Scolaris Content Display Scolaris Content Display

Study flow diagram.
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Figure 1

Study flow diagram.

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.

Forest plot of comparison: 1 Muscle relaxant versus control, outcome: 1.1 Pain 24 hrs.
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Figure 3

Forest plot of comparison: 1 Muscle relaxant versus control, outcome: 1.1 Pain 24 hrs.

Forest plot of comparison: 1 Muscle relaxant versus control, outcome: 1.2 Pain 1‐2 weeks.
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Figure 4

Forest plot of comparison: 1 Muscle relaxant versus control, outcome: 1.2 Pain 1‐2 weeks.

Forest plot of comparison: 5 Muscle relaxant versus control ‐ safety, outcome: 5.1 Withdrawal due to adverse events.
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Figure 5

Forest plot of comparison: 5 Muscle relaxant versus control ‐ safety, outcome: 5.1 Withdrawal due to adverse events.

Forest plot of comparison: 5 Muscle relaxant versus control ‐ safety, outcome: 5.2 Total adverse events.
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Figure 6

Forest plot of comparison: 5 Muscle relaxant versus control ‐ safety, outcome: 5.2 Total adverse events.

Forest plot of comparison: 5 Muscle relaxant versus control ‐ safety, outcome: 5.3 Total adverse events ‐ trials greater than 24hrs duration.
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Figure 7

Forest plot of comparison: 5 Muscle relaxant versus control ‐ safety, outcome: 5.3 Total adverse events ‐ trials greater than 24hrs duration.

Forest plot of comparison: 5 Muscle relaxant versus control ‐ safety, outcome: 5.5 Subgroups adverse events.
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Figure 8

Forest plot of comparison: 5 Muscle relaxant versus control ‐ safety, outcome: 5.5 Subgroups adverse events.

Comparison 1 Muscle relaxant versus control, Outcome 1 Pain 24hrs.
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Analysis 1.1

Comparison 1 Muscle relaxant versus control, Outcome 1 Pain 24hrs.

Comparison 1 Muscle relaxant versus control, Outcome 2 Pain 1‐2 weeks.
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Analysis 1.2

Comparison 1 Muscle relaxant versus control, Outcome 2 Pain 1‐2 weeks.

Comparison 2 Benzodiazepine versus placebo, Outcome 1 Pain 24hrs.
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Analysis 2.1

Comparison 2 Benzodiazepine versus placebo, Outcome 1 Pain 24hrs.

Comparison 2 Benzodiazepine versus placebo, Outcome 2 Pain 1 week.
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Analysis 2.2

Comparison 2 Benzodiazepine versus placebo, Outcome 2 Pain 1 week.

Comparison 2 Benzodiazepine versus placebo, Outcome 3 Sleep (MSLT).
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Analysis 2.3

Comparison 2 Benzodiazepine versus placebo, Outcome 3 Sleep (MSLT).

Comparison 2 Benzodiazepine versus placebo, Outcome 4 Sleep (Polysomnography).
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Analysis 2.4

Comparison 2 Benzodiazepine versus placebo, Outcome 4 Sleep (Polysomnography).

Comparison 2 Benzodiazepine versus placebo, Outcome 5 Sleep (Patient reported outcome measures).
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Analysis 2.5

Comparison 2 Benzodiazepine versus placebo, Outcome 5 Sleep (Patient reported outcome measures).

Comparison 2 Benzodiazepine versus placebo, Outcome 6 Depression.
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Analysis 2.6

Comparison 2 Benzodiazepine versus placebo, Outcome 6 Depression.

Comparison 3 Benzodiazepine + NSAID versus NSAID ‐ pain, Outcome 1 Pain 24hrs.
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Analysis 3.1

Comparison 3 Benzodiazepine + NSAID versus NSAID ‐ pain, Outcome 1 Pain 24hrs.

Comparison 3 Benzodiazepine + NSAID versus NSAID ‐ pain, Outcome 2 Sleep (Wolff Sleep Score).
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Analysis 3.2

Comparison 3 Benzodiazepine + NSAID versus NSAID ‐ pain, Outcome 2 Sleep (Wolff Sleep Score).

