Relevant Randomized Controlled Trials Research Articles

Efficacy and safety of electroacupuncture in patients with postpartum depression: a meta-analysis.

This study aimed to assess the clinical effectiveness and safety of electroacupuncture (EA) for the treatment of postpartum depression (PPD). We systematically retrieved relevant randomized controlled trials (RCTs) from electronic databases, including PubMed, Cochrane Library, China National Knowledge Infrastructure, EMBASE, China Science and Technology Journal Database, Chinese Biological Medical Database, and the Wanfang database from their inception to November 2023. The outcomes measured were the Hamilton Depression Rating Scale (HAMD) scores, Edinburgh Postnatal Depression Scale (EPDS) scores, adverse events (AEs), and the total response rate. The study aimed to estimate heterogeneity, publication bias, mean difference (MD), and risk ratios (RR) with 95% confidence intervals (CIs). This study included 12 RCTs with a total of 1364 participants (571 in the treatment group and 793 in the control group) for analysis. The results of the meta-analysis indicated that EA did not significantly reduce HAMD (MD = 1.49, 95% CI = [-0.30, 3.27], P = 0.1, I2 = 0%) and EPDS (MD = 1.12, 95% CI = [-1.62, 3.85], P = 0.42, I2 = 32%) scores compared to sham EA among patients with PPD, resulting in low heterogeneity. In terms of the total response rate, the EA group exhibited superior results compared to the placebo group (RR = 1.77, 95% CI = [1.15, 2.74], P = 0.01, I2 = 0%) and the sham EA group (RR = 1.2, 95% CI = [1.02, 4.4], P = 0.02, I2 = 0%), with statistical significance and low heterogeneity. The incidence of AEs was lower, also with low heterogeneity (RR = 0.9, 95% CI = [0.57, 1.43], P = 0.66, I2 = 12%). The current evidence indicates that the effectiveness and safety of EA in the treatment of PPD warrant affirmation. However, EA does not demonstrate superiority over sham EA in reducing HAMD and EPDS scores in patients with PPD. Due to the limited quantity and quality of curent research, the above conclusion should be further validated through high-quality studies to confirm the efectiveness of EA in PPD management. https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=318917, identifier CRD42023318917.

Non-pharmacological interventions for the reduction and maintenance of blood pressure in people with prehypertension: a systematic review protocol

IntroductionPrehypertension is defined as blood pressure that is above the normal range but not high enough to be classed as hypertension. Prehypertension is a warning of development of hypertension as...

Comparison of various doses of oral cannabidiol for treating refractory epilepsy indications: a network meta-analysis.

To evaluate the comparative efficacy and safety of various doses of oral cannabidiol (CBD) in treating refractory epilepsy indications, thus providing more informative evidence for clinical decision-making. A literature search of PubMed, Embase, the Cochrane library, and Web of Science (WoS) was performed to retrieve relevant randomized controlled trials (RCTs) that compared different doses of oral CBD with placebo or each other in refractory epilepsy indications. The search was limited from the inception of each database to January 3, 2023. Relative risk [RR] with a 95% confidence interval [CI] was used to express results. STATA/SE 14 was employed for network meta-analysis. Six RCTs involving 972 patients were included in the final data analysis. Network meta-analysis showed that, CBD10 (10 mg/kg/day) (RR: 1.77, 95%CI: 1.28 to 2.44), CBD20 (20 mg/kg/day) (RR: 1.91, 95%CI: 1.49 to 2.46), CBD25 (25 mg/kg/day) (RR: 1.61, 95%CI: 0.96 to 2.70), and CBD50 (50 mg/kg/day) (RR: 1.78, 95%CI: 1.07 to 2.94) were associated with higher antiseizure efficacy although the pooled result for CBD25 was only close to significant. In addition, in terms of the risk of treatment-emergent adverse events (TEAEs), the difference between different doses is not significant. However, CBD20 ranked first in terms of antiseizure efficacy, followed by CBD50, CBD10, and CBD25. For TEAEs, CBD25 ranked first, followed by CBD10, CBD50, CBD5, and CBD20. For refractory indications, CBD20 may be optimal option for antiseizure efficacy; however, CBD25 may be best for TEAEs. Therefore, an appropriate dose of oral CBD should be selected based on the actual situation. Due to the limitations of eligible studies and the limited sample size, more studies are needed in the future to validate our findings.

