Displaying publications 1 - 20 of 466 in total

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  1. Bernhardt J, Lindley RI, Lalor E, Ellery F, Chamberlain J, Van Holsteyn J, et al.
    BMJ, 2015 Dec 11;351:h6432.
    PMID: 26658193 DOI: 10.1136/bmj.h6432
    OBJECTIVE: To report the number of participants needed to recruit per baby born to trial staff during AVERT, a large international trial on acute stroke, and to describe trial management consequences.

    DESIGN: Retrospective observational analysis.

    SETTING: 56 acute stroke hospitals in eight countries.

    PARTICIPANTS: 1074 trial physiotherapists, nurses, and other clinicians.

    OUTCOME MEASURES: Number of babies born during trial recruitment per trial participant recruited.

    RESULTS: With 198 site recruitment years and 2104 patients recruited during AVERT, 120 babies were born to trial staff. Births led to an estimated 10% loss in time to achieve recruitment. Parental leave was linked to six trial site closures. The number of participants needed to recruit per baby born was 17.5 (95% confidence interval 14.7 to 21.0); additional trial costs associated with each birth were estimated at 5736 Australian dollars on average.

    CONCLUSION: The staff absences registered in AVERT owing to parental leave led to delayed trial recruitment and increased costs, and should be considered by trial investigators when planning research and estimating budgets. However, the celebration of new life became a highlight of the annual AVERT collaborators' meetings and helped maintain a cohesive collaborative group.

    TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry no 12606000185561.

    DISCLAIMER: Participation in a rehabilitation trial does not guarantee successful reproductive activity.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  2. Van Rostenberghe H, Ho JJ, Lim CH, Abd Hamid IJ
    Cochrane Database Syst Rev, 2020 07 01;7:CD012011.
    PMID: 32609375 DOI: 10.1002/14651858.CD012011.pub2
    BACKGROUND: Phototherapy is a well-established effective therapy for treating babies with significant neonatal jaundice. Studies have shown that increasing light intensity will increase its efficiency. A potentially inexpensive and easy way of increasing the intensity of light on the body of the infant may be to hang reflective materials from the sides of phototherapy units.

    OBJECTIVES: To assess the effects of reflective materials in combination with phototherapy compared with phototherapy alone for unconjugated hyperbilirubinaemia in neonates.

    SEARCH METHODS: We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 11), in the Cochrane Library; Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions(R); and the Cumulative Index of Nursing and Allied Health Literature (CINAHL), on 1 November 2019. We also searched clinical trials databases and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.

    SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials if the participants, who were term or preterm infants, received phototherapy with curtains made of reflective materials of any type in the treatment arm, and if those in the comparison arm received similar phototherapy without curtains or other intensified phototherapy, such as a double bank of lights.

    DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. We used the GRADE approach to assess the certainty of evidence.

    MAIN RESULTS: Of 15 studies identified, we included 12 (1288 babies) in the review - 11 comparing phototherapy with reflective materials and phototherapy alone, and one comparing a single phototherapy light bank with reflective materials with double phototherapy. All reflective materials consisted of curtains on three or four sides of the cot and were made of white plastic (five studies), white linen (two studies), or aluminium (three studies); materials were not specified in two studies. Only 11 studies (10 comparing reflective materials versus none and one comparing reflective curtains and a single bank of lights with a double (above and below) phototherapy unit) provided sufficient data to be included in the meta-analysis. Two excluded studies used the reflective materials in a way that did not meet our inclusion criteria, and we excluded one study because it compared four different phototherapy interventions not including reflective materials. The risk of bias of included studies was generally low, but all studies had high risk of performance bias due to lack of blinding of the intervention. Three studies (281 participants) reported a decline in serum bilirubin (SB) (μmol/L) at four to eight hours (mean difference (MD) -14.61, 95% confidence interval (CI) -19.80 to -9.42; I² = 57%; moderate-certainty evidence). Nine studies (893 participants) reported a decline in SB over 24 hours and showed a faster decline in SB in the intervention group, but heterogeneity (I² = 97%) was too substantial to permit a meaningful estimate of the actual effect size (very low-certainty evidence). Subgroup analysis by type of reflective material used did not explain the heterogeneity. Exchange transfusion was reported by two studies; both reported none in either group. Four studies (466 participants) reported the mean duration of phototherapy, and in each of these studies, it was reduced in the intervention group but there was substantial heterogeneity (I² = 88%), precluding meaningful meta-analysis of data. The only two studies that reported the mean duration of hospital stay in hours showed a meaningful reduction (MD -41.08, 95% CI -45.92 to -36.25; I² = 0; moderate-certainty evidence). No studies reported costs of the intervention, parental or medical staff satisfaction, breastfeeding outcomes, or neurodevelopmental follow-up. The only study that compared use of curtains with double phototherapy reported similar results for both groups. Studies that monitored adverse events did not report increased adverse events related to the use of curtains, including acute life-threatening events, but other rarer side effects could not be excluded.

