Clinical Effectiveness and Safety of Bairui Granules （百蕊颗粒） in Treating Patients with Acute Pharyngitis with Wind-Heat Syndrome： A Multi-Center， Double-Blind， Double-Simulation， Randomized Controlled Trial / 中医杂志

ObjectiveTo evaluate the clinical effectiveness and safety of Bairui Granules （百蕊颗粒） in the treatment of acute pharyngitis with wind-heat syndrome. MethodsA multicenter， double-blind， double-simulation， randomised controlled trial was conducted， in which 162 patients with acute pharyngitis and wind-heat syndrome from 7 centers were recruited， and each center was divided into trial group and control group on the ratio of 2∶1. In the trial group， 108 cases were orally administered with Bairui Granules plus Reyanning Granules （热炎宁颗粒） simulant， and in the control group， 54 cases were orally administered with Reyanning Granules plus Bairui Granules simulant for 5 days， with a follow-up visit on the 6th day. Full analysis set （FAS） analysis and per protocol set （PPS） were used for analysis， respectively. The primary efficacy index was the disappearance rate of sore throat after 5-day treatment； the secondary efficacy indexes were the disappearance rate of sore throat after 3-day treatment， as well as the visual analogue score （VAS） of sore throat before treatment， every day during the treatment， and follow-up on day 6， and the traditional Chinese medicine （TCM） syndrome score was performed before treatment and at the follow-up on day 6. The effectiveness on TCM syndrome was evaluated at the follow-up on day 6， and the changes of vital signs， blood routine， urine routine， liver functions， kidney function， the adverse events before and after the treatment were recorded， and safety analysis set （SS） was analysed. Results162 patients entered the FAS and SS analyses， and 158 cases （105 cases in the trial group and 53 cases in the control group） entered the PPS analysis. FAS analysis showed that the disappearance rate of sore throat after 5-day treatment was 80.56% （87/108） in the trial group and 64.81% （35/54） in the control group， and the difference between groups was statistically significant （χ2 = 5.10， P = 0.0239）. PPS analysis showed that the disappearance rate of sore throat after 5-day treatment was 80.00% （84/105） in the trial group and 64.15% （34/53） in the control group， and the difference between groups was statistically significant （χ2 =4.85， P = 0.0277）. FAS and SS analyses both showed that the difference in disappearance rate of sore throat between groups on 3-day treatment was not statistically significant （P＞0.05）. Compared with those before treatment， the VAS scores of sore throat were lower in both groups during treatment on day 2， 3， 4， 5， and follow-up on day 6 （P＜0.01）， but the difference between groups at each time point was not statistically significant （P＞0.05）. TCM syndrome scores of both groups at the follow-up were lower than that before treatment， and those of the trial group were lower than those of the control group （P＜0.01）. The cure rate and effective rate of TCM syndrome of the trial group were significantly higher than those of the control group （P＜0.01）. There was no significant difference in blood routine， urine routine， liver function， kidney function between groups before and after treatment （P＞0.05）， and no serious adverse events occured in both groups. ConclusionBairui Granules showed clinical effectiveness in the treatment of acute pharyngitis of wind-heat syndrome， and it could significantly improve the clinical symptoms， accelerate the disappearance time of sore throat with good safety.

Effect size varies based on calculation method and may affect interpretation of treatment effect: an illustration using randomised clinical trials in osteoarthritis

Abstract Background To illustrate how (standardised) effect sizes (ES) vary based on calculation method and to provide considerations for improved reporting. Methods Data from three trials of tanezumab in subjects with osteoarthritis were analyzed. ES of tanezumab versus comparator for WOMAC Pain (outcome) was defined as least squares difference between means (mixed model for repeated measures analysis) divided by a pooled standard deviation (SD) of outcome scores. Three approaches to computing the SD were evaluated: Baseline (the pooled SD of WOMAC Pain values at baseline [pooled across treatments]); Endpoint (the pooled SD of these values at the time primary endpoints were assessed); and Median (the median pooled SD of these values based on the pooled SDs across available timepoints). Bootstrap analyses were used to compute 95% confidence intervals (CI). Results ES (95% CI) of tanezumab 2.5 mg based on Baseline, Endpoint, and Median SDs in one study were - 0.416 (- 0.796, - 0.060), - 0.195 (- 0.371, - 0.028), and - 0.196 (- 0.373, - 0.028), respectively; negative values indicate pain improvement. This pattern of ES differences (largest with Baseline SD, smallest with Endpoint SD, Median SD similar to Endpoint SD) was consistent across all studies and doses of tanezumab. Conclusion Differences in ES affect interpretation of treatment effect. Therefore, we advocate clearly reporting individual elements of ES in addition to its overall calculation. This is particularly important when ES estimates are used to determine sample sizes for clinical trials, as larger ES will lead to smaller sample sizes and potentially underpowered studies. Trial Registration Clinicaltrials.gov NCT02697773, NCT02709486, and NCT02528188.

