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1.
Front Endocrinol (Lausanne) ; 15: 1324782, 2024.
Article in English | MEDLINE | ID: mdl-38601203

ABSTRACT

Objective: This study aims to map evidence from Randomized Controlled Trials (RCTs) and systematic reviews/Meta-analyses concerning the treatment of Diabetic Nephropathy (DN) with Traditional Chinese Medicine (TCM), understand the distribution of evidence in this field, and summarize the efficacy and existing problems of TCM in treating DN. The intention is to provide evidence-based data for TCM in preventing and treating DN and to offer a reference for defining future research directions. Methods: Comprehensive searches of major databases were performed, spanning from January 2016 to May 2023, to include clinical RCTs and systematic reviews/Meta-analyses of TCM in treating DN. The analysis encompasses the publishing trend of clinical studies, the staging of research subjects, TCM syndrome differentiation, study scale, intervention plans, and outcome indicators. Methodological quality of systematic reviews was evaluated using the AMSTAR (Assessment of Multiple Systematic Reviews) checklist, and evidence distribution characteristics were analyzed using a combination of text and charts. Results: A total of 1926 RCTs and 110 systematic reviews/Meta-analyses were included. The majority of studies focused on stage III DN, with Qi-Yin deficiency being the predominant syndrome type, and sample sizes most commonly ranging from 60 to 100. The TCM intervention durations were primarily between 12-24 weeks. Therapeutic measures mainly consisted of Chinese herbal decoctions and patented Chinese medicines, with a substantial focus on clinical efficacy rate, TCM symptomatology, and renal function indicators, while attention to quality of life, dosage of Western medicine, and disease progression was inadequate. Systematic reviews mostly scored between 5 and 8 on the AMSTAR scale, and evidence from 94 studies indicated potential positive effects. Conclusion: DN represents a significant health challenge, particularly for the elderly, with TCM showing promise in symptom alleviation and renal protection. Yet, the field is marred by research inconsistencies and methodological shortcomings. Future investigations should prioritize the development of standardized outcome sets tailored to DN, carefully select evaluation indicators that reflect TCM's unique intervention strategies, and aim to improve the robustness of clinical evidence. Emphasizing TCM's foundational theories while incorporating advanced scientific technologies will be essential for innovating research methodologies and uncovering the mechanisms underlying TCM's efficacy in DN management.


Subject(s)
Diabetes Mellitus , Diabetic Nephropathies , Drugs, Chinese Herbal , Humans , Diabetes Mellitus/drug therapy , Diabetic Nephropathies/drug therapy , Drugs, Chinese Herbal/therapeutic use , Medicine, Chinese Traditional/methods , Meta-Analysis as Topic , Randomized Controlled Trials as Topic , Systematic Reviews as Topic , Treatment Outcome
2.
Front Neurol ; 15: 1361037, 2024.
Article in English | MEDLINE | ID: mdl-38562427

ABSTRACT

Objective: This study aims to evaluate the efficacy and safety of various acupuncture treatments in conjunction with multimodal analgesia (MA) for managing postoperative pain and improving knee function in patients undergoing total knee arthroplasty (TKA), based on the findings from clinical research indicating the potential benefits of acupuncture-related therapies in this context. Methods: We searched Web of Science, PubMed, SCI-hub, Embase, Cochrane Library, China Biology Medicine (CBM), China National Knowledge Infrastructure (CNKI), Wanfang Data, and Chinese Scientific Journal Database (VIP) to collect randomized controlled trials of acupuncture-related therapies for post-TKA pain. After independent screening and data extraction, the quality of the included literature was evaluated. The potential for bias in the studies incorporated in the analysis was assessed according to the guidelines outlined in the Cochrane Handbook 5.1. Network meta-analysis (NMA) was conducted using RevMan 5.4 and Stata 16.0 software, with primary outcome measures including visual analog scale (VAS), pain pressure threshold (PPT), hospital for special surgery knee score (HSS), and knee joint range of motion (ROM). Furthermore, the interventions were ranked based on the SUCRA value. Results: We conducted an analysis of 41 qualifying studies encompassing 3,003 patients, examining the efficacy of four acupuncture therapies (acupuncture ACU, electroacupuncture EA, transcutaneous electrical acupoint stimulation TEAS, and auricular acupoint therapy AAT) in conjunction with multimodal analgesia (MA) and MA alone. The VAS results showed no significant difference in efficacy among the five interventions for VAS-3 score. However, TEAS+MA (SMD: 0.67; 95%CI: 0.01, 1.32) was more effective than MA alone for VAS-7 score. There was no significant difference in PPT score among the three interventions. ACU + MA (SMD: 6.45; 95%CI: 3.30, 9.60), EA + MA (SMD: 4.89; 95%CI: 1.46, 8.32), and TEAS+MA (SMD: 5.31; 95%CI: 0.85, 9.78) were found to be more effective than MA alone for HSS score. For ROM score, ACU + MA was more efficacious than EA + MA, TEAS+MA, and AAT + MA, MA. Regarding the incidence of postoperative adverse reactions, nausea and vomiting were more prevalent after using only MA. Additionally, the incidence of postoperative dizziness and drowsiness following ACU + MA (OR = 4.98; 95%CI: 1.01, 24.42) was observed to be higher compared to that after AAT + MA intervention. Similarly, the occurrence of dizziness and drowsiness after MA was found to be significantly higher compared to the following interventions: TEAS+MA (OR = 0.36; 95%CI: 0.18, 0.70) and AAT + MA (OR = 0.20; 95%CI: 0.08, 0.50). The SUCRA ranking indicated that ACU + MA, EA + MA, TEAS+MA, and AAT + MA displayed superior SUCRA scores for each outcome index, respectively. Conclusion: For the clinical treatment of post-TKA pain, acupuncture-related therapies can be selected as a complementary and alternative therapy. EA + MA and TEAS+MA demonstrate superior efficacy in alleviating postoperative pain among TKA patients. ACU + MA is the optimal choice for promoting postoperative knee joint function recovery in TKA patients. AAT + MA is recommended for preventing postoperative adverse reactions. Systematic review registration: https://www.crd.york.ac.uk/, identifier (CRD42023492859).

