High-quality Randomized Controlled Trials Research Articles

The use of ketogenic diets in children living with drug-resistant epilepsy, glucose transporter 1 deficiency syndrome and pyruvate dehydrogenase deficiency: A scoping review.

The ketogenic diet (KD) is a high fat, moderate protein and very low carbohydrate diet. It can be used as a medical treatment for drug-resistant epilepsy (DRE), glucose transporter 1 deficiency syndrome and pyruvate dehydrogenase deficiency. The aim of this scoping review was to map the KD literature, with a focus on epilepsy and associated metabolic conditions, to summarise the current evidence-base and identify any gaps. This review was conducted using JBI scoping review methodological guidance and the PRISMA extension for scoping reviews reporting guidance. A comprehensive literature search was conducted in September 2021 and updated in February 2024 using MEDLINE, CINAHL, AMED, EmBASE, CAB Abstracts, Scopus and Food Science Source databases. The initial search yielded 2721 studies and ultimately, data were extracted from 320 studies that fulfilled inclusion criteria for the review. There were five qualitative studies, and the remainder were quantitative, including 23 randomised controlled trials (RCTs) and seven quasi-experimental studies. The USA published the highest number of KD studies followed by China, South Korea and the UK. Most studies focused on the classical KD and DRE. The studies key findings suggest that the KD is efficacious, safe and tolerable. There are opportunities available to expand the scope of future KD research, particularly to conduct high-quality RCTs and further qualitative research focused on the child's needs and family support to improve the effectiveness of KDs.

Meta-analysis and trial sequential analysis of Shenshao Capsules in treatment of angina pectoris in coronary heart disease

The efficacy and safety of Shenshao Capsules in combination with conventional western medicine for the treatment of angina pectoris in coronary heart disease were systematically evaluated. Computer search of seven databases, including CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, and Cochrane Library, was conducted to identify randomized controlled trial(RCT) on Shenshao Capsules for the treatment of angina pectoris in coronary heart disease up to December 2023. According to inclusion and exclusion criteria, articles were screened, and data was extracted. Cochrane bias risk assessment tool 2.0(RoB 2.0) was used to evaluate the quality of the included articles. Meta-analysis was performed by RevMan 5.4 and Stata/SE 15.1 software, and evidence quality was rated by the GRADE system. TSA 0.9.5.10 beta software was used for the trial sequential analysis(TSA). Twelve RCTs, with a total of 1 128 participants(567 in the experimental group and 561 in the control group), were included. Meta-analysis showed that Shenshao Capsules + conventional western medicine significantly improved clinical efficacy(RR=1.20, 95%CI[1.15, 1.26], P<0.000 01) and electrocardiogram efficacy(RR=1.16, 95%CI[1.04, 1.30], P=0.01), reduced the frequency of weekly angina pectoris attacks(MD=-2.85, 95%CI[-5.27,-0.43], P=0.02), daily angina pectoris attacks(MD=-0.30, 95%CI[-0.57,-0.03], P=0.03) and the duration of angina pectoris attacks(RR=-2.28, 95%CI[-3.44,-1.12], P=0.000 1). There was no statistically significant difference in adverse reactions between the two groups(RR=1.33, 95%CI[0.71, 2.51], P=0.37). TSA indicated that the cumulative evidence for clinical efficacy exceeded the traditional boundary but did not exceed the TSA boundary, suggesting a potential false positive result. According to GRADE assessment, except for clinical efficacy, which was rated as low-quality evidence, the remaining outcomes were rated as very low-quality evidence. The results indicate that Shenshao Capsules + conventional western medicine may have certain advantages in improving clinical efficacy and electrocardiographic efficacy, reducing the frequency and duration of angina pectoris attacks. However, due to the limitations of this study, more rigorous and high-quality RCT is needed to validate its efficacy and safety.

Personalizing Locoregional Therapy in Patients With Breast Cancer in 2024: Tailoring Axillary Surgery, Escalating Lymphatic Surgery, and Implementing Evidence-Based Hypofractionated Radiotherapy.