Comparative efficacy and safety of six photoelectric therapies for the atrophic acne scars: A network meta-analysis

Objectives: This network meta-analysis assessed the relative efficacy and safety of six common photoelectric therapies including 1064-nm neodymium-doped yttrium aluminum garnet (Nd: YAG), fractional carbon dioxide laser(FSCO2), fractional micro-plasma radiofrequency(Plasma), micro-needling fractional radiofrequency (MRF), 1550nm or 1540nm erbium-glass non-ablative fractional laser (NAFL) fractional erbium-doped yttrium aluminum garnet (Er: YAG). Methods: A comprehensive search to identify relevant studies was conducted using four electronic databases. Outcome measures were extracted based on subjective and objective indexes, including the dermatologists’ evaluation(DE), the patients’ overall satisfaction(PS), VAS score, and Postinflammatory hyperpigmentation (PIH). Results: Eleven published clinical research studies, involving 405 patients were included in this study. Ranking of DE from large to small is as follows: Nd: YAG, FSCO2, Er: YAG, Plasma, NAFL, MRF. In terms of PS, the rand from high to low can be described as follows: Er: YAG, Nd: YAG, FSCO2, Plasma, NAFL, MRF. In connection with the sequencing of adverse events, pain severity from slight to severe as follows: Er:YAG, Nd:YAG, FSCO2, NAFL, MRF, Plasma. The probability of having PIH are presented in order from lowest to highest as follows: MRF, Plasma, Nd: YAG, NAFL, Er: YAG, FSCO2. Conclusion: FSCO2 remains the mainstream of potentially curative treatment, then again Nd: YAG and Er: YAG require greater efforts to prove their superior effectiveness. NAFL might be appropriate for mild and moderate improvement with its strengths of good tolerance while Plasma fits into patients with higher pain thresholds but an expectation of higher results. MRF has not given expression on absolute predominance for the present. Registration: PROSPERO CRD42021242160(available from https://www.crd.york.ac.uk/PROSPERO)

Short-Term Effectiveness of Sand Bag Breathing Technique on Subjects with Mechanical Low Back Pain-A Randomized Controlled Trial

Background: Mechanical low back pain is a common cumulative musculoskeletal problem if left untreated may cause severe derangements in the spine leading to excruciating pain. The diaphragm forms a major part of the core muscle, which has a connection with obliques, rectus abdominis and transverses abdominis which further connects with latissimus dorsii and other back extensors via spiral muscle sling. Sand Bag breathing technique a type of PNF is well understood in treating respiratory disorders like asthma and COPD as it helps in the relaxation of the muscles and improves the efficiency of the respiratory muscles, thus having a positive effect on breathing. Dirth in the literature suggests that less studies have been conducted demonstrating the effects of San Bag Breathing on low back ache. Hence this study is been undertaken. Objective: To investigate the Effectiveness of Sand Bag Breathing in subjects with mechanical low back pain. Methodology: This is a randomized controlled trial conducted on mechanical low back pain 50 subjects who were divided into two groups; experimental and control. Results: Results indicated that therapy was statistically significant in the outcome measures: Pain (0.05 and 0.05), Resting Muscle thickness of Multifidus (<0.05 and 0.214), Kinesiophobia (0.05 and 0.765) and modified Oswestry disability questionnaire (0.05 and 0.212) for experimental and control group respectively. Conclusion: The Sand Bag Breathing Technique showed a significant effect in, improving the parameters related to mechanical low back pain thus suggesting it to be used as a protocol for treating subjects with back aches.

