Effect of large dosage of Prunella on Hashimoto's thyroiditis: A protocol of systematic review and meta-analysis of randomized clinical trials

Medicine (Baltimore). 2020 Dec 11;99(50):e23391. doi: 10.1097/MD.0000000000023391.


Introduction: Hashimoto's Thyroiditis (HT) is one of the common autoimmune diseases, which can lead to thyroid reduction, increase the risk of tumor, and seriously affect women's reproductive health. Many other autoimmune diseases are easy to occur, seriously harming people's health.large dose herb Prunella or compound prescription contain large dose Prunella for treatment of HT has already been confirmed. However, due to the lack of evidence, there is no specific method or suggestion, it is necessary to carry out a systematic evaluation on Prunella and provide effective evidence for further research.

Methods and analysis: The following databases will be searched from their inception to October 2020: Electronic database includes PubMed, Embase, Cochrane Library, Web of Science, Nature, Science online, Chinese Biomedical Database WangFang, VIP medicine information, and China National Knowledge Infrastructure.

Main results: serum thyroid peroxidase antibody (TPOAb), thyroid globulin antibody (TGAb), other results: serum thyroid stimulating hormone (TSH), serum free triiodothyronine (FT3), serum free thyroid hormone (FT4). Data will be extracted by 2 researchers independently, risk of bias of the meta-analysis will be evaluated based on the Cochrane Handbook for Systematic Reviews (SR)of Interventions. All data analysis will be conducted by data statistics software Review Manager V.5.3. and Stata V.12.0.

Results: The results of this study will systematically evaluate the efficacy and safety of large dose prunella salicorrhizae in the intervention of people with HT.

Conclusion: The systematic review of this study will summarize the current published evidence of large dose prunella for the treatment of HT, which can further guide the promotion and application of it.

Ethics and communication: This study is a systematic review, the outcomes are based on the published evidence, so examination and agreement by the ethics committee are not required in this study. We intend to publish the study results in a journal or conference presentations.Open Science Fra mework (OSF) registration number:October 21, 2020.osf.io/fcyqp. (https://osf.io/fcyqp).

MeSH terms

  • Adult
  • Antithyroid Agents / administration & dosage*
  • Dose-Response Relationship, Drug
  • Drugs, Chinese Herbal / administration & dosage*
  • Female
  • Hashimoto Disease / blood
  • Hashimoto Disease / drug therapy*
  • Humans
  • Meta-Analysis as Topic
  • Prunella*
  • Randomized Controlled Trials as Topic
  • Research Design
  • Systematic Reviews as Topic
  • Thyroid Function Tests
  • Thyroid Hormones / blood
  • Treatment Outcome


  • Antithyroid Agents
  • Drugs, Chinese Herbal
  • Thyroid Hormones