Study Preview
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? |
Primary Publication Information
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 | ||
2 | No intervention (non-placebo) |
Question... Follow Up | Answer | Follow-up Answer | |
---|---|---|---|
Specific KQ | KQ 4b: Non-Pharmacologic (recur prev) | ||
KQ 4b: Non-Pharmacologic (recur prev) | |||
Study Design | RCT | ||
RCT | |||
Country ... Specify | Other ... | Japan | |
Funder | Not reported (or unclear) | ||
Study name | |||
Associated articles | |||
ClinicalTrials.gov identifier | |||
Start and end years of the Study | 2012 | ||
2017 | |||
Inclusion criteria | Diagnosed with CDB or uncomplicated ACD and aged between 20 and 85 years | ||
Exclusion criteria | colon cancer, intestinal bowel disease, pregnancy, severe comorbidities, acute appendicitis, history of colonic surgery or colon cancer | ||
Specific population? | No (all comers) | ||
Was diverticulitis diagnosed with CT? ... | Unclear/Multiple methods (explain) ... | Confirmed by CT and/or US | |
If NRCS, what analytic method was used to account for differences between study arms? | |||
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. | ||
Note/Comment about Design (or overall study) |
Baseline Characteristics
Question | Burdock tea | No intervention (non-placebo) | Total | Comments | |||
---|---|---|---|---|---|---|---|
Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | ||
Participant race/ethnicity characteristics | Male | 55.3 | Male | 47.7 | Male | 51.6 | |
Participant Age - Continuous data (in years) | Mean | 48 | Mean | 53 | |||
Range | 24-82 | Range | 27-79 | ||||
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) | |||
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: 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) |
Enter a numeric value or title (required) years |
N Analyzed | 47 | 44 | 0.013 | |
Counts | 5 | 14 | |||
Percentage | 10.6 | 31.8 |
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) |
Enter a numeric value or title (required) years |
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 | ||
Q15: Cochrane - Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment | Low | ||
Q16: Cochrane - Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study | Low | ||
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 | ||
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 | ||
Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data | Low | ||
Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting | Low | ||
Q22: Cochrane - Other Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes. | Low | ||
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. | No Data | ||
Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described? | Yes | ||
Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population? | Yes | ||
Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? | Yes |
Quality Rating
No quality rating data was found.