    AUTHORS' CONCLUSIONS: Moderate-certainty evidence shows that the use of reflective curtains during phototherapy may result in greater decline in SB. Very low-certainty evidence suggests that the duration of phototherapy is reduced, and moderate-certainty evidence shows that the duration of hospital stay is also reduced. Available evidence does not show any increase in adverse events, but further studies are needed.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  3. Pui Kei C, Mohd Nordin NA, Abdul Aziz AF
    Medicine (Baltimore), 2020 Nov 20;99(47):e23296.
    PMID: 33217861 DOI: 10.1097/MD.0000000000023296
    INTRODUCTION: Stroke survivors are commonly at risk of functional decline following discharge from rehabilitation, which increase their susceptibility to falls, dependency in activities of daily living and emotional disturbances. To combat these, continued therapy is important. Home-based therapy (HBT) has been shown to be useful in maintaining functional performance and quality of life of chronic stroke survivors. However, evidence on its effectiveness remains limited, while no studies are available to date which report the benefit of HBT on stroke survivors self-efficacy and emotional status. Therefore, this study aims to assess the effectiveness of post-discharge HBT in comparison to usual practice on functional outcome (mobility and gait speed), self-efficacy and anxiety level among stroke survivors.

    METHODS: This is an assessor-blinded randomized control trial comparing 2 types of intervention which are HBT (experimental group) and usual practice (UP) (control group). Based on sample size calculation using GPower, a total number of 42 participants will be recruited and allocated into either the HBT or the UP group. Participants in HBT group will receive a set of structured exercise therapy consisting of progressive strengthening, balance and task-related exercises. While participants in UP group will receive a usual "intervention" practised by rehabilitation professional prior to discharging stroke patients from their care. Both groups are advised to perform the given interventions for 3 times per week for 12 weeks under the supervision of their caregiver. Outcomes of interventions will be measured using timed up and go test (for mobility), ten-meter walk test (for gait speed), stroke self-efficacy questionnaire (for self-efficacy) and hospital anxiety and depression scale (for anxiety level). All data will be analyzed using descriptive and inferential statistics.

    DISCUSSION: This study will provide the information on the effectiveness of HBT in comparison to UP among stroke population who are discharged from rehabilitation. Findings from the study will enable rehabilitation professionals to design effective discharge care plan for stroke survivors in combating functional decline when no longer receiving hospital-based therapy.

    TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12619001182189 (last updated 22/11/2019).

    Matched MeSH terms: Randomized Controlled Trials as Topic/methods*
  4. Johar MN, Mohd Nordin NA, Abdul Aziz AF
    Medicine (Baltimore), 2022 Jan 14;101(2):e28580.
    PMID: 35029235 DOI: 10.1097/MD.0000000000028580
    INTRODUCTION: Stroke survivors are commonly at risk of functional decline, which increase their dependency in activities of daily living and eventually affects their motivation level, self-efficacy, and quality of life. Circuit exercise has been shown to be useful in enhancing functional performance and quality of life of chronic stroke survivors. There is a need to review the existing "usual circuit exercise" and develop a better approach, such as game-based circuit exercise. Training in enriched and fun environment may possibly further promote neuroplasticity. However, evidence on inducing fun element in the existing circuit exercise among stroke survivors is limited. Also, no studies are available to date which report the benefit of circuit exercise on stroke survivors' self-efficacy and motivation level. Therefore, this study aims to assess the effectiveness of game-based circuit exercise in comparison to conventional circuit exercise on functional outcome (lower limb strength, postural stability and aerobic endurance), motivation level, self-efficacy and quality of life among stroke survivors. This study also aims to assess whether the outcomes gained from the 2 interventions could be sustained at week 12 and 24 post-trial.

