Displaying publications 61 - 80 of 504 in total

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  1. Mohammad Farris Iman Leong Abdullah, Mohd Afifuddin Mohamad
    MyJurnal
    This narrative review present and critically appraise the evidence of psychosocial interventions in enhancing post- traumatic growth (PTG) and spirituality in cancer patients and survivors. A comprehensive search of published En- glish language literatures which include both quantitative and qualitative studies was conducted via Google Scholar, PubMed, Medline, PsycINFO, EMBASE, Cochrane Library, Scopus and Web of Science up to September 2018. Out of an initial 17,000 articles, 10 studies were finally included in the review. There were three randomized controlled trials, two non-randomized comparison trials, three time series/pre and post-intervention designs, one mixed design study and one qualitative study which demonstrated psychosocial interventions enhanced PTG and spirituality in cancer patients and survivors. We concluded mindfulness-based interventions may be promising to enhance PTG and spirituality in cancer patients and survivors. On the contrary, evidence for psycho-spiritual therapy, cancer sup- port group, health behavioural change intervention and individual psychotherapy were lacking and poor.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  2. Pheh KS, Tan KA, Ibrahim N, Sidik SM
    PMID: 33573341 DOI: 10.3390/ijerph18031257
    Attention-deficit/hyperactivity disorder (ADHD), a common neurodevelopmental disorder, often persists into adulthood. In Malaysia, the prevalence rate of hyperactivity symptoms is highest among Chinese Malaysians. There are limited evidence-based treatment options targeting the core symptoms of ADHD, as well as executive functioning. In addition, conventional psychotherapeutic approaches for adults with ADHD have been found to be highly labor-intensive. The present study will evaluate the effectiveness of an online mindfulness-based intervention to reduce inattention and hyperactivity-impulsivity and improve executive functioning among Chinese Malaysian college emerging adults with ADHD. Informed by established literature, we will design an 8-week online mindfulness-based intervention (i.e., iMBI). We will conduct a two-arm randomized controlled trial comparing an iMBI plus treatment-as-usual group (n = 54) and an enhanced treatment-as-usual control group (n = 54). Outcome measures of inattention, hyperactivity-impulsivity, and executive functioning will be collected at baseline, immediately post-intervention, and 1-month post-intervention. The findings of the present study will not only demonstrate the implementation of iMBI as a new treatment modality but also inform practitioners on the effectiveness of iMBI in reducing the burden of adults living with ADHD.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  3. Destiani DP, Naja S, Dewi S, Rahmadi AR, Sulaiman SAS, Abdulah R
    Osteoporos Int, 2021 May;32(5):805-816.
    PMID: 33210179 DOI: 10.1007/s00198-020-05743-z
    Even though new drugs for the treatment of rheumatoid arthritis (RA) have been developed, methotrexate (MTX) remains a commonly used drug for RA management. In addition to monitoring disease activity during RA treatment, bone erosion should be closely assessed throughout long-term RA management. In this review article, we present a systematic review of MTX effectiveness in reducing the risk of bone erosion. We reviewed randomized controlled trial studies that involved MTX monotherapy or MTX in combination with placebo. Evaluation of the progression of bone erosion was examined by radiographic assessment such as total Sharp score (TSS) or van der Heijde score (SvdH or vdH TSS), joint space narrowing (JSN), erosion score (ERO), and proportion of radiographic nonprogressors. Several key factors were found to influence the response to MTX treatment, such as gene polymorphism. The exact mechanism of the prevention of bone erosion by MTX remains unclear, which warrants future investigations. The variability of RA disease activity in study subjects resulted in variations in the results reported by individual studies. Collective analysis suggests that MTX could slow down the progression of bone erosion based on a radiographic score of less than 0.5-1/year.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  4. Nath S, Pulikkotil SJ, Dharmarajan L, Arunachalam M, Jing KT
    Dent Res J (Isfahan), 2020 08 14;17(4):235-243.
    PMID: 33282148
    Background: Scaling and root planing (SRP) for the treatment of periodontitis may be less effective in some patients. This study evaluated the effectiveness of local doxycycline as an adjunct to SRP among smokers with periodontitis compared to SRP alone in randomized controlled trials (RCTs).