An RCT META analysis based on the effect of tai chi exercise therapy on the outcome of elderly patients with moderate-to-severe sleep disorders-A systematic review study

BackgroundAccording to statistics, about one-fifth of the world's elderly people suffer from sleep disorders, and the problem of sleep disorders in the elderly is extremely serious, and this problem is one of the important causes of chronic diseases such as hypertension, hyperlipidemia, diabetes mellitus, and coronary heart disease in the elderly. The positive effect of Tai Chi exercise therapy on sleep problems has been confirmed, but at present, the effect of the specific duration of Tai Chi exercise on the improvement of elderly people with moderate to severe sleep disorders varies. ObjectiveMETA analysis was used to investigate and find that long-term Tai Chi exercise therapy has the best effect on improving sleep in elderly patients with moderate to severe sleep disorders. Methods: META analysis was performed using Revman 5.3 after searching Web of science, Pubmed, Scopus, The Cochroae Library, OVID, CBM, CNKI, VIP, and other databases, and then filtering and extracting. ResultsA total of seven papers were included. Meta-analysis showed that tai chi exercise was more effective in improving sleep problems in elderly patients with sleep disorders compared to the control group, and the difference was significant. This was demonstrated by a decrease in the global Pittsburgh Sleep Quality Index (PSQI) score [SMD = −0.66, 95 % CI (−0.91, −0.41), P < 0.00001], as well as its subdomains of subjective sleep quality [SMD = −0.79, 95 % CI (−1.06, −0.52), P < 0.00001], sleep latency [SMD = −0.80, 95 % CI (−1.21, −0.40), P < 0.00001], sleep duration [SMD = −0.38, 95 % CI (−0.72, −0.04), P = 0.03], habitual sleep efficiency [SMD = −0.58, 95 % CI (−0.84, −0.31), P < 0.0001], sleep disturbance [SMD = −0.51, 95 % CI (−0.78, −0.25), P = 0.00001] and daytime dysfunction [SMD = −0.33, 95 % CI (−0.59, −0.07), P = 0.01]. Improvement was also observed in the Epworth Sleepiness Scale (ESS) and Insomnia Severity Index Scale (ISI). The results showed that the optimal duration and frequency of Tai Chi exercise therapy for improving moderately severe elderly patients with sleep disorders was long-term. ConclusionThis study systematically assessed the efficacy of Tai Chi exercise therapy for elderly patients with moderate-to-severe sleep disorders. Through a meta-analysis of relevant randomized controlled trials (RCTs), it aims to determine the effectiveness of Tai Chi exercise in improving sleep quality in elderly patients with moderate-to-severe sleep disorders, as well as to compare its effects with those of traditional treatments; to analyze the safety of Tai Chi exercise for this patient population and assess its feasibility as a non-pharmacological therapy; and to fill the research gaps and provide more comprehensive and systematic evidence support. This study provides a practical approach to reducing the risk of medication side effects in older adults with sleep disorders and offers a potentially effective non-pharmacological treatment option, especially for those who are unable or unwilling to use medication. Tai chi exercise may not only improve sleep, but also improve coordination, muscle strength, balance, and reduce stress and anxiety in older adults. It also helps older adults socialize and enhances their social connections and emotional support. This study suggests that community centers or activity centers for the elderly can organize tai chi classes to promote the participation of older adults, and can be used as a scientific exercise rehabilitation tool in clinical treatment, incorporating tai chi practice into daily life, such as tai chi practice at a fixed time every day or every week, which not only helps to improve the sleep disorders of older adults, but also improves their overall quality of life.

Comparison of osimertinib plus bevacizumab against osimertinib alone in NSCLC harboring EGFR mutations: a systematic review and meta-analysis.

Frequent failures observed in some trials comparing the efficacy and safety of osimertinib plus bevacizumab to osimertinib monotherapy in advanced non-small-cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) alterations have brought questions. To evaluate the efficacy and safety of these two treatment regimens in advanced NSCLC patients harboring EGFR mutations. This study is a systematic review and meta-analysis. PubMed, Embase, Cochrane Library, Web of Science, CNKI, Wanfang, and VIP databases were extensively searched for relevant randomized controlled trials (RCTs) on 14 May 2023. Two researchers independently screened the literature, assessed quality, and extracted data. The primary outcomes were progression-free survival (PFS), overall survival (OS), and objective response rate (ORR). The secondary outcomes were adverse events (AEs) and PFS stratified by patients' characteristics. STATA 17.0 software (StataCorp LLC, USA) was adopted for meta-analysis. A total of four RCTs involving 390 patients were included. Overall, the risk of bias across the studies was moderate to low. Pooled results showed that compared to osimertinib alone, the addition of bevacizumab to osimertinib failed to show prolongation of PFS [hazard ratio (HR) = 1.00, 95% confidence interval (CI): 0.78-1.27], OS (HR = 1.01, 95% CI: 0.73-1.41), or improvement of the ORR (risk ratio = 1.12, 95% CI: 0.90-1.38), while an increased incidence of some AEs was observed, such as nausea, oral mucositis, hypertension, and proteinuria. Notably, combination treatment did significantly prolong the PFS in the subset of smokers (HR = 0.64, 95% CI: 0.44-0.94). A mild trend toward PFS benefit under the combined regimen was also noted in patients with brain metastases and first-line treatment, though not reaching statistical significance. Based on the available evidence, the addition of bevacizumab to osimertinib could not provide additional survival benefits with higher but manageable toxicity for EGFR-mutant NSCLC patients. Osimertinib monotherapy remains the prioritized treatment. Further investigation is warranted.

