Displaying publications 121 - 140 of 364 in total

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  1. Yusof Y, Mukari SZS, Dzulkifli MA, Chellapan K, Ahmad K, Ishak I, et al.
    Geriatr Gerontol Int, 2019 Aug;19(8):768-773.
    PMID: 31237107 DOI: 10.1111/ggi.13710
    AIM: To evaluate the efficacy of a newly developed auditory-cognitive training system on speech recognition, central auditory processing and cognition among older adults with normal cognition (NC) and with neurocognitive impairment (NCI).

    METHODS: A double-blind quasi-experiment was carried out on NC (n = 43) and NCI (n = 33) groups. Participants in each group were randomly assigned into treatment and control programs groups. The treatment group underwent auditory-cognitive training, whereas the control group was assigned to watch documentary videos, three times per week, for 8 consecutive weeks. Study outcomes that included Montreal Cognitive Assessment, Malay Hearing in Noise Test, Dichotic Digit Test, Gaps in Noise Test and Pitch Pattern Sequence Test were measured at 4-week intervals at baseline, and weeks 4, 8 and 12.

    RESULTS: Mixed design anova showed significant training effects in total Montreal Cognitive Assessment and Dichotic Digit Test in both groups, NC (P 

    Matched MeSH terms: Double-Blind Method
  2. Soraganvi P, Nagakiran KV, Raghavendra-Raju RP, Anilkumar D, Wooly S, Basti BD, et al.
    Malays Orthop J, 2019 Nov;13(3):8-14.
    PMID: 31890104 DOI: 10.5704/MOJ.1911.002
    Introduction: Plantar fasciitis is characterised by pain in the heel, which is aggravated on weight bearing after prolonged rest. Many modalities of treatment are commonly used in the management of plantar fasciitis including steroid injection. Many studies show that steroid injection provides pain relief in the short term but not long lasting. Recent reports show autologous platelet-rich plasma (PRP) injection promotes healing, resulting in better pain relief in the short as well as long term. The present study was undertaken to compare the effects of local injection of platelet-rich plasma and Corticosteroid in the treatment of chronic plantar fasciitis. Materials and methods: Patients with the clinical diagnosis of chronic plantar fasciitis (heel pain of more than six weeks) after failed conservative treatment and plantar fascia thickness more than 4mm were included in the study. Patients with previous surgery for plantar fasciitis, active bilateral plantar fasciitis, vascular insufficiency or neuropathy related to heel pain, hypothyroidism and diabetes mellitus were excluded from the study. In this prospective double-blind study, 60 patients who fulfilled the criteria were divided randomly into two groups. Patients in Group A received PRP injection and those in Group B received steroid injection. Patients were assessed with visual analog scale (VAS) and American Orthopedic Foot and Ankle Society (AOFAS) score. Assessment was done before injection, at six weeks, three months and six months follow-up after injection. Plantar fascia thickness was assessed before the intervention and six months after treatment using sonography. Results: Mean VAS in Group A decreased from 7.14 before injection to 1.41 after injection and in Group B decreased from 7.21 before injection to 1.93 after injection, at final follow-up. Mean AOFAS score in Group A improved from 54 to 90.03 and in Group B from 55.63 to 74.67 at six months' follow-up. The improvements observed in VAS and AOFAS were statistically significant. At the end of six months' follow-up, plantar fascia thickness had reduced in both groups (5.78mm to 3.35mm in Group A and 5.6 to 3.75 in Group B) and the difference was statistically significant. Conclusion: Local injection of platelet-rich plasma is an effective treatment option for chronic plantar fasciitis when compared with steroid injection with long lasting beneficial effect.
    Matched MeSH terms: Double-Blind Method
  3. Ng YT, Phang SCW, Tan GCJ, Ng EY, Botross Henien NP, M Palanisamy UD, et al.
    Nutrients, 2020 May 23;12(5).
    PMID: 32456230 DOI: 10.3390/nu12051522
