| Product |
Study ID |
Outcome measure |
p value |
Analysis population |
Statistical test |
Description |
| Adant |
Roman 2000 |
Patient global assessment |
P (paper): <0.05, R (report):0.07 |
ITT |
chi‐square of 95% CI |
At three months P reports significance, 50% versus 21.1% |
| |
|
Painful injection |
P:<0.001, R:0.4 |
ITT |
chi‐square of 95% CI |
8 of 49=16.3% Total population, 6 of 30=20% Adant, and 2 of 19=10.5% Hyalgan. Appears an error in P as they report 8 of 49=20% Total population and 16.3% Adant. |
| BioHy (Euflexxa) |
Thompson 2002 |
Patient global (subjective) assessment |
P:0.03, R:0.5 |
ITT |
Wilcoxon's two‐sample test |
P reports significance comparing number of patients very satisfied between groups. R compares very satisfied and satisfied versus slightly satisfied and dissatisfied. |
| Euflexxa |
Kirchner 2005 |
WOMAC OA Index physical function subscale |
P: ns, R: 0.02 |
ITT |
one‐way ANOVA (GLM) |
P reports no statistically significant between group difference whereas RevMan detected a statistically significant between group difference both at 1 to 4 and 5 to 13 weeks postinjection |
| Euflexxa |
Kirchner 2005 |
Number of patients symptom‐free (WOMAC pain) |
P: 0.038, R: 0.05 |
ITT |
Cochran‐Mantel‐Haenszel test |
P reports significance. R no statistically significant difference. |
| Euflexxa |
Kirchner 2005 |
Number of patients assessing the treatment as 'very satisfied' (P) or 'very satisfied or satisfied' (R) |
P: 0.03, R: 0.23 |
ITT |
Wilcoxon's two‐sample test |
P reports significance whereas R detects no difference but this may be attributable to the categories which were compared. |
| Euflexxa |
Kirchner 2005 |
Number of patients requiring rescue medication during trial |
P: 0.013, R: 0.02 |
ITT |
Cochran‐Mantel‐Haenszel test |
Both P and R report significance, but P values differ. |
| Durolane |
Altman 2004 |
WOMAC OA Index pain subscale |
P: ns; R:0.04 |
ITT |
Wilcoxon rank sum test for change from baseline |
P reports no statistically significant between‐group difference while R detected a statistically significant difference at week 2 in favour of saline |
| |
Altman 2004 |
WOMAC OA Index stiffness subscale |
P:s; R: ns |
ITT |
Wilcoxon rank sum test for change from baseline |
P reports a statistically significant between‐group difference at week 26 while R detected no statistically significant between‐group difference |
| |
Altman 2004 |
WOMAC OA Index physical function subscale |
P:s; R:ns |
ITT |
Wilcoxon rank sum test for change from baseline |
P reports a statistically significant between‐group difference at week 2 while R detected no statistically significant between‐group difference |
| Suplasyn |
Petrella 2002 |
Pain relief |
P:HA=NSAID |
ITT |
within‐group repeated ANOVA |
P concludes HA=NSAID for resting pain relief. R finds no difference. |
| |
|
Pain with physical activity |
HA>PL |
ITT |
within‐group repeated ANOVA |
P concludes HA may be superior to PL alone/NSAID alone. R no difference. |
| |
|
Pain at rest |
PL>HA P value 0.04 |
ITT |
within‐group repeated ANOVA |
P does not report between‐group comparisons. R found difference in favour of PL. |
| |
|
Functional performance |
HA>PL |
ITT |
within‐group repeated ANOVA |
P concludes HA may be superior to PL alone/NSAID alone. R finds no difference. |
| Orthovisc |
Brandt 2001 |
WOMAC pain categoric improvement |
P:0.04, R:0.05 |
Effectiveness |
Wilcoxon rank sum tests |
P concludes HA>PL. R RR of 58% versus 40% no significant difference. |
| |
|
Six month pain on walking |
P:ns, R:0.008 |
ITT |
one‐way ANOVA |
P: no significant difference, R: significant difference in favour of Orthovisc |
| |
|
Six month Lequesne Index |
P:ns, R:0.03 |
ITT |
one‐way ANOVA |
P: no significant difference, R: significant difference in favour of Orthovisc |
| |
|
Six month flexion |
P:ns, R:0.04 |
ITT |
one‐way ANOVA |
P: no significant difference, R: significant difference in favour of Orthovisc |
| |
