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. Author manuscript; available in PMC: 2014 Apr 28.
Published in final edited form as: Cochrane Database Syst Rev. 2012 Oct 17;10:CD008424. doi: 10.1002/14651858.CD008424.pub2

SUMMARY OF FINDINGS FOR THE MAIN COMPARISON [Explanation]

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

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

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

*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.
1

Both arms received standard care and mesalamine or sulfasalazine

2

Scores range from 0 to 12 (high scores reflect more severe disease)

3

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

4

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

5

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

6

Publication Bias: Unlikely as the search was comprehensive

7

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

8

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

9

Scores assess healing of ulcers on sigmoidoscopy; range 1 to 4, with high scores indicating severe disease activity

10

The assumed risk is the risk in the control group