    Materials and Methods: For this systematic review and meta-analysis, PubMed and Scopus databases were searched till November 2018 for English publications. RCTs that compared the effect of local doxycycline adjunct to SRP among smokers with periodontitis were selected. Patient characteristics, disease characteristics, and outcome data on clinical attachment level (CAL) and periodontal probing depth at 1, 3- and 6-month follow-up was extracted. Quality of selected studies was assessed by the revised Cochrane Risk of Bias 2.0 tool. Random effects model and trial sequential analysis were performed. GRADE approach was used to assess the quality of evidence. P > 0.05 was considered as statistically significant.

    Results: Five trials were included in the review. Local use of doxycycline as an adjunct to SRP was effective in gain of 1.1 mm (0.47-1.74, P = 0.091) in CAL at 6 months calculated from two studies. The evidence was of low quality, and at least a total of 866 patients are required for conclusiveness.

    Conclusion: Local doxycycline as an adjunct to SRP significantly improved clinical attachment in smokers with periodontitis and can be recommended. Studies are required with long-term follow-up and patient-related outcome data.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  5. Nagendrababu V, Duncan HF, Bjørndal L, Kvist T, Priya E, Pulikkotil SJ, et al.
    Int Endod J, 2019 Jul;52(7):974-978.
    PMID: 30702139 DOI: 10.1111/iej.13087
    Randomized clinical trials are acknowledged as the most appropriate methodology for demonstrating the efficacy or effectiveness of one intervention as opposed to another and thus play a major role in clinical decision-making. However, it is recognized that despite the existence of various guidelines, for example, the Consolidated Standards for Reporting Trials (CONSORT) statement, the quality of manuscripts describing randomized trials is often suboptimal. The current project aims to develop and disseminate new guidelines, Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE), to improve the planning and reporting quality of randomized trials in the field of Endodontics. The project leads (VN, PD) designed a robust process to develop the PRIRATE guidelines. At first, a steering committee of eight members, including the project leads, was formed. Thereafter, a five-stage consensus process will be followed: initial steps, pre-meeting activities, face-to-face consensus meeting, post-meeting activities and post-publication activities. The steering committee will develop the first draft of the PRIRATE guidelines by identifying relevant and important items from various sources including the CONSORT guidelines and the Clinical and Laboratory Images in Publications (CLIP) principles. This will be followed by the establishment of a PRIRATE Delphi Group (PDG) consisting of 30 members. The individual items of the first draft of the PRIRATE guidelines developed by the steering committee will be evaluated and scored on a 9-point Likert scale by the PDG members. Items with a score of seven and above by more than 70% of PDG members will be included in the second draft of the guidelines, and the Delphi process will be repeated until each item fulfils the set conditions. After obtaining consensus from the PDG, the PRIRATE guidelines will be discussed by 20 selected individuals within a PRIRATE Face-to-face Consensus Meeting Group (PFCMG) to arrive at a final consensus. The final PRIRATE guidelines will be accompanied with an explanation and elaboration document developed by the steering committee and approved by six members, three from the PDG and three from the PFCMG. The PRIRATE guidelines will be published in journals and actively disseminated to educational institutions, national and international academic societies and presented at scientific meetings. The steering committee will periodically revise and update the PRIRATE guidelines based on feedback from stakeholders.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  6. Ahmad P, Dummer PMH, Chaudhry A, Rashid U, Saif S, Asif JA
    Int Endod J, 2019 Sep;52(9):1297-1316.
    PMID: 31009099 DOI: 10.1111/iej.13131
    AIM: To identify and analyse the main features of the top 100 most-cited randomized controlled trials, systematic reviews and meta-analyses published in endodontic journals from 1961 to 2018.

    METHODOLOGY: The Clarivate Analytics' Web of Science 'All Databases' was used to search and analyse the 100 most frequently cited randomized controlled trials, systematic reviews and meta-analyses having 'randomized', 'randomised', 'randomized controlled', 'randomised controlled', 'randomized controlled trial', 'randomized controlled trials', 'clinical trial', 'systematic', 'systematic review', 'meta-analysis', and 'meta-analyses' in the title section. The 'International Endodontic Journal', 'Journal of Endodontics', 'Oral Surgery Oral Medicine Oral Pathology Oral Radiology and Endodontology', 'Australian Endodontic Journal', 'Endodontics & Dental Traumatology', 'Endo-Endodontic Practice Today' and 'European Endodontic Journal' were included in the publication name section. After ranking the articles in a descending order based on their citation counts, each article was cross-matched with the citation counts in Elsevier's Scopus and Google Scholar. The articles were analysed, and information on citation counts, citation density, year of publication, contributing authors, institutions and countries, journal of publication, study design, topic of the article and keywords was extracted.

