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Temas

Study flow diagram.
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Figure 1

Study flow diagram.

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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 2

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

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Forest plot of comparison: 1 Acute low back pain ‐ paracetamol versus placebo, outcome: 1.1 Pain.
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Figure 3

Forest plot of comparison: 1 Acute low back pain ‐ paracetamol versus placebo, outcome: 1.1 Pain.

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Forest plot of comparison: 1 Acute low back pain ‐ paracetamol versus placebo, outcome: 1.2 Disability
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Figure 4

Forest plot of comparison: 1 Acute low back pain ‐ paracetamol versus placebo, outcome: 1.2 Disability

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Comparison 1 Acute low back pain ‐ paracetamol versus placebo, Outcome 1 Pain.
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Analysis 1.1

Comparison 1 Acute low back pain ‐ paracetamol versus placebo, Outcome 1 Pain.

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Comparison 1 Acute low back pain ‐ paracetamol versus placebo, Outcome 2 Disability.
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Analysis 1.2

Comparison 1 Acute low back pain ‐ paracetamol versus placebo, Outcome 2 Disability.

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Comparison 1 Acute low back pain ‐ paracetamol versus placebo, Outcome 3 Quality of life, physical component.
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Analysis 1.3

Comparison 1 Acute low back pain ‐ paracetamol versus placebo, Outcome 3 Quality of life, physical component.

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Comparison 1 Acute low back pain ‐ paracetamol versus placebo, Outcome 4 Quality of life, mental component.
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Analysis 1.4

Comparison 1 Acute low back pain ‐ paracetamol versus placebo, Outcome 4 Quality of life, mental component.

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Comparison 1 Acute low back pain ‐ paracetamol versus placebo, Outcome 5 Function.
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Analysis 1.5

Comparison 1 Acute low back pain ‐ paracetamol versus placebo, Outcome 5 Function.

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Comparison 1 Acute low back pain ‐ paracetamol versus placebo, Outcome 6 Adverse events.
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Analysis 1.6

Comparison 1 Acute low back pain ‐ paracetamol versus placebo, Outcome 6 Adverse events.

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Comparison 1 Acute low back pain ‐ paracetamol versus placebo, Outcome 7 Global impression of recovery.
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Analysis 1.7

Comparison 1 Acute low back pain ‐ paracetamol versus placebo, Outcome 7 Global impression of recovery.

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Comparison 1 Acute low back pain ‐ paracetamol versus placebo, Outcome 8 Poor sleep quality.
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Analysis 1.8

Comparison 1 Acute low back pain ‐ paracetamol versus placebo, Outcome 8 Poor sleep quality.

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Comparison 1 Acute low back pain ‐ paracetamol versus placebo, Outcome 9 Patient adherence.
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Analysis 1.9

Comparison 1 Acute low back pain ‐ paracetamol versus placebo, Outcome 9 Patient adherence.

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Comparison 1 Acute low back pain ‐ paracetamol versus placebo, Outcome 10 Use of rescue medication.
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Analysis 1.10

Comparison 1 Acute low back pain ‐ paracetamol versus placebo, Outcome 10 Use of rescue medication.

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Summary of findings for the main comparison. Paracetamol compared with placebo for acute low back pain

Paracetamol compared with placebo for acute low back pain

Patient or population: People with acute low back pain

Settings: Primary care

Intervention: Paracetamol

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

Paracetamol

Pain

1 week (immediate term)

(NRS 0 to 100)

The mean pain in the control group was

36 points

The mean pain in the intervention group was
1.49 higher

(1.30 lower to 4.28 higher)

‐

1520
(1 study)

⊕⊕⊕⊕
high

The difference is not statistically
or clinically significant

Pain

12 weeks (short term)

(NRS 0 to 100)

The mean pain in the control group was

13 points

The mean pain in the intervention group was
0.50 lower

(2.92 lower to 1.92 higher)

‐

1526
(1 study)

⊕⊕⊕⊕
high

The difference is not statistically
or clinically significant

Disability

1 week (immediate term)

(RMDQ 0 to 24)

The mean disability in the control group was

8.3 points

The mean disability in the intervention group was
0.45 lower

(1.15 lower to 0.25 higher)

‐

1511
(1 study)

⊕⊕⊕⊕
high

The difference is not statistically
or clinically significant

Disability

12 weeks (short term)

(RMDQ 0 to 24)

The mean disability in the control group was

2.4 points

The mean disability in the intervention group was
0.10 higher

(0.39 lower to 0.59 higher)

‐

1522
(1 study)

⊕⊕⊕⊕
high

The difference is not statistically
or clinically significant

Any adverse events

Up to 12 weeks' follow‐up

107 per 1000

115 per 1000
(92 to 142)

RR 1.07

(0.86 to 1.33)

1624
(1 study)

⊕⊕⊕⊕
high

The difference is not statistically
or clinically significant

Serious adverse events

Up to 12 weeks' follow‐up

90 per 1000

81 per 1000
(27 to 240)

