Controlled Clinical Trial Research Articles

Report on Cardiovascular Health and Diseases in China 2023: An Updated Summary

Since 1990, China has made considerable progress in resolving the problem of “treatment difficulty” of cardiovascular diseases (CVD). The prevalent unhealthy lifestyle among Chinese residents has exposed a massive proportion of the population to CVD risk factors, and this situation is further worsened due to the accelerated aging population in China. CVD remains one of the greatest threats to the health of Chinese residents. In terms of the proportions of disease mortality among urban and rural residents in China, CVD has persistently ranked first. In 2021, CVD accounted for 48.98% and 47.35% of deaths in rural and urban areas, respectively. Two out of every five deaths can be attributed to CVD. To implement a national policy “focusing on the primary health institute and emphasizing prevention” and truly achieve a shift of CVD prevention and treatment from hospitals to communities, the National Center for Cardiovascular Diseases has organized experts from relevant fields across China to compile the “Report on Cardiovascular Health and Diseases in China” annually since 2005. The 2024 report is established based on representative, published, and high-quality big-data research results from cross-sectional and cohort population epidemiological surveys, randomized controlled clinical trials, large sample registry studies, and typical community prevention and treatment cases, along with data from some projects undertaken by the National Center for Cardiovascular Diseases. These firsthand data not only enrich the content of the current report but also provide a more timely and comprehensive reflection of the status of CVD prevention and treatment in China.

Abdominal muscles infiltration analgesia for donor-site pain in autologous ear reconstruction: A randomized controlled clinical trial

BackgroundCostal cartilage donor-site pain is an adverse effect of autologous ear reconstruction. This study aimed to introduce rectus abdominis and external oblique muscle infiltration analgesia (RAM+EOM-IA) for costal cartilage donor-site pain and evaluate its efficacy and safety. MethodsThe study was a randomized controlled clinical trial. Patients were randomized between intermittent RAM+EOM-IA combined with intravenous patient-controlled anesthesia (IPCA) and IPCA alone. Thirty patients were followed in the RAM+EOM-IA combined with the IPCA group and 30 patients in the IPCA alone group. The primary outcome was the numerical rating score (NRS) of pain recorded during 48 h postoperatively. Secondary outcomes included the Barthel index (BI) and rescue analgesic consumption. Sensory block areas were tested using a cold stimulus. ResultsNRS was significantly lower with RAM+EOM-IA combined with IPCA than with IPCA alone at 28 h (P < 0.01), 32 h (P < 0.01), 36 h (P < 0.01), 44 h (P < 0.001), and 48 h (P < 0.01) postoperatively. The number of patients who received rescue analgesics (P < 0.01) and consumption (P < 0.01) was significantly higher for IPCA alone. RAM+EOM-IA improved the BI at 24 h postoperatively (P < 0.001), especially for mobility (P < 0.001), using the stairs (P < 0.001) and toilet use domains (P < 0.001). At 10 and 60 min after RAM+EOM-IA, the total sensory block area in the abdomen had not extended proximally beyond the xiphoid, distally beyond the navel, and beyond midaxillary and midsternal lines on either side. ConclusionRAM+EOM-IA effectively and safely prevented costal cartilage donor-site pain by blocking anterior and lateral cutaneous branches of intercostal nerves from T6 to T10 in microtia patients.

Green Tea Kombucha Impacts Inflammation and Salivary Microbiota in Individuals with Excess Body Weight: A Randomized Controlled Trial.

Green tea kombucha (GTK) is a fermented beverage with promising health benefits, but few studies proved its impact on human health. Thus, we aimed to investigate the impact of GTK on weight loss, inflammation, and salivary microbiota in individuals with excess body weight. This is a randomized controlled clinical trial that lasted 10 weeks with two groups of individuals with excess body weight: control (CG; n = 29; caloric restriction) and kombucha (KG; n = 30; caloric restriction + 200 mL GTK). Body composition, anthropometry, saliva, and blood collection were performed in the beginning and end of the intervention. Plasma interleukins were determined by flow cytometry. Salivary microbiota was analyzed by 16S rRNA sequencing. Both groups decreased weight, BMI, and body fat (p < 0.001) after the intervention, but there were no differences between groups. The KG reduced lipid accumulation product (LAP) (p = 0.029). Both groups decreased IL-1β and IL-8, but IL-6 increased in the CG (p = 0.023) compared to the kombucha group. Alpha and beta diversity of salivary microbiota increased in the KG. Moreover, the KG presented lower Bacillota/Bacteroidota ratio (p = 0.028), and BMI was positively associated with the Bacillota phylum. GTK did not enhance weight loss, but it decreased the LAP. GTK helped in the inflammatory profile and induced positive changes in oral microbiota composition.

