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HIV/AIDS

H/A: MNT (2009)

Citation:

Schwenk A, Steuck H, Kremer G. Oral supplements as adjunctive treatment to nutritional counseling in malnourished HIV-infected patients: randomized controlled trial. Clinical Nutrition. 1999; 18(6): 371-374.

PubMed ID: 10634923
 
Study Design:
Randomized Controlled Trial
Class:
A - Click here for explanation of classification scheme.
Quality Rating:
Negative NEGATIVE: See Quality Criteria Checklist below.
Research Purpose:

The purpose of the study was to compare nutritional counseling alone with counseling plus oral supplements in HIV-infected individuals with recent and ongoing weight loss.

Inclusion Criteria:
  • HIV-seropositive
  • Previous weight loss (more than 5% total weight loss)
  • Actively losing weight (more than 3% within the last month).
Exclusion Criteria:
  • During the previous three months the patients had been prescribed:
    • Oral supplements
    • Nutritional counseling
    • Hormonal or appetite stimulant
    • Enteral or parenteral nutrition.
  • Unable to swallow usual food or severe lactose intolerance
  • Initially the study excluded patients whose antiretroviral treatment was changed within one month from study entry, but because the protease inhibitors became the standard of care for any patient with weight loss, a second stratum was opened for patients who started a new treatment including protease inhibitors at study entry.
Description of Study Protocol:

Recruitment

Methods not described. 

Design

Randomized controlled trial.

Blinding used

None.

Intervention

Patients were randomly assigned to one of two groups. Group A received a written list of household measures to increase caloric intake, such as adding butter or cream to usual food. Group B was provided a range of fortified oral supplements ranging from 0.6kcal per ml to 1.5kcal per ml in energy density and were either 200-ml drinks or 125g semi-liquid diet with a soy protein basis; one exception was a maltodextrin-based fruit drink. Packages were labeled according to energy content and patients recorded the intake of units in a diary. They were advised not to replace usual food by supplements.

Nutritional counseling was provided by the same dietitian. All patients were advised to increase their current food intake by 600kcal per day. 

Statistical Analysis

Mann-Whitney U test and Kruskal-Wallis test were used for group comparison, and Wilcoxon test was used for intra-individual comparison. The sample size was adaptively modified, with a planned interim analysis after the 50th included patient. The significance level set at P <0.05.

Data Collection Summary:

Timing of Measurements

Measurements were taken at baseline (week zero) and weeks two, four, six and eight.

Dependent Variables

  • Body composition measured by BIA
  • Body cell mass (BCM)
  • Extracellular mass (ECM)
  • Fat-free mass (FFM)
  • Weight, measured on electronic scale
  • Food intake, via retrospective 24-hour recall.

Independent Variable

HIV-positive status.

 

Description of Actual Data Sample:

Initial N: 50

Attrition (final N): 45

Age: Group A, 39.5±10.2 years; Group B, 39.4±9.2 years

Ethnicity: Unknown

Other relevant demographics: Group A, 21 male (88 %); Group B, 26 male (100%); P=0.06

Anthropometrics: There were no significant differences between groups with regards to age, BMI, CD4 cell count, number of previous AIDS-defining disease episodes and those continuing treatment without protease inhibitor at baseline

Location: Unknown.

 

 

Summary of Results:

  Group A: Counseling   Group B: Counseling + Supplement

Week

Kcal per kg Total

P vs. Baseline

Kcal per kg total

P vs. Baseline

Kcal per kg as Supplement

P Between Groups for Total Intake

0

26.7±5.3

 

25.5±4.9

 

0

0.31

 

2

30.2±5.2

0.006

35.8±6.9

<0.0001

11.0±2.6

0.002

 

4

31.8±7.0

0.002

37.0±6.1

<0.0001

10.8±2.4

0.006

 

6

33.3±8.4

0.005

34.3±6.2

<0.0001

9.7±3.1

0.66

 

8

32.4±8.9

0.006

34.5±7.7

0.0004

9.2±3.5

0.13

 

There were no significant changes in body composition between groups at the end of the eight weeks.

Fat-free mass increased from baseline to week eight (P<0.05) with no differences between groups A and B.

Body cell mass and weight gain were not significant and equal between groups.

Total energy intake was not different between groups at weeks six and eight.

 

Author Conclusion:

Nutritional counseling and oral supplements are both feasible methods to restore food energy intake in malnourished HIV-infected patients. Although normal food is partially replaced, oral supplements may improved the adherence to a weight-gain regimen.

Funding Source:
Industry:
Reviewer Comments:

Recruitment criteria unknown, 24-hour recall may not have been as accurate as a three-day diet diary, do not know activity level of subjects, compliance was not measured, study was not blinded and study was funded by a supplement company.

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? ???
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? Yes
  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? ???
3. Were study groups comparable? No
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) ???
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? No
  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? Yes
  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? No
  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? No
  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? N/A
  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? ???
  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? ???
  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? ???
  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? ???
  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)? ???
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? Yes
  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? ???
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? No
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? No