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Fulltext Comparing the effects of vitamin E tocotrienol-rich fraction supplementation and α-tocopherol supplementation on gene expression in healthy older adults

Ghani SMA, Goon JA, Azman NHEN, Zakaria SNA, Hamid Z, Ngah WZW

Clinics (Sao Paulo), 2019 03 07;74:e688.
PMID: 30864639 DOI: 10.6061/clinics/2019/e688

OBJECTIVES: This study aims to compare the differential gene expression resulting from tocotrienol-rich fraction and α-tocopherol supplementation in healthy older adults.
METHODS: A total of 71 eligible subjects aged 50 to 55 years from Gombak and Kuala Lumpur, Malaysia, were divided into three groups and supplemented with placebo (n=23), α-tocopherol (n=24) or tocotrienol-rich fraction (n=24). Blood samples were collected at baseline and at 3 and 6 months of supplementation for microarray analysis.
RESULTS: The number of genes altered by α-tocopherol was higher after 6 months (1,410) than after 3 months (273) of supplementation. α-Tocopherol altered the expression of more genes in males (952) than in females (731). Similarly, tocotrienol-rich fraction modulated the expression of more genes after 6 months (1,084) than after 3 months (596) and affected more genes in males (899) than in females (781). α-Tocopherol supplementation modulated pathways involving the response to stress and stimuli, the immune response, the response to hypoxia and bacteria, the metabolism of toxins and xenobiotics, mitosis, and synaptic transmission as well as activated the mitogen-activated protein kinase and complement pathways after 6 months. However, tocotrienol-rich fraction supplementation affected pathways such as the signal transduction, apoptosis, nuclear factor kappa B kinase, cascade extracellular signal-regulated kinase-1 and extracellular signal-regulated kinase-2, immune response, response to drug, cell adhesion, multicellular organismal development and G protein signaling pathways.
CONCLUSION: Supplementation with either α-tocopherol or tocotrienol-rich fraction affected the immune and drug response and the cell adhesion and signal transduction pathways but modulated other pathways differently after 6 months of supplementation, with sex-specific responses.

Matched MeSH terms: Single-Blind Method
Fulltext Spinal anaesthesia with bupivacaine and intrathecal morphine versus combined spinal-epidural anaesthesia using Bupivacaine and Epidural infusion of bupivacaine plus fentanyl for postoperative analgesia after hip and knee arthroplasty

Mohd Azizan, G., Karis, M., Noordin, Y.

Journal of Surgical Academia, 2013;3(2):46-53.
MyJurnal

This randomised single-blinded study was conducted to evaluate if there was any difference between spinal anaesthesia with hyperbaric bupivacaine 0.5% and intrathecal morphine 0.2mg and combined-spinal epidural using hyperbaric bupivacaine 0.5% with epidural infusion of bupivacaine 0.1% plus fentanyl 2.0μg/ml for 24 hours, postoperative analgesia following hip and knee arthroplasty, in terms of pain score and side effects (nausea, vomiting, pruritus and respiratory depression). Eighty patients ASA I or ASA II, aged between 18 to 75 years who underwent knee and hip arthroplasty of approximately 3-4 hours, duration were recruited. They were randomly allocated to one of two groups by using computer generated randomised numbers. The pain score during the postoperative period was evaluated using Visual Analogue Score (VAS pain score) and the side effects were documented and treated accordingly. Results showed that patients in Group 1 and Group 2 were comparable in terms of age, gender, height, weight and race. There was no statistical difference in VAS pain score between the two groups at all times intervals. However, patients in Group 1 had a higher incidence of nausea and pruritus than patients in Group 2. None of the patients in either group, experienced respiratory depression. Thus, it was concluded that both intrathecal morphine 0.2mg and epidural infusion of bupivacaine 0.1% plus fentanyl 2.0μg/ml were comparable in providing postoperative analgesia up to 24 hours following hip and knee arthroplasty. Nevertheless, the use of spinal morphine led to a higher incidence of side effects namely nausea and pruritus.

