Study

Randomisation

Allocation conceal.

Treatment blinding

ITT analysis

Total drop‐out

Selective drop‐out

Blind outcome‐assess

Overall quality

A=adequate
B=unknown or inadequate

A=adequate
B=unknown or inadequate

A=adequate B=blinding but method unclear
C=non‐blinded, inadequate, or unknown

A=adequate B=ITT inadequate C=unclear or no reported data on drop‐out or loss to follow up

A<15%
B>/=15% or unknown

A=difference in drop‐out rate in main groups<10% B>/=10% or unknown

A=adequate B=mentioning of blinding but exact method unclear C=non blinded, inadequate or unknown

A=all quality criteria met
B=one or more quality criteria only partially met C=one or more criteria not met

Alloway
1993

B

B

C

C

B

A

C

C

Man
2007

A

A

B

A

A

B

C

B

Siegel
1994

B

B

C

C

A

A

C

C

Study

n

Outcome

Results

Note

Alloway 1993

I = 14; C = 13

Average number of days until complete resolution

I 7.4 (SD 4.55); C 8.3 (SD4.35); Difference 0.9
p=0.66

3 of 10 patients received a second injection (= I). Lost to follow up: n=7 (I: n=4; C: n=3)

Mean joint score after 1 to 2, 3 to 4, and 10 to14 days (5‐point scale: 0=total resolution, 1=improvement of > 50%, 2=improvement of <50%, 3=no change, 4=worsening of symptoms)

I: 1.0 (SD 0.72) to 0.62 (SD 0.78) to 0.50 (SD 0 .16).
C: 1.5 (SD 0.85) to 0.65 (SD 0.63) to 0.20 (SD 0.37); Differences: 0.5 (p=0.24), 0.03 (p=0.94), and ‐0.30 (p=025)

3 of 10 patients received a second injection (=I). 7 patients were lost to follow up (I: n=4; C: n=3)

Mann 2007

I = 44; C = 46

Mean decrease (mm on a VAS) per hour of pain at rest within the first 2 hours

I ‐9.5 (SD 10.5); C ‐6.4 (SD 8.3); Difference 3.2
(95%CI ‐0.78 to 7.14), p=0.12

The difference in mean pain score was at no time more than 13mm, which was unlikely to be clinically relevant according to the authors.

Mean decrease (mm on a VAS) per hour of pain during activity within the first 2 hours

I ‐19.2 (SD 11.2); C ‐20.3 (SD 9.1); Difference ‐1.1 (95%CI:
‐5.34 to 3.24), p=0.63

The difference in mean pain score was at no time more than 13mm, which was unlikely to be clinically relevant according to the authors.

Mean decrease (mm on a VAS) per day of pain at rest after 2 weeks

I ‐0.7 (SD 1.2); C ‐0.3 (SD0.7); Difference 0.5 (95%CI: 0.03 to 0.89), p=0.04

The difference in mean pain score was at no time more than 13mm, which was unlikely to be clinically relevant according to the authors.
Lost to follow up: n=7 (I: n=0; C: n=7*) * had to stop the study after adverse effects

Mean decrease (mm on a VAS) per day of pain during activity after 2 weeks

I ‐2.9 (SD 2.0); C ‐1.7 (SD 1.6); Difference 1.2 (95%CI: 0.44 to 2.00). p=0.0026

The difference in mean pain score was at no time more than 13mm, which was unlikely to be clinically relevant according to the authors.
Lost to follow up: n=7 (I: n=0; C: n=7*) * had to stop the study after adverse effects

Siegel 1994

I = 16; C = 15

Average number of days until complete resolution

I 7.6; 7.9; Difference 0.3
p=0.89

4 of 16 patients required a second I‐injection, 9 of 14 a second C‐injection. 3 patients required a third C‐injection.
Lost to follow up: n=3 (I: n=0; C: n=3*) *2 because of <50% improvement after 3 C‐injections

I = Intervention; C = Control

SD = Standard Deviation