    METHODS: This is an assessor-blinded randomized control trial comparing 2 types of intervention which are game-based circuit exercise (experimental group) and conventional circuit exercise (control group). Based on sample size calculation using GPower, a total number of 82 participants will be recruited and allocated into either the experimental or the control group. Participants in the experimental group will receive a set of structured game-based exercise therapy which has the components of resistance, dynamic balance and aerobic exercises. While participants in the control group will receive a conventional circuit exercise as usually conducted by physiotherapists consisting of 6 exercise stations; cycling, repeated sit to stand, upper limb exercise, lower limb exercise, stepping up/down and walking over obstacles. Both groups will perform the given interventions for 2 times per week for 12 weeks under the supervision of 2 physiotherapists. Outcomes of the interventions will be measured using 30-second chair rise test (for lower limb strength), Dynamic Gait Index (for postural stability), 6-minute walk test (aerobic capacity), Intrinsic Motivation Inventory questionnaire (for motivation level), stroke self-efficacy questionnaire (for self-efficacy) and Short Form-36 quality of life questionnaire (for quality of life). All data will be analyzed using descriptive and inferential statistics.

    DISCUSSION: This study will provide the information regarding the effectiveness of including game elements into circuit exercise training. Findings from this study will enable physiotherapists to design more innovative exercise therapy sessions to promote neuroplasticity and enhance functionality and quality of life among stroke survivors under their care.

    TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN 12621001489886 (last updated 1/11/2021).

    Matched MeSH terms: Randomized Controlled Trials as Topic
  5. Khor BH, Tiong HC, Tan SC, Wong SK, Chin KY, Karupaiah T, et al.
    PLoS One, 2021;16(7):e0255205.
    PMID: 34297765 DOI: 10.1371/journal.pone.0255205
    Studies investigating the effects of tocotrienols on inflammation and oxidative stress have yielded inconsistent results. This systematic review and meta-analysis aimed to evaluate the effects of tocotrienols supplementation on inflammatory and oxidative stress biomarkers. We searched PubMed, Scopus, and Cochrane Central Register of Controlled Trials from inception until 13 July 2020 to identify randomized controlled trials supplementing tocotrienols and reporting circulating inflammatory or oxidative stress outcomes. Weighted mean difference (WMD) and corresponding 95% confidence interval (CI) were determined by pooling eligible studies. Nineteen studies were included for qualitative analysis, and 13 studies were included for the meta-analyses. A significant reduction in C-reactive protein levels (WMD: -0.52 mg/L, 95% CI: -0.73, -0.32, p < 0.001) following tocotrienols supplementation was observed, but this finding was attributed to a single study using δ-tocotrienols, not mixed tocotrienols. There were no effects on interleukin-6 (WMD: 0.03 pg/mL, 95% CI: -1.51, 1.58, p = 0.966), tumor necrosis factor-alpha (WMD: -0.28 pg/mL, 95% CI: -1.24, 0.68, p = 0.571), and malondialdehyde (WMD: -0.42 μmol/L, 95% CI: -1.05, 0.21, p = 0.189). A subgroup analysis suggested that tocotrienols at 400 mg/day might reduce malondialdehyde levels (WMD: -0.90 μmol/L, 95% CI: -1.20, -0.59, p < 0.001). Future well-designed studies are warranted to confirm the effects of tocotrienols on inflammatory and oxidative stress biomarkers, particularly on different types and dosages of supplementation. PROSPERO registration number: CRD42020198241.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  6. Li S, Shaharudin S, Abdul Kadir MR
    Am J Phys Med Rehabil, 2021 Apr 01;100(4):337-344.
    PMID: 33727516 DOI: 10.1097/PHM.0000000000001567
    BACKGROUND: Due to the pain caused by knee injuries, low-load resistance training with blood flow restriction (L-BFR) may be a potential adjuvant therapeutic tool in the rehabilitation of knee injuries. This review aimed to analyze the effectiveness of L-BFR training modality in knee rehabilitation.

    DESIGN: A meta-analysis was conducted to determine the potential impact of blood flow restriction on patients with knee injuries. PubMed, EBSCO, and Web of Science databases were searched for eligible studies from January 2000 until January 2020. The mean differences of the data were analyzed using Revman 5.3 software with a 95% confidence interval.