Comparison 4 Non‐benzodiazepine versus placebo, Outcome 1 Pain.
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Analysis 4.1

Comparison 4 Non‐benzodiazepine versus placebo, Outcome 1 Pain.

Comparison 4 Non‐benzodiazepine versus placebo, Outcome 2 Functional Status.
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Analysis 4.2

Comparison 4 Non‐benzodiazepine versus placebo, Outcome 2 Functional Status.

Comparison 4 Non‐benzodiazepine versus placebo, Outcome 3 Sleep (Polysomnography).
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Analysis 4.3

Comparison 4 Non‐benzodiazepine versus placebo, Outcome 3 Sleep (Polysomnography).

Comparison 4 Non‐benzodiazepine versus placebo, Outcome 4 Sleep (Patient reported outcomes) Spiegel Sleep Questionnaire.
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Analysis 4.4

Comparison 4 Non‐benzodiazepine versus placebo, Outcome 4 Sleep (Patient reported outcomes) Spiegel Sleep Questionnaire.

Comparison 4 Non‐benzodiazepine versus placebo, Outcome 5 Sleep (Patient reported outcomes) Leeds Sleep Evaluation.
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Analysis 4.5

Comparison 4 Non‐benzodiazepine versus placebo, Outcome 5 Sleep (Patient reported outcomes) Leeds Sleep Evaluation.

Comparison 5 Muscle relaxant versus control ‐ safety, Outcome 1 Withdrawal due to adverse events.
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Analysis 5.1

Comparison 5 Muscle relaxant versus control ‐ safety, Outcome 1 Withdrawal due to adverse events.

Comparison 5 Muscle relaxant versus control ‐ safety, Outcome 2 Total Adverse Events.
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Analysis 5.2

Comparison 5 Muscle relaxant versus control ‐ safety, Outcome 2 Total Adverse Events.

Comparison 5 Muscle relaxant versus control ‐ safety, Outcome 3 Total Adverse events ‐ trials greater than 24hrs duration.
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Analysis 5.3

Comparison 5 Muscle relaxant versus control ‐ safety, Outcome 3 Total Adverse events ‐ trials greater than 24hrs duration.

Comparison 5 Muscle relaxant versus control ‐ safety, Outcome 4 Total adverse events ‐ trials 24hr duration only.
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Analysis 5.4

Comparison 5 Muscle relaxant versus control ‐ safety, Outcome 4 Total adverse events ‐ trials 24hr duration only.

Comparison 5 Muscle relaxant versus control ‐ safety, Outcome 5 Subgroups Adverse Events.
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Analysis 5.5

Comparison 5 Muscle relaxant versus control ‐ safety, Outcome 5 Subgroups Adverse Events.

Summary of findings for the main comparison. Muscle relaxant versus control for pain management in rheumatoid arthritis

Muscle relaxant versus control for pain management in rheumatoid arthritis

Patient or population: patients with pain management in rheumatoid arthritis
Settings:
Intervention: muscle relaxant versus control

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

Muscle Relaxant versus control

Pain ‐ 24hrs (Single dose)
Follow‐up: 24 hours

The mean Pain ‐ 24hrs (Single dose) in the intervention groups was
0.22 lower
(1.02 lower to 0.58 higher)

104
(3 studies)

⊕⊕⊝⊝
low1,2

No significant difference. Absolute risk difference 2% (6% to 10%) and relative percent change 8% (‐38% to 22%).

Pain ‐ 1‐2 weeks
Follow‐up: 1 weeks

The mean Pain ‐ 1‐2 weeks in the intervention groups was
0.20 standard deviations lower
(0.59 lower to 0.18 higher)

104
(3 studies)

⊕⊝⊝⊝
very low2,3,4

No significant difference. Absolute risk difference ‐5% (‐15% to 5%) and relative percent change ‐4% (‐11% to 3%).

Withdrawal due to Adverse Events
Follow‐up: 2 weeks

0 per 1000

0 per 1000
(0 to 0)

RR 2.84
(0.31 to 26.08)

180
(5 studies5)

⊕⊝⊝⊝
very low2,3,4

The event rate in the control group was zero. Absolute risk difference 1% (‐4% to 6%), relative percent change 184% (‐69% to 251%).