The effect of periodontal treatments on endothelial function in degrees of periodontitis patients: A systematic review and meta-analysis.

This article focus on patients with moderate-to-severe periodontitis and periodontitis patients with cardiovascular disease. After they received periodontal initial therapy or antimicrobial drug treatment, was there any improvement in endothelial function during short- and long-term followups? Relevant randomized controlled trials and clinical trials up to 30th June 2024 were identified and retrieved from electronic databases including PubMed, Cochrane Library, Web of Science and CNKI databases, with periodontitis therapy, periodontal disease and endothelial function as the keywords. The weighted (WMD) or standardized mean difference (SMD) was calculated using a fixed- or random-effect model and assessed heterogeneous results. Generally, 14 studies published between 2004 and 2022 were eligible for the meta-analysis, which are all randomised clinical trials. A total of 491 periodontitis patients were screened. All participants received whole-mouth supragingival and subgingival scaling and root planing of the teeth, some trials combined with antimicrobial drug treatment as well as extracting teeth that could not be saved. The outcome indicators were measured by flow-mediated dilatation(FMD) levels. The results of the short term (≤3 months) periodontitis initial therapy group showed positive results (WMD = -3.78,95%CI = [-5.49,-2.07], P<0.0001), while the results of the long term (6 months) periodontitis therapy group exhibited significant difference (WMD = -0.96,95%CI = [-2.06,0.14],P = 0.09). Furthermore, study population were categorized according to the severity of periodontitis, the presence of comorbidities, endothelial dysfunction, and the inclusion of extractions and antimicrobial therapy in the treatment process. The effects of each of these factors on FMD were explored and the results of these subgroups all support periodontitis therapy. The results showed that periodontal treatment enhances endothelial function. Additionally, after subgroup analysis of long-term and short-term follow-up, patients with severe periodontitis, and different periodontal treatments, periodontal therapy was shown to increase FMD levels.

KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease in Children and Adults: a commentary from the European Renal Best Practice (ERBP)

ABSTRACT The Kidney Disease: Improving Global Outcomes (KDIGO) 2024 Guideline for Identification and Management of Chronic Kidney Disease (CKD) is a welcome development, coming 12 years after the paradigm-changing 2012 guidelines. We are living in an unprecedented era in nephrology with novel therapies, including sodium-glucose cotransporter-2 inhibitors, glucagon-like peptide-1 receptor agonists and non-steroidal mineralocorticoid receptor antagonists, now being proven in multiple randomized controlled clinical trials to reduce both the progression of CKD and cardiovascular morbidity and mortality. The KDIGO 2024 CKD Guideline is aimed at a broad audience looking after children and adults with CKD and provide practical and actionable steps to improve care. This commentary reviews the guideline sections pertaining to the evaluation and risk assessment of individuals with CKD from a European perspective. We feel that despite the last guideline being published 12 years ago, and the fact that the assessment of CKD has been emphasized by many other national/international nephrology, cardiology and diabetology guidelines and societies, the diagnosis and treatment of CKD remains poor across Europe. As such, the KDIGO 2024 CKD Guideline should be seen as an urgent call to action to improve diagnosis and care of children and adults with CKD across Europe. We know what we need to do. We now need to get on and do it.

Similar short-term outcomes for bone-level implants with or without intermediate abutments.