Network meta-analysis of treatment interventions for Helicobacter pylori infection in adult populations in East and Southeast Asia.

Helicobacter pylori (H. pylori) infection poses a global health challenge, necessitating diverse treatment strategies. This network meta-analysis aimed to assess various treatment regimens for H. pylori in East and Southeast Asian populations. A systematic search was conducted in PubMed, Embase, and the Cochrane Library databases from inception to 20 Dec 2023, to identify relevant randomized controlled trials (RCTs) on H. pylori treatment interventions in East Asian and Southeast Asian populations. The primary outcome focused on effectiveness, specifically the rate of H. pylori eradication, while the secondary outcome evaluated overall safety, including the incidence of total and serious adverse effects. Network geometry plots were generated to illustrate direct and indirect treatment comparisons, using triple therapy (TT) as the reference standard. Odds Ratios (ORs) and 95% confidence intervals (CIs) were calculated using random-effects models to account for study heterogeneity and consistency models for indirect comparisons. The treatment hierarchy was assessed using the ranking probabilities and surface under the cumulative ranking curve (SUCRA) values. 79 studies met the inclusion criteria, with 99 paired comparisons. The included studies, conducted in Southeast Asia and among East Asian populations, included 29,903 patients. Significant outcomes in treat effectiveness were observed in various comparisons, such as sequential therapy vs. TT, bismuth quadruple therapy (BQT) vs. TT, high-dose dual therapy (HDDT) vs. TT, concomitant therapy vs. TT, P-CAB-based therapy vs. TT, and R-HT/HT vs. TT. R-HT/HT was the top choice based on rankograms and SUCRA values (SUCRA = 96.5). Regarding overall safety, significant results were noted in comparisons involving BQT, HDDT, concomitant therapy, sequential therapy, and P-CAB-based therapy. HDDT achieved the highest overall safety based on rankograms and SUCRA values (SUCRA = 0.0). HDDT demonstrated the lowest incidence of serious adverse events, according to global rankograms and SUCRA values (SUCRA = 19.7). This network meta-analysis highlights the complexity of treating H. pylori in East and Southeast Asia. R-HT/HT emerged as the most effective regimen, while HDDT proved to be the safest, with the lowest incidence of serious adverse events. These findings are crucial for optimizing treatment protocols in these regions. https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023435318.

The efficacy and safety of different Janus kinase inhibitors as monotherapy in rheumatoid arthritis: A Bayesian network meta-analysis.

This study aims to evaluate the efficacy and safety of JAK inhibitors in the treatment of patients with RA. The databases CNKI, VIP, Wanfang, CBM, and PubMed, Embase, Cochrane Library and Web of Science were searched to identify relevant randomized controlled trials (RCTs), all from the time of database creation to April 2024. Screening, data extraction, and risk of bias assessment (using Review Manager-5.3 software) were independently performed by at least two authors. The network meta-analysis was conducted using R 4.1.3 software. PROSPERO registration number: CRD42022370444. Thirty-three RCTs included 15,961 patients The experimental groups involved six JAK inhibitors (filgotinib, tofacitinib, decernotinib, baricitinib, upadacitinib and peficitinib) and 12 interventions (different doses of the six JAK inhibitors), and the control group involved adalimumab (ADA) and placebo. Compared with placebo, all JAK inhibitors showed a significant increase in efficacy measures (ACR20/50/70). Compared with ADA, only tofacitinib, low-dose decernotinib, and high-dose peficitinib showed a significant increase in ACR20/50/70. Decernotinib ranked first in the SUCRA ranking of ACR20/50/70. In terms of safety indicators, only those differences between low-dose filgotinib and high-dose upadacitinib, low-dose tofacitinib and high-dose upadacitinib were statistically significant. Low-dose filgotinib ranked first in the SUCRA ranking with adverse events as safety indicators. Only the efficacy and safety of tofacitinib ranked higher among different SUCRA rankings. Six JAK inhibitors have better efficacy than placebo. The superior efficacy of decernotinib and safety of low-dose filgotinib can be found in the SUCRA. However, there are no significant differences in safety between the different JAK inhibitors. Head-to-head trials, directly comparing one against each other, are required to provide more certain evidence.

Efficacy and safety of first-line therapy in patients with HER2-positive advanced breast cancer: a network meta-analysis of randomized controlled trials