Total Number of Adverse Events ‐ only studies >24hrs duration
Follow‐up: 2 weeks

29 per 1000

117 per 1000
(31 to 438)

RR 4.03
(1.08 to 15.10)

74
(2 studies)

⊕⊝⊝⊝
very low2,3,4

Number needed to harm (NNTH) was 3 (2 to 8). Absolute risk difference 40% (23% to 57%), relative percentage change 303% (8% to 1410%)

Total Number of Adverse Events ‐ single dose studies
Follow‐up: 24 hours

288 per 1000

403 per 1000
(167 to 982)

RR 1.40
(0.58 to 3.41)

106
(3 studies)

⊕⊝⊝⊝
very low2,3

No significant difference. Absolute risk difference ‐6% (‐23% to 10%) and relative percent change ‐22% (‐59% to 48%).

CNS adverse events
Follow‐up: 1‐2 weeks

57 per 1000

340 per 1000
(101 to 1000)

RR 5.96
(1.77 to 20.08)

74
(2 studies)

⊕⊝⊝⊝
very low2,3,4

NNTH was 3 (CI 2 to 11). Absolute risk difference 35% (‐13% to 83%), relative percent change 496% (77% to 1908%).

*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 Hetergeneous interventions and controls
2 Wide confidence intervals given small number of participants and small event rate
3 All three studies had high risk of bias.
4 Heterogenous interventions, outcomes, study design and length of follow up
5 Three of the five trials hand event rates of 0

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Summary of findings for the main comparison. Muscle relaxant versus control for pain management in rheumatoid arthritis
Comparison 1. Muscle relaxant versus control

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pain 24hrs Show forest plot

3

104

Mean Difference (IV, Random, 95% CI)

‐0.22 [‐1.02, 0.58]

2 Pain 1‐2 weeks Show forest plot

3

104

Std. Mean Difference (IV, Random, 95% CI)

‐0.20 [‐0.59, 0.18]

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Comparison 1. Muscle relaxant versus control
Comparison 2. Benzodiazepine versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pain 24hrs Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

1.1 24hrs (Single dose)

1

36

Mean Difference (IV, Fixed, 95% CI)

‐0.90 [‐1.77, ‐0.03]

2 Pain 1 week Show forest plot

2

64

Std. Mean Difference (IV, Random, 95% CI)

‐0.19 [‐0.68, 0.30]

3 Sleep (MSLT) Show forest plot

1

30

Mean Difference (IV, Fixed, 95% CI)

3.10 [1.20, 5.00]

4 Sleep (Polysomnography) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

4.1 Sleep Latency

1

30

Mean Difference (IV, Fixed, 95% CI)

‐8.40 [‐33.05, 16.25]

4.2 Total Sleep Time (mins)

1

30

Mean Difference (IV, Fixed, 95% CI)

19.10 [5.34, 32.86]

4.3 Number of awakenings (>15sec)

1

30

Mean Difference (IV, Fixed, 95% CI)

7.20 [0.90, 13.50]

5 Sleep (Patient reported outcome measures) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

5.1 Sleep Latency (mins)

1

30

Mean Difference (IV, Fixed, 95% CI)

‐11.7 [‐22.89, ‐0.51]

5.2 Duration Sleep (mins)

1

30

Mean Difference (IV, Fixed, 95% CI)

37.40 [10.85, 63.95]

5.3 Number of awakenings

1

30

Mean Difference (IV, Fixed, 95% CI)

‐1.20 [‐2.05, ‐0.35]

6 Depression Show forest plot

1

30

Std. Mean Difference (IV, Random, 95% CI)

0.17 [‐0.55, 0.88]

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Comparison 2. Benzodiazepine versus placebo
Comparison 3. Benzodiazepine + NSAID versus NSAID ‐ pain

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pain 24hrs Show forest plot

2

68

Std. Mean Difference (IV, Random, 95% CI)

‐0.14 [‐1.65, 1.36]

2 Sleep (Wolff Sleep Score) Show forest plot

2

68

Std. Mean Difference (IV, Random, 95% CI)

0.37 [‐0.11, 0.85]

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Comparison 3. Benzodiazepine + NSAID versus NSAID ‐ pain
Comparison 4. Non‐benzodiazepine 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, Fixed, 95% CI)

Subtotals only

1.1 Present Pain Intensity (2 weeks)

1

40

Mean Difference (IV, Fixed, 95% CI)

