The objectives of the study were to evaluate and compare the effects of the systemic consumption of probiotic curd and the topical application of probiotic toothpaste on the Streptococcus mutans levels in the plaque of orthodontic patients.
It has long been postulated that the relative abundance of specific nutrients can affect cognitive processes and emotions. Newly described influences of dietary factors on neuronal function and synaptic plasticity have revealed some of the vital mechanisms that could be responsible for the action of diet on brain health and cognitive function. Here, through a double-blind, randomized, placebo-controlled trial, we asked if the newly discovered chicken meat ingredient-168 (CMI-168) could be beneficial to the cognitive function in healthy adults.
The objectives of this study were to determine the efficacy and safety of aripiprazole for treatment of psychosis, retention and abstinence in patients with methamphetamine dependence.
A considerable number of patients with severely elevated LDL-C do not achieve recommended treatment targets, despite treatment with statins. Adults at high cardiovascular risk with hypercholesterolemia and LDL-C ≥ 2.59 and ≤ 4.14 mmol/L (N = 250), pretreated with atorvastatin 20 mg were randomized to ezetimibe/simvastatin 10/40 mg or atorvastatin 40 mg for 6 weeks. The percent change in LDL-C and other lipids was assessed using a constrained longitudinal data analysis method with terms for treatment, time, time-by-treatment interaction, stratum, and time-by-stratum interaction. Percentage of subjects achieving LDL-C < 1.81 mmol/L, < 2.00 mmol/L, or < 2.59 mmol/L was assessed using a logistic regression model with terms for treatment and stratum. Tolerability was assessed.
BACKGROUND: Although thromboprophylaxis reduces the incidence of venous thromboembolism in acutely ill medical patients, an associated reduction in the rate of death from any cause has not been shown.
METHODS: We conducted a double-blind, placebo-controlled, randomized trial to assess the effect of subcutaneous enoxaparin (40 mg daily) as compared with placebo--both administered for 10±4 days in patients who were wearing elastic stockings with graduated compression--on the rate of death from any cause among hospitalized, acutely ill medical patients at participating sites in China, India, Korea, Malaysia, Mexico, the Philippines, and Tunisia. Inclusion criteria were an age of at least 40 years and hospitalization for acute decompensated heart failure, severe systemic infection with at least one risk factor for venous thromboembolism, or active cancer. The primary efficacy outcome was the rate of death from any cause at 30 days after randomization. The primary safety outcome was the rate of major bleeding during and up to 48 hours after the treatment period.
RESULTS: A total of 8307 patients were randomly assigned to receive enoxaparin plus elastic stockings with graduated compression (4171 patients) or placebo plus elastic stockings with graduated compression (4136 patients) and were included in the intention-to-treat population. The rate of death from any cause at day 30 was 4.9% in the enoxaparin group as compared with 4.8% in the placebo group (risk ratio, 1.0; 95% confidence interval [CI], 0.8 to 1.2; P=0.83). The rate of major bleeding was 0.4% in the enoxaparin group and 0.3% in the placebo group (risk ratio, 1.4; 95% CI, 0.7 to 3.1; P=0.35).
CONCLUSIONS: The use of enoxaparin plus elastic stockings with graduated compression, as compared with elastic stockings with graduated compression alone, was not associated with a reduction in the rate of death from any cause among hospitalized, acutely ill medical patients. (Funded by Sanofi; LIFENOX ClinicalTrials.gov number, NCT00622648.).
Note: Malaysia is a study site: participating investigators: Yaw Chong Hwa (WT Ma), Najihah I, SH How, Abdul Razak AM, Law WC (ST Tie), Bharathan T, Monniaty M, Aris Chandran, Ngau Yen Yew, Aziah AM, Irene Wong, CK Chuah, Rosemi S, KK Sia, Jeyaindran S, CY Leong
To evaluate the effect of a single 250-mg dose of 17 alpha-hydroxyprogesterone caproate (17-OHPC) intramuscularly as adjunct to nifedipine tocolysis in preterm labor.