The management of axillary lymph nodes in breast cancer is continually evolving. Recent data now support omitting axillary lymph node dissection (ALND) in most patients with metastases in up to two sentinel lymph nodes (SLNs) during upfront surgery and those with residual isolated tumor cells after neoadjuvant chemotherapy (NACT). In the upfront surgery setting, ALND is still indicated, however, in patients with clinically node-positive breast cancer or more than two positive SLNs and, after NACT, in case of residual micrometastases and macrometastases. Omission of the sentinel lymph node biopsy (SLNB) can be considered in many postmenopausal patients with small luminal breast cancer, particularly when axillary ultrasound is negative. Several randomized controlled trials (RCTs) are currently aiming at eliminating the remaining indications for ALND and also establishing omission of SLNB in a broader patient population. The movement to deescalate axillary staging is in part because of the association between ALND and lymphedema, which is swelling of an extremity because of lymphatic damage and obstructed lymphatic drainage. To reduce the risk of developing this condition, patients undergoing ALND can undergo reverse mapping of the axilla and immediate reconstruction or bypass of the lymphatics from the involved extremity. Decongestion and compression are the foundation of conservative treatment for established lymphedema, while lymphovenous bypass and lymph node transfer are surgical procedures to address the physiologic dysfunction. Radiotherapy is an essential component of breast locoregional therapy: more than three decades of radiation research has optimized treatment according to patient's risk of local recurrence while substantially reducing the number of treatment visits. High-quality RCTs have shown the efficacy and safety of hypofractionation-more than 2Gy radiation dose per treatment (fraction)-significantly reducing the burden of radiotherapy treatment for many patients with breast cancer. In 2024, guidelines recommend no more than 15-16 fractions for whole-breast and nodal radiotherapy, with some recommending five fractions for whole-breast radiotherapy. In addition, simultaneous integrated boost (SIB) has been shown to be noninferior to sequential boost with regards to ipsilateral breast tumor recurrence with similar or reduced long-term side effects, also reducing overall treatment length. Further RCTs are underway investigating other indications for five fractions, including SIB and regional node irradiation, such that, in future, it may be possible for the majority of breast radiotherapy patients to be treated with a 1-week course. This manuscript serves to outline the latest updates on axillary surgical staging, lymphatic surgery, and evidence-based radiotherapy in the treatment of breast cancer.

Effectiveness and safety of thoracic manipulation in the treatment of neck pain: An updated systematic review and meta-analysis.

The purpose of this meta-analysis was to evaluate the effectiveness and safety of thoracic manipulation (TM) in patients with neck pain (NP). The purpose of this meta-analysis was to evaluate the effectiveness and safety of thoracic manipulation (TM) in patients with neck pain (NP). Seven electronic databases were searched from their inception through October 2023 by two authors. The methodological quality assessments were performed with the Physiotherapy Evidence Database (PEDro) scale. Pain, cervical range of motion (ROM), disability, and quality of life (QOL) were estimated for TM treatment in patients with NP. Eighteen randomized controlled trials (RCTs) with 914 patients were included with a PEDro score of 6.923 ± 3.120. Pooled effect sizes of pain (SMD =-0.481, 95% CI -0.653 to -0.309, P= 0.000), disability (SMD =-1.435, 95% CI -2.480 to -0.390, P= 0.007), QOL-physical component score (PCS) (SMD = 0.658, 95% CI 0.290 to 1.025, P= 0.000), ROM of flexion (SMD = 0.921, 95% CI 0.287 to 1.555, P= 0.000), ROM of extension (SMD = 0.572, 95% CI 0.321 to 0.822, P= 0.000), ROM of left lateral flexion (SMD = 0.593, 95% CI 0.075 to 1.112, P= 0.025) and ROM of left rotation (SMD = 0.230, 95% CI 0.010 to 0.450, P= 0.04) were favored by the TM group. TM provides short-term effect on relieving neck pain, increasing cervical ROM, and disability in patients with NP without serious side effects. Continuous therapy and distraction therapy are recommended as optimal choice on reducing pain and improving cervical ROM, especially in patients with chronic NP (> 3 months). The TM-induced improvements in the QOL of patients with NP should be verified by more further high-quality RCTs.

Effects of Therapies Involving Plyometric-Jump Training on Physical Fitness of Youth with Cerebral Palsy: A Systematic Review with Meta-Analysis.

The aim of this systematic review was to assess the effects of plyometric-jump training (PJT) on the physical fitness of youth with cerebral palsy (CP) compared with controls (i.e., standard therapy). The PRISMA 2020 guidelines were followed. Eligibility was assessed using the PICOS approach. Literature searches were conducted using the PubMed, Web of Science, and SCOPUS databases. Methodological study quality was assessed using the PEDro scale. Data were meta-analyzed by applying a random-effects model to calculate Hedges' g effect sizes (ES), along with 95% confidence intervals (95% CI). The impact of heterogeneity was assessed (I2 statistic), and the certainty of evidence was determined using the GRADE approach. Eight randomized-controlled studies with low-to-moderate methodological quality were included, involving male (n = 225) and female (n = 138) youth aged 9.5 to 14.6 years. PJT interventions lasted between 8 and 12 weeks with 2-4 weekly sessions. Compared with controls, PJT improved the muscle strength (ES = 0.66 [moderate], 95% CI = 0.36-0.96, p < 0.001, I2 = 5.4%), static (ES = 0.69 [moderate], 95% CI= 0.33-1.04, p < 0.001, I2 = 0.0%) and dynamic balance (ES = 0.85 [moderate], 95% CI = 0.12-1.58, p = 0.023, I2 = 81.6%) of youth with CP. Therefore, PJT improves muscle strength and static and dynamic balance in youth with CP compared with controls. However, more high-quality randomized-controlled trials with larger sample sizes are needed to provide a more definitive recommendation regarding the use and safety of PJT to improve measures of physical fitness.

Clinical and cost-effectiveness of telemedicine among patients with type 2 diabetes in primary care: A systematic review and meta-analysis.

