Intra‐articular corticosteroid for knee osteoarthritis

Peter Jüni; Roman Hari; Anne WS Rutjes; Roland Fischer; Maria G Silletta; Stephan Reichenbach; Bruno R da Costa

doi:10.1002/14651858.CD005328.pub3

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Figure 1

Study flow chart. *records with the exact same bibliographic information of another already‐screened record.

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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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Figure 3

Forest plot of comparison: 1 Pain, outcome: 1.1 Pain ‐ Main.

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Figure 4

Contour‐enhanced funnel plot for effects on knee pain. Numbers on x axis refer to standardised mean differences (SMDs), on y axis to standard errors of SMDs

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Figure 5

Forest plot of comparison: 1 Pain, outcome: 1.2 Pain ‐ Time points. P for trend = 0.001

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Figure 6

Forest plot of comparison: 2 Function, outcome: 2.1 Function ‐ Main.

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Figure 7

Contour‐enhanced funnel plot for effects on knee function. Numbers on x axis refer to standardised mean differences (SMDs), on y axis to standard errors of SMDs

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Figure 8

Forest plot of comparison: 2 Function, outcome: 2.2 Function ‐ Time points. P for trend = 0.011

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Figure 9

Forest plot of comparison: 3 Quality of life, outcome: 3.1 Quality of life ‐ Main.

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Figure 10

Forest plot of comparison: 7 Joint space narrowing, outcome: 7.1 Joint space narrowing ‐ Main.

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Figure 11

Forest plot of comparison: 4 Number of participants experiencing any adverse event, outcome: 4.1 Number of participants experiencing any adverse event ‐ Main.

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Figure 12

Forest plot of comparison: 5 Number of participants who withdraw because of adverse events, outcome: 5.1 Number of participants who withdraw because of adverse events ‐Main.

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Figure 13

Forest plot of comparison: 6 Number of participants experiencing any serious adverse event, outcome: 6.1 Number of participants experiencing any serious adverse event ‐ Main.

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Analysis 1.1

Comparison 1 Pain, Outcome 1 Pain ‐ Main.

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Analysis 1.2

Comparison 1 Pain, Outcome 2 Pain ‐ Timepoints.

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Analysis 2.1

Comparison 2 Function, Outcome 1 Function ‐ Main.

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Analysis 2.2

Comparison 2 Function, Outcome 2 Function ‐ Timepoints.

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Analysis 3.1

Comparison 3 Quality of life, Outcome 1 Quality of life ‐ Main.

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Analysis 4.1

Comparison 4 Number of participants experiencing any adverse event, Outcome 1 Number of participants experiencing any adverse event ‐ Main.

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Analysis 5.1

Comparison 5 Number of participants who withdraw because of adverse events, Outcome 1 Number of participants who with draw because of adverse events ‐Main.

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Analysis 6.1

Comparison 6 Number of participants experiencing any serious adverse event, Outcome 1 Number of participants experiencing any serious adverse event ‐ Main.

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Analysis 7.1

Comparison 7 Joint space narrowing, Outcome 1 Joint space narrowing ‐ Main.

