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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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Net efficacy adjusted for risk
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Figure 3

Net efficacy adjusted for risk

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Comparison 1 Opioid versus placebo, Outcome 1 Pain VAS.
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Analysis 1.1

Comparison 1 Opioid versus placebo, Outcome 1 Pain VAS.

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Comparison 1 Opioid versus placebo, Outcome 2 Mean daily pain intensity.
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Analysis 1.2

Comparison 1 Opioid versus placebo, Outcome 2 Mean daily pain intensity.

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Comparison 1 Opioid versus placebo, Outcome 3 Mean daily pain relief (maximum score = 4, negative score = pain worse).
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Analysis 1.3

Comparison 1 Opioid versus placebo, Outcome 3 Mean daily pain relief (maximum score = 4, negative score = pain worse).

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Comparison 1 Opioid versus placebo, Outcome 4 Pain relief of 50% or better.
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Analysis 1.4

Comparison 1 Opioid versus placebo, Outcome 4 Pain relief of 50% or better.

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Comparison 1 Opioid versus placebo, Outcome 5 Withdrawal due to inadequate analgesia.
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Analysis 1.5

Comparison 1 Opioid versus placebo, Outcome 5 Withdrawal due to inadequate analgesia.

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Comparison 1 Opioid versus placebo, Outcome 6 Patient reported global impression of clinical change (PGIC) 'good' or 'very good'.
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Analysis 1.6

Comparison 1 Opioid versus placebo, Outcome 6 Patient reported global impression of clinical change (PGIC) 'good' or 'very good'.

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Comparison 1 Opioid versus placebo, Outcome 7 Desire to resume treatment.
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Analysis 1.7

Comparison 1 Opioid versus placebo, Outcome 7 Desire to resume treatment.

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Comparison 1 Opioid versus placebo, Outcome 8 Functional status (HAQ).
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Analysis 1.8

Comparison 1 Opioid versus placebo, Outcome 8 Functional status (HAQ).

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Comparison 1 Opioid versus placebo, Outcome 9 Participants reporting adverse events.
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Analysis 1.9

Comparison 1 Opioid versus placebo, Outcome 9 Participants reporting adverse events.

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Comparison 1 Opioid versus placebo, Outcome 10 Serious adverse events.
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Analysis 1.10

Comparison 1 Opioid versus placebo, Outcome 10 Serious adverse events.

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Comparison 1 Opioid versus placebo, Outcome 11 Withdrawal due to adverse events.
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Analysis 1.11

Comparison 1 Opioid versus placebo, Outcome 11 Withdrawal due to adverse events.

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Comparison 1 Opioid versus placebo, Outcome 12 Withdrawal due to adverse event or inefficacy.
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Analysis 1.12

Comparison 1 Opioid versus placebo, Outcome 12 Withdrawal due to adverse event or inefficacy.

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Comparison 2 Opioid versus NSAID, Outcome 1 Change in 100mm pain VAS.
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Analysis 2.1

Comparison 2 Opioid versus NSAID, Outcome 1 Change in 100mm pain VAS.

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Comparison 2 Opioid versus NSAID, Outcome 2 Global efficacy.
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Analysis 2.2

Comparison 2 Opioid versus NSAID, Outcome 2 Global efficacy.

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Comparison 2 Opioid versus NSAID, Outcome 3 Desire to resume treatment.
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Analysis 2.3

Comparison 2 Opioid versus NSAID, Outcome 3 Desire to resume treatment.

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Comparison 2 Opioid versus NSAID, Outcome 4 Withdrawal due to inadequate analgesia.
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Analysis 2.4

Comparison 2 Opioid versus NSAID, Outcome 4 Withdrawal due to inadequate analgesia.

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Comparison 2 Opioid versus NSAID, Outcome 5 Participants reporting adverse events.
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Analysis 2.5

Comparison 2 Opioid versus NSAID, Outcome 5 Participants reporting adverse events.

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Comparison 2 Opioid versus NSAID, Outcome 6 Withdrawal due to adverse events.
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Analysis 2.6

Comparison 2 Opioid versus NSAID, Outcome 6 Withdrawal due to adverse events.