    RESULTS: The citation counts of the 100 most-cited articles varied from 235 to 20 (Web of Science), 276 to 17 (Scopus) and 696 to 1 (Google Scholar). The year in which the top 100 articles were published was 2010 (n = 13). Among 373 authors, the greatest number of articles was associated with three individuals namely Reader A (n = 5), Beck M (n = 5) and Kvist T (n = 5). Most of the articles originated from the United States (n = 24) with the greatest contribution from Ohio State University (USA) (n = 5). Randomized controlled trials were the most frequent study design (n = 45) followed by systematic reviews (n = 30) with outcome studies of root canal treatment being the major topic (n = 35). The Journal of Endodontics published the largest number of included articles (n = 70) followed by the International Endodontic Journal (n = 27). Among 259 unique keywords, meta-analysis (n = 23) and systematic review (n = 23) were the most frequently used.

    CONCLUSION: This study has revealed that year of publication had no obvious impact on citation count. The bibliometric analysis highlighted the quantity and quality of research, and the evolution of scientific advancements made in the field of Endodontology over time. Articles before 1996, that is prior to the CONSORT statement that encouraged authors to include specific terms in the title and keywords, may not have been included in this electronic search.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  7. Li Y, Ren J, Li N, Liu J, Tan SC, Low TY, et al.
    Exp Gerontol, 2020 11;141:111110.
    PMID: 33045358 DOI: 10.1016/j.exger.2020.111110
    BACKGROUND: Dehydroepiandrosterone (DHEA) has been aggressively sold as a dietary supplement to boost testosterone levels although the impact of DHEA supplementation on testosterone levels has not been fully established. Therefore, we performed a systematic review and meta-analysis of RCTs to investigate the effect of oral DHEA supplementation on testosterone levels.

    METHODS: A systematic literature search was performed in Scopus, Embase, Web of Science, and PubMed databases up to February 2020 for RCTs that investigated the effect of DHEA supplementation on testosterone levels. The estimated effect of the data was calculated using the weighted mean difference (WMD). Subgroup analysis was performed to identify the source of heterogeneity among studies.

    RESULTS: Overall results from 42 publications (comprising 55 arms) demonstrated that testosterone level was significantly increased after DHEA administration (WMD: 28.02 ng/dl, 95% CI: 21.44-34.60, p = 0.00). Subgroup analyses revealed that DHEA increased testosterone level in all subgroups, but the magnitude of increment was higher in females compared to men (WMD: 30.98 ng/dl vs. 21.36 ng/dl); DHEA dosage of ˃50 mg/d compared to ≤50 mg/d (WMD: 57.96 ng/dl vs. 19.43 ng/dl); intervention duration of ≤12 weeks compared to ˃12 weeks (WMD: 44.64 ng/dl vs. 19 ng/dl); healthy participants compared to postmenopausal women, pregnant women, non-healthy participants and androgen-deficient patients (WMD: 52.17 ng/dl vs. 25.04 ng/dl, 16.44 ng/dl and 16.47 ng/dl); and participants below 60 years old compared to above 60 years old (WMD: 31.42 ng/dl vs. 23.93 ng/dl).

    CONCLUSION: DHEA supplementation is effective for increasing testosterone levels, although the magnitude varies among different subgroups. More study needed on pregnant women and miscarriage.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  8. Xie M, Zhong Y, Xue Q, Wu M, Deng X, O Santos H, et al.
    Exp Gerontol, 2020 07 15;136:110949.
    PMID: 32304719 DOI: 10.1016/j.exger.2020.110949
    BACKGROUND AND AIM: Inconsistencies exist with regard to the influence of dehydroepiandrosterone (DHEA) supplementation on insulin-like growth factor 1 (IGF-1) levels. The inconsistencies could be attributed to several factors, such as dosage, gender, and duration of intervention, among others. To address these inconsistencies, we conducted a systematic review and meta-analysis to combine findings from randomized controlled trials (RCTs) on this topic.

    METHODS: Electronic databases (Scopus, PubMed/Medline, Web of Science, Embase and Google Scholar) were searched for relevant literature published up to February 2020.