‐0.20 [‐0.77, 0.37]

1.2 Total Pain Rating Index (2 weeks)

1

40

Mean Difference (IV, Fixed, 95% CI)

‐6.60 [‐16.25, 3.05]

2 Functional Status Show forest plot

1

40

Std. Mean Difference (IV, Random, 95% CI)

0.08 [‐0.54, 0.70]

3 Sleep (Polysomnography) Show forest plot

1

80

Mean Difference (IV, Fixed, 95% CI)

‐0.42 [‐1.73, 0.89]

3.1 Total sleep

1

40

Mean Difference (IV, Fixed, 95% CI)

‐16.0 [‐53.73, 21.73]

3.2 Number of awakenings (>2min)

1

40

Mean Difference (IV, Fixed, 95% CI)

‐0.40 [‐1.71, 0.91]

4 Sleep (Patient reported outcomes) Spiegel Sleep Questionnaire Show forest plot

1

160

Mean Difference (IV, Fixed, 95% CI)

‐0.11 [‐0.38, 0.17]

4.1 Sleep Latency (0‐5)

1

40

Mean Difference (IV, Fixed, 95% CI)

‐0.70 [‐1.27, ‐0.13]

4.2 Duration Sleep (0‐5)

1

40

Mean Difference (IV, Fixed, 95% CI)

‐0.20 [‐0.69, 0.29]

4.3 Frequency of awakenings

1

40

Mean Difference (IV, Fixed, 95% CI)

‐0.60 [‐1.13, ‐0.07]

4.4 Patient Global Sleep

1

40

Mean Difference (IV, Fixed, 95% CI)

1.70 [1.03, 2.37]

5 Sleep (Patient reported outcomes) Leeds Sleep Evaluation Show forest plot

1

120

Mean Difference (IV, Fixed, 95% CI)

‐7.53 [‐12.20, ‐2.86]

5.1 Sleep Latency

1

40

Mean Difference (IV, Fixed, 95% CI)

‐12.0 [‐19.27, ‐4.73]

5.2 Frequency awakenings

1

40

Mean Difference (IV, Fixed, 95% CI)

0.90 [‐7.88, 9.68]

5.3 Patient Global Sleep

1

40

Mean Difference (IV, Fixed, 95% CI)

‐9.30 [‐17.76, ‐0.84]

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Comparison 4. Non‐benzodiazepine versus placebo
Comparison 5. Muscle relaxant versus control ‐ safety

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Withdrawal due to adverse events Show forest plot

5

180

Risk Ratio (M‐H, Random, 95% CI)

2.84 [0.31, 26.08]

2 Total Adverse Events Show forest plot

5

180

Risk Ratio (M‐H, Random, 95% CI)

1.40 [0.58, 3.41]

3 Total Adverse events ‐ trials greater than 24hrs duration Show forest plot

2

74

Risk Ratio (M‐H, Random, 95% CI)

4.03 [1.08, 15.10]

4 Total adverse events ‐ trials 24hr duration only Show forest plot

3

106

Risk Ratio (M‐H, Fixed, 95% CI)

0.78 [0.41, 1.48]

5 Subgroups Adverse Events Show forest plot

5

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

5.1 Benzodiazepine vs Placebo 24hrs

3

106

Risk Ratio (M‐H, Random, 95% CI)

0.77 [0.40, 1.48]

5.2 Benzodiazepine vs Placebo 1‐2 weeks

1

34

Risk Ratio (M‐H, Random, 95% CI)

3.00 [1.21, 7.45]

5.3 Benzodiazepine + NSAID vs NSAID

2

68

Risk Ratio (M‐H, Random, 95% CI)

0.77 [0.27, 2.21]

5.4 Non Benzodiazepine vs Placebo

1

40

Risk Ratio (M‐H, Random, 95% CI)

14.04 [0.87, 227.89]

5.5 CNS effects

2

74

Risk Ratio (M‐H, Random, 95% CI)

5.96 [1.77, 20.08]

5.6 Gastrointestinal events

5

180

Risk Ratio (M‐H, Random, 95% CI)

0.25 [0.03, 2.20]

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Comparison 5. Muscle relaxant versus control ‐ safety