PurposeThe numerous first-line treatment regimens for human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer (ABC) necessitate a comprehensive evaluation to inform clinical decision-making. We conducted a Bayesian network meta-analysis (NMA) to compare the efficacy and safety of different interventions.MethodsWe systematically searched for relevant randomized controlled trials (RCTs) in Pubmed, Embase, Cochrane Library and online abstracts from inception to June 1, 2023. NMA was performed to calculate and analyze progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and adverse events of grade 3 or higher (≥ 3 AEs).ResultsOut of the 10,313 manuscripts retrieved, we included 28 RCTs involving 11,680 patients. Regarding PFS and ORR, the combination of trastuzumab with tyrosine kinase inhibitors (TKIs) was more favorable than dual-targeted therapy. If only using trastuzumab, combination chemotherapy is superior to monochemotherapy in terms of PFS. It is important to note that the addition of anthracycline did not result in improved PFS. For patients with hormone receptor-positive HER2-positive diseases, dual-targeted combined with endocrine therapy showed better benefit in terms of PFS compared to dual-targeted alone, but it did not reach statistical significance. The comprehensive analysis of PFS and ≥ 3 AEs indicates that monochemotherapy combined with dual-targeted therapy still has the optimal balance between efficacy and safety.ConclusionMonochemotherapy (Docetaxel) plus dual-target (Trastuzumab and Pertuzumab) therapy remains the optimal choice among all first-line treatment options for ABC. The combination of trastuzumab with TKIs (Pyrotinib) demonstrated a significant improvement in PFS and ORR, but further data are warranted to confirm the survival benefit.

Transcutaneous spinal cord stimulation on motor function in patients with spinal cord injury: A meta-analysis.

It has been suggested that transcutaneous spinal cord stimulation (SCS) is effective in the rehabilitation of patients with spinal cord injury (SCI). However, the evidence is mainly based on case reports. To summarize the influence of transcutaneous SCS on extremity motor function of patients with SCI in a meta-analysis. A systematic literature search was performed in electronic databases including PubMed, Cochrane library, Embase, Web of Science, Wanfang, and CNKI to obtain relevant randomized controlled trials (RCTs). A random-effects model was used to pool the results by incorporating the impact of the potential heterogeneity. The most recent database search was conducted on December 31, 2023. Six small-scale open-label or single-blind RCTs were included. Transcutaneous SCS on the basis of conventional rehabilitation could significantly improve limb strength (mean difference: 4.82, p = 0.004; I2 = 0%) and attenuate spasticity (MD: -0.40, p = 0.02; I2 = 0%). The upper-extremity motor function was not significantly affected (p = 0.75). However, transcutaneous SCS significantly improved mobility as indicated by walking speed (MD: 0.13 m/s, p = 0.009; I2 = 0%) and walking distance (standardized MD: 0.62, I2 = 0%). Transcutaneous SCS is effective in improving limb strength, spasticity and mobility of patients with SCI.

Herbal Medicine for Sarcopenia: A Systematic Review of Randomized Controlled Trials

Objectives: Sarcopenia is an age-associated skeletal muscle disorder that can profoundly impact the health of elderly people. However, the efficacy of herbal medicine in sarcopenia is uncertain. This review aims to investigate evidence of the effect of herbal medicine on sarcopenia.Methods: We systematically searched 12 electronic databases for relevant randomized controlled trials (RCTs). Only trials that met the inclusion criteria were selected, and the characteristics of the included studies were extracted and synthesized in a narrative manner. The quality of the included studies was assessed using Cochrane’s Risk of Bias (RoB) 2.0 tool.Results: 7 RCTs involving 672 participants with sarcopenia met the inclusion criteria. The intervention combining herbal medicine and conventional treatment (i.e., exercise, nutritional support) had a significant therapeutic effect compared with the conventional treatment, showing improvement in muscle strength (i.e., grip strength), muscle mass (i.e., appendicular skeletal muscle mass index), and physical function (i.e., gait speed, short physical performance battery, and timed up and go test). However, the methodological quality of the included RCTs was relatively low due to their high RoB, making it difficult to evaluate the efficacy of herbal medicine in sarcopenia. In terms of safety, several adverse events were reported.Conclusion: This review suggests that herbal medicine has a positive effect on muscle strength, muscle mass, and physical performance in elderly patients with sarcopenia, but there is a clear need for further research in this area.

Acupoint Stimulation for Pain Control in Enhanced Recovery After Surgery: Systematic Review and Meta-Analysis.

Introduction: Postoperative pain control is a challenge in enhanced recovery after surgery (ERAS). The current study reviewed the efficacy and safety of incorporating acupoint stimulation for postoperative pain control in ERAS. Methods: Ten databases for relevant randomized controlled trials (RCTs) published in English or Mandarin Chinese were searched from 1997 to 2022. The quality of each article was appraised using the Cochrane Collaboration Risk of Bias Criteria and the modified Jadad Scale. The primary outcome was pain control, measured using the visual analog scale 24 h after surgery. Results: Eleven trials met the eligibility criteria and were included in the study. Acupoint stimulation was found more effective than control treatments in terms of pain intensity (standardized mean difference [SMD] -0.94; 95% confidence interval [CI] -1.35 to -0.53), analgesic drug consumption (SMD -1.87; 95% CI -2.98 to -0.75), postoperative nausea (PON; SMD 0.31; 95% CI 0.13 to 0.73), postoperative vomiting (POV; SMD 0.57; 95% CI 0.11 to 2.92), and PON and POV (PONV; SMD 0.29; 95% CI 0.16 to 0.53). The Zusanli (ST36) and Neiguan (PC6) were the most-used acupoints in the included trials (8/11). The reported adverse reaction was only one case of bruising. Discussion: Acupoint stimulation improved pain control in patients undergoing ERAS more than control treatments. The findings provide an evidence-based premise for incorporating acupoint stimulation into ERAS strategies. More rigorous RCTs are needed in the future.

