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Efficacy of N-acetylcysteine for treating dryness symptoms of Sjögren's disease: randomised placebo-controlled double-blind clinical study.
D'Agostino Gennari, Juliana; Deveza, Giordano B H; Ribeiro, Carolina T; Seguro, Antonio C; Aikawa, Nádia E; Shimizu, Maria Heloisa M; Leon, Elaine Pires; Guedes, Lissiane K N; Kupa, Léonard V K; Silva, Clovis A A; Bonfa, Eloisa; Pasoto, Sandra Gofinet.
Affiliation
  • D'Agostino Gennari J; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Brazil.
  • Deveza GBH; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Brazil.
  • Ribeiro CT; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Brazil.
  • Seguro AC; Nephrology Division, and Laboratories of Medical Investigations (LIM/12), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Brazil.
  • Aikawa NE; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Brazil.
  • Shimizu MHM; Laboratories of Medical Investigations (LIM/12), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Brazil.
  • Leon EP; Rheumatology Division, and Laboratories of Medical Investigations (LIM/17), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Brazil.
  • Guedes LKN; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Brazil.
  • Kupa LVK; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Brazil.
  • Silva CAA; Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Brazil.
  • Bonfa E; Rheumatology Division, and Laboratories of Medical Investigations (LIM/17), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Brazil.
  • Pasoto SG; Rheumatology Division, and Laboratories of Medical Investigations (LIM/17), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Brazil. sandragpasoto@gmail.com.
Clin Exp Rheumatol ; 2024 Sep 27.
Article in En | MEDLINE | ID: mdl-39360368
ABSTRACT

OBJECTIVES:

N-acetylcysteine (NAC) is used in Sjögren's disease (SjD) based on limited evidence. The aim of this study was to assess the efficacy of NAC for relieving dryness symptoms in SjD.

METHODS:

In this placebo-controlled double-blind trial, 60 adult SjD females (with low disease activity) were randomised to receive NAC (1,200 mg/day orally) or placebo. At baseline (D0), 30 days (D30) and 90 days (D90), all participants underwent the following evaluations EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Ocular Surface Disease Index (OSDI), Xerostomia Inventory (XI), Leicester Cough Questionnaire (LCQ), unstimulated/stimulated salivary flow, Schirmer's test, and plasma levels of thiobarbituric acid reactive substances (TBARS), glutathione and NAC.

RESULTS:

At inclusion, both groups were balanced for age, ethnicity, disease duration, ESSPRI, OSDI, XI, Schirmer's test, salivary flow, ESSDAI and topical/systemic treatments (p>0.05). No significant differences were observed between NAC and placebo groups on D30 and D90 regarding ESSPRI, XI, OSDI, LCQ, Schirmer's test, stimulated salivary flow, ESSDAI and topical/systemic treatments (p>0.05). Unstimulated salivary flow was significantly higher in the placebo group on D90 (p=0.018). NAC blood concentrations were significantly higher in the NAC group on D30 (p=0.018) and D90 (p<0.001), however, no differences were found in TBARS and glutathione. Further analysis showed decrease≥1 in ESSPRI in the NAC compared with placebo group on D30 (p=0.045), a result not found on D90 (p=0.696).

CONCLUSIONS:

NAC is recommended as a rescue therapy for SjD. However, our well-designed study provides novel evidence demonstrating its inefficacy for improving dryness symptoms or reducing oxidative stress. CLINICALTRIALS gov-NCT04793646.

Full text: 1 Collection: 01-internacional Database: MEDLINE Language: En Journal: Clin Exp Rheumatol Year: 2024 Document type: Article Affiliation country: Brazil Country of publication: Italy

Full text: 1 Collection: 01-internacional Database: MEDLINE Language: En Journal: Clin Exp Rheumatol Year: 2024 Document type: Article Affiliation country: Brazil Country of publication: Italy