    Chronic hyperglycemia increases oxidative stress, activates inflammatory pathways and reduces nerve growth factor (NGF) among diabetic patients, which contribute to development of diabetic peripheral neuropathy (DPN). Tocotrienol-Rich Vitamin E (Tocovid) possesses potent antioxidant and anti-inflammatory properties which are postulated to target these pathogeneses in order to ameliorate DPN. This study aims to evaluate the effects of Tocovid on nerve conduction parameters and serum biomarkers among diabetic patients. This multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial was conducted on 80 eligible participants. The intervention group (n = 39) was randomly allocated to receive 200 mg of Tocovid twice a day, and the control group (n = 41) received placebo twice a day. At the end of eight weeks, the nerve conduction parameters, as assessed by nerve conduction study, as well as serum biomarkers (NGF, malondialdehyde, vascular cell adhesion molecule 1, tumor necrosis factor receptor 1 and thromboxane B2) were compared between the two groups. Compared to placebo, Tocovid significantly improves the nerve conduction velocities of all nerves (+1.25 m/s, interquartile range [IQR] 3.35, p < 0.001, median nerve; +1.60 m/s, IQR 1.80, p < 0.001, sural nerve; +0.75 m/s, IQR 2.25, p < 0.001, tibial nerve). Meanwhile, the levels of serum NGF were significantly higher in the Tocovid group as compared to placebo at eight weeks post-intervention. Participants receiving Tocovid illustrated highly significant improvement in terms of nerve conduction velocities for all nerves tested after eight weeks of supplementation. In addition, Tocovid supplementation elevated the levels of serum NGF, in which its increase is postulated to reflect enhanced neuronal functions. This novel finding suggests that Tocovid could be a disease-modifying agent targeting serum NGF to improve nerve conduction velocities.
    Matched MeSH terms: Double-Blind Method
  4. Hidrus A, Kueh YC, Norsaádah B, Chang YK, Hung TM, Naing NN, et al.
    PMID: 32268601 DOI: 10.3390/ijerph17072507
    Brain Breaks videos are web-based structured physical activity (PA) videos that aim at stimulating an interest in learning and promoting health. Exercise is one of the important treatment regimens for people with type 2 diabetes mellitus (T2DM). Thus, the objective of this study was to determine the effects that Brain Breaks videos have on the motives for PA, as measured by the Physical Activity and Leisure Motivation Scale-Malay (PALMS-M), and the amount of PA, as measured by the International Physical Activity Questionnaire-Malay (IPAQ-M), in T2DM patients (the most common type of diabetes mellitus patients). This study was conducted using a randomized, double-blind design and grouped subjects under two research conditions: an experimental group given Brain Breaks videos and a control group. Purposive sampling was employed to recruit 70 T2DM patients (male = 39, female = 31) with the mean age of 57.6 (SD = 8.5) from Hospital Universiti Sains Malaysia, Kelantan. Over a four-month period, the participants in the experimental group were asked to perform PA daily based on a Brain Breaks video (10 min in duration) that was shared through a WhatsApp group. All participants from both groups answered the PALMS-M questionnaire five times: pre-intervention, the end of the first month, second month, and third month, and post-intervention. A repeated measure multivariate analysis of variance and a repeated measure analysis of variance were performed for the analyses of the data. The results demonstrated that four (appearance, others' expectations, physical condition, and mastery) out of eight motives for PA produced a significant mean score difference between the two study groups. All eight motives for PA showed an upward trend for the experimental group during the study period, while the control group showed a downward trend for all motives during the study period. As for the amount of PA, both groups showed significant differences (p = 0.001). The amount of PA increased in the experimental group during the study period, while it decreased in the control group. Therefore, Brain Breaks videos can be considered as an effective intervention for motivating T2DM patients for PA and improving their amount of PA.
    Matched MeSH terms: Double-Blind Method
  5. 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: Double-Blind Method
  6. Bakar NA, Jayah NI, Mohamed NR, Ali SM, Nasir SH, Hashim R, et al.
    J World Fed Orthod, 2020 03;9(1):3-8.
    PMID: 32672665 DOI: 10.1016/j.ejwf.2019.11.004
    INTRODUCTION: Gingivitis is one of the commonest problems faced by patients with fixed appliances (FA) as there is close relation between the appliances to gingival sulcus. Stichopus horrens (SH) is a sea cucumber from the Indo-Pacific that has medical healing properties which have been traditionally used.