A single-center (university-setting), prospective, longitudinal, split-mouth, single-blind, randomized controlled clinical trial investigated peri-implant parameters of bone-level implants restored with either screw-retained prostheses connected directly to the implants or with intermediate abutments over a 3-year period. The study adhered to the ethical principles of the Helsinki Declaration and the CONSORT guidelines. Ethical approval was granted, and the trial was registered at Clinicaltrials.gov . Participants included were over 18 years of age, had a plaque index below 25%, and were missing at least two adjacent teeth, allowing for rehabilitation with screw-retained fixed partial prostheses over two implants and 2-4 prosthetic units. Exclusion criteria included long-term use of medications affecting bone metabolism, smoking more than 10 cigarettes per day, history of local radiotherapy, untreated periodontitis, and the need for rehabilitation in the anterior sextant of the maxilla. The primary clinical outcome was marginal bone loss (MBL), while secondary outcomes included probing pocket depth (PPD), plaque index (PI), bleeding on probing (BOP), and patient-reported outcomes (PROs). The study schedule included a screening (visit 1), implant surgery (visit 2), stage-two 8 weeks post-surgery (visit 3), impressions taken 4 weeks post stage-two (visit 4), baseline standardized radiograph (visit 5), followed by 6-month (visit 6), 12-month (visit 7), and 36-month (visit 8) follow-up visits. Descriptive statistics and quantitative measures included means, standard deviations (SDs), minimum and maximum values, and 95% confidence intervals (CIs). Clinical parameters (six sites per implant) measured were MBL, PPD, PI, and BOP. Paired t tests were utilized for intragroup comparisons across different time points and intergroup comparisons at each time point. PROs at 36 months were compared using Student's t test. The alpha significance level was set at 0.05. The study included 36 patients (72 implants), with two not completing the follow-up due to death and relocation. No implants showed signs of inflammation or mobility. Mean interproximal bone level (IBL) at baseline was 0.13 mm ± 0.15 mm for the control group and 0.10 ± 0.13 mm for the test group. At the 36-month follow-up, mean IBL was 0.13 ± 0.18 mm for the control group and 0.20 ± 0.24 mm for the test group, with no significant differences (F(1, 32) = 1.06; p > 0.05). Clinical parameters (PPD, BOP, PI) at 36 months showed no significant differences between groups. Minor complications occurred in 6.7% of the control group and 5.3% of the test group. PROs indicated no significant differences in general satisfaction, esthetics, comfort, phonetics, and masticatory function between the groups. After a 36-month follow-up, bone-level implants restored with CAD/CAM prostheses directly connected to the implants displayed similar clinical outcomes, PROs, and marginal bone level changes as those restored with intermediate standardized abutments.

Guided biofilm therapy versus conventional protocol—clinical outcomes in non-surgical periodontal therapy

BackgroundThe aim of the randomized controlled clinical trial study was to evaluate the effectiveness in reducing pathologically increased pocket probing depths (PPD > 3 mm) using the Guided Biofilm Therapy (GBT) protocol (adapted to the clinical conditions in non-surgical periodontal therapy (NSPT): staining, air-polishing, ultrasonic scaler, air-polishing) compared to conventional instrumentation (staining, hand curettes/sonic scaler, polishing with rotary instruments) both by less experienced practitioners (dental students).MethodsAll patients were treated according to a split-mouth design under supervision as diseased teeth of quadrants I/III and II/IV randomly assigned to GBT or conventional treatment. In addition to the treatment time, periodontal parameters such as PPD and bleeding on probing (BOP) before NSPT (T0) and after NSPT (T1: 5 ± 2 months after T0) were documented by two calibrated and blinded examiners (Ethics vote/ Trial-register: Kiel-D509-18/ DRKS00026041).ResultsData of 60 patients were analyzed (stage III/IV: n = 36/ n = 24; grade A/ B/ C: n = 1/ n = 31/ n = 28). At T1, a PPD reduction of all diseased tooth surfaces was observed in 57.0% of the GBT group and 58.7% of the control group (p = 0.067). The target endpoint (PPD ≤ 4 mm without BOP) was achieved in 11.5% for GBT (conventional treatment: 11.2%; p = 0.714). With the exception for number of sites with BOP, which was at T1 15.9% in the GBT group and 14.3% in the control group (p < 0.05) no significant differences between the outcomes of the study were found. At 30.3(28.3) min, the treatment time was significantly shorter in GBT than in the control group at 34.6(24.5) min (p < 0.001).ConclusionsWith both protocols (GBT/ conventional instrumentation) comparably good clinical treatment results can be achieve in NSPT in stage III-IV periodontitis patients.Trial registrationThe study was registered before the start of the study and can be found under the number DRKS00026041 in the German Clinical Trials Register. The registration date was 19/08/2021.

