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Study Title and Description

Randomised clinical trial: mesalazine versus placebo in the prevention of diverticulitis recurrence. -B



Key Questions Addressed
4 KEY QUESTION 4 KQ 4: What are the effects, comparative effects, and harms of pharmacological interventions (e.g., mesalamine), non-pharmacological interventions (e.g., medical nutrition therapy), and elective surgery to prevent recurrent diverticulitis? • Do the (comparative) effects and harms vary by patient characteristics, course of illness, or other factors?
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Primary Publication Information
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TitleData
Title Randomised clinical trial: mesalazine versus placebo in the prevention of diverticulitis recurrence. -B
Author Kruis W., Kardalinos V., Eisenbach T., Lukas M., Vich T., Bunganic I., Pokrotnieks J., Derova J., Kondrackiene J., Safadi R., Tuculanu D., Tulassay Z., Banai J., Curtin A., Dorofeyev AE., Zakko SF., Ferreira N., Björck S., Diez Alonso MM., Mäkelä J., Talley NJ., Dilger K., Greinwald R., Mohrbacher R., Spiller R.
Country Cologne, Germany.
Year 2017
Numbers Pubmed ID: 28543263

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Extraction Form for KQs 2 and 4
Arms
Number Title Description Comments
1 Pharm: 5-ASA (1.5 g/d)
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2 Pharm: 5-ASA (3.0 g/d)
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3 Placebo
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Design Details
Question... Follow Up Answer Follow-up Answer
Specific KQ KQ 2b: Antibiotics (acute)
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KQ 2b: Antibiotics (acute)
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KQ 2b: Antibiotics (acute)
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KQ 2b: Antibiotics (acute)
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KQ 2b: Antibiotics (acute)
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Study Design RCT
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RCT
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RCT
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RCT
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RCT
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Country USA
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Germany
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USA
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Germany
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USA
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Germany
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USA
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Germany
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USA
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Germany
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Funder Not reported (or unclear)
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Study name SAG-57
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Associated articles
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ClinicalTrials.gov identifier NCT01038739
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Start and end years of the Study 2010
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2013
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Inclusion criteria 30-80 yrs old. Prior diagnosis of left-sided uncomplicated acute diverticulitis confirmed by ultrasonography or CT with >=1 diverticulum in the left colon. Assessment of colonic wall thickening by ultrasonography or CT was required. Prior episode of left-sided uncomplicated diverticulitis was within the preceding 6 months and has been brought to clinical remission with antibiotics and/or dietary modification, documented by medical records. ≥3 of the following symptoms at the start of the most recent episode of diverticulitis: left lower quadrant pain, fever, altered bowel habit (diarrhoea, constipation, passage of mucus, or urgency) and systemic signs (nausea, lethargy). CRP > ULN at start of most recent attack.
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Exclusion criteria Chronic IBD. Complicated diverticulitis (diverticulitis with associated abscess, fistula, obstruction or perforation), right-sided diverticulitis, previous colonic surgery, symptomatic organic disease of the GI tract, active colorectal cancer or history of colorectal cancer, active malignancy other than colorectal cancer or TX with anticancer drugs during the previous 5 yrs, haemorrhagic diathesis, active peptic ulcer disease, local intestinal infection, asthma without careful medical monitoring, abnormal hepatic function or liver cirrhosis, abnormal renal function, severe co-morbidity and/or immobility. Patients who received mesalazine-containing drugs, glucocorticosteroids, opioid analgesics, laxatives, antidiarrhoeals, immunosuppressants or non-steroidal anti-inflammatory drugs after the most recent episode.
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Specific population? No (all comers)
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Was diverticulitis diagnosed with CT? CT
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If NRCS, what analytic method was used to account for differences between study arms?
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How was diverticulitis diagnosed Ultrasonography or CT with at least one diverticulum in the left colon.
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Note/Comment about Design (or overall study)
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Baseline Characteristics
Question Pharm: 5-ASA (1.5 g/d) Pharm: 5-ASA (3.0 g/d) Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 30.9 Male 43.3 Male 44.1 Male 38.9
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Participant Age - Continuous data (in years) Mean 55.6 Mean 55.2 Mean 55.4 Mean 55.4
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SD 10.4 SD 11.3 SD 10.3 SD 10.6
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Participant Age - Categorical data No data entered.
Participants with Un/Complicated Diverticulitis No data entered.
Specific Complications of Diverticulitis No data entered.
Number of Prior Episodes of Diverticulitis (categorical) 1 53.7 1 53.3 1 46.8 1 51.2
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2 29.3 2 26.7 2 36.9 2 31.2
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>=3 5.7 >=3 7.7 >=3 9.0 >=3 7.4
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Other_1 (include definition in %) 3: 11.4 Other_1 (include definition in %) 3: 12.2 Other_1 (include definition in %) 3: 7.2 Other_1 (include definition in %) 3: 10.2
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History of (Prior) Complicated Diverticulitis No data entered.
KQ 4: Time Since Last Episode of Diverticulitis Mean 93 days Mean 87 days Mean 88 days Mean 89 days
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SD 44 days SD 44 days SD 45 days SD 44 days
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Median 78 days Median 76 days Median 79 days Median 78 days
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Range 5-223 days Range 8-212 days Range 22-219 days Range 5-223 days
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Note/Comment about baseline characteristics All information was retrieved from the supplementary table S1. All information was retrieved from the supplementary table S1. All information was retrieved from the supplementary table S1. All information was retrieved from the supplementary table S1.
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Number of Prior Episodes of Diverticulitis (continuous) Mean 93 days Mean 87 days Mean 88 days Median 78 days
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SD 44 days SD 44 days SD 45 days Range 5-223 days
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Results & Comparisons


