H/A: MNT (2009)
Rabeneck L, Palmer A, Knowles JB, Seidehamel RJ, Harris CL, Merkel KL, Risser JMH, Akrabawi SS. A randomized controlled trial evaluating nutrition counseling with or without oral supplementation in malnourished HIV-infected patients. J Am Diet Assoc. 1998; 98: 434-438.PubMed ID: 9550167
The objective of this study was to evaluate the effects of nutrition counseling with or without oral supplementation on malnourished HIV-infected patients.
To be eligible for this study subjects had to be:
- Age 18 years or older
- CD4+ cell count fewer than 500 cells per cubic millimeter
- Less than 90% usual weight-for-height or had an involuntary weight loss of more than 10% body weight in the previous six months
- Able to care for themselves as denoted of a Karnofsky score of 50 or more
- Life expectancy of at least 12 weeks
- If receiving drug therapy, the regimen must have been unchanged for eight weeks.
- Severe diarrhea (more than six watery stools per day for seven or more days)
- Cytomegalovirus or Mycobacterium avium complex infection
- Suspected or treated infection (fever, chills)
- Diagnosis of infection or hospitalization within the preceding two weeks
- Receiving anabolic agents, appetite stimulants or chemotherapy.
HIV-infected patients were recruited from three sources: the Houston Veterans Administration Medical Center Special Medicine clinic, an outpatient facility for HIV-infected veterans; the Thomas Street Clinic, an outpatient facility that serves Harris County (Texas) and the private practices of several physicians in the Houston, TX, area.
The study consisted of a two-week baseline period followed by a six-week treatment period. During the baseline period, patients were seen at weekly intervals (visit one, visit two). At visit one, a history and physical examination were completed, the Karnofsky score was determined and a blood sample was obtained for analysis. A 24-hour dietary recall was obtained. Each patient was instructed about how to use the three-day food records that were to be completed and returned at all subsequent visits. At visit two and all subsequent visits, nutritional status, grip strength, cognitive function and quality-of-life were assessed. At visit three, patients were randomly assigned to either a normal diet (control group) or a normal diet plus oral supplement (supplement group) for six weeks. All patients in both groups received individual nutritional counseling and were told how to consume a diet intended to achieve a specific energy target (approximately 960kcal per day more than estimated total energy expenditure). Patients were seen every two weeks during the treatment period. When a patient's dietary intake did not achieve the energy target, he was counseled by the study dietitian.
The supplemented group was provided with a specialized, medium-chain triglyceride formula suitable for HIV-infected patients with fat malabsorption.
Fisher's exact test was used to evaluate differences in study discontinuation rates and adverse event rates in the treatment groups. All P values were based on two-tailed tests. Differences in baseline variables and in end-point change from baseline were evaluated using either analysis of variance (for baseline age, Karnofsky score, body mass index); and for end-point change in weight, cognitive function, quality-of-life or the Wilcoxon rank sum test (for baseline weight, cognitive function, quality-of-life and of baseline and end-point change in laboratory, skinfold thickness, bioelectrical impedance and grip-strength measurements). Analysis of covariance was also used to evaluate end-point change from baseline in quality-of-life scores.
Timing of Measurements
Measurements were done at baseline and then every two weeks during the six-week treatment phase.
- Nutritional parameters (weight, height, skinfold thickness, grip strength, body composition measures)
- Cognitive function (Buschke selective reminding test, which evaluates recall, short-term recall, long-term storage, long-term retrieval and consistent long-term retrieval)
- Quality-of-life (self-administered questionnaire developed for this study, evaluates physical, emotional function, burden of symptoms and sense of well-being).
Nutrition counseling only vs. nutrition counseling plus oral supplement.
- HIV status
Initial N: 118 men (59 in each treatment group)
Attrition (final N): 99 (49 in supplement group, 50 in the control group)
Age: Mean age: supplementation group, 39 years; control group, 41 years
Ethnicity: Not mentioned
Anthropometrics: Only significant difference between groups is that the total quality-of-life score was higher in the control group (P=0.025) than the supplement group
Location: Houston, Texas.
There were no significant differences in hematologic parameters, CD4+ cell count or serum albumin level. The control group had a median increase in serum triglyceride level of 0.55mmol per liter compared with an increase of 0.02mmol per liter in the supplement group (P=0.04).
No significant differences were observed in weight, body fat, skinfold thickness, grip strength or fat-free mass. There was a significant difference between groups in total body water (change from baseline 0.6kg±0.5kg in supplement group, -0.4kg±0.3kg in control group, P=0.039). Patients in the supplement group experienced improvement in short-term recall (P=0.029) and long-term storage (P=0.047). No difference the total quality-of-life scores was detected.
The proportions of patients in the supplement (56%) and control (50%) groups who achieved 80% or more of energy target were not significantly different.
In the short term, nutrition counseling with our without oral supplementation can achieve a substantial increase in energy intake in approximately 50% of malnourished HIV-infected patients. Further study is needed to evaluate the effects of longer treatment periods on patient outcomes.
- Caloric intake not measured in groups at baseline
- Off the 19 subjects not completing the study, 17 did so for "unrelated reasons." It would have been important to know what those reasons were.
- Potential bias in measurements, especially cognitive function and quality-of-life tests
- Protocol for supplementation not well-described.
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?||Yes|
|2.4.||Were the subjects/patients a representative sample of the relevant population?||???|
|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?||???|
|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%.)||???|
|4.3.||Were all enrolled subjects/patients (in the original sample) accounted for?||Yes|
|4.4.||Were reasons for withdrawals similar across groups?||???|
|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?||N/A|
|5.1.||In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?||N/A|
|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.)||N/A|
|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?||Yes|
|6.2.||In observational study, were interventions, study settings, and clinicians/provider described?||Yes|
|6.3.||Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?||???|
|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?||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?||???|
|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?||No|
|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?||???|
|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)?||Yes|
|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?||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?||???|
|10.1.||Were sources of funding and investigators' affiliations described?||Yes|
|10.2.||Was the study free from apparent conflict of interest?||???|