    OBJECTIVE: To assess the effects of toothpaste containing aqueous SH extract on plaque-induced gingivitis following orthodontic bond-up and to identify the optimal concentration of SH.

    METHODS: A single-centred; triple-blinded randomized controlled trial conducted in 40 patients with FA. Participants were randomly assigned to one of the four groups with toothpaste which has concentration of SH extract of 0%, 3%, 6% or 9%. The statistician, the participants and the researchers involved in data collection were kept blinded from the allocation. Gingival Index (GI) and Bleeding on Probing (BOP) for each group were taken at day 0,7,14 and 30.

    RESULTS: 9% of SH-containing toothpaste (SHCT) showed most substantial result as there were significance difference of GI (P = 0.020) from Day 7 to 14 and from Day 0 to 14 (P = 0.020). There was also significance difference of BOP from Day 0 to 14 (P = 0.022) and from Day 0 to 30 (P = 0.027). Significant difference was seen in 3% of SHCT group with the decrease of GI (P = 0.004) from Day 1 to 14. There were no significant difference noted for 0% and 6% SHCT.

    CONCLUSION: The 9% SHCT is the most effective concentration to reduce both the gingival inflammation (up to day 14) and bleeding on probing (up to day 30).

    Matched MeSH terms: Double-Blind Method
  7. Barden A, Phillips M, Mas E, Hill LM, Mowat I, Loh PS, et al.
    PMID: 32084530 DOI: 10.1016/j.prostaglandins.2020.106427
    BACKGROUND: Dexamethasone is commonly given as an antiemetic during surgical procedures. It has immunosuppressive effects and can affect key enzymes involved in the synthesis of specialised lipid mediators of inflammation resolution (SPM) that direct inflammation resolution and have anti-nociceptive actions. This study examined the effect of dexamethasone on plasma SPM, and the relationship between SPM and perceived pain in women undergoing surgery.

    METHODS: Plasma SPM were measured in samples obtained from two double-blind controlled interventions. The first, included 51 women mean age 53 ± 1.5 years, undergoing breast surgery allocated to either intravenous saline, or dexamethasone (4 mg or 8 mg) after induction of anaesthesia. The second study included 31 women of mean age 44 ± 0.5 years undergoing laparoscopic gynecological surgery that were allocated to either saline, or dexamethasone (4 mg). SPM (18-HEPE, 17-HDHA, RvE2, RvD1 17R-RvD1 and RvD2) were measured in plasma collected prior to induction of anaesthesia and at 24 h, and 6 weeks post-surgery. Pain was assessed using a verbal analogue scale at discharge from the post-anaesthesia recovery unit. The data from each study was combined to examine the effect of dexamethasone on plasma SPM. The relationship between pain score and SPM was examined using ordinal logistic regression.

    RESULTS: The SPM 18-HEPE, 17-HDHA, RvE2, RvD1 17R-RvD1 and RvD2 were detectable in all plasma samples. There was no significant difference in any SPM due to dexamethasone over the duration of the study. There was a fall in 17-HDHA between baseline and 24 h in both the dexamethasone and saline groups (P = 0.003) but no change in the downstream SPM (RvD1, 17R-RvD1 and RvD2) or 18-HEPE and RvE2. Pain score was negatively related to levels of RvE2 measured prior to induction of anaesthesia (rho = -0.2991, P = 0.006) and positively related to BMI (rho = 0.279, P = 0.011). In ordinal logistic regression the odds ratio for RvE2 was 0.931 (CI 0.880, 0.986; P = 0.014); after adjusting for the effect of BMI indicating that an increase in RvE2 of 1 pg/ml would result in a 6.9 % fall in pain score. Allocation to a dexamethasone group did not influence the pain score or the relationship between RvE2 and pain score.