Effect of extracorporeal shock wave combined with autologous platelet-rich plasma injection on rotator cuff calcific tendinitis: study protocol for a randomized controlled trial

BackgroundRotator cuff calcific tendinitis (RCCT) is a common shoulder disease whose main symptoms include shoulder pain, limited mobility, and calcification deposits in the shoulder. Traditional treatment methods have certain limitations, so finding new treatment methods has become the focus of research. Extracorporeal shock wave (ESW) and platelet-rich plasma (PRP) treatments have attracted much attention due to their non-invasive and tissue repair-promoting properties; however, the efficacy of their combined treatment in RCCT remains unclear.MethodsThis study is designed as a single-center, assessment-blind, randomized controlled clinical trial with three parallel groups. Sixty subjects will be recruited and randomly divided into the ESW group, PRP group, and ESW combined with PRP group, in a 1:1:1 ratio. The entire intervention period is 4 weeks, and the follow-up period is 4 weeks. Outcomes will be measured at baseline (T0), after 1 week of intervention (T1), after 2 weeks of intervention (T2), after 4 weeks of intervention (T3), and after an additional 4 weeks of follow-up period (T4). The primary endpoint is the VAS score. Secondary endpoints are ASES, CMS, UCLA, and the location and size of calcified areas.DiscussionThis study aims to evaluate the efficacy of ESW therapy combined with PRP in treating RCCT. We compare the effects of single and combined treatments to explore their impact on disease symptoms, functional improvement, and calcification regression. This provides a scientific basis for identifying more effective treatment options.Trial registrationClinicalTrials.gov NCT06372600. Registered on April 17, 2024; version 1.

Lung-Protective Mechanical Ventilation in Patients with Severe Acute Brain Injury: A Multicenter Randomized Clinical Trial (PROLABI).

Rationale: Lung-protective strategies using low Vt and moderate positive end-expiratory pressure (PEEP) are considered best practice in critical care, but interventional trials have never been conducted in patients with acute brain injuries because of concerns about carbon dioxide control and the effect of PEEP on cerebral hemodynamics. Objectives: To test the hypothesis that ventilation with lower VT and higher PEEP compared to conventional ventilation would improve clinical outcomes in patients with acute brain injury. Methods: In this multicenter, open-label, controlled clinical trial, 190 adult patients with acute brain injury were assigned to receive either a lung-protective or a conventional ventilatory strategy. The primary outcome was a composite endpoint of death, ventilator dependency, and acute respiratory distress syndrome (ARDS) at Day 28. Neurological outcome was assessed at ICU discharge by the Oxford Handicap Scale and at 6 months by the Glasgow Outcome Scale. Measurements and Main Results: The two study arms had similar characteristics at baseline. In the lung-protective and conventional strategy groups, using an intention-to-treat approach, the composite outcome at 28 days was 61.5% and 45.3% (relative risk [RR], 1.35; 95% confidence interval [CI], 1.03-1.79; P = 0.025). Mortality was 28.9% and 15.1% (RR, 1.91; 95% CI, 1.06-3.42; P = 0.02), ventilator dependency was 42.3% and 27.9% (RR, 1.52; 95% CI, 1.01-2.28; P = 0.039), and incidence of ARDS was 30.8% and 22.1% (RR, 1.39; 95% CI, 0.85-2.27; P = 0.179), respectively. The trial was stopped after enrolling 190 subjects because of termination of funding. Conclusions: In patients with acute brain injury without ARDS, a lung-protective ventilatory strategy, as compared with a conventional strategy, did not reduce mortality, percentage of patients weaned from mechanical ventilation, or incidence of ARDS and was not beneficial in terms of neurological outcomes. Because of the early termination, these preliminary results require confirmation in larger trials. Clinical trial registered with www.clinicaltrials.gov (NCT01690819).

Homeopathy, Acupuncture and Phytotherapy in the Veterinary Treatment or Prophylaxis of Diseases in Animals: An Overview of Systematic Reviews.