Telemedicine has been promoted as an effective way of managing type-2 diabetes (T2DM) in primary care. However, the effectiveness of telemedicine is unclear. We investigated the clinical and cost-effectiveness of different telemedicine interventions for people with T2DM, compared to usual care. We searched Medline, Embase, Cochrane, CINHAL, ProQuest and EconLit for randomized controlled trials (RCTs) that examined the effectiveness of telemedicine interventions on clinical outcomes (HbA1c, body mass index [BMI], weight, diastolic blood pressure [DBP], systolic blood pressure [SBP], fasting blood glucose, high-density lipoprotein [HDL] cholesterol, low-density lipoprotein [LDL] cholesterol, total cholesterol and triglyceride) in adults with T2DM, published in English from inception until 31 December 2022. Meta-analyses were conducted using random-effects models pooling mean differences, heterogeneity was quantified using the I2 statistic. Publication bias was assessed using funnel plots, Egger tests and trim and fill. Subgroup analyses included type of telemedicine intervention, telemedicine mode of delivery and type of healthcare professionals. This study was registered with PROSPERO, CRD 42022375128. Of the 4093 records identified, 21 RCTs, 10,732 participants from seven regions, were included. Reported interventions included telephone (k = 16 studies), internet-based (k = 2), videoconference (k = 2) and telephone and emails (k = 1). We observed no statistically significant differences between synchronous or asynchronous telemedicine interventions compared to usual care for HbA1c (-0.08%(-0.88 mmol/mol); 95% CI: -0.18, 0.02), BMI (0.51 kg/m2; 95% CI: -0.21, 1.22), SBP (-1.48 mmHg; 95% CI: -3.22, 0.26), DBP (3.23 mmHg; 95% CI: -0.89, 7.34), HDL-cholesterol (0.01 mmol/L; 95% CI: -0.03, 0.05), LDL-cholesterol (0.08 mmol/L; 95% CI: -0.22, 0.37), triglycerides (-0.08 mmol/L, 95% CI: -0.31, -0.15), total cholesterol (-0.10 mmol/L; 95% CI: -0.25, 0.04) and weight (-0.50 kg; 95% CI: -1.21, 0.21). Telemedicine was as effective as usual care in improving health outcomes of people with T2DM. They can provide a safe solution in times of rising demands for primary healthcare services, or in extreme events, like a global pandemic. More high-quality RCTs are needed on the cost evaluation of telemedicine.

Management of systemic lupus erythematosus: a systematic literature review informing the 2023 update of the EULAR recommendations

ObjectivesTo analyse the new evidence (2018–2022) for the management of systemic lupus erythematosus (SLE) to inform the 2023 update of the European League Against Rheumatism (EULAR) recommendations.MethodsSystematic literature reviews were...

Regulatory patterns of Chinese patent medicine for lipid metabolism disorders in patients with type 2 diabetes mellitus complicated by ischemic stroke: A systematic review and network meta-analysis.

To investigate the regulatory patterns of Chinese patent medicine (CPM) interventions on lipid metabolism disorders in patients with type 2 diabetes mellitus (T2DM) complicated by ischemic stroke. Two researchers independently searched 8 major databases and created a comprehensive database containing all randomized controlled trials (RCTs) that investigated the application of "blood-activating and stasis-removing" CPM in the treatment of stroke combined with T2DM until October 1, 2022. The collected data were compiled and organized in Excel. Quality assessment was performed using the Cochrane 5.3 bias risk assessment tool, and the network meta-analysis was conducted using R software. A total of 12 articles were included in the final analysis, covering 4 types of CPM: Naoxintong Capsules (NXT), Tongmai Jiangtang Capsules, Tongxinluo Capsules (TXL), and Yindan Xinnaotong Soft Capsules. Among these, CPM formulations containing herbs with blood-activating and stasis-removing properties were the most commonly used. The results of the network meta-analysis are as follows: (1) the combination of 3 CPM formulations showed superior efficacy in improving total cholesterol levels compared to conventional Western medicine treatment (CT). In particular, Yindan Xinnaotong Soft Capsules + CT (surface under the cumulative ranking curve [SUCRA] = 97.24%) demonstrated the highest efficacy, followed by NXT + CT (SUCRA = 66.23%), and then TXL + CT (SUCRA = 55.16%). (2) TXL + CT treatment exhibited the most promising efficacy in improving triglyceride levels (P < .05), while the effects of the other 3 CPM formulations were not statistically significant. (3) In terms of improving low-density lipoprotein levels, NXT + CT (SUCRA = 82.27%) showed better efficacy than TXL + CT (SUCRA = 73.99%), while the effects of the other 2 CPM formulations were not statistically significant. (4) The combination of CPM formulations and CT resulted in a lower incidence of adverse reactions compared to CT (P < .05). The treatment of patients with T2DM complicated by ischemic stroke commonly involved the use of "blood-activating and stasis-removing" herbal medicines. These herbal medicines have shown effectiveness in regulating patients' blood lipid levels. However, it is crucial to acknowledge that the analysis was influenced by variations in the number and quality of RCTs involving different CPM formulations. Therefore, additional validation through large-scale, high-quality RCT studies is required.

