Efficacy and safety of Prunella vulgaris L. combined with antithyroid drugs for hyperthyroidism: A meta-analysis of randomized controlled trials

Maoying Wei ¹ Qiyao Zhao ^1* Mingyi Yuan ¹ Yu Yun Fan ^2,3* Mingdi Li ^3*

• ¹ Beijing University of Chinese Medicine, Beijing, Beijing Municipality, China
• ² Linyi People's Hospital, Linyi, Shandong Province, China
• ³ Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, Beijing Municipality, China

Objective: To systematically evaluate the efficacy and safety of Prunella vulgaris L. (PVL) preparations combined with ATDs for the treatment of hyperthyroidism.Methods: Eight Chinese and English databases were searched for randomized controlled trials (RCTs) comparing PVL preparations combined with ATDs and ATDs for hyperthyroidism treatment. The Cochrane risk-of-bias assessment tool was used to evaluate the quality of included studies. Statistical analyses were performed using the Revman 5.3 software. Stata software (version 16.0) was used to detect publication bias. The GRADE system was used to assess the level of evidence.Results: Seventeen studies were analyzed. The total sample size was 1366 patients. Meta-analysis revealed that treatment with PVL preparations in combination with ATDs effectively reduced FT3 [SMD = -0.98, 95%CI (-1.39, -0.57), P < 0.00001], FT4 [SMD = -0.82, 95% confidence interval (CI) (-1.16, -0.47), P < 0.00001], TSH [SMD = -1.11, 95%CI (-1.52, -0.71), P < 0.00001], TIT [mean difference (MD) = -0.13, 95%CI (-0.15, -0.10), P < 0.00001], WLTL [MD = -0.22, 95%CI (-0.27, -0.17), P < 0.00001],TLTL [MD = - 0.22, 95%CI (-0.33, -0.10), P = 0.0003], LLTL [MD = -0.63, 95%CI (-0.79, -0.47), P < 0.00001], WRTL [MD = -0.21, 95%CI (-0.26, -0.16), P < 0.00001], TRTL [MD = -0.27, 95%CI (-0.32, -0.22), P < 0.00001], LRTL [MD = -0.45, 95%CI (-0.61, -0.28), P < 0.00001], incidence of AE [RR = 0.34, 95%CI (0.24, 0.50), P < 0.00001], TNF-α [SMD = -2.05, 95%CI (-2.85, -1.25), P < 0.00001], and increasing TSH [SMD = 0.71, 95%CI (0.43, 0.99), P < 0.00001], and IL-10 [MD = 1.73, 95%CI (1.35, 2.10), P < 0.00001] better than that of ATDs alone. Combination therapy with PVL preparations was comparable to the efficacy of ATDs alone in improving relapse rates and IL-6 and IFN-γ levels.Conclusion: Treatment of hyperthyroidism with PVL preparations in combination with ATDs was superior to treatment with ATDs alone in terms of improvements in thyroid function, thyroid antibodies, thyroid gland size, inflammation, and incidence of adverse events. However, owing to the low strength of evidence from the included studies, this conclusion requires further validation in more high-quality RCTs.