Vitamin E is an essential fat-soluble vitamin that has been shown to induce favorable effects on animal and human immune systems. The objective of this study was to assess the effects of tocotrienol-rich fraction (TRF) supplementation on immune response following tetanus toxoid (TT) vaccine challenge in healthy female volunteers.
Strontium ranelate is a new effective anti-osteoporotic treatment having a unique mode of action, reducing bone resorption while promoting continued bone formation, with a broad range of anti-fracture efficacy at vertebral as well as peripheral sites. In Phase III studies, it has proven its early and sustained efficacy against vertebral fractures in Caucasians along with a significant increase in lumbar bone mineral density (BMD). The aim of this randomized double-blind study was to demonstrate the efficacy of strontium ranelate (2 g/day) on lumbar spine bone mineral density and the clinical and biological safety in Asian postmenopausal osteoporotic patients compared to placebo over 1 year. Three hundred and twenty-nine eligible women from mainland China, Hong Kong and Malaysia were randomized into the study. The baseline characteristics were similar in the treatment and placebo groups: mean age of 66.2+/-6.5 years, time since menopause 17.6+/-7.2 years. In the Full Analysis Set (FAS, N=302), the mean baseline lumbar L2-L4 BMD was 0.715+/-0.106 g/cm(2) in the strontium ranelate group and 0.708 +/- 0.109 g/cm2 in the placebo group. The mean baseline femoral neck BMD was 0.575+/-0.074 g/cm2 and 0.566+/-0.069 g/cm2 respectively and mean total hip BMD was 0.642+/-0.080 g/cm2 and 0.631 +/-0.088 g/cm2 respectively. The overall compliance was 91.4% in the study drug group, and 97.4% in the placebo group. After 1 year of treatment, the lumbar spine, femoral neck and total hip BMD in the treated group was significantly increased by 3-5% as compared to placebo. Strontium ranelate was well tolerated. The most frequently reported emergent adverse events were comparable in both groups (60.4% versus 60.0%), with majority of them being mild gastrointestinal disorders. There were no clinically relevant changes in laboratory tests, such as blood routine, hepatic and renal function. It is thus concluded that the effects of 2 g/day strontium ranelate on BMD and its safety profile in this cohort of postmenopausal osteoporotic Asian women were consistent with results obtained from Caucasian women in which the efficacy on the reduction in risk of fracture has been proven.
We studied the effect of fentanyl pretreatment on alleviating pain during the injection of Propofol-Lipuro. One hundred and seventy patients were randomly allocated to receive either 100 mcg of intravenous fentanyl or normal saline (placebo) followed by intravenous Propofol-Lipuro premixed with 20 mg lignocaine. The incidence of injection pain was 32% and 13% in the placebo and fentanyl groups, respectively. We found a statistically significant reduction in incidence of injection pain in the fentanyl group when compared with the placebo group (p<0.003). The number needed to treat was 6 (3.2< 95% CI <15.1). In conclusion, fentanyl pretreatment is effective in alleviating pain during injection of Propofol-Lipuro.
A double blind, randomized, controlled Phase 2 clinical trial was conducted to assess the safety, immunogenicity, and biologic impact of the vaccine candidate Apical Membrane Antigen 1-Combination 1 (AMA1-C1), adjuvanted with Alhydrogel. Participants were healthy children 2-3 years old living in or near the village of Bancoumana, Mali. A total of 300 children received either the study vaccine or the comparator. No impact of vaccination was seen on the primary endpoint, the frequency of parasitemia measured as episodes >3000/microL/day at risk. There was a negative impact of vaccination on the hemoglobin level during clinical malaria, and mean incidence of hemoglobin <8.5 g/dL, in the direction of lower hemoglobin in the children who received AMA1-C1, although these differences were not significant after correction for multiple tests. These differences were not seen in the second year of transmission.
To evaluate the recurrence rate, surgical time, and postoperative pain between conjunctival autografting with sutures and with fibrin adhesive in pterygium surgery.
