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A clinical and economic study of community-acquired pneumonia between single versus combination therapy

Hasali MA, Ibrahim MI, Sulaiman SA, Ahmad Z, Hasali JB

Pharm World Sci, 2005 Jun;27(3):249-53.
PMID: 16096896

BACKGROUND: Pneumonia is one of the leading causes of morbidity and mortality among children in many developing countries. It is reported that 12.9 million children under 5 years of age died world-wide in 1990 and one-third of these deaths or 4.3 million annually were attributed to acute respiratory infection with pneumonia.
OBJECTIVES: On this basis, a study was conducted in a district hospital to study the therapy outcomes of antibiotic regimens used in pediatric community-acquired pneumonia (CAP) management and to conduct a cost-effectiveness analysis (CE) between IV ampicillin versus combination therapy of IV ampicillin and IV gentamicin.
METHOD: A prospective, randomized, controlled, single blind study was conducted in a pediatric ward in a 80-bed district hospital. Pediatric patients diagnosed with CAP aged 2 months to 5 years old were randomly and equally divided into two treatment arms: ampicillin versus ampicillin plus gentamicin. The dose of IV ampicillin used in this study was 100 mg/kg/day divided every 6 h and 5 mg/kg of IV gentamicin as a single daily dose. Both clinical and economic evaluations were carried out to compare both treatment arms.
RESULTS: With the inclusion and exclusion criteria, only 40 patients diagnosed with CAP were included in the study. The results showed that the two treatment arms were significantly different (P < 0.05) in terms of duration of patients on ampicillin, number of days of hospitalization and time to switch to oral therapy. A significant difference was noted between the two treatment modalities in terms of effectiveness and cost (P < 0.05).
CONCLUSION: Overall, the endpoint of this study showed that the total cost per patient of ampicillin-treated group is cheaper than the total cost with the combination therapy (ampicillin plus gentamicin) and reduced unnecessary exposure to adverse effects or toxicities. Besides that, addition of gentamicin in the treatment modalities will only increase the cost of treatment without introducing any changes in the treatment outcome.

Matched MeSH terms: Double-Blind Method
Fulltext Weight Maintenance with Litramine (IQP-G-002AS): A 24-Week Double-Blind, Randomized, Placebo-Controlled Study

Grube B, Chong PW, Alt F, Uebelhack R

J Obes, 2015;2015:953138.
PMID: 26435849 DOI: 10.1155/2015/953138

Litramine (IQP-G-002AS) was shown to be effective and safe for weight loss in overweight and obese subjects. However, long-term effectiveness on maintenance of body weight loss has yet to be ascertained.

Matched MeSH terms: Double-Blind Method
Effect of supplementation of fermented milk drink containing probiotic Lactobacillus casei Shirota on the concentrations of aflatoxin biomarkers among employees of Universiti Putra Malaysia: a randomised, double-blind, cross-over, placebo-controlled study

Mohd Redzwan S, Abd Mutalib MS, Wang JS, Ahmad Z, Kang MS, Abdul Rahman N', et al.

Br J Nutr, 2016 Jan 14;115(1):39-54.
PMID: 26490018 DOI: 10.1017/S0007114515004109

Human exposure to aflatoxin is through the diet, and probiotics are able to bind aflatoxin and prevent its absorption in the small intestine. This study aimed to determine the effectiveness of a fermented milk drink containing Lactobacillus casei Shirota (LcS) (probiotic drink) to prevent aflatoxin absorption and reduce serum aflatoxin B1-lysine adduct (AFB1-lys) and urinary aflatoxin M1 concentrations. The present study was a randomised, double-blind, cross-over, placebo-controlled study with two 4-week intervention phases. In all, seventy-one subjects recruited from the screening stage were divided into two groups--the Yellow group and the Blue group. In the 1st phase, one group received probiotic drinks twice a day and the other group received placebo drinks. Blood and urine samples were collected at baseline, 2nd and 4th week of the intervention. After a 2-week wash-out period, the treatments were switched between the groups, and blood and urine samples were collected at the 6th, 8th and 10th week (2nd phase) of the intervention. No significant differences in aflatoxin biomarker concentrations were observed during the intervention. A within-group analysis was further carried out. Aflatoxin biomarker concentrations were not significantly different in the Yellow group. Nevertheless, ANOVA for repeated measurements indicated that AFB1-lys concentrations were significantly different (P=0·035) with the probiotic intervention in the Blue group. The 2nd week AFB1-lys concentrations (5·14 (SD 2·15) pg/mg albumin (ALB)) were significantly reduced (P=0·048) compared with the baseline (6·24 (SD 3·42) pg/mg ALB). Besides, the 4th week AFB1-lys concentrations were significantly lower (P<0·05) with probiotic supplementation than with the placebo. Based on these findings, a longer intervention study is warranted to investigate the effects of continuous LcS consumption to prevent dietary aflatoxin exposure.