Diabetes prevention through digital therapy for highrisk individuals: Study protocol for the Malaysia Diabetes Prevention Programme (MyDiPP)

@#Introduction: Intervention approaches that integrate human coaching into technology are considered as a convenient, accessible and scalable method to reach a larger population at risk. The objective of this paper is to present the protocol for a randomised controlled trial that evaluates the efficacy of a lifestyle intervention programme via a mobile phone app (MyDiPP), which aims to prevent diabetes among adults at risk of developing diabetes. Methods: MyDiPP intervention is to be delivered for 12 months with multiple approaches (weight loss, dietary modification, physical activity, and quality of life). Eligible adults aged 18-65 years, overweight/obese (body mass index, BMI ≥ 23kg/m2), and at high risk of type 2 diabetes [American Diabetes Association (ADA) Diabetes Risk Score ≥5, or haemoglobin A1c (HbA1c) of 5.6-6.2%], will be randomly assigned to one of two study groups (intervention or usual care control groups) in a 1:1 ratio using simple randomisation. Results: Changes in weight and HbA1c level (primary outcomes), and changes in physical activity level, dietary intake, and quality of life (secondary outcomes) will be assessed at 6 and 12 months. Conclusion: This study protocol describes the first digital therapy for diabetes prevention in Malaysia, which will determine whether the effect of this intervention is larger than the effect of usual care in reducing body weight and HbA1c level, and improving dietary intake, physical activity, and quality of life of high-risk individuals. Results from this trial may be useful for preventing type 2 diabetes mellitus in Malaysia.

Clinical effects of aseptic gauze dressing vs alginate dressing on PICC puncture site in breast cancer patients:a comparative study / 现代临床护理

Objective To investigate the clinical effects of two methods of compressive coverage with aseptic gauze dressing and alginate dressing on haemostasis in placement of peripherally inserted central catheter(PICC)so as to provide a new dressing method for clinical application.Methods A total of 416 breast cancer patients undergoing PICC were randomly divided into two groups,with 208 per group.In the control group,the puncture sites for PICC were dressed with aseptic gauze immediately after the placement of PICC,with a daily aseptic gauze dressing change once per 24 hours.In the trial group,the puncture sites were dressed with alginate dressing immediately after the placement of PICC,with a weekly dressing change at the 7th day after PICC placement,while no local bleeding on the puncture site.The incidence,within 24 hours,of bleeding,degree of comfort,frequency and cost of dressing change as well as the infection rate within 7 days after the PICC placement were monitored and compared between the groups.Results A total of 205 patients in the control group and 208 in the observation group had completed the study.In the trial group,the incidence of bleeding at puncture sites within 24 hours after placement of PICC was significantly lower than that of the control group(27.88%vs.38.05%,χ2=4.829,P=0.028).The frequency of dressing change within 24 hours in the observation group was significantly less than that of the control group(Z=205.235,P<0.001).The cost of dressing change in the observed groups was also significantly less than that of the control group(56.94 vs.10.20 yuan in average,Z=-8.990,P<0.001).The incidence rates of local pain and itche reported by the patients in the observation group were significantly lower than those in the control group(Z=-12.079,P<0.001;Z=-12.194,P<0.001).No infection at the puncture site was observed in both groups.Conclusions Application of alginate dressing immediately after PICC placement in breast cancer patients can extend the time for initial dressing change up to 7 days in the patient without bleeding at the puncture site within 24 hours after the placement of PICC.An alginate dressing can reduce the incidence of bleeding at the puncture site,increase the comfort of patients,lower the frequency and cost of dressing change hence the nursing workload.

Humidification effects between humidifiers Venturi high-flow oxygen therapy and high-flow humidified oxygen therapy in treatment of tracheotomy patients after withdrawal of ventilator / 现代临床护理

