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ONC: Probiotics (2006)

Citation:
 
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:
To evaluate if the probiotic, VSL/3, prevented diarrhea in patients treated with radiation therapy (XRT) to the pelvic area. Improvement in quality of life and tolerance of probiotic were also being evaluated.
Inclusion Criteria:
  • Performance status of >70 (measure not specified)
  • Diagnosis of colo-rectal carcinoma status-post surgical anterior resection OR uterine cancer status-post hystero annessiectomy
  • XRT to pelvis (range from obturator foramina to the L5-S1 region and laterally to 1.5 cm past the innominate hip)
Exclusion Criteria:
None listed
Description of Study Protocol:

Recruitment occurred from 5/99 to 1/01 at the Division of Oncologic Radiotherapy of the Azienda Policlinico of Messina, Italy.

 

Design: Patients were matched for disease pathology and XRT technique and subdivided into the two groups, intervention (receiving a probiotic preparation) and a control group. All patients were instructed to follow a "mild hypercaloric; hypolipidemic; advised to eat glucides, simple sugars and fructose; normal fiber; with oligopeptide chains as the protein source; and to eat this over 5 feedings daily".

 

Blinding used: N/A

 

Intervention:

Patients were administered one VSL/3 bag three times a day on an empty stomach beginning with the first day of XRT and continuing until the end of XRT treatment.

  • XRT - daily dose of 180 cGy for total of 60-70 Gy
  • XRT field size- 45 Gy
  • XRT duration- 6-7 weeks

    Statistical Analysis

    Descriptive statistics for distribution of subjects by degree of gastroenteric toxicity expressed as WHO diarrhea scores.

     

    • Data Collection Summary:

    Timing of Measurements

    Patients completed 6-7 weeks of XRT and were assessed sometime thereafter (not specified) for gastroenteric toxicity.

    Dependent Variables

    Gastroenteric toxicity using the World Health Organization's toxicity evaluation scores for grading diarrhea.

    Independent Variables

    Administration of one VSL/3 three times a day.

    Control Variables

    Daily XRT only.

    Description of Actual Data Sample:

     

    Initial N: 190 patients (96 female, 94 male)

    Final N: 188 (2 discontinued in control group secondary to acute enteritis)

    • Intervention - 95 patients (no breakdown for sex between groups)
    • Control - 93 patients

    Age range: 45-65 years (no breakdown between groups, mean age not provided)

    Ethnicity: not provided

    Other relevant demographics:

    Anthropometrics: No other anthropometric data provided.

    Location: Division of Oncologic Radiotherapy of the Azienda Policlinico of Messina, Italy.

     

    Summary of Results:

     

    Variables

    Treatment (VSL/3)Group

     

    Control group

     

    Statistical Significance of Group Difference

    % of patients who experienced gastroenteric toxicity

    30.5% (36 of 95)

    50.6% (52 of 93)

    Not provided
    Degree 0 (absent or <= 2 days) 0 4  

    Degree 1 (transitory <= 2 days)

    9

    9

     
    Degree 2 (tolerable > 2 days) 20 11  
    Degree 3 (required treatment) 7 16  

    Degree 4 (hemorrhage or diarrhea)

    0

    12

     

    Numbers represent patient count unless otherwise specified.

     

     

    Author Conclusion:

    The prophylactic treatment with VSL/3 was effective in preventing the occurrence of diarrhea in those patients submitted to radiation therapy.

    Funding Source:
    University/Hospital: University Hospital Messina Italy
    Reviewer Comments:

    Although the study had adequate accrual numbers, this is not a very strong study to support the authors' claims.

    Strengths:

    • Did specify area of XRT
    • Started VSL/3 at beginning of XRT
    • Use of standardized assessment tool for GI toxicity

    Limitations:

    • Limited demographic/descriptors of each study group (stages, weight)
    • Diet guidelines very unspecific
    • Did not check compliance of treatment regimen
    • Did not evaluate pre-XRT GI toxicity
    • Did not evaluate or comment on self-prescribed or other anti-diarrheal agents patients may have been taking
    • Did not indicate when to take treatment regimen (could have taken 3 bags at one time or some other formation of this), did not explain how to take it (mix with water, etc.)
    • Did not exclude patients with GI disorders, diarrhea at start of study, patients receiving chemotherapy
    • Did not explain composition of VSL/3 (except that it had 7 bacterial species), where patients received this (from study or on own), etc.
    • No information on study funding
    • No statistical interpretation
    • Author talks about improving patient's quality of life and tolerance of product but no evaluation was completed on these parameters.

     

    Quality Criteria Checklist: Primary Research
    Relevance Questions
      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
     
    Validity Questions
    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? ???
      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? No
      2.2. Were criteria applied equally to all study groups? Yes
      2.3. Were health, demographics, and other characteristics of subjects described? ???
      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) No
      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.) No
      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? ???
      6.1. In RCT or other intervention trial, were protocols described for all regimens studied? ???
      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? No
      6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? Yes
      6.6. Were extra or unplanned treatments described? No
      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? ???
      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? No
      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? No
      8.1. Were statistical analyses adequately described and the results reported appropriately? No
      8.2. Were correct statistical tests used and assumptions of test not violated? No
      8.3. Were statistics reported with levels of significance and/or confidence intervals? No
      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)? No
      8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? No
      8.6. Was clinical significance as well as statistical significance reported? No
      8.7. If negative findings, was a power calculation reported to address type 2 error? N/A
    9. Are conclusions supported by results with biases and limitations taken into consideration? No
      9.1. Is there a discussion of findings? Yes
      9.2. Are biases and study limitations identified and discussed? No
    10. Is bias due to study's funding or sponsorship unlikely? ???
      10.1. Were sources of funding and investigators' affiliations described? No
      10.2. Was the study free from apparent conflict of interest? ???