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Study Title and Description

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



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. -A
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 (3.0 g/d)
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2 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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Study Design RCT
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RCT
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RCT
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Country Germany
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Germany
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Germany
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Funder Not reported (or unclear)
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Study name SAG-37
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Associated articles
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ClinicalTrials.gov identifier NCT00695643
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Start and end years of the Study 2008
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2011
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Inclusion criteria 40-80 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 (3.0 g/d) Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 38.2 Male 44 Male 41.1
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White 100 White 99.4 White 99.7
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Asian 0 Asian 0.6 Asian 0.3
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Participant Age - Continuous data (in years) Mean 58.8 Mean 58.3 Mean 58.6
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SD 9.1 SD 9.5 SD 9.3
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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 55.8 1 54.2 1 55
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2 30.9 2 30.4 2 30.6
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>=3 6.7 >=3 5.4 >=3 6
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Other_1 (include definition in %) 3: 6.7 Other_1 (include definition in %) 3: 9.5 Other_1 (include definition in %) 3: 8.1
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History of (Prior) Complicated Diverticulitis No data entered.
KQ 4: Time Since Last Episode of Diverticulitis Mean 84 days Mean 90 days Mean 87 days
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SD 42 days SD 53 days SD 48 days
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Median 74 days Median 76 days Median 75 days
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Range 3-202 days Range 7-334 days Range 3-334 days
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Note/Comment about baseline characteristics Information about all baseline chars retrieved from the supplementary file. Information regarding race/ethnicity retrieved from the CSR Synopsis PDF. Information about all baseline chars retrieved from the supplementary file. Information regarding race/ethnicity retrieved from the CSR Synopsis PDF. Information about all baseline chars retrieved from the supplementary file. Information regarding race/ethnicity retrieved from the CSR Synopsis PDF.
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Number of Prior Episodes of Diverticulitis (continuous) No data entered.



Results & Comparisons


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


48 weeks

N Analyzed 165 168 0.226
Counts 112 125
Percentage 67.9 74.4
Outcome: Without recurrence      Population: 1 episode
Time Point Measure Pharm: 5-ASA (3.0 g/d) Placebo


48 weeks

N Analyzed 92 91
Counts 61 71
Percentage 66.3 78
Outcome: Without recurrence      Population: >1 episode
Time Point Measure Pharm: 5-ASA (3.0 g/d) Placebo


48 weeks

N Analyzed 73 76
Counts 51 54
Percentage 69.9 71.1
Hazard Ratio (HR) 95% CI low 95% CI high
Outcome: Recurrence of diverticulitis      Population: All Participants Between-Arm Comparisons
Time Point Measure Pharm: 5-ASA (3.0 g/d) Placebo Comparison Measure Pharm: 5-ASA (3.0 g/d) vs. Placebo


48 weeks

N Analyzed 165 168 0.60
Counts 31 20 0.34
Percentage 18.8 11.9 1.05
Outcome: Adverse event - any      Population: All Participants
Time Point Measure Pharm: 5-ASA (3.0 g/d) Placebo


48 weeks

N Analyzed 387 285
Counts 327 225
Percentage 85 79
Outcome: AE - Serious (SAE)      Population: All Participants
Time Point Measure Pharm: 5-ASA (3.0 g/d) Placebo


48 weeks

N Analyzed 387 285
Counts 55 29
Percentage 14 10
Outcome: Adverse event - leading to discontinuation      Population: All Participants
Time Point Measure Pharm: 5-ASA (3.0 g/d) Placebo


48 weeks

N Analyzed 387 285
Counts 97 51
Percentage 25 18


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.