    CONCLUSION: Dexamethasone administered as an anti-emetic does not affect plasma SPM levels. An elevated RvE2 level prior to surgery is predictive of a lower perceived pain score post-anaesthesia.

    Matched MeSH terms: Double-Blind Method
  8. Khor CS, Tsuji R, Lee HY, Nor'e SS, Sahimin N, Azman AS, et al.
    Nutrients, 2021 Dec 16;13(12).
    PMID: 34960061 DOI: 10.3390/nu13124507
    Dengue fever (DF) is a mosquito-borne disease still with no effective treatment or vaccine available. A randomized, placebo-controlled, double-blinded, parallel-group trial was undertaken to evaluate the efficacy of oral intake of Lactococcus lactis strain plasma (LC-Plasma) on the presentation and severity of DF-like symptoms among healthy volunteers. Study participants (320) were assigned into two groups, and consumed either placebo or LC-Plasma tablets (approximately 100 billion cells/day) for 8 weeks. The clinical symptoms of DF were self-recorded through questionnaires, and exposure to DENV was determined by serum antibody and/or DENV antigen tests. No significant differences between groups were observed for exposure to DENV, or the symptomatic ratio. Results obtained showed that participants from the LC-Plasma group reported a significant reduction in the cumulative incidence days of DF-like symptoms, which include fever (p < 0.001), muscle pain (p < 0.005), joint pain (p < 0.001), and pain behind the eyes (p < 0.001), compared to that of the placebo group. Subgroup analysis revealed a significantly (p < 0.05) reduced severity score in the LC-Plasma group when study sites were separately analyzed. Overall, our findings suggest that LC-Plasma supplementation reduces the cumulative days with DF-like symptoms, and the severity of the symptoms. Daily oral intake of LC-Plasma, hence, is shown to mitigate the DF-like symptoms.
    Matched MeSH terms: Double-Blind Method
  9. Leeyaphan C, Varothai S, Trakanwittayarak S, Suphatsathienkul P, Pattaravadee S, Matthapan L, et al.
    J Cosmet Dermatol, 2022 Feb;21(2):679-688.
    PMID: 33811776 DOI: 10.1111/jocd.14125
    BACKGROUND: Intertrigo is an inflammatory skin-fold condition. Candida infections may occur concurrently or afterward. Topical corticosteroids may reduce inflammation but exacerbate Candida infections. The treatment is contentious.

    OBJECTIVE: To evaluate the efficacies and safety of adsorbent lotion containing tapioca starch, spent grain wax, Butyrospermum parkii extract, argania spinosa kernel oil, aloe barbadensis, rosehip oil, and allantoin for the treatment of mild-to-moderate intertrigo, relative to 1% hydrocortisone cream.

    METHODS: This randomized, double-blinded study enrolled 40 intertrigo patients. Twice daily, 20 patients applied adsorbent lotion while the remainder used 1% hydrocortisone cream. Efficacy evaluation, skin biophysical measurements, skin tolerability, safety, and visual analog scale (VAS) patient-satisfaction scores were evaluated at baseline and Week 2.

    RESULTS: The adsorbent lotion showed higher complete cure rates for color, partial epidermal loss, papules/pustules/vesicles/patches, dryness, and scaling than the corticosteroid without statistical significance. Adsorbent lotion demonstrated significantly higher reduction in pruritus than the corticosteroid treatment. Reduction of erythema level using Mexameter and VAS patient-satisfaction scores were not statistically different between adsorbent lotion and hydrocortisone cream. No adverse effects or superimposed infections were reported.

    CONCLUSIONS: The anti-inflammatory efficacies of adsorbent lotion and low-potency steroid were equivalent. The lotion was safe and produced excellent pruritus reduction. Patient satisfaction was high.

