Curcumin versus placebo for maintenance of remission in ulcerative colitis | |||||||
Patient or population: Maintenance of remission in ulcerative colitis | |||||||
Settings: Tertiary care centres in a high income country | |||||||
Intervention: Curcumin versus placebo1 | |||||||
Outcomes |
Illustrative comparative risks* (95% CI) |
Relative effect (95% CI) |
No of Participants (studies) |
Quality of the evidence (GRADE) |
Comments | ||
Assumed risk10 | Corresponding risk | ||||||
Control | Curcumin placebo | versus | |||||
Relapse at 6 months Clinical Disease Activty Index more than 42 Follow-up: 6 months |
182 per 1000 |
44 per 1000 (9 to 198) |
RR 0.24 (0.05 to 1.09) |
89 (1 study) |
⊕⊕○○ low3,4,5,6,7 |
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Relapse at 12 months Clinical Disease Activty Index more than 42 Follow-up: 12 months |
318 per 1000 |
223 per 1000 (111 to 445) |
RR 0.7 (0.35 to 1.4) |
89 (1 study) |
⊕⊕○○ low3,4,6,7,7 |
||
Clinical Activity Index at 6 months Clinical Disease Activty Index 2. Scale from: 0 to 12. Follow-up: 6 months |
The mean clinical activ- ity index at 6 months in the control groups was 2. 2 points |
The mean Clinical Activity Index at 6 months in the intervention groups was 1.2 lower (2.14 to 0.26 lower) |
82 (1 study) |
⊕⊕○○ low3,4,6,7 |
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Endoscopic Index at 6 months Endoscopic Index9. Scale from: 1 to 4. Follow-up: 6 months |
The mean endoscopic in- dex at 6 months in the control groups was 1.6 points |
The mean Endoscopic In- dex at 6 months in the in- tervention groups was 0.8 lower (1.33 to 0.27 lower) |
82 (1 study) |
⊕⊕○○ low3,4,6,7 |
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*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; RR: Risk 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. |
Both arms received standard care and mesalamine or sulfasalazine
Scores range from 0 to 12 (high scores reflect more severe disease)
No study limitations: Central randomization and allocation concealed; investigators, outcome assessors and participants were blinded; analysis was by intention to treat; no overt reporting biases; no conflicts of interest
No serious indirectness: This trial included only adults (who constitute about 95% of those with ulcerative colitis). This is a validated, clinically relevant outcome measure. Not downgraded
Serious imprecision: There are relatively few events and wide confidence intervals around the estimate of effect that suggests appreciable benefit with curcumin as well as non-appreciable benefit with placebo. Downgraded by 1
Publication Bias: Unlikely as the search was comprehensive
Very serious imprecision: There are relatively few events and wide confidence intervals around the estimate of effect that suggests appreciable benefit with curcumin as well as with placebo and no statistically significance between the interventions. Downgraded by 2
Serious imprecision: There are relatively few events and wide confidence intervals (CI) around the estimate of effect with the lower limit of the CI crossing 0.5. Downgraded by 1
Scores assess healing of ulcers on sigmoidoscopy; range 1 to 4, with high scores indicating severe disease activity
The assumed risk is the risk in the control group