Matched MeSH terms: Double-Blind Method
Fulltext Polymer-free drug-coated coronary stents in patients at high bleeding risk

Urban P, Meredith IT, Abizaid A, Pocock SJ, Carrié D, Naber C, et al.

N Engl J Med, 2015 Nov 19;373(21):2038-47.
PMID: 26466021 DOI: 10.1056/NEJMoa1503943

BACKGROUND: Patients at high risk for bleeding who undergo percutaneous coronary intervention (PCI) often receive bare-metal stents followed by 1 month of dual antiplatelet therapy. We studied a polymer-free and carrier-free drug-coated stent that transfers umirolimus (also known as biolimus A9), a highly lipophilic sirolimus analogue, into the vessel wall over a period of 1 month.
METHODS: In a randomized, double-blind trial, we compared the drug-coated stent with a very similar bare-metal stent in patients with a high risk of bleeding who underwent PCI. All patients received 1 month of dual antiplatelet therapy. The primary safety end point, tested for both noninferiority and superiority, was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy end point was clinically driven target-lesion revascularization.
RESULTS: We enrolled 2466 patients. At 390 days, the primary safety end point had occurred in 112 patients (9.4%) in the drug-coated-stent group and in 154 patients (12.9%) in the bare-metal-stent group (risk difference, -3.6 percentage points; 95% confidence interval [CI], -6.1 to -1.0; hazard ratio, 0.71; 95% CI, 0.56 to 0.91; P<0.001 for noninferiority and P=0.005 for superiority). During the same time period, clinically driven target-lesion revascularization was needed in 59 patients (5.1%) in the drug-coated-stent group and in 113 patients (9.8%) in the bare-metal-stent group (risk difference, -4.8 percentage points; 95% CI, -6.9 to -2.6; hazard ratio, 0.50; 95% CI, 0.37 to 0.69; P<0.001).
CONCLUSIONS: Among patients at high risk for bleeding who underwent PCI, a polymer-free umirolimus-coated stent was superior to a bare-metal stent with respect to the primary safety and efficacy end points when used with a 1-month course of dual antiplatelet therapy. (Funded by Biosensors Europe; LEADERS FREE ClinicalTrials.gov number, NCT01623180.).

Matched MeSH terms: Double-Blind Method
Fulltext A Double-Blind Randomized Controlled Trial Investigating the Most Efficacious Dose of Botulinum Toxin-A for Sialorrhea Treatment in Asian Adults with Neurological Diseases

Mazlan M, Rajasegaran S, Engkasan JP, Nawawi O, Goh KJ, Freddy SJ

Toxins (Basel), 2015 Sep;7(9):3758-70.
PMID: 26402703 DOI: 10.3390/toxins7093758

This study aims to determine the most efficacious dose of Botulinum neurotoxin type A (BoNT-A) in reducing sialorrhea in Asian adults with neurological diseases. A prospective, double-blind randomized controlled trial was conducted over 24 weeks. Thirty patients with significant sialorrhea were randomly assigned to receive a BoNT-A (Dysport(®)) injection into the submandibular and the parotid glands bilaterally via an ultrasound guidance. The total dose given per patient was either BoNT-A injection of (i) 50 U; (ii) 100 U; or (iii) 200 U. The primary outcome was the amount of saliva reduction, measured by the differential weight (wet versus dry) of intraoral dental gauze at baseline and at 2, 6, 12, and 24 weeks after injection. The secondary outcome was the subjective report of drooling using the Drooling Frequency and Severity Scale (DFS). Saliva reduction was observed in response to all BoNT-A doses in 17 patients who completed the assessments. Although no statistically significant difference among the doses was found, the measured reduction was greater in groups that received higher doses (100 U and 200 U). The group receiving 200 U of Dysport(®) showed the greatest reduction of saliva until 24 weeks and reported the most significant improvement in the DFS score.

Matched MeSH terms: Double-Blind Method
Fulltext Blood-pressure lowering in intermediate-risk persons without cardiovascular disease

Lonn EM, Bosch J, López-Jaramillo P, Zhu J, Liu L, Pais P, et al.