Objective To explore the humidification effects between the humidifiers Venturi high-flow oxygen therapy(HVHF)and the high-flow humidified oxygen therapy in the treatment of patients with tracheotomy after the withdrawal of ventilator,and analyse the humidification performance and effect of airway humidification on the two oxygen therapies hence to provide an objective basis for selection of a humidified oxygen therapy.Methods A total of 146 ICU patients who had tracheotomy and completely withdrawal of ventilator in a general hospital in Shenzhen from July 2020 to December 2021 were randomly divided into trial group(n=73)and control group(n=73).With identical speed of airflow,patients in the trial groups were treated with HVHF and the patients of control group were offered with high-flow humidified oxygen therapy via AIRVOTM2.Data of the two groups were compared at the time points of days 0,2,7 and 14 in terms of absolute humidity(AH),relative humidity(RH),temperature(T)),sputum viscosity,arterial partial pressure of oxygen(PaO2),arterial partial pressure of carbon dioxide(PaCO2),oxygenation index(PaO2/FIO2)and the incidence of pulmonary infection.Results In the study,total of 61 patients in the control group and 72 patients in the trial group completed the high-flow humidified oxygen therapies,due to tubing detachments in 12 and 1 patients in the two groups,respectively.Repeated-Measures ANOVA analysis showed that,in both groups,there was a time effect(P<0.05)between the absolute humidity,relative humidity,temperature of the gas,PaO2,PaCO2,and PaO2/FiO2 at different time points.PaO2 and PaO2/FiO2 in both groups showed interactions at different time points(P<0.05).PaO2 and PaO2/FiO2 in the trial group were better than those in the control group at the time points of days 2,7 and 14(P<0.05).On days 2,7 and 14,the viscosity of sputum in the intervention group was better than that in the control group,and the incidence of pulmonary infection in the trial group was significantly lower than that in the control group(P<0.05).Conclusions HVHF and AIRVOTM2 both exhibit no obvious difference in gas humidification via high-flow humidification oxygen therapy in the patients with tracheotomy after withdrawal of ventilator.However,HVHF is superior to AIRVOTM2 in terms of improving airway humidification and oxygenation as well as reducing lung infection.Therefore,it is suggested that an HVHF is preferable for high-flow humidified oxygen therapy in treating the patients with tracheotomy after the withdrawal of ventilator.

Effect of lung recruitment manoeuvre mode implemented by ICU specialist nurses on remission of patients with acute respiratory distress syndrome / 现代临床护理

Objective To analyse the effects of the lung recruitment manoeuvre(RM)mode implemented by ICU specialist nurses on remission of the patients with acute respiratory distress syndrome(ARDS),with the aim to explore the safety,feasibility and effectiveness of clinical implementation,and to further provide a new mode for patient management in nursing practice.Methods A total of 40 ARDS patients admitted into the ICU from January 2018 to August 2021 were randomly selected and divided into control group and trial group in equal number with a random number table.Patients in the control group was treated with a conventional RM mode implemented by doctors,and the RM mode implemented by the ICU specialist nurses was applied to the patients in trial group.The indexes of arterial blood gas analysis,mechanical ventilation time,length of ICU stay,number of RM,number of adjustments to a RM plan,and complication rate were compared between the two groups after the second RM implementation.Results There was no statistically significant difference in arterial partial pressure of oxygen,arterial partial pressure of carbon dioxide and oxygenation index between the groups at 1h and 24h after the second RM implementation(P>0.05).There was no statistically significant difference in the number of RM,mechanical ventilation and length of ICU stay between the groups(P>0.05).The number of modifications of the RM plan in the trial group was significantly more than that in the control group(P<0.05).There was no complication of RM in both groups.Conclusions The RM mode implemented by ICU specialist nurses could achieve good clinical effects in the treatment of patients with ARDS. The approach is safe and practicable.

A Prospective Study to Evaluate the Possible Role of Cholecalciferol Supplementation on Autoimmunity in Hashimoto’s Thyroiditis

Introduction : Several studies have reported a low Vitamin D status in Autoimmune Thyroid Diseases (AITD), indicating association between Vitamin D deficiency (<20 ng/ml) and thyroid autoimmunity. If supplementation of Vitamin D decreases anti-TPO antibody titres, in future it may become a part of AITDs' treatment, especially in those with Vitamin D insufficiency (21-29 ng/ml) or deficiency. Objectives : Our study aims to assess any potential therapeutic role of Vitamin D in the management of HT. Study Design : It is a randomised, double blind, single centre, placebo-controlled study. Results : Significant negative correlation between Serum anti TPO Antibody and Vitamin D level; statistically significant reduction of anti TPO Antibody titre in intervention group compared to placebo group. Conclusions : Vitamin D can be a therapeutic option in Hashimoto's Thyroiditis.

Effectiveness of an integrated-Weight Management Programme (i-WMP) in Reducing Body Weight among Noncommunicable Disease Patients in Malaysian Government Primary Care Clinics: A Randomised Controlled Trial