    RESULTS: Nine studies fulfilled the inclusion criteria. These studies involved 179 patients who received L-BFR, 96 patients who underwent high-load resistance training, and another 94 patients who underwent low-load resistance training. The analysis of pooled data showed that patients in both the L-BFR (standardized mean difference, 0.83 [0.53, 1.14], P < 0.01) and high-load resistance training (standardized mean difference, -0.09 [-0.43, 0.24], P = 0.58) groups experienced an increase in muscle strength after the training. In addition, pain score was significantly reduced in the L-BFR group compared with the other two groups (standardized mean difference, -0.61 [-1.19, -0.03], P = 0.04).

    CONCLUSIONS: Muscle strength increased after L-BFR and high-load resistance training compared with low-load resistance training. Furthermore, pain score was significantly reduced after L-BFR. Hence, L-BFR is a potential intervention to be applied in rehabilitation of knee injuries.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  7. Maarof NNN, Alsalahi A, Abdulmalek E, Fakurazi S, Tejo BA, Abdul Rahman MB
    Cancers (Basel), 2021 Feb 08;13(4).
    PMID: 33567737 DOI: 10.3390/cancers13040688
    Several randomized controlled trials (RCTs) evaluated the afatinib efficacy in patients with advanced non-small cell lung cancer (NSCLC) and recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). This review systemically outlined and meta-analyzed the afatinib efficacy in NSCLC and R/M HNSCC in terms of overall survival (OS) and progression-free survival (PFS) endpoints. Records were retrieved from PubMed, Web of Science, and ScienceDirect from 2011 to 2020. Eight afatinib RCTs were included and assessed for the risk of bias. In meta-analysis, overall pooled effect size (ES) of OS in afatinib group (AG) significantly improved in all RCTs and NSCLC-RCTs [hazard ratios (HRs): 0.89 (95% CI: 0.81-0.98, p = 0.02); I2 = 0%, p = 0.71/ 0.86 (95% CI: 0.76-0.97; p = 0.02); I2 = 0%, p = 0.50, respectively]. ES of PFS in AG significantly improved in all RCTs, NSCLC-RCTs, and HNSCC-RCTs [HRs: 0.75 (95% CI: 0.68-0.83; p < 0.00001); I2 = 26%, p = 0.24; 0.75 (95% CI: 0.66-0.84; p < 0.00001); I2 = 47%, p = 0.15/0.76 (95% CI: 0.65-88; p = 0.0004); I2 = 34%, p = 0.0004, respectively]. From a clinical viewpoint of severity, interstitial lung disease, dyspnea, pneumonia, acute renal failure, and renal injury were rarely incident adverse events in the afatinib group. In conclusion, first- and second-line afatinib monotherapy improved the survival of patients with NSCLC, while second-line afatinib monotherapy could be promising for R/M HNSCC. The prospective protocol is in PROSPERO (ID = CRD42020204547).
    Matched MeSH terms: Randomized Controlled Trials as Topic
  8. Cheah KL, Norhayati MN, Husniati Yaacob L, Abdul Rahman R
    PLoS One, 2021;16(9):e0257843.
    PMID: 34559859 DOI: 10.1371/journal.pone.0257843
    OBJECTIVE: To determine the effect of Ashwagandha extract on sleep.

    METHODS: A comprehensive search was conducted in CENTRAL, MEDLINE, SCOPUS, Google Scholars, World Health Organization Trials Portal, ClinicalTrials.gov, Clinical Trial Registry of India, and AYUSH Research Portal for all appropriate trials. Randomized controlled trials that examined the effect of Ashwagandha extract versus placebo on sleep in human participants 18 years old and above were considered. Two authors independently read all trials and independently extracted all relevant data. The primary outcomes were sleep quantity and sleep quality. The secondary outcomes were mental alertness on rising, anxiety level, and quality of life.

    RESULTS: A total of five randomized controlled trials containing 400 participants were analyzed. Ashwagandha extract exhibited a small but significant effect on overall sleep (Standardized Mean Difference -0.59; 95% Confidence Interval -0.75 to -0.42; I2 =  62%). The effects on sleep were more prominent in the subgroup of adults diagnosed with insomnia, treatment dosage ≥600 mg/day, and treatment duration ≥8 weeks. Ashwagandha extract was also found to improve mental alertness on rising and anxiety level, but no significant effect on quality of life. No serious side effects were reported.

