Effectiveness of the Nutraceutical Prunella vulgaris on Auto-immunity and Quality of Life in Women with Hashimoto Thyroiditis: Case-Control Pilot Study

Abstract

Background: In Hashimoto’s thyroiditis (HT), symptoms and impaired quality of life (QoL) are described even when thyroid hormones are in the normal range. In Chinese medicine, the nutraceutical Prunella vulgaris is used for its supposed anti-inflammatory and immunomodulatory activity. Aim: To evaluate the effects of Prunella vulgaris on autoimmunity, mainly thyroid peroxidase antibodies (TPOAb) and QoL, in HT women. Methods: Prospective open-label case-control study in 62 adult HT women randomized to the nutraceutical (group 1) or not (group 2). Prunella vulgaris (Tireomab-H®; 1 pill: stock 4:1 194.4 mg, powder 155.6 mg) was given at the dosage of 2 + 2 pills/day for 3 months. The women's usual therapy was not changed. Some clinical and laboratory data were collected, as were QoL scores on the ThyPRO questionnaire. TPOAb levels were evaluated as xULNR (upper limit normal range). Results: Thirty-one group 1 women and 27 group 2 women completed the study. On two ThyPRO scales (Tiredness, Emotional Susceptibility) no differences between the groups were initially noted.  TPOAb xULNR values were 13.6 (median; IQR 9.1-37.8) in group 1 and 14.7 (3.6-40.0) in group 2. After 3 months, TPOAb had significantly dropped in group 1 (10.1; 4.4-36.0; P=0.002) but not in group 2 (16.3; 3.0-55.6). In group 1, 12 ThyPRO scales had significantly improved, while in group 2, all but one scale were unchanged. The other clinical and laboratory data did not change in either group. Percentage changes in TPOAb levels did not correlate with percentage changes in ThyPRO scales in either group. No adverse events were reported. Conclusions: In HT women, Prunella vulgaris significantly reduces TPOAb levels and improves QoL. The absence of correlation between percentage changes in TPOAb and percentage changes in ThyPRO suggests that the effect on QoL could be a direct neuroendocrine effect of the nutraceutical. More studies are needed.