UWL: Association With Outcomes (2009)

Citation:
 
Study Design:
Class:
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Quality Rating:
Research Purpose:

To determine the impact of antidepressant treatment on undernutrition in an elderly population after three months of stable treatment.

Inclusion Criteria:
  • Independently mobile outpatients managed by the Poitiers geriatric day hospital for problems of loss of home support, rehabilitation and medical or psychological care
  • All patients lived at home and had conserved physical mobility
  • Only those regularly attending the geriatric day hospital and whose treatment remained stable for six months were included.
Exclusion Criteria:
  • Patients presenting with a progressive inflammatory or cancer or diabetes mellitus (N=22)
  • Patients without a stable treatment (N=7).
Description of Study Protocol:

Recruitment

Independently mobile outpatients managed by the Poitiers geriatric day hospital for problems of loss of home support, rehabilitation and medical or psychological care, who agreed to take part in the study. The vast majority of patients attended the hospital once a week, more rarely twice per week.

Design

Non-randomized Clinical Trial 

Blinding used (if applicable)

Intervention (if applicable)

  • Antidepressant therapies—not specifically described

Statistical Analysis

  • Student's paired T-test was used to determine the statistical significance of nutritional changes over the three months of the study and student's T-test or ANOVA to compare the quantitative results for the different populations
  • The chi-square test was used to compare the sub-populations
  • For anorexia, Wilcoxon test was used to compare variations during the period of the study, and the Mann Whitney test to compare subpopulations.
Data Collection Summary:

Timing of Measurements

The study was implemented from March 1999 to March 2000. The study addressed the time course of nutritional parameters from baseline to three-months post-inclusion. Weighing was done monthly, while the MNA and serum albumin were measured at baseline and at three months. 

Dependent Variables

  • Weight
  • Mini-Nutritional Assessment
  • Serum albumin
  • Cognitive assessment using the Mini Mental State instrument
  • Evaluation of depression using Cornell's scale.

Independent Variables

Antidepressant therapies—not specifically described

Control Variables

 

Description of Actual Data Sample:

Initial N

168 patients attended the geriatric day hospital during the study period, but only 139 patients attending regularly and whose treatment remained stable for six months were included.

Attrition (final N)

139 independently mobile outpatients, 52 men and 87 women

Age

Mean age men: 76.3±6.7 years (range 62 to 87 years), mean age women: 81.0±7.2 years (range 65 to 100 years).

Ethnicity

Not mentioned

Other relevant demographics

Anthropometrics

Location

France

 

Summary of Results:

Change in nutritional parameters over three months of follow-up

Variables Non-demented without Antidepressant (N=26) Non-demented with Antidepressant (N=34) Non-demented with Serotoninergic Antidepressant (N=23) Demented without Antidepressant (N=39)

Demented with Antidepressant (N=40)

Demented with Serotoninergic Antidepressant (n=31)

Change in Weight (kg)

0.40 1.44, P<0.05 1.87, P<0.05 -1.01, P<0.05 0.73, P<0.05 0.68

Change in MNA Score

-0.08 0.76, P<0.05 1.15, P<0.05 -0.70, P<0.05

0.29

0.27

Change in Appetite Score 0.03 0.39, P<0.05 0.74, P<0.05 -0.24, P<0.05 0.28, P<0.05 0.58, P<0.05
Change in Serum Albumin (g/L) 0.04 1.78, P<0.05 2.23, P<0.05 -1.89, P<0.05 0.68 0.42

Other Findings

79 patients presented with dementia (62 of the Alzheimer type, 17 of another type).

74 patients were receiving an antidepressant (34 non-demented and 40 demented):

  • 54 were taking serotonin reuptake inhibitors (23 non-demented and 31 demented)
  • 15 were taking paroxetine
  • 15 were taking fluoxetine
  • 17 were taking citalopram
  • Seven were taking sertraline
  • 14 were taking mianserin
  • Six were taking venlafaxine.

The patients free from dementia and not receiving antidepressants had nutritional indices that did not vary over the study period.

Irrespective of the sub-population compared, demented vs. non-demented, Student's T-test showed a significant difference (P<0.01) for body weight, which was in all cases markedly lower in the demented population.

The dementia-free patients receiving antidepressants gained 1.44kg (1.87kg on serotonin reuptake inhibitors), showed an improvement in MNA of 0.76/30 and showed a significant improvement in serum albumin of 1.78g/L.

The demented patients not receiving antidepressants lost 1.01kg, MNA score fell and serum albumin significantly decreased.

At three months, patients taking antidepressants have a better appetite than non-treated patients (P=0.02).

On antidepressants, the demented patients significantly gained weight (0.73kg) while no deterioration in the other parameters reflecting undernutrition was observed. 

Author Conclusion:

Antidepressant drugs do not induce weight loss or do not affect appetite. They may help prevent undernutrition in demented patients. Antidepressant drugs seem to have a positive effect on nutrition perhaps by correcting the anorexia related to depression.

Funding Source:
Other: Not reported
Reviewer Comments:

Subjects had only been on treatment for six months; measurement period lasted three months. Antidepressant therapies not described. Small numbers of subjects in antidepressant groups.

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? 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? ???
  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? 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? ???
  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.) ???
  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? 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? ???
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? ???
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? N/A
  6.6. Were extra or unplanned treatments described? N/A
  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? 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? 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)? N/A
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? ???
  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? No
  9.1. Is there a discussion of findings? N/A
  9.2. Are biases and study limitations identified and discussed? No
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? No
  10.2. Was the study free from apparent conflict of interest? Yes