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Intra‐articular corticosteroid compared with sham injection for osteoarthritis of the knee
Patient or population: participants with osteoarthritis of the knee Settings: various orthopaedic or rheumatology clinics Intervention: intra‐articular corticosteroid Comparison: sham injection
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Sham injection	Intra‐articular corticosteroid
Pain intensity Various pain scales. (median follow‐up: 12 weeks)	‐1.8 cm change on 10‐cm VAS¹ 29% improvement	‐2.8 cm change (Δ ‐1.0 cm, ‐1.5 to ‐0.6)² 46% improvement (Δ 17%, 10% to 25%)³	SMD ‐0.40 (‐0.58 to ‐0.22) Predictive interval (‐1.20 to 0.40)	1749 (26)	⊕⊕⊝⊝ low⁹	NNTB 8 (95% CI 6 to 13)⁴
Function Various function scales. (median follow‐up: 12 weeks)	‐1.2 units on WOMAC (range 0 to 10)¹ 21% improvement	‐1.9 units on WOMAC (Δ ‐0.7, ‐1.2 to ‐0.2)⁵ 34% improvement (Δ 13%, 4% to 22%)⁶	SMD ‐0.33 (‐0.56 to ‐0.09) Predictive interval (‐1.19 to 0.54)	1014 (15)	⊕⊕⊝⊝ low⁹	NNTB 10 (95% CI 7 to 33)⁷
Number of participants experiencing any adverse event (median follow‐up: 17 weeks)	150 per 1000 participant‐years⁸	134 per 1000 participant‐years (96 to 185)	RR 0.89 (0.64 to 1.23)	84 (2)	⊕⊕⊝⊝ low¹⁰	Little evidence of harmful effect (NNTB not statistically significant)
Number of participants who withdraw because of adverse events (median follow‐up: 25 weeks)	17 per 1000 participant‐years⁸	6 per 1000 participant‐years (1 to 35)	RR 0.33 (0.05 to 2.07)	204 (2)	⊕⊕⊝⊝ low¹⁰	Little evidence of harmful effect (NNTB not statistically significant)
Number of participants experiencing any serious adverse event (median follow‐up: 26 weeks)	4 per 1000 participant‐years⁸	3 per 1000 participant‐years (1 to 11)	RR 0.63 (0.15 to 2.67)	331 (5)	⊕⊕⊝⊝ low¹⁰	Little evidence of harmful effect (NNTB not statistically significant)
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; NNTB: number needed to treat for an additional beneficial outcome; RR: risk ratio; SMD: standardised mean difference; VAS: visual analogue scale; WOMAC: Western Ontario and McMaster Universities Arthritis Index
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 Median reduction as observed across placebo groups in large osteoarthritis trials (see methods section, Nüesch 2009). ² SMDs were back‐transformed onto a 10‐cm visual analogue scale (VAS) on the basis of a typical pooled standard deviation (SD) of 2.5 cm in large trials that assessed pain using a VAS and expressed as change based on an assumed standardised reduction of 0.72 SD units in the control group. ³ Percentage of improvement was calculated based on median observed pain at baseline across control groups of large osteoarthritis trials of 6.1 cm on 10‐cm VAS (Nüesch 2009). ⁴ Absolute response risks for pain in the control groups were assumed 31% (see methods section). ⁵ SMDs were back‐transformed onto a standardised Western Ontario and McMaster Universities Arthritis Index (WOMAC) disability score ranging from 0 to 10 on the basis of a typical pooled SD of 2.1 in trials that assessed function using WOMAC disability scores and expressed as change based on an assumed standardised reduction of 0.58 SD units in the control group. ⁶ Percentage of improvement was calculated based on median observed WOMAC function scores at baseline across control groups of large osteoarthritis trials of 5.6 units (Nüesch 2009). ⁷ Absolute response risks for function in the control groups were assumed 26% (see methods section). ⁸ Median control risk across placebo groups in large osteoarthritis trials (see methods section, Nüesch 2009). ⁹ Downgraded (2 levels) because: Most studies that reported this outcome are of high or unclear risk of bias, and statistical heterogeneity is large. ¹⁰ Downgraded (3 levels) because: 50% or more of the studies that reported this outcome are of high or unclear risk of bias, and the confidence interval of the pooled estimate is wide and includes the null effect.

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Table 1. Stratified analyses: Pain

