Blinding assessment in clinical trials of traditional Chinese medicine: Exploratory principles and protocol

Wang, Xiao-cong; Liu, Xiao-yu; Shi, Kang-le; Meng, Qing-gang; Yu, Yue-fan; Wang, Shi-yao; Wang, Juan; Qu, Chang; Lei, Cong; Yu, Xin-ping

doi:10.1016/j.joim.2023.10.003

Cited by 2 publications

(1 citation statement)

References 37 publications

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“…It has been shown that in randomized trials with ambiguous blinding or lack of blinding, the value of their intervention effect on outcomes was exaggerated from the estimated value ( Tack, 2023 ). In general, the more subjective the trial outcome, the greater the bias it creates ( Wang et al, 2023 ). However, the risk of measurement bias was low herein because the outcomes were objective and did not influence the measurement and assessment of the outcome.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of Shen Gui capsules for chronic heart failure: a systematic review and meta-analysis

Yan,

Zhang,

Wang

et al. 2024

Front. Pharmacol.

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BackgroundAlthough Shen Gui capsules (SGCP) are widely used as an adjuvant treatment for chronic heart failure (CHF), their clinical efficacy and safety remain controversial.PurposeTo assess the efficacy and safety of SGCP in the treatment of CHF through a systematic review and meta-analysis, to provide high-quality evidence for evidence-based medicine.MethodsSeven databases were searched for randomized controlled trials (RCTs) assessing SGCP for CHF, from inception to 9 January 2023. RCT quality of evidence was evaluated using the Cochrane Handbook for the Evaluation of Intervention Systems to assess risk of bias and Grading of Recommendations Assessment, Development, and Evaluation. A meta-analysis with subgroup and sensitivity analyses was performed using Review Manager 5.4 and Stata 12.ResultsNine RCTs representing 888 patients with CHF were included in the review. Meta-analysis revealed that SGCP combined with conventional heart failure therapy is more advantageous for improving left ventricular ejection fraction [LVEF; mean difference (MD) = 5.26, 95% confidence interval (CI) (3.78, 6.74), p < 0.0000] and increasing effective rate [relative risk (RR) = 1.21, 95%CI (1.14, 1.29), p < 0.001] compared with conventional therapy alone. The experimental treatment also reduced brain natriuretic peptide [MD = −100.15, 95%CI (−157.83, −42.47), p = 0.0007], left ventricular end-diastolic diameter [MD = −1.93, 95%CI (−3.22, −0.64), p = 0.003], and hypersensitive C-reactive protein [MD = −2.70, 95%CI (−3.12,−2.28), p < 0.001] compared with the control group. However, there was not a statistically significant difference in tumor necrosis factor-α [MD = −14.16, 95%CI (−34.04, 5.73), p = 0.16] or left ventricular end-systolic diameter [MD = −1.56, 95%CI (−3.13, 0.01), p = 0.05]. Nor was there a statistically significant between-groups difference in incidence of adverse events (p > 0.05).ConclusionSGCP combined with conventional heart failure therapy can improve LVEF and increase the effective rate to safely treat patients with CHF. However, further high-quality studies are needed to confirm these findings, due to the overall low quality of evidence in this literature.Clinical Trial Registration:https://www.crd.york.ac.uk/PROSPERO/logout.php, PROSPERO [CRD42023390409].

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Section: Discussionmentioning

confidence: 99%

Efficacy and safety of Shen Gui capsules for chronic heart failure: a systematic review and meta-analysis

Yan,

Zhang,

Wang

et al. 2024

Front. Pharmacol.

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Efficacy of combined electroacupuncture and moxibustion for treatment of neurogenic bladder after spinal cord injury: A retrospective analysis

Wang,

2024

Medicine

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This retrospective study evaluates the clinical efficacy of combined electroacupuncture and moxibustion for the treatment of neurogenic bladder in patients with spinal cord injury. Ninety patients with neurogenic bladder after spinal cord injury who were admitted to the hospital between January 2021 and August 2023 were included. The patients were divided into the study and control groups (n = 45 each) using a random number table method. The study group was treated with electroacupuncture combined with moxibustion, while the control group was treated with electroacupuncture alone. The variables evaluated to assess the clinical efficacy of each treatment included number of cases in which bladder function reached a balanced state, initial bladder capacity sensation, maximum detrusor pressure before versus after treatment, maximum urine flow rate, maximum renal pelvic separation width, urine white blood cell count, and subjective quality of life profile score. In the study group, bladder pressure, residual urine volume, frequency of urination, and subjective quality of life profile score increased after versus before treatment (P < .05), whereas the maximal renal pelvis separation width and urinary white blood cell count decreased after versus before treatment (P < .05). Moreover, the study group exhibited significantly greater improvement than the control group (P < .05). The efficacy rates in the study and control groups were 75.6% and 95.6%, respectively; this difference was statistically significant (P < .05). Compared to electroacupuncture alone, electroacupuncture combined with moxibustion reduced the incidence of urinary tract infection, reduced residual urine volume, increased bladder capacity, and achieved balanced bladder function in patients with neurogenic bladder.

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Blinding assessment in clinical trials of traditional Chinese medicine: Exploratory principles and protocol

Cited by 2 publications

References 37 publications

Efficacy and safety of Shen Gui capsules for chronic heart failure: a systematic review and meta-analysis

Efficacy and safety of Shen Gui capsules for chronic heart failure: a systematic review and meta-analysis

Efficacy of combined electroacupuncture and moxibustion for treatment of neurogenic bladder after spinal cord injury: A retrospective analysis

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