Matched MeSH terms: Single-Blind Method
Fulltext A Single Blinded Randomized Controlled Study of the Effect of Conventional Oral Hypoglycemic Agents Versus Intensive Short-Term Insulin Therapy on Pure Tone Audiometry in Type II Diabetes Mellitus

Asma A, Azmi MN, Mazita A, Marina MB, Salina H, Norlaila M

Indian J Otolaryngol Head Neck Surg, 2011 Apr;63(2):114-8.
PMID: 22468245 DOI: 10.1007/s12070-011-0132-y

Neuropathy is frequently a late complication of diabetes mellitus. Auditory neuropathy and microangiopathy of inner ear are the possible causes of hearing loss in diabetics. To study the correlation between glycaemic control and hearing threshold in patients with type 2 diabetes mellitus and to determine the differences of hearing threshold between groups treated with different modality. This single blind randomized controlled study was performed at the Department of Medicine and Department of Otorhinolaryngology, Hospital Universiti Kebangsaan Malaysia (UKM) between 1st May 2003 and 31st September 2004. This study was approved by Research Ethics Committee (code number FF-137). Subjects were randomized into two groups. Group 1 were patients treated with conventional oral hypoglycemic agents. The patients in group 2 were those treated with insulin injection. The subjects were seen 4 weekly for 3 months. Audiometric test were performed in all subjects at each visit. Blood were taken for fasting blood glucose, Hb1Ac, and fructosamine at every visit to determine the glycaemic controls of the subject. They were 11 patients (22 ears) treated with oral hypoglycemic agents and 17 patients treated (34 ears) with subcutaneous insulin. There is no significant difference between mean pure tone threshold before and after treatment at all frequencies in both groups. There is also no significance different in fasting glucose level and fructosamine. However, there is significant difference HbA1c levels between the two groups after treatment (P

Matched MeSH terms: Single-Blind Method
Fulltext Effectiveness of Islamic Rehabilitation Intervention Module (ISRIM) on reduction of relapses among opioid dependents in Felda communities in Jengka, Pahang

Amir Faisal Mohd. Khairi, Hejar Abdul Rahman, Norsiah Ali

Malaysian Journal of Medicine and Health Sciences, 2019;15(104):55-55.
MyJurnal

Introduction: Methadone Maintenance Treatment (MMT) is the commonly used intervention for opioid dependents among Malays in FELDA settlements. However, relapse is common. Since majority of Malays are Muslims, Islamic Rehabilitation Intervention Module (ISRIM) using Health Belief Model (HBM) can be implemented as an intervention for reduction of relapse among opioid dependents in FELDA community. The objective of this study were to develop, implement and evaluate the effectiveness of ISRIM in the reduction of relapse among opioids dependent Malay males in FELDA communities in Jengka, Pahang. Methods: A single blind, cluster randomized controlled trial utilizing simple randomization was conducted, involving 10 MMT clinics. Intervention group received ISRIM for one session per week for four consecutive weeks, while control group were put on wait-list. Outcome was relapse, measured monthly for 6 months follow-up by the positive urine for drugs rapid test. Generalized Estimating Equations (GEE) was used as the main effectiveness analysis. Intention-to-treat (ITT), per protocol (PP) analysis, interaction terms, construct terms and key assumption terms were utilized. Results: Individual participation rate was 88.3%. All group comparisons at baseline were not significant (p>0.05). Cumulative relapse after 6-months follow-up for intervention and control group was 13.8% and 31.2%. There was significant difference in relapse between baseline, post-inter-vention and 6-months follow-up within intervention and control group (Q=29.06 vs 61.39,p

Matched MeSH terms: Single-Blind Method
Fulltext Comparison of the ease of insertion of the laryngeal tube VBM and laryngeal mask airway during manual in-line neck stabilization