N Engl J Med, 2016 May 26;374(21):2009-20.
PMID: 27041480 DOI: 10.1056/NEJMoa1600175

BACKGROUND: Antihypertensive therapy reduces the risk of cardiovascular events among high-risk persons and among those with a systolic blood pressure of 160 mm Hg or higher, but its role in persons at intermediate risk and with lower blood pressure is unclear.
METHODS: In one comparison from a 2-by-2 factorial trial, we randomly assigned 12,705 participants at intermediate risk who did not have cardiovascular disease to receive either candesartan at a dose of 16 mg per day plus hydrochlorothiazide at a dose of 12.5 mg per day or placebo. The first coprimary outcome was the composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke; the second coprimary outcome additionally included resuscitated cardiac arrest, heart failure, and revascularization. The median follow-up was 5.6 years.
RESULTS: The mean blood pressure of the participants at baseline was 138.1/81.9 mm Hg; the decrease in blood pressure was 6.0/3.0 mm Hg greater in the active-treatment group than in the placebo group. The first coprimary outcome occurred in 260 participants (4.1%) in the active-treatment group and in 279 (4.4%) in the placebo group (hazard ratio, 0.93; 95% confidence interval [CI], 0.79 to 1.10; P=0.40); the second coprimary outcome occurred in 312 participants (4.9%) and 328 participants (5.2%), respectively (hazard ratio, 0.95; 95% CI, 0.81 to 1.11; P=0.51). In one of the three prespecified hypothesis-based subgroups, participants in the subgroup for the upper third of systolic blood pressure (>143.5 mm Hg) who were in the active-treatment group had significantly lower rates of the first and second coprimary outcomes than those in the placebo group; effects were neutral in the middle and lower thirds (P=0.02 and P=0.009, respectively, for trend in the two outcomes).
CONCLUSIONS: Therapy with candesartan at a dose of 16 mg per day plus hydrochlorothiazide at a dose of 12.5 mg per day was not associated with a lower rate of major cardiovascular events than placebo among persons at intermediate risk who did not have cardiovascular disease. (Funded by the Canadian Institutes of Health Research and AstraZeneca; ClinicalTrials.gov number, NCT00468923.).
Note: Malaysia is a study site (Author: Yusoff K)

Matched MeSH terms: Double-Blind Method
Fulltext Cholesterol lowering in intermediate-risk persons without cardiovascular disease

Yusuf S, Bosch J, Dagenais G, Zhu J, Xavier D, Liu L, et al.

N Engl J Med, 2016 May 26;374(21):2021-31.
PMID: 27040132 DOI: 10.1056/NEJMoa1600176

BACKGROUND: Previous trials have shown that the use of statins to lower cholesterol reduces the risk of cardiovascular events among persons without cardiovascular disease. Those trials have involved persons with elevated lipid levels or inflammatory markers and involved mainly white persons. It is unclear whether the benefits of statins can be extended to an intermediate-risk, ethnically diverse population without cardiovascular disease.
METHODS: In one comparison from a 2-by-2 factorial trial, we randomly assigned 12,705 participants in 21 countries who did not have cardiovascular disease and were at intermediate risk to receive rosuvastatin at a dose of 10 mg per day or placebo. The first coprimary outcome was the composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, and the second coprimary outcome additionally included revascularization, heart failure, and resuscitated cardiac arrest. The median follow-up was 5.6 years.
RESULTS: The overall mean low-density lipoprotein cholesterol level was 26.5% lower in the rosuvastatin group than in the placebo group. The first coprimary outcome occurred in 235 participants (3.7%) in the rosuvastatin group and in 304 participants (4.8%) in the placebo group (hazard ratio, 0.76; 95% confidence interval [CI], 0.64 to 0.91; P=0.002). The results for the second coprimary outcome were consistent with the results for the first (occurring in 277 participants [4.4%] in the rosuvastatin group and in 363 participants [5.7%] in the placebo group; hazard ratio, 0.75; 95% CI, 0.64 to 0.88; P<0.001). The results were also consistent in subgroups defined according to cardiovascular risk at baseline, lipid level, C-reactive protein level, blood pressure, and race or ethnic group. In the rosuvastatin group, there was no excess of diabetes or cancers, but there was an excess of cataract surgery (in 3.8% of the participants, vs. 3.1% in the placebo group; P=0.02) and muscle symptoms (in 5.8% of the participants, vs. 4.7% in the placebo group; P=0.005).
CONCLUSIONS: Treatment with rosuvastatin at a dose of 10 mg per day resulted in a significantly lower risk of cardiovascular events than placebo in an intermediate-risk, ethnically diverse population without cardiovascular disease. (Funded by the Canadian Institutes of Health Research and AstraZeneca; HOPE-3 ClinicalTrials.gov number, NCT00468923.).
Note: Malaysia is a study site (Author: Yusoff K)