    Matched MeSH terms: Double-Blind Method
  10. Ng AWA, Muller R, Orton J
    Undersea Hyperb Med, 2017 8 5;44(2):101-107.
    PMID: 28777900
    CONTEXT: Middle ear barotrauma (MEB) is common during chamber compression in hyperbaric oxygen therapy. However, little evidence exists on an optimal compression protocol to minimize the incidence and severity of MEB.

    OBJECTIVE: To compare the incidence of MEB during hyperbaric oxygen therapy using two different chamber compression protocols.

    DESIGN: Double-blinded, randomized controlled trial.

    SETTING: Hyperbaric Medicine Unit, The Townsville Hospital, Queensland, Australia, September 2012 to December 2014.

    PATIENTS: 100 participants undergoing their first hyperbaric oxygen therapy session.

    INTERVENTION: Random assignment to a staged (n=50) or a linear (n=50) compression protocols. Photographs of tympanic membranes were taken pre- and post-treatment and then graded. Middle ear barotrauma was defined as an increase of at least one grade on a modified TEED scale.

    RESULTS: The observed MEB incidence under the staged protocol was 48% compared to 62% using the linear protocol (P=0.12, exact one-sided binomial test), and thus the staged protocol did not show a significant improvement in MEB. However, the staged protocol resulted in significantly less severe deteriorations in MEB grades when compared to the linear protocol (P=0.028, exact one-sided Mann-Whitney type test).

    CONCLUSION: The use of the assessed staged compression protocol for the first hyperbaric oxygen treatment showed no significant effect on the overall incidence of MEB when compared to the gold standard linear protocol but resulted in a significant improvement in the severity of the experienced MEBs. Further studies are needed to elucidate an optimal compression protocol to minimize middle ear barotrauma.

    Matched MeSH terms: Double-Blind Method
  11. Arslan H, Doğanay E, Karataş E, Ünlü MA, Ahmed HMA
    J Endod, 2017 Nov;43(11):1765-1769.
    PMID: 28967495 DOI: 10.1016/j.joen.2017.06.028
    INTRODUCTION: Low-level laser therapy (LLLT) is a practical, nonpharmacologic technique for reducing pain. This study evaluated the effect of LLLT on postoperative pain after root canal retreatment (RCR).

    METHODS: This study enrolled patients (N = 36) who required root canal retreatment (RCR) on mandibular molar teeth, presented with periapical lesions with periapical index scores of 2 or 3, and had a pain visual analog scale (VAS) <50 and a percussion pain VAS <50. The participants were divided into 2 groups: (1) patients scheduled for RCR followed by LLLT (n = 18) and (2) patients scheduled for RCR followed by a mock LLLT (placebo) (n = 18). Postoperative pain was assessed using the VAS. Data were collected and statistically analyzed with the chi-square test, the independent sample t test, and the Mann-Whitney U test (P = .05).

    RESULTS: On the first 4 days, postoperative pain significantly reduced in the LLLT group compared with the placebo group (P  .05). The number of patients who needed analgesics was lower in the LLLT group than in the placebo group (P 

