Significance and Implications of Patient-reported Xerostomia in Sjögren's Syndrome: Findings From the National Institutes of Health Cohort

Background: Xerostomia is a chief complaint of patients with Sjögren's syndrome (SS). However, newer proposals for SS classification remove xerostomia and hyposalivation from the criteria list. Given these developments and the importance of patient-centered research outcomes, we sought to evalu...

Full description

Bibliographic Details
Main Authors: Monisha Billings, DDS, MPH, PhD, Bruce A. Dye, DDS, MPH, Timothy Iafolla, DMD, MPH, Alan N. Baer, MD, Margaret Grisius, DDS, Ilias Alevizos, DMD, PhD
Format: Article
Language:English
Published: Elsevier 2016-10-01
Series:EBioMedicine
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S235239641630411X
_version_ 1811325440174850048
author Monisha Billings, DDS, MPH, PhD
Bruce A. Dye, DDS, MPH
Timothy Iafolla, DMD, MPH
Alan N. Baer, MD
Margaret Grisius, DDS
Ilias Alevizos, DMD, PhD
author_facet Monisha Billings, DDS, MPH, PhD
Bruce A. Dye, DDS, MPH
Timothy Iafolla, DMD, MPH
Alan N. Baer, MD
Margaret Grisius, DDS
Ilias Alevizos, DMD, PhD
author_sort Monisha Billings, DDS, MPH, PhD
collection DOAJ
description Background: Xerostomia is a chief complaint of patients with Sjögren's syndrome (SS). However, newer proposals for SS classification remove xerostomia and hyposalivation from the criteria list. Given these developments and the importance of patient-centered research outcomes, we sought to evaluate the utility of patient-reported xerostomia with implications for classification criteria, and clinical trials targeting SS treatment modalities. Methods: A nested case-control study was designed within The National Institute of Dental and Craniofacial Research/National Institutes of Health (NIDCR/NIH) SS Cohort - one of the largest SS cohorts in the US. Clinical characteristics of those with and without xerostomia in SS and other salivary gland dysfunctions were compared. Several analytical methods were employed, including multivariable logistic regression modeling. Findings: The NIDCR/NIH Sjögren's Syndrome Clinic has an open cohort with ongoing enrollment since 1984. This open cohort comprised of 2046 participants by August 27, 2015. Baseline data of 701 SS, 355 Sicca, and 247 ISS participants within the source cohort were analyzed. Xerostomia was highest among SS participants (87.4%, 95% CI: 84.8%–89.8%) compared to Sicca (72.4%, 95% CI: 67.4%–77.0%, p < 0.001) and ISS groups (38.1%, 95% CI: 32.0%–44.4%, p < 0.001). Those with xerostomia were more likely to have SS than Sicca/ISS (OR = 4.98, 95% CI: 3.78–6.56). The ability of xerostomia to screen for SS among those with salivary gland dysfunction was higher than screening for Sicca/ISS. Screening diagnostics of xerostomia were of greater utility compared to hyposalivation. After adjusting for confounding in multivariable modeling, SS participants with xerostomia were more likely to be White (Black/African Americans (OR: 0.40, 95% CI: 0.23–0.68, p-value = 0.001) and Asians (OR: 0.49, 95% CI: 0.25–0.96, p-value = 0.038) were less likely to have xerostomia compared to Whites), have dry eye symptoms for >3 months (OR: 5.80, 95% CI: 3.62–9.28, p-value <0.001), a lower Van Bijsterveld score (OR: 0.55, 95%CI: 0.34–0.90, p-value = 0.017), a lower stimulated salivary flow rate (OR: 1.67, 95% CI: 1.06–2.65, p-value = 0.028), a focus score of >2 (OR: 1.92, 95% CI: 1.20–3.09, p-value = 0.007), and salivary gland swelling (OR: 49.39, 95% CI: 2.02–1206.30, p-value = 0.017). Age, gender, fatigue, pain, anxiety, and autoantibodies were not significantly associated with xerostomia. Interpretation: Findings from this study indicate that patient-reported xerostomia is highly prevalent among SS patients and is associated with several clinical phenotypes of this complex syndrome, thereby making it an important indicator of SS. The evidence also suggests that xerostomia is not limited to low salivary flow but might be reflective of compositional changes of saliva. Consequently, these findings suggest the need to consider xerostomia in the development of SS classification criteria and in patient-centered outcomes research in SS intervention trials. This research was supported by the Intramural Research Program of the National Institutes of Health (NIH), National Institute of Dental and Craniofacial Research (NIDCR) Grant # DE000704-15. Dr. Baer is supported by RO1-DE-12354-15A1.