    RESULTS: Twenty-four qualified trials were included in this meta-analysis. It was found that serum IGF-1 levels were significantly increased in the DHEA group compared to the control (weighted mean differences (WMD): 16.36 ng/ml, 95% CI: 8.99, 23.74; p = .000). Subgroup analysis revealed that a statistically significant increase in serum IGF-1 levels was found only in women (WMD: 23.30 ng/ml, 95% CI: 13.75, 32.87); in participants who supplemented 50 mg/d DHEA (WMD: 15.75 ng/ml, 95% CI: 7.61, 23.89); in participants undergoing DHEA intervention for >12 weeks (WMD: 17.2 ng/ml, 95% CI: 8.02, 26.22); in participants without an underlying comorbidity (WMD: 19.11 ng/ml, 95% CI: 10.69, 27.53); and in participants over the age of 60 years (WMD: 19.79 ng/ml, 95% CI: 9.86, 29.72).

    CONCLUSION: DHEA supplementation may increase serum IGF-I levels especially in women and older subjects. However, further studies are warranted before DHEA can be recommended for clinical use.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  9. Alhabeeb H, Kord-Varkaneh H, Tan SC, Găman MA, Otayf BY, Qadri AA, et al.
    PMID: 33356450 DOI: 10.1080/10408398.2020.1863905
    BACKGROUND: Inconsistencies exist with regard to the influence of omega-3 supplementation on 25-hydroxyvitamin D (25(OH)D) levels, which could be attributed to many factors, such as the duration and dose of omega-3 supplementation, and individuals' baseline 25(OH)D levels. Therefore, to address the inconsistencies, we conducted a systematic review and dose-response meta-analysis to accurately determine the effect of omega-3 supplementation on 25(OH)D levels in humans.

    METHODS: We performed a comprehensive literature search in Web of Science, PubMed/Medline, Scopus, and Embase databases from inception up to January 2020. We included only randomized controlled trials (RCTs). We used weighted mean difference (WMD) with 95% confidence interval (CI) to assess the influence of omega-3 supplementation on serum 25(OH)D levels using the random-effects model.

    RESULTS: Our pooled results of 10 RCTs demonstrated an overall significant increase in 25(OH)D levels following omega-3 intake (WMD = 3.77 ng/ml, 95% CI: 1.29, 6.25). In addition, 25(OH)D levels were significantly increased when the intervention duration lasted >8 weeks and when the baseline serum 25(OH)D level was ˂20 ng/ml. Moreover, omega-3 intake ≤1000 mg/day resulted in higher 25(OH)D levels compared to omega-3 intake >1000 mg/day.

    CONCLUSION: In conclusion, omega-3 supplementation increased 25(OH)D concentrations, particularly with dosages ≤1000 mg/day and intervention durations >8 weeks.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  10. Xia W, Tang N, Kord-Varkaneh H, Low TY, Tan SC, Wu X, et al.
    Pharmacol Res, 2021 01;163:105167.
    PMID: 32860944 DOI: 10.1016/j.phrs.2020.105167
    Matched MeSH terms: Randomized Controlled Trials as Topic
  11. Alhadidi MM, Lim Abdullah K, Yoong TL, Al Hadid L, Danaee M
    Int J Soc Psychiatry, 2020 09;66(6):542-552.
    PMID: 32507073 DOI: 10.1177/0020764020919475
    BACKGROUND: Schizophrenia is one of the most complicated psychiatric disorders, and, although medication therapy continues to be the core treatment for schizophrenia, there is a need for psychotherapy that helps in providing patients comprehensive mental health care. Psychoeducation is one of the most recognized psychosocial interventions specific to schizophrenia. Further knowledge about the impact of this type of intervention on patients diagnosed with schizophrenia needs to be acquired.

    AIM: This review aimed to explore the effects of psychoeducational interventions on improving outcome measures for patients diagnosed with schizophrenia.

    METHODS: The Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guideline was used in this systematic review. Two reviewers were involved in screening articles for inclusion and in the data extraction process. The selected studies were assessed for quality using the 'Consolidated Standards of Reporting Trial (CONSORT)' checklist. Out of the 441 records identified, 11 papers were considered for full review (from 2000 to 2018).

    RESULTS: The psychoeducational interventions showed a consistent improvement in many outcome measures. Most of the reviewed studies focused on outpatients and the method of delivering the psychoeducational interventions was mostly in lecture format.

