Norwegian LongoVital and recurrent aphthous ulceration: a randomized, double-blind, placebo-controlled study.

OBJECTIVE

LongoVital (LV) is a herbal-based tablet enriched with the recommended daily doses of vitamins. The present study was undertaken to investigate possible prevention of recurrent aphthous ulceration (RAU) during 4 months daily intake of the Norwegian LV.

DESIGN

The study was a placebo-controlled, double-blind, randomized, clinical trial.

SUBJECTS

Sixty otherwise healthy patients with at least one attack of minor RAU per 2 months were included in the study.

METHODS

After an introduction period (IP) of 60 days, the patients were randomly divided into three groups and given either LV, the herbs of LV only, or placebo. Three test tablets were taken every day together with breakfast for 4 months [tablet period (TP)] and the patients followed up for another 4 months (F-UP). The number of new ulcers (NU) and ulcer-free days (UFD) were observed.

RESULTS

Fifty-two patients completed the study. Neither NU nor UFD showed any statistical significant differences between any of the groups in any of the periods. All three groups, however, showed a significant increase in UFD during the first 2 months of TP compared to IP. Within the LV group only, there was a further increase in UFD after 2 months intake of the tablets. The number of NU and UFD decreased significantly in both the LV and the herbal group in F-UP compared with TP.

CONCLUSION

Neither the Norwegian LV nor the herbal component alone was superior to placebo in the prevention of RAU. The results, however, indicate that neither the LV nor the herbal group benefited from the treatment.