TCM manipulation is an important way for the treatment of cervical spondylosis. A large number of randomized controlled trials (RCTs) about TCM manipulation for cervical spondylosis have been published as relevant research develops. However, various levels of qualities of these RCTs may be non-beneficial to the promotion of TCM manipulation and the generation of high-quality clinical evidence.
To evaluate the quality of RCTs of TCM manipulation for cervical spondylosis.
We searched RCTs of TCM manipulation for cervical spondylosis in databases of CNKI, Wanfang Data, VIP, SinoMed, PubMed, Embase and Cochrane Library from inception to June 2021. RCTs enrollment and data extraction were performed by two researchers, separately. Quality assessment was conducted using the PEDro Rating Scale, The Cochrane Collaboration's tool for assessing risk of bias, and the CONSORT 2010 Statement and other six indicators (whether the RCT is multicenter, with ethical approval, informed consent, quality control for intervention, efficacy assessment criteria, and acknowledgement) .
Finally, 81 RCTs were included, of which 28 were published from 2006 to 2014, annually averaged 3.11, other 53 were published from 2015 to 2021, annually averaged 7.57. By the PEDro Rating Scale, the quality of only 7 (8.6%) RCTs was rated as high-quality (≥7 points) . By the Cochrane Collaboration's tool for assessing risk of bias, the percentage of RCTs with high risk of bias was the least, followed by that of those with low risk of bias. Most of RCTs had unclear risk of bias due to reported incomplete information. By the CONSORT 2010 Statement, the rates of title, abstract, methods, results, discussion and other information reported by the included RCTs were insufficient. By other six indicators, the rate of RCTs with a multicenter design, ethical approval, quality control for intervention, and acknowledgement was low.
The quality of current RCTs about TCM manipulation for cervical spondylosis is generally low. The improvement recommendation for relevant researchers is writing RCTs about the TCM manipulation for cervical spondylosis standardly in accordance with the PEDro Rating Scale, the Cochrane Collaboration's tool for assessing risk of bias, and the CONSORT 2010 Statement.
The prevalence of inflammatory bowel disease (IBD) increases annually in China. The integrated traditional Chinese and western medicine is helpful to alleviate and control symptoms of IBD. Quality of life (QoL) is an important index to evaluate the clinical efficacy of IBD. However, there are few studies about IBD patient-reported outcomes (PROs) based on TCM theories.
To determine the framework and items, and then use them to develop the IBD PROs scale using TCM theories.
Under the guidance of the TCM theory of "body and mind harmony, and man's adaptation to his total environment" , literature review, core-group discussion and expert consultation were carried out. The conceptual framework and item pool of the draft of an IBD PROs scale were developed, then the corresponding items were determined, forming the draft of the IBD PROs scale. Then the draft scale was pre-tested in IBD patients treated in Department of Spleen and Stomach Diseases, the First Affiliated Hospital of Guangzhou University of Chinese Medicine from January to June 2021. The dispersion tendency, Cronbach's α and correlation analysis were used for further item selection.
The final IBD PROs scale is composed of two domains: body and mind harmony (12 body-related items, and 9 mind-related items) and man's adaptation to his total environment (6 items) .
The IBD PROs scale developed based on theories of TCM could be used to evaluate the QoL of IBD patients. But further clinical research is still needed to verify its reliability and validity.
Qingrexiaozheng formula (QRXZF) has been shown to be effective in improving kidney injury in diabetic kidney disease (DKD) , but the mechanism remains to be unclear.
To explore the effect and mechanism of action of QRXZF in the improvement of kidney injury induced by unilateral nephritic resection combined with streptozotocin (STZ) in DKD rats.
The experiment was implemented from July to November, 2019. Thirty healthy SPF male SD rats were randomly divided into sham operation group (NC group, n=10) and model group (n=20) . Rats in NC group received 1 cm transverse incision performed at the body surface anatomical position of the right kidney and sutured, and intraperitoneal injection of citric acid buffer when the wound healed one week later. Those in model group were treated with right nephrectomy, and received a single intraperitoneal injection of STZ solution (55 mg/kg) with the same volume as the citric acid buffer for the NC group one week later to establish the DKD model. Then rats in the model group were randomly divided into DKD subgroup (n=10) and QRXZF subgroup (n=10) when the modeling was successfully achieved. After this, rats in NC group and DKD subgroup received intragastric administration of the same amount (1 ml/100 g) of 0.9% sodium chloride solution once a day, and those in QRXZF subgroup received intragastric administration of QRXZF at a dose of 7.92 g·kg-1·d-1. During the intervention, weight was measured every week. After 16 weeks of intervention, a 24-hour urine, serum and kidney tissue specimens were collected, kidney weight was measured, and the kidney weight index was calculated. Enzyme-linked immunosorbent assay was used to detect the microalbumin in 24-hour urine (24 hUpro) . The automatic biochemical analyzer was used to analyze serum creatinine (Scr) , blood urea nitrogen (BUN) and serum albumin (ALB) . Hematoxylin-eosin staining, Periodic Acid-Schiff staining and Masson's trichrome staining were performed to observe the damage degree of kidney tissue. Immunohistochemical method was used to detect the expression level of Caspase-3 and p16 in kidney tissue. The apoptosis of renal tubular cells was detected by in situ terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling.
Compared with rats in the NC group, those in DKD and QRXZF subgroups had lower weight and higher kidney weight index (P<0.01) . Rats in QRXZF subgroup had higher weight and lower kidney weight index than those in DKD subgroup (P<0.01) . In comparison to rats in the NC group, rats in DKD subgroup had higher levels of 24 hUpro, Scr and BUN lower level of ALB (P<0.01) , and those in QRXZF subgroup had higher levels of 24 hUpro and BUN, and lower level of ALB (P<0.01) . Rats in QRXZF subgroup had higher levels of 24 hUpro, Scr and BUN, and lower level of ALB than did those in DKD subgroup (P<0.01) . Compared with rats in the NC group, obvious pathological injury, glomerular hypertrophy and interstitial tubular fibrosis were observed in kidney tissues in rats of both DKD and QRXZF subgroups, but the degree of pathological changes was much lighter in QRXZF subgroup. Immunohistochemistry analysis showed that the expression levels of P16 and Caspase-3 in renal tissue in DKD or QRXZF subgroup were higher than those in NC group (P<0.01) . The expression levels of P16 and Caspase-3 in renal tissue in QRXZF subgroup were lower than those in DKD subgroup (P<0.01) . The rate of renal tubular cell apoptosis in DKD or QRXZF subgroup was higher than that in NC group (P<0.01) . The rate of renal tubular cell apoptosis in QRXZF subgroup was lower than that in DKD subgroup (P<0.01) .
QRXZF effectively improved the renal function, attenuate the pathological damage and fibrosis of the kidney, inhibit the expression of Caspase-3 and p16 in renal tissues, and decrease the rate of renal tubular cell apoptosis in DKD rats, suggesting that the mechanism of QRXZF in improving kidney may be related to inhibiting the aging and apoptosis of kidney cells.