Noor Zairul M, Khairul Faizi A, Norzalina E

Med J Malaysia, 2006 Jun;61(2):157-61.
PMID: 16898305

The purpose of this study is to assess whether the newly developed laryngeal tube (LT) VBM is easy, simple to use and able to provide adequate ventilation and oxygenation to a patient with an unstable neck who required airway management. We compared the LT to the laryngeal mask airway (LMA) as alternative airway management tool in adult patient with unstable neck who underwent intubation with manual in-line neck stabilization. A randomized single-blinded prospective study was conducted involving a total of 40 ASA I and II premedicated patients who were divided into two groups with 20 patients for each group; either LT or LMA group for airway management during elective surgery. After preoxygenation, anaesthesia was induced and neuromuscular blockade was produced with intravenous drugs. The LT or LMA was inserted after neuromuscular blockade was confirmed using a peripheral nerve stimulator (TOF 1). A size 3, 4 or 5 LT OR a size 3 or 4 LMA was inserted while the patient's head and neck were being stabilized by an assistant who held the sides of the neck and the mastoid processes (manual in-line stabilization). If it was not possible to ventilate the lungs, or if endotrachial carbon dioxide (ETCO2) and/or chest movement did not indicate a patent airway, the LT or LMA was removed. After three failed attempts, the study was terminated and the airway was secured in the most suitable manner determined by the anaesthetist. There was a statistically significant difference for both groups in the time required for successful insertion (time required for LT was 24.8 +/- 7.7 seconds and LMA was 36.1+/-17.3 seconds) (p= 0.01). There was no statistical differences (p>0.05) in number of attempts needed to achieve a patent airway although we were able to achieve a clear airway in all patients in LT group at the first attempt compared with 85% in LMA group. successful insertion rate was 100% for both groups. We conclude that the LT is easier to insert and is a suitable alternative to the LMA for airway management when the patient's head and neck are stabilized by manual in-line method.

Matched MeSH terms: Single-Blind Method
Fulltext Post-intubation airway related adverse effects: a aomparison between intra-cuff dexamethasone and intra-cuff alkalinized lignocaine

Kep, Kee W., Nadia, M.N., Melvin, K., Muhammad, M., Raha, R., Nurlia, Y.

Journal of Surgical Academia, 2013;3(2):26-31.
MyJurnal

Post-intubation airway related adverse effects such as coughing on the endotracheal tube (ETT), restlessness, hoarseness and sore throat are common and undesirable outcomes of anaesthesia using endotracheal intubation. This prospective randomized single blind study was carried out to compare the effectiveness of intra-cuff dexamethasone and alkalinized lignocaine in reducing the incidence of post-intubation airway related adverse effects. Eighty four patients aged 18 – 60 years, of ASA status I or II, were randomly allocated into three groups: air, dexamethasone and alkalinized lignocaine. Their ETT cuffs were inflated according to the group they were allocated to. The incidence of coughing on the ETT, restlessness, hoarseness and sore throat was assessed, postoperatively. The results showed a significant difference in the incidence of cough, restlessness, hoarseness and sore throat in the dexamethasone group compared to the air group. All the patients had minimal or no sore throat at all documented times. Both intra-cuff dexamethasone and alkalinized lignocaine significantly reduced the incidence of hoarseness. However, alkalinized lignocaine additionally lowered the incidence of restlessness, significantly.

Matched MeSH terms: Single-Blind Method
Sedation with dexmedetomidine versus propofol during regional anaesthesia: comparing haemodynamic parameters, respiratory rates and offset times

Nadia, M.N., Samsul Johari, M.A., Muhammad, M., Raha, A.R., Nurlia, Y.

Journal of Surgical Academia, 2012;2(2):15-20.
MyJurnal

This study aimed to compare dexmedetomidine and propofol, in terms of haemodynamic parameters, respiratory rates and offset times, when used for sedation in patients undergoing elective orthopaedic and surgical procedures under regional anaesthesia. This was a prospective, randomised, single-blind study where 88 patients were recruited. Patients were randomised into two groups to receive either dexmedetomidine or propofol infusion. Central neuraxial blockade (spinal, epidural or combined spinal epidural) was performed. After ensuring an adequate block and stable haemodynamic parameters, dexmedetomidine was infused 15 minutes later at 0.4 μg/kg/hr, and propofol, at a target concentration of 2.5 μg/ml. Both drugs were titrated to achieve a bispectral index score of 70 before surgery commenced. Sedation level was monitored using the bispectral index score and assessed by the Observer Assessment of Alertness Scale score. Drug infusion was adjusted to maintain bispectral index scores ranging between 70-80 during surgery. Both groups showed reductions in mean arterial pressure and heart rate from baseline readings throughout the infusion time. However there was no significant reduction in the first 15 minutes from baseline (p > 0.05). Haemodynamic parameters and respiratory rate between both groups were not significantly different (p > 0.05). No patient demonstrated significant respiratory depression or SpO2 ≤ 95%. Offset times were also not significantly different between both groups (p = 0.594). There were no significant differences in haemodynamic parameters, respiratory rates and offset times between dexmedetomidine and propofol used for sedation in patients undergoing elective orthopaedic and surgical procedures under regional anaesthesia.