Matched MeSH terms: Double-Blind Method
Effect of multi-strain probiotics (multi-strain microbial cell preparation) on glycemic control and other diabetes-related outcomes in people with type 2 diabetes: a randomized controlled trial

Firouzi S, Majid HA, Ismail A, Kamaruddin NA, Barakatun-Nisak MY

Eur J Nutr, 2017 Jun;56(4):1535-1550.
PMID: 26988693 DOI: 10.1007/s00394-016-1199-8

AIM: Evidence of a possible connection between gut microbiota and several physiological processes linked to type 2 diabetes is increasing. However, the effect of multi-strain probiotics in people with type 2 diabetes remains unclear. This study investigated the effect of multi-strain microbial cell preparation-also refers to multi-strain probiotics-on glycemic control and other diabetes-related outcomes in people with type 2 diabetes.
DESIGN: A randomized, double-blind, parallel-group, controlled clinical trial.
SETTING: Diabetes clinic of a teaching hospital in Kuala Lumpur, Malaysia.
PARTICIPANTS: A total of 136 participants with type 2 diabetes, aged 30-70 years, were recruited and randomly assigned to receive either probiotics (n = 68) or placebo (n = 68) for 12 weeks.
OUTCOMES: Primary outcomes were glycemic control-related parameters, and secondary outcomes were anthropomorphic variables, lipid profile, blood pressure and high-sensitivity C-reactive protein. The Lactobacillus and Bifidobacterium quantities were measured before and after intervention as an indicator of successful passage of the supplement through gastrointestinal tract.
STATISTICAL ANALYSIS: Intention-to-treat (ITT) analysis was performed on all participants, while per-protocol (PP) analysis was performed on those participants who had successfully completed the trial with good compliance rate.
RESULTS: With respect to primary outcomes, glycated hemoglobin decreased by 0.14 % in the probiotics and increased by 0.02 % in the placebo group in PP analysis (p

Matched MeSH terms: Double-Blind Method
Microbial cell preparation in enteral feeding in critically ill patients: A randomized, double-blind, placebo-controlled clinical trial

Malik AA, Rajandram R, Tah PC, Hakumat-Rai VR, Chin KF

J Crit Care, 2016 Apr;32:182-8.
PMID: 26777745 DOI: 10.1016/j.jcrc.2015.12.008

Gut failure is a common condition in critically ill patients in the intensive care unit (ICU). Enteral feeding is usually the first line of choice for nutrition support in critically ill patients. However, enteral feeding has its own set of complications such as alterations in gut transit time and composition of gut eco-culture. The primary aim of this study was to investigate the effect of microbial cell preparation on the return of gut function, white blood cell count, C-reactive protein levels, number of days on mechanical ventilation, and length of stay in ICU. A consecutive cohort of 60 patients admitted to the ICU in University Malaya Medical Centre requiring enteral feeding were prospectively randomized to receive either treatment (n = 30) or placebo (n = 30). Patients receiving enteral feeding supplemented with a course of treatment achieved a faster return of gut function and required shorter duration of mechanical ventilation and shorter length of stay in the ICU. However, inflammatory markers did not show any significant change in the pretreatment and posttreatment groups. Overall, it can be concluded that microbial cell preparation enhances gut function and the overall clinical outcome of critically ill patients receiving enteral feeding in the ICU.

Matched MeSH terms: Double-Blind Method
Fulltext Randomized Controlled Trial on the Effect of Channa striatus Extract on Measurement of the Uterus, Pulsatility Index, Resistive Index of Uterine Artery and Superficial Skin Wound Artery in Post Lower Segment Caesarean Section Women

Abu Bakar MR, Abdul Kadir A, Abdul Wahab SZ, Abdul Karim AH, Nik Hussain NH, Mohd Noor N, et al.