    CONCLUSION: This systematic review of randomized controlled trial studies emphasizes the positive impact of psychoeducational interventions for patients diagnosed with schizophrenia concerning various outcome measures. The findings of this review have important implications for both nursing practice and research, as the information presented can be used by the administrators and stakeholders of mental health facilities to increase their understanding and awareness of the importance of integrating psychoeducational interventions in the routine care of patients diagnosed with schizophrenia.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  12. Mohammadi S, Su TT, Jalaludin MY, Dahlui M, Azmi Mohamed MN, Papadaki A, et al.
    Front Public Health, 2020;8:549637.
    PMID: 33072694 DOI: 10.3389/fpubh.2020.549637
    Introduction: School environments can influence students' dietary habits. Hence, implementing a healthy canteen intervention programme in schools is a recommended strategy to improve students' dietary intake. This study will evaluate the feasibility of providing healthier food and beverage options in selected secondary schools in Malaysia by working with canteen vendors. It also will assess the changes in food choices before and after the intervention. Methods: A feasibility cluster randomised controlled study will be conducted in six secondary schools (intervention, n = 4; control, n = 2) comprising of rural and urban schools located in Selangor and Perak states in Malaysia. Four weeks of intervention will be conducted among Malaysian adolescents aged 15 years old. Two interventions are proposed that will focus on providing healthier food options in the canteen and convenience shops in the selected schools. Interventions 1 and 2 will entail training the canteen and school convenience shop operators. Intervention 2 will be applied to subsidise the cost of low energy-dense kuih (traditional cake), vegetables, and fruits. The control group will continue to sell the usual food. Trained dietitians will audit the canteen menu and food items sold by the school canteen and convenience shops in all schools. Anthropometric measurements, blood pressure and dietary assessment will be collected at baseline and at the end of 4-week intervention. Focus group discussions with students and in-depth interviews with headmasters, teachers, and school canteen operators will be conducted post-intervention to explore intervention acceptability. Under this Healthy School Canteen programme, school canteens will be prohibited from selling "red flag" foods. This refers to foods which are energy-dense and not nutritious, such as confectionery and deep-fried foods. They will also be prohibited from selling soft drinks, which are sugar-rich. Instead, the canteens will be encouraged to sell "green flag" food and drinks, such as fruits and vegetables. Conclusion: It is anticipated that this feasibility study can provide a framework for the conception and implementation of nutritional interventions in a future definitive trial at the school canteens in Malaysia.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  13. Muneswarao J, Hassali MA, Ibrahim B, Saini B, Hyder Ali IA, Rehman AU, et al.
    J Allergy Clin Immunol Pract, 2020 10;8(9):3036-3055.
    PMID: 32502547 DOI: 10.1016/j.jaip.2020.05.032
    BACKGROUND: The effectiveness of home visits is well discussed for children with asthma, but limited in adults.

    OBJECTIVE: The present systematic review aimed to investigate the potential role of home visits in improving outcomes among adult patients with asthma.

    METHODS: The systematic review was performed in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. An extensive literature search was conducted using databases such as PubMed, ProQuest, CINAHL, The Cochrane Library, PsycINFO, and Google Scholar from inception to June 2019. The studies included were randomized controlled trials, which reported asthma outcomes in adult patients.

    RESULTS: The literature search yielded 8331 publications, of which 63 studies were selected for full-text review, and of these studies, 9 studies with a total of 2011 patients were included in the final analysis. The included randomized controlled trials reported quality of life, asthma symptoms, exacerbations, health care utilization, and pulmonary function. Improvements in asthma outcomes were observed predominantly in quality of life. The effects on asthma symptom control were inconsistent. The evidence on the impact of home visits in asthma exacerbations and health care utilization was rather limited. There were no significant differences observed between intervention versus control arms in terms of pulmonary function; however, 1 study reported significant improvements in peak expiratory flow rate.

    CONCLUSIONS: Home visits may serve as an adjuvant activity that complements the existing health care system-based initiatives. It may be concluded that home visits have the potential to improve outcomes in adult patients with asthma; however, the randomized controlled trials reviewed in the present systematic review reported several limitations that warrant further investigation.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  14. Kua KP, Lee DSWH
    Rev Environ Health, 2021 Sep 27;36(3):297-307.
    PMID: 33544536 DOI: 10.1515/reveh-2020-0169
    OBJECTIVES: Poor housing conditions have been associated with increased risks of respiratory infections. This review aims to determine whether modifying the physical environment of the home has benefits in reducing respiratory infections.