    CONCLUSION: Ashwagandha extract appears to has a beneficial effect in improving sleep in adults. However, data on the serious adverse effects of Ashwagandha extract are limited, and more safety data would be needed to assess whether it would be safe for long-term use.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  9. Aziz Z, Abdul Rasool Hassan B
    Burns, 2017 Feb;43(1):50-57.
    PMID: 27576926 DOI: 10.1016/j.burns.2016.07.004
    Evidence from animal studies and trials suggests that honey may accelerate wound healing. The objective of this review was to assess the effects of honey compared with silver dressings on the healing of burn wounds. Relevant databases for randomized controlled trials (RCTs) of honey compared with silver sulfadiazine (SSD) were searched. The quality of the selected trials was assessed using the Cochrane Risk of Bias Assessment Tool. The primary endpoints considered were wound healing time and the number of infected wounds rendered sterile. Nine RCTs met the inclusion criteria. Based on moderate quality evidence there was a statistically significant difference between the two groups, favoring honey in healing time (MD -5.76days, 95% CI -8.14 to -3.39) and the proportions of infected wounds rendered sterile (RR 2.59; 95% CI 1.58-2.88). The available evidence suggests that honey dressings promote better wound healing than silver sulfadiazine for burns.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  10. Yap E, Law ZK, Aslan Abdullah NM, Abdul Wahid SF
    EXCLI J, 2017;16:1233-1248.
    PMID: 29285019 DOI: 10.17179/excli2017-805
    Patients with advanced aggressive B-cell non-Hodgkin lymphomas (NHL) are usually treated with rituximab in combination with chemotherapy. However, disease relapse rates are high. Radiotherapy (RT) has been shown to be efficacious in treating early-stage NHL but its role in advanced stage diseases is unclear. We performed a systematic review of randomized controlled trials (RCTs) comparing chemotherapy with RT to chemotherapy alone in patients with newly diagnosed advanced aggressive NHL. We searched online databases and pooled similar outcome estimates. For time-to-event outcomes, we estimated hazard ratios (HR) for overall survival (OS) and event-free survival (EFS) using the fixed-effect model. Two RCTs involving 254 patients met inclusion criteria. The trials were single-centre RCTs with follow-up period of five and ten years. Both trials were conducted in the pre-rituximab era. Patients treated with consolidation RT had better OS (HR for mortality 0.61; 95 % CI 0.38 to 0.97) and EFS (HR for mortality 0.67; 95 % CI 0.46 to 0.98) compared to those who received no RT. There was an apparent benefit of RT on local control (OR 0.09; 95 % CI 0.04 to 0.20); although this was estimated as a dichotomous rather than time-to-event outcome. Limited evidence shows benefits of consolidation RT in advanced aggressive NHL. However, we were not able to estimate the effect size with confidence due to small number of trials and sample size. We cannot recommend routine consolidation RT in advanced aggressive NHL. More RCTs with the inclusion of rituximab and PET-CT monitoring are needed.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  11. 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
  12. Loh PS, Yeong CH, Masohood NS, Sulaiman N, Zaki RA, Fabell K, et al.
    Sci Rep, 2021 01 27;11(1):2299.
    PMID: 33504909 DOI: 10.1038/s41598-021-81913-1
    Microwave ablation (MWA) is gaining popularity for the treatment of small primary hepatocellular carcinoma and metastatic lesions especially if patients are not candidates for surgical resection. Deep neuromuscular blockade (DMB) is perceived to improve surgical working conditions compared to moderate neuromuscular blockade (MMB) but no studies have examined the same benefits in MWA of liver tumours. This study aimed to compare the clinical outcomes of DMB and MMB in MWA of liver tumours in terms of liver excursion, performance scores by the interventional radiologists and patients, requirements of additional muscle relaxants and complications. 50 patients were recruited and 45 patients (22 in MMB group, 23 in DMB group) completed the study. The mean liver excursion for the MMB group (1.42 ± 1.83 mm) was significantly higher than the DMB group (0.26 ± 0.38 mm) (p = 0.001). The mean Leiden-Surgical Rating Scale (L-SRS) rated by the two interventional radiologists were 4.5 ± 0.59 and 3.6 ± 0.85 for the DMB and MMB groups, respectively (p = 0.01). There was also statistically significant difference on patient satisfaction scores (0-10: Extremely Dissatisfied-Extremely Satisfied) between DMB (8.74 ± 1.1) and MMB (7.86 ± 1.25) groups (p = 0.01). 5 patients from MMB group and none from DMB group required bolus relaxant during the MWA procedure. Adverse events were also noted to be more severe in the MMB group. In conclusion, DMB significantly reduced liver excursion and movement leading to improved accuracy, safety and success in ablating liver tumour.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  13. Kundakci B, Kaur J, Goh SL, Hall M, Doherty M, Zhang W, et al.
    Pain, 2022 Aug 01;163(8):1432-1445.
    PMID: 34813518 DOI: 10.1097/j.pain.0000000000002500
    Fibromyalgia is a highly heterogeneous condition, but the most common symptoms are widespread pain, fatigue, poor sleep, and low mood. Nonpharmacological interventions are recommended as first-line treatment of fibromyalgia. However which interventions are effective for the different symptoms is not well understood. The objective of this study was to assess the efficacy of nonpharmacological interventions on symptoms and disease-specific quality of life. Seven databases were searched from their inception until June 1, 2020. Randomised controlled trials comparing any nonpharmacological intervention to usual care, waiting list, or placebo in people with fibromyalgia aged >16 years were included without language restriction. Fibromyalgia Impact Questionnaire (FIQ) was the primary outcome measure. Standardised mean difference and 95% confidence interval were calculated using random effects model. The risk of bias was evaluated using the modified Cochrane tool. Of the 16,251 studies identified, 167 randomised controlled trials (n = 11,012) assessing 22 nonpharmacological interventions were included. Exercise, psychological treatments, multidisciplinary modality, balneotherapy, and massage improved FIQ. Subgroup analysis of different exercise interventions found that all forms of exercise improved pain (effect size [ES] -0.72 to -0.96) and depression (ES -0.35 to -1.22) except for flexibility exercise. Mind-body and strengthening exercises improved fatigue (ES -0.77 to -1.00), whereas aerobic and strengthening exercises improved sleep (ES -0.74 to -1.33). Psychological treatments including cognitive behavioural therapy and mindfulness improved FIQ, pain, sleep, and depression (ES -0.35 to -0.55) but not fatigue. The findings of this study suggest that nonpharmacological interventions for fibromyalgia should be individualised according to the predominant symptom.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  14. 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
  15. Khani Jeihooni A, Jormand H, Saadat N, Hatami M, Abdul Manaf R, Afzali Harsini P
    BMC Cardiovasc Disord, 2021 Dec 07;21(1):589.
    PMID: 34876014 DOI: 10.1186/s12872-021-02399-3
    BACKGROUND: Nutritional factors have been identified as preventable risk factors for cardiovascular disease; this study aimed to investigate the application of the Theory of Planned Behavior (TPB) in nutritional behaviors related to cardiovascular diseases among the women in Fasa city, Fars province, Iran.