Complementary and alternative veterinary medicine (CAVM) has been intensively used, and there is currently an increasing demand for a more rigorous approach regarding its clinical effectiveness. The objectives of this overview were: first, to identify systematic reviews on homeopathy, acupuncture and phytotherapy in veterinary medicine and assess their methodological quality; and second, to map interventions and findings in the treatment or prophylaxis of any medical conditions in any animal species for which high-quality systematic reviews had identified reliable evidence of efficacy or effectiveness in randomized controlled trials (RCTs) or controlled clinical trials (CCTs). The study was an overview of systematic reviews published in the years 2000 to 2022 inclusive. The following databases were used: CAB Abstracts, PubMed and Vet Index, from which the abstracts of 173 articles were extracted, 22 of which were initially included for complete analysis. After excluding 15 studies according to the exclusion/inclusion criteria, 7 review papers were comprehensively analyzed. The review quality was assessed by the Measurement Tool to Assess Systematic Reviews (AMSTAR 2) method. The reported RCTs/CCTs in these reviews were analyzed for their reliability, and the results were classified according to statistical significance and risk of bias. Seven eligible systematic reviews reported studies on dogs, horses, cats, cattle, sheep, goats, swine, rabbits and poultry. The number of primary RCTs/CCTs was 38 for homeopathy, 35 for acupuncture, and 171 for phytotherapy. The AMSTAR 2 evaluation ranked two reviews of veterinary homeopathy as high-quality, in which two placebo-controlled RCTs comprised reliable evidence, one of which reported efficacy of homeopathy as prophylaxis for diarrhea in pigs. The systematic reviews of acupuncture and phytotherapy were all of low quality, preventing formal assessment of their reviewed RCTs/CCTs. Only the systematic reviews of homeopathy were rated of sufficient quality to enable the assessment of reliable evidence within their reviewed RCTs. Contemporary high-quality systematic reviews of clinical trials in each of the three areas of CAVM are required.

Effects of inspiratory muscle training on lung function parameter in swimmers: a systematic review and meta-analysis.

This systematic review and meta-analysis aimed to assess the impact of inspiratory muscle training (IMT) on lung function parameters (MIP, MEP, FEV1, and FVC) between both elite and non-elite swimmers. We searched for controlled clinical trials (CCT) and prospective longitudinal studies (PLS) in elite and non-elite swimmers following an inspiratory muscle training (IMT) protocol with a standardized device, published between 2012 and 2023. The databases used in the search were PubMed, Science Direct, Scopus, Springer, Cochrane Central Register of Controlled Trials, and Google Scholar. The primary outcome assessed was the impact of IMT on lung function parameters, including MIP, MEP, FEV1, and FVC. We selected 13 articles involving 277 subjects aged 11-21 years, with 61.4% being male, and 84.6% being elite swimmers. The most commonly used IMT device was the PowerBreathe®, prescribed for 3-12 weeks, 1-2 sessions per day, 3-6 times per week, with 30 repetitions, starting at 50% of MIP and progressing up to 80%. The meta-analysis showed that IMT was associated with a higher MIP (MD = 29.35 cmH2O, 95% CI: 13.04-45.65 cmH2O, p < 0.01) without affecting FEV1 and FVC. The swimmers that used IMT improved muscle strength, specifically MIP, without changes in MEP, FEV1, and FVC.

Microbiological and clinical effects of probiotic-related Zeger therapy on gingival health: a randomized controlled clinical trial

BackgroundThis single-blind randomized controlled trial was aimed to evaluate the microbiological and clinical effects of Zeger therapy on gingival health.MethodsTwenty-four adults with gingivitis were recruited and monitored micro-biologically and clinically at baseline (Day 0), 4 weeks (Day 29) after therapy. All volunteers received one-stage full-mouth supragingival scaling as basic oral health care for baseline, and then randomly divided into experimental (koumiss, n = 12) or control (none, n = 12) group. The koumiss was used once a day for 4 weeks.ResultsThe microbial diversity of the experimental group increased significantly after drinking koumiss (p < 0.05), mainly owing to increasing of Gram-positive bacteria (p = 0.038) and oral health-related microbes (Rothia, Corynebacterium, Actinomyces, Saccharibacteria_TM7, etc.), decreasing of Gram-negative bacteria (p = 0.009) and periodontal disease-related microbes (Porphyromonas, Fusobacterium, Veillonella, etc.), while the microbial diversity of the control group had no significant change (p > 0.05). However, there was no significant difference between the two groups in the clinical parameters (p > 0.05).ConclusionsZeger therapy promotes the diversity of supragingival microbiome in adults with gingivitis and increases the abundance of some beneficial flora while decreasing some harmful without clinical parameters marked changing, which holds promise for improving of gingivitis and may be a valuable oral health care approach in the future.Trial registrationThe clinical trial was approved by the Medical Ethics Committee of West China Hospital of Stomatology, Sichuan University, batch No. WCHSIRB-D-2021-428. Before patient registration began, the prospective clinical trial was registered in www.clinicaltrials.gov public repository in China under the registration number ChiCTR2200060555 on 04/06/2022.