Results Data
P-Value P-Value
Outcome: Without recurrence      Population: All Participants Between-Arm Comparisons
Time Point Measure Pharm: 5-ASA (1.5 g/d) Pharm: 5-ASA (3.0 g/d) Placebo Comparison Measure Pharm: 5-ASA (3.0 g/d) vs. Placebo


48 weeks

 N Analyzed 87 75 81 0.520
Counts 40 39 47
Percentage 46 52 58


96 weeks

 N Analyzed 58 51 52 0.110
Counts 4 5 12
Percentage 6.9 9.8 23.1
Outcome: Without recurrence      Population: 1 episode
Time Point Measure Pharm: 5-ASA (1.5 g/d) Pharm: 5-ASA (3.0 g/d) Placebo


48 weeks

 N Analyzed 47 38 33
Counts 26 21 20
Percentage 55.3 55.3 60.6


96 weeks

 N Analyzed
Counts
Percentage
Outcome: Without recurrence      Population: >1 episode
Time Point Measure Pharm: 5-ASA (1.5 g/d) Pharm: 5-ASA (3.0 g/d) Placebo


48 weeks

 N Analyzed 40 37 48
Counts 14 18 27
Percentage 35 48.6 56.3


96 weeks

 N Analyzed
Counts
Percentage
Hazard Ratio (HR) 95% CI low 95% CI high P-Value
Outcome: Recurrence of diverticulitis      Population: All Participants Between-Arm Comparisons
Time Point Measure Pharm: 5-ASA (1.5 g/d) Pharm: 5-ASA (3.0 g/d) Placebo Comparison Measure Pharm: 5-ASA (1.5 g/d) vs. Placebo Pharm: 5-ASA (3.0 g/d) vs. Placebo


48 weeks

 N Analyzed 87 75 81 0.74 1.02
Counts 15 15 17 0.38 0.53
Percentage 17.2 20 21 1.43 1.94
0.369 0.957
Outcome: Time to recurrence      Population: All Participants
Time Point Measure Pharm: 5-ASA (1.5 g/d) Pharm: 5-ASA (3.0 g/d) Placebo


48 weeks

 SD 134 125 162
Mean 116 191 147


Quality Dimensions
Dimension Value Notes Comments
Q14: Cochrane - Random sequence generation (selection bias): Selection bias (biased allocation to interventions) due to inadequate generation of a randomized sequence Low Randomization was performed by means of a computer-generated randomization list, using randomly permuted blocks
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Q15: Cochrane - Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment Low The appearance and size of the placebo treatments were indistinguishable from the active mesalazine treatments and both patients and investigator were unaware of the treatment assignment.
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Q16: Cochrane - Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study Low Double-blind
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Q17: Cochrane - Blinding of personnel/ care providers (performance bias): Performance bias due to knowledge of the allocated interventions by personnel/care providers during the study. Low Double-blind
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Q18: Cochrane - FOR OBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. Yes Low risk of detection bias because outcome assessors were blinded (NCT).
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data Low Missing outcome data was balanced in numbers, with similar reasons for missing data across both groups. Reasons for discontinuation are provided in Figure 1A and results section 3.1.
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting Low Study protocol is unavailable, but expected outcomes were reported.
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Q22: Cochrane - Other Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes. Low Study appears to be free of other sources of bias.
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Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study?
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Q3: ROBINS-I 1.4. Did the authors use an appropriate analysis method that controlled for all the important confounding domains?
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Q4: ROBINS-I 1.5. If Y/PY to 1.4: Were confounding domains that were controlled for measured validly and reliably by the variables available in this study?
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Q5: ROBINS-I 1.6. Did the authors control for any post-intervention variables that could have been affected by the intervention?
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Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING
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Q7: ROBINS-I 2.1. Was selection of participants into the study (or into the analysis) based on participant characteristics observed after the start of intervention?
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Q8: ROBINS-I 2.2. If Y/PY to 2.1: Were the post-intervention variables that influenced selection likely to be associated with intervention?
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Q9: ROBINS-I 2.3 If Y/PY to 2.2: Were the post-intervention variables that influenced selection likely to be influenced by the outcome or a cause of the outcome?
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Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants?
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Q12: ROBINS-I 2.5. If Y/PY to 2.2 and 2.3, or N/PN to 2.4: Were adjustment techniques used that are likely to correct for the presence of selection biases?
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Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY
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Q2: Did the study divide the follow up time of each individual participant into the different interventions?
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Q11: Did the start and follow up calendar years coincide for most participants in the study?
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Q19: Cochrane - FOR SUBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. Yes Low risk of detection bias because patients were blinded.
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Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described?
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Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population?
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Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants?
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Quality Rating
No quality rating data was found.