Blinding assessment in clinical trials of traditional Chinese medicine: Exploratory principles and protocol / 中西医结合学报

As one of the key components of clinical trials, blinding, if successfully implemented, can help to mitigate the risks of implementation bias and measurement bias, consequently improving the validity and reliability of the trial results. However, successful blinding in clinical trials of traditional Chinese medicine (TCM) is hard to achieve, and the evaluation of blinding success through blinding assessment lacks established guidelines. Taking into account the challenges associated with blinding in the TCM field, here we present a framework for assessing blinding. Further, this study proposes a blinding assessment protocol for TCM clinical trials, building upon the framework and the existing methods. An assessment report checklist and an approach for evaluating the assessment results are presented based on the proposed protocol. It is anticipated that these improvements to blinding assessment will generate greater awareness among researchers, facilitate the standardization of blinding, and augment the blinding effectiveness. The use of this blinding assessment may further advance the quality and precision of TCM clinical trials and improve the accuracy of the trial results. The blinding assessment protocol will undergo continued optimization and refinement, drawing upon expert consensus and experience derived from clinical trials. Please cite this article as: Wang XC, Liu XY, Shi KL, Meng QG, Yu YF, Wang SY, Wang J, Qu C, Lei C, Yu XP. Blinding assessment in clinical trials of traditional Chinese medicine: Exploratory principles and protocol. J Integr Med. 2023; 21(6): 528-536.

Severity of sepsis is correlated with the elevation of serum high-mobility group box 1 in rats / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Sepsis is a leading cause of death in the intensive care units. The late inflammatory cytokine, high-mobility group box 1 (HMGB1), plays a critical role in sepsis. In the present study, we investigated the association between the serum HMGB1 levels and the severity of organ injury in the lipopolysaccharide-induced sepsis in rats.</p><p><b>METHODS</b>To produce an animal model of sepsis with different degree of organ injury, animals were treated with three different doses of lipopolysaccharide (4, 8 and 16 mg/kg), and the animals in control group were treated with the same volume of the vehicle (saline). The levels of serum HMGB1 were measured at 0, 2, 4, 8, 16, 24, 32 and 48 hours after lipopolysaccharide (LPS) or vehicle injection, meanwhile the biochemical and histopathological indicators for the severity of organ injury were assessed.</p><p><b>RESULTS</b>The level of HMGB1 had a positive, high correlation with the abnormal changes of serum cardiac troponin I, alanine aminotransferase, aspartate aminotransferase, creatinine and blood urea nitrogen, as well as the pathologic scores of heart, lung, liver and kidney.</p><p><b>CONCLUSIONS</b>The level of serum HMGB1 is highly correlated with the severity of sepsis in rats, suggesting that HMGB1 could serve as a valuable adjunct in the diagnosis and management of sepsis.</p>

Qualitative analysis on the denervating action of botulinum toxin A in gel / 中国应用生理学杂志

<p><b>AIM</b>To ascertain the bioactivity and to analyse quantificationally the denervating action of botulinum toxin A (BTXA) in gel.</p><p><b>METHODS</b>36 Sprague-Dawley rats were randomized into four groups. In group A - D, the gastrocnemius muscle of one leg was randomly selected to receive injection of BTXA solution 5U in 0.1 ml, BTXA gel 12.5U in 0.1 ml, BTXA gel 5U in 0.1 ml and BTXA gel 2U in 0.1 ml respectively, while the gastrocnemius muscle of other leg was injected with 0.1 ml of saline solution in group A and 0.1 ml of gel in group B to group D as control. Compound muscle action potential (CMAP) of both gastrocnemius muscles were measured and the amplitudes were recorded before injections, and 5 days, 2 weeks, 3 weeks, 1 month, 2 months and 3 months after the injections respectively.</p><p><b>RESULTS</b>The reduction of CMAP amplitude was significantly different at various time (P < 0.01), and CMAP amplitude decreased significantly after the treatment of BTXA (P < 0.01). The reduction of CMAP amplitude was significantly dif ferent in group A to I) (P < 0.01), and more reduction was found in group A and B (P < 0.01), and the reduction was higher in group C than in group D (P < 0.05). However, there were no significant differences in the reduction of CMAP amplitude between group A and group B.</p><p><b>CONCLUSION</b>Bioactivity of BTXA in gel was showed and the denervating action of BTXA in gel was demonstrated in a dosage and time dependent manner.</p>