Treatment of non-small cell lung cancer with Yiqi Buxue prescriptions combined with adjuvant chemotherapy on the cancer therapy-related cardiovascular toxicity: A systematic review and meta-analysis

Ethnopharmacological relevanceThe treatment and prognosis of patients with non-small cell lung cancer (NSCLC) was affected by the occurrence of cancer therapy-related cardiovascular toxicity (CTR-CVT). Yiqi Buxue prescriptions were a class of traditional single or compounded formulations that have become a consensus for NSCLC. There was no clear information and or summary available for Yiqi Buxue prescriptions combined with adjuvant chemotherapy for NSCLC in reducing CTR-CVT. Aim of the studyTo systematically evaluate the Yiqi Buxue prescriptions combined with adjuvant chemotherapy in reducing CTR-CVT for patients with NSCLC. Materials and methodsSearch strategies were developed to identify relevant randomized controlled trials (RCTs) in PubMed, Embase, Web of Science, The Cochrane Library, China National Knowledge Infrastructure (CNKI), SinoMed and WanFang Data from database inception date to October 2022. The methodological quality of evidence was assessed using the Cochrane risk of bias (ROBs) assessment tool, and the meta-analysis was analyzed using RevMan 5.3. ResultsA total of 9 studies were included. Compared with the adjuvant chemotherapy group, Yiqi Buxue prescriptions combined with adjuvant chemotherapy group showed no statistically significant in reducing CTR-CVT (RR 0.67, 95%CI 0.11 to 3.93, P = 0.65) and in CD4+/CD8+(MR 0.32, 95%CI -0.13 to 0.77, P = 0.16). However, it significantly improved the objective response rate (ORR) (RR 1.57, 95%CI 1.32 to 1.87, P < 0.00001), disease control rate (DCR) (RR 1.25, 95%CI 1.15 to 1.35, P < 0.00001), Karnofsky performance status (KPS) improvement rate (RR 1.34, 95%CI 1.16 to 1.55, P < 0.0001), CD3+ (MR 4.17, 95%CI 3.68 to 4.66, P < 0.00001), CD4+ (MR 4.87, 95%CI 4.28 to 5.46, P < 0.00001), and CD8+ (MR 3.12, 95%CI 2.57 to 3.67, P < 0.00001). ConclusionsThe current RCTs are hampered by small sample sizes and poor methodological quality. More rigorously designed and large sample RCTs with primary outcome of CTR-CVT are needed to investigate the effectiveness of Yiqi Buxue prescriptions combined with adjuvant chemotherapy in reducing CTR-CVT for patients with NSCLC.

Clinical efficacy and safety of adjunctive treatment of chronic ischemic heart failure with Qishen Yiqi dropping pills: a systematic review and meta-analysis.

Our study was to evaluate the effect of Qishen Yiqi Dropping Pills(QSYQ) on the prognosis of chronic ischemic heart failure(CIHF) and its safety. Databases including CNKI, Wanfang, VIP, CBM, PubMed, Web of Science, The Cochrane Library and EMbase were searched from their inception to April 2023 to screen relevant randomized controlled trials (RCTs). Primary indicators included readmission rates, rates of major adverse cardiovascular events (MACE), and all-cause mortality rates. The quality of the literature was assessed according to the Cochrane Reviewers' Handbook 5.0 and the Modified Jadad Scale (with a score of 4-7 rated as high quality). Meta-analysis was performed using the meta-package created by R software version 4.2.3, continuous data were compared using SMDs, and dichotomous and ordered data were compared using ORs; and the I2 test was used to assess the heterogeneity. Fifty-nine studies out of 1,745 publications were finally included, totalling 6,248 patients. Most studies were poorly designed and had some publication bias, with only 26 high-quality papers (Jadad score ≥4). Meta-analysis showed that the combined application of QSYQ was able to reduce the readmission rate [OR = 0.42, 95% CI (0.33, 0.53), P < 0.001], all-cause mortality rate [OR = 0.43, 95% CI (0.27, 0.68), P < 0.001], and the incidence of MACE [OR = 0.42, 95% CI (0.31, 0.56), P < 0.001]. Also, the treatment method can improve clinical effectiveness [OR = 2.25, 95% CI (1.97, 2.58), P < 0.001], increase 6-min walking distance (6MWD) [SMD = 1.87, 95% CI (1.33, 2.41), P < 0.0001] and left ventricular ejection fraction (LVEF) [SMD = 1.08, 95% CI (0.83, 1.33), P < 0.0001], and decrease the Minnesota Living with Heart Failure Questionnaire (MLHFQ) scores [SMD = -2.03, 95% CI (-3.0, -1.07), P < 0.0001], BNP levels [SMD = -2.07, 95% CI (-2.81, -1.33), P < 0.0001] and NT-ProBNP levels [SMD = -2.77, 95% CI (-4.90, -0.63), P < 0.05]. A total of 21 studies (n = 2,742) evaluated their adverse effects, of which 13 studies reported no adverse effects and 8 studies reported minor adverse effects. Our results suggest that the combined application of QSYQ can further improve patients' cardiac function and exercise tolerance, improve their quality of life, and ultimately improve patients' prognosis with a favorable safety profile. Nonetheless, limited by the quality and high heterogeneity of the literature, we must be conservative and cautious about the present results. PROSPERO (CRD42023449251).