3.
Syst Rev ; 13(1): 110, 2024 Apr 19.
Article in English | MEDLINE | ID: mdl-38641831

ABSTRACT

BACKGROUND: Vitiligo is a disease that affects people of all skin shades and can impact their quality of life. Reliable evidence on the effectiveness and adverse events associated with the recent use of Janus kinase (JAK) inhibitors to treat vitiligo is needed. This protocol for a systematic review and meta-analysis seeks to collect evidence from both randomized controlled trials (RCTs) and observational studies to determine the effectiveness and patient-centered outcomes concerning treatment with JAK inhibitors. METHODS: We will conduct a systematic review of the literature for RCTs and observational studies that used upadacitinib, ritlecitinib, brepocitinib, ifidancitinib, cerdulatinib, deglocitinib, baricitinib, tofacitinib, and ruxolitinib JAK inhibitors as treatments for vitiligo compared to placebo, no treatment, or combination therapies. We will systematically search from inception in Epistemonikos, MEDLINE, Scopus, Cochrane Central Register of Controlled Trials, EMBASE, ClinicalTrials.gov, PsycINFO, Allied and Complementary Medicine Database, Latin American and Caribbean Health Sciences Literature, Web of Science Core Collection, relevant preprint servers, and the gray literature. Ethics approval was not sought as the protocol and systematic review will not involve human participants, but rather summarized and anonymous data from studies. Primary outcomes include quality of life, percentage repigmentation, decreased vitiligo within 1 year or more, lasting repigmentation after a 2-year follow-up, cosmetic acceptability of repigmentation and tolerability or burden of treatment, and adverse events. Secondary outcomes are patient and study characteristics. We will include full-text articles, preprints, and clinical trial data in any language and all geographic regions. For data sources unavailable in English, we will obtain translations from global collaborators via the Cochrane Engage network. We will exclude articles for which sufficient information cannot be obtained from the authors of articles and systematic reviews. At least two investigators will independently assess articles for inclusion and extract data; reliability will be assessed before subsequent selection and data extraction of remaining studies. The risk of bias and certainty of evidence with Grading of Recommendations Assessment, Development, and Evaluation guidelines will be assessed independently by at least two investigators. We will estimate treatment effects by random-effects meta-analyses and assess heterogeneity using I2. Data that cannot be included in the meta-analysis will be reported narratively using themes. DISCUSSION: The proposed systematic review and meta-analysis describe the methods for summarizing and synthesizing the evidence on the effectiveness and patient-centered outcomes concerning the treatment of vitiligo with JAK inhibitors that were recently approved for this indication. To disseminate further the results of our systematic review, we plan to present them at international conferences and meetings. Our findings will provide robust evidence to facilitate decision-making at the policy or practitioner level. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42023383920.


Subject(s)
Janus Kinase Inhibitors , Systematic Reviews as Topic , Vitiligo , Vitiligo/drug therapy , Humans , Janus Kinase Inhibitors/therapeutic use , Meta-Analysis as Topic , Quality of Life , Randomized Controlled Trials as Topic , Pyrimidines/therapeutic use
4.
Front Pharmacol ; 15: 1242525, 2024.
Article in English | MEDLINE | ID: mdl-38510651

ABSTRACT

Background: Acute respiratory tract infections (ARTIs) are the most common cause of morbidity and mortality worldwide, with most people experiencing at least one episode per year. Current treatment options are mainly symptomatic therapy. Antivirals, antibiotics, and glucocorticoids are of limited benefit for most infections. Traditional Chinese medicine has shown potential benefits in the treatment of ARTIs. Objective: The objective of this study was to determine the efficacy, effectiveness, and safety of Phragmites communis Trin. (P. communis, a synonym of Phragmites australis (Cav.) Trin. ex Steud) as monotherapy or as part of an herb mixture for ARTIs. Method: Eight databases and two clinical trial registries were searched from inception to 8 February 2023 for randomized controlled trials (RCTs) evaluating any preparation involving P. communis without language restrictions. The Risk of Bias Tool 2.0 was used to assess the risk of bias of the included trials. RevMan 5.3 software was used for data analyses with effects estimated as risk ratios (RRs), mean differences (MDs), or standardized mean differences (SMDs) with 95% confidence intervals (CIs). The online GRADEpro tool was used to assess the certainty of the evidence, if available. Results: Forty-two RCTs involving 6,879 patients with ARTIs were included, with all trials investigating P. communis as part of an herbal mixture. Of the included trials, the majority (38/42) were considered high risk. Compared to the placebo, P. communis preparations improved the cure rate [RR = 1.60, 95% CI (1.13, 2.26)] and fever clearance time [MD = -2.73 h, 95% CI (-4.85, -0.61)]. Compared to usual care alone, P. communis preparations also significantly improved the cure rate [RR = 1.57, 95% CI (1.36, 1.81)] and fever clearance time [SMD = -1.24, 95% CI (-2.37, -0.11)]. P. communis preparations plus usual care compared to usual care alone increased the cure rate [RR = 1.55, 95% CI (1.35, 1.78)], shortened the fever clearance time [MD = -19.31 h, 95% CI (-33.35, -5.27)], and improved FEV1 [ MD = 0.19 L, 95% CI (0.13, 0.26)] and FVC [ MD = 0.16 L, 95% CI (0.03, 0.28)]. Conclusion: Low- or very low-certainty evidence suggests that P. communis preparations may improve the cure rate of ARTIs, shorten the fever clearance time in febrile patients, and improve the pulmonary function of patients with acute exacerbation of chronic obstructive pulmonary disease or chronic bronchitis. However, these findings are inconclusive and need to be confirmed in rigorously designed trials. Systematic review registration: PROSPERO, identifier CRD42021239936.

