Summary of findings 6. Persea gratissma + Glycine max (ASU 300 mg) for treating osteoarthritis.
| Persea gratissma + Glycine max (ASU 300 mg) for treating osteoarthritis | ||||||
| Patient or population: patients with osteoarthritis Settings: Community: France (3), Belgium (1). Intervention:Persea gratissma + Glycine max (ASU 300 mg) | ||||||
| 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 | Persea gratissma + Glycine max (ASU 300mg) | |||||
| Pain Global pain VAS 0‐100 (higher scores mean worse) Follow‐up: 3 to 12 months | Weighted mean pain in the control groups at end of treatment was 40.53 (0 to 100 scale). | Weighted mean pain in the intervention groups was 8.47 lower (15.90 to 1.04 lower) | ‐ | 651 (4 studies) | ⊕⊕⊕⊝ moderate1 | Absolute improvement in pain was 8% (1% to 16%); Relative improvement in pain was 15% (2% to 29%)2; NNTB 8 (4 to 77)3 |
| Function Multiple tools4 Follow‐up: 3 to 12 months | Mean disability in the control group at end of treatment was 47.10 mm, on VAS 0 to 100 mm scale (higher scores mean worse)5. | Mean disability in the intervention groups was 7 mm lower (12 mm to 2 mm lower6) | ‐ | 642 (4 studies) | ⊕⊕⊕⊝ moderate1 | SMD ‐0.42 (95% CI ‐0.73 to ‐0.11), in favour of ASU 300mg Absolute improvement in disability was 7% (2% to 12%); Relative improvement in disability was 13% (4% to 23%)7; NNTB 5 (3 to 19)3 |
| Adverse events Participants (n) reported adverse events Follow‐up: 3 to 36 months | 510 per 1000 | 531 per 1000 (495 to 572) | RR 1.04 (0.97 to 1.12) | 1050 (5 studies) | ⊕⊕⊕⊝ moderate1 | Absolute risk of adverse events is 2% higher in the ASU group (2% lower to 7% higher); Relative percentage change 4% worsening (9% improvement to 12% worsening); NNT n/a3 |
|
Adverse events Participants (n) withdrew due to adverse effects |
148 per 1000 |
169 per 100 (108 to 267) |
RR 1.14 (0.73 to 1.80) |
398 (1 study) |
⊕⊕⊕⊝ moderate8 | Absolute risk of participants withdrawing due to adverse events in 2% higher in ASU group (5% lower to 9% higher); Relative percentage change 14% worsening (27% improvement to 90% worsening); NNT n/a.3,9 |
|
Adverse events Participants (n) reported serious adverse events |
325 per 1000 |
397 per 1000 (306 to 517) |
RR 1.22 (0.94 to 1.59) |
398 (1 study) |
⊕⊕⊕⊝ moderate8 | Absolute risk of serious adverse events is 7% higher in the ASU group (2% lower to 17% higher); Relative percentage change 22% worsening (6% improvement to 59% worsening); NNT n/a.3,9 |
|
Radiographic joint changes Change in Joint Space Width (JSW) from baseline (higher scores mean worse). Follow up: 24 to 36 months. |
Weighted mean JSW change from baseline in the control groups at end of treatment was 0.65. | Mean JSW change from baseline in the intervention groups was 0.12 lower (0.43 lower to 0.19 higher) | ‐ | 453 (2 studies) |
⊕⊕⊕⊝ moderate8 | Absolute change NNT n/a.3,9 |
| Quality of life | See comment | See comment | Not estimable | ‐ | See comment | Quality of life not measured. |
| *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; 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. | ||||||
1Downgrade due to heterogeneity, inconsistency
2 Calculations based on control group baseline pain measure taken from Blotman 1997, the most heavily weighted study in the meta‐analysis. Control group baseline mean (SD) pain 54.3 (11.9).
3 Number needed to treat to benefit (NNTB), or to harm (NNTH) = not applicable (n/a) when result is not statistically significant. NNT for dichotomous outcomes calculated using Cates NNT calculator (http://www.nntonline.net/visualrx/)NNT for continuous outcomes calculated using Wells Calculator (CMSG editorial office), assuming a minimal clinically important difference of 15 mm on a 0 to 100 mm pain scale, and 10 mm on a 0 to 100 mm function scale.
4 Multiple tools: Disability VAS reported in one study only (Maheu 1998); WOMAC change score reported in one study (Maheu 2013); Lequesne algofunctional index reported in four studies, but to avoid over‐reporting, data were extracted on this outcome from three studies only (Appelboom 2001, Blotman 1997, Lequesne 2002)
5 From Maheu 1998: follow‐up disability score in the control group 47.10 mm (VAS 0 to 100 mm scale)
6 Four trials pooled (Appelboom 2001, Blotman 1997, Lequesne 2002, Maheu 1998) using SMD, and re‐expressed as MD by multiplying the SMD (95% CI) by the baseline SD in the control group of Maheu 1998 (16.78).
7 Calculations based on data from Maheu 1998: control group baseline mean (SD) disability 52.5 (16.78), 0 to 100 mm VAS scale.
8 Downgrade estimate due to imprecision: few participants.
9 Treatment effect crosses midline (no effect).