cholinergic medication

Tammenmaa 2002; 2016 update to be published.

Gamma‐aminobutyric acid agonists

Alabed 2011; 2016 update to be published.

Miscellaneous treatments

Soares‐Weiser 2003; 2016 update to be published.

Neuroleptic reduction or cessation (or both) and neuroleptics

Soares‐Weiser 2006; 2016 update to be published.

Non‐neuroleptic catecholaminergic drugs

El‐Sayeh 2006; 2016 update to be published.

Vitamin E

Soares‐Weiser 2011; 2016 update to be published.

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Table 1. Other reviews in the series
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Comparison 1. Benzodiazepines versus placebo/treatment as usual (TAU)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Tardive dyskinesia (TD) symptoms: no clinically important improvement (> 50% improvement on any TD scale) Show forest plot

2

32

Risk Ratio (M‐H, Fixed, 95% CI)

1.12 [0.60, 2.09]

1.1 Diazepam vs placebo ‐ short term

1

17

Risk Ratio (M‐H, Fixed, 95% CI)

0.73 [0.24, 2.23]

1.2 Diazepam vs TAU ‐ medium term

1

15

Risk Ratio (M‐H, Fixed, 95% CI)

1.5 [0.71, 3.16]

2 TD symptoms: not any improvement Show forest plot

2

32

Risk Ratio (IV, Fixed, 95% CI)

1.49 [0.33, 6.74]

2.1 Diazepam vs placebo ‐ short term

1

17

Risk Ratio (IV, Fixed, 95% CI)

0.55 [0.04, 7.25]

2.2 Diazepam vs TAU ‐ medium term

1

15

Risk Ratio (IV, Fixed, 95% CI)

2.5 [0.39, 16.05]

3 TD symptoms: deterioration Show forest plot

2

30

Risk Ratio (IV, Fixed, 95% CI)

1.48 [0.22, 9.82]

3.1 Diazepam vs placebo ‐ short term

1

17

Risk Ratio (IV, Fixed, 95% CI)

0.55 [0.04, 7.25]

3.2 Diazepam vs TAU ‐ medium term

1

13

Risk Ratio (IV, Fixed, 95% CI)

4.67 [0.29, 75.02]

4 TD symptoms: mean TD score at the end of treatment Show forest plot

3

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

4.1 Diazepam vs placebo ‐ Gerlach Dyskinesia Scale (GDS) scores (idiopathic Parkinson's disease (IPD), greater = worse) ‐ short term

1

17

Mean Difference (IV, Fixed, 95% CI)

‐0.29 [‐1.57, 0.99]

4.2 Diazepam vs TAU ‐ Abnormal Involuntary Movement Scale (AIMS) scores (IPD, greater = worse) ‐ medium term

1

13

Mean Difference (IV, Fixed, 95% CI)

5.80 [0.49, 11.11]

4.3 Clonazepam vs placebo ‐ AIMS scores (IPD, greater = worse) ‐ medium term

1

24

Mean Difference (IV, Fixed, 95% CI)

‐3.22 [‐4.63, ‐1.81]

5 Mental state: mean score at the end of treatment (Brief Psychiatric Rating Scale (BPRS), low = best) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

5.1 Diazepam vs TAU ‐ medium term

1

11

Mean Difference (IV, Fixed, 95% CI)

‐0.5 [‐13.83, 12.83]

6 Leaving the study early Show forest plot

3

56

Risk Ratio (M‐H, Fixed, 95% CI)

2.73 [0.15, 48.04]

6.1 Clonazepam vs placebo ‐ medium term

1

24

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.2 Diazepam vs placebo ‐ short term

1

17

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.3 Diazepam vs TAU ‐ medium term

1

15

Risk Ratio (M‐H, Fixed, 95% CI)

2.73 [0.15, 48.04]
Figuras y tablas -
Comparison 1. Benzodiazepines versus placebo/treatment as usual (TAU)
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Comparison 2. Benzodiazepines vs other compounds

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Tardive dyskinesia (TD) symptoms: no clinically important improvement (> 50% improvement on any TD scale) ‐ short term Show forest plot

1

Risk Ratio (IV, Fixed, 95% CI)

Subtotals only

1.1 Clonazepam vs phenobarbital (as active placebo)

1

21

Risk Ratio (IV, Fixed, 95% CI)

0.44 [0.20, 0.96]

2 TD symptoms: not any improvement ‐ short term Show forest plot

1

Risk Ratio (IV, Fixed, 95% CI)

Subtotals only

2.1 Clonazepam vs phenobarbital (as active placebo)

1

21

Risk Ratio (IV, Fixed, 95% CI)

0.36 [0.02, 8.03]

3 Adverse events: any adverse events ‐ short term Show forest plot

1

Risk Ratio (IV, Fixed, 95% CI)

Subtotals only

3.1 Clonazepam vs phenobarbital (as active placebo)

1

21

Risk Ratio (IV, Fixed, 95% CI)

1.53 [0.97, 2.41]

4 Leaving the study early ‐ short term Show forest plot

1

Risk Difference (IV, Fixed, 95% CI)

Subtotals only

4.1 Clonazepam vs phenobarbital (as active placebo)

1

21

Risk Difference (IV, Fixed, 95% CI)

0.0 [‐0.17, 0.17]
Figuras y tablas -
Comparison 2. Benzodiazepines vs other compounds
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