Pulsed Radiofrequency Neuromodulation of the Greater Occipital Nerve for the Treatment of Headache Disorders in Adults: A Systematic Review

ABSTRACT Background Pulsed radiofrequency neuromodulation (PRFN) of greater occipital nerve (GON) is considered in patients with headaches failing to achieve sustained analgesic benefit from nerve blocks with local anesthetic and steroids. However, the evidence supporting this practice is unclear. Aims This narrative systematic review aims to explore the effectiveness and safety of GON PRFN on headaches. Methods Databases were searched for studies, published up to February 1, 2024, investigating PRFN of GON for adults with headaches. s and posters were excluded. Primary outcome was change in headache intensity. Secondary outcomes included effect on monthly headache frequency (MHF), mental and physical health, mood, sleep, analgesic consumption, and side-effects. Two reviewers screened and extracted data. Results Twenty-two papers (2 randomized controlled trials (RCT), 11 cohort, and 9 case reports/series) including 608 patients were identified. Considerable heterogeneity in terms of study design, headache diagnosis, PRF target and settings, and image-guidance was noted. PRFN settings varied (38–42°C, 40–60 V, and 150–400 Ohms). Studies demonstrated PRFN to provide significant analgesia and reduction of MHF in chronic migraine (CM) from 3 to 6 months; and significant pain relief for ON from six to ten months. Mild adverse effects were reported in 3.1% of cohort. A minority of studies reported on secondary outcomes. The quality of the evidence was low. Conclusions Low-quality evidence indicates an analgesic benefit from PRFN of GON for ON and CM, but its role for other headache types needs more investigation. Optimal PRFN target and settings remain unclear. High-quality RCTs are required to further explore the role of this intervention. PROSPERO ID CRD42022363234.

Tension-Type Headache Management: A Systematic Review and Network Meta-analysis of Complementary and Alternative Medicine.

Tension-type headache (TTH) is common but challenging to manage due to limited effectiveness of conventional treatments. This study examines six complementary and alternative medicine (CAM) interventions through network meta-analysis to identify effective TTH management strategies. We searched PubMed, Embase, Web of Science, Cochrane Library, OVID, CNKI, Wanfang, VIP, and CBM databases for randomized controlled trials on CAM for TTH treatment. Headache frequency and intensity were the primary outcomes. Methodological quality was evaluated on the basis of the Cochrane risk of bias tool. We used R software to conduct this Bayesian network meta-analysis. We used mean difference (MD) with 95% credible intervals (CI) to calculate the continuous outcomes and analyzed the percentages of the surface under the cumulative ranking (SUCRA) curve. In total, 32 randomized controlled trials (RCTs) with 2405 participants were analyzed. For reducing headache intensity, the network meta-analysis shows that acupuncture therapy combined with traditional Chinese medicine (AT_TCM), manual therapy (MT), psychological treatment (PT), and traditional Chinese medicine combined with acupuncture and manual therapy (TCM_AT_MT) are superior to Western medicine (WM). In the SUCRA curve, TCM_AT_MT is the best for reducing headache frequency (HF). This review, assessed as low-quality evidence by GRADE, cautiously suggests potential benefits of PT over other CAM interventions for TTH and indicates TCM_AT_MT might better reduce HF. It proposes that combining CAM interventions could enhance outcomes. Due to the preliminary nature of these findings, further high-quality RCTs are essential to confirm these suggestions and provide clearer clinical guidance. CRD42021252073.

Efficacy of Anti-Interleukin-1 Therapeutics in the Treatment of Knee Osteoarthritis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials from the Years 2000 to 2023.

Objectives: This study aimed to evaluate the efficacy of anti-interleukin-1 therapeutics for treating knee osteoarthritis (KOA). Our research included interleukin-1 (IL-1) inhibitors, IL-1 antibodies and IL-1 receptor antagonists (IL-1 Ras). Methods: We systematically searched PubMed and Mendeley to find randomized control trials (RCTs) or clinical trials (CTs) of anti-interleukin-1 therapeutics in KOA from 2000 to 2023. The outcomes were changes in pain, function and stiffness scores. The research was conducted between November 2023 and January 2024. The risk of bias was assessed using Cochrane Risk of Bias tool RoB 2. Results: Analysis of the nine included studies showed a statistically significant difference in terms of the pain relief group (SMD = -0.20, 95% CI: -0.39 to -0.01, p = 0.0348), physical function improvement (SMD = -0.20, 95% CI: -0.39 to 0.00, p = 0.0479) and stiffness reduction (SMD = -0.22, 95% CI: -0.43 to 0.00, p = 0.0475) between anti-IL-1 therapeutics and placebo or nonsteroidal anti-inflammatory drugs (NSAIDs). However, when we separately analysed placebo and NSAIDs subgroups, the statistical significance was observed only in the placebo group. Our article was limited by the quality of the included RCTs. Two of the included trials were of poor methodological quality, and five showed selective reporting. Conclusions: The results of our study suggest that anti-IL-1 therapeutics might have better efficacy in KOA treatment than placebo or NSAIDs; yet, taking into account the limited availability of studies and data concerning anti-IL-1 in osteoarthritis treatment, we think that more high-quality RCTs on this subject are needed.