    Matched MeSH terms: Double-Blind Method
  12. Alhelou Y, Mat Adenan NA, Ali J
    Reprod Biol, 2018 Mar;18(1):40-45.
    PMID: 29279181 DOI: 10.1016/j.repbio.2017.12.003
    A parallel group superiority prospective randomised controlled trial was devised to compare the culture characteristics of human pre-implantation stage embryos during uninterrupted culture in a time lapse incubator (TLI) versus the conventional model of interrupted culture in a standard incubator (SI) under low oxygen tension using a single step medium. 221 patients aged 35-and-under, 124 patients aged between 36 and 39 and 86 patients aged 40-and-over years were randomised and cultured either in a SI or in a TLI. Patients in the three age groups were distributed between the TLI and SI in a 1:1 ratio. The development of embryos on days 2, 3 and 5, and the clinical pregnancy and implantation rates were recorded. The fertilisation rate, development of day 2 and clinical pregnancy rates were similar in both treatments but the 8-cell development rate in all age groups combined (p = 0.016), blastocyst development rate (p = 0.0022) and the implantation rate (p = 0.0022) was significantly higher for the uninterrupted culture. These findings demonstrated significant differences between the two incubation groups. It also indicated less efficacious embryonic development with age in both treatments which appeared more pronounced in the conventional incubator. In conclusion uninterrupted culture is superior compared to the interrupted incubation culture system.
    Matched MeSH terms: Double-Blind Method
  13. Oo MMT, Oo PH, Saddki N
    Int J Dent Hyg, 2023 Feb;21(1):195-202.
    PMID: 35946123 DOI: 10.1111/idh.12614
    OBJECTIVES: This study determined the efficacy of alcohol-free 0.05% cetylpyridinium chloride (CPC) mouthwash as an adjunct to twice-daily toothbrushing in comparison with 0.12% chlorhexidine gluconate (CHX) mouthwash and a placebo in reducing plaque accumulation and gingival inflammation. The side effects of the mouthwashes were also determined.

    MATERIALS AND METHODS: A double-blind, parallel, randomized control trial was conducted with 219 university students who were divided into three trial groups using block randomization: CPC, CHX and placebo groups. Clinical oral examinations to assess dental plaque accumulation (modified Quigley-Hein Plaque Index), gingival health (Löe and Silness Gingival Index) and tooth staining (modified Lobene Stain Index) were performed at baseline and at 6 weeks.

    RESULTS: Plaque and gingivitis scores were not significantly different among participants at baseline. After 6 weeks, plaque and gingivitis scores between the CPC and placebo groups and between the CHX and placebo groups were found to be significantly different. However, there was no significant difference between the CPC and CHX groups. The staining scores of participants in the CPC group were lower than those in the CHX group, but the difference was not significant. Taste alteration and numbness were more common among participants in the CHX group than in the CPC group. No significant difference in the perception of a burning sensation was observed.

    CONCLUSIONS: The 0.05% CPC mouthwash was as efficient as 0.12% CHX mouthwash in reducing dental plaque accumulation and gingival inflammation with fewer side effects, supporting its use as an adjunct to toothbrushing.

    Matched MeSH terms: Double-Blind Method
  14. Henderson AM, Aleliunas RE, Loh SP, Khor GL, Harvey-Leeson S, Glier MB, et al.
    J Nutr, 2018 Jun 01;148(6):885-890.
    PMID: 29878267 DOI: 10.1093/jn/nxy057
    BACKGROUND: Folic acid fortification of grains is mandated in many countries to prevent neural tube defects. Concerns regarding excessive intakes of folic acid have been raised. A synthetic analog of the circulating form of folate, l-5-methyltetrahydrofolate (l-5-MTHF), may be a potential alternative.

    OBJECTIVE: The objective of this study was to determine the effects of folic acid or l-5-MTHF supplementation on blood folate concentrations, methyl nutrient metabolites, and DNA methylation in women living in Malaysia, where there is no mandatory fortification policy.

    METHODS: In a 12-wk, randomized, placebo-controlled intervention trial, healthy Malaysian women (n = 142, aged 20-45 y) were randomly assigned to receive 1 of the following supplements daily: 1 mg (2.27 μmol) folic acid, 1.13 mg (2.27 μmol) l-5-MTHF, or a placebo. The primary outcomes were plasma and RBC folate and vitamin B-12 concentrations. Secondary outcomes included plasma total homocysteine, total cysteine, methionine, betaine, and choline concentrations and monocyte long interspersed nuclear element-1 (LINE-1) methylation.