5.
J Evid Based Med ; 17(1): 54-64, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38465845

ABSTRACT

OBJECTIVE: To evaluate the sole impact of blinding patients and outcome assessors in acupuncture randomized controlled trials (RCTs) on treatment effects while considering the type of outcome measures. METHODS: We searched databases for the meta-analyses on acupuncture with both blinded and non-blinded RCTs. Mixed-effects meta-regression models estimated the average ratio of odds ratios (ROR) and differences in standardized mean differences (dSMD) for non-blinded RCTs versus blinded mixed-effects meta-regression model. RESULTS: The study included 96 meta-analyses (1012 trials). The average ROR for lack of patient blinding was 1.08 (95% confidence intervals 0.79-1.49) in 18 meta-analyses with binary patient-reported outcomes. The average ROR for lack of outcome assessor blinding was 0.98 (0.77-1.24) in 43 meta-analyses with binary subjective outcomes. The average dSMD was -0.38 (-0.96 to 0.20) in 10 meta-analyses with continuous patient-reported outcomes. The average dSMD was -0.13 (-0.45 to 0.18) in 25 meta-analyses with continuous subjective outcomes. The results of the subgroup analysis were consistent with the primary analysis findings. CONCLUSIONS: Blinding of participants and outcome assessors does not significantly influence acupuncture treatment efficacy. It underscores the practical difficulties of blinding in acupuncture RCTs and the necessity to distinguish between trials with and without successful blinding to understand treatment expectations' effects. Enhancing blinding procedures' quality and assessment in future research is crucial for improving RCTs' internal validity and reliability.


Subject(s)
Acupuncture Therapy , Outcome Assessment, Health Care , Humans , Randomized Controlled Trials as Topic , Outcome Assessment, Health Care/methods , Treatment Outcome , Epidemiologic Studies , Acupuncture Therapy/methods
6.
Front Physiol ; 15: 1348028, 2024.
Article in English | MEDLINE | ID: mdl-38444768

ABSTRACT

The objective of this study is to evaluate the effectiveness and safety of ozone therapy (OT) in the treatment of knee osteoarthritis (KOA), which is the most common form of the disease. We analysed systematic reviews (SRs) of randomised controlled trials (RCTs) using the "A MeaSurement Tool to Assess systematic Reviews" (AMSTAR2) instrument to evaluate their quality. We developed a narrative synthesis report with eight SRs (15 RCTs/3,685 patients) to summarise the findings. The AMSTAR2 analysis indicated that all reviews had critically low confidence ratings. Statistically significant effects in pain reduction using OT compared to placebo groups were reported in three SRs. OT was shown to be comparable to other therapies in one SR and not superior in the other five. Six SRs highlighted the need for additional RCTs with improved methodological quality to confirm the efficacy of OT for KOA. SRs found fewer consistent effects for improving joint function. Regarding safety, seven SRs reported a low prevalence of minor adverse events linked with OT. Finally, this umbrella review highlights the beneficial effects and safety of OT in the treatment of KOA, particularly in pain control. The low methodological quality of RCTs and SRs limits the possibility of drawing conclusions on the effectiveness of the procedure in comparison to other therapies. Ensure adequate compliance with guidelines such as Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and AMSTAR2 has the ability to improve the quality of SRs in this area.

7.
Int Arch Allergy Immunol ; 185(6): 545-589, 2024.
Article in English | MEDLINE | ID: mdl-38442688

ABSTRACT

BACKGROUND: This scoping review aims to critically assess gaps in the current literature on atopic dermatitis (AD) by evaluating the overall effectiveness of dietary interventions. Through a comprehensive analysis that follows the Preferred Reporting Item for Systematic Review and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) guidelines, we conducted a thorough search on the Web of Science database in May 2023 using specific search strategies to identify all relevant studies on the research topic. SUMMARY: A total of 104 full-text articles were included for review. Our synthesis identified seven notable categories of dietary interventions for AD, showcasing the diversity of interventions utilized. This includes vitamin supplementation, probiotic and prebiotic supplementation, dietary fat, biological compounds, foods from natural sources, major nutrients, and diet-related approaches. Further analyses stratified by targeted populations revealed a predominant focus on pediatrics, particularly in probiotic supplementation, and on adults, with an emphasis on vitamin D and E supplementation. KEY MESSAGES: Despite most dietary interventions demonstrating overall effectiveness in improving AD severity and its subjective symptoms, several significant gaps were identified. There was a scarcity of studies on adults and whole-diet interventions, a prevalence of short-term interventions, heterogeneity in study outcomes, designs, and population, occasional disparity between statistical significance and clinical relevance, and a lack of a comprehensive multidisciplinary approach. Nonetheless, these findings offer valuable insights for future AD research, guiding additional evidence-driven dietary interventions and informing healthcare professionals, researchers, and individuals, advancing both understanding and management of AD.


