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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 Glycerol laxative versus Tuina massage, Outcome 1 Global or clinical change in constipation: change in frequency of defecation.
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Analysis 1.1

Comparison 1 Glycerol laxative versus Tuina massage, Outcome 1 Global or clinical change in constipation: change in frequency of defecation.

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Comparison 2 Glycerol laxative versus acupuncture, Outcome 1 Global or clinical change in constipation: change in frequency of defecation.
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Analysis 2.1

Comparison 2 Glycerol laxative versus acupuncture, Outcome 1 Global or clinical change in constipation: change in frequency of defecation.

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Comparison 3 Mannitol versus phenolphthalein or rhubarb soda, Outcome 1 Global or clinical change in constipation: change in frequency of defecation.
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Analysis 3.1

Comparison 3 Mannitol versus phenolphthalein or rhubarb soda, Outcome 1 Global or clinical change in constipation: change in frequency of defecation.

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Table 1. Suggested design of future study

Methods

Allocation: centralised, randomised, sequence generation described.

Blinding: participants, personnel recruiting and assigning participants, and assessors. Blinding can be tested by asking participants and raters to guess the assigned treatment.

Study duration: 12 weeks.

Setting: Inpatients and outpatients

Participants

Diagnosis: antipsychotic‐related constipation or antipsychotic induced gastrointestinal hypomotility

N = sample size obtained through power calculation*

Age: any

Sex: both

Intervention

Any of the interventions listed in Appendix 1 compared against any other intervention or placebo,

Outcomes

Primary Outcomes

1. Global or clinical change in constipation

1.1 Change in the frequency of defecation (e.g. complete spontaneous bowel movements per week)
1.2 Change in straining at defecation
1.3 Change in the frequency of lumpy or hard stools
1.4 Change in the frequency of manual manoeuvres to facilitate defecation

Secondary outcomes

  1. Global state

  2. Need for rescue medication for constipation

  3. Objective constipation‐related outcomes (e.g. gastrointestinal transit time measurement (determined by gastrointestinal motility studies), Presence of antipsychotic‐related constipation complications such as bowel obstruction)

  4. Satisfaction with treatment

  5. Quality of life

  6. Adverse effects

  7. Leaving the study early

  8. Economic Costs

Notes

* Size of study with sufficient power to detect a approximate 10% difference between the two groups for the primary outcome with 80% certainty.

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Table 1. Suggested design of future study
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Summary of findings for the main comparison. Glycerol laxative versus tuina massage for antipsychotic‐related constipation

Glycerol laxative versus tuina massage

Patient or population: antipsychotic‐related constipation
Setting: inpatient
Intervention: glycerol
Comparison: tuina

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with Tuina

Risk with Glycerol

1. Global or clinical change in constipation

(a) as defined by the study

Still constipated (no defecation) at 2 days

Study population

RR 2.88
(1.89 to 4.39)

120
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1, 2

283 per 1000

816 per 1000
(536 to 1,000)

Global or clinical change in constipation

(a) as defined by the study

Still constipated (no defecation) at 3 days

Study population

RR 4.80
(1.96 to 11.74)

120
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1, 2

83 per 1000

400 per 1000
(163 to 978)

(b) Change in the frequency of defecation

No studies reported these important outcomes

(c) Change in straining at defecation

(d) Change in the frequency of lumpy or hard stools

(e) Change in the frequency of manual manoeuvres to facilitate defecation

2. Need for rescue medication

3. Presence of antipsychotic‐related constipation complications such as bowel obstruction

4. Quality of life (changed to any extent)

5. Adverse events

6. Leaving the study early

7. Economic costs

*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; RR: Risk ratio; OR: Odds 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

1 Randomisation and allocation concealment methods unclear. Management of incomplete outcome data unclear. Blinding unlikely to have occurred ‐ rated as very serious ‐ downgraded by 2.

2 No validated method used for measuring constipation. Unclear how reported defecation was assessed (e.g. stool chart, participant recall from memory). No recording of any of the other ROME constipation symptoms (e.g. straining, stool consistency, manual manoeuvres) ‐ rated as serious ‐ downgraded by 1.

