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. 2023 Feb 6;23(1):37.
doi: 10.1186/s12906-023-03864-6.

Benefit-risk assessment of traditional Chinese medicine preparations of sinomenine using multicriteria decision analysis (MCDA) for patients with rheumatoid arthritis

Gao Xiang #  1 , Min Gao #  2 , Huirong Qin  1 , Xiaolan Shen  1 , Huilian Huang  3 , Xiaoqiang Hou  4   5 , Zhitao Feng  6   7
Affiliations

Benefit-risk assessment of traditional Chinese medicine preparations of sinomenine using multicriteria decision analysis (MCDA) for patients with rheumatoid arthritis

Gao Xiang et al. BMC Complement Med Ther. .

Abstract

Objective: A multicriteria decision analysis (MCDA) model was used to evaluate the benefits and risks of traditional Chinese medicine preparations of sinomenine alone or in combination with conventional drugs in the treatment of rheumatoid arthritis (RA) and to provide a basis for the rational clinical application of sinomenine.

Methods: A study search was performed using six major databases, and Review Manager 5.3 was used for data analysis. Then, an MCDA model evaluation system was established for the treatment of RA with sinomenine preparations, and the benefit values, risk values, and total benefit-risk values of sinomenine preparations alone or in combination with conventional drugs were calculated using Hiview 3.2 software. Finally, Monte Carlo simulations were performed using Crystal Ball embedded in Excel software to calculate the 95% confidence intervals (95% CI), and the probability of the differences between the 2 drug regimens was determined to optimize the evaluation results.

Results: Forty-four randomized controlled trials (RCTs) were included. Quantitative assessment of the MCDA model showed that the sinomenine preparation alone offered less benefits than when combined with conventional drugs with a benefit difference of 20 (95% CI 3.06, 35.71). However, the risk of the combination was significantly lower with a risk difference of 13(95% CI -10.26, 27.52). The total value of the benefit-risk of sinomenine alone and in combination with conventional drugs was 46 and 53 at 60% and 40% of the benefit-risk ratio of the two dosing regimens, respectively, with a difference of 7 (95% CI -4.26, 22.12). The probability that the comprehensive score of the combined regimen is greater than that of sinomenine alone is 90.1%, and the evaluation was steady.

Conclusion: The benefit-risk of the combined application regimen of sinomenine is greater than that of sinomenine alone.

Keywords: Benefit-risk assessment; Multicriteria decision analysis; Rheumatoid arthritis; Sinomenine; Traditional Chinese medicine.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Benefit-risk evaluation effects tree of sinomenine in the treatment of RA. Benefit: Positive outcomes for patients Risk: Negative outcomes for patients TJC: tender joint count SJC: swollen joint count RF: rheumatoid factor CRP: C-reactive protein ESR: erythrocyte sedimentation rate
Fig. 2
Fig. 2
Publication bias of included literature
Fig. 3
Fig. 3
Differential benefits between alone and combined use
Fig. 4
Fig. 4
The deviation of risk between alone and combined
Fig. 5
Fig. 5
Benefits—risks of alone and combined
Fig. 6
Fig. 6
The probability of combined use being better than alone
Fig. 7
Fig. 7
Sensitivity analysis of benefit-risk
See this image and copyright information in PMC

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