Evaluation of Estonia’s enhanced care management program: protