Cochrane · systematic review · CD000544
Oral 5‐aminosalicylic acid for maintenance of remission in ulcerative colitis
Murray, A, Nguyen, TM, Parker, CE, et al. · Cochrane Database of Systematic Reviews · 2020 · Cochrane Library
SoF tableOnly the outcomes this review put in its Summary of Findings table are listed (the Cochrane Handbook caps them at about seven per comparison). Its other analyses are not shown here.
Questions
24
current version
GRADE rated
20
No studies
4
Included studies
NR
No studies 4 · 16.7%Ungraded 0 · 0%Very low 2 · 8.3%Low 4 · 16.7%Moderate 9 · 37.5%High 5 · 20.8%
Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.
Questions and results
Current version onlyOral 5‐aminosalicylic acid versus placebo for maintenance of remission in ulcerative colitis
Population: people with quiescent UC
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure to maintain clinical or endoscopic remission Oral 5‐aminosalicylic acid vs placebo | RR 0.68 [0.61, 0.76] | 8 studies · 1555 participants | High |
Failure to adhere to study medication Oral 5‐aminosalicylic acid vs placebo | no estimate extracted | NR | No studies |
Adverse events Oral 5‐aminosalicylic acid vs placebo | RR 0.93 [0.73, 1.18] | 5 studies · 1132 participants | Moderate Downgraded: imprecision |
Serious adverse events Oral 5‐aminosalicylic acid vs placebo | RR 0.6 [0.19, 1.84] | 3 studies · 826 participants | Low Downgraded: imprecision |
Withdrawal due to adverse event Oral 5‐aminosalicylic acid vs placebo | RR 1.22 [0.76, 1.95] | 7 studies · 1454 participants | Moderate Downgraded: imprecision |
Exclusion/withdrawal after entry Oral 5‐aminosalicylic acid vs placebo | RR 1.13 [0.88, 1.44] | 5 studies · 1074 participants | Moderate Downgraded: imprecision |
Oral 5‐aminosalicylic acid versus sulfasalazine for maintenance of remission in ulcerative colitis
Population: people with quiescent ulcerative colitis
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure to maintain clinical or endoscopic remission Oral 5‐aminosalicylic acid vs sulfasalazine | RR 1.14 [1.03, 1.27] | 12 studies · 1655 participants | High |
Failure to adhere to study medication Oral 5‐aminosalicylic acid vs sulfasalazine | no estimate extracted | NR | No studies |
Adverse event Oral 5‐aminosalicylic acid vs sulfasalazine | RR 1.07 [0.82, 1.4] | 7 studies · 1138 participants | Moderate Downgraded: imprecision |
Serious adverse events Oral 5‐aminosalicylic acid vs sulfasalazine | no estimate extracted | NR | No studies |
Withdrawal due to adverse event Oral 5‐aminosalicylic acid vs sulfasalazine | RR 1.27 [0.87, 1.87] | 10 studies · 1585 participants | Moderate Downgraded: imprecision |
Exclusion/withdrawal after entry Oral 5‐aminosalicylic acid vs sulfasalazine | RR 1.3 [1.04, 1.63] | 9 studies · 1497 participants | Moderate Downgraded: imprecision |
Once‐daily dosing versus conventional dosing for maintenance of remission in ulcerative colitis
Population: people with quiescent UC
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure to maintain clinical or endoscopic remission Once‐daily dosing vs conventional dosing | RR 0.94 [0.88, 1.01] | 10 studies · 3910 participants | High |
Failure to adhere to study medication regimen Once‐daily dosing vs conventional dosing | RR 1.18 [0.72, 1.93] | 9 studies · 2306 participants | Moderate Downgraded: imprecision |
Adverse event Once‐daily dosing vs conventional dosing | RR 0.98 [0.92, 1.04] | 8 studies · 3497 participants | High |
Serious adverse events Once‐daily dosing vs conventional dosing | RR 1.2 [0.77, 1.87] | 7 studies · 3196 participants | Moderate Downgraded: imprecision |
Withdrawal due to adverse events Once‐daily dosing vs conventional dosing | RR 1.18 [0.74, 1.89] | 8 studies · 4340 participants | Very low Downgraded: risk of bias, imprecision |
Exclusion/withdrawal after entry Once‐daily dosing vs conventional dosing | RR 0.99 [0.85, 1.15] | 7 studies · 3737 participants | High |
Oral 5‐aminosalicylic acid versus comparator 5‐aminosalicylic acid formulation for maintenance of remission in ulcerative colitis
Population: people with quiescent UC
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure to maintain clinical or endoscopic remission Oral 5‐aminosalicylic acid vs comparator 5‐aminosalicylic acid formulation | RR 1.08 [0.91, 1.28] | 6 studies · 707 participants | Low Downgraded: risk of bias, imprecision |
Failure to adhere to study medication regimen Oral 5‐aminosalicylic acid vs comparator 5‐aminosalicylic acid formulation | no estimate extracted | NR | No studies |
Adverse event Oral 5‐aminosalicylic acid vs comparator 5‐aminosalicylic acid formulation | RR 0.94 [0.83, 1.07] | 4 studies · 357 participants | Low Downgraded: risk of bias, imprecision |
Serious adverse events Oral 5‐aminosalicylic acid vs comparator 5‐aminosalicylic acid formulation | RR 0.56 [0.14, 2.22] | 1 study · 95 participants | Low Downgraded: imprecision |
Withdrawal due to adverse events Oral 5‐aminosalicylic acid vs comparator 5‐aminosalicylic acid formulation | RR 1.25 | 5 studies · 457 participants | Very low Downgraded: risk of bias, imprecision |
Exclusion/withdrawal after entry Oral 5‐aminosalicylic acid vs comparator 5‐aminosalicylic acid formulation | RR 1.23 [0.9, 1.7] | 5 studies · 457 participants | Moderate Downgraded: imprecision |
Oral 5‐ASA versus placebo for maintenance of remission in ulcerative colitis
Population: Patients with quiescent ulcerative colitis
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure to maintain clinical or endoscopic remission at study end‐point Oral 5‐ASA vs placebo | RR 0.69 [0.62, 0.77] | 7 studies · 1298 participants | High |
Any adverse event Oral 5‐ASA vs placebo | RR 0.94 [0.77, 1.15] | 3 studies · 774 participants | Moderate Downgraded: imprecision |
Withdrawal due to adverse event Oral 5‐ASA vs placebo | RR 0.86 [0.46, 1.63] | 5 studies · 1096 participants | Moderate Downgraded: imprecision |
Oral 5‐ASA versus SASP for maintenance of remission in ulcerative colitis
Population: Patients with quiescent ulcerative colitis
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure to maintain clinical or endoscopic remission at study end‐point Oral 5‐ASA vs SASP | RR 1.14 [1.03, 1.27] | 12 studies · 1655 participants | High |
Any adverse event Oral 5‐ASA vs SASP | RR 1.07 [0.82, 1.4] | 7 studies · 1138 participants | Moderate Downgraded: imprecision |
Withdrawal due to adverse event Oral 5‐ASA vs SASP | RR 1.27 [0.87, 1.87] | 10 studies · 1585 participants | Moderate Downgraded: imprecision |
Once daily dosing versus conventional dosing for maintenance of remission in ulcerative colitis
Population: Patients with quiescent ulcerative colitis
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure to maintain clinical or endoscopic remission at 6 months Once daily dosing vs conventional dosing | RR 1.02 [0.85, 1.23] | 3 studies · 1871 participants | Low Downgraded: risk of bias, imprecision |
Failure to maintain clinical or endoscopic remission at 12 months Once daily dosing vs conventional dosing | RR 0.91 [0.82, 1.01] | 8 studies · 3127 participants | Moderate Downgraded: risk of bias, imprecision |
Failure to adhere to study medication regimen Once daily dosing vs conventional dosing | RR 1.22 [0.91, 1.64] | 6 studies · 1462 participants | Moderate Downgraded: imprecision |
Development of any adverse event Once daily dosing vs conventional dosing | RR 1 [0.92, 1.08] | 6 studies · 2714 participants | High |
Withdrawal due to adverse events Once daily dosing vs conventional dosing | RR 1.31 [0.8, 2.13] | 7 studies · 3737 participants | Low Downgraded: risk of bias, imprecision |
Oral 5‐ASA versus comparator 5‐ASA formulation for maintenance of remission in ulcerative colitis
Population: Patients with quiescent ulcerative colitis
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure to maintain clinical or endoscopic remission at 12 months Oral 5‐ASA vs comparator 5‐ASA formulation | RR 1.08 [0.91, 1.28] | 6 studies · 707 participants | Low Downgraded: risk of bias, imprecision |
Development of any adverse event Oral 5‐ASA vs comparator 5‐ASA formulation | RR 0.94 [0.83, 1.07] | 4 studies · 357 participants | Low Downgraded: risk of bias, imprecision |
Withdrawal due to adverse events Oral 5‐ASA vs comparator 5‐ASA formulation | RR 1.25 [0.56, 2.78] | 5 studies · 457 participants | Very low Downgraded: risk of bias, imprecision |
High dose oral 5‐ASA versus low dose 5‐ASA for maintenance of remission in ulcerative colitis
Population: Patients with quiescent ulcerative colitis
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure to maintain clinical or endoscopic remission at 12 months High dose oral 5‐ASA vs low dose 5‐ASA | RR 0.8 [0.46, 1.38] | 1 study · 112 participants | Very low Downgraded: risk of bias, imprecision |
Oral 5‐ASA versus placebo for maintenance of remission in ulcerative colitis
Population: Patients with quiescent ulcerative colitis
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure to maintain clinical or endoscopic remission at study end‐point Oral 5‐ASA vs placebo | RR 0.69 [0.62, 0.77] | 7 studies · 1298 participants | High |
Any adverse event Oral 5‐ASA vs placebo | RR 0.94 [0.77, 1.15] | 3 studies · 774 participants | Moderate Downgraded: imprecision |
Withdrawal due to adverse event Oral 5‐ASA vs placebo | RR 0.86 [0.46, 1.63] | 5 studies · 1096 participants | Moderate Downgraded: imprecision |
Oral 5‐ASA versus SASP for maintenance of remission in ulcerative colitis
Population: Patients with quiescent ulcerative colitis
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure to maintain clinical or endoscopic remission at study end‐point Oral 5‐ASA vs SASP | RR 1.14 [1.03, 1.27] | 12 studies · 1655 participants | High |
Any adverse event Oral 5‐ASA vs SASP | RR 1.07 [0.82, 1.4] | 7 studies · 1138 participants | Moderate Downgraded: imprecision |
Withdrawal due to adverse event Oral 5‐ASA vs SASP | RR 1.27 [0.87, 1.87] | 10 studies · 1585 participants | Moderate Downgraded: imprecision |
Once daily dosing versus conventional dosing for maintenance of remission in ulcerative colitis
Population: Patients with quiescent ulcerative colitis
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure to maintain clinical or endoscopic remission at 6 months Once daily dosing vs conventional dosing | RR 1.02 [0.85, 1.23] | 3 studies · 1871 participants | Low Downgraded: risk of bias |
Failure to maintain clinical or endoscopic remission at 12 months Once daily dosing vs conventional dosing | RR 0.92 [0.83, 1.03] | 7 studies · 2826 participants | Moderate Downgraded: risk of bias, imprecision |
Failure to adhere to study medication regimen Once daily dosing vs conventional dosing | RR 1.21 [0.9, 1.63] | 5 studies · 1161 participants | Moderate Downgraded: risk of bias, imprecision |
Development of any adverse event Once daily dosing vs conventional dosing | RR 1 [0.89, 1.11] | 4 studies · 1587 participants | High |
Withdrawal due to adverse events Once daily dosing vs conventional dosing | RR 1.26 [0.76, 2.1] | 6 studies · 3436 participants | Low Downgraded: risk of bias, imprecision |
Oral 5‐ASA versus alternative 5‐ASA formulation for maintenance of remission in ulcerative colitis
Population: Patients with quiescent ulcerative colitis
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure to maintain clinical or endoscopic remission at 12 months Oral 5‐ASA vs alternative 5‐ASA formulation | RR 1.01 [0.8, 1.28] | 5 studies · 457 participants | Low Downgraded: imprecision |
Development of any adverse event Oral 5‐ASA vs alternative 5‐ASA formulation | RR 0.94 [0.83, 1.07] | 4 studies · 357 participants | Low Downgraded: risk of bias, imprecision |
Withdrawal due to adverse events Oral 5‐ASA vs alternative 5‐ASA formulation | RR 1.25 [0.56, 2.78] | 5 studies · 457 participants | Low Downgraded: risk of bias, imprecision |
High dose oral 5‐ASA versus low dose 5‐ASA for maintenance of remission in ulcerative colitis
Population: Patients with quiescent ulcerative colitis
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure to maintain clinical or endoscopic remission at 12 months High dose oral 5‐ASA vs low dose 5‐ASA | RR 0.76 [0.21, 2.79] | 2 studies · 216 participants | Very low Downgraded: imprecision, inconsistency |