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Study Title and Description

Intermittent treatment with mesalazine in the prevention of diverticulitis recurrence: a randomised multicentre pilot double-blind placebo-controlled study of 24-month duration.



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 Intermittent treatment with mesalazine in the prevention of diverticulitis recurrence: a randomised multicentre pilot double-blind placebo-controlled study of 24-month duration.
Author Parente F., Bargiggia S., Prada A., Bortoli A., Giacosa A., Germanà B., Ferrari A., Casella G., De Pretis G., Miori G.
Country Gastrointestinal Unit, Gastroenterology and Digestive Endoscopy Division, Ospedale "A. Manzoni", Via dell'Eremo 9/11, 23900, Lecco, Italy, f.parente@ospedale.lecco.it.
Year 2013
Numbers Pubmed ID: 23754545

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
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2 Placebo an identically appearing placebo
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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 Industry (fully or in part)
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Study name
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Associated articles
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ClinicalTrials.gov identifier NCT01120340
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Start and end years of the Study 2005
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2006
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Inclusion criteria age between 18 and 85 years, endoscopic and/or radiologic evidence of diverticular disease of the left colon (already known before the uncomplicated diverticulitis episode or confirmed within the subsequent months), documented (see above) episode of uncomplicated diverticulitis during the last months (maximum 12 months), recruitment which was considered possible only after the complete clinical remission of diverticulitis flare and presence of symptoms attributable to diverticular disease of the colon such as upper and/or lower abdominal pain/discomfort, bloating, tenesmus, diarrhoea, abdominal tenderness, nausea, emesis, fe- ver, dysuria and bleeding.
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Exclusion criteria complicated diverticulitis (fistulas, stenosis, abscesses and/or bleeding), previous colonic surgery, ascertained hypersensitivity to the salicylates, any severe pathology that could interfere with the treatment or the clinical or instrumental test of the trial, clinically significant renal or hepatic impairment, oesophageal, gastric or duodenal ulcer within 30 days prior to randomisation, patients with active malignancy of any type or history of a malignancy (patients with history of malignancies that had been surgically removed and who had no evidence of recurrence for at least 5 years before study enrolment were also acceptable), treatment with any investigational drug within 30 days before enrolment, treatment with lactulose or with any compound that lowering the colonic pH could pre- vent the release of the active moiety from the tablets, recent history or suspicion of alcohol abuse or drug addiction, patients who became unable to conform to protocol, women with ascertained pregnancy
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Specific population? No (all comers)
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Was diverticulitis diagnosed with CT? ... Unclear/Multiple methods (explain) ... U/S or 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 Uncomplicated diverticulitis was initially diagnosed on clinical basis in patients with known or suspected diverticular dis- ease of the colon presenting with abdominal pain, fever and leukocytosis plus increased erythrocyte sedimentation rate/C-reactive protein and subsequently confirmed by a localised thickening of the colonic wall with signs of inflammation of the pericolic fat at abdominal US or CT.
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Note/Comment about Design (or overall study)
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Baseline Characteristics
Question Pharm: 5-ASA Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 44.4 Male 53.2
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Participant Age - Continuous data (in years) Mean 61.9 Mean 61.1
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SD 10.0 SD 12.2
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Range 35-80 Range 23-84
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Participant Age - Categorical data No data entered.
Participants with Un/Complicated Diverticulitis Uncomplicated diverticulitis 100 Uncomplicated diverticulitis 100
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Specific Complications of Diverticulitis No data entered.
Number of Prior Episodes of Diverticulitis (categorical) 0 100 0 100
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History of (Prior) Complicated Diverticulitis No 100 No 100
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KQ 4: Time Since Last Episode of Diverticulitis 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
Outcome: Recurrence of diverticulitis      Population: All Participants Between-Arm Comparisons
Time Point Measure Pharm: 5-ASA Placebo Comparison Measure Pharm: 5-ASA vs. Placebo


2 years

 N Analyzed 45 47 >0.05
Counts 6 13
Percentage 13.3 27.7
Outcome: Adverse event - any      Population: All Participants
Time Point Measure Pharm: 5-ASA Placebo


2 years

 N Analyzed 45 47
Counts 6 3
Percentage 13.3 6.4
Outcome: AE - Serious (SAE)      Population: All Participants
Time Point Measure Pharm: 5-ASA Placebo


2 years

 N Analyzed 45 47
Counts 4 2
Percentage 8.9 4.3
Outcome: AE - severe      Population: All Participants
Time Point Measure Pharm: 5-ASA Placebo


2 years

 N Analyzed 45 47
Counts 8 9
Percentage 17.8 19.2
Outcome: Adverse event - leading to discontinuation      Population: All Participants
Time Point Measure Pharm: 5-ASA Placebo


2 years

 N Analyzed 45 47
Counts 8 4
Percentage 17.8 8.5
P-Value
Outcome: Physical condition      Population: All Participants Between-Arm Comparisons
Time Point Measure Pharm: 5-ASA Placebo Comparison Measure Pharm: 5-ASA vs. Placebo


2 years

 N Analyzed 45 47 0.022
Mean 5.4 8.3
SD 2.7 5.7
P-Value
Outcome: Time to recurrence      Population: All Participants Between-Arm Comparisons
Time Point Measure Pharm: 5-ASA Placebo Comparison Measure Pharm: 5-ASA vs. Placebo


2 years

 N Analyzed 45 47 >0.05
Mean 219.0 369.8
SD 180.0 226.9


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 Unsure
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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 Unsure
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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
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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
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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 High
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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. Low
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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? Unsure 16/92 discontinued due to dropouts or side effects developed
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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.