Collaborative care approaches for people with severe mental illness.

Collaborative care for severe mental illness (SMI) is a community-based intervention that promotes interdisciplinary working across primary and secondary care. Collaborative care interventions aim to improve the physical and/or mental health care of individuals with SMI. This is an update of a 2013 Cochrane review, based on new searches of the literature, which includes an additional seven studies. To assess the effectiveness of collaborative care approaches in comparison with standard care (or other non-collaborative care interventions) for people with diagnoses of SMI who are living in the community. We searched the Cochrane Schizophrenia Study-Based Register of Trials (10 February 2021). We searched the Cochrane Common Mental Disorders (CCMD) controlled trials register (all available years to 6 June 2016). Subsequent searches on Ovid MEDLINE, Embase and PsycINFO together with the Cochrane Central Register of Controlled Trials (with an overlap) were run on 17 December 2021. Randomised controlled trials (RCTs) where interventions described as 'collaborative care' were compared with 'standard care' for adults (18+ years) living in the community with a diagnosis of SMI. SMI was defined as schizophrenia, other types of schizophrenia-like psychosis or bipolar affective disorder. The primary outcomes of interest were: quality of life, mental state and psychiatric admissions at 12 months follow-up. Pairs of authors independently extracted data. We assessed the quality and certainty of the evidence using RoB 2 (for the primary outcomes) and GRADE. We compared treatment effects between collaborative care and standard care. We divided outcomes into short-term (up to six months), medium-term (seven to 12 months) and long-term (over 12 months). For dichotomous data we calculated the risk ratio (RR) and for continuous data we calculated the standardised mean difference (SMD), with 95% confidence intervals (CIs). We used random-effects meta-analyses due to substantial levels of heterogeneity across trials. We created a summary of findings table using GRADEpro. Eight RCTs (1165 participants) are included in this review. Two met the criteria for type A collaborative care (intervention comprised of the four core components). The remaining six met the criteria for type B (described as collaborative care by the trialists, but not comprised of the four core components). The composition and purpose of the interventions varied across studies. For most outcomes there was low- or very low-certainty evidence. We found three studies that assessed the quality of life of participants at 12 months. Quality of life was measured using the SF-12 and the WHOQOL-BREF and the mean endpoint mental health component scores were reported at 12 months. Very low-certainty evidence did not show a difference in quality of life (mental health domain) between collaborative care and standard care in the medium term (at 12 months) (SMD 0.03, 95% CI -0.26 to 0.32; 3 RCTs, 227 participants). Very low-certainty evidence did not show a difference in quality of life (physical health domain) between collaborative care and standard care in the medium term (at 12 months) (SMD 0.08, 95% CI -0.18 to 0.33; 3 RCTs, 237 participants). Furthermore, in the medium term (at 12 months) low-certainty evidence did not show a difference between collaborative care and standard care in mental state (binary) (RR 0.99, 95% CI 0.77 to 1.28; 1 RCT, 253 participants) or in the risk of being admitted to a psychiatric hospital at 12 months (RR 5.15, 95% CI 0.67 to 39.57; 1 RCT, 253 participants). One study indicated an improvement in disability (proxy for social functioning) at 12 months in the collaborative care arm compared to usual care (RR 1.38, 95% CI 0.97 to 1.95; 1 RCT, 253 participants); we deemed this low-certainty evidence. Personal recovery and satisfaction/experience of care outcomes were not reported in any of the included studies. The data from one study indicated that the collaborative care treatment was more expensive than standard care (mean difference (MD) international dollars (Int$) 493.00, 95% CI 345.41 to 640.59) in the short term. Another study found the collaborative care intervention to be slightly less expensive at three years. This review does not provide evidence to indicate that collaborative care is more effective than standard care in the medium term (at 12 months) in relation to our primary outcomes (quality of life, mental state and psychiatric admissions). The evidence would be improved by better reporting, higher-quality RCTs and the assessment of underlying mechanisms of collaborative care. We advise caution in utilising the information in this review to assess the effectiveness of collaborative care.

Efficacy and safety of Chinese herbal medicine in treating postcholecystectomy diarrhea: A systematic review and meta-analysis.