first_indexed 2024-04-13T14:33:11Z
format Article
id doaj.art-bf49d8b316114e449862b2856dba1ce1
institution Directory Open Access Journal
issn 2352-3964
language English
last_indexed 2024-04-13T14:33:11Z
publishDate 2016-10-01
publisher Elsevier
record_format Article
series EBioMedicine
spelling doaj.art-bf49d8b316114e449862b2856dba1ce12022-12-22T02:43:08ZengElsevierEBioMedicine2352-39642016-10-0112C27027910.1016/j.ebiom.2016.09.005Significance and Implications of Patient-reported Xerostomia in Sjögren's Syndrome: Findings From the National Institutes of Health CohortMonisha Billings, DDS, MPH, PhD0Bruce A. Dye, DDS, MPH1Timothy Iafolla, DMD, MPH2Alan N. Baer, MD3Margaret Grisius, DDS4Ilias Alevizos, DMD, PhD5Molecular Physiology and Therapeutics Branch, National Institutes of Health, National Institute of Dental and Craniofacial Research, Bethesda, MD, USAProgram Analysis and Reporting Branch, National Institutes of Health, National Institute of Dental and Craniofacial Research, Bethesda, MD, USAProgram Analysis and Reporting Branch, National Institutes of Health, National Institute of Dental and Craniofacial Research, Bethesda, MD, USAMolecular Physiology and Therapeutics Branch, National Institutes of Health, National Institute of Dental and Craniofacial Research, Bethesda, MD, USAMolecular Physiology and Therapeutics Branch, National Institutes of Health, National Institute of Dental and Craniofacial Research, Bethesda, MD, USAMolecular Physiology and Therapeutics Branch, National Institutes of Health, National Institute of Dental and Craniofacial Research, Bethesda, MD, USABackground: Xerostomia is a chief complaint of patients with Sjögren's syndrome (SS). However, newer proposals for SS classification remove xerostomia and hyposalivation from the criteria list. Given these developments and the importance of patient-centered research outcomes, we sought to evaluate the utility of patient-reported xerostomia with implications for classification criteria, and clinical trials targeting SS treatment modalities. Methods: A nested case-control study was designed within The National Institute of Dental and Craniofacial Research/National Institutes of Health (NIDCR/NIH) SS Cohort - one of the largest SS cohorts in the US. Clinical characteristics of those with and without xerostomia in SS and other salivary gland dysfunctions were compared. Several analytical methods were employed, including multivariable logistic regression modeling. Findings: The NIDCR/NIH Sjögren's Syndrome Clinic has an open cohort with ongoing enrollment since 1984. This open cohort comprised of 2046 participants by August 27, 2015. Baseline data of 701 SS, 355 Sicca, and 247 ISS participants within the source cohort were analyzed. Xerostomia was highest among SS participants (87.4%, 95% CI: 84.8%–89.8%) compared to Sicca (72.4%, 95% CI: 67.4%–77.0%, p < 0.001) and ISS groups (38.1%, 95% CI: 32.0%–44.4%, p < 0.001). Those with xerostomia were more likely to have SS than Sicca/ISS (OR = 4.98, 95% CI: 3.78–6.56). The ability of xerostomia to screen for SS among those with salivary gland dysfunction was higher than screening for Sicca/ISS. Screening diagnostics of xerostomia were of greater utility compared to hyposalivation. After adjusting for confounding in multivariable modeling, SS participants with xerostomia were more likely to be White (Black/African Americans (OR: 0.40, 95% CI: 0.23–0.68, p-value = 0.001) and Asians (OR: 0.49, 95% CI: 0.25–0.96, p-value = 0.038) were less likely to have xerostomia compared to Whites), have dry eye symptoms for >3 months (OR: 5.80, 95% CI: 3.62–9.28, p-value <0.001), a lower Van Bijsterveld score (OR: 0.55, 