Subject(s)
Dermatitis, Atopic , Dietary Supplements , Probiotics , Dermatitis, Atopic/diet therapy , Dermatitis, Atopic/therapy , Humans , Probiotics/therapeutic use , Probiotics/administration & dosage , Diet , Prebiotics/administration & dosage
8.
Complement Ther Clin Pract ; 55: 101841, 2024 May.
Article in English | MEDLINE | ID: mdl-38387324

ABSTRACT

BACKGROUND: Hypnotherapy continues to be a controversial practice in medicine. It is surrounded by myth and misuses that instill doubts about its legitimacy and usefulness. PURPOSE: In this paper, we will distinguish pseudoscientific claims from evidence-based uses of hypnotherapy. RESULTS: The use and acceptability of hypnotherapy has varied over history. Pseudoscientific uses, based on outdated theories that it can access the unconscious mind, have delegitimized hypnotherapy. Modern theories that hypnosis uses common social, emotional, and cognitive processes combined with evidence-based methods have re-established the use of hypnotherapy in many physical and mental health disorders and symptoms. Currently it is a widely accepted and recommended treatment for irritable bowel syndrome, with evidence building for many other applications. CONCLUSION: Hypnotherapy, as a pseudoscience, can become unethical and cause distress for the patient and their families. Hypnotherapy, as an evidence-based treatment, can be used as a powerful tool to treat physical and psychological symptoms related to medical ailments.


Subject(s)
Hypnosis , Irritable Bowel Syndrome , Mental Disorders , Humans , Pseudoscience , Irritable Bowel Syndrome/therapy , Irritable Bowel Syndrome/diagnosis , Irritable Bowel Syndrome/psychology , Emotions
9.
Eur J Investig Health Psychol Educ ; 14(2): 351-367, 2024 Feb 11.
Article in English | MEDLINE | ID: mdl-38391491

ABSTRACT

This study aimed to assess the efficacy of various music therapy interventions in ameliorating depressive symptoms in dementia patients, utilizing a network meta-analysis approach. We rigorously selected randomized controlled trials focused on music therapy for dementia with depressive symptoms from major electronic databases. The primary outcome measured was the impact on depressive symptoms, with the secondary outcome evaluating dropout rates across different intervention groups and standard care control groups. The research protocol has been duly registered with PROSPERO (Registration ID: CRD42023393059). Our network meta-analysis incorporated 14 randomized controlled trials involving a total of 1080 participants and examined a range of interventions, including active music therapy, listening to music, rhythmic music therapy, singing, and tailored music interventions. The analysis revealed that active music therapy combined with singing emerged as the most effective intervention, demonstrating a significant improvement in depressive symptoms in dementia patients (Standardized Mean Difference [SMD] = -0.89, 95% Confidence Interval [CI]: -1.48 to -0.30). In contrast, listening to music alone showed a smaller effect (SMD = -0.26, 95% CI: -0.71 to 0.20). This study was particularly noteworthy for not showing higher dropout rates compared to standard care, indicating its feasibility and acceptability in clinical settings. The findings of our study indicate that active music therapy combined with singing is an effective approach to reducing depressive symptoms in dementia patients, potentially due to enhanced social interaction. These results offer new perspectives for dementia care, suggesting a promising direction for further research and clinical application.

10.
Front Aging Neurosci ; 16: 1333217, 2024.
Article in English | MEDLINE | ID: mdl-38343878

ABSTRACT

Introduction: Nutrition plays a pivotal role in the multidisciplinary approach to rehabilitating middle to old-aged patients with neurological diseases including movement disorders (MDs). Despite the prevalence of vitamin D deficiency in many patients with MDs, data supporting supplementation's effectiveness and safety is sparse and conflicting, therefore, our explicit objective was to provide an all-encompassing review of the subject. Methods: A comprehensive search of PubMed, Embase, and other scientific databases was conducted up to November 1 2023. The searches included RCTs in all languages with human participants aged 35 and above and not meeting these requirements led to exclusion. Results: Four studies on Parkinson's disease (PD) and one on restless legs syndrome (RLS) including 369 MD patients, however, none in a rehabilitation context, were found. Although three of the four PD studies showed better outcomes, such as decreasing levodopa-induced dyskinesia or enhancing physical performance in some or all domains, the RLS study did not identify symptom improvement. The one serious adverse effect observed, cerebral infarction, aroused safety concerns, however its relationship to vitamin D consumption is questionable. Structurally the studies can be characterized by large variations in patient populations, in primary outcomes, and disease severity, but typically a relatively short duration of therapy in most cases. With other limitations such as the small number of studies, major trial design heterogeneity, limited sample sizes, and a greatly variable Cochrane risk of bias (RoB) evaluation, only a qualitative synthesis was feasible. Discussion: Two main implications can be inferred from these results, which we interpret as cautiously promising but overall insufficient for firm recommendations. First, there is an urgent need for more research on the role of vitamin D in MDs in the middle- to older-aged population, particularly during rehabilitation. Second, given the benefits of vitamin D supplementation for those who are deficient, we recommend routine screening and supplementation for MD patients.