Postcholecystectomy diarrhea (PCD) is among the most distressing and well-known clinical complications of cholecystectomy. Despite various available treatment options, clinical outcomes are greatly limited by unclear pathophysiological mechanisms. Chinese herbal medicine (CHM) is widely used as a complementary and alternative therapy for the treatment of functional diarrhea. Thus, we conducted a meta-analysis of randomized controlled trials (RCTs) to evaluate the efficacy and safety of CHM for the treatment of PCD. Electronic database searches were conducted using the Cochrane Library, PubMed, Web of Science, Embase, Wanfang Data, China National Knowledge Infrastructure, and the Chinese Scientific Journal Database. All RCTs on CHMs for managing patients with PCD were included. The meta-analysis was performed using RevMan 5.4 software. The present meta-analysis included 14 RCTs published between 2009 and 2021 in China. The primary findings indicated that CHM had a higher total efficacy and cure rate as a monotherapy for PCD (P < .00001). Two trials reported the scores of the main symptoms with statistically significant differences in stool nature (P < .00001), defecation frequency (P = .002), and abdominal pain and bloating (P < .00001). In addition, CHM reduced CD3+ and CD4+ levels more effectively in terms of T lymphocyte subset determination (P < .00001). The main symptoms of PCD in traditional Chinese medicine (TCM) are splenic deficiency and liver stagnation. All treatments were used to strengthen the spleen and (or) soothing the liver. CHM had a favorable effect on PCD. No adverse events were observed. Larger, high-quality RCTs are warranted to draw definitive conclusions and standardize treatment protocols.

Network Meta-analysis of traditional Chinese medicine injections in treatment of chronic pulmonary heart disease

Based on the network Meta-analysis, the efficacy and safety of different traditional Chinese medicine(TCM) injections in the treatment of chronic pulmonary heart disease(CPHD) were systematically evaluated. CNKI, Wanfang, VIP, SinoMed, Web of Science, PubMed, EMbase, and Cochrane Library were searched to collect randomized controlled trial(RCT) of TCM injection in the treatment of CPHD from inception to October 1, 2023. The quality of the included studies was evaluated by the bias risk assessment tool recommended by the Cochrane systematic evaluation manual version 5.3. Stata 17.0 and RevMan 5.4 software were used for statistical analysis of the data. Finally, 103 RCTs were included, involving 9 332 patients and 13 kinds of TCM injections. Network Meta-analysis yielded the following results.(1)In terms of improving the total clinical effective rate, the top three intervention measures in SUCRA ranking are Shuxuetong Injection + conventional western medicine&gt;Ligustrazine Injection + conventional western medicine&gt;Xinmailong Injection + conventional western medicine.(2)In terms of reducing pulmonary artery pressure, the top three intervention measures in SUCRA ranking are Salvia Miltiorrhiza Ligustrazine Injection + conventional western medicine&gt;Ligustrazine Injection + conventional western medicine&gt;Shenmai Injection + conventional western medicine.(3)In terms of improving left ventricular ejection fraction(LVEF), the top three intervention measures in SUCRA ranking are Xinmailong Injection + conventional western medicine&gt;Danhong Injection + conventional western medicine&gt;Ginkgo Damo Injection + conventional western medicine.(4) In terms of reducing brain natriuretic peptide(BNP), the top three intervention measures in SUCRA ranking are Xinmailong Injection + conventional wes-tern medicine&gt;Ginkgo Damo Injection + conventional western medicine&gt;Danhong Injection + conventional western medicine.(5) In terms of increasing arterial oxygen partial pressure(PaO_2) and reducing arterial carbon dioxide partial pressure(PaCO_2), the top three intervention measures in SUCRA ranking are Shenxiong Glucose Injection + conventional western medicine&gt;Shenmai Injection + conventional western medicine&gt;Shenfu Injection + conventional western medicine.(6) In terms of improving arterial oxygen saturation(SaO_2), the top three intervention measures in SUCRA ranking are Salvia Miltiorrhiza Ligustrazine Injection + conventional western medicine&gt;Xinmailong Injection + conventional western medicine&gt;Shenmai Injection + conventional western medicine.(7) In terms of increasing the percentage of forced expiratory volume in the first second(FEV_1%), the top three intervention measures in SUCRA ranking are Shenfu Injection + conventional western medicine&gt;Tanshinone Sodium Ⅱ_A Sulfonate Injection + conventional western medicine&gt;Shenmai Injection + conventional western medicine.(8) In terms of increasing the proportion of forced expiratory volume to forced vital capacity in the first second(FEV_1/FVC), the top three intervention measures in SUCRA ranking are Salvia Miltiorrhiza Ligustrazine Injection + conventional western medicine&gt;Shuxuetong Injection + conventional western medicine&gt;Danhong Injection + conventional western medicine.(9) In terms of safety, neither the experimental group nor the control group experienced any serious adverse drug reactions during the treatment period. In summary, combining TCM injection with conventional western medicine treatment can improve the comprehensive efficacy of treating CPHD, reduce pulmonary artery pressure, and improve cardiopulmonary function and arterial blood gas levels. However, due to the limitations of the quality and quantity of research methodology included, the above conclusions need to be further validated by more well-designed and high-quality RCT.

First and second-generation endometrial ablation devices: A network meta-analysis

ObjectiveFirst-generation and second-generation endometrial ablation (EA) techniques, along with medical treatment and invasive surgery, are considered successful lines of management for abnormal uterine bleeding (AUB). We set out to determine...

