OBJECTIVE:Sjögren's syndrome (SS) is a chronic autoimmune disease complex of unknown aetiology. There is no curative treatment for SS, however, in recent years the influence of nutrients on autoimmune processes has attracted increasing attention. LongoVital (LV) (DK. Reg. No. 5178/75) is an herbal-based tablet enriched with the recommended daily doses of vitamins. The purpose of the present study was to investigate whether 4 months' daily intake of LV as compared to placebo would affect clinical and laboratory disease parameters in patients with SS. METHODS:Forty patients with SS participated in aplacebo-controlled, double-blind, randomised, clinical, 8 month cross-over study. Group A (n = 22) received LV during the first 4 months and Group B (n = 18) LV during the last 4 months. RESULTS: The unstimulated salivary flow rate increased during the LV period in Group A (p < 0.001). The stimulated salivary flow rate increased in Group B during the LV period (p < 0.05), and in Group A during the subsequent 4 months on placebo (p < 0.05). The rose bengal score decreased in Group B during (p < 0.01) and in Group A after the LV intake (p < 0.05). During the last 4 months of the study both groups showed an increase in serum levels of alpha-amylase (total: Group A, p < 0.01; Group B, p < 0.05; pancreatic fraction: Group A, p < 0.0001; Group B, p < 0.01) and in serum levels of IgM (Group A and B: p < 0.001), while levels of circulating immune complexes decreased (Group A, p < 0.05; Group B, p < 0.001). CONCLUSION: It is concluded that LV has a beneficial and prolonged effect on some of the clinical and immunoinflammatory disease markers in SS.
RCT Entities:
OBJECTIVE: Sjögren's syndrome (SS) is a chronic autoimmune disease complex of unknown aetiology. There is no curative treatment for SS, however, in recent years the influence of nutrients on autoimmune processes has attracted increasing attention. LongoVital (LV) (DK. Reg. No. 5178/75) is an herbal-based tablet enriched with the recommended daily doses of vitamins. The purpose of the present study was to investigate whether 4 months' daily intake of LV as compared to placebo would affect clinical and laboratory disease parameters in patients with SS. METHODS: Forty patients with SS participated in a placebo-controlled, double-blind, randomised, clinical, 8 month cross-over study. Group A (n = 22) received LV during the first 4 months and Group B (n = 18) LV during the last 4 months. RESULTS: The unstimulated salivary flow rate increased during the LV period in Group A (p < 0.001). The stimulated salivary flow rate increased in Group B during the LV period (p < 0.05), and in Group A during the subsequent 4 months on placebo (p < 0.05). The rose bengal score decreased in Group B during (p < 0.01) and in Group A after the LV intake (p < 0.05). During the last 4 months of the study both groups showed an increase in serum levels of alpha-amylase (total: Group A, p < 0.01; Group B, p < 0.05; pancreatic fraction: Group A, p < 0.0001; Group B, p < 0.01) and in serum levels of IgM (Group A and B: p < 0.001), while levels of circulating immune complexes decreased (Group A, p < 0.05; Group B, p < 0.001). CONCLUSION: It is concluded that LV has a beneficial and prolonged effect on some of the clinical and immunoinflammatory disease markers in SS.