Botulinum toxin is effective in reducing spasticity post stroke. As there are limited data on post stroke spasticity in Asia, we undertake this study to determine the effectiveness and safety of intramuscular injection of botulinum toxin type-A (BTX-A), in the treatment of chronic focal post-stroke hand spasticity, and the impact of BTX-A on the activities of daily living and quality of life, in comparison to placebo, in Malaysian stroke patients. This was a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of BTX-A in 27 subjects with wrist and finger spasticity after a stroke. The outcome measures were assessed with the Modified Ashworth Scale (MAS) to assess spasticity of the flexor muscles, Barthel Index (BI) for activities of daily living and EQ-5D and EQ VAS for quality of life. Assessments were performed at baseline and 1 and 3 months after injection. Compared to placebo, the BTX-A group had greater improvement in the flexor tone of the wrist and fingers (p = 0.001 and p < 0.001, respectively), at first month follow-up visit and sustained the improvement through to three months. Although there was an improvement in the measures of global function and quality of life in the BTX-A group, there was no significant improvement in between the two groups. No serious BTX-A related adverse effects were reported. The results of this study demonstrate that intramuscular injection of botulinum toxin A is safe and effective in the treatment of chronic focal post-stroke spasticity of the hand.
Vitamin E is divided into two subgroups; tocopherols and tocotrienols. Both have protective roles in biological systems. The present study was conducted to compare the effect of short-term supplementation at 200 mg/d of either alpha-tocopherol or a tocotrienol-rich fraction (TRF) from palm oil on immune modulation and plasma vitamin E levels in normal healthy Asian volunteers. In a randomised, double-blind placebo-controlled trial conducted, fifty-three healthy volunteers aged 20-50 years were recruited based on the study's inclusion and exclusion criteria. They were randomly assigned into three groups, i.e. two experimental groups that received daily supplementation at 200 mg of either alpha-tocopherol or the TRF, and the control group that received a placebo. Blood was drawn on days 0, 28 and 56 for several laboratory analyses. Differences in the production of IL-4 or interferon-gamma by concanavalin A-stimulated lymphocytes isolated from these volunteers were not significant (P>0.05). There were no significant differences observed in immune parameters between the healthy volunteers who received daily supplementation with either alpha-tocopherol or the TRF. As these observations were made in the absence of any immunogenic challenge, we feel it would be of benefit to study if there would be any differences observed when an immunogenic challenge such as vaccination were introduced.
The free radical theory of aging (FRTA) suggests that free radicals are the leading cause of deteriorating physiologic function during senescence. Free radicals attack cellular structures or molecules such as DNA resulting in various modifications to the DNA structures. Accumulation of unrepaired DNA contributes to a variety of disorders associated with the aging process.
BACKGROUND: Data comparing the effect of losartan and perindopril on aortic stiffness among hypertensive subjects without A(1166)C polymorphism was not available.
METHODS: The short-term and long-term effects of losartan (50 mg) and perindopril (4 mg) on aortic stiffness measured as carotid femoral pulse wave velocity (PWV) were compared in 39 middle-aged Malay subjects with mild-to-moderate hypertension in a 4-month, double-blind, randomized, controlled, parallel-design study.
RESULTS: Four-month treatment with both drugs showed a significant reduction in blood pressure (BP) (P < .005) and PWV (P < .05) as compared to the baseline. On the other hand 1-month treatment showed a significant reduction in BP only in perindopril group (P < .05) but not in the losartan group. There was no significant reduction in pulse pressure and PWV after 1 month treatment by both drugs. No significant difference was seen in reduction in BP after 1 month and 4 months treatment between the two drugs. Similarly no significant difference was seen in reduction in PWV between the two drugs after 1 month (P = .613) and 4 months (P = .521) of treatment. Reduction in PWV by losartan (r = 0.470) and perindopril (r = 0.457) correlated significantly only with reduction in DBP (P < .05) and remained significant even after controlling for reduction in DBP (P < .05). Reduction in PWV by both losartan and perindopril was independent of reduction in BP by these drugs.
CONCLUSIONS: These results showed that long-term treatment with losartan shows similar pressure independent reduction in PWV as perindopril among Malay hypertensive subjects with a homogenous "AA" genotype for angiotensin II type 1 receptor and may serve as a suitable alternative to perindopril.
