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OBJECTIVE: To evaluate the efficacy and safety of Wuda Granule (WDG) on recovery of gastrointestinal function after laparoscopic bowel resection in the setting of enhanced recovery after surgery (ERAS)-based perioperative care. METHODS: A total of 108 patients aged 18 years or older undergoing laparoscopic bowel resection with a surgical duration of 2 to 4.5 h were randomly assigned (1:1) to receive either WDG or placebo (10 g/bag) twice a day from postoperative days 1-3, combining with ERAS-based perioperative care. The primary outcome was time to first defecation. Secondary outcomes were time to first flatus, time to first tolerance of liquid or semi-liquid food, gastrointestinal-related symptoms and length of stay. Subgroup analysis of the primary outcome according to sex, age, tumor site, surgical time, histories of underlying disease or history of abdominal surgery was undertaken. Adverse events were observed and recorded. RESULTS: A total of 107 patients [53 in the WDG group and 54 in the placebo group; 61.7 ± 12.1 years; 50 males (46.7%)] were included in the intention-to-treat analysis. The patients in the WDG group had a significantly shorter time to first defecation and flatus [between-group difference -11.01 h (95% CI -20.75 to -1.28 h), P=0.012 for defecation; -5.41 h (-11.10 to 0.27 h), P=0.040 for flatus] than the placebo group. Moreover, the extent of improvement in postoperative gastrointestinal-related symptoms in the WDG group was significantly better than that in the placebo group (P<0.05). Subgroup analyses revealed that the benefits of WDG were significantly superior in patients who were male, or under 60 years old, or surgical time less than 3 h, or having no history of basic disease or no history of abdominal surgery. There were no serious adverse events. CONCLUSION: The addition of WDG to an ERAS postoperative care may be a viable strategy to enhance gastrointestinal function recovery after laparoscopic bowel resection surgery. (Registry No. ChiCTR2100046242).

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OBJECTIVE: Characterized by its disabling nature, obsessive compulsive disorder (OCD) affects individuals profoundly, with nearly 40% of patients showing resistance to initial treatment methods. Despite being safe and easily accessible, transcranial direct current stimulation (tDCS) lacks extensive substantiation supporting its efficacy in treating OCD. The objective of this study was to evaluate how cathodal high-definition transcranial direct current stimulation (HD-tDCS) applied to the right orbitofrontal cortex affected patients with OCD in terms of efficacy. METHOD: 47 patients with OCD were enrolled. They were randomly allocated to active or sham stimulation groups, and underwent HD-tDCS stimulation treatment for 2 weeks. The central electrode located in the right orbitofrontal cortex region was cathodic. The severity of the patients' obsessive-compulsive symptoms, depression and anxiety were assessed before and after treatment. RESULT: Out of the total, 44 patients concluded the treatment, comprising 23 participants from the active stimulation group and 21 from the sham stimulation group. Notably, substantial reductions in symptoms related to OCD, depression, and anxiety were exhibited in both groups. With a response rate of 26.1% in the active stimulation group and 23.8% in the sham stimulation group, there was no significant difference in efficacy observed. Furthermore, the reduction in depression and anxiety symptoms at the conclusion of the treatment was not notably superior in the active stimulation group. CONCLUSION: This study provided evidence for the acceptability and safety of HD-tDCS. Nevertheless, the study did not reveal notable clinical effectiveness of tDCS in addressing moderate to severe OCD in comparison to the sham stimulation group.

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Background: Repetitive transcranial magnetic stimulation (rTMS) has been proven to be safe and effective in treating major depressive disorder (MDD). However, the treatment parameters of rTMS are still divergent and need to be optimized further. The aim of this study was to compare the efficacy of rTMS in treating MDD with different parameters of stimulating frequency and location, and course of treatment. Methods: A total of 221 patients with MDD were recruited in the randomized, double-blind, controlled trial. All eligible patients were randomly assigned into four treatment groups: (1) 10 Hz in left dorsolateral pre-frontal cortex (DLPFC) (n = 55), (2) 5 Hz in left DLPFC (n = 53), (3) 10 Hz in bilateral DLPFC (n = 57), and (4) 5 Hz in bilateral DLPFC (n = 56). The patients received treatment for 6 weeks and an additional 6-week optional treatment. The efficacies were evaluated by Hamilton Depression Rating Scale-24 items (HDRS) and Clinical Global Impressions Scale (CGI). The trial is registered at the Chinese Clinical Trial Registry as ChiCTR-TRC-12002248. Results: The ANOVAs of HDRS scores up to 6 weeks and 12 weeks with repeated measure of time showed a significant effect of duration without statistical difference among four treatment groups and no significance when time was interacted with inter-group as well. The response rates up until the 5th week were significantly different with the previous week. Conclusions: It concludes that there were no statistical differences in the efficacy of rTMS between unilateral left and bilateral DLPFC, and between 5 and 10 Hz for treating MDD.