    CONTENT: We performed a systematic review and meta-analysis of the effectiveness of home environmental interventions for preventing respiratory tract infections. Ten electronic databases were searched to identify randomized controlled trials published from inception to July 31, 2020. Random-effects meta-analyses were used to assess the study outcomes. Our search identified 14 eligible studies across 12 countries, which comprised 87,428 households in total. The type of interventions on home environment included kitchen appliance and design, water supply and sanitation, house insulation, and home heating. Meta-analysis indicated a potential benefit of home environmental interventions in preventing overall respiratory tract infections (Absolute RR=0.89, 95% CI=0.78-1.01, p=0.07; Pooled adjusted RR=0.72, 95% CI=0.63-0.84, p<0.0001). Subgroup analyses depicted that home environmental interventions had no significant impact on lower respiratory tract infections, pneumonia, and severe pneumonia. A protective effect against respiratory infections was observed in high income country setting (RR=0.82, 95% CI=0.78-0.87, p<0.00001).

    SUMMARY AND OUTLOOK: Home environmental interventions have the potential to reduce morbidity of respiratory tract infections. The lack of significant impact from stand-alone housing interventions suggests that multicomponent interventions should be implemented in tandem with high-quality health systems.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  15. Ashraf S, Ashraf S, Akmal R, Ashraf M, Kalsoom L, Maqsood A, et al.
    Trials, 2021 Sep 15;22(1):618.
    PMID: 34526081 DOI: 10.1186/s13063-021-05510-3
    OBJECTIVES: Considering the therapeutic potential of honey and Nigella sativa (HNS) in coronavirus disease 2019 (COVID-19) patients, the objective of the study is defined to evaluate the prophylactic role of HNS.

    TRIAL DESIGN: The study is a randomized, placebo-controlled, adaptive clinical trial with parallel group design, superiority framework with an allocation ratio of 1:1 among experimental (HNS) and placebo group. An interim analysis will be done when half of the patients have been recruited to evaluate the need to adapt sample size, efficacy, and futility of the trial.

    PARTICIPANTS: All asymptomatic patients with hospital or community based COVID-19 exposure will be screened if they have had 4 days exposure to a confirmed case. Non-pregnant adults with significant exposure level will be enrolled in the study High-risk exposure (<6 feet distance for >10min without face protection) Moderate exposure (<6 feet distance for >10min with face protection) Subjects with acute or chronic infection, COVID-19 vaccinated, and allergy to HNS will be excluded from the study. Recruitment will be done at Shaikh Zayed Post-Graduate Medical Institute, Ali Clinic and Doctors Lounge in Lahore (Pakistan).

    INTERVENTION AND COMPARATOR: In this clinical study, patients will receive either raw natural honey (0.5 g) and encapsulated organic Nigella sativa seeds (40 mg) per kg body weight per day or empty capsule with and 30 ml of 5% dextrose water as a placebo for 14 days. Both the natural products will be certified for standardization by Government College University (Botany department). Furthermore, each patient will be given standard care therapy according to version 3.0 of the COVID-19 clinical management guidelines by the Ministry of National Health Services of Pakistan.

    MAIN OUTCOMES: Primary outcome will be Incidence of COVID-19 cases within 14 days of randomisation. Secondary endpoints include incidence of COVID-19-related symptoms, hospitalizations, and deaths along with the severity of COVID-19-related symptoms till 14th day of randomization.

    RANDOMISATION: Participants will be randomized into experimental and control groups (1:1 allocation ratio) via the lottery method. There will be stratification based on high risk and moderate risk exposure.

    BLINDING (MASKING): Quadruple blinding will be ensured for the participants, care providers and outcome accessors. Data analysts will also be blinded to avoid conflict of interest. Site principal investigator will be responsible for ensuring masking.

    NUMBERS TO BE RANDOMISED (SAMPLE SIZE): 1000 participants will be enrolled in the study with 1:1 allocation.

    TRIAL STATUS: The final protocol version 1.4 was approved by institutional review board of Shaikh Zayed Post-Graduate Medical Complex on February 15, 2021. The trial recruitment was started on March 05, 2021, with a trial completion date of February 15, 2022.

    TRIAL REGISTRATION: Clinical trial was registered on February 23, 2021, www.clinicaltrials.gov with registration ID NCT04767087 .

    FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). With the intention of expediting dissemination of this trial, the conventional formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  16. Tan TK, Ng KT, Lim HJ, Radic R
    J Orthop Surg (Hong Kong), 2021 5 25;29(2):23094990211017352.
    PMID: 34027721 DOI: 10.1177/23094990211017352
    PURPOSE: Perioperative blood loss remains a major challenge to surgeons in anterior cruciate ligament reconstruction (ACLR) surgery, despite of the introduction of minimally invasive approach. Tranexamic acid (TXA) is believed to reduce blood loss, which may minimise the complication of postoperative haemarthrosis with insufficient evidence on its effectiveness in ACLR. The primary aim of this study was to examine the effect of TXA on postoperative blood loss and other secondary outcomes in patients undergoing arthroscopic ACLR surgery.

    METHOD: PUBMED, EMBASE, MEDLINE and CENTRAL database were systematically searched from its inception until November 2020. All randomised clinical trials (RCTs) comparing TXA (intravenous or intra-articular) versus placebo in the arthroscopic ACLR surgery were included. Case series, case report and editorials were excluded.

    RESULTS: Five RCTs comprising of a total of 580 patients (291 in TXA group, 289 in control group) were included for qualitative and quantitative meta-analysis. In comparison to placebo, TXA group was significantly associated with lower postoperative blood loss (mean difference (MD): -81.93 ml; 95% CI -141.80 to -22.05) and lower incidence of needing knee aspiration (odd ratio (OR): 0.19; 95% CI 0.08 to 0.44). Patients who randomised to TXA were also reported to have better range of movement (MD: 2.86; 95% CI 0.54 to 5.18), lower VAS Pain Score (MD: -1.39; 95% CI -2.54 to -0.25) and higher Lysholm Score (MD: 7.38; 95% CI 2.75 to 12.01).

    CONCLUSION: In this meta-analysis, TXA reduced postoperative blood loss with lesser incidence of needing knee aspiration along with better range of knee movement and Lysholm score in patients undergoing arthroscopic ACLR surgery.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  17. Sawangjit R, Puttarak P, Saokaew S, Chaiyakunapruk N
    Phytother Res, 2017 Apr;31(4):555-567.
    PMID: 28165166 DOI: 10.1002/ptr.5783
    Cissus quadrangularis L. (Cissus) is a medicinal plant commonly used for centuries for various conditions, but lacks critical appraisal of its clinical effects. This study aimed to determine the efficacy and safety of Cissus in all conditions. Publications from 12 electronic databases were searched from inception through November 2016. A total of nine studies with 1108 patients were included. Each outcome was pooled using a random effects model. Effects of Cissus on hemorrhoid symptoms were not different from any comparators but had significant effects on bone pain. Effects of Cissus combination products on body weight reduction, low-density lipoprotein, triglyceride, total cholesterol, and fasting blood sugar were superior to placebo, with weighted mean difference of -5.19 kg (-8.82, -1.55), -14.43 mg/dl (-20.06, -8.80), -37.50 mg/dl (-48.71, -26.29), -50.50 mg/dl (-70.97, -30.04), and -10.39 mg/dl (-14.60, -6.18), respectively. No serious adverse effects were reported. Quality of evidence based on Grades of Recommendations Assessment Development and Evaluation (GRADE) indicated low (bone fractures) to high quality (hemorrhoids, body weight reduction).In conclusion, Cissus had benefit for bone fractures, but not for hemorrhoids. For obesity/overweight, only combination products are pooled and show benefit. However, high-quality studies remain needed. Copyright © 2017 John Wiley & Sons, Ltd.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  18. Yahaya Mohammed Katagum, Hayati Kadir @ Shahar, Faisal Ibrahim
    MyJurnal
    Poor diagnosis, treatment and prevention practices had characterised Patent Medicine Vendor (PMV) activities in malaria control despite expectations on their contributions to check the menace. Interventions reversing this situation reduces disease burden and legitimise PMV inclusion in basic healthcare delivery. This study seeks to identify and review studies addressing this priority problem. Steps outlined in PRISMA guidelines were adopted to search and conduct reviews via electronic databases. Randomized trials with intervention effects on PMVs were considered and thirteen articles were ultimately reviewed and narratively evaluated. Analysis of search outputs identified intervention types, methods used, sample sizes, intervention periods, knowledge, attitude and practice variables, other outcomes and listing of priority systematic review topics, using pre-determined criteria. All reviewed studies were found to be effective despite adopting different intervention approaches. Furthermore, identifying and prioritizing reviews greatly improves future malaria interventions and results thereof, thereby maximising opportunities to deliver appropriate and evidence-based healthcare.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  19. Naing C, Whittaker MA, Htet NH, Aye SN, Mak JW
    PLoS One, 2019;14(12):e0225882.
    PMID: 31856172 DOI: 10.1371/journal.pone.0225882
    BACKGROUND: The WHO recommends artemisinin-based combination therapies (ACTs) for the treatment of uncomplicated falciparum malaria. Hence, monitoring the efficacy of antimalarial drugs is a key component of malaria control and elimination. The published randomized trials that assessed comparisons of ACTs for treating uncomplicated falciparum malaria reported conflicting results in treatment efficacy. A network meta-analysis is an extension of pairwise meta-analysis that can synthesize evidence simultaneously from both direct and indirect treatment comparisons. The objective was to synthesize evidence on the comparative efficacy of antimalarial drugs for treatment of uncomplicated falciparum malaria in Asian region.