11.
BMC Neurol ; 24(1): 55, 2024 Feb 03.
Article in English | MEDLINE | ID: mdl-38308217

ABSTRACT

OBJECTIVE: This study aims to evaluate the efficacy and safety of adjunctive hyperbaric oxygen therapy (HBOT) in acute ischaemic stroke (AIS) based on existing evidence. METHODS: We conducted a comprehensive search through April 15, 2023, of seven major databases for randomized controlled trials (RCTs) comparing adjunctive hyperbaric HBOT with non-HBOT (no HBOT or sham HBOT) treatments for AIS. Data extraction and assessment were independently performed by two researchers. The quality of included studies was evaluated using the tool provided by the Cochrane Collaboration. Meta-analysis was conducted using Rev Man 5.3. RESULTS: A total of 8 studies involving 493 patients were included. The meta-analysis showed no statistically significant differences between HBOT and the control group in terms of NIHSS score (MD = -1.41, 95%CI = -7.41 to 4.58), Barthel index (MD = 8.85, 95%CI = -5.84 to 23.54), TNF-α (MD = -5.78, 95%CI = -19.93 to 8.36), sICAM (MD = -308.47, 95%CI = -844.13 to 13227.19), sVCAM (MD = -122.84, 95%CI = -728.26 to 482.58), sE-selectin (MD = 0.11, 95%CI = -21.86 to 22.08), CRP (MD = -5.76, 95%CI = -15.02 to 3.51), adverse event incidence within ≤ 6 months of follow-up (OR = 0.98, 95%CI = 0.25 to 3.79). However, HBOT showed significant improvement in modified Rankin score (MD = 0.10, 95%CI = 0.03 to 0.17), and adverse event incidence at the end of treatment (OR = 0.42, 95%CI = 0.19 to 0.94) compared to the control group. CONCLUSION: While our findings do not support the routine use of HBOT for improving clinical outcomes in AIS, further research is needed to explore its potential efficacy within specific therapeutic windows and for different cerebral occlusion scenarios. Therefore, the possibility of HBOT offering clinical benefits for AIS cannot be entirely ruled out.


Subject(s)
Hyperbaric Oxygenation , Ischemic Stroke , Humans , Hyperbaric Oxygenation/adverse effects , Ischemic Stroke/etiology
12.
Front Pharmacol ; 15: 1288479, 2024.
Article in English | MEDLINE | ID: mdl-38318135

ABSTRACT

Background: This study aimed to assess the overall reporting quality of randomized controlled trials (RCTs) in Chinese herbal medicine (CHM) formulas for patients with diabetes, and to identify factors associated with better reporting quality. Methods: Four databases including PubMed, Embase, Cochrane Library and Web of Science were systematically searched from their inception to December 2022. The reporting quality was assessed based on the Consolidated Standards of Reporting Trials (CONSORT) statement and its CHM formula extension. The overall CONSORT and its CHM formula extension scores were calculated and expressed as proportions separately. We also analyzed the pre-specified study characteristics and performed exploratory regressions to determine their associations with the reporting quality. Results: Seventy-two RCTs were included. Overall reporting quality (mean adherence) were 53.56% and 45.71% on the CONSORT statement and its CHM formula extension, respectively. The strongest associations with reporting quality based on the CONSORT statement were multiple centers and larger author numbers. Compliance with the CHM formula extension, particularly regarding the disclosure of the targeted traditional Chinese medicine (TCM) pattern (s), was generally insufficient. Conclusion: The reporting quality of RCTs in CHM formulas for diabetes remains unsatisfactory, and the adherence to the CHM formula extension is even poorer. In order to ensure transparent and standardized reporting of RCTs, it is essential to advocate for or even mandate adherence of the CONSORT statement and its CHM formula extension when reporting trials in CHM formulas for diabetes by both authors and editors.

13.
Pharm Biol ; 62(1): 170-182, 2024 Dec.
Article in English | MEDLINE | ID: mdl-38334090

ABSTRACT

CONTEXT: Chinese medicine injections (CMIs) are widely used as adjuvant therapy for cervical cancer in China. However, the effectiveness of different types of CMIs remains uncertain. OBJECTIVE: To assess the effectiveness and safety of CMIs when used in conjunction with radiotherapy (RT) or concurrent chemoradiotherapy (CCRT), particularly in combination with cisplatin (DDP), docetaxel plus cisplatin (DP), and paclitaxel plus cisplatin (TP). MATERIALS AND METHODS: Randomized controlled trials (RCTs) were searched in databases including CNKI, WanFang, VIP, SinoMed, PubMed, Cochrane Library, Embase, and Web of Science from inception to September 2023. We calculated the risk ratio with a 95% confidence interval and the surface under the cumulative ranking area curve (SUCRA) for the clinical efficacy rate (CER), the efficacy rate by Karnofsky Performance Status (KPS), and the rates of leukopenia reduction (LRR) and gastrointestinal reactions (GRR). RESULTS: Forty-seven RCTs were included, including nine CMI types: Aidi, Fufangkushen, Huangqi, Kangai (KA), Kanglaite (KLT), Renshenduotang, Shenqifuzheng (SQFZ), Shenmai (SM), and Yadanzi. KLT and KA were likely optimal choices with radiotherapy for CER and KPS, respectively. KA and KLT were optimal choices with RT + DDP for CER and GRR, respectively. KLT was the likely optimal choice with RT + DP for CER and KA for both KPS and GRR. SM and SQFZ were the likely optimal choices with RT + TP for CER and LRR, respectively. CONCLUSIONS: The optimal recommendation depends on whether CMIs are used with radiotherapy or concurrent chemoradiotherapy. More high-quality RCTs are needed to confirm further and update the existing evidence.