Effectiveness of behavior change and self-management theoretically-informed telehealth interventions for stroke secondary prevention: An overview of systematic reviews

Introduction Despite the increased use of telehealth interventions, low-level evidence supports their use for behavior change and self-management in stroke secondary prevention. Therefore, this overview of systematic reviews (SRs) critically appraises and consolidates the evidence about theoretically-informed telehealth interventions in stroke secondary prevention. Methods Two phases were conducted independently by two reviewers. Phase-1 included SRs contemplating randomized controlled trials (RCTs) implementing telehealth interventions with individuals post-stroke, targeting cardiovascular events, risk-reducing health behaviors or physiological risk factors. Phase-2 interrogated RCTs from these SRs that implemented theoretically-informed interventions. Best-evidence synthesis of published meta-analyses and new meta-analyses of theoretically-informed interventions were conducted. GRADE evidence was applied. Results In Phase-1 (15 SRs), best-evidence synthesis identified telehealth interventions as effective in reducing recurrent angina and recurrent stroke rates (both with very low GRADE), improving medication adherence (low GRADE), physical activity participation (very low GRADE), and blood pressure targets (very low GRADE), reducing systolic blood pressure (SBP) (moderate GRADE) and low-density lipoprotein levels (very low GRADE). In Phase-2 (14 RCTs), new meta-analyses identified theoretically-informed telehealth interventions as effective in improving medication adherence (SMD: 0.38; 95%CI: 0.13–0.64; I²: 72%, low GRADE) and healthy eating (SMD: 0.38; 95%CI: 0.15–0.60; I²: 38%, low GRADE), and decreasing SBP (MD: −9.19; 95%CI: −5.49 to −12.89; I²: 0%, moderate GRADE). Discussion Telehealth demonstrates utility in stroke secondary prevention, notably in SBP reduction. High-quality RCTs are required given the lack of current evidence supporting theoretically-informed telehealth interventions addressing primary outcomes of secondary prevention, and the low certainty evidence identified for health behavior change.

Lifestyle modification as intervention for seasonal affective disorder: A systematic review

Bright light therapy (BLT) and pharmacological therapies currently represent the first line treatments for patients with seasonal affective disorder (SAD). Lifestyle modifications offer a diverse field of additional intervention options. Since it is unclear, if lifestyle modifications are effective in SAD patients, this systematic review aims to synthesize the current evidence on their effectiveness and safety.We systematically searched for randomized controlled trials (RCTs) assessing lifestyle modifications (nutrition, exercise, staying outdoors, sleep, social aspects, mindfulness methods) in SAD patients. We defined the primary outcome as the post-therapeutic extent of depressive symptoms, measured by validated psychiatric symptom scales. Due to the insufficient number of studies and the high heterogeneity of the interventions we were not able to calculate a meta-analysis.We identified 6 studies from the following areas of lifestyle modification: diet, exercise, staying outdoors, sleep and music therapy. All studies showed improvements of depression scores in the intervention as well as in the control groups. The risk of bias was rated as high for all studies and the certainty of evidence was rated as very low.The results point towards the possible effectiveness of the interventions examined, but due to the small number of studies found, too small sample sizes and methodological limitations, we cannot draw a valid conclusion about the effectiveness of lifestyle-modifying measures in SAD patients. Larger, high-quality RCTs are needed to make evidence-based recommendations and thus to expand the range of therapeutic options for SAD.

Efficacy and safety of lurasidone for schizophrenia: A systematic review and meta‑analysis of eight short‑term, randomized, double‑blind, placebo‑controlled clinical trials.

Lurasidone is an atypical anti-psychotic approved by the US Food and Drug Administration. It is mainly used to treat schizophrenia in adults through its antagonistic action on dopamine and 5-hydroxytryptamine receptors. The present study systematically assessed the efficacy and safety of lurasidone in the treatment of schizophrenia. Clinical, double-blind, parallel, randomized controlled trials (RCTs) of lurasidone in the treatment of schizophrenia were retrieved from PubMed\Medline, EBSCO, Embase, Cochrane Library, OVID, Web of Science and related clinical trial registration websites up to May 2023. A total of two investigators independently screened the included references and evaluated their quality. RevMan 5.3 software was used for meta-analysis of each measure outcome. The present systematic review was registered in PROSPERO (ID=CRD42018108178). A total of eight RCTs were included in the present study, including a total of 2,456 patients with schizophrenia. All eight references were randomized, double-blind and parallel control trials. All eight references were evaluated as high quality. The meta-analysis results demonstrated that there were no significant change in total Positive and Negative Syndrome Scale (PANSS) score, Clinical Global Impression of Severity (CGI-S) score and Montgomery-Asberg Depression Rating Scale (MADRS) between the 40 mg lurasidone group and the placebo group (P>0.05). However, as the dosage increased, the 80, 120 and 160 mg lurasidone groups had significant changes in total PANSS score, CGI-S score and MADRS Compared with placebo (P<0.05), although changes in MADRS in the 120 mg lurasidone group were not statistically significant (P>0.05). In terms of safety, the changes in the incidence of agitation in the 40 mg lurasidone group (P<0.05), vomiting in the 80 mg group (P<0.05) and akathisia in the 160 mg group (P<0.05) were statistically significant and there were also statistically significant changes in the incidence of akathisia, nausea, somnolence and extrapyramidal disorder among the 40, 80 and 120 mg lurasidone groups (P<0.05); No statistically significant changes in the in the incidence of other adverse reactions (P>0.05). In conclusion, existing evidence suggests that the initial dose of lurasidone for schizophrenia can be adjusted to 80 mg. As the condition aggravates, the dose can be incrementally increased to 160 mg. A dose of 160 mg lurasidone is recommended as the most efficacious and safe dose for acute schizophrenia and the risk of occurrence of akathisia, nausea, somnolence and extrapyramidal disorder is still high when lurasidone is administered at a dose of 80-120 mg. The dose should be promptly adjusted or the drug should be withdrawn if the aforementioned adverse reactions worsen. Multi-center, high-quality and long-term clinical RCTs influenced by the included references are still necessary to support the aforementioned conclusions.

