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Study Title and Description

Effects of Burdock tea on recurrence of colonic diverticulitis and diverticular bleeding: An open-labelled randomized clinical trial.



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 Effects of Burdock tea on recurrence of colonic diverticulitis and diverticular bleeding: An open-labelled randomized clinical trial.
Author Mizuki A., Tatemichi M., Nakazawa A., Tsukada N., Nagata H., Kinoshita Y.
Country Department of Internal Medicine, Keiyu Hospital, Yokohama, Japan. amizuki2@yahoo.co.jp.
Year 2019
Numbers Pubmed ID: 31043657

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 Burdock tea
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2 No intervention (non-placebo)
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Design Details
Question... Follow Up Answer Follow-up Answer
Specific KQ KQ 4b: Non-Pharmacologic (recur prev)
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KQ 4b: Non-Pharmacologic (recur prev)
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Study Design RCT
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RCT
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Country ... Specify Other ... Japan
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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 2012
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2017
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Inclusion criteria Diagnosed with CDB or uncomplicated ACD and aged between 20 and 85 years
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Exclusion criteria colon cancer, intestinal bowel disease, pregnancy, severe comorbidities, acute appendicitis, history of colonic surgery or colon cancer
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Specific population? No (all comers)
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Was diverticulitis diagnosed with CT? ... Unclear/Multiple methods (explain) ... Confirmed by CT and/or US
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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 Acute colonic diverticulitis was suspected in patients with lower abdominal pain, abdominal tenderness on physical examination, and leukocytosis on laboratory testing. The diagnosis was confirmed by ultrasound (US) and/or CT. All patients who met the inclusion criteria and did not meet the exclusion criteria were enrolled into the study, regardless of whether the ACD was right-sided or left-sided.
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Note/Comment about Design (or overall study)
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Baseline Characteristics
Question Burdock tea No intervention (non-placebo) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 55.3 Male 47.7 Male 51.6
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Participant Age - Continuous data (in years) Mean 48 Mean 53
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Range 24-82 Range 27-79
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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) Other_1 (include definition in %) 18% (number of prior episodes not clear) Other_1 (include definition in %) 8% (number of prior episodes not clear)
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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
P-Value
Outcome: Recurrence of diverticulitis      Population: All Participants Between-Arm Comparisons
Time Point Measure Burdock tea No intervention (non-placebo) Comparison Measure Burdock tea vs. No intervention (non-placebo)


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N Analyzed 47 44 0.013
Counts 5 14
Percentage 10.6 31.8
P-Value
Outcome: Acute Colonic Diverticulitis free time      Population: All Participants Between-Arm Comparisons
Time Point Measure Burdock tea No intervention (non-placebo) Comparison Measure Burdock tea vs. No intervention (non-placebo)


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N Analyzed 47 44 0.012
Mean 59.3 45.1
95% CI low 54 37.1
95% CI high 64.7 53


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 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. No Data
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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. Low
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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. No Data
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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.