CD: Gastrointestinal Outcomes (2006)

Citation:
 
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:
To investigate oesophageal motor abnormalities in a series of adult sprue patients from a clinical and manometric point of view. 
Inclusion Criteria:
Consecutive adult sprue patients referred for evaluation as outpatients.  Diagnosis of celiac sprue was based on demonstration of characteristic histological abnormalities of the intestinal mucosa and unequivocal clinical improvement after gluten-free diet.
Exclusion Criteria:
No subject was taking drugs known to influence esophageal motility or had previous esophageal surgery.
Description of Study Protocol:

Recruitment

Consecutive adult sprue subjects.  Controls taken from random sample from the population.

Design

Case-Control Study.

Blinding used (if applicable)

Lab tests.

Intervention (if applicable)

Questionnaires, manometry, pH-metry.

Statistical Analysis

Student's t test for unpaired data and the chi-squared test were adopted where appropriate.  Values of P < 0.05 were chosen for rejection of the null hypothesis.

Data Collection Summary:

Timing of Measurements

Oesophageal clinical symptoms compared with those of 144 controls and manometry compared with 34 healthy volunteers.

Dependent Variables

  • Clinical questionnaire on GI symptoms, previously validated
  • Oesophageal manometry for 18 patients
  • pH-metry for 8 patients

Independent Variables

  •  Gluten-free diet for 22 patients.  Not defined nor monitored.

Control Variables

 

Description of Actual Data Sample:

Initial N: 36 adult sprue patients (14 during florid phase and 22 on gluten-free diet), 144 healthy controls (4 controls per subject)

Attrition (final N):  36 patients (8 men, 28 women)

Age:  Patients mean age 39.7 +/- 2.6 years 

Ethnicity: Not mentioned

Other relevant demographics:

Anthropometrics:  Controls were age and sex-matched

Location:   Italy 

Summary of Results:

 

GI Symptoms reported by celiac patients  
Abdominal Pain 76%

Diarrhea

68%

Weight Loss 65%
Nausea 50%
Dysphagia 50%
Vomiting 30%
Constipation 27%
Chest Pain 14%

Odynophagia

14%

Other Findings

Of celiac patients, 50% complained of dysphagia (P < 0.001 vs 9% of controls) and 14% noncardiac chest pain (P = NS vs 5% of controls).  None of the other esophageal symptoms investigated were significantly different between patients and controls.

Manometric examination showed motor abnormalities in 67% of subjects examined, consisting of nutcracker esophagus, hypotonic lower esophageal sphincter associated with simultaneous contractions, and frequent repetitive (> 3 peaks) contractions.  These abnormalities were equally distributed among free and gluten-free diet patients.

pH-metry showed only one pathological reflux out of 8 studied. 

Author Conclusion:
In conclusion, we have shown that adult celiac sprue patients display a high prevalence of esophageal symptoms and motor abnormalities, thereby confirming that abnormal GI motility disorders should probably be added to the clinical spectrum of the disease.
Funding Source:
University/Hospital: Universita degli Cagliari; Universita degli Studi di Prugia (Italy)
Reviewer Comments:
4 age- and sex-matched controls per subject.  Validated questionnaire.
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? 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? Yes
3. Were study groups comparable? Yes
  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? Yes
  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.) Yes
  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? Yes
  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.) Yes
  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? Yes
  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? Yes
  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? 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? ???
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? Yes
  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? 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? Yes
  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)? N/A
  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? N/A
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? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? Yes