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Summary of findings for the main comparison. Opioids for rheumatoid arthritis pain

Opioids for rheumatoid arthritis pain

Patient or population: patients with rheumatoid arthritis pain
Settings:
Intervention: Opioids1

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

Opioids

Patient reported global impression of clinical change (PGIC) 'good' or 'very good'
PGIC scale: Very poor, Poor, No change, Good, Very good.
Follow‐up: 1‐6 weeks

398 per 1000

573 per 1000
(410 to 808)

RR 1.44
(1.03 to 2.03)

324
(3 studies)

⊕⊕⊝⊝
low2,3

Absolute risk difference = 18% (1% to 41%). Relative percent change = 44% (3% to 103%). NNT = 6 (3 to 84)4

Withdrawal due to inadequate analgesia
Follow‐up: median 1.5 weeks

78 per 1000

64 per 1000
(27 to 157)

RR 0.82
(0.34 to 2.01)

345
(4 studies)

⊕⊕⊝⊝
low2

Not statistically significant4

Functional status (HAQ)
HAQ. Scale from: 0 to 3.
Follow‐up: 1‐2 weeks

The mean Functional status (HAQ) in the intervention groups was
0.1 lower
(0.33 lower to 0.13 higher)

243
(2 studies)

⊕⊕⊝⊝
low5

HAQ only reported in two studies (of duration one week and two weeks).

Withdrawal due to adverse events
Follow‐up: 1‐6 weeks

53 per 1000

142 per 1000
(28 to 729)

RR 2.67
(0.52 to 13.75)

331
(3 studies)

⊕⊕⊝⊝
low3,6

Not statistically significant4

Participants reporting adverse events
Follow‐up: 1‐6 weeks

209 per 1000

508 per 1000
(379 to 634)

OR 3.90
(2.31 to 6.56)

371
(4 studies8)

⊕⊕⊝⊝
low3,7

Absolute risk difference = 30% (17% to 42%). Relative percent change = 143% (81% to 203%). NNTH = 4 (3 to 6)4

Serious adverse events
Follow‐up: 1 weeks

See comment

See comment

Not estimable

317
(2 studies)

⊕⊕⊝⊝
low9,10

Two studies reported serious adverse events. In each study, one participant in the opioid group experienced an SAE. There were no deaths.

*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; OR: Odds 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 There was heterogeneity in the choice of opioid and the use of an adjunctive non‐opioid analgesic. 10 of the 11 included studies used a weak opioid. Oral morphine was the only strong opioid used.
2 Included studies were potentially biased due to unclear or inadequate sequence generation, allocation concealment and management of incomplete data.
3 Substantial secular changes in the management of rheumatoid arthritis may limit the applicability of the findings to patients in the current era.
4 Note: Number needed to treat (NNT) = n/a when result is not statistically significant. NNT for dichotomous outcomes calculated using Cates NNT calculator (http://nntonline.net/visualrx/).
5 Only two studies reported this outcome; Moran 1991 was at high risk of bias due to a change in design resulting from an unexpectedly high number of withdrawals. Lee 2006 reported HAQ scores for only 223 of the 267 participants; no explanation was provided.
6 Adequate data for this outcome was only available for three trials, none of which clearly described the randomization or allocation concealment methods.
7 Data for this outcome was available from four trials, none of which clearly described the randomization or allocation concealment methods.
8 One of the four trials was cross‐over design
9 Bedi 1969 at high risk of bias due to inadequate randomization, potential for carry‐over effects, and incomplete outcome data. Single SAE (upper GI bleed) occurred in the combination treatment group in phase I.
10 Only two SAEs were reported in the 11 included studies. Only one study (Lee 2006) pre‐specified SAEs as an outcome measure. 9 of the 11 studies reported adverse events.

