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)

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.

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>

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

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.

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.

Enhancement of carer skills and patient function in the non-pharmacological management of frontotemporal dementia - FTD: a call for randomised controlled studies / Reforço da s habilidades dos cuidadores e da função do paciente no manejo não farmacológico da demência frontotemporal -DFT: necessidade para estudos clínicos randomizadose controlados

FTD is a unique condition which manifests with a range of behavioural symptoms, marked dysfunction in activities of daily living ADL and increased levels of carer burden as compared to carers of other dementias. No efficacious pharmacological interventions to treat FTD currently exist, and research on pharmacological symptom management isvariable. The few studies on non-pharmacological interventions in FTD focus on either the carer or the patients? symptoms, and lack methodological rigour. This paper reviews and discusses current studies utilising non-pharmacological approaches, exposing the clear need for more rigorous methodologies to be applied in this . Finally, a successful randomised controlled trial helped reduce behaviours of concern in dementia, and through implementing participation in tailored activities, the FTD-specific Tailored Activities Program TAP is presented. Crucially, this protocol has scope to target both the person with FTD and their carer. This paper highlights that studies in this area would help to elucidate the potential for using activities to reduce characteristic behaviours in FTD, improving quality of life and the caregiving experience in FTD.

A DFT é uma condição única que se manifesta por uma variedade de sintomas, principalmente em atividades da vida diária (AVD) e aumento da carga sobre os cuidadores em comparação aos cuidadores de outras demências. Não existe nenhuma intervenção farmacológica para tratamento da DFT até o momento e pesquisas sobre o manejo farmacológico dos sintomas são variáveis. Os poucos estudos em intervenção não farmacológica em DFT focam nos cuidadores ou emsintomas dos pacientes, faltando rigor metodológico. Este artigo revisa e discute os estudos atuais que utilizam abordagem não farmacológica, o que expõe a clara necessidade para metodologias mais rigorosas a serem aplicadas neste campo. Finalmente, um ensaio clinico randomizado bem sucedido ajudou na redução de comportamentos em demência, através da implementação da participação em atividades ajustadas, é apresentado o FTD-specific Tailored Activities Program (TAP). Este protocolo visa abordar tanto o paciente com DFT quanto seu cuidador. Este manuscrito evidencia que pesquisas dentro desta area ajudariam a elucidar o potencial em usar estas atividades para redução dos comportamentos característicos em DFt, melhorando a qualidade de vida e experiências dos cuidadores em DFT.

The efficacy of mild hypothermia for the treatment of patients successfully resuscitated from cardiac arrest: a meta-analysis / 中华急诊医学杂志

Objective To study the effectiveness and safety of therapeutic mild hypothermia in patients successfully resuscitated from cardiac arrest using a meta-analysis.Methods We searched the MEDLINE (1966-April 2012),OVID (1980 to April 2012),EMBASE (1980 to April 2012),Chinese bio-medical literature & retrieval system (CBM) (1978 to April 2012),Chinese medical current contents (CMCC) (1995 to April 2012),and Chinese medical academic conference (CMAC) (1994 to April 2012).Studies were included (1) the study design was a randomized controlled trial (RCT); (2) the study population included patients successfully resuscitated from cardiac arrest,and received either conventional post-resuscitation care with normothermia or mild hypothermia; (3) the study provided data about good neurologic outcome and survival till hospital discharge.Relative risk (RR) and 95％ corfidence interval (CI) were used to pool the effect.Results The study included four RCTs with a collected total of 417 patients successfully resuscitated from cardiac arrest.Compared to conventional post-resuscitation care with normothermia,patients in the hypothermia group were more likely to have good neurologic outcome (RR =1.43,95％ CI 1.14 ～ 1.80,P =0.002) and were more likely to survive till hospital discharge (RR =1.32,95％ CI 1.08 ～ 1.63,P =0.008).From all over the studies there was no significant difference in reported adverse events between the normothermia and hypothermia group (P ＞ 0.05).There did not exist heterogeneity and publication bias.Conclusions Therapeutic mild hypothermia improves neurologic outcome and survival in patients successfully resuscitated from cardiac arrest.

Options for clinical trials of pre and post-natal treatments for congenital toxoplasmosis

Clinical trials comparing different drug regimens and strategies for the treatment of congenital toxoplasmosis and its clinical manifestations in the liveborn child in different clinical settings should aim at formally evaluating the net benefit of existing treatments and at developing new therapeutic options. Currently, there is no ideal drug for congenital toxoplasmosis; future research should focus on the screening of new active drugs and on their pre-clinical and early clinical development, with a focus on pharmacokinetic/dynamic studies and teratogenicity. For the prenatal treatment of congenital toxoplasmosis, a trial comparing spiramycine to pyrimethamine-sulphadiazine and placebo would allow a formal estimation of the effect of both drugs in infected pregnant women. In newborn children, the net benefit of pyrimethamine-sulphadiazine should also be formally assessed. These trials will be implemented in settings where prenatal screening for Toxoplasma gondii is currently implemented. Trials should be carefully designed to allow for translation to other settings and modelling tools like cost-effectiveness analysis should be used to provide clinicians and founders with the best available evidence to establish recommendations.