Table 3

Summary-of-findings table generated for case-control studies in primary-2002 patients with Sjögren syndrome

Author (year)PatientsDesign (duration)Intervention, dose (patients)Comparison (patients)Differences between-groups (p value)Differences within-groups (p value)Safety profile
Alpöz et al (2008)3829Case controlXialineWaterRelief xerostomia complaints (0.06)p values not detailedNot detailed
(2 w)VAS improvement for Xialine group in mastication (0.06), swallowing (0.027), daily liquid consumption (0.019), mouth burning (0.025), the need to sip liquids to aid swallowing (0.023), difficulty in speaking (0.004)
VAS satisfaction better for Xialine (0.011)
VAS satisfaction better for Xialine (0.011)No differences for VAS burning tongue (0.925), diminished taste (0.527), waking up at night to sip water (0.066)
Qiu et al (2013)3940Case control (nd)Plug (n=21)Artificial tears (AT) (n=19)OSDI score, BUT, Schirmer I, corneal staining score (p>0.05)Plug group: better OSDI score, BUT, Schirmer I, corneal staining score (p<0.001)Not detailed
AT group: better OSDI score, BUT, Schirmer I, corneal staining score (p<0.001)
Lin et al (2015)4040Case control0.1% fluorometholone (FML) (n=20)Topical cyclosporine A (n=20)CFS score (>0.05), OSDI score (>0.05), Schirmer (>0.05), conjunctival goblet cell density (p<0.001)FML group: better CFS score (<0.001), BUT (<0.001), OSDI score (<0.001), Schirmer (>0.05), conjunctival goblet cell density (ns), conjunctival congestion at week 4 (p=0.035)No serious or severe adverse effects occurred
(8 w)Mean BUT longer in FML group (0.04)CyA group: better CFS score (<0.001), BUT (<0.001), OSDI score (<0.001), Schirmer (>0.05), conjunctival goblet cell density (ns)Moderate/severe transient burning sensation (CsA 31.25%, FML 0%)
Less severe conjunctival congestion in FML group at week 4 compared with CsA group (p=0.035)
Mean IOP +0.4 mm Hg FML vs −1.15 mm Hg CsA (p=0.389)
Li J et al (2015)4137ComparativeAutologous serum (AS) (n=18)Bandage contact lens (BCL) (n=19)BUT (>0.05), corneal staining (>0.05), Schirmer (>0.05), BCVA (>0.05)AS group: BUT (0.001), corneal staining (0.001), Schirmer (>0.05), BCVA (>0.05)No adverse events
(6 w)
OSDI: 47.1 AS vs 31 BCL (<0.01)BCL group: BUT (<0.001), corneal staining (<0.001), Schirmer (>0.05), BCVA (0.003)
Noaiseh et al (2014)42118Case controlPilocarpine first line (n=59)Cevimeline first line (n=59)Failure rates among first-time users: Cevimeline vs pilocarpine 27% vs 47% (p=0.02)ANA (+) was associated with failure:(59% vs 38%) (p=0.03)Pilocarpine first line: 28 patients (47%) discontinued treatment due to AE.
(2.8 y)Pilocarpine second line (n=13)Cevimeline second line (n=32)Failure rates among all users: Cevimeline vs pilocarpine 32% vs 61% (p<0.001).Sweating (n=15), nausea, dyspepsia or vomiting (n=6), flushing/hot flashes (n=3), paresthesias (n=1), myalgias (n=1), headaches (n=1) and rash (n=1).
Cevimeline (first-time users) had lower failure rates due to AE vs pilocarpine (p=0.02)11 patients (19%) discontinued therapy due to lack of efficacy
Previously failed one secretagogue were less likely to discontinue treatment with the other agent, 52% of first-time users vs 27% of second-time users (p=0.004).Cevimeline first line: 16 patients (27%) discontinued due to AE:
Sweating (n=8), nausea, dyspepsia and vomiting (n=5), flushing/hot flashes (n=1), headaches (n=1) and breast swelling (n=1)
6 patients (10%) due to lack of efficacy
Pilocarpine second line: 3 patients (23%) developed AE requiring discontinuation
Sweating (n=1), dyspepsia (1) and flushing/hot flashes (1)
Two patients stopped treatment due to lack of efficacy
Cevimeline second line: 7 (22%) developed AE requiring discontinuation
Sweating (n=2), dyspepsia (1), flushing flushing/ hot flashes (1), diarrhoea (1), parotid swelling (1) and postnasal drip (1)
None stopped treatment due to lack of efficacy
Severe sweating more frequently in pilocarpine (25%) than cevimeline (11%) users (p=0.02)
  • ANA, antinuclear antibody; AT, artificial tears; BCVA, best-corrected visual acuity; BUT, tear breakup time; CFS, Corneal Fluorescein Staining; CyA, cyclosporine A; CyA, cyclosporine A; FML, fluorometholone; IOP, intraocular pressure; OSDI, Ocular Surface Disease Index; VAS, visual analogue scale; w, week.