CI: Enteral Nutrition and Fiber (2011)
Emery EA, Ahmad S, Koethe JD, Skipper A, Perlmutter S, Paskin DL. Banana flakes control diarrhea in enterally fed patients. Nutr Clin Pract. 1997 Apr;12(2):72-5.PubMed ID: 9155405
Evaluate effectiveness of banana flakes in reducing severity of diarrhea in critically-ill patients who receive EN.
- Critically-ill patient in either ICU or a step-down unit
- Receiving EN
- Diarrhea of three or more days duration.
- Age under 18 or over 90 years
- Administration of lactulose or sodium polystyrene sulfonate within 72 hours prior to or during the study period
- Need for tightly restricted potassium intake
- Inflammatory bowel disease
- Short bowel syndrome
- Documented protein or carbohydrate malabsorptioon
- EN duration less than three days.
Patients meeting inclusion criteria.
- Randomized by birthdate to receive either routine medical treatment or banana flakes for diarrhea.
Not blinded (medical personnel knew whether patients were receiving banana flakes or medical treatment for diarrhea).
- Treatment Group: Banana flakes, one to two tablespoons administered every eight hours and increasing to three tablespoons every eight hours, according to clinical judgment of the dietitian or physician (dried banana flakes contain 6.25g carbohydrates, 0.5g fiber, negligible protein and fat)
- Control Group: Routine medical treatment (included tincture of opium, diphenoxylate hydrochloride, loperamide and kaolin).
- Parametric statistics to analyze group differences for all seven days
- Since all data were highly positively skewed, raw Hart scores were transformed into natural logarithms to normalize data
- Mann-Whitney U-test for analysis
- Fisher's exact test to compare numbers of patients testing positive for C.difficile toxin.
Timing of Measurements
- Diarrhea was measured with each bowel movement
- Biochemical profile was monitored at least three times weekly
- Treatment continued until diarrhea resolved or patients transferred from study unit
- Any patient with less than three diarhea were dropped from study.
Diarrhea (measured by scale developed by Hart and Dobb).
Treatment with banana flakes or medicine (control group).
- All patients received full-strength, lactose-free fiber-free feeding formulas that ranged is osmolality from 300mOsm to 690mOsm per kg
- Formulas administered via pump as continuous drip, starting at 20ml to 40ml per hour and advancing as tolerated with a goal of 30kcal to 35kcal per kg body weight.
31 (no gender given).
Attrition (Final N)
- Medical Treatment (control) Group: 51 to 87 years
- Banana Flakes (treatment) Group: 41 to 78 years.
Other Relevant Demographics
- One patient in the Medical Treatment (control) Group had jejunostomy tube, one had PEG and the remainder nasoenteric feeding tubes
- Banana Flakes Group: Three had PEG, two jejunostomy and the remainder were fed by nasoenteric tube
- No APACHE II scores or other indicators of illness severity
Banana Flakes (treatment) Group
Control (medical treatment) Group
Statistical Significance of Group Difference
Duration of Treatment (days)
Mean Diarrhea Score
C. Difficile Positive
|Diarrhea-Free on Last Treatment Day||
Cost of banana flakes was less than medical treatment.
Banana flakes can be given concurrently with workup for C. difficile. This expedites treatment of diarrhea.
|University/Hospital:||Pennsylvania Hospital, Philadelphia, PA|
- This study received a neutral-quality rating because it was difficult to determine whether the two groups were comparable: There was no Table One, giving distribution of disease status, prognostic factors and other factors (e.g., demographics) similar across study groups at baseline
- It is likely this study was underpowered: There was no power analysis and all findings were negative.