95%CI: 0.34–0.90, p-value = 0.017), a lower stimulated salivary flow rate (OR: 1.67, 95% CI: 1.06–2.65, p-value = 0.028), a focus score of >2 (OR: 1.92, 95% CI: 1.20–3.09, p-value = 0.007), and salivary gland swelling (OR: 49.39, 95% CI: 2.02–1206.30, p-value = 0.017). Age, gender, fatigue, pain, anxiety, and autoantibodies were not significantly associated with xerostomia. Interpretation: Findings from this study indicate that patient-reported xerostomia is highly prevalent among SS patients and is associated with several clinical phenotypes of this complex syndrome, thereby making it an important indicator of SS. The evidence also suggests that xerostomia is not limited to low salivary flow but might be reflective of compositional changes of saliva. Consequently, these findings suggest the need to consider xerostomia in the development of SS classification criteria and in patient-centered outcomes research in SS intervention trials. This research was supported by the Intramural Research Program of the National Institutes of Health (NIH), National Institute of Dental and Craniofacial Research (NIDCR) Grant # DE000704-15. Dr. Baer is supported by RO1-DE-12354-15A1.http://www.sciencedirect.com/science/article/pii/S235239641630411XSjogren's syndromeXerostomiaHyposalivationAutoimmune disordersSalivary gland dysfunction
spellingShingle Monisha Billings, DDS, MPH, PhD
Bruce A. Dye, DDS, MPH
Timothy Iafolla, DMD, MPH
Alan N. Baer, MD
Margaret Grisius, DDS
Ilias Alevizos, DMD, PhD
Significance and Implications of Patient-reported Xerostomia in Sjögren's Syndrome: Findings From the National Institutes of Health Cohort
EBioMedicine
Sjogren's syndrome
Xerostomia
Hyposalivation
Autoimmune disorders
Salivary gland dysfunction
title Significance and Implications of Patient-reported Xerostomia in Sjögren's Syndrome: Findings From the National Institutes of Health Cohort
title_full Significance and Implications of Patient-reported Xerostomia in Sjögren's Syndrome: Findings From the National Institutes of Health Cohort
title_fullStr Significance and Implications of Patient-reported Xerostomia in Sjögren's Syndrome: Findings From the National Institutes of Health Cohort
title_full_unstemmed Significance and Implications of Patient-reported Xerostomia in Sjögren's Syndrome: Findings From the National Institutes of Health Cohort
title_short Significance and Implications of Patient-reported Xerostomia in Sjögren's Syndrome: Findings From the National Institutes of Health Cohort
title_sort significance and implications of patient reported xerostomia in sjogren s syndrome findings from the national institutes of health cohort
topic Sjogren's syndrome
Xerostomia
Hyposalivation
Autoimmune disorders
Salivary gland dysfunction
url http://www.sciencedirect.com/science/article/pii/S235239641630411X
work_keys_str_mv AT monishabillingsddsmphphd significanceandimplicationsofpatientreportedxerostomiainsjogrenssyndromefindingsfromthenationalinstitutesofhealthcohort
AT bruceadyeddsmph significanceandimplicationsofpatientreportedxerostomiainsjogrenssyndromefindingsfromthenationalinstitutesofhealthcohort
AT timothyiafolladmdmph significanceandimplicationsofpatientreportedxerostomiainsjogrenssyndromefindingsfromthenationalinstitutesofhealthcohort
AT alannbaermd significanceandimplicationsofpatientreportedxerostomiainsjogrenssyndromefindingsfromthenationalinstitutesofhealthcohort
AT margaretgrisiusdds significanceandimplicationsofpatientreportedxerostomiainsjogrenssyndromefindingsfromthenationalinstitutesofhealthcohort
AT iliasalevizosdmdphd significanceandimplicationsofpatientreportedxerostomiainsjogrenssyndromefindingsfromthenationalinstitutesofhealthcohort