Subject(s)
Drugs, Chinese Herbal , Uterine Cervical Neoplasms , Female , Humans , Cisplatin/adverse effects , Network Meta-Analysis , Uterine Cervical Neoplasms/drug therapy , Medicine, Chinese Traditional , Drugs, Chinese Herbal/adverse effects , Combined Modality Therapy
14.
Soc Work ; 69(2): 158-166, 2024 Mar 19.
Article in English | MEDLINE | ID: mdl-38364292

ABSTRACT

This study aimed to assess the efficacy of a guided online mindfulness-based intervention (iMBI) for community residents experiencing emotional distress during the COVID-19 pandemic in Hong Kong. In a randomized controlled trial, 64 participants were recruited from collaborating community-based mental health service units in Hong Kong and assigned to either the treatment (n = 32) or control (n = 32) groups. The treatment group received a guided iMBI consisting of 16 online modules, weekly telephone counseling, and two half-day online workshops on mindfulness practice. In contrast, the waitlist control group did not receive any intervention during the initial stage. Using a 2 (two groups) × time (pre versus post) repeated measures linear mixed model and one-way analysis of variance, authors demonstrated that the treatment group experienced a significantly larger reduction in anxiety and depressive symptoms with a large effect size compared with the control group. Additionally, the treatment group showed a significantly greater improvement in mindfulness with a moderate effect size. The findings support the effectiveness of guided iMBI for community residents experiencing emotional distress during the COVID-19 pandemic in Hong Kong.


Subject(s)
COVID-19 , Mindfulness , Psychological Distress , Humans , Pandemics , Social Work
15.
J Ethnopharmacol ; 326: 117925, 2024 May 23.
Article in English | MEDLINE | ID: mdl-38395177

ABSTRACT

ETHNOPHARMACOLOGICAL RELEVANCE: Hundreds of randomized controlled trials (RCT) on Chinese herbal drugs (CHDs) including Shexiang baoxin pill (BXP), compound Danshen dripping pill (DSP), compound Danshen tablet (DST), Suxiao jiuxin pill (JXP), Naoxintong capsule (NXT), Tongxinluo capsule (TXL), and Di'ao xinxuekang capsule (XXK) and conventional chemical drugs, such as isosorbide dinitrate (ISDN), for angina pectoris are available but have not been evaluated by a PRISMA-compliant network meta-analysis (NMA). AIM OF THE STUDY: This study aimed to compare the efficacy of nine anti-anginal drugs through NMA on RCTs. METHODS: RCTs of drug treatment for adult patients with angina pectoris for improvements in symptoms and electrocardiography were retrieved. Odds ratios and 95% credible intervals were computed to measure effect sizes. RCT quality was evaluated with the Cochrane risk of bias tool. Evidence synthesis was performed with Bayesian NMA. Essential analyses including subgroup analysis, sensitivity analysis, meta-regression analysis, publication bias analysis, and ranking analysis were conducted to assess the robustness of efficacies. Evidence strength was assessed with the GRADE approach. RESULTS: A total of 331 RCTs with 36,467 participants were eligible. The overall quality of all included RCTs was low. Overall efficacy estimates from different approaches of evidential synthesis found that BXP, TXL, and DSP were more efficacious than DST and ISDN. Essential analyses indicated consistent efficacy estimates, insignificant publication bias, and corroborative ranking results. The overall GRADE evidence strength was low. CONCLUSION: This comprehensive Bayesian NMA found BXP, TXL, and DSP to be the top three candidates among the seven tested CHDs for treating adults suffering from angina pectoris. However, the quality and the evidence strength of eligible RCTs were low. Further high-quality RCTs with more outcome measures and their NMAs are warranted. REGISTRATION: PROSPERO CRD42014007035.


Subject(s)
Drugs, Chinese Herbal , Humans , Angina Pectoris/drug therapy , Drugs, Chinese Herbal/therapeutic use , Isosorbide Dinitrate/therapeutic use , Network Meta-Analysis , Tablets , Treatment Outcome , Adult , Randomized Controlled Trials as Topic
16.
Tech Coloproctol ; 28(1): 37, 2024 Feb 24.
Article in English | MEDLINE | ID: mdl-38401006