    METHODS: The study was conducted in two stages. First, the factors affecting nutritional behaviors associated with cardiovascular disease on 350 women who were referred to Fasa urban health centers were determined based on the TPB. In the second stage, based on the results of a cross-sectional study, quasi-expeimental study was performed on 200 women covered by Fasa health centers. The questionnaire used for the study was a questionnaire based on TPB. The questionnaire was completed by the experimental and control groups before and three months after the intervention. Data were analyzed by SPSS software using logistic regression, paired t-test, independent sample t-test, and chi-square test. The level of significance is considered 0.05.

    RESULT: The constructs of attitude, subjective norms, and perceived behavioral control (PBC) were predictors of nutritional behaviors associated with cardiovascular disease in women. The constructs predicted 41.6% of the behavior. The results showed that mean scores of attitude, subjective norms, PBC, intention, nutritional performance related to the cardiovascular disease before intervention were, respectively, 24.32, 14.20, 18.10, 13.37 and 16.28, and after the intervention, were, respectively, 42.32, 25.40, 33.72, 30.13 and 41.38. All the constructs except the attitude in the intervention group were significantly higher (p 

    Matched MeSH terms: Non-Randomized Controlled Trials as Topic
  16. Nalliah S, Wg P, Masten Singh PK, Naidu P, Lim V, Ahamed AA
    Aust Fam Physician, 2017 Mar;46(3):139-144.
    PMID: 28260277
    BACKGROUND: Overactive bladder syndrome (OAB) is a common medical condition that causes significant distress and impact on the quality of life in women. Muscarinic receptor antagonists remain the mainstay of therapy, but they are limited by their efficacy and adverse effects. The objective of the article was to compare the clinical efficacy and tolerability of medications used to treat OAB in women through network meta-analysis.