Figuras y tablas -
Summary of findings for the main comparison. Opioids for rheumatoid arthritis pain
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Comparison 1. Opioid versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pain VAS Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Totals not selected

1.1 Morphine, measured at 2 weeks

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Morphine, measured at 4 weeks

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.3 Tilidine/naloxone, measured at 6 weeks

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 Mean daily pain intensity Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

2.1 Tramadol/paracetamol

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 Mean daily pain relief (maximum score = 4, negative score = pain worse) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

3.1 Tramadol/paracetamol

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 Pain relief of 50% or better Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

4.1 Codeine/paracetamol

1

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

5 Withdrawal due to inadequate analgesia Show forest plot

4

345

Risk Ratio (M‐H, Random, 95% CI)

0.82 [0.34, 2.01]

5.1 Codeine/paracetamol

1

39

Risk Ratio (M‐H, Random, 95% CI)

0.19 [0.01, 3.73]

5.2 Tilidine/naloxone

1

19

Risk Ratio (M‐H, Random, 95% CI)

0.73 [0.13, 4.13]

5.3 Tramadol/paracetamol

1

267

Risk Ratio (M‐H, Random, 95% CI)

0.33 [0.02, 5.18]

5.4 Morphine

1

20

Risk Ratio (M‐H, Random, 95% CI)

1.33 [0.40, 4.49]

6 Patient reported global impression of clinical change (PGIC) 'good' or 'very good' Show forest plot

3

324

Risk Ratio (M‐H, Random, 95% CI)

1.44 [1.03, 2.03]

6.1 Tilidine/naloxone

1

19

Risk Ratio (M‐H, Random, 95% CI)

1.09 [0.45, 2.63]

6.2 Tramadol/paracetamol

1

267

Risk Ratio (M‐H, Random, 95% CI)

1.33 [0.97, 1.82]

6.3 Codeine/paracetamol

1

38

Risk Ratio (M‐H, Random, 95% CI)

2.33 [1.14, 4.77]

7 Desire to resume treatment Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

7.1 Codeine/paracetamol

1

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8 Functional status (HAQ) Show forest plot

2

243

Mean Difference (IV, Random, 95% CI)

‐0.10 [‐0.33, 0.13]

8.1 Tramadol/paracetamol

1

223

Mean Difference (IV, Random, 95% CI)

‐0.07 [‐0.32, 0.18]

8.2 Morphine

1

20

Mean Difference (IV, Random, 95% CI)

‐0.30 [‐0.94, 0.34]

9 Participants reporting adverse events Show forest plot

4

Odds Ratio (Random, 95% CI)

3.90 [2.31, 6.56]

9.1 Codeine/paracetamol

1

Odds Ratio (Random, 95% CI)

2.33 [0.64, 8.55]

9.2 Tilidine/naloxone

1

Odds Ratio (Random, 95% CI)

2.00 [0.31, 12.85]

9.3 Tramadol/paracetamol

1

Odds Ratio (Random, 95% CI)

4.70 [2.48, 8.91]

9.4 Pentazocine

1

Odds Ratio (Random, 95% CI)

4.33 [0.79, 23.70]

10 Serious adverse events Show forest plot

2

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

10.1 Tramadol/paracetamol

1

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 Dextropropoxyphene plus aspirin versus aspirin alone

1

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

11 Withdrawal due to adverse events Show forest plot

3

331

Risk Ratio (M‐H, Random, 95% CI)

2.67 [0.52, 13.75]

11.1 Codeine/paracetamol

1

40

Risk Ratio (M‐H, Random, 95% CI)

0.67 [0.12, 3.57]

11.2 Tilidine/naloxone

1

19

Risk Ratio (M‐H, Random, 95% CI)

5.25 [0.31, 89.35]

11.3 Tramadol/paracetamol

1

272

Risk Ratio (M‐H, Random, 95% CI)

6.37 [1.58, 25.69]

12 Withdrawal due to adverse event or inefficacy Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected
Figuras y tablas -
Comparison 1. Opioid versus placebo
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Comparison 2. Opioid versus NSAID

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Change in 100mm pain VAS Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Subtotals only

2 Global efficacy Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

3 Desire to resume treatment Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

4 Withdrawal due to inadequate analgesia Show forest plot

1

58

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

5 Participants reporting adverse events Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

6 Withdrawal due to adverse events Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only
Figuras y tablas -
Comparison 2. Opioid versus NSAID
Ir a la tabla de la revisión