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Study Title and Description

Mesalamine did not prevent recurrent diverticulitis in phase 3 controlled trials.-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 Mesalamine did not prevent recurrent diverticulitis in phase 3 controlled trials.-A
Author Raskin JB., Kamm MA., Jamal MM., Márquez J., Melzer E., Schoen RE., Szalóki T., Barrett K., Streck P.
Country University of Miami Miller School of Medicine, Miami, Florida. Electronic address: JRaskin@med.miami.edu.
Year 2014
Numbers Pubmed ID: 25038431

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 Placebo
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2 Pharm: 5-ASA (1.2 g/d)
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3 Pharm: 5-ASA (2.4 g/d)
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4 Pharm: 5-ASA (4.8 g/d)
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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 USA
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UK
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Other ... Argentina, Australia, Colombia, France, India, Israel, New Zealand, Spain, Sweden (from NCT)
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Funder Industry (fully or in part)
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Study name PREVENT1
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Associated articles
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ClinicalTrials.gov identifier NCT00545740
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Start and end years of the Study 2007
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2013
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Inclusion criteria >= 18 years. 1 documented episodes of acute diverticulitis in the previous 24 months that resolved w/o colonic resection, and w/o signs/symptoms of diverticulitis within 6 wks of enrollment. Confirmation of diverticulosis via endoscopic evaluation of the sigmoid colon w/ at >= 3 diverticula noted.
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Exclusion criteria Previous colorectal surgery, surgical intervention for diverticular disease (w/ exceptions of hemorrhoidectomy, colonic removal of polyps, appendectomy); no complicated diverticulitis (no perforation or fistulization present on CT); right-sided diverticulosis only; active peptic ulcer disease; history or current IBD. Active irritable bowel syndrome, GI bleeding, endometriosis or dysmenorrhea (6 months before baseline), or current or historical use of biologic drugs, immunomodulators, or systemic/rectal steroids (6 wks before baseline) (from NCT).
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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 Endoscopic confirmation of >= 3 diverticula was required. CT, MRI, ultrasound, colonoscopy, sigmoidoscopy, and barium enema.
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Note/Comment about Design (or overall study)
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Baseline Characteristics
Question Placebo Pharm: 5-ASA (1.2 g/d) Pharm: 5-ASA (2.4 g/d) Pharm: 5-ASA (4.8 g/d) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 48.3 Male 55.2 Male 51.7 Male 52.7 Male 52.8
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White 83 White 79 White 83.2 White 82 White 81.8
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Black 1.4 Black 3.5 Black 1.4 Black 2.7 Black 2.2
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Hispanic/Latino 20.4 Hispanic/Latino 25.9 Hispanic/Latino 25.9 Hispanic/Latino 21.3 Hispanic/Latino 23.3
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Asian 2.7 Asian 2.8 Asian 2.1 Asian 2 Asian 2.4
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Other (or specific) race/ethnicity 1 - include race/ethnicity in parentheses 12.9 Other (or specific) race/ethnicity 1 - include race/ethnicity in parentheses 14.7 Other (or specific) race/ethnicity 1 - include race/ethnicity in parentheses 13.3 Other (or specific) race/ethnicity 1 - include race/ethnicity in parentheses 13.3 Other (or specific) race/ethnicity 1 - include race/ethnicity in parentheses 13.6
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Participant Age - Continuous data (in years) Mean 57.1 Mean 55.1 Mean 54.5 Mean 54.5 Mean 55.3
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SD 10.42 SD 11.11 SD 11.96 SD 11.93 SD 11.39
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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) 0 0 0 0 0 1.4 0 0 0 0.3
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1 60.5 1 55.9 1 60.1 1 56 1 58.1
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2 23.1 2 29.4 2 22.4 2 26.7 2 25.4
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Other_1 (include definition in %) 4-5: 4.8 Other_1 (include definition in %) 4-5: 5.6 Other_1 (include definition in %) 4-5: 7.7 Other_1 (include definition in %) 4-5: 4.0 Other_1 (include definition in %) 4-5: 5.5
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Other_2 (include definition in %) 6-10: 2.7 Other_2 (include definition in %) 6-10: 1.4 Other_2 (include definition in %) 6-10: 1.4 Other_2 (include definition in %) 6-10: 2.7 Other_2 (include definition in %) 6-10: 2.1
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History of (Prior) Complicated Diverticulitis No data entered.
KQ 4: Time Since Last Episode of Diverticulitis Median 14.7 weeks Median 12 weeks Median 12.9 weeks Median 13.6 weeks Median 13 weeks
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Range 0-94 weeks Range 1-419 weeks Range 1-93 weeks Range 1-114 weeks Range 0-419 weeks
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Note/Comment about baseline characteristics No data entered.
Number of Prior Episodes of Diverticulitis (continuous) No data entered.