Figuras y tablas -
Summary of findings for the main comparison. Glycerol laxative versus tuina massage for antipsychotic‐related constipation
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Summary of findings 2. Glycerol laxative versus acupuncture for antipsychotic‐related constipation

Glycerol laxative versus acupuncture

Patient or population: antipsychotic‐related constipation
Setting: inpatient
Intervention: glycerol laxative
Comparison: acupuncture

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with acupuncture

Risk with glycerol laxative

1. Global or clinical change in constipation

(a) as defined by the study

Still constipated (no defecation) at 2 days

Study population

RR 3.50
(2.18 to 5.62)

120
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1, 2

233 per 1000

817 per 1000
(509 to 1000)

Still constipated (no defecation) at 3 days

Study population

RR 8.00
(2.54 to 25.16)

120
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1, 2

50 per 1000

400 per 1000
(127 to 1000)

(b) Change in the frequency of defecation

No studies reported these important outcomes

(c) Change in straining at defecation

(d) Change in the frequency of lumpy or hard stools

(e) Change in the frequency of manual manoeuvres to facilitate defecation

2. Need for rescue medication

3. Presence of antipsychotic‐related constipation complications such as bowel obstruction

4. Quality of life (changed to any extent)

5. Adverse events

6. Leaving the study early

7. Economic costs

*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; RR: Risk ratio; OR: Odds 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

1 Randomisation and allocation concealment methods unclear. Management of incomplete outcome data unclear. Blinding unlikely to have occurred ‐ rated as very serious ‐ downgraded by 2.

2 No validated method used for measuring constipation. Unclear how reported defecation was assessed (e.g. stool chart, participant recall from memory). No recording of any of the other ROME constipation symptoms (e.g. straining, stool consistency, manual manoeuvres) ‐ rated as serious ‐ downgraded by 1.

Figuras y tablas -
Summary of findings 2. Glycerol laxative versus acupuncture for antipsychotic‐related constipation
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Summary of findings 3. Mannitol versus phenolphthalein or rhubarb soda for antipsychotic‐related constipation

Mannitol versus phenolphthalein or rhubarb soda

Patient or population: antipsychotic‐related constipation
Setting: inpatient
Intervention: mannitol
Comparison: phenolphthalein or rhubarb soda

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with phenolphthalein or rhubarb soda

Risk with Mannitol

1. Global or clinical change in constipation

as defined by the study

a) Still constipated (no defecation) at 24 hours

Study population

RR 0.07
(0.02 to 0.27)

240
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1, 2

Results from the phenolphthalein and rhubarb soda groups were combined by the study authors.

250 per 1000

18 per 1000
(5 to 68)

(b) Change in the frequency of defecation

No studies reported these important outcomes

(c) Change in straining at defecation

(d) Change in the frequency of lumpy or hard stools

(e) Change in the frequency of manual manoeuvres to facilitate defecation

2. Need for rescue medication

3. Presence of antipsychotic‐related constipation complications such as bowel obstruction

4. Quality of life (changed to any extent)

5. Adverse events

0 per 1000

0 per 1000

Not estimable

240

(1 RCT)

‐

It is highly questionable how well adverse effects were monitored and recorded. The study simply notes "No side‐effects were detected in the two groups after treatment".

6. Leaving the study early

No studies reported these important outcomes

7. Economic costs

*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; RR: Risk ratio; OR: Odds 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

1 Randomisation and allocation concealment methods unclear. Management of incomplete outcome data unclear. Blinding unlikely to have occurred ‐ rated as very serious ‐ downgraded by 2.

2 No validated method used for measuring constipation. Unclear how reported defecation was assessed (e.g. stool chart, participant recall from memory). No recording of any of the other ROME constipation symptoms (e.g. straining, stool consistency, manual manoeuvres) ‐ rated as serious ‐ downgraded by 1.

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Summary of findings 3. Mannitol versus phenolphthalein or rhubarb soda for antipsychotic‐related constipation
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Comparison 1. Glycerol laxative versus Tuina massage

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Global or clinical change in constipation: change in frequency of defecation Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 no defecation by 2 days

1

120

Risk Ratio (M‐H, Fixed, 95% CI)

2.88 [1.89, 4.39]

1.2 no defecation by 3 days

1

120

Risk Ratio (M‐H, Fixed, 95% CI)

4.8 [1.96, 11.74]
Figuras y tablas -
Comparison 1. Glycerol laxative versus Tuina massage
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Comparison 2. Glycerol laxative versus acupuncture

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Global or clinical change in constipation: change in frequency of defecation Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 no defecation by 2 days

1

120

Risk Ratio (M‐H, Fixed, 95% CI)

3.5 [2.18, 5.62]

1.2 no defecation by 3 days

1

120

Risk Ratio (M‐H, Fixed, 95% CI)

8.0 [2.54, 25.16]
Figuras y tablas -
Comparison 2. Glycerol laxative versus acupuncture
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Comparison 3. Mannitol versus phenolphthalein or rhubarb soda

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Global or clinical change in constipation: change in frequency of defecation Show forest plot

1

240

Risk Ratio (M‐H, Fixed, 95% CI)

0.07 [0.02, 0.27]

1.1 no defecation by 24 hours

1

240

Risk Ratio (M‐H, Fixed, 95% CI)

0.07 [0.02, 0.27]
Figuras y tablas -
Comparison 3. Mannitol versus phenolphthalein or rhubarb soda
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