Measurement of disability and breathlessness in asthma is important to guide treatment. Using an incentive spirometer, Triflo II (Tyco Healthcare, Mansfield, MA, USA), we developed a three-minute respiratory exercise test (3-MRET) to score the maximal breathing capacity (MBC) and perception of dyspnea (POD) index by means of repetitive inspiratory efforts achieved within 3 minutes. POD index was calculated based on the ratio of breathlessness on visual analogue scale over MBC score. In 175 normal healthy subjects and 158 asthmatic patients of mild (n = 26), moderate (n = 78), and severe (n = 54), severity, the mean (95% CI) MBC scores in mild, moderate, and severe asthma patients were 168 (145-192), 153 (136-169), and 125 (109-142) respectively, and 202 (191-214) in normal subjects (p < 0.001). The mean POD index in mild, moderate, and severe asthma patients was 16 (9-23), 25 (14-37), and 57 (14-100), respectively, and 6 (4-7) in normal subjects (p < 0.001). Intraclass correlation coefficients for MBC score and POD index in 17 asthmatic and 20 normal subjects were high. In 14 asthmatic patients randomized to receiving nebulized beta2-agonist or saline in a cross-over, double-blind study, % forced expiratory volume in one second (FEV1) change correlated with % change in MBC score [r(s) = 0.49, p < 0.01] and POD index [r(s)-0.46, p = 0.012]. In 21 asthmatic and 26 normal subjects, the MBC score and POD index correlated with the walking distance and walking POD index of the six-minute walking test (6MWT). We conclude that 3MRET is discriminative between asthmatic patients of varying severity and normal subjects, is reproducible, is responsive to bronchodilator effect, and is comparable with 6MWT. Taken together, it has the potential to score disability and POD in asthma simply and effectively.
Post Arthroscopic intra-articular analgesia is a better method to avoid post-operative pain after arthroscopic surgery, thus avoiding the adverse effects of systemic analgesics. In this prospective randomized double blind study conducted on 90 patients, 30 patients in group A received 20 ml of intra-articular saline, 30 patients in Group B received 10 ml of intra-articular saline and 10 ml of 0.25% bupivacaine and 30 patients in Group C received 10 ml of 0.25% bupivacaine, 1 ml (30 mg) of ketorolac and 9 ml of saline intra-articularly. Ambulatory status, duration of analgesia and requirement for supplemented analgesia were compared in these three groups. Patients receiving this intra-articular analgesic combination of bupivacaine and ketorolac required significantly less supplemental postoperative analgesics. This combination significantly prolonged the duration of analgesia. Patients receiving this combination of drugs for intra-articular analgesia ambulated earlier.
The objective of this study was to assess the efficacy and safety of oral 30% dextrose during venepuncture in neonates. Neonates admitted in the Special Care Nursery for jaundice from September 200 to January 2001 were recruited for this double-blind randomised controlled trial. The intervention consisted of administration of either 2 ml of oral 30% dextrose or 2 ml of sterile water 2 minutes before venepuncture. The primary outcome measure was the cumulative Neonatal Infant Pain Scale (NIPS) score at 3 minutes after venepuncture and the duration of cry assessed from a videotaped recording. Twenty-six neonates received 30% dextrose and 26 neonates received sterile water. The cumulative NIPS score at 3 minutes (median, IQR) after venepuncture for neonates given 30% dextrose (13, 6.8-21) was significantly (p = 0.03) lower than that for neonates given sterile water (21, 13.8-21). The duration of cry in neonates given 30% dextrose (median 45 sec IQR 1.5-180.8 sec) was significantly (p = 0.03) shorter than that in neonates given sterile water (median 191 sec IQR 52.3-250 sec). No neonates developed diarrhoea, fever or rash during the 24 hour observation period. Both the intra-rater (ICC 0.993 95% CI 0.988-0.996) and inter rater (ICC 0.988 95% CI 0.980-0.993) agreement on the 3-minute NIPS score were good. In conclusion oral 30% dextrose given 2 minutes before venepuncture was effective in reducing neonatal pain following venepuncture. It is a simple, safe and fast acting analgesic and should be considered for minor invasive procedure in term neonates.