Quality Criteria Checklist: Primary Research
|1.||Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)||Yes|
|2.||Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?||Yes|
|3.||Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?||Yes|
|4.||Is the intervention or procedure feasible? (NA for some epidemiological studies)||Yes|
|1.||Was the research question clearly stated?||Yes|
|1.1.||Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?||Yes|
|1.2.||Was (were) the outcome(s) [dependent variable(s)] clearly indicated?||Yes|
|1.3.||Were the target population and setting specified?||Yes|
|2.||Was the selection of study subjects/patients free from bias?||Yes|
|2.1.||Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?||Yes|
|2.2.||Were criteria applied equally to all study groups?||Yes|
|2.3.||Were health, demographics, and other characteristics of subjects described?||No|
|2.4.||Were the subjects/patients a representative sample of the relevant population?||Yes|
|3.||Were study groups comparable?||???|
|3.1.||Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)||Yes|
|3.2.||Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?||???|
|3.3.||Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)||Yes|
|3.4.||If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?||N/A|
|3.5.||If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)||N/A|
|3.6.||If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?||N/A|
|4.||Was method of handling withdrawals described?||Yes|
|4.1.||Were follow-up methods described and the same for all groups?||Yes|
|4.2.||Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)||Yes|
|4.3.||Were all enrolled subjects/patients (in the original sample) accounted for?||Yes|
|4.4.||Were reasons for withdrawals similar across groups?||N/A|
|4.5.||If diagnostic test, was decision to perform reference test not dependent on results of test under study?||N/A|
|5.||Was blinding used to prevent introduction of bias?||No|
|5.1.||In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?||No|
|5.2.||Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)||Yes|
|5.3.||In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?||N/A|
|5.4.||In case control study, was case definition explicit and case ascertainment not influenced by exposure status?||N/A|
|5.5.||In diagnostic study, were test results blinded to patient history and other test results?||N/A|
|6.||Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?||Yes|
|6.1.||In RCT or other intervention trial, were protocols described for all regimens studied?||Yes|
|6.2.||In observational study, were interventions, study settings, and clinicians/provider described?||N/A|
|6.3.||Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?||Yes|
|6.4.||Was the amount of exposure and, if relevant, subject/patient compliance measured?||Yes|
|6.5.||Were co-interventions (e.g., ancillary treatments, other therapies) described?||Yes|
|6.6.||Were extra or unplanned treatments described?||Yes|
|6.7.||Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?||Yes|
|6.8.||In diagnostic study, were details of test administration and replication sufficient?||N/A|
|7.||Were outcomes clearly defined and the measurements valid and reliable?||Yes|
|7.1.||Were primary and secondary endpoints described and relevant to the question?||Yes|
|7.2.||Were nutrition measures appropriate to question and outcomes of concern?||Yes|
|7.3.||Was the period of follow-up long enough for important outcome(s) to occur?||Yes|
|7.4.||Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?||Yes|
|7.5.||Was the measurement of effect at an appropriate level of precision?||Yes|
|7.6.||Were other factors accounted for (measured) that could affect outcomes?||Yes|
|7.7.||Were the measurements conducted consistently across groups?||Yes|
|8.||Was the statistical analysis appropriate for the study design and type of outcome indicators?||Yes|
|8.1.||Were statistical analyses adequately described and the results reported appropriately?||Yes|
|8.2.||Were correct statistical tests used and assumptions of test not violated?||Yes|
|8.3.||Were statistics reported with levels of significance and/or confidence intervals?||Yes|
|8.4.||Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?||Yes|
|8.5.||Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?||N/A|
|8.6.||Was clinical significance as well as statistical significance reported?||Yes|
|8.7.||If negative findings, was a power calculation reported to address type 2 error?||No|
|9.||Are conclusions supported by results with biases and limitations taken into consideration?||Yes|
|9.1.||Is there a discussion of findings?||Yes|
|9.2.||Are biases and study limitations identified and discussed?||Yes|
|10.||Is bias due to study's funding or sponsorship unlikely?||Yes|
|10.1.||Were sources of funding and investigators' affiliations described?||Yes|
|10.2.||Was the study free from apparent conflict of interest?||Yes|