H/A: MNT (2009)
The purpose of this study was to determine whether a standardized program of complementary therapies in addition to appropriate standard medical care could reduce the progression of HIV disease in a self-selected group of asymptomatic HIV-positive gay males.
Asymptomatic HIV-positive individuals.
None stated.
Recruitment
Subjects were recruited by answering an advertisement in a San Francisco press.
Design
Study subjects were 10 asymptomatic HIV-positive individuals with varying CD4 counts who agreed to modify their diet and lifestyle per the study protocol and to return at three-month intervals for follow-up laboratory and physical examinations. They were compared to with groups. The first comparison group was comprised of asymptomatic HIV-positive gay males who were being followed by the same laboratory during the same time period and had the same medical tests as the study group. The second comparison group was data from published observations of the San Francisco Men's Health Study.
Blinding used
None
Intervention
Participants agreed to follow this program:
- A diet of adequate protein and calories consisting primarily of whole grains, fruits, vegetables, fish, poultry, eggs, seeds, nuts, herbs and spices (preferably naturally grown, harvested locally and in season)
- High-potency multivitamin and mineral capsules (two capsules twice daily), vitamin C (1000mg, two capsules twice daily), vitamin E (400 units, one capsule twice daily), beta carotene (25,000 units, one capsule daily), acidophilus (one capsule twice daily) and Resist (an astragalus-based herbal supplement containing several commonly used Oriental herbs, four capsules three times daily)
- Exercise no less than three times per week. Recommended exercise activities included walking, jogging, swimming and weightlifting.
- Refrain from the use of cigarettes, marijuana, alcohol and other recreational drugs during the study period
- Listen to a 15-minute stress-reduction tape twice daily
- Meet in a professionally facilitated emotional support group monthly.
- Continue the use of standard medical therapies [azidothymidine (AZT), trimethoprim and sulfamethoxazole double-strength (Septra DS), aerosolized pentamidine, etc.] as prescribed by their primary care physician.
Statistical Analysis
Mean values were reported.
Timing of Measurements
Laboratory values were measured at baseline and every three months for 30 months. Five-day diet diary was obtained at the time of enrollment.
Dependent Variables
- CD4 and CD8 counts
- CD4/CD8 ratio
- Complete blood count
- Incidence of significant symptoms (by history and physical exam).
Independent Variables
Participation in the program.
Control Variables
- Sex
- Authors mentioned grouping subjects into two subgroups: CD4 more than 300 and CD4 less than 300.
Initial N: 10 men
Attrition (final N): 10 men
Age: Mean age, 42 years
Ethnicity: Not stated
Other relevant demographics: Subjects were grouped by CD4 levels at baseline
Location: San Francisco Bay area.
Other Findings
- Study subjects' mean CD4 value was 407.8 at baseline, 390.8 at the end of the study (30 months): percentage change, -4.1%
- Comparison group one's mean CD4 number decreased by 18%. Comparison group two's mean CD4 count decreased by 49%.
- At the end of the study (30-month point) the mean CD4 number was 96% of baseline, and hematocrit was also 96% of baseline
- Self-reported stable or improved quality-of-life was reported by nine of the 10 study participants
- Mortality rate was 0%.
These data suggest that patients who are presented counseling on good nutrition, vitamin supplementation, stress reduction, exercising and involving oneself in community potentially can continue to live asymptomatic lives that in quality and length exceed the lives of those HIV-positive individuals not presented such counseling.
Subjects were a self-selected group. Compliance with study program was not measured. Unclear if the supplements were provided by the study staff or if subjects had to purchase (cost prohibitive?). Total number of vitamin/nutritional supplements was 25 capsules per day.
No exclusion criteria listed (co-existing medical conditions?)
Statistical methods not described. Levels of significance not measured.
Comparison group two data was collected 12 to 14 years prior to this study. Have standard treatments changed that would have accounted for the reduced mortality in this study group?
Did authors have bias regarding the Resist supplements?
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Quality Criteria Checklist: Primary Research
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| 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? | No | |
| 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? | ??? | |
| 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? | ??? | |
| 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.) | No | |
| 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? | No | |
| 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? | ??? | |
| 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? | ??? | |
| 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? | ??? | |
| 7.6. | Were other factors accounted for (measured) that could affect outcomes? | ??? | |
| 7.7. | Were the measurements conducted consistently across groups? | ??? | |
| 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? | ??? | |
| 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)? | ??? | |
| 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? | No | |
| 9. | Are conclusions supported by results with biases and limitations taken into consideration? | ??? | |
| 9.1. | Is there a discussion of findings? | Yes | |
| 9.2. | Are biases and study limitations identified and discussed? | ??? | |
| 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? | ??? | |