Prunella Oral Liquid in Combination with Western Medical Treatment for Graves' Disease: A Systematic Review and Meta-Analysis.

Abstract

Ethnopharmacological relevancePrunella Oral Liquid is a Chinese patent medicine prepared from Prunella vulgaris L. Modern pharmacological studies indicate that its primary active constituents, such as rosmarinic acid, possess significant anti-inflammatory, immunomodulatory, and antioxidant properties. Although it is widely used in clinical practice for Graves' disease (GD) , uncertainty remains.Aim of the studyThis study aimed to evaluate the efficacy and safety of Prunella Oral Liquid in patients with GD.Materials and methodsWe searched seven databases for the randomized controlled trials (RCTs) of Prunella Oral Liquid on GD patients from inception to September 2025, and references in the literature were hand searched. Risk of bias was assessed using the Cochrane RoB 1.0. Data analysis was performed using RevMan 5.4. The certainty of evidence was evaluated with the GRADE framework.ResultsNine RCTs involving 966 patients were included. All included trials compared Prunella Oral Liquid in combination with Western medical treatment with the corresponding Western medical treatment alone. Compared to antithyroid drug (ATD) alone, Prunella Oral Liquid combined with ATD further reduced FT3 (SMD = -0.94, 95%CI[-1.63, -0.26]) and FT4 (SMD = -0.87, 95%CI[-1.55, -0.19]), increased TSH (SMD = 0.79, 95%CI[0.31, 1.27]), lowered TRAb (SMD = -1.26, 95%CI[-1.69, -0.83]) and TgAb (IU/mL) (MD = -105.33, 95%CI[-128.03, -82.63]), decreased the anteroposterior diameter of the right thyroid lobe (cm) (MD = -0.28, 95%CI [-0.39,-0.17]), the anteroposterior diameter of the left thyroid lobe (cm) (MD = -0.27, 95%CI [-0.42,-0.12]), the transverse diameter of the right thyroid lobe (cm) (MD = -0.23, 95%CI [-0.31,-0.15]), and the transverse diameter of the left thyroid lobe (cm) (MD = -0.25, 95%CI [-0.32,-0.18]), the longitudinal diameter of the right thyroid lobe (cm) (MD = -0.44, 95%CI [-0.65,-0.22]), the longitudinal diameter of the left thyroid lobe (cm) (MD = -0.70, 95%CI [-0.93,-0.48]), the thyroid isthmus thickness (cm) (MD = -0.14, 95%CI [-0.17,-0.11]), and lowered risk of adverse events (RR = 0.35, 95%CI [0.13,0.94]). Compared with Iodine-131 (131I) alone, Prunella Oral Liquid plus 131I further reduced TRAb (U/mL) (MD = -17.00, 95%CI [-20.02,-13.98]), TgAb (U/mL) (MD = -132.00, 95%CI [-149.75,-114.25]), and TPOAb (SMD = -2.98, 95%CI [-4.29,-1.67]). Prunella Oral Liquid, when used in combination with ATD plus nutritional supplements, further reduced FT3 (pmol/L) (MD = -0.93, 95%CI [-1.42,-0.44]), and increased TSH (μIU/mL) (MD =0.17, 95%CI [0.07,0.27]). Risk of bias was primarily attributable to unclear allocation concealment and performance bias due to lack of blinding. According to GRADE, the certainty of evidence ranged from low to very low.ConclusionsPrunella Oral Liquid combined with Western medical treatment may provide additional clinical benefits for patients with GD. Given the low certainty of evidence and methodological limitations identified, these findings should be interpreted with caution. Rigorously designed multicenter RCTs with standardized protocols are needed to confirm its efficacy and safety.