No benefit of soluble fiber on liver function.

Background: To conduct a systematic review and dose-response meta-analysis of current findings from randomized controlled trials (RCTs) on the effect of soluble fiber supplementation on liver function in both healthy individuals and people with specific health conditions, PubMed, Scopus, and ISI Web of Science were systematically searched for relevant RCTs published prior to April 2022. Methods: We estimated the change in liver function parameters for each 5 g/d increment in soluble fiber in each trial and then calculated the mean difference (MD) and 95%CI. A total of 25 RCTs with 27 treatment arms (1744 subjects; 884 cases, 860 controls) were included. Results: A total of 25 RCTs with 27 treatment arms were included. The intervention duration of the included studies ranged from 3 to 52 weeks and the dose of soluble fiber supplementation varied from 0.0025 to 40 g/d. Soluble fiber supplementation could not significantly affect serum alanine transaminase (MD: -0.02 U/L, 95% CI: -1.06 to 1.01), aspartate transaminase (MD: -0.34 U/L, 95% CI: -0.84 to 0.15), alkaline phosphatase (MD: 0.29 U/L, -0.14 to 0.71), gamma-glutamyl transferase (MD: 0.12 U/L; 95% CI: -0.81 to 1.05), serum bilirubin (MD: 0.42μmol/L, 95% CI: -0.08 to 0.93) and albumin (MD: 0.64 g/dl, 95% CI: -0.42 to 1.70) levels. Conclusions: Findings from this study did not support the beneficial effects of soluble fiber supplementation on liver function biomarkers. There is a need for long-term high-quality interventions to examine the effects of different types and doses of soluble fibers on liver function as primary outcome.

Effect of camel milk on lipid profile among patients with diabetes: a systematic review, meta-analysis, and meta-regression of randomized controlled trials

The effects of camel milk (CM) intake on lipid profile among patients with diabetes remain controversial. This systematic review and meta-analysis of randomized controlled trials (RCTs) aimed to calculate the effect size of CM intake on blood lipids among patients with type 1 (T1D) and type 2 (T2D) diabetes. We searched nine databases from inception until December 31, 2022, to identify relevant RCTs. Effect sizes for total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), very low-density lipoprotein (VLDL), and high-density lipoprotein (HDL) were calculated and expressed using mean differences (MD) and confidence intervals (CI). Of 4,054 retrieved articles, 10 RCTs (a total of 347 participants aged 8–70 years, 60.5% male) were eligible for inclusion. The pooled results from a random-effects model showed statistically significant decreases in TC (MD − 21.69, 95% CI: 41.05, − 2.33; p = 0.03; I2=99%), TG (MD − 19.79, 95% CI: −36.16, − 3.42; p=0.02, I2=99%), and LDL (MD −11.92, CI: −20.57, −3.26; p = 0.007, I2=88%), and a significant increase in HDL (MD 10.37, 95% CI, 1.90, 18.84; p=0.02, I2=95%) in patients with diabetes supplemented with CM compared with usual care alone. Subgroup analysis revealed that only long-term interventions (> 6 months) elicited a significant reduction in TC levels and TG levels. Consumption of fresh CM by patients with diabetes resulted in significant reductions in TC, TG, and LDL levels, while showing a significant increase in HDL levels. Patients with T1D elicited a more beneficial effect in lowering TC, LDL, and TG levels and in increasing HDL levels than their corresponding partners with T2D. In conclusion, long-term consumption of CM for patients with diabetes, especially those with T1D, could be a useful adjuvant therapy to improve lipid profile alongside prescribed medications. However, the high heterogeneity in the included studies suggests that more RCTs with larger sample sizes and longer intervention durations are required to improve the robustness of the available evidence.

