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Table 2 Summary of Randomized controlled clinical trials in the systemic oral treatment of ocular complications of Sjögren’s syndrome

From: Systematic review of randomized controlled trials in the treatment of dry eye disease in Sjogren syndrome

Ono, M., et al. (2004) 60 patients
Group i (20)
Group ii (21)
Group iii (19)
Oral Cevimeline
20 mg or 30 mg 3 times daily
i. Placebo
ii. Cevimeline
4 weeks • Dry eye symptoms (VAS)
• CFS
• Rose Bengal test
• Schirmer I
• TBUT
Cevimeline 20 mg: Improvement in symptoms, Rose Bengal test, CFS, TBUT compared with placebo. • No drop outs mentioned
Petrone, D., et al. (2002) 197 patients
Group i (70)
Group ii (65)
Group iii (62)
Oral Cevimeline 15 mg or 30 mg 3 times daily i. Placebo
ii. Cevimeline
12 weeks • Dry eye symptoms (VAS)
• Schirmer I
Cevimeline 30 mg: Improved in VAS (P = 0.045) and Schirmer (p = 0.043) • Short study period
Yoon, C. H., et al. (2016) 26 patients
Group i (11)
Group ii (15)
Oral HCQ 300 mg daily i. HCQ,
ii. Placebo
12 weeks • OSDI
• CFS
• Schirmer I
• TBUT
All outcomes are not significant between i and ii at 12 weeks. • Small sample size
• Short study period
• Insufficient washout period
Gottenberg, J. E., et al. (2014) 120 patients
Group i (56)
Group ii (64)
Oral HCQ 400 mg daily i. HCQ
ii. Placebo
48 weeks • Dry eye symptoms (VAS) No improvement in VAS between i and ii • Short study period
• Ocular outcome is too subjective
• No drop outs mentioned
Sankar, V., et al. (2004) 28 patients
Group i (14)
Group ii (14)
Etanercept 25 mg twice weekly subcutaneous i. Etanercept
ii. Placebo
12 weeks • Dry eye symptoms (VAS)
• LGS
• Schirmer I
No difference in ocular outcomes between i and ii • Short study period
• Small sample size
Tsifetaki, N., et al. (2003) 85 patients
Group i (29)
Group ii (28)
Group iii (28)
Oral pilocarpine 5 mg 2 times daily i. Pilocarpine
ii. Artificial tears
iii. Inferior lacrimal puncta occlusion
12 weeks • Dry eye symptoms (VAS)
• Rose Bengal stain
• Schirmer I
i improved in symptoms and Rose Bengal stain (P < 0.05) compared with ii and iii • Short study period
• All female subjects
Dogru, m., et al. (2007) 10 patients
Group i (3)
Group ii (7)
Oral Lactoferrin 270 mg daily i. Oral lactoferrin
ii. Placebo
1 month • Dry eye symptoms (VAS)
• Corneal sensitivity
• Schirmer I
• TBUT
• Tear lipid thickness
• Vital staining scores
Significant improvement with Corneal sensitivity, tear lipid thickness and TBUT after 1 month of treatment • No masking of investigator
• Small sample size
• Short study period
Seitsalo, H., et al. (2007) 22 patients Oral doxycycline 20 mg 2 times daily i. Low dose doxycycline
ii. Placebo
10 weeks • Dry eye symptoms (VAS) No difference between i and ii in terms of VAS • Small sample size
• No objective signs reported
• Cross-over study
• All female subjects
Pillemer, S. R., et al. (2004) 23 patients
Group i (10)
Group ii (13)
Oral DHEA 200 mg daily i. DHEA
ii. Placebo
24 weeks • Dry eye symptoms (VAS)
• Schirmer I
• LGS
No differences between i and ii for dry eye symptoms or Schirmer I. • Small sample size
• Limited ocular outcome measurements
Hu, W., et al. (2014) 240 patients
Group i (160)
Group ii (80)
Oral ShengJinRunZaoYangXue granules 200 g daily i. ShengJinRunZaoYangXue granules
ii. Placebo
6 weeks • Dry eye symptoms (11 point-Numerical Rating Scale)
• Schirmer I
Schirmer I improved in i (P = 0.03 for left eye, P = 0.02 for right eye) • Only 1 objective ocular outcome
• Short study period
Aragona, P., et al. (2005) 40 patients
Group i (20)
Group ii (20)
Oral Linoleic acid (omega-6 essential FA) 112 mg + γ-linolenic acid 15 mg daily i. Omega 6 essential fatty acid
ii. Placebo
1 month • Dry eye symptoms (0–3 scoring system)
• CFS
• Schirmer I
• TBUT
• PGE1 (ELISA)
Significantly less symptoms in i compared to ii, reduced CFS in i than ii • Small sample size
• Short study period
Brown, S., et al. (2014) 110 patients Intravenous Rituximab 1000 mg i. Rituximab
ii. Placebo
48 weeks • Dry eye symptoms (VAS)
• Schirmer I
No significance between i and ii for dry eye symptoms and Schirmer I • Small sample size
Devauchelle-Pensec, V., et al. (2012) 122 patients Intravenous Rituximab 1000 mg i. Rituximab
ii. Placebo
24 weeks • Dry eye symptoms (VAS)
• Schirmer I
No significance between i and ii for dry eye symptoms and Schirmer I • Small sample size
  1. CFS, Corneal fluorescein staining
  2. DHEA Dehydroepiandrosterone
  3. ELIZA Enzyme linked immunesorbent assay
  4. HCQ Hydroxychloroquine
  5. LGS Lissamine green stain
  6. OSDI Ocular surface disease index
  7. PGE1 Prostaglandin E1
  8. TBUT Tear breakup test
  9. VAS Visual analogue scale