Matched MeSH terms: Single-Blind Method
Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk

Windecker S, Latib A, Kedhi E, Kirtane AJ, Kandzari DE, Mehran R, et al.

N Engl J Med, 2020 03 26;382(13):1208-1218.
PMID: 32050061 DOI: 10.1056/NEJMoa1910021

BACKGROUND: Polymer-free drug-coated stents provide superior clinical outcomes to bare-metal stents in patients at high bleeding risk who undergo percutaneous coronary intervention (PCI) and are treated with 1 month of dual antiplatelet therapy. Data on the use of polymer-based drug-eluting stents, as compared with polymer-free drug-coated stents, in such patients are limited.
METHODS: In an international, randomized, single-blind trial, we compared polymer-based zotarolimus-eluting stents with polymer-free umirolimus-coated stents in patients at high bleeding risk. After PCI, patients were treated with 1 month of dual antiplatelet therapy, followed by single antiplatelet therapy. The primary outcome was a safety composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year. The principal secondary outcome was target-lesion failure, an effectiveness composite of death from cardiac causes, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. Both outcomes were powered for noninferiority.
RESULTS: A total of 1996 patients at high bleeding risk were randomly assigned in a 1:1 ratio to receive zotarolimus-eluting stents (1003 patients) or polymer-free drug-coated stents (993 patients). At 1 year, the primary outcome was observed in 169 of 988 patients (17.1%) in the zotarolimus-eluting stent group and in 164 of 969 (16.9%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% confidence interval [CI], 3.5; noninferiority margin, 4.1; P = 0.01 for noninferiority). The principal secondary outcome was observed in 174 patients (17.6%) in the zotarolimus-eluting stent group and in 169 (17.4%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% CI, 3.5; noninferiority margin, 4.4; P = 0.007 for noninferiority).
CONCLUSIONS: Among patients at high bleeding risk who received 1 month of dual antiplatelet therapy after PCI, use of polymer-based zotarolimus-eluting stents was noninferior to use of polymer-free drug-coated stents with regard to safety and effectiveness composite outcomes. (Funded by Medtronic; ONYX ONE ClinicalTrials.gov number, NCT03344653.).

Matched MeSH terms: Single-Blind Method
Fulltext Effect of Short-Term Mobile Phone Base Station Exposure on Cognitive Performance, Body Temperature, Heart Rate and Blood Pressure of Malaysians

Malek F, Rani KA, Rahim HA, Omar MH

Sci Rep, 2015;5:13206.
PMID: 26286015 DOI: 10.1038/srep13206

Individuals who report their sensitivity to electromagnetic fields often undergo cognitive impairments that they believe are due to the exposure of mobile phone technology. The aim of this study is to clarify whether short-term exposure at 1 V/m to the typical Global System for Mobile Communication and Universal Mobile Telecommunications System (UMTS) affects cognitive performance and physiological parameters (body temperature, blood pressure and heart rate). This study applies counterbalanced randomizing single blind tests to determine if sensitive individuals experience more negative health effects when they are exposed to base station signals compared with sham (control) individuals. The sample size is 200 subjects with 50.0% Idiopathic Environmental Intolerance attributed to electromagnetic fields (IEI-EMF) also known as sensitive and 50.0% (non-IEI-EMF). The computer-administered Cambridge Neuropsychological Test Automated Battery (CANTAB eclipse(TM)) is used to examine cognitive performance. Four tests are chosen to evaluate Cognitive performance in CANTAB: Reaction Time (RTI), Rapid Visual Processing (RVP), Paired Associates Learning (PAL) and Spatial Span (SSP). Paired sample t-test on the other hand, is used to examine the physiological parameters. Generally, in both groups, there is no statistical significant difference between the exposure and sham exposure towards cognitive performance and physiological effects (P's > 0.05).