ABSTRACT

BACKGROUND: Sacral nerve neuromodulation (SNM) has been considered the optimal second-line treatment for fecal incontinence (FI). However, SNM involves high cost and requires highly skilled operators. Percutaneous tibial nerve stimulation (PTNS) has emerged as an alternative treatment modality for FI, yielding varying clinical outcomes. We conducted this meta-analysis to evaluate the effectiveness and safety of PTNS compared to sham electrical stimulation for FI. METHODS: PubMed, Embase, Web of Science, and the Cochrane Library were searched for studies from May 12, 2012 to May 12, 2022. RESULTS: Four randomized controlled studies were included in this review, involving a total of 439 adult patients with FI (300 in the PTNS group and 194 in the sham electrical stimulation group). Our meta-analysis revealed that PTNS demonstrated superior efficacy in reducing weekly episodes of FI compared to the control groups (MD - 1.6, 95% CI - 2.94 to - 0.26, p = 0.02, I2 = 30%). Furthermore, a greater proportion of patients in the PTNS group reported more than a 50% reduction in FI episodes per week (RR 0.73, 95% CI 0.57-0.94, p = 0.02, I2 = 6%). However, no significant differences were observed in any domains of the FI Quality of Life (QoL) and St Mark's incontinence scores (MD - 2.41, 95% CI - 5.1 to 0.27, p = 0.08, I2 = 67%). Importantly, no severe adverse events related to PTNS were reported in any of the participants. CONCLUSIONS: Our meta-analysis revealed that PTNS was more effective than sham stimulation in reducing FI episodes and led to a higher proportion of patients reporting more than a 50% reduction in weekly FI episodes.


Subject(s)
Fecal Incontinence , Randomized Controlled Trials as Topic , Tibial Nerve , Transcutaneous Electric Nerve Stimulation , Humans , Fecal Incontinence/therapy , Transcutaneous Electric Nerve Stimulation/methods , Transcutaneous Electric Nerve Stimulation/adverse effects , Treatment Outcome , Adult , Female , Middle Aged , Male , Quality of Life , Aged
17.
Front Endocrinol (Lausanne) ; 15: 1327623, 2024.
Article in English | MEDLINE | ID: mdl-38362274

ABSTRACT

Background: Elderly people are at high risk of falls due to decreased muscle strength. So far, there is currently no officially approved medication for treating muscle strength loss. The active vitamin D analogues are promising but inconsistent results have been reported in previous studies. The present study was to meta-analyze the effect of active vitamin D analogues on muscle strength and falls in elderly people. Methods: The protocol was registered with PROSPERO (record number: CRD42021266978). We searched two databases including PubMed and Cochrane Library up until August 2023. Risk ratio (RR) and standardized mean difference (SMD) with 95% confidence intervals (95% CI) were used to assess the effects of active vitamin D analogues on muscle strength or falls. Results: Regarding the effects of calcitriol (n= 1), alfacalcidol (n= 1) and eldecalcitol (n= 1) on falls, all included randomized controlled trials (RCT) recruited 771 participants. Regarding the effects of the effects of calcitriol (n= 4), alfacalcidol (n= 3) and eldecalcitol (n= 3) on muscle strength, all included RCTs recruited 2431 participants. The results showed that in the pooled analysis of three active vitamin D analogues, active vitamin D analogues reduced the risk of fall by 19%. Due to a lack of sufficient data, no separate subgroup analysis was conducted on the effect of each active vitamin D analogue on falls. In the pooled and separate analysis of active vitamin D analogues, no significant effects were found on global muscle, hand grip, and back extensor strength. However, a significant enhancement of quadriceps strength was observed in the pooled analysis and separate analysis of alfacalcidol and eldecalcitol. The separate subgroup analysis on the impact of calcitriol on the quadriceps strength was not performed due to the lack to sufficient data. The results of pooled and separate subgroup analysis of active vitamin D analogues with or without calcium supplementation showed that calcium supplementation did not affect the effect of vitamin D on muscle strength. Conclusions: The use of active vitamin D analogues does not improve global muscle, hand grip, and back extensor strength but improves quadriceps strength and reduces risk of falls in elderly population.


Subject(s)
Accidental Falls , Muscle Strength , Vitamin D , Humans , Accidental Falls/prevention & control , Muscle Strength/drug effects , Aged , Vitamin D/analogs & derivatives , Vitamin D/pharmacology , Hydroxycholecalciferols/therapeutic use , Hydroxycholecalciferols/pharmacology , Calcitriol/analogs & derivatives , Calcitriol/pharmacology , Randomized Controlled Trials as Topic
18.
Complement Ther Med ; 80: 103023, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38232905

ABSTRACT

BACKGROUND: Systematic reviews suggest that animal-assisted therapy (AAT) and pet-robot interventions (PRI) achieve a reduction in mental health variables such as depressive symptoms. However, these systematic reviews include both randomised and non-randomised studies, which prevents an adequate assessment of the effect of confounding variables. OBJECTIVE: This systematic review and meta-analysis aimed to evaluate the comparative effectiveness of AAT and PRI through randomized controlled trials (RCTs) in reducing depression in older adults. METHODS: Our study is a systematic review. We searched three databases of scientific articles: SCOPUS, Web of Science and PubMed. We included studies that their population was older adults, aged 65 years or older, with or without a clinical condition, clinical diagnosis based on mental examination/test or documentation from medical records, accredited by the facilities' staff. We included trials in which the comparator was a passive intervention or an active intervention. We used the Cochrane risk-of-bias tool for randomised trials (RoB 2) to assess the risk of bias for each study. Our study was registered in PROSPERO (CRD42023393740). RESULTS: Twenty-three studies were included in this systematic review. However, only 19 trials were included in the meta-analysis. At the overall risk of bias level, 78.9% of the studies were at high risk of bias (n = 15). We found that AAT (g= -0.72; 95%CI -1.13 to -0.31; p = 0.001) has a moderate and statistically significant effect as an intervention to reduce depressive symptoms in older adults. However, the PRIs do not show a significant effect on reducing depressive symptoms in older adults. In addition, a sub-analysis based on dog-assisted therapy (g= -0.65; 95%CI -1.21 to -0.08; p = 0.025), a specific type of AAT, showed a modest effect on reducing depressive symptoms. CONCLUSIONS: Our study concluded that AAT and DAT had a moderate and statistically significant effect as interventions to reduce depressive symptoms in older adults. On the other hand, PRI did not show a significant effect in reducing depressive symptoms.