@#Introduction: Obesity is a global issue called as “globesity”. Overweight and obesity may lead to many noncommunicable diseases (NCDs). Primary care is the first centre to monitor and follow-up the progress of NCD patients. Therefore, the objective of this study was to determine the effectiveness of an integrated-Weight Management Programme (i-WMP) to reduce body weight among NCD patients from two Government primary care clinics from Hulu Langat District. Methods: This study was single-blinded randomised controlled trial by design. There were 244 eligible patients were randomised into intervention (n = 122) or wait-list control group (n = 122). The i-WMP was developed based on the behaviour change wheel through the operationalization of behaviour change techniques. The duration of this intervention programme was four weeks. Data collected at week 0, week 4, and week 12. The software IBM SPSS was used to analyse the data. Generalized linear mixed model analysis with intention-to-treat principle was applied. Results: The retention rate was 74.2%. Findings showed that the i-WMP was significantly effective in reducing not only body weight as primary outcome but also secondary outcomes such as waist-to-height ratio, waist circumference, body mass index, and total sitting time. It also improved effectively other secondary outcomes such as participants’ knowledge, attitude, and practice towards dietary and towards physical activity. However, no significant changes were reported for body fat percentage and total physical activity metabolic equivalent of task-minutes/week. Conclusion: Implications surrounding the implementation of i-WMP in the primary care clinics are recommended.

Fruit and vegetable intake among overweight and obese school children: A cluster randomised control trial

@#Introduction: Adequate daily intake of fruits and vegetables is crucial for the prevention of chronic diseases. This study aimed to determine the effects of My Body is Fit and Fabulous at School (MyBFF@school) with nutrition education intervention (NEI) on the stages of change for fruit and vegetable intake among overweight and obese secondary school children based on the trans-theoretical model (TTM). Methods: This was a cluster randomised controlled trial involving 15 out of 415 eligible government secondary schools in central Peninsular Malaysia, which were randomly assigned into intervention (six schools; 579 school children) and control (nine schools; 462 school children). The intervention group was given NEI for 24 weeks, while the control group followed the existing school programme by the Ministry of Education. Results: There was no significant difference between the intervention and control groups for the stages of change, with majority at the maintenance stage after six months (intervention: 34.9%; control: 39.0%). The within group analysis showed a significant reduction after six months for those at the action stage (action and maintenance stage) from 68.0% to 60.4% in the intervention group and from 71.4% to 65.6% in the control group. However, there was a significant increase among those with adequate fruit and vegetable intake in the intervention group and no significant increase in the control group. Conclusion: MyBFF@school with NEI based on TTM provided acceptable changes in fruit and vegetable intake among overweight and obese secondary school children.

Preliminary Result of Randomised Controlled Trial of Three Different Coated Archwires Part 1: Tooth Alignment and Coating Loss

@#Introduction: Coated archwires improve aesthetics during orthodontic treatment. However, little is known regarding their clinical benefit. This randomised controlled trial (RCT) compared the tooth alignment (TA), coating loss (CL), colour change (∆E*), and patient perception of coated archwires with their controls. Details of ∆E* and perception were reported in the second part of the articles. Methods: This RCT was done at three centres. Participants were randomised to receive one of four treatment interventions using 0.014” superelastic coated nickel-titanium archwires from Orthocare, RMO, G&H, and conventional uncoated 3M Unitek® archwires. These archwires were ligated during bonding and collected after eighth week and questionnaires were distributed to participants in the experimental groups only. After removal, TA and CL were measured using Little’s Irregularity Index and Autodesk® AutoCAD® software, respectively. At the time of this preliminary reporting, 84 participants had completed the trial. Two archwires fractured and were excluded. Therefore, 166 archwires (n = 166) were analysed. Results: Only non-extraction cases showed statistically significant differences in TA change between all groups (p = 0.005) and RMO showed significantly lowest mean of TA (1.5 mm). RMO and Orthocare showed significant TA change in the upper and lower arches (p = 0.037, 0.048). CL was found to be insignificant for both extraction and non-extraction cases (p >0.05). Comparison between upper and lower arches revealed no significant difference in TA and CL in all groups (p >0.05). Conclusion: From this preliminary analysis, Orthocare provides better TA in non-extraction cases despite highest percentage of coating loss.

Accelerometer-based facilitated walking program in addition to usual care for the management of patients with low back pain at medium or high risk of chronicity: a randomised controlled trial protocol