Matched MeSH terms: Single-Blind Method
The impact of music guided deep breathing exercise on blood pressure control - A participant blinded randomised controlled study

Kow FP, Adlina B, Sivasangari S, Punithavathi N, Ng KK, Ang AH, et al.

Med J Malaysia, 2018 08;73(4):233-238.
PMID: 30121686 MyJurnal

INTRODUCTION: As pharmacological treatment of hypertension has become a burden worldwide, the study looked into nonpharmacological ways of reducing blood pressure. The objective was to determine if music guided, slow and deep breathing will reduce the blood pressure among patients with hypertension in eight weeks.
METHODS: A participant blinded, multi-centre, randomised controlled trial was conducted in which the participants in the intervention group (IG) practiced deep breathing exercise guided by sound cues and those in the control group (CG) listened to the music. The primary end point was reduction in blood pressure at eight weeks.
RESULTS: 87 patients, 46 males and 41 females with mean age of 61.1 years were recruited and 93.1% of them successfully completed the study. There was significant reduction in systolic and diastolic Blood Pressure from baseline by 8 weeks in both groups. The reduction in Mean systolic blood pressure (SBP) in the control arm was 10.5mmHg compared to 8.3mmHg (p<0.001) in intervention group. Diastolic blood pressure (DBP) reduction in control and intervention groups were 5.2 mmHg (p<0.001) and 5.6 mmHg (p<0.001) respectively. The absolute difference in SBP reduction from baseline in IG & CG was -2.2 (95%CI: -7.8 to 3.5) and DBP was -0.4 (95%CI: -2.9 to 3.6). However, blood pressure reduction between the two groups was not significant.
CONCLUSIONS: Both listening to music and deep breathing exercise were associated with a clinically significant reduction in SBP and DBP. However, deep breathing exercise did not augment the benefit of music in reducing BP.

Matched MeSH terms: Single-Blind Method
Fulltext Ascaris and Trichuris do not contribute to growth retardation in primary school children

Lai KP, Kaur H, Mathias RG, Ow-Yang CK

Southeast Asian J. Trop. Med. Public Health, 1995 Jun;26(2):322-8.
PMID: 8629068

To access the effectiveness of the treatment of soil-transmitted helminthiasis (STH) on the growth of primary school children, 353 children were block stratified to receive either mebendazole plus pyrantel oxantel pamoate every three months or a placebo. The children were followed for two years with 89% completing the trial. Follow-up stools indicated that the treatment was efficacious for ascariasis and trichuriasis. There was virtually no hookworm infection. The children were malnourished as measured by the number below -2 SD of height and weight standards. There was no difference in height or weight between the treatment and control groups by sex initially or at the end of two years of follow-up. The treatment of Ascaris and Trichuris had no effect on growth parameters. The effect of STH on growth may be mediated through hookworm infections.

Matched MeSH terms: Single-Blind Method
Comparison of Plaque Removal and Wear between Charcoal Infused Bristle and Nylon Bristle Toothbrushes: A Randomized Clinical Crossover Study

Kini V, Yadav S, Rijhwani JA, Farooqui A, Joshi AA, Phad SG

J Contemp Dent Pract, 2019 Mar 01;20(3):377-384.
PMID: 31204332

AIM: To compare plaque removal and wear between charcoal infused bristle toothbrushes (T1) and nylon bristle toothbrushes (T2) in a randomized clinical crossover study.
MATERIALS AND METHODS: A cross-over study was conducted in 2 phases of 6 weeks duration each with an intervening 2-week washout. Twenty-five participants meeting inclusion criteria were randomly allocated into groups A (13) and B (12). In phase 1: group A was assigned T1 and group B was assigned T2. Toothbrushing was advised twice daily for 2 minutes by modified bass technique after meals. At baseline, 3 weeks and 6 weeks the wear index (WI), plaque index (PI) and gingival index (GI) were recorded. Following washout in phase 2 group A was assigned T2 and group B was assigned T1 and the same study protocol was followed.
RESULTS: Intra-group comparison between baseline, 3 and 6 weeks by the paired t-test resulted in significant reduction in PI, GI and increase in WI (p <0.05) for T1 and T2. Inter-group comparison using the unpaired t-test resulted in WI for T1 being significantly higher (p <0.05) at 3 weeks and lower at 6 weeks (p <0.05) compared to T2. PI for T1 was significantly higher at 3 weeks (p <0.05) and lower at 6 weeks (p <0.05) compared to T2. No significant difference in GI scores between T1 and T2 at 3 and 6 weeks was observed (p >0.05).
CONCLUSION: Charcoal infused bristles demonstrated less wear and more plaque removal compared to nylon bristles.
CLINICAL SIGNIFICANCE: Charcoal infused bristles demonstrate less wear compared to nylon bristles.