Variable	Number of studies	N of participants corticosteroids	N of participants control	Pain intensity SMD (95% CI)	Heterogeneity I² (%)	P value*
All trials	26	922	827	‐0.40 (‐0.58 to ‐0.22)	68%
Allocation concealment						0.15
Adequate	2	88	83	‐0.16 (‐0.46 to 0.14)	0%
Inadequate or unclear	24	834	744	‐0.42 (‐0.62 to ‐0.22)	69%
Blinding of participants						0.64
Adequate	6	220	218	‐0.34 (‐0.61 to ‐0.06)	49%
Inadequate or unclear	20	702	609	‐0.42 (‐0.65 to ‐0.19)	72%
Blinding of therapists						0.45
Adequate	3	92	92	‐0.24 (‐0.66 to 0.17)	44%
Inadequate or unclear	23	830	735	‐0.42 (‐0.62 to ‐0.22)	70%
Intention‐to‐treat analysis						0.29
Yes	9	236	233	‐0.26 (‐0.57 to 0.06)	59%
No or unclear	17	686	594	‐0.47 (‐0.69 to ‐0.24)	71%
Type of control intervention						0.08
Sham injection	19	614	526	‐0.50 (‐0.72 to ‐0.28)	65%
No intervention	7	284	280	‐0.18 (‐0.47 to 0.11)	63%
Funding independent of industry						0.80
Yes	11	341	333	‐0.37 (‐0.55 to ‐0.18)	26%
No or unclear	15	581	494	‐0.41 (‐0.70 to ‐0.12)	78%
Trial size						0.05
≥ 50 per trial group	3	205	204	‐0.13 (‐0.37 to 0.12)	34%
< 50 per trial group	23	717	623	‐0.44 (‐0.65 to ‐0.24)	67%
Trial size						0.013
≥ 100 per trial group	1	103	103	0.00 (‐0.27 to 0.27)	N/A
< 100 per trial group	25	819	724	‐0.42 (‐0.61 to ‐0.23)	66%
Publication type						0.93
Full journal article	22	785	706	‐0.40 (‐0.61 to ‐0.20)	70%
Other type or unpublished material	4	137	121	‐0.38 (‐0.84 to ‐0.08)	65%
Ultrasound guidance of injections						0.71
Yes	2	70	70	‐0.62 (‐1.83 to 0.58)	89%
No or unclear	24	852	757	‐0.39 (‐0.57 to ‐0.20)	67%
Use of local anaesthetic						0.41
Yes	5	172	157	‐0.55 (‐0.93 to ‐0.16)	62%
No or unclear	21	750	670	‐0.36 (‐0.57 to ‐0.15)	70%
Concomitant viscosupplementation						0.08
Yes	4	129	127	‐0.16 (‐0.42 to 0.09)	4%
No or unclear	22	793	700	‐0.46 (‐0.67 to ‐0.25)	71%
Concomitant joint lavage						≤ 0.001
Yes	4	197	187	‐0.06 (‐0.26 to 0.15)	0%
No or unclear	26	725	640	‐0.57 (‐0.78 to ‐0.35)	72%
Use of crystalline preparation						0.82
Yes	18	623	562	‐0.47 (‐0.69 to ‐0.24)	72%
No or unclear	12	299	265	‐0.52 (‐0.90 to ‐0.14)	76%
Prednisolone equivalence dose						0.53
≥ 50 mg	17	520	470	‐0.55 (‐0.85 to ‐0.25)	80%
< 50 mg	13	402	357	‐0.43 (‐0.66 to ‐0.20)	56%
Number of randomised comparisons are shown in "number of studies" for stratified analyses according to use of lavage as co‐intervention, crystalline preparation, prednisolone equivalence. *P value for interaction. N/A: not available. CI: confidence interval SMD: standardised mean difference

Table 1. Stratified analyses: Pain

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Table 2. Stratified analyses: Function

Variable	Number of studies	N of participants corticosteroids	N of participants control	Function SMD (95% CI)	Heterogeneity I² (%)	P value*
All trials	15	546	468	‐0.33 (‐0.56 to ‐0.09)	69%
Allocation concealment						0.25
Adequate	2	88	83	‐0.09 (‐0.49 to 0.32)	43%
Inadequate or unclear	13	458	385	‐0.37 (‐0.64 to ‐0.10)	72%
Blinding of participants						0.97
Adequate	5	201	199	‐0.32 (‐0.82 to 0.18)	83%
Inadequate or unclear	10	345	269	‐0.33 (‐0.59 to ‐0.07)	58%
Blinding of therapists						0.78
Adequate	2	75	75	‐0.48 (‐1.65 to 0.70)	91%
Inadequate or unclear	13	471	393	‐0.31 (‐0.55 to ‐0.06)	66%
Intention‐to‐treat analysis						0.49
Yes	5	161	159	‐0.21 (‐0.59 to 0.17)	62%
No or unclear	10	385	309	‐0.38 (‐0.69 to ‐0.07)	73%
Type of control intervention						0.031
Sham injection	11	409	334	‐0.45 (‐0.74 to ‐0.15)	73%
No intervention	4	137	134	‐0.01 (‐0.27 to 0.25)	13%
Funding independent of industry						0.73
Yes	9	310	302	‐0.36 (‐0.66 to ‐0.07)	68%
No or unclear	6	236	166	‐0.27 (‐0.71 to 0.16)	76%
Trial size						0.023
≥ 50 per trial group	2	102	101	0.05 (‐0.23 to 0.32)	0%
< 50 per trial group	13	444	367	‐0.40 (‐0.67 to ‐0.13)	70%
Trial size						N/A
≥ 100 per trial group	0	0	0	N/A	N/A
< 100 per trial group	15	546	468	‐0.33 (‐0.56 to ‐0.09)	69%
Publication type						0.023
Full journal article	14	514	438	‐0.37 (‐0.61 to ‐0.13)	68%
Other type or unpublished material	1	32	30	0.28 (‐0.22 to 0.78)	N/A
Ultrasound guidance of injections						0.49
Yes	2	70	70	‐0.14 (‐0.70 to 0.43)	58%
No or unclear	13	476	398	‐0.36 (‐0.62 to ‐0.09)	71%
Use of local anaesthetic						0.34
Yes	4	105	105	‐0.60 (‐1.25 to 0.05)	78%
No or unclear	11	441	363	‐0.25 (‐0.51 to 0.00)	68%
Concomitant viscosupplementation						0.06
Yes	2	85	84	‐0.00 (‐0.30 to 0.30)	0%
No or unclear	13	461	384	‐0.39 (‐0.66 to ‐0.12)	72%
Concomitant joint lavage						0.18
Yes	3	94	84	‐0.13 (‐0.55 to 0.28)	48%
No or unclear	16	452	384	‐0.46 (‐0.71 to ‐0.21)	70%
Use of crystalline preparation						0.66
Yes	12	365	319	‐0.37 (‐0.66 to ‐0.08)	73%
No or unclear	7	181	149	‐0.47 (‐0.83 to ‐0.11)	61%
Prednisolone equivalence dose						0.16
≥ 50 mg	12	328	277	‐0.52 (‐0.83 to ‐0.20)	74%
< 50 mg	7	218	191	‐0.22 (‐0.48 to 0.05)	47%
Number of randomised comparisons are shown in "number of studies" for stratified analyses according to use of lavage as co‐intervention, crystalline preparation, prednisolone equivalence. *P value for interaction. N/A: not available. CI: confidence interval SMD: standardised mean difference

