Efficacy and safety of standardized Ginkgo biloba L. leaves extract as an adjuvant therapy for sudden sensorineural hearing loss: A systematic review and meta-analysis
Authors: Lin Huang
Xia Si
Zhiying Yu
Xiaolei Ren
Yufei Feng
Journal: Journal of Ethnopharmacology (2022)
Discipline: PHARMACOLOGY & TOXICOLOGY
Keywords: Corticosteroids; GRADE; Ginkgo biloba L.; Meta-analysis; Randomized controlled trial
Affiliations: Department of pharmacy, Peking University People's Hospital, Beijing, 100044, China. Electronic address: .

Abstract:  Ethnopharmacological relevance: Ginkgo biloba L. has been used for medical purposes in China for centuries. Standardized Ginkgo biloba L. leaves extract (GBE) is a widely used botanical drug which displays a variety of pharmacological effects against sudden sensorineural hearing loss (SSNHL). Aim of the study: To evaluate the efficacy and safety of GBE as an adjuvant therapy, administered with corticosteroids, for the initial management of patients with SSNHL. Materials and methods: We searched seven databases for randomized clinical trials (RCTs) comparing GBE plus corticosteroids with corticosteroids alone for SSNHL treatment. Data analysis was carried out by Review Manager 5.4 and Stata 16.0 software. The study was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. We subsequently evaluated the certainty of evidence using the GRADE (Grading of Recommendation Assessment, Development and Evaluation) approach. Results: A total of 11 RCTs involving 1069 patients were included. Meta-analysis indicated that the clinical cure rate (RR = 1.33, 95% CI = 1.12 to 1.58, P = 0.001) and total effective rate (RR = 1.24, 95%CI = 1.17 to 1.31, P &lt; 0.001) in SSNHL patients receiving GBE plus corticosteroids was superior to patients receiving corticosteroids alone. After treatment, pure tone average (PTA) improvement of observation group was better than that in the control group (WMD = 10.33, 95%CI = 6.46 to 14.21, P &lt; 0.001). The levels of whole blood high shear viscosity (WMD = 0.93, 95%CI = 0.28 to 1.59, P = 0.005), whole blood medium shear viscosity (WMD = 0.53, 95%CI = 0.11 to 0.95, P = 0.01), whole blood low shear viscosity (WMD = 1.26, 95%CI = 0.80 to 1.72, P &lt; 0.001), plasma viscosity (WMD = 0.19, 95%CI = 0.09 to 0.30, P &lt; 0.001) and fibrinogen (WMD = 0.80, 95%CI = 0.25 to 1.35, P = 0.004) were lower than those in the control group. There was no significant difference in the change of hematokrit between two groups (WMD = 4.23, 95%CI = -0.54 to 8.99, P = 0.08). GBE was generally well tolerated, and there was no significant difference in the incidence of adverse reactions between two groups (RR = 1.01, 95%CI = 0.57 to 1.79, P = 0.97). Conclusion: The results of the current study suggested that GBE might be effective and promising as an adjuvant to corticosteroids in the initial treatment of moderate to profound SSNHL. However, the GRADE assessment indicated that the overall strength of evidence was not high. Further studies with high methodological quality and low risk of bias are needed to confirm the positive results. PROSPERO registration No. CRD 42020190113. 

Retracted: No

PubPeer comments:
 ## 1. Introduction To date, various analytical techniques have been studied for control the quality of GBE(*Ginkgo biloba* L. leaves extract) (Wang et al., 2017; Zhang et al., 2019). References M.Q. Zhang, C. Zhao, Q.J. Shao, Z.D. Yang, X.F. Zhang, X.F. Xu, M. Hassan Determination of water content in corn stover silage using near-infrared spectroscopy Int. J. Agric. Bilo. Eng., 12 (2019), pp. 143-148, 10.25165 j.ijabe.20191206.4914 There is no relevant content in Zhang et al. ,