Efficacy of fire needle combined with 308 nm excimer laser therapy for vitiligo: A systematic review and meta-analysis of randomized controlled trials.

Vitiligo is a common depigmenting skin disorder. This work is performed to systematically evaluate the efficacy and safety of fire needles combined with 308 nm excimer laser therapy in treating vitiligo. We searched the PubMed, EMBASE, Cochrane Library, Web of Science, CNKI, Wanfang, and VIP databases. Randomized controlled trials (RCTs) on fire needles combined with 308 nm excimer laser therapy with 308 nm excimer laser therapy alone for vitiligo were included. The Cochrane Collaborative Network Tool was used to assess the risk of bias. Statistical analysis was completed using RevMan5.3 software and Stata 15.0 software. The GRADE system was used to evaluate the quality of evidence for outcomes. In this study, 10 RCTs and 1333 patients were included. The results showed that compared with 308 nm excimer laser therapy alone, fire needle combined with 308 nm excimer laser therapy is more effective in improving clinical effective rate (RR = 1.36, 95% CI [1.24, 1.50], p < 0.00001), serum CD4+ level (MD = 3.12, 95% CI [2.50, 3.74], p < 0.00001), CD4+/CD8+ ratio (MD = 0.24, 95% CI [0.09, 0.39], p = 0.001), and quality of life measured by the Dermatology Life Quality Index (DLQI) (MD = 3.76, 95% CI [3.33, 4.19], p < 0.00001), and reducing the Vitiligo Area Score Index (VASI) (MD = -5.47, 95% CI [-6.56, -4.37], p < 0.00001). The reported adverse events, including redness, swelling, pain, blisters, and itching, were controllable, and all these events were well tolerated. The current evidence indicates that fire needle combined with 308 nm excimer laser therapy is effective and safe for vitiligo. However, owing to the suboptimal quality of the included studies, more high-quality and large-scale RCTs are needed for comprehensive analysis and further validation.

Best acupuncture method for mammary gland hyperplasia: Evaluation of randomized controlled trials and Bayesian network meta-analysis

ObjectiveTo evaluate the effectiveness of different acupuncture treatments for mammary gland hyperplasia (MGH) using a network meta-analysis. MethodsSeveral databases were searched without language restrictions from 2000 to February 2023, including PubMed, Embase, Web of Science, Cochrane Library, China Science and Technology Journal Database, China Biology Medicine Database, Wanfang Database, China National Knowledge Infrastructure Database, and other professional websites and gray literature. Inclusion criteria were adult women diagnosed with MGH; intervention measures included acupuncture and related therapies; the control group was treated with simple drugs; and the research type was a randomized controlled trial (RCT). The primary outcomes were treatment effectiveness and estradiol and progesterone levels. Secondary outcomes were breast lump size and visual analog scale (VAS) score of breast pain. Exclusion criteria were studies unrelated to MGH, incorrect study populations, control measures or interventions, incomplete data, non-RCTs, case reports, and animal experiments. Cochrane tools were used to assess the risk of bias. The R software (x64 version 4.2.1), Review Manager 5.3 software and STATA 16.0 software were used for data analysis. ResultsFollowing a rigorous screening process, data extraction, and quality assessment, 48 eligible RCTs encompassing 4,500 patients with MGH and 16 interventions were included. The results indicated that acupuncture, alone or in combination with traditional Chinese or Western medicine, had better therapeutic effects than conventional therapy. In terms of effectiveness, warm needle acupuncture was the best choice (94.6%). Bloodletting pricking was the most effective method (85.7%) for lowering progesterone levels. Bloodletting pricking was the most effective method (98.3%) for lowering estradiol levels. Manual acupuncture combined with traditional Chinese medicine was the most effective (74.5%) treatment to improve the size of the breast lump. Warm needle acupuncture was the most effective (69.8%) in improving the VAS score. ConclusionAcupuncture therapy was more effective in treating MGH than drug therapy alone, and warm needle acupuncture and bloodletting pricking were the two best options. However, larger sample sizes and high-quality RCTs are required.