Kalay 1997 |
Activity pain 21st day (1 to 4 weeks) |
P:0.0303, R:0.5 |
ITT |
Mann‐Whitney U test |
P: significant difference in favour of OR+PT, R: no significant difference |
| |
|
Night pain 56th day (5 to 13 weeks) |
P:0.0284, R:0.07 |
ITT |
Mann‐Whitney U test |
P: significant difference in favour of OR+PT, R: no significant difference |
| |
|
Walk time 21st day (1 to 4weeks) |
P:0.0049, R: 0.4 |
ITT |
Mann‐Whitney U test |
P: significant difference in favour of OR+PT, R: no significant difference |
| |
|
Walk time 56th day (5 to 13 weeks) |
P:0.0001, R:0.2 |
ITT |
Mann‐Whitney U test |
P: significant difference in favour of OR+PT, R: no significant difference |
| Hylan G‐F 20 |
Dickson 2001 |
WOMAC pain (5 to 13 weeks) |
P:0.04, R:0.11 |
ITT |
repeated measures ANOVA corrected for statistically significant covariates |
P: significant difference in favour of Hylan G‐F 20 compared to PL, R: no significant difference |
| |
|
WOMAC function (5 to 13 weeks) |
P:0.05, R:0.01 |
ITT |
repeated measures ANOVA |
P: 0.05 which we would classify as not significant; Hylan G‐F 20 > PL |
| |
|
Lequesne Index (5 to 13 weeks) |
P:0.17, R:0.02 |
ITT |
repeated measures ANOVA |
P: no significnt difference, R: significant difference in favour of Hylan G‐F 20 compared to PL |
| |
Adams 1995 |
Pain at rest (5 to 13 weeks) |
P:0.05, R:0.6 |
ITT |
ANOVA |
P: Hylan G‐F 20 > NSAID, R: no significant difference |
| Hyalgan |
Dougados 1993 |
Lequesne Index (45 to 52 weeks) |
P:0.046,R:0.17 |
|
One‐sided Student's t‐test |
P: Hyalgectin > PL, R: no significant difference |
| Hyalgan |
Tsai 2003 |
WOMAC function (14 to 26 weeks) |
P:0.0038, R:0.07 |
ITT |
ANOVA |
P: Hyalgan > PL, R: no significant difference |
| Hyalgan |
Jubb 2003 |
Joint space width (week 52) |
P:ns,R:0.03 |
ITT |
t‐test |
P: No significant difference in total population, but significant difference in >=4.6 mm subgroup; R: difference in total population but not in the 2 subgroups |
| Hylan G‐F 20 |
Auerbach 2002 |
Pain under load (45 to 52 weeks) |
P:0.001, R:0.2 |
ITT |
Wilcoxon test |
P: Hylan G‐F 20 > O2; R: no significant difference |
| |
|
WOMAC pain (45 to 52 weeks) |
P:0.003, R:0.3 |
ITT |
Wilcoxon test |
P: Hylan G‐F 20 > O2; R: no significant difference |
| |
|
WOMAC function (45 to 52 weeks) |
P:0.001, R:0.16 |
ITT |
Wilcoxon test |
P: Hylan G‐F 20 > O2; R: no significant difference |
| Artz |
Day 2004 |
WOMAC pain (5 to 13 weeks) |
P:0.045, R:0.07 |
ITT |
Repeated measures ANCOVA |
P: Artz > PL; R: no significant difference |
| |
|
WOMAC stiffness (5 to 13 weeks) |
P:0.024, R:0.07 |
ITT |
Repeated measures ANCOVA |
P: Artz > PL; R: no significant difference |
| Artz |
Puhl 1993 |
Lequesne Index (1 to 4 weeks) [t6] |
P:0.043, R:0.7 |
ITT |
Simultaneous t‐tests, MANOVA |
P: Artz > PL; R: no significant difference |
| |
|
Lequesne Index (5 to 13 weeks) [t14] |
P:0.0053, R: 0.5 |
ITT |
Simultaneous t‐tests, MANOVA |
P: Artz > PL; R: no significant difference |
| Hyalgan |
Jubb 2003 |
Pain (number of patients improved)(5‐13 wk) |
P:0.04, R:0.16 |
ITT |
Chi‐square |
P: HA > PL; R: no significant difference |
| Hyalgan |
Forster 2003 |
Knee Society Score (six months) |
P: ns, R:0.03 |
ITT |
Mann‐Whitney |
P: no significant difference; R: HA>Arthroscopy |
| Hyalgan |
Jones 1995 |
Pain at rest (week 29) |
P:significant; R:0.09 |
|
Not reported in publication. |
P: significant difference in favour of HA versus TH (Table III) but with ITT, LOCF no statistically significant difference. R: based on Table III, no significant difference. |
| |
|
Pain on nominated activity (week 29) |
P:significant, R: 0.4 |
|
Not reported in publication. |
P: significant difference in favour of HA versus TH (Table III) but with ITT, LOCF no statistically significant difference. R: based on Table III, no significant difference. |
| Hyalgan |
Listrat 1997 |
AIMS (45 to 52 weeks) |
P:0.047, R:0.6 |
ITT |
ANCOVA |
P: HA > conventional care; R: no significant difference |