Table 2. Stratified analyses: Function

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Comparison 1. Pain

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain ‐ Main Show forest plot	26	1749	Std. Mean Difference (Random, 95% CI)	‐0.40 [‐0.58, ‐0.22]

2 Pain ‐ Timepoints Show forest plot	26		Std. Mean Difference (Random, 95% CI)	Subtotals only

2.1 Pain‐ 1‐2 week	16	1041	Std. Mean Difference (Random, 95% CI)	‐0.48 [‐0.70, ‐0.27]
2.2 Pain‐ 4‐6 week	22	1529	Std. Mean Difference (Random, 95% CI)	‐0.41 [‐0.61, ‐0.21]
2.3 Pain‐ 3 months	18	1233	Std. Mean Difference (Random, 95% CI)	‐0.22 [‐0.44, 0.00]
2.4 Pain‐ 6 months	7	526	Std. Mean Difference (Random, 95% CI)	‐0.07 [‐0.25, 0.11]

Comparison 1. Pain

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Comparison 2. Function

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Function ‐ Main Show forest plot	15	1014	Std. Mean Difference (Random, 95% CI)	‐0.33 [‐0.56, ‐0.09]

2 Function ‐ Timepoints Show forest plot	15		Std. Mean Difference (Random, 95% CI)	Subtotals only

2.1 Function ‐ 1‐2 weeks	10	763	Std. Mean Difference (Random, 95% CI)	‐0.43 [‐0.72, ‐0.14]
2.2 Function ‐ 4‐6 weeks	12	818	Std. Mean Difference (Random, 95% CI)	‐0.36 [‐0.63, ‐0.09]
2.3 Function ‐ 3 months	11	800	Std. Mean Difference (Random, 95% CI)	‐0.13 [‐0.37, 0.10]
2.4 Function ‐ 6 months	4	328	Std. Mean Difference (Random, 95% CI)	0.06 [‐0.16, 0.28]

Comparison 2. Function

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Comparison 3. Quality of life

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Quality of life ‐ Main Show forest plot	2	184	Std. Mean Difference (Random, 95% CI)	‐0.01 [‐0.30, 0.28]

Comparison 3. Quality of life

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Comparison 4. Number of participants experiencing any adverse event

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number of participants experiencing any adverse event ‐ Main Show forest plot	2	84	Risk Ratio (IV, Random, 95% CI)	0.89 [0.64, 1.23]

Comparison 4. Number of participants experiencing any adverse event

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Comparison 5. Number of participants who withdraw because of adverse events

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number of participants who with draw because of adverse events ‐Main Show forest plot	2	204	Risk Ratio (IV, Random, 95% CI)	0.33 [0.05, 2.07]

Comparison 5. Number of participants who withdraw because of adverse events

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Comparison 6. Number of participants experiencing any serious adverse event

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number of participants experiencing any serious adverse event ‐ Main Show forest plot	5	331	Risk Ratio (IV, Random, 95% CI)	0.63 [0.15, 2.67]

Comparison 6. Number of participants experiencing any serious adverse event

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Comparison 7. Joint space narrowing

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Joint space narrowing ‐ Main Show forest plot	1	68	Std. Mean Difference (Random, 95% CI)	‐0.02 [‐0.49, 0.46]

Comparison 7. Joint space narrowing

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