    METHODS: Relevant randomized trials that assessed efficacy of antimalarial drugs for patients having uncomplicated falciparum malaria in Asian region were searched in health-related databases. We evaluated the methodological quality of the included studies with the Cochrane risk of bias tool. Main outcome was treatment success at day 28 as determined by the absence of parasiteamia. We performed network meta-analysis of the interventions in the trials, and assessed the overall quality of evidence using the GRADE approach.

    RESULTS: Seventeen randomized trials (n = 5043) were included in this network meta-analysis study. A network geometry was formed with 14 antimalarial treatment options such as artemether-lumefantrine (AL), artemisinin-piperaquine, artesunate-amodiaquine, artesunate-mefloquine (ASMQ), artesunate-chloroquine, artesunate-mefloquine home treatment, artesunate-mefloquine 2-day course, artesunate plus sulfadoxine-pyrimethamine, chloroquine, dihydroartemisinin-piperaquine (DHP), dihydroartemisinin-piperaquine home treatment, dihydroartemisinin-piperaquine 4-day course, dihydroartemisinin-piperaquine and added artesunate, sulfadoxine-pyrimethamine. A maximum number of trials included was DHP compared to ASMQ (n = 5). In general, DHP had better efficacy than AL at day 28 (DHP vs AL: OR 2.5, 95%CI:1.08-5.8). There is low certainty evidence due to limited number of studies and small trials.

    DISCUSSION/ CONCLUSIONS: The findings suggest the superiority of DHP (3-day course) to AL and other comparator ACTs are with the overall low/very low quality of evidence judgements. Moreover, one drug regimen is better than another is only if current drug-resistance patterns are at play. For example, the AL might be better than DHP in areas where both artemisinin and piperaquine resistance patterns are prevalent. For substantiation, well-designed larger trials from endemic countries are needed. In the light of benefit versus harm concept, future analysis with safety information is recommended.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  20. Pierot L, Jarayaman M, Szikora I, Hirsch J, Baxter B, Miyachi S, et al.
    Can J Neurol Sci, 2019 05;46(3):269-274.
    PMID: 30890199 DOI: 10.1017/cjn.2019.1
    After five positive randomized controlled trials showed benefit of mechanical thrombectomy in the management of acute ischemic stroke with emergent large-vessel occlusion, a multi-society meeting was organized during the 17th Congress of the World Federation of Interventional and Therapeutic Neuroradiology in October 2017 in Budapest, Hungary. This multi-society meeting was dedicated to establish standards of practice in acute ischemic stroke intervention aiming for a consensus on the minimum requirements for centers providing such treatment. In an ideal situation, all patients would be treated at a center offering a full spectrum of neuroendovascular care (a level 1 center). However, for geographical reasons, some patients are unable to reach such a center in a reasonable period of time. With this in mind, the group paid special attention to define recommendations on the prerequisites of organizing stroke centers providing medical thrombectomy for acute ischemic stroke, but not for other neurovascular diseases (level 2 centers). Finally, some centers will have a stroke unit and offer intravenous thrombolysis, but not any endovascular stroke therapy (level 3 centers). Together, these level 1, 2, and 3 centers form a complete stroke system of care. The multi-society group provides recommendations and a framework for the development of medical thrombectomy services worldwide.
    Matched MeSH terms: Randomized Controlled Trials as Topic
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