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BACKGROUND: There are still no sufficient data regarding the use of deep brain stimulation (DBS) in Gilles de la Tourette syndrome (GTS) and no agreement on optimal target. OBJECTIVE: To compare efficacy and safety of bilateral DBS of thalamus (centromedian-ventro-oral internus, CM-Voi) versus posteroventral lateral globus pallidus internus (pvl GPi)) versus sham stimulation, and baseline in severe medically refractory GTS. METHODS: In this randomized double-blind sham stimulation-controlled trial (RCT), 10 patients (3 women, mean age = 29.4 ± 10.2 SD, range 18-47) underwent three blinded periods each lasting three months including (i) sham, (ii) pvl GPi (on-GPi), and (iii) thalamic stimulation (on-thal) followed by an open uncontrolled long-term follow-up (up to 9 years) with individually determined target and stimulation settings. RESULTS: Nine patients completed the RCT. At group level, on-GPi - but not on-thal - resulted in a significant tic reduction compared to baseline, but had no effect on premonitory urges and psychiatric comorbidities. Direct comparisons of targets resulted in inconsistent or negative (compared to sham) findings. During follow-up, we found no improvement of tics, comorbidities, and quality of life at group level, however, single patients benefitted continuously from thalamic DBS. At last follow-up 89.9 months (mean) after surgery, 50% of patients had discontinued DBS. Hardware infections occurred in 3/10 patients. CONCLUSION: Our data suggest that the initial effect of pvl GPi DBS is superior to thalamic (CM-Voi) DBS. While half of the patients discontinued treatment, single patients benefitted from thalamic DBS even after years. It is likely that outcome is influenced by various factors beyond the mere change in tic severity.

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BACKGROUND: Diabetes mellitus (DM) is a metabolic disorder syndrome caused by relative or absolute lack of insulin and varying degrees of insulin resistance. The type and regimen of anesthesia may affect perioperative hyperglycemia following major surgical stress. The effect of perioperative anesthetics on the blood glucose level of diabetic patients will play an essential role in the postoperative recovery of patients. However, there is no rigorously-designed randomized controlled trial to compare the effects of total intravenous anesthesia (TIVA) and total inhalation anesthesia (TIHA) on blood glucose and complications in type 2 diabetes. Hence, we design this clinical trial to compare the effects of TIVA and TIHA of hyperglycemia and clinical outcomes in type 2 diabetes undergoing surgery. METHODS: This is a randomized, double-blind, parallel controlled trial. One hundred twelve patients with type 2 DM who meet the qualification criteria will be randomly divided into two groups: TIVA group and TIHA group. The levels of serum insulin and cortisol will be measured before and after the operation, and the levels of blood glucose at different setting time will be monitored. All patients will be followed up by blinded evaluators at baseline and 1, 3, 7, and 30 days after the intervention. The follow-up included postoperative complications [such as myocardial infarction (MI), stroke, renal failure, anastomotic fistula, stress ulcer, incision infection, lung infection] and adverse events. DISCUSSION: The routinely used clinical anesthesia schemes are TIVA, TIHA and intravenous-inhalation combined anesthesia. We expect that the results of this trial will provide high-quality clinical evidence for the choice of anesthesia options for patients with type 2 DM. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2000029247, registration date: 20 January 2020.

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BACKGROUND: Children with cow's milk allergy (CMA) are at risk for inadequate nutritional intake and growth. Dietary management of CMA, therefore, requires diets that are not only hypoallergenic but also support adequate growth in this population. This study assessed growth of CMA infants when using a new amino acid-based formula (AAF) with prebiotics and probiotics (synbiotics) and evaluated its safety in the intended population. METHODS: In a prospective, randomized, double-blind controlled study, full-term infants with diagnosed CMA received either an AAF (control; n = 56) or AAF with synbiotics (oligofructose, long-chain inulin, acidic oligosaccharides, Bifidobacterium breve M-16V) (test; n = 54) for 16 wk. Primary outcome was growth, measured as weight, length and head circumference. Secondary outcomes included allergic symptoms and stool characteristics. RESULTS: Average age (±SD) of infants at inclusion was 4.5 ± 2.4 months. Both formulas equally supported growth according to WHO 2006 growth charts and resulted in similar increases of weight, length and head circumference. At week 16, differences (90% CI) in Z-scores (test-control) were as follows: weight 0.147 (-0.10; 0.39, p = 0.32), length -0.299 (-0.69; 0.09, p = 0.21) and head circumference 0.152 (-0.15; 0.45, p = 0.40). Weight-for-age and length-for-age Z-scores were not significantly different between the test and control groups. Both formulas were well tolerated and reduced allergic symptoms; the number of adverse events was not different between the groups. CONCLUSIONS: This is the first study that shows that an AAF with a specific synbiotic blend, suitable for CMA infants, supports normal growth and growth similar to the AAF without synbiotics. This clinical trial is registered as NCT00664768.

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