Study Preview
Study Title and Description
A randomized double-blind placebo-controlled trial of a multi-strain probiotic in treatment of symptomatic uncomplicated diverticular disease.-B
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? |
Primary Publication Information
Title | A randomized double-blind placebo-controlled trial of a multi-strain probiotic in treatment of symptomatic uncomplicated diverticular disease.-B |
Author | Kvasnovsky CL., Bjarnason I., Donaldson AN., Sherwood RA., Papagrigoriadis S. |
Country | University of Maryland Medical Center, Baltimore, MD, USA. |
Year | 2017 |
Numbers |
Pubmed ID: 28528364 |
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: Probiotics | Symprove | |
2 | Placebo |
Question... Follow Up | Answer | Follow-up Answer | |
---|---|---|---|
Specific KQ | KQ 4a: Pharmacologic (recur prev) | ||
KQ 4a: Pharmacologic (recur prev) | |||
Study Design | RCT | ||
RCT | |||
RCT | |||
Country | USA | ||
Canada | |||
Germany | |||
Other ... | Finland, Hungary, Italy, Netherlands, Romania, South Africa (from NCT) | ||
Funder | Industry (fully or in part) | ||
Study name | |||
Associated articles | |||
ClinicalTrials.gov identifier | NCT02115867 | ||
Start and end years of the Study | 2007 | ||
2011 | |||
Inclusion criteria | Persistent abdominal symptoms (of >= 3-month duration) w/ a diagnosis of uncomplicated diverticulosis (diagnosis of diverticulosis established by colonoscopy and/or CT scan, with or without raised inflammatory markers, and without a past diagnosis of IBS). | ||
Exclusion criteria | Surgery for diverticulitis or its attendant complications, right-sided diverticulitis, and predominant bleeding symptoms. | ||
Specific population? | No (all comers) | ||
Was diverticulitis diagnosed with CT? ... | Unclear/Multiple methods (explain) ... | Colonoscopy and/or CT | |
If NRCS, what analytic method was used to account for differences between study arms? | |||
How was diverticulitis diagnosed | Colonoscopy and/or CT scan, w/ or w/o raised inflammatory markers, and without a past diagnosis of IBS | ||
Note/Comment about Design (or overall study) |
Baseline Characteristics
Question | Pharm: Probiotics | Placebo | Total | Comments | |||
---|---|---|---|---|---|---|---|
Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | ||
Participant race/ethnicity characteristics | Male | 55.6 | Male | 44.4 | |||
White | 51.7 | White | 48.3 | ||||
Black | 50 | Black | 50 | ||||
Other (or specific) race/ethnicity 1 - include race/ethnicity in parentheses | 33.3 | Other (or specific) race/ethnicity 1 - include race/ethnicity in parentheses | 66.7 | ||||
Participant Age - Continuous data (in years) | Median | 60 | Median | 63.5 | |||
IQR | 52-72 | IQR | 54-72.5 | ||||
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) | No data entered. | ||||||
History of (Prior) Complicated Diverticulitis | No data entered. | ||||||
KQ 4: Time Since Last Episode of Diverticulitis | No data entered. | ||||||
Note/Comment about baseline characteristics | No data entered. | ||||||
Number of Prior Episodes of Diverticulitis (continuous) | No data entered. |
Results & Comparisons
Results Data
Outcome: Acute Colonic Diverticulitis free time Population: All Participants | Between-Arm Comparisons | ||||
---|---|---|---|---|---|
Time Point | Measure | Pharm: Probiotics | Placebo | Comparison Measure | Pharm: Probiotics vs. Placebo |
Enter a numeric value or title (required) years |
N Analyzed | NR | NR | 0.12 | |
Percentage | 4 | 32 | 0.01 | ||
0.97 |
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 | No | Randomization performed with a computerized protocol. | |
Q15: Cochrane - Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment | No | The placebo and probiotic were packaged in identical sealed boxes, identified by a trial batch/code number only. | |
Q16: Cochrane - Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study | No | Double-blind | |
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. | No | Double-blind | |
Q18: Cochrane - FOR OBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. | No | Outcome assessors were blinded (from NCT). | |
Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data | No | Reasons for missing data were <20% for short-term follow-up and reasons for missing outcome data were explained. | |
Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting | Yes | Poorly reported, post hoc, subgroup analysis that is likely highly at risk for reporting bias. | |
Q22: Cochrane - Other Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes. | No | Study appears to be free of other sources of bias. | |
Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study? | |||
Q3: ROBINS-I 1.4. Did the authors use an appropriate analysis method that controlled for all the important confounding domains? | |||
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? | |||
Q5: ROBINS-I 1.6. Did the authors control for any post-intervention variables that could have been affected by the intervention? | |||
Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING | |||
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? | |||
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? | |||
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? | |||
Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants? | |||
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? | |||
Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY | |||
Q2: Did the study divide the follow up time of each individual participant into the different interventions? | |||
Q11: Did the start and follow up calendar years coincide for most participants in the study? | |||
Q19: Cochrane - FOR SUBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. | Yes | Outcome assessors were blinded (from NCT). | |
Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described? | |||
Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population? | |||
Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? |
Quality Rating
No quality rating data was found.