Matched MeSH terms: Single-Blind Method
Comparison between the use of LMA™ and SLIPA™ in patients undergoing minor surgeries

Wan Rahiza, W.M., Nurlia, Y., Abd Rahman, I., Esa, K., Nadia, M.N., Raha, A. R.

Journal of Surgical Academia, 2012;2(1):8-13.
MyJurnal

Supraglottic airway devices have been used as safe alternatives to endotracheal intubation in appropriate types of surgery. This was a prospective, randomised, single blind study comparing the use of LMA™ and SLIPA™ in terms of ease of insertion, haemodynamic changes and occurrence of adverse effects (e.g. blood stains on the device upon removal and sore throat). A total of 62 ASA I or II patients, aged between 18 to 70 years were recruited for this study. Patients were randomised into two groups; LMA™ and SLIPA™ group. Following induction of anaesthesia, an appropriate sized LMA™ or SLIPA™ was inserted after ensuring adequate depth of anaesthesia. Anaesthesia was maintained with oxygen, nitrous oxide and sevoflurane. The ease of insertion was graded and haemodynamic changes were recorded at 2 minute intervals up to 10 minutes after insertion of the airway devices. The presence of blood stains upon airway device removal at the end of surgery and incidence of sore throat was also recorded. No difficult insertion was experienced in either of these devices. Insertion was either easy [LMA™ 87.1% versus SLIPA™ 80.6% (p = 0.49)] or moderate [LMA™ 12.9% versus SLIPA™ 19.4% (p = 0.16)]. Throughout the study period, the haemodynamic changes that occurred in both groups were not statistically different. Traces of blood were noted on the surface of the device in 9.7% of patients in the SLIPA™ group versus 6.5% of patients in the LMA™ group. The incidence of sore throat was recorded in 12.9% versus 19.4% of patients in the SLIPA™ and the LMA™ groups respectively. These findings were not statistically significant. In conclusion, this study showed no significant differences between the use of LMA™ and SLIPA™ in terms of ease of insertion, haemodynamic changes and adverse effects in patients undergoing minor surgical procedures.

Matched MeSH terms: Single-Blind Method
Fulltext Routine intraoperative forced-air warmer usage in prevention of perioperative hypothermia: to use or not to use in daycare breast lumpectomy?

Nadia, H.I., Raha, A.R.

Journal of Surgical Academia, 2015;5(1):34-43.
MyJurnal

Intraoperative active warming in daycare surgery may be least popular compared to major elective surgeries due to the lesser risk of perioperative hypothermia. This prospective, single blind, randomized, controlled trial in daycare breast lumpectomy was done to evaluate the routine use of intraoperative forced-air warmer in the presence of other warming modalities in prevention of perioperative hypothermia. Fifty patients were randomized into two groups; Group 1 received forced-air warmer and Group 2 received a standard cotton thermal blanket. Both groups received circulating-water mattress. Intraoperatively, all patients received pre-warmed intravenous fluid with an in-line warmer. Ear and ambient temperature was recorded using infrared ear thermometer and digital thermo-hygrometer respectively. Measurement was done before induction, every 15 minutes intraoperatively, upon arrival in recovery room and 30 mins later, postoperatively. All patients were normothermic prior to induction of anaesthesia. During the initial half an hour post-induction, both groups mean core temperature decreased at approximately 0 ̊.C5 . Both showed no statistical difference in mean core temperature (0.04 ̊C) within the initial half an hour. The next half an hour, both groups had approximately 0 ̊.C2 decrement but this time, Group 2 had a slightly higher mean core temperature than Group 1 which maintained until the end of surgery. Overall, within the initial one hour post- induction of GA, there was a drop of 0.7 ̊C and 0.6°C in Group 1 and Group 2 respectively, however the difference in final mean core temperature between the two groups was 0.05°C and it was not statistically significant (p value < 0.05). None of the patients experienced intraoperative hypothermia (< 36 ̊C) and all remained in the normothermic range with no shivering or sense of feeling cold, postoperatively. The results of the present study found no significant difference in the changes of final core temperature with or without the usage of intraoperative forced-air warmer in the presence of other warming measures in daycare breast lumpectomy.