PLoS One, 2015;10(7):e0133514.
PMID: 26222158 DOI: 10.1371/journal.pone.0133514

AIM: To compare the mean of anteroposterior (AP) measurements of the uterus in longitudinal and oblique transverse planes, and the pulsatility index (PI) and resistive index (RI) of the uterine artery and superficial skin wound artery between patients taking Channa striatus and placebo.
BACKGROUND: Channa striatus, also known as haruan, is a fresh water snakehead fish consumed in many parts of Southeast Asia. Channa striatus is also normally consumed by women postpartum to promote wound healing as well as to reduce post-operative pain.
METHODOLOGY: This study is a randomised, double blind, placebo-controlled study conducted in women after Lower Segment Caesarean Section (LSCS). Subjects were randomised to either a Channa striatus or a placebo group and were given a daily dosage of 500 mg of Channa striatus extract or 500 mg maltodextrin, respectively, for six weeks post LSCS. The anteroposterior measurements of the uterus in the longitudinal and oblique transverse planes, and the pulsatility index (PI) and resistive index (RI) of the uterine and superficial skin wound arteries were assessed using pelvic Gray-scale ultrasound and Doppler ultrasound at baseline (Day 3) and at two weeks, four weeks and six weeks post-operatively.
RESULTS: Sixty-six subjects were randomised into the study with 33 in the Channa striatus group and 33 in the placebo group. No significant differences were detected in terms of the pulsatility index (PI) and the resistive index (RI) of the uterine and superficial skin wound arteries between the Channa striatus and placebo groups. However, in the Channa striatus group, the AP measurements of the uterus on the longitudinal and oblique transverse planes were significantly lower compared to the placebo group (p<0.05 and p<0.001, respectively).
CONCLUSION: Daily intake of Channa striatus extract results in marked differences compared to placebo in terms of uterine involution and recovery in women post LSCS.
TRIAL REGISTRATION: www.isrctn.com 11960786.

Matched MeSH terms: Double-Blind Method
Fulltext Magnetic stimulation for stress urinary incontinence: study protocol for a randomized controlled trial

Lim R, Liong ML, Leong WS, Khan NA, Yuen KH

Trials, 2015;16:279.
PMID: 26093910 DOI: 10.1186/s13063-015-0803-1

There is currently a lack of randomized, sham-controlled trials that are adequately powered, using validated outcomes, to allow for firm recommendations on the use of magnetic stimulation for stress urinary incontinence. We report a protocol of a multicenter, randomized, double-blind, sham-controlled parallel-group trial to evaluate the efficacy of magnetic stimulation for stress urinary incontinence.

Matched MeSH terms: Double-Blind Method
Addition of inhaled salmeterol to inhaled corticosteroids in patients with poorly controlled nocturnal asthma

Norhaya MR, Yap TM, Zainudin BM

Respirology, 1999 Mar;4(1):77-81.
PMID: 10339734 DOI: 10.1046/j.1440-1843.1999.00153.x

The effect of adding inhaled salmeterol to inhaled corticosteroids was studied in patients with poorly controlled nocturnal asthma. In a double-blind, cross-over study, 20 patients were randomized to receive either salmeterol 50 micrograms twice daily or placebo via a Diskhaler after a 1-week run-in period. After 4 weeks of treatment, patients were subsequently crossed over to receive the other treatment for a further 4 weeks with a 2-week wash-out period in between. The response to treatment was assessed by peak expiratory flow rates (PEF) measured in the morning and evening, symptom scores of asthma, number of bronchodilators used, forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) at regular intervals. Patients' preference for the Diskhaler or metered-dose inhaler was assessed at the last visit. The results showed that morning PEF was significantly higher while on salmeterol than on placebo (296.9 +/- 70.2 vs 274.6 +/- 77.4 L/min). Evening PEF showed a trend towards a higher value while on salmeterol than on placebo (321.1 +/- 73.4 vs 288.7 +/- 79.4 L/min), but the difference was not significant. There was no statistically significant improvement in symptom scores, number of rescue bronchodilators used and FEV1 or FVC between the two treatment groups. The occurrence of side effects in terms of tremors and palpitations between treatment and placebo were similar. There were more patients who preferred Diskhaler to metered-dose inhaler (70% vs 30%). We conclude that salmeterol 50 micrograms twice daily produces significant improvement in morning PEF and is well tolerated in patients with nocturnal asthma. Diskhaler is a device which is easy to use and preferred to a metered-dose inhaler.
Study site: Respiratory Clinic, Pusat Perubatan Universiti Kebangsaan Malaysia (PPUKM), Kuala Lumpur, Malaysia