Background:The synergistic action of local anesthetics and morphine is well known, morphine probably more superior for postoperative analgesia, when compared to other opioids. Preservative-free morphine is now available in India making intrathecal administration possible. The present randomized double blind study was designed to evaluate the effect of adding preservative free morphine to hyperbaric bupivacaine given intrathecally for abdominal hysterectomy.Methods:Following approval by the institutional review board and institutional research grant committee, eighty patients presenting for elective abdominal hysterectomy were included in this randomized, double blind study. All drugs used for spinal anesthesia were autoclaved as per the departmental protocol. 3.5 ml of hyperbaric bupivacaine 0.5% [heavy] was given in both groups along with preservative free morphine accordingto study group.Results:27.5% (11/40) patients in group A, 17.5% (7/40) patients in group B received one dose of rescue analgesia (ketorolac 10 mg),during the 24 hours for pain relief while 29 patients is group A (72.5%) and 82.5% (33/40) patients in group B received 2 doses of rescue analgesia. 10% patients in Group A (4/40) and 10% patients in Group B (4/40) had a sedation score of 1(drowsy and arousable). Conclusions: The mean duration of analgesia in patients who received 250 μgms of intrathecal morphine was 18.725±1.38 hours while in patients who received 150 μgms it is 16.075±1.23 hours. We conclude that 250 μgms of preservative-free intrathecal morphine provides longer duration of analgesia when compared to 150 μgms morphine, with hardly any additional adverse effects.

A Randomized Comparative Study on Efficacy and Safety Profile of Ivabradine and Ranolazine, in Patients of Chronic Stable Angina Pectoris

Background: Ischemic heart disease is one of the leading causes of global disease burden. Despite treatment with standard therapy, many patients with chronic stable angina pectoris remain symptomatic making it an urgent necessity to introduce new strategies. Hence this study was planned to compare the efficacy and tolerability of Ivabradine and Ranolazine; the two novel antianginal drugs. Methods: This was a single blind, randomised, controlled trial. Thirty patients each taking IVA 5 mg twice daily or RAN 500 mg twice daily were randomised into two groups. Patients filled a pretested questionnaire on frequency of angina attacks and adverse reactions experienced at baseline and 2, 4 and 8 weeks. The haemodynamic parameters, routine laboratory investigations were evaluated at the baseline and after intervention. Results: There was no significant difference in the frequency of angina attacks per week between the IVA and RAN study groups. There was a statistically significant difference (P < 0.01) in the number of patients reporting ADR from the IVA group as compared to RAN group. In the IVA group, the most common ADR was dizziness (36.6%); whereas nausea (30%) and dizziness (23.3%) was most common in RAN group. The routine haematological and biochemical evaluations did not show any significant difference between the baseline and post intervention. However, IVA significantly decreased the resting heart rate after eight weeks of intervention.. Conclusion: Both IVA and RAN are comparable and efficacious antianginal agents. However, RAN had a better safety and tolerability profile than IVA.

Rhythmical massage improves autonomic nervous system function: a single-blind randomised controlled trial / 中西医结合学报

<p><b>BACKGROUND</b>Rhythmical massage therapy (RMT) is a massage technique used in anthroposophic medicine.</p><p><b>OBJECTIVE</b>The authors aimed to investigate the physiological action of RMT on the cardiovascular system by analysing heart rate variability (HRV).</p><p><b>DESIGN, SETTING, PARTICIPANTS AND INTERVENTION</b>This study was a randomised, controlled and single-blinded trial, involving 44 healthy women (mean age: (26.20 ± 4.71) years). The subjects were randomised to one of three arms: RMT with aromatic oil (RA), RMT without aromatic oil (RM) or standardised sham massage (SM). In the study the subjects were exposed to a standardised stress situation followed by one of the study techniques and Holter electrocardiograms (ECGs) were recorded for 24 h.</p><p><b>MAIN OUTCOME MEASURES</b>HRV parameters were calculated from linear (time and frequency domain) and nonlinear dynamics (symbolic dynamics, Poincare plot analysis) of the 24-h Holter ECG records.</p><p><b>RESULTS</b>Short- and long-term effects of massage on autonomic regulation differed significantly among the three groups. Immediately after an RMT session, stimulation of HRV was found in the groups RA and RM. The use of an aromatic oil produced greater short-term measurable changes in HRV compared with rhythmic massage alone, but after 24 h the effect was no longer distinguishable from the RM group. The lowest stimulation of HRV parameters was measured in the SM group.</p><p><b>CONCLUSION</b>RMT causes specific and marked stimulation of the autonomic nervous system. Use of a medicinal aromatic oil had only a temporary effect on HRV, indicating that the RM causes the most relevant long-term effect. The effect is relatively specific, as the physiological effects seen in the group of subjects who received only SM were considerably less pronounced.</p><p><b>TRIAL REGISTRATION</b>Registration trial DRKS00004164 on DRKS.</p>

Placebo Controlled Trials: Interests of Subjects versus Interests of Drug Regulators

The use of placebo-controlled trials in situations where established therapies are available is considered ethically problematic since the patients randomised to the placebo group are deprived of the beneficial treatment. The pharmaceutical industry and drug regulators seem to argue that placebo-controlled trials with extensive precautions and control measures in place should still be allowed since they provide necessary scientific evidence for the efficacy and safety of new drugs. On the other hand, the scientific value and usefulness for clinical decision-making may be much higher if the new drug is compared directly to existing therapies. As such, it may still be unethical to impose the burden and risk of placebo-controlled trials on patients even if extensive precautions are taken. A few exceptions do exist. The use of placebo-controlled trials in situations where an established, effective and safe therapy exists remains largely controversial.