Matched MeSH terms: Single-Blind Method
Fulltext Effect of sternal closure with biological bone adhesive on pain visual analogue score and serum cytokine

Hashim S, Chin LY, Krishnasamy S, Sthaneswar P, Raja Mokhtar RA

J Cardiothorac Surg, 2015;10:32.
PMID: 25890367 DOI: 10.1186/s13019-015-0230-0

Recently a biocompatible bone adhesive was introduced in addition to the sternal wires to expedite sternal union and improve patient recovery. In this study we aim to objectively assess the biomarker of pain in patient who received the biocompatible bone adhesive.

Matched MeSH terms: Single-Blind Method
Fulltext Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study

Abbott CA, Chatwin KE, Foden P, Hasan AN, Sange C, Rajbhandari SM, et al.

Lancet Digit Health, 2019 10;1(6):e308-e318.
PMID: 33323253 DOI: 10.1016/S2589-7500(19)30128-1

BACKGROUND: Prevention of diabetic foot ulcer recurrence in high risk patients, using current standard of care methods, remains a challenge. We hypothesised that an innovative intelligent insole system would be effective in reducing diabetic foot ulcer recurrence in such patients.
METHODS: In this prospective, randomised, proof-of-concept study, patients with diabetes, and with peripheral neuropathy and a recent history of plantar foot ulceration were recruited from two multidisciplinary outpatient diabetic foot clinics in the UK, and were randomly assigned to either intervention or control. All patients received an insole system, which measured plantar pressure continuously during daily life. The intervention group received audiovisual alerts via a smartwatch linked to the insole system and offloading instructions when aberrant pressures were detected; the control group did not receive any alerts. The primary outcome was plantar foot ulcer occurrence within 18 months. This trial is registered with ISRCTN, ISRCTN05585501, and is closed to accrual and complete.
FINDINGS: Between March 18, 2014, and Dec 20, 2016, 90 patients were recruited and consented to the study, and 58 completed the study. At follow-up, ten ulcers from 8638 person-days were recorded in the control group and four ulcers from 11 835 person-days in the intervention group: a 71% reduction in ulcer incidence in the intervention group compared with the control group (incidence rate ratio 0·29, 95% CI, 0·09-0·93; p=0·037). The number of patients who ulcerated was similar between groups (six of 26 [control group] vs four of 32 [intervention group]; p=0·29); however, individual plantar sites ulcerated more often in the control group (ten of 416) than in the intervention group (four of 512; p=0·047). In an exploratory analysis of good compliers (n=40), ulcer incidence was reduced by 86% in the intervention group versus control group (incidence rate ratio 0·14, 95% CI 0·03-0·63; p=0·011). In the exploratory analysis, plantar callus severity (change from baseline to 6 months) was greater in re-ulcerating patients (6·5, IQR 4·0-8·3) than non-re-ulcerating patients (2·0, 0·0-4·8; p=0·040).
INTERPRETATION: To our knowledge, this study is the first to show that continuous plantar pressure monitoring and dynamic offloading guidance, provided by an innovative intelligent insole system, can lead to a reduction in diabetic foot ulcer site recurrence.
FUNDING: Diabetes UK and Orpyx Medical Technologies.