Guidelines for prevention and treatment of colorectal adenoma with integrated Chinese and western medicine

The Guidelines for prevention and treatment of colorectal adenoma with integrated Chinese and western medicine are put forward by Nanjing University of Chinese Medicine and approved by China Association of Chinese Medicine. According to the formulation processes and methods of relevant clinical practice guidelines, the experts in clinical medicine and methodology were organized to discuss the key problems to be addressed in the clinical prevention and treatment of colorectal adenoma(CRA) and provided answers following the evidence-based medicine method, so as to provide guidance for clinical decision-making. CRA is the major precancerous disease of colorectal cancer. Although the prevention and treatment with integrated Chinese and western medicine have been applied to the clinical practice of CRA, there is still a lack of high-quality guidelines. Four basic questions, 15 clinical questions, and 10 outcome indicators were determined by literature research and Delphi questionnaire. The relevant randomized controlled trial(RCT) was retrieved from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, Web of Science, and 2 clinical trial registries, and finally several RCTs meeting the inclusion criteria were included. The data extracted from the RCT was imported into RevMan 5.3 for evidence synthesis, and the evidence was evaluated based on the Grading of Recommendations, Assessment, Development, and Evaluations(GRADE). The final recommendations were formed by the nominal group method based on the evidence summary table. The guidelines involve the diagnosis, screening, treatment with integrated Chinese and western medicine, prevention, and follow-up of colorectal adenoma, providing options for the clinical prevention and treatment of CRA.

Evaluation of Global Post-Outbreak COVID-19 Treatment Interventions: A Systematic Review and Bibliometric Analysis of Randomized Controlled Trials.

The outbreak of COVID-19 has led to a global pandemic with millions of cases and deaths. Many randomized controlled trials (RCTs) were conducted to establish effective therapies. However, the methodological quality of these trials is paramount, as it directly impacts the reliability of results. This systematic review and bibliometric analysis aim to assess the methodological approach, execution diversity, global trends, and distribution of COVID-19 treatment RCTs post-outbreak, covering the period from the second wave and onward up to the present. We utilize articles from three electronic databases published from September 1, 2020, to April 1, 2023. Inclusion and exclusion criteria were applied to identify relevant RCTs. Data extraction involved the collection of various study details. Risk of Bias (RoB) 2 tool assessed methodological quality, while implementation variability was evaluated against registration information. Bibliometric analysis, including keyword co-occurrence and country distribution, used VOSviewer and Tableau software. Initially, 501 studies were identified, but only 22 met the inclusion criteria, of which 19 had registration information. The methodological quality assessment revealed deficiencies in five main domains: randomization process (36%), deviations from intended interventions (9%), missing outcome data (4%), measurement of the outcome (18%), and selection of reported results (4%). An analysis of alignment between research protocols and registration data revealed common deviations in eight critical aspects. Bibliometric findings showcased global collaboration in COVID-19 treatment RCTs, with Iran and Brazil prominently contributing, while keyword co-occurrence analysis illuminated prominent research trends and terms in study titles and abstracts. This study offers valuable insights into the evaluation of COVID-19 treatment RCTs. The scarcity of high-quality RCTs highlights the importance of enhancing trial rigor and transparency in global health emergencies.

The Comparative Effectiveness of A+AVD vs PET-guided ABVD for the Management of Patients with Advanced Hodgkin Lymphoma: A Systematic Review and Matching-Adjusted Indirect Treatment Comparison

Introduction: In advanced Hodgkin lymphoma (aHL), adriamycin (doxorubicin), bleomycin, vinblastine, and dacarbazine (ABVD) is a recommended chemotherapy regimen despite a substantial proportion of patients experiencing relapse or incomplete disease control. Per the National Comprehensive Care Network (NCCN) guidelines, positron-emission tomography (PET)-guided ABVD and brentuximab vedotin + adriamycin (doxorubicin), vinblastine and dacarbazine (A+AVD) are preferred options for the front-line treatment of aHL (NCCN Guidelines. Hodgkin lymphoma. Version 2. 2023). In the ECHELON-1 (E1) trial, superiority of A+AVD vs ABVD x6 cycles (without PET adaptation at cycle 2) was demonstrated statistically in terms of overall survival (OS) and progression-free survival (PFS). Six-year follow-up of E1 patients showed improved OS with A+AVD vs ABVD. The aim of this study was to indirectly compare the effectiveness (OS and PFS) of A+AVD vs PET-guided ABVD as front-line treatments in the management of patients aged ≤60 years with aHL (Stage III or IV). Methods: A systematic literature review was conducted using electronic databases such as MEDLINE, Embase, and the Cochrane Library (database inception to July 2022), supplementary sources and data on file for relevant materials reporting on the clinical efficacy of front-line treatments for aHL. Following the identification of relevant randomized controlled trials (RCTs), unanchored matching-adjusted indirect comparison was performed to compare the efficacy of A+AVD (the E1 trial) with PET-guided ABVD (the Risk-Adapted Therapy for aHL [RATHL] trial). As the outcomes used in the analyses were reported among the overall population in RATHL, rather than stratified by specific treatment, there was no potential anchor for the analysis. PFS and OS data from RATHL were only available for adult patients ≤60 years old with stage III/IV aHL, therefore the treatment comparison was limited to patients within this age group. Matching variables were selected based on literature review and the results of Cox regression analyses of the E1 trial data. The International Prognostic Score and Eastern Cooperative Oncology Group scores were used as matching factors as available. The weights generated from the matching procedure were incorporated in weighted Cox regression models to generate hazard ratios (HR) and corresponding 95% confidence intervals (CI). To account for the potential of violating the proportional hazards assumption, additional metrics were calculated including piecewise HRs (95% CI) using Cox regression models for specific time intervals (i.e., 0 to 24, 24 months +) and restricted mean survival times (RMST). Results : In adult patients aged ≤60 years with Stage III/IV aHL, treatment with A+AVD generally led to increased PFS and OS vs PET-guided ABVD (Table1). As the proportional hazard assumption was violated, additional metrics were calculated (RMST and piecewise HRs). HRs and RMST for survival outcomes are reported in Table1. Conclusions: The findings of this indirect treatment comparison support the improved efficacy of A+AVD relative to PET-guided ABVD with respect to OS and PFS in patients with stage III and IV aHL consistent with the results of E1 study.