    RESULTS: The folic acid and l-5-MTHF groups had higher (P 

    Matched MeSH terms: Double-Blind Method
  15. Joseph P, Pais P, Gao P, Teo K, Xavier D, Lopez-Jaramillo P, et al.
    Nutr Metab Cardiovasc Dis, 2023 Feb;33(2):434-440.
    PMID: 36604262 DOI: 10.1016/j.numecd.2022.11.001
    BACKGROUND AND AIMS: Vitamin D has mostly been tested in Western populations. We examined the effect of high dose vitamin D in a population drawn predominantly from outside of Western countries.

    METHODS AND RESULTS: This randomized trial tested vitamin D 60,000 IU monthly in 5670 participants without vascular disease but at increased CV risk. The primary outcome was fracture. The secondary outcome was the composite of CV death, myocardial infarction stroke, cancer, fracture or fall. Death was a pre-specified outcome. Mean age was 63.9 years, and 3005 (53.0%) were female. 3034 (53.5%) participants resided in South Asia, 1904 (33.6%) in South East Asia, 480 (8.5%) in South America, and 252 (4.4%) in other regions. Mean follow-up was 4.6 years. A fracture occurred in 20 participants (0.2 per 100 person years) assigned to vitamin D, and 19 (0.1 per 100 person years) assigned to placebo (HR 1.06, 95% CI 0.57-1.99, p-value = 0.86). The secondary outcome occurred in 222 participants (1.8 per 100 person years) assigned to vitamin D, and 198 (1.6 per 100 person years) assigned to placebo (HR 1.13, 95% CI 0.93-1.37, p = 0.22). 172 (1.3 per 100 person years) participants assigned to vitamin D died, compared with 135 (1.0 per 100 person years) assigned to placebo (HR 1.29, 95% CI 1.03-1.61, p = 0.03).

    CONCLUSION: In a population predominantly from South Asia, South East Asia and South America, high-dose vitamin D did not reduce adverse skeletal or non-skeletal outcomes. Higher mortality was observed in the vitamin D group.

    REGISTRATION NUMBER: NCT01646437.