Effect of Probiotic Microbial Cell Preparation (MCP) on Fasting Blood Glucose, Body Weight, Waist Circumference, and Faecal Short Chain Fatty Acids among Overweight Malaysian Adults: A Pilot Randomised Controlled Trial of 4 Weeks

Introduction: Probiotic microbial cell preparation (MCP) supplementation is one of the approaches to modulate alterations in gut microbiota (GM). This double-blind randomised controlled trial investigated the effect of 4 weeks of MCP supplementation on fasting blood glucose levels (FBG), body weight (BW), waist circumference (WC), and faecal short chain fatty acids (SCFA) among 24 healthy and overweight (with BMI = 23 kg/m2) Malaysian adults. Methods: Twenty-six subjects were randomised to receive either MCP (n= 12) or placebo (n=14), twice daily, for 4 weeks. The probiotic powder contained a mix of six strains namely, Lactobacillus acidophilus, Lactobacillus lactis, Lactobacillus casei,Bifidobacterium longum, Bifidobacterium bifidum and Bifidobacterium infantis (3.0 x 1010 cfu). FBG, BW, WC, WHR, faecal SCFA, physical activity levels and dietary intake were measured and changes were determined using repeated measures ANOVA. Results: Twenty-four subjects successfully completed the 4-week study period. Changes in FBG, BW, WC and SCFA were not significantly different between the groups. Only subjects in the MCP group significantly reduced their energy intake compared to baseline (1671?±476 vs 1386?±447 kcal, P=0.045). Conclusion: A 4-week supplementation of the MCP mix powder did not have significant effects on the variables studied. However, the significant reduction in dietary energy intake in the MCP group suggests the potential of probiotics as an adjuvant to dietary therapy for weight los

Effectiveness of a healthy lifestyle intervention for low back pain and osteoarthritis of the knee: protocol and statistical analysis plan for two randomised controlled trials

ABSTRACT Background These trials are the first randomised controlled trials of telephone-based weight management and healthy lifestyle interventions for low back pain and knee osteoarthritis. This article describes the protocol and statistical analysis plan. Method These trials are parallel randomised controlled trials that investigate and compare the effect of a telephone-based weight management and healthy lifestyle intervention for improving pain intensity in overweight or obese patients with low back pain or knee osteoarthritis. The analysis plan was finalised prior to initiation of analyses. All data collected as part of the trial were reviewed, without stratification by group, and classified by baseline characteristics, process of care and trial outcomes. Trial outcomes were classified as primary and secondary outcomes. Appropriate descriptive statistics and statistical testing of between-group differences, where relevant, have been planned and described. Conclusions A protocol for standard analyses was developed for the results of two randomised controlled trials. This protocol describes the data, and the pre-determined statistical tests of relevant outcome measures. The plan demonstrates transparent and verifiable use of the data collected. This a priori protocol will be followed to ensure rigorous standards of data analysis are strictly adhered to.

A randomised crossover trial comparing the Airtraq ® NT, McGrath ® MAC and Macintosh laryngoscopes for nasotracheal intubation of simulated easy and difficult airways in a manikin / Estudo cruzado e randômico comparando os laringoscópios Airtraq ® NT, McGrath ® MAC e Macintosh para intubação nasotraqueal em simulação de via aérea fácil e difícil em manequim