Matched MeSH terms: Double-Blind Method
The effect of prophylactic metaraminol on systemic hypotension caused by induction of anaesthesia with propofol in patients over 55 years old

Chiu CL, Tew GP, Wang CY

Anaesthesia, 2001 Sep;56(9):893-7.
PMID: 11531679

We conducted a double-blind, randomised, placebo-controlled study evaluating the efficacy of prophylactic metaraminol for preventing propofol-induced hypotension. Thirty patients aged 55-75 years undergoing general anaesthesia were randomly allocated to receive either metaraminol 0.5 mg or saline before administration of fentanyl 1 microg.kg(-1) and propofol 2 mg.kg(-1). Induction of anaesthesia was associated with a decrease in mean and systolic arterial pressure in both groups (p = 0.0001). However, there was no significant difference between the two groups. These results show that prophylactic use of metaraminol 0.5 mg does not prevent the decrease in blood pressure following fentanyl and propofol induction in older patients.

Matched MeSH terms: Double-Blind Method
Effect of angiotensin II on pulse wave velocity in humans is mediated through angiotensin II type 1 (AT(1)) receptors

Rehman A, Rahman AR, Rasool AH

J Hum Hypertens, 2002 Apr;16(4):261-6.
PMID: 11967720

The objective of this study was to examine the effect of angiotensin II (Ang II) and angiotensin II type 1 (AT(1)) receptor blockade on pulse wave velocity (PWV) in healthy humans. We studied nine young male volunteers in a double-blind randomised crossover design. Carotid-femoral PWV (an index of arterial stiffness) was measured by using a Complior machine. Subjects were previously treated for 3 days with once-daily dose of either a placebo or valsartan 80 mg. On the third day, they were infused with either placebo or 5 ng/kg/min of Ang II over 30 min. Subjects thus received placebo capsule + placebo infusion (P), valsartan + placebo infusion (V), placebo + Ang II infusion (A), and valsartan + Ang II infusion (VA) combinations. Heart rate (HR), blood pressure and PWV were recorded at baseline and then every 10 min during infusion and once after the end of infusion. There were significant increases in systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressure (MAP) with A compared with P (P = 0.002, P = 0.002, P = 0.001 respectively). These rises in blood pressure were completely blocked by valsartan. A significant rise in PWV by A was seen compared with P (8.38 +/- 0.24 vs 7.48 +/- 0.24 m/sec, P = 0.013) and was completely blocked by valsartan; VA compared with P (7.27 +/- 0.24 vs 7.48 +/- 0.24 m/sec, P = NS). Multiple linear regression analysis showed that blockade of Ang II induced increase in blood pressure by valsartan contributed to only 30% of the total reduction in Ang II induced rise in PWV (R(2) = 0.306). The conclusions were that valsartan completely blocks the effect of Ang II on PWV. The effect of Ang II on PWV is mediated through AT(1)receptors. Reduction in PWV by Ang II antagonist is not fully explained by its pressure lowering effect of Ang II and may be partially independent of its effect on blood pressure.

Matched MeSH terms: Double-Blind Method
Intubation without muscle relaxant: an alternative technique for rapid tracheal intubation

Wong AK, Teoh GS

Anaesth Intensive Care, 1996 Apr;24(2):224-30.
PMID: 9133197

The quality of laryngoscopy and tracheal intubation with propofol augmented by alfentanil was investigated as an alternative technique for rapid tracheal intubation. 119 patients aged between 18 and 60 years (ASA 1 and 2) undergoing elective surgery were prospectively studied in a randomized double-blind controlled fashion. Tracheal intubation facilitated by suxamethonium 1.0 mg/kg alfentanil 15 mu g/kg alfentanil 30 mu g/kg or saline control was compared after propofol induction. The quality of laryngoscopy and intubation were graded according to jaw relaxation, ease of insertion of the endotracheal tube and coughing on intubation. Failure to intubate occurred in 4% and 17% with alfentanil 15 mu g/kg and saline control respectively Tracheal intubation was successful in all patients with alfentanil 30 mu g/kg and suxamethonium 1.0 mg/kg. Alfentanil 15 mu g/kg was not statistically significantly different from saline (P = 0.112). Alfentanil 30 mu g/kg provided similar overall intubating conditions (P = 0.5) to suxamethonium 1.0 mg/kg. Alfentanil in both dosages effectively attenuated the haemodynamic responses to laryngoscopy and tracheal intubation.