Clinical and radiographic evaluation of Ga-Al-As diode in immature permanent mandibular first molars direct pulp capping: A 12-month randomized controlled clinical trial

Clinical and radiographic evaluation of Ga-Al-As diode in immature permanent mandibular first molars direct pulp capping: A 12-month randomized controlled clinical trial

Comparative Analysis of LORETA Z Score Neurofeedback and Cognitive Rehabilitation on Quality of Life and Response Inhibition in Individuals with Opioid Addiction.

Background. Previous studies has shown that conventional neurofeedback and cognitive rehabilitation can improve psychological outcomes in people with opioid use disorders. However, the effectiveness of LORETA Z-score neurofeedback (LZNFB) and attention bias modification training on quality of life and inhibitory control of these people has not been investigated yet. LZNFB targets deeper brain structures with higher precision, compared to conventional neurofeedback that typically focuses on surface EEG activity. The present study aims to compare the effect of these two methods on quality of life and response inhibition in men with opioid use disorders under methadone maintenance therapy (MMT). Methods. In this randomized controlled clinical trial with a pre-test, post-test, follow-up design, 30 men with opioid use disorders under MMT were randomly assigned into three groups of LZNFB, attention bias modification training, and control (MMT alone). The LZNFB and Cognitive Rehabilitation groups received 20 and 15 sessions of treatment, respectively. The Persian versions WHO Quality of Life-BREEF questionnaire and the Go/No-Go test were completed by the participants before, immediately after, and one month after interventions. The collected data were analyzed in SPSS v.22 software. Results. Both intervention groups showed a significant improvement in quality-of-life score and a significant reduction in response time at the post-test phase (P < .05), where LZNFB group showed more improvement in quality of life and more reduction in response inhibition. After one month, the increase in quality of life continued in both groups, while the decrease in response time continued only in the LZNFB group. Conclusion. Both LZNFB and attention bias modification training are effective in improving quality of life and response inhibition of men with OUD under MMT, however, LZNFB is more effective.

Research on the soothing Liver - Qi stagnation method in the treatment of postoperative papillary thyroid carcinoma patients' concomitant depression: A randomized controlled clinical trial.

Postoperative papillary thyroid carcinoma (P-PTC) patients often grapple with depression fueled by the looming threat of recurrence. While the Liver-Qi stagnation method is frequently employed for depression management, a notable scarcity of clinical trials exists regarding its application in patients with P-PTC and concurrent depression. This study presents a randomized controlled clinical trial, aiming to establish the efficacy of the Liver-Qi stagnation method in alleviating depression in patients with P-PTC. In this randomized controlled clinical trial, P-PTC patients diagnosed with concomitant depression were systematically enrolled. Subjects were randomly assigned to either the control or test group, both receiving standard treatment comprising Levothyroxine sodium tablets and decoction of benefiting Qi and nourishing Yin. Additionally, the test group received supplementation with bupleuri radix-paeoniae alba radix (CH-BS) alongside the baseline therapy. The intervention spanned 12 weeks. Pre- and post-treatment evaluations were conducted using the Hamilton Depression Scale (HAMD), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and Traditional Chinese Medicine (TCM) syndrome score scale. Concurrently, blood inflammatory factors and serum 5-hydroxytryptamine (5-HT) levels were measured to comprehensively assess treatment outcomes. During the 12-week intervention, the test group demonstrated a significant reduction in HAMD scores compared to the control group (P < .05). Moreover, post-treatment serum 5-HT levels were significantly elevated in the test group compared to the control group (P < .05). Findings gleaned from the EORTC QLQ - C30 revealed a noteworthy improvement in social function and overall quality of life scores within both groups post-treatment in comparison to baseline (P < .05). Concurrently, post-treatment scores for fatigue and insomnia symptoms witnessed a significant decrease compared to baseline (P < .05). Notably, the test group exhibited superior scores in the emotional domain in contrast to the control group (P < .05). Both groups exhibited a substantial decrease in TCM syndrome scores from baseline (P < .05). Noteworthy increases were found in IFN-γ < 2.44 rate (62.86%) and IL-6 < 2.44 rate (74.29%) in the test group compared to pretreatment levels (P < .05). The soothing Liver-Qi stagnation method induces a rise in serum 5-HT levels, reducing depression-related inflammatory factors, culminating in the alleviation of depression for P-PTC.