    METHODS: Data from eligible studies of commonly prescribed pharmacological agents in the treatment of OAB in women were entered into Net-MetaXL after a literature search using two online databases (PubMed and Cochrane). Studies between 31 July 2000 and 31 July 2015 were included in this study.

    RESULTS: Five quantitative studies were eligible for analysis. The most efficacious drug to treat OAB in women appears to be solifenacin 10 mg once daily (OD), followed by oxybutynin 3 mg three times a day. However, solifenacin 10 mg OD caused more adverse effects that the other treatments.

    DISCUSSION: Our results are similar to those of another systematic review. When considering efficacy, tolerability and cost, solifenacin 5 mg once daily is the drug of choice as it is more efficacious, albeit with more adverse effects, than other treatments. If solifenacin is unsuitable, oxybutynin 3 mg TDS is recommended.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  17. Ismail NA, Hashim HA, Ahmad Yusof H
    Games Health J, 2022 Feb;11(1):1-17.
    PMID: 34851732 DOI: 10.1089/g4h.2021.0104
    Recently, exergames have been widely applied as exercise platforms among older adults. However, studies on the influence of exergames on older adults' physical activity remain scarce. The review article highlights the potential benefit of exergames as a physical activity tool for older adults. The literature search followed the PRISMA guidelines on databases PubMed (Public/Publisher MEDLINE), CINAHL (Cumulative Index to Nursing and Allied Health Literature), Cochrane, and Scopus. The literature included studies that evaluated the influence of exergames on older adults' physical activity. Articles were excluded if the mixed intervention was used, emphasizing specific limbs, improving specific tasks, or not mentioning intervention. The review article identified 25 studies that reported on 855 older adults 55 years of age and older. In addition, the common exergaming technology platforms examined were Microsoft Kinect™, Nintendo® Wii™, cybercycling, and interactive video dance games. Meanwhile, 11 studies used a pretest/post-test design and randomized controlled trial design in 14 studies. The review found that exergames significantly impacted the older adults' physical activity level as participants experienced improved balance and cognitive function, and enjoyed playing exergame, thus prolonging their game engagement. Although research on exergames is still new, current evidence showed a significant potential benefit of exergames as a physical activity tool for older adults. To overcome the limitation on various parameters that showed different effects and outcomes of exergames, the study recommends implementing randomized controlled trials with long-term observation using a mixed-method approach. Moreover, a multidisciplinary method involving exercise and neuromotor control experts could determine potential mechanisms of action that benefited from the exercises.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  18. Al-Awadi A, Grove J, Taylor M, Valdes A, Vijay A, Bawden S, et al.
    BMJ Open, 2021 10 07;11(10):e045802.
    PMID: 34620653 DOI: 10.1136/bmjopen-2020-045802
    INTRODUCTION: A Low Glycaemic Index (LGI) diet is a proposed lifestyle intervention in non-alcoholic fatty liver diseases (NAFLD) which is designed to reduce circulating blood glucose levels, hepatic glucose influx, insulin resistance and de novo lipogenesis. A significant reduction in liver fat content through following a 1-week LGI diet has been reported in healthy volunteers. Changes in dietary fat and carbohydrates have also been shown to alter gut microbiota composition and lead to hepatic steatosis through the gut-liver axis. There are no available trials examining the effects of an LGI diet on liver fat accumulation in patients with NAFLD; nor has the impact of consuming an LGI diet on gut microbiota composition been studied in this population. The aim of this trial is to investigate the effects of LGI diet consumption on liver fat content and its effects on gut microbiota composition in participants with NAFLD compared with a High Glycaemic Index (HGI) control diet.

