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Study Title and Description

Long-term treatment with mesalazine and rifaximin versus rifaximin alone for patients with recurrent attacks of acute diverticulitis of colon.



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 Long-term treatment with mesalazine and rifaximin versus rifaximin alone for patients with recurrent attacks of acute diverticulitis of colon.
Author Tursi A., Brandimarte G., Daffinà R.
Country Emergency Division, L. Bonomo Hospital, Andria BA, Italy. antotursi@tiscalinet.it
Year 2002
Numbers Pubmed ID: 12236485

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 + Rifaximin
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2 Pharm: Rifaximin
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Design Details
Question... Follow Up Answer Follow-up Answer
Specific KQ KQ 4a: Pharmacologic (recur prev)
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Study Design RCT
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Country ... Specify Other ... Italy
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Funder Not reported (or unclear)
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Study name
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Associated articles
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ClinicalTrials.gov identifier
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Start and end years of the Study NR
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NR
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Inclusion criteria diverticulitis, presenting with at least two attacks of acute diverticulitis in the previous year
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Exclusion criteria recent antibiotic treatment (~2 weeks), active or recent peptic ulcer, chronic renal failure, allergy to salicylates and other complications of diverticulitis (fistulas, abscesses and/or haemorrhage)
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Specific population? No (all comers)
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Was diverticulitis diagnosed with CT? ... Unclear/Multiple methods (explain) ... colonoscopy or by double contrast X-ray study of the colon
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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 Diagnosis of diverticulitis, defined as inflammation and/or infection associated with diverticula of the colon
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Note/Comment about Design (or overall study)
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Baseline Characteristics
Question Pharm: 5-ASA + Rifaximin Pharm: Rifaximin Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 59.0 Male 61.4 Male 60.1
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Participant Age - Continuous data (in years) Mean 66.5 Mean 62.1 Mean 64.3
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Range 51, 79
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Participant Age - Categorical data No data entered.
Participants with Un/Complicated Diverticulitis Not reported Not reported Not reported
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Specific Complications of Diverticulitis No data entered.
Number of Prior Episodes of Diverticulitis (categorical) 2 82.6 2 84.4 2 83.5
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>=2 17.4 >=2 15.6 >=2 16.5
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History of (Prior) Complicated Diverticulitis Not reported Not reported Not reported
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KQ 4: Time Since Last Episode of Diverticulitis Not reported Not reported Not reported
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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 P-Value P-Value P-Value
Outcome: Return to normal bowel function      Population: All Participants Between-Arm Comparisons
Time Point Measure Pharm: 5-ASA + Rifaximin Pharm: Rifaximin Comparison Measure Pharm: 5-ASA + Rifaximin vs. Pharm: Rifaximin


3 months

N Analyzed 109 109 <0.005
Counts 42 19
Percentage 38.53 17.43


6 months

N Analyzed 109 109 <0.001
Counts 57 33
Percentage 52.77 31.73


9 months

N Analyzed 109 109 <0.001
Counts 71 46
Percentage 66.35 47.42


12 months

N Analyzed 109 109 <0.001
Counts 82 53
Percentage 78.85 59.55
P-Value
Outcome: Recurrence of diverticulitis      Population: All Participants Between-Arm Comparisons
Time Point Measure Pharm: 5-ASA + Rifaximin Pharm: Rifaximin Comparison Measure Pharm: 5-ASA + Rifaximin vs. Pharm: Rifaximin


12 months

N Analyzed 109 109 <0.01
Counts 3 20
Percentage 2.75 17.98
P-Value P-Value P-Value P-Value
Outcome: Resolution of diverticulitis      Population: All Participants Between-Arm Comparisons
Time Point Measure Pharm: 5-ASA + Rifaximin Pharm: Rifaximin Comparison Measure Pharm: 5-ASA + Rifaximin vs. Pharm: Rifaximin


3 months

N Analyzed 109 109 <0.005
Counts 44 19
Percentage 40.36 17.43


6 months

N Analyzed 109 109 <0.001
Counts 68 31
Percentage 62.96 29.80


9 months

N Analyzed 109 109 <0.0001
Counts 79 38
Percentage 73.83 39.27


12 months

N Analyzed 109 109 <0.0005
Counts 89 44
Percentage 85.57 49.43
Outcome: Mortality - All-cause (non-AE)      Population: All Participants
Time Point Measure Pharm: 5-ASA + Rifaximin Pharm: Rifaximin


12 months

N Analyzed 109 109
Counts 1 1
Percentage 0.9 0.9


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 High
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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 High
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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 High
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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. High
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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. Low
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data Low
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting Low
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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.
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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.
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Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described? Yes
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Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population? Yes
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Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? Yes
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Quality Rating
No quality rating data was found.