Investigating the efficacy of acupuncture in treating patients with metabolic-associated fatty liver disease: a protocol for a randomised controlled clinical trial

IntroductionAcupuncture is widely used for metabolic-associated fatty liver disease (MAFLD) treatment; however, the clinical efficacy has not been confirmed due to the lack of high-level evidence-based clinical practice. The purpose...

Electroacupuncture versus solifenacin succinate for female overactive bladder: study protocol for a multicentre, randomised, controlled, double-dummy, non-inferiority trial

IntroductionOveractive bladder (OAB) affects approximately 500 million people worldwide, with a higher prevalence in women than in men, significantly impacting the quality of life of female patients. Treatment options for...

Efficacy of injectable platelet rich fibrin (i-PRF) as novel vehicle for local drug delivery (LDD) in non-surgical periodontal pocket therapy - a randomised controlled clinical trial.

Efficacy of injectable platelet rich fibrin (i-PRF) as novel vehicle for local drug delivery (LDD) in non-surgical periodontal pocket therapy - a randomised controlled clinical trial.

Immediate versus conventional loading in short and ultra-short implants: a protocol design.

After tooth extraction, inevitable resorption of the postextraction socket occurs. Placing an immediate implant does not fully preserve the bone integrity of the socket. Preservation techniques cannot avoid alveolar resorption. In residual atrophies, bone augmentation techniques are necessary for subsequent rehabilitation with implants. The aim of this study was to propose a protocol of immediate loading in short implants as an alternative to bone augmentation techniques, comparing the immediate versus conventional loading, evaluating peri-implant bone loss, the biological and prosthetic complications, the survival of the implant and prosthesis and the patient satisfaction after one year. This study consists of a randomized controlled clinical trial. For implant planning, periapical intraoral radiographs and Cone Beam Computed Tomography will be used. All patients will receive Straumann Group® (Basel, Switzerland) titanium-zirconia implants with a 4.1mm or 4.8mm diameter and a 4 mm or 6 mm length. The expected results show similar or even minor bone loss, biological and prosthetic complications, identical or even better survival of the short implants with immediate loading, and greater satisfaction. Short implants demonstrate similar survival to conventional length implants, with comparable or even minor biological and prosthetic complications and bone loss. Immediate loading gives satisfactory results similar to conventional loading, with similar biological and prosthetic complications, and generally depends on poor hygiene levels. Bone loss is even less, and the satisfaction increases.

Current Utilization and Research Status of Herbal Medicine Sipjeondaebotang for Anemia: A Scoping Review.

Anemia is a global health issue affecting diverse populations, particularly older adults, and conventional treatments often show limited efficacy. This study aimed to evaluate the utilization and effectiveness of Sipjeondaebotang (SDT), a prescription drug used in traditional East Asian medicine, in treating various types of anemia. A scoping review was conducted following Arksey and O'Malley's framework and PRISMA-ScR guidelines. Six electronic databases were searched for clinical studies on SDT, while focusing on human participants and excluding animal and cellular studies. Sixteen studies, including nine randomized controlled trials, two controlled clinical trials, two case series, and three case reports, involving 863 participants, were analyzed. These studies were primarily conducted in China, Korea, and Japan. According to the analysis, SDT improved hemoglobin levels across all types of anemia studied, with all controlled studies showing significant improvements compared with the control groups. Additionally, SDT reduced blood loss, improved recovery times, and decreased transfusion requirements in patients with post-operative anemia, with lower adverse event rates than those in the control groups. These findings suggest that SDT may enhance hematological parameters and improve overall patient outcomes. In conclusion, SDT may be an effective treatment for anemia that improves hemoglobin levels and patient outcomes. However, further high-quality, large-scale studies are necessary to standardize SDT prescriptions, confirm the optimal treatment duration, and validate its efficacy and safety across different anemia types.