Matched MeSH terms: Double-Blind Method
The effect of mivacurium pretreatment on intra-ocular pressure changes induced by suxamethonium

Chiu CL, Lang CC, Wong PK, Delilkan AE, Wang CY

Anaesthesia, 1998 May;53(5):501-5.
PMID: 9659028

Forty patients without eye disease, undergoing elective nonophthalmic surgery, were studied in a double-blind, randomised, placebo-controlled study evaluating the efficacy of mivacurium pretreatment in attenuating the rise in intra-ocular pressure in response to suxamethonium administration, laryngoscopy and intubation. The patients were randomly allocated to receive either mivacurium 0.02 mg.kg-1 or normal saline as pretreatment 3 min before a rapid sequence induction technique using alfentanil, propofol and suxamethonium. Suxamethonium induced a significant increase in intra-ocular pressure in the control group but not in the mivacurium pretreatment group (mean (SEM) increase = 3.5 (1.2) mmHg vs. 0.4 (0.8) mmHg, p < 0.05). There was a decrease in intra-ocular pressure in both groups after laryngoscopy and intubation with no significant difference between the two groups. These results show that mivacurium pretreatment is effective in preventing the increase in intra-ocular pressure after suxamethonium administration.

Matched MeSH terms: Double-Blind Method
Trans (elaidic) fatty acids adversely affect the lipoprotein profile relative to specific saturated fatty acids in humans

Sundram K, Ismail A, Hayes KC, Jeyamalar R, Pathmanathan R

J Nutr, 1997 Mar;127(3):514S-520S.
PMID: 9082038

Although dietary trans fatty acids can affect plasma lipoproteins negatively in humans, no direct comparison with specific saturated fatty acids has been reported, even though trans fatty acids were designed to replace saturates in foods and food processing. In this study, dietary trans 18:1 [elaidic acid at 5.5% energy (en)] was specifically exchanged for cis 18:1, 16:0 or 12:0 + 14:0 in 27 male and female subjects consuming moderate fat (31% en), low cholesterol (<225 mg/d) whole food diets during 4-wk diet periods in a crossover design. The trans-rich fat significantly elevated total cholesterol and LDL cholesterol relative to the 16:0-rich and 18:1-rich fats and uniquely depressed HDL cholesterol relative to all of the fats tested. Trans fatty acids also elevated lipoprotein (a) [Lp(a)] values relative to all dietary treatments. Furthermore, identical effects on lipoproteins were elicited by 16:0 and cis 18:1 in these subjects. The current results suggest that elaidic acid, one of the principal trans isomers produced during industrial hydrogenation of edible oils, adversely affects plasma lipoproteins. Thus, the negative effect of elaidic acid on the lipoprotein profile of humans appears to be unmatched by any other natural fatty acid(s).

Matched MeSH terms: Double-Blind Method
A double-blind placebo-controlled trial of zopiclone 7.5 mg and temazepam 20 mg in insomnia

Ngen CC, Hassan R

Int Clin Psychopharmacol, 1990 Jul;5(3):165-71.
PMID: 2230060

Zopiclone, a cyclopyrrolone with hypnotic properties was compared with temazepam and placebo in the treatment of insomnia. After a week's washout period, suitable subjects were allocated at random to zopiclone 7.5 mg or temazepam 20 mg or placebo for 2 weeks. Measurements of psychomotor function using the Leed's psychomotor tester and letter cancellation were carried out on day 0, 7 and 14. Sleep latency, duration of sleep and number of times waking during the night were recorded on a sleep diary filled by the subjects nightly. Forty-four subjects completed the trial, 15 taking zopiclone, 16 taking temazepam and 10 taking placebo. Both zopiclone and temazepam had significant hypnotic properties when compared to placebo. Zopiclone increased total sleep time in both weeks of the trial while temazepam increased sleep time in the first week only. There was no significant deterioration in psychomotor performance at the end of both weeks for zopiclone. Critical flicker fusion was significantly increased in subjects on temazepam. There were no abnormalities for both zopiclone and temazepam subjects in the blood picture, renal profile, liver function, urine and ECG before and after the study. Zopiclone is an effective hypnotic comparable to temazepam.