Matched MeSH terms: Single-Blind Method
Fulltext The Malaysian Childhood Obesity Treatment Trial (MASCOT)

Sharifah WW, Nur HH, Ruzita AT, Roslee R, Reilly JJ

Malays J Nutr, 2011 Aug;17(2):229-36.
PMID: 22303576 MyJurnal

INTRODUCTION: The present study describes a randomised controlled trial (RCT) based on a novel, generalisable intervention for childhood obesity, comparing the intervention with a no-treatment control group.
METHOD: The Malaysian Childhood Obesity Treatment Trial (MASCOT) was a single-blind RCT of a dietetic treatment for childhood obesity in children of primary school age (7 to 11 years old) in Kuala Lumpur, Malaysia. The MASCOT comprising eight sessions, of an 8-hour family-centred group treatment programme is described, based on behavioural change techniques. The study sample was characterised by BMI z-score, health related quality of life reported by participants and their parents (PedsQL questionnaire), objectively measured habitual physical activity and sedentary behaviour (Actigraph accelerometry)
RESULTS: The MASCOT sample of 107 children was characterised by a low quality of life, mean total score on PedsQL 67.7 (4.5) as reported by the children, and 66.0 (16.4) as reported by their parents. The children spent, on average, 89% of their waking day on sedentary activity, and 1% of the day in moderate-vigorous intensity physical activity, equivalent to only around 8 minutes/day.
CONCLUSION: Obese children in the MASCOT study had an impaired quality of life, high levels of sedentary behaviour and very low levels of physical activity.

Matched MeSH terms: Single-Blind Method
Fulltext Effectiveness of teaching automated external defibrillators use using a traditional classroom instruction versus self-instruction video in non-critical care nurses

Saiboon IM, Qamruddin RM, Jaafar JM, Bakar AA, Hamzah FA, Eng HS, et al.

Saudi Med J, 2016 Apr;37(4):429-35.
PMID: 27052286 DOI: 10.15537/smj.2016.4.14833

To evaluate the effectiveness and retention of learning automated external defibrillator (AED) usage taught through a traditional classroom instruction (TCI) method versus a novel self instructed video (SIV) technique in non-critical care nurses (NCCN).

Matched MeSH terms: Single-Blind Method
Fulltext Local antibiotics are equivalent to intravenous antibiotics in the prevention of superficial wound infection in inguinal hernioplasty

Praveen S, Rohaizak M

Asian J Surg, 2009 Jan;32(1):59-63.
PMID: 19321405 DOI: 10.1016/S1015-9584(09)60011-7

Antibiotic prophylaxis for inguinal hernioplasty is still practiced in many hospitals to prevent consequences of infected mesh, mesh removal and hernia recurrence. The common route of administration is intravenous. However this method can be associated with systemic side effects. Alternatively, locally applied antibiotics have been used and proven to significantly reduce the infection rate after inguinal hernioplasty.

Matched MeSH terms: Single-Blind Method
A cluster randomised controlled trial on effectiveness of carbon monoxide measurement feedback among college smoker : A study protocol

Muhammad Aidil ZA, Hayati K, Rosliza AM

Med J Malaysia, 2019 02;74(1):62-66.
PMID: 30846665

INTRODUCTION: For the last 30 years, tobacco smoking has continued to be the leading cause of premature deaths in Malaysia. Majority of the smokers in Malaysia are at the precontemplation and contemplation stages. Therefore, for the purpose of increasing smoking cessation among this group, the strategies that motivate them to quit smoking have to be reviewed.
OBJECTIVE: This study aims to evaluate the effectiveness of carbon monoxide measurement feedback and the standard brief motivation adopted to encourage the smoker to quit.
METHODS: A single-blind, cluster randomised controlled trial was conducted at ten tertiary colleges in Selangor. The study recruited young adult smokers at the precontemplation and contemplation stages. The subjects in the control group received a standard brief motivational strategy. On the other hand, the intervention group received additional carbon monoxide measurement and a motivational feedback module. A follow up was conducted at the first, third and sixth month to measure changes in smoking cessation stage. Subsequently, the secondary outcomes of a mean number of cigarette consumption and quit smoking attempt were analysed. A total of 160 subjects were required to detect the expected difference of 17% in primary outcomes between the groups. This study utilised Generalised Estimating Equations (GEE) to handle the clustering effects.
CONCLUSION: Biomedical risk assessment feedback mechanism by using carbon monoxide is a promising aid to motivate the smoker to quit. This mechanism is a relatively easy, quick and non-invasive technique. Thus, it can be utilised as a reinforcement relating to the harmful effect of smoking. Besides, it can also increase the smokers' selfefficacy and decisional balance to adopt behavioural changes.

Matched MeSH terms: Single-Blind Method

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