    METHODS AND ANALYSIS: A 2×2 cross-over randomised mechanistic dietary trial will allocate 16 participants with NAFLD to a 2-week either HGI or LGI diet followed by a 4-week wash-out period and then the LGI or HGI diet, alternative to that followed in the first 2 weeks. Baseline and postintervention (four visits) outcome measures will be collected to assess liver fat content (using MRI/S and controlled attenuation parameter-FibroScan), gut microbiota composition (using 16S RNA analysis) and blood biomarkers including glycaemic, insulinaemic, liver, lipid and haematological profiles, gut hormones levels and short-chain fatty acids.

    ETHICS AND DISSEMINATION: Study protocol has been approved by the ethics committees of The University of Nottingham and East Midlands Nottingham-2 Research Ethics Committee (REC reference 19/EM/0291). Data from this trial will be used as part of a Philosophy Doctorate thesis. Publications will be in peer-reviewed journals.

    TRIAL REGISTRATION NUMBER: NCT04415632.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  19. Lim J, Onozawa M, Saad M, Ong TA, A-CaP (Asian Prostate Cancer) Study, J-CaP (Japan Prostate Cancer Study Group), et al.
    Cancer Sci, 2021 Jun;112(6):2071-2080.
    PMID: 33738901 DOI: 10.1111/cas.14889
    The number of newly diagnosed prostate cancer cases varies across Asia, with higher mortality-to-incidence ratio reported in developing nations. Androgen deprivation therapy (ADT), alone or in combination, remains the mainstay of first-line treatment for advanced prostate cancer. Key findings of extensive research and randomized controlled trials have shaped current clinical practice and influenced clinical guideline recommendations. We describe here the recent trend of ADT in newly diagnosed prostate cancer for Asia focusing on Japan (high-income country) and Malaysia (middle-income country) based on the Asian Prostate Cancer (A-CaP) Study. The combination of radiotherapy and ADT or ADT alone was common in patients with intermediate-to-high risk localized and locally advanced disease. For metastatic prostate cancer, maximum androgen blockade (gonadotrophin-releasing hormone [GnRH] agonist/antagonist plus antiandrogen) was prevalent among the Japanese patients while primary ADT alone with GnRH agonist/antagonist was widely practiced in the Malaysian cohort. Upfront combined therapy (ADT plus docetaxel or androgen receptor pathway inhibitor) has significantly improved the outcomes of patients with metastatic castration-naïve prostate cancer. Its application, however, remains low in our cohorts due to patients' financial capacity and national health insurance coverage. Early detection remains the cornerstone in prostate cancer control to improve treatment outcome and patient survival.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  20. Berwanger O, Abdelhamid M, Alexander T, Alzubaidi A, Averkov O, Aylward P, et al.
    Clin Cardiol, 2018 Oct;41(10):1322-1327.
    PMID: 30098028 DOI: 10.1002/clc.23043
    Primary percutaneous coronary intervention (PCI) is the preferred reperfusion method in patients with ST-segment elevation myocardial infarction (STEMI). In patients with STEMI who cannot undergo timely primary PCI, pharmacoinvasive treatment is recommended, comprising immediate fibrinolytic therapy with subsequent coronary angiography and rescue PCI if needed. Improving clinical outcomes following fibrinolysis remains of great importance for the many patients globally for whom rapid treatment with primary PCI is not possible. For patients with acute coronary syndrome who underwent primary PCI, the PLATO trial demonstrated superior efficacy of ticagrelor relative to clopidogrel. Results in the predefined subgroup of patients with STEMI were consistent with the overall PLATO trial. Patients who received fibrinolytic therapy in the 24 hours before randomization were excluded from PLATO, and there is thus a lack of data on the safety of using ticagrelor in conjunction with fibrinolytic therapy in the first 24 hours after STEMI. The TREAT study addresses this knowledge gap; patients with STEMI who had symptom onset within the previous 24 hours and had received fibrinolytic therapy (of whom 89.4% had also received clopidogrel) were randomized to treatment with ticagrelor or clopidogrel (median time between fibrinolysis and randomization: 11.5 hours). At 30 days, ticagrelor was found to be non-inferior to clopidogrel for the primary safety outcome of Thrombolysis in Myocardial Infarction (TIMI)-defined first major bleeding. Considering together the results of the PLATO and TREAT studies, initiating or switching to treatment with ticagrelor within the first 24 hours after STEMI in patients receiving fibrinolysis is reasonable.
    Matched MeSH terms: Randomized Controlled Trials as Topic*
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