ABSTRACT OBJECTIVE: Several devices can aid nasotracheal intubation when managing difficult airways. The McGrath MAC and Airtraq NT were compared with a Macintosh laryngoscope when studying the performance of anaesthetists with different levels of experience, in a manikin model of easy or difficult airway scenarios. METHODS: Sixty-three anaesthetists were recruited into a randomised trial in which each performed nasotracheal intubation with all laryngoscopes, in both scenarios. The main endpoint was intubation time. Additional endpoints included laryngoscopic view, intubation success, number of optimisation manoeuvres, audible dental clicks and the force applied to the upper airway. RESULTS: Intubation time was significantly shorter using the McGrath MAC in both scenarios and using the Airtraq in the difficult scenario, when compared with the Macintosh laryngoscope. Both devices gave more Cormack and Lehane grade 1 or 2 views than the Macintosh in the difficult scenario (p < 0.001). The McGrath MAC had the best first-attempt success rate (98.4% vs. 96.8% and 95.8%, p < 0.001 for the Airtraq NT and Macintosh laryngoscopes respectively). The number of optimisation manoeuvres, audible dental clicks and subjective assessment of the degree of force applied were significantly lower for indirect laryngoscopes versus the Macintosh laryngoscope (p < 0.001). CONCLUSION: In a manikin, the Airtraq and the McGrath laryngoscopes appeared superior to the Macintosh laryngoscope when dealing with simulated airway scenarios. Both devices were associated with better views, intubation times and rates of success, especially in a simulated "difficult airway". Overall satisfaction was highest with the McGrath laryngoscope. Similar clinical studies are needed.

RESUMO OBJETIVO: Vários dispositivos podem ajudar a intubação nasotraqueal no manejo de via aérea difícil. Os laringoscópios McGrath MAC e Airtraq NT foram comparados com um laringoscópio Macintosh em estudo do desempenho de anestesistas com diferentes níveis de experiência, em manequim com cenário de via aérea fácil ou difícil. MÉTODOS: Foram recrutados 63 anestesistas para um estudo randômico, no qual cada um fez intubação nasotraqueal com todos os laringoscópios, em ambos os cenários. O desfecho primário foi o tempo de intubação. Desfechos adicionais incluíram vista laringoscópica, sucesso na intubação, número de manobras de aprimoramento, cliques dentais audíveis e força aplicada nas vias aéreas superiores. RESULTADOS: O tempo de intubação foi significativamente menor com o uso do laringoscópio McGrath MAC em ambos os cenários e com o uso do Airtraq no cenário difícil, em comparação com o laringoscópio Macintosh. Ambos os dispositivos obtiveram mais grau 1 ou 2 de Cormack e Lehane para visualização do que o Macintosh em cenário difícil (p < 0,001). O McGrath MAC teve a melhor taxa de sucesso na primeira tentativa (98,4% vs. 96,8% e 95,8%, p < 0,001, para os laringoscópios Airtraq NT e Macintosh, respectivamente). O número de manobras de aprimoramento, os cliques dentais audíveis e a avaliação subjetiva do grau de força aplicada foram significativamente menores para os laringoscópios indiretos versus o laringoscópio Macintosh (p < 0,001). CONCLUSÃO: Em um manequim, os laringoscópios Airtraq e McGrath pareceram superiores ao laringoscópio Macintosh para lidar com cenários das vias aéreas simuladas. Ambos os dispositivos foram associados a melhores visibilidades, tempos de intubação e taxas de sucesso, especialmente em simulação de "via aérea difícil". A satisfação geral foi maior com o laringoscópio McGrath. Estudos clínicos similares são necessários.

Safety and effectiveness of autoinoculation therapy in cutaneous warts: A double - blind, randomized, placebo - controlled study.

Background: In spite of the availability of multiple treatment options, viral warts are known for their persistence and recurrence, causing frustration to patients and treating physicians. Aims: To study the effectiveness and safety of autoinoculation as a treatment modality in cutaneous warts. Methods: A double‑blind, placebo‑controlled study was carried out. In the treatment group, full‑thickness warty tissue was excised, minced and implanted in a small dermal pocket. In the control group, warty tissue was only excised and not implanted, though a dermal pocket was made. Patients were evaluated every four weeks with lesion counts. The procedure was repeated at 4 and 8 weeks. Response was assessed at each visit and at 12 weeks. Results: Forty‑eight patients with cutaneous warts (male: female = 32:16) were randomized into autoinoculation and control groups. The number of warts at baseline was comparable in both groups (P = 0.293). Reduction in the number of warts was significantly more in the autoinoculation group (8.50 ± 13.88) than in the control group (10.04 ± 5.80) from 8 weeks onwards (P = 0.010). Complete resolution occurred only in the autoinoculation group, in 62.5% of cases. Adverse effects were seen in 11 patients, including infection of the donor site (5 cases), keloid formation (3) and hypopigmentation (3). Conclusion: Autoinoculation may be an effective therapeutic modality for cutaneous warts and two sessions may be required for optimum results.