Fermented Ophiocordyceps sinensis mycelium products for preventing contrast-associated acute kidney injury: a systematic review of randomized controlled trials

Abstract

Background

To evaluate the efficacy, effectiveness and safety of fermented Ophiocordyceps sinensis mycelium (FOSM) products for preventing contrast-associated acute kidney injury (CA-AKI).

Methods

Randomized controlled trials were searched from four Chinese and four English electronic databases and three clinical trial registries up to July 2023. Methodological quality was assessed by using the Cochrane risk-of-bias tool 2.0. Risk difference (RD) or risk ratio (RR) and mean difference (MD) were calculated along with the 95% confidence intervals (CIs).

Results

Fourteen trials testing three types of FOSM products (Bailing, Zhiling, and Jinshuibao capsules) involving 1271 participants injected contrast agents were included. For the risk of bias, all trials were rated as some concerns. Compared with routine preventive procedure (RPP) (saline hydration and alprostadil), FOSM products plus RPP showed beneficial effects in reducing the incidence of CA-AKI (14.62% and 5.35%, respectively; RD −0.06, 95% CI −0.09 to −0.03). Subgroup analysis showed that Bailing/Jinshuibao plus RPP demonstrated lower incidence of CA-AKI compared to RPP. However, there was no statistically significant difference between Zhiling with RPP and RPP in the incidence of CA-AKI. Additionally, only when FOSM products were taken before injection of the contrast, it was superior to RPP in reducing the incidence of CA-AKI. There was no statistical difference in adverse events between these two groups.

Conclusions

Low certainty evidence suggests that preventive oral use of FOSM products as an adjuvant agent was safe and might decrease the incidence of CA-AKI. However, high-quality placebo-controlled trials are needed to confirm its benefit.

Keywords:

• Chinese patent medicine
• Ophiocordyceps sinensis
• contrast-associated acute kidney injury
• randomized clinical trials
• systematic review

Acknowledgements

We gratefully acknowledge the assistance of Qihe Xu, Jianping Liu, and Nicola Robinson in reviewing and modifying the article.

Author contributions

Conceptualization: JP Liu and FL Pu. Methodology: FL Pu. Software: FL Pu and TL Li. Formal analysis: FL Pu. Data curation: FL Pu and TL Li. Writing – original draft: FL Pu. Writing – review and editing: JP Liu, TL Li, Q Xu, C Shen, YQ Wang, CM Tang, XW Zhang, and LJ Yan. Funding acquisition: JP Liu.

Ethical approval

This work did not require ethical approval as it does not involve any human or animal experiments.

Consent form

The author confirms that the work described has not been published before, that it is not under consideration for publication elsewhere, and that its publication has been approved by all coauthors.

Disclosure statement

All authors declare that there is no conflict of interest.

Data availability statement

The original data and material are available in this article/supplementary material and further enquiries can be directed to the authors.

Additional information

Funding

This work was supported by the Innovation Team and Talents Cultivation Program of National Administration of Traditional Chinese Medicine (ZYYCXTD-C-202006) and High-level Traditional Chinese Medicine Key Subjects Construction Project of National Administration of Traditional Chinese Medicine—Evidence-based Traditional Chinese Medicine (zyyzdxk-2023249).