RR 0.90

(0.30 to 2.67)

1643
(1 study)

⊕⊕⊕
moderate1

The difference is not statistically
or clinically significant

*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; NRS: Numeric Rating Scale; RMDQ: Roland Morris Disability Questionnaire; 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. Downgraded for imprecision.
Figuras y tablas -
Summary of findings for the main comparison. Paracetamol compared with placebo for acute low back pain
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Comparison 1. Acute low back pain ‐ paracetamol versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pain Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 1 week (immediate‐term)

1

1520

Mean Difference (IV, Random, 95% CI)

1.49 [‐1.30, 4.28]

1.2 2 weeks

1

1505

Mean Difference (IV, Random, 95% CI)

1.0 [‐1.70, 3.70]

1.3 4 weeks

1

1516

Mean Difference (IV, Random, 95% CI)

0.49 [‐1.99, 2.97]

1.4 12 weeks (short‐term)

1

1526

Mean Difference (IV, Random, 95% CI)

‐0.50 [‐2.92, 1.92]

2 Disability Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Subtotals only

2.1 1 week (immediate‐term)

1

1511

Mean Difference (IV, Random, 95% CI)

‐0.45 [‐1.15, 0.25]

2.2 2 weeks

1

1501

Mean Difference (IV, Random, 95% CI)

0.00 [‐0.65, 0.65]

2.3 4 weeks

1

1506

Mean Difference (IV, Random, 95% CI)

0.05 [‐0.50, 0.60]

2.4 12 weeks (short‐term)

1

1522

Mean Difference (IV, Random, 95% CI)

0.10 [‐0.39, 0.59]

3 Quality of life, physical component Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Subtotals only

3.1 4 weeks

1

1145

Mean Difference (IV, Random, 95% CI)

‐0.79 [‐1.94, 0.36]

3.2 12 weeks (short‐term)

1

760

Mean Difference (IV, Random, 95% CI)

0.41 [‐0.91, 1.72]

4 Quality of life, mental component Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Subtotals only

4.1 4 weeks

1

1145

Mean Difference (IV, Random, 95% CI)

‐0.60 [‐1.38, 0.17]

4.2 12 weeks (short‐term)

1

760

Mean Difference (IV, Random, 95% CI)

0.90 [0.08, 1.72]

5 Function Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Subtotals only

5.1 1 week (immediate‐term)

1

1511

Mean Difference (IV, Random, 95% CI)

‐0.05 [‐0.32, 0.22]

5.2 2 weeks

1

1499

Mean Difference (IV, Random, 95% CI)

‐0.15 [‐0.42, 0.12]

5.3 4 weeks

1

1502

Mean Difference (IV, Random, 95% CI)

‐0.05 [‐0.31, 0.21]

5.4 12 weeks (short‐term)

1

1518

Mean Difference (IV, Random, 95% CI)

0.0 [‐0.23, 0.23]

6 Adverse events Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

6.1 Any adverse events (up to 12 weeks)

1

1624

Risk Ratio (M‐H, Random, 95% CI)

1.07 [0.86, 1.33]

6.2 Serious adverse events (up to 12 weeks)

1

1643

Risk Ratio (M‐H, Random, 95% CI)

0.90 [0.30, 2.67]

7 Global impression of recovery Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Subtotals only

7.1 1 week (immediate‐term)

1

1515

Mean Difference (IV, Random, 95% CI)

‐0.05 [‐0.28, 0.18]

7.2 2 weeks

1

1501

Mean Difference (IV, Random, 95% CI)

‐0.05 [‐0.28, 0.18]

7.3 4 weeks

1

1511

Mean Difference (IV, Random, 95% CI)

‐0.10 [‐0.33, 0.13]

7.4 12 weeks (short‐term)

1

1523

Mean Difference (IV, Random, 95% CI)

‐0.05 [‐0.26, 0.17]

8 Poor sleep quality Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

8.1 1 week (immediate‐term)

1

1511

Risk Ratio (M‐H, Random, 95% CI)

1.05 [0.87, 1.25]

8.2 2 weeks

1

1500

Risk Ratio (M‐H, Random, 95% CI)

1.01 [0.80, 1.28]

8.3 4 weeks

1

1510

Risk Ratio (M‐H, Random, 95% CI)

1.11 [0.82, 1.52]

8.4 12 weeks (short‐term)

1

1523

Risk Ratio (M‐H, Random, 95% CI)

1.26 [0.90, 1.76]

9 Patient adherence Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

9.1 4 weeks

1

1311

Risk Ratio (M‐H, Random, 95% CI)

1.08 [0.96, 1.22]

10 Use of rescue medication Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

10.1 Up to 2 weeks

1

1548

Risk Ratio (M‐H, Random, 95% CI)

0.50 [0.16, 1.55]
Figuras y tablas -
Comparison 1. Acute low back pain ‐ paracetamol versus placebo
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