Surgical Outcomes in Total Neoadjuvant Therapy for Rectal Cancer Versus Standard Long-course Chemoradiation: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

This systematic review and meta-analysis seeks to evaluate the impact of total neoadjuvant therapy (TNT) for rectal cancers on surgical complications and surgical pathology when compared with standard long-course chemoradiotherapy (LCRT). The oncological benefits of TNT are well published in previous meta-analyses, but there is little synthesized information on how it affects surgical outcomes. A recent study has suggested an increase in local recurrence and higher rates of breached total mesorectal excision (TME) plane in TNT patients. This study conformed to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. A search was performed in Medline (via PubMed), Cochrane databases, EMBASE and CINAHL to identify relevant randomized controlled trials (RCTs) comparing outcomes between TNT and LCRT. Meta-analyses of pooled proportions between TNT and LCRT were performed, comparing primary outcomes of surgical mortality, morbidity and all reported complications; surgical-pathology differences, namely mesorectal quality, R0 resection rates, circumferential resection margin positive rates, and sphincter preservation rates. Death and progression of disease during neoadjuvant treatment period was also compared. Risk of bias of RCTs was performed using the Cochrane risk-of-bias tool by 2 independent reviewers. A total of 3185 patients with rectal cancer from 11 RCTs were included in the analysis: 1607 received TNT and 1578 received LCRT, of which 1422 (TNT arm) and 1391 (LCRT arm) underwent surgical resection with curative intent. There was no significant difference in mortality [risk ratio (RR)=0.86, 95% CI: 0.13-5.52, P =0.88, I2 =52%] or major complications (RR=1.04, 95% CI: 0.86-1.26, P =0.70, I2 =0%) between TNT and LCRT. There was a significantly higher risk of breached TME in TNT group on pooled analysis (RR=1.49, 95% CI: 1.03-12.16, P =0.03, I2 =0%), and on subgroup analysis there is higher risk of breached TME in those receiving extended duration of neoadjuvant treatment (>17 weeks from start of treatment to surgery) when compared with LCRT (RR=1.61, 95% CI: 1.06-2.44, P =0.03). No difference in R0 resection rates (RR=0.85, 95% CI: 0.66-1.10, P =0.21, I2 =15%), circumferential resection margin positive rates (RR=0.87, 95% CI: 0.65-1.16, P =0.35, I2 =10%) or sphincter preservation rates (RR=1.02, 95% CI: 0.83-1.25, P =0.88, I2 =57%) were observed. There was a significantly lower risk of progression of disease to an unresectable stage during the neoadjuvant treatment period in TNT patients (RR=0.60, 95% CI: 0.39-0.92, P =0.03, I2 =18%). On subgroup analysis, it appears to favor those receiving extended duration of neoadjuvant treatment (RR=0.44, 95% CI: 0.26-0.80, P =0.002), and those receiving induction-type chemotherapy in TNT (RR=0.25, 95% CI: 0.07-0.88, P =0.03). TNT increases rates of breached TME which can contribute to higher local recurrence rates. TNT, however, improves systemic control by reducing early progression of disease during neoadjuvant treatment period. Further research is warranted to identify patients that will benefit from this strategy.

Promoting Medication Adherence in Children with Attention Deficit Hyperactivity Disorder: A Mixed-Methods Systematic Review with Meta-analysis and Qualitative Comparative Analysis.

To evaluate the efficacy of ADHD medication adherence interventions and explore the pathways to effectiveness. A systematic review was conducted using multiple databases to identify relevant randomized controlled trials (RCTs). Pooled effect sizes were calculated for medication adherence and ADHD symptom outcomes. Qualitative Comparative Analysis (QCA) was used to identify pathways to effectiveness. Six RCTs were included. The interventions significantly improved medication adherence (OR = 2.39, 95% CI [1.19, 4.79]) and ADHD symptoms (Hedges' g = -0.96, 95% CI [-1.38, -0.54]). Multi-regression analysis showed a positive relationship between medication adherence and ADHD symptom reduction. QCA revealed two paths for effectiveness: (1) Presence of ADHD drug education and absence of reminder and (2) Presence of tracking and absence of reminder. ADHD medication adherence interventions have a positive impact on both medication adherence and ADHD symptoms. Interventions should consider including ADHD drug education or tracking to maximize effectiveness.