Subject(s)
Animal Assisted Therapy , Robotics , Humans , Animals , Dogs , Aged , Depression/therapy , Mental Health
19.
Am J Health Promot ; 38(4): 560-575, 2024 05.
Article in English | MEDLINE | ID: mdl-38205783

ABSTRACT

OBJECTIVE: To review mindfulness-based interventions (MBIs) tested in randomized controlled trials (RCT) across the cancer continuum. DATA SOURCE: Articles identified in PubMed, CINAHL, Web of Science, PsycINFO, and Embase. STUDY INCLUSION AND EXCLUSION CRITERIA: Two independent reviewers screened articles for: (1) topic relevance; (2) RCT study design; (3) mindfulness activity; (4) text availability; (5) country (United States); and (6) mindfulness as the primary intervention component. DATA EXTRACTION: Twenty-eight RCTs met the inclusion criteria. Data was extracted on the following variables: publication year, population, study arms, cancer site, stage of cancer continuum, participant demographic characteristics, mindfulness definition, mindfulness measures, mindfulness delivery, and behavioral theory. DATA SYNTHESIS: We used descriptive statistics and preliminary content analysis to characterize the data and identify emerging themes. RESULTS: A definition of mindfulness was reported in 46% of studies and 43% measured mindfulness. Almost all MBIs were tested in survivorship (50%) or treatment (46%) stages of the cancer continuum. Breast cancer was the focus of 73% of cancer-site specific studies, and most participants were non-Hispanic white females. CONCLUSION: The scoping review identified 5 themes: (1) inconsistency in defining mindfulness; (2) differences in measuring mindfulness; (3) underrepresentation of racial/ethnic minorities; (4) underrepresentation of males and cancer sites other than breast; and (5) the lack of behavioral theory in the design, implementation, and evaluation of the MBI.


Subject(s)
Breast Neoplasms , Mindfulness , Text Messaging , Male , Female , Humans , United States , Research Design
20.
Eur J Pediatr ; 183(4): 1475-1483, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38206398

ABSTRACT

Vitamin D deficiency is associated with obesity and its associated metabolic disorders, as specified in many epidemiological studies. The assertion that vitamin D can mitigate insulin insensitivity in obese children and adolescents lacks adequate empirical substantiation. Thus, the study utilized some clinical trials on vitamin D interventions to examine the impact of vitamin D supplementation on insulin resistance in obese children and adolescents. The literature was extracted by applying the PRISMA method through electronic databases such as Scopus, Science Direct, Medline, the Cochrane Library, and PubMed from 2012 to 2022. All the articles were in English, and the inclusion criteria for each article were based on the study design and the anthropometric and biochemical parameters of the subjects. A total of 572 research articles were acquired, out of which only seven closely adhered to the inclusion criteria of the study. The studies in this systematic review are based on randomized control trials. The age range of the children in this study spans from 2 to 19 years, and the follow-up period ranges from 3 to 12 months. The range of daily vitamin D doses provided varied from 2000 to 10,000 IU. The results indicate that four randomized controlled trials have demonstrated a positive impact on glycemic parameters, such as insulin levels, fasting blood sugar, and insulin resistance, in the subjects following vitamin D treatment. However, the three trials did not provide sufficient evidence to support a statistically significant effect. CONCLUSION: The present review highlights that a significant proportion of the studies incorporated in the analysis demonstrate that the administration of vitamin D may be a preventive measure in ameliorating insulin resistance among pediatric patients with obesity, but it is advisable to implement a prolonged intervention with a substantial sample size and perform micro-level analysis at the gene level to evaluate the impact of vitamin D treatment. WHAT IS KNOWN: • Childhood obesity and its associated metabolic disorder is a concerned global problem. • Several studies showed an association of vitamin D deficiency with adiposity- induced metabolicdisorders which are still controversial. This study focused on finding interlink between vitamin Dsupplementation with obesity induced insulin resistance in children and adolescents. WHAT IS NEW: • This study supports that high dosage of Vitamin D in long term may be protective against insulinresistance in obese paediatric individuals. • A new factor is also reported in the study that vitamin D may alter the composition of gut microbiotawhich represents a compelling approach to the therapeutic management of obesity and diabetes.


Subject(s)
Glucose Intolerance , Insulin Resistance , Insulins , Pediatric Obesity , Vitamin D Deficiency , Adolescent , Child , Humans , Infant , Glucose Intolerance/complications , Pediatric Obesity/complications , Vitamin D , Vitamin D Deficiency/complications , Vitamin D Deficiency/drug therapy , Vitamins/therapeutic use
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