Results & Comparisons


Results Data
P-Value
Outcome: No recurrence      Population: All Participants Between-Arm Comparisons
Time Point Measure Placebo Pharm: 5-ASA (1.2 g/d) Pharm: 5-ASA (2.4 g/d) Pharm: 5-ASA (4.8 g/d) Comparison Measure Placebo vs. Pharm: 5-ASA (1.2 g/d) Placebo vs. Pharm: 5-ASA (2.4 g/d) Placebo vs. Pharm: 5-ASA (4.8 g/d)


104 weeks

 N Analyzed 147 143 143 150 0.780 0.741 0.047
Counts 95 89 90 79
Percentage 64.6 62.2 62.9 52.7
Outcome: Adverse event - any      Population: All Participants
Time Point Measure Placebo Pharm: 5-ASA (1.2 g/d) Pharm: 5-ASA (2.4 g/d) Pharm: 5-ASA (4.8 g/d)


104 weeks

 N Analyzed 147 143 143 150
Counts 112 109 106 101
Percentage 76.2 76.2 74.1 67.3
Outcome: AE - Serious (SAE)      Population: All Participants
Time Point Measure Placebo Pharm: 5-ASA (1.2 g/d) Pharm: 5-ASA (2.4 g/d) Pharm: 5-ASA (4.8 g/d)


104 weeks

 N Analyzed 147 [1] 143 143 150
Counts 16 16 15 18
Percentage 10.9 11.19 10.49 12
Footnotes
1. From NCT
Outcome: AE - Sepsis (CD IV)      Population: All Participants
Time Point Measure Placebo Pharm: 5-ASA (1.2 g/d) Pharm: 5-ASA (2.4 g/d) Pharm: 5-ASA (4.8 g/d)


104 weeks

 N Analyzed 147 [1] 143 143 150
Counts 0 1 0 1
Percentage 0 0.7 0 0.67
Footnotes
1. From NCT
Outcome: AE - Major cardiac event (CD IV)      Population: All Participants
Time Point Measure Placebo Pharm: 5-ASA (1.2 g/d) Pharm: 5-ASA (2.4 g/d) Pharm: 5-ASA (4.8 g/d)


104 weeks

 N Analyzed 147 [1] 143 143 150
Counts 2 1 0 0
Percentage 1.36 0.70 0 0
Footnotes
1. From NCT
Outcome: AE - Infection requiring Abx (CD II)      Population: All Participants
Time Point Measure Placebo Pharm: 5-ASA (1.2 g/d) Pharm: 5-ASA (2.4 g/d) Pharm: 5-ASA (4.8 g/d)


104 weeks

 N Analyzed 147 143 143 150
Counts 17 14 12 8
Percentage 11.6 9.8 8.4 5.3


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 Patients were randomly assigned in a 1:1:1:1 ratio.
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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 Intervention assigned to each patient was determined by a computer-generated fixed-block randomization schedule.
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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 Patients who completely withdrew from the study before week 104 without a protocol-defined recurrence of diverticulitis were considered dropouts and assumed to be treatment failures for the intention-to-treat primary analysis. Additional sensitivity analyses were performed using different methods for handling dropouts. Reasons for withdrawals are provided in Figure 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 in patient-reported outcomes because participants 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.