Table 3: Summary of the evidence and quality of the findings (GRADE).
|
Natural products versus placebo in the treatment of RAS |
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|
Outcomes |
No of participants (studies) Follow up |
Quality of the evidence (GRADE) |
Relative effect (95% CI) |
Anticipated absolute effects |
|
|
Risk with placebo |
Risk difference with Natural products (95% CI) |
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|
Ulcer size 3-4 days (mm) |
373 (7 studies) 3-4 days |
⊕⊕⊕⊝ MODERATE1 due to risk of bias |
NA |
NA |
The mean ulcer size at 3-4 days in the intervention groups was -1.739 mm lower than the placebo groups (-3.151 to -0.327 lower) |
|
Ulcer size 5-7 days (mm) |
373 (7 studies) 3-4 days |
⊕⊕⊕⊝ MODERATE1 due to risk of bias |
NA |
NA |
The mean ulcer size at 5-7 days in the intervention groups was -1.873 mm lower than the placebo groups (-3.393 to -0.352 lower) |
|
Pain intensity at 3-4 days Various scales |
373 (7 studies) 3-4 days |
⊕⊕⊕⊝ MODERATE1 due to risk of bias |
NA |
NA |
The mean pain intensity at 3-4 days in the intervention groups was -0.794 standard deviations lower (-1.447 to -0.141 lower) |
|
Pain intensity at 5-7 days Various scales |
373 (7 studies) 5-7 days |
⊕⊕⊕⊝ MODERATE1 due to risk of bias |
NA |
NA |
The mean pain intensity at 5-7 days in the intervention groups was -1.094 standard deviations lower (-1.709 to -0.479 lower) |
|
Significant improvement in ulcer size at 3-4 days |
277 (2 studies) 3-4 days |
⊕⊕⊝⊝ LOW1,2 due to imprecision and risk of bias |
RR 2.556 (1.084 to 6.030) |
165 per 1000 |
257 more per 1000 (from 14 more to 832 more) |
|
Significant improvement in ulcer size at 5-7 days |
277 (2 studies) 6 days |
⊕⊕⊝⊝ LOW1,2 due to imprecision and risk of bias |
RR 1.532 (1.091 to 2.152) |
504 per 1000 |
268 more per 1000 (from 46 more to 580 more) |
|
Level of erythema and exudation at day 2 (scale 0-3) |
162 (2 studies) 2 days |
⊕⊕⊝⊝ LOW1,2 due to imprecision and risk of bias |
NA |
NA |
The mean level of erythema and exudation in the intervention groups was -0.779 lower (scale 0-3) at day 2 (-1.738 lower to + 0.180 higher) |
|
Level of erythema and exudation at day 6 (scale 0-3) |
162 (2 studies) 6 days |
⊕⊕⊝⊝ LOW1,2 due to imprecision and risk of bias |
NA |
NA |
The mean level of erythema and exudation in the intervention groups was -0.865 lower (scale 0-3) at day 6 (-1.938 lower to + 0.208 higher) |
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.
190% of the studies had an overall unclear or high risk of bias
2Only two studies reported this outcome with small sample size < 400 participants
CI: Confidence Interval; RR: Risk Ratio; NA: Not Available.