    Matched MeSH terms: Double-Blind Method
  16. Hasain Z, Raja Ali RA, Ahmad HF, Abdul Rauf UF, Oon SF, Mokhtar NM
    Nutrients, 2022 Sep 19;14(18).
    PMID: 36145254 DOI: 10.3390/nu14183878
    Probiotics are widely used as an adjuvant therapy in various diseases. Nonetheless, it is uncertain how they affect the gut microbiota composition and metabolic and inflammatory outcomes in women who have recently experienced gestational diabetes mellitus (post-GDM). A randomized, double-blind, placebo-controlled clinical trial involving 132 asymptomatic post-GDM women was conducted to close this gap (Clinical Trial Registration: NCT05273073). The intervention (probiotics) group received a cocktail of six probiotic strains from Bifidobacterium and Lactobacillus for 12 weeks, while the placebo group received an identical sachet devoid of living microorganisms. Anthropometric measurements, biochemical analyses, and 16S rRNA gene sequencing results were evaluated pre- and post-intervention. After the 12-week intervention, the probiotics group’s fasting blood glucose level significantly decreased (mean difference −0.20 mmol/L; p = 0.0021). The HbA1c, total cholesterol, triglycerides, and high-sensitivity C-reactive protein levels were significantly different between the two groups (p < 0.05). Sequencing data also demonstrated a large rise in the Bifidobacterium adolescentis following probiotic supplementation. Our findings suggest that multi-strain probiotics are beneficial for improved metabolic and inflammatory outcomes in post-GDM women by modulating gut dysbiosis. This study emphasizes the necessity for a comprehensive strategy for postpartum treatment that includes probiotics to protect post-GDM women from developing glucose intolerance.
    Matched MeSH terms: Double-Blind Method
  17. Mohamad Ikram I, Quah BS, Noraida R, Djokomuljanto S, Faris Irfan CY, Van Rostenberghe H
    Singapore Med J, 2011 May;52(5):356-60.
    PMID: 21633770
    The addition of glutamine to parenteral nutrition (PN) in neonates has not shown significant benefits as compared to adults thus far. This study aimed to determine the potential benefits of the addition of glutamine to neonatal PN in a tertiary hospital in a middle-income country.
    Matched MeSH terms: Double-Blind Method
  18. Hassan Y, Alfadly SO, Azmin MN, Peh KK, Tan TF, Noorizan AA, et al.
    Singapore Med J, 2007 Sep;48(9):819-23.
    PMID: 17728962
    A bioequivalence study of two oral formulations of 500 mg tablets of ciprofloxacin (RAZA Pharmaniaga, Malaysia) as test and Ciprobay (Bayer AG, Germany) as reference, was carried out in 24 healthy human volunteers. Each volunteer received a single dose of ciprofloxacin.
    Matched MeSH terms: Double-Blind Method
  19. Lee ST, Amin MJ
    Singapore Med J, 1994 Dec;35(6):591-4.
    PMID: 7761882
    Nonsedating selective peripheral H1 receptor antagonists are an important advance in antihistaminic therapy in allergic patients. This is a randomised, double-blind parallel group study comparing the use of two such agents viz loratadine 10mg daily and astemizole 10mg daily for two weeks in 39 Malaysian allergic rhinitis patients. At these dosages, both drugs were demonstrated to be efficacious (p < 0.05) for controlling nasal symptoms and safe in terms of short term biochemical and haematological changes and adverse effects noted. Evaluating efficacy criteria utilised in this study loratadine and astemizole were comparable but loratadine was significantly more effective in three areas viz: (i) in diminishing nasal symptoms after 2 weeks of treatment (p = 0.03); (ii) physician's efficacy evaluation after 2 weeks' treatment (p = 0.009); (iii) patient's efficacy evaluation after 2 weeks' treatment (p = 0.019).
    Study site: Allergy clinic, University Malaya Medical Centre (UMMC), Kuala Lumpur, Malaysia
    Matched MeSH terms: Double-Blind Method
  20. Chong HX, Yusoff NAA, Hor YY, Lew LC, Jaafar MH, Choi SB, et al.
    J Dairy Sci, 2019 Jun;102(6):4783-4797.
    PMID: 30954261 DOI: 10.3168/jds.2018-16103
    The aims of this study were to investigate the effects of Lactobacillus plantarum DR7 isolated from bovine milk against upper respiratory tract infections (URTI) and elucidate the possible mechanisms underlying immunomodulatory properties. The DR7 strain (9 log cfu/d) was administered for 12 wk in a randomized, double-blind, and placebo-controlled human study involving 109 adults (DR7, n = 56; placebo, n = 53). Subjects were assessed for health conditions monthly via questionnaires, and blood samples were evaluated for cytokine concentrations, peroxidation and oxidative stress, and gene expression in T cells and natural killer (NK) cells. The administration of DR7 reduced the duration of nasal symptoms (mean difference 5.09 d; 95% CI: 0.42-9.75) and the frequency of URTI (mean difference 0.32; 95% CI: 0.01-0.63) after 12 and 4 wk, respectively, compared with the placebo. The DR7 treatment suppressed plasma proinflammatory cytokines (IFN-γ, TNF-α) in middle-aged adults (30 to 60 yr old), while enhancing anti-inflammatory cytokines (IL-4, IL-10) in young adults (<30 yr old), accompanied by reduced plasma peroxidation and oxidative stress levels compared with the placebo. Young adults who received DR7 showed higher expression of plasma CD44 and CD117 by 4.50- and 2.22-fold, respectively, compared with the placebo. Meanwhile, middle-aged adults showed lower expression of plasma CD4 and CD8 by 11.26- and 1.80-fold, respectively, compared with the placebo, indicating less T-cell activation. In contrast, both young and middle-aged adults who received DR7 showed enhanced presence of nonresting and mature NK cells compared with those who received the placebo. We postulate that DR7 alleviated the symptoms of URTI by improving inflammatory parameters and enhancing immunomodulatory properties.
    Matched MeSH terms: Double-Blind Method
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