Matched MeSH terms: Double-Blind Method
Fulltext A randomized half-body, double blind, controlled trial on the effects of a pH-modified moisturizer vs. standard moisturizer in mild to moderate atopic dermatitis

Goh SW, Jamil A, Safian N, Md Nor N, Muhammad N, Saharudin NL

An Bras Dermatol, 2020 03 21;95(3):320-325.
PMID: 32291095 DOI: 10.1016/j.abd.2019.11.007

BACKGROUND: Higher skin pH in atopic dermatitis contributes to impaired epidermal barrier. A moisturizer compatible with physiological pH could improve atopic dermatitis.
OBJECTIVE: To determine the effect of a physiologically compatible pH moisturizer in atopic dermatitis.
METHODS: A randomized half body, double blind, controlled trial involving patients with stable atopic dermatitis was performed. pH-modified moisturizer and standard moisturizer were applied to half body for 6 weeks.
RESULTS: A total of 6 (16.7%) males and 30 (83.3%) females participated. Skin pH reductions from week 0, week 2 and 6 were significant at the forearms (5.315 [0.98] to 4.85 [0.54] to 5.04 [0.78], p=0.02) and abdomen (5.25 [1.01], 4.82 [0.64], 5.01 [0.59], p=0.00) but not at the shins (5.01 [0.80], 4.76 [0.49], 4.85 [0.79], p=0.09) with pH-modified moisturizer. Transepidermal water loss (TEWL) at the forearms decreased (4.60 [2.55] to 3.70 [3.10] to 3.00 [3.55], p=0.00), abdomen (3.90 [2.90] to 2.40 [3.45] to 2.70 [2.25], p=0.046). SCORAD improved from 14.1±12.75 to 10.5±13.25 to 7±12.25, p=0.00. In standard moisturizer group, pH reductions were significant at the forearms (5.29 [0.94] to 4.84 [0.55] to 5.02 [0.70], p=0.00) and abdomen (5.25 [1.09], 4.91 [0.63], 5.12 [0.66], p=0.00). TEWL at the forearm were (4.80 [2.95], 4.10 [2.15], 4.60 [3.40], p=0.67), shins (3.80 [1.40], 3.50 [2.35], 4.00 [2.50], p=0.91) and abdomen (3.70 [2.45], 4.10 [3.60], 3.40 [2.95], p=0.80). SCORAD improved from 14.2±9.1 to 10.9±10.65 to 10.5±11, p=0.00. Reduction in pH was observed with both moisturizers while TEWL significantly improved with pH-modified moisturizer. pH-modified moisturizer resulted in greater pH, TEWL and SCORAD improvements however the differences were not significant from standard moisturizer.
STUDY LIMITATION: Skin hydration was not evaluated.
CONCLUSION: Moisturization is beneficial for atopic dermatitis; use of physiologically compatible pH moisturizer is promising.

Matched MeSH terms: Double-Blind Method
Comparison of posterior subthalamic area deep brain stimulation for tremor using conventional landmarks versus directly targeting the dentatorubrothalamic tract with tractography

Low HL, Ismail MNBM, Taqvi A, Deeb J, Fuller C, Misbahuddin A

Clin Neurol Neurosurg, 2019 Oct;185:105466.
PMID: 31466022 DOI: 10.1016/j.clineuro.2019.105466

OBJECTIVE: To compare posterior subthalamic area deep brain stimulation (PSA-DBS) performed in the conventional manner against diffusion tensor imaging and tractography (DTIT)-guided lead implantation into the dentatorubrothalamic tract (DRTT).
PATIENTS AND METHODS: Double-blind, randomised study involving 34 patients with either tremor-dominant Parkinson's disease or essential tremor. Patients were randomised to Group A (DBS leads inserted using conventional landmarks) or Group B (leads guided into the DRTT using DTIT). Tremor (Fahn-Tolosa-Marin) and quality-of-life (PDQ-39) scores were evaluated 0-, 6-, 12-, 36- and 60-months after surgery.
RESULTS: PSA-DBS resulted in marked tremor reduction in both groups. However, Group B patients had significantly better arm tremor control (especially control of intention tremor), increased mobility and activities of daily living, reduced social stigma and need for social support as well as lower stimulation amplitudes and pulse widths compared to Group A patients. The better outcomes were sustained for up to 60-months from surgery. The active contacts of Group B patients were consistently closer to the centre of the DRTT than in Group A. Speech problems were more common in Group A patients.
CONCLUSION: DTIT-guided lead placement results in better and more stable tremor control and fewer adverse effects compared to lead placement in the conventional manner. This is because DTIT-guidance allows closer and more consistent placement of leads to the centre of the DRTT than conventional methods.

Matched MeSH terms: Double-Blind Method

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