Table 3.
Summary-of-findings table generated for case-control studies in primary-2002 patients with Sjögren syndrome
| Author (year) | Patients | Design (duration) | Intervention, dose (patients) | Comparison (patients) | Differences between-groups (p value) | Differences within-groups (p value) | Safety profile |
| Alpöz et al (2008)38 | 29 | Case control | Xialine | Water | Relief xerostomia complaints (0.06) | p values not detailed | Not 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)39 | 40 | Case 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)40 | 40 | Case control | 0.1% 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)41 | 37 | Comparative | Autologous 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)42 | 118 | Case control | Pilocarpine 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.