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Study Title and Description

One year intermittent rifaximin plus fibre supplementation vs. fibre supplementation alone to prevent diverticulitis recurrence: a proof-of-concept study.



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 One year intermittent rifaximin plus fibre supplementation vs. fibre supplementation alone to prevent diverticulitis recurrence: a proof-of-concept study.
Author Lanas A., Ponce J., Bignamini A., Mearin F.
Country Service of Digestive Diseases, University Hospital Lozano Blesa, IIS Aragón, CIBERehd, University of Zaragoza, Spain. alanas@unizar.es
Year 2013
Numbers Pubmed ID: 23092785

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: Rifaximin intermittent rifaximin plus fibre supplementation
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2 Placebo fibre supplementation
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Design Details
Question... Follow Up Answer Follow-up Answer
Specific KQ KQ 4a: Pharmacologic (recur prev)
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KQ 4a: Pharmacologic (recur prev)
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KQ 4a: Pharmacologic (recur prev)
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KQ 4a: Pharmacologic (recur prev)
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Study Design RCT
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Country ... Specify Other ... Spain
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Funder Industry (fully or in part)
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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 2007
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2008
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Inclusion criteria adult outpatients ≥18years old of either sex with 1 or more recent (within the last two months prior to enrolment) episodes of acute diverticulitis but in remission at the time of enrolment. The recent acute episodes were to be confirmed by CT scan, ultrasonography or endoscopy as routinely applied at the individual centre, in addition to have suffered at least 2 out of these 3 sign/symptoms: fever, leukocytosis and/or pain or tenderness at physical exploration of the abdomen
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Exclusion criteria patients with acute episode at recruitment, with history of intolerance or allergy to rifaximin or study drugs, with cancer or other disease limiting life expectancy, immunodepressed, in poor health conditions, with severe renal, hepatic or cardiac insufficiency, pregnant or lactating women
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Specific population? No (all comers)
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Was diverticulitis diagnosed with CT? ... Unclear/Multiple methods (explain) ... CT scan, ultrasonography or endoscopy
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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 The recent acute episodes were to be confirmed by CT scan, ultrasonography or endoscopy as routinely applied at the individual centre, in addition to have suffered at least 2 out of these 3 sign/symptoms: fever, leukocytosis and/or pain or tenderness at physical exploration of the abdomen.
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Note/Comment about Design (or overall study) The trial was switched from evidence-gathering to proof-of-concept because the recruitment rate was largely below the minimum anticipated to ensure appropriate consistency of the monitored population.
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Baseline Characteristics
Question Pharm: Rifaximin Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 66.2 Male 62.5
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Participant Age - Continuous data (in years) Mean 53.6 Mean 54.7
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SD 12.0 SD 13.2
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Participant Age - Categorical data No data entered.
Participants with Un/Complicated Diverticulitis Not reported Not reported
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Specific Complications of Diverticulitis No data entered.
Number of Prior Episodes of Diverticulitis (categorical) Other_1 (include definition in %) patients had to be with 1 or more recent (within the last two months prior to enrolment) episodes of acute diverticulitis but in remission at the time of enrolment. Other_1 (include definition in %) patients had to be with 1 or more recent (within the last two months prior to enrolment) episodes of acute diverticulitis but in remission at the time of enrolment.
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History of (Prior) Complicated Diverticulitis Not reported Not reported
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KQ 4: Time Since Last Episode of Diverticulitis Median 51 Median 50
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IQR 45-60 IQR 41-59
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Note/Comment about baseline characteristics No data entered.
Number of Prior Episodes of Diverticulitis (continuous) Not reported Not reported
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Results & Comparisons


Results Data
Odds Ratio (OR) 95% CI low 95% CI high P-Value
Outcome: Recurrence of diverticulitis      Population: All Participants Between-Arm Comparisons
Time Point Measure Pharm: Rifaximin Placebo Comparison Measure Pharm: Rifaximin vs. Pharm: Rifaximin


Enter a numeric value or title (required) years

N Analyzed 77 88 3.20
Counts 8 17 1.16
Percentage 10.4 19.3 8.82
0.025
Outcome: Hospitalization (or re-hospitalization) for diverticulitis (avoidance)      Population: All Participants
Time Point Measure Pharm: Rifaximin Placebo


Enter a numeric value or title (required) years

N Analyzed 77 88
Counts 2 6
Percentage 3 7
P-Value
Outcome: Adverse event - any      Population: All Participants Between-Arm Comparisons
Time Point Measure Pharm: Rifaximin Placebo Comparison Measure Pharm: Rifaximin vs. Placebo


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N Analyzed 77 88 0.225
Counts 17 13
Percentage 22.1 14.8


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
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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
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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. High The number of patients was insufficient to yield probative information. With the number of patients actually recruited, and in view of the hetero- geneity of recruitment rate across centres, several considerations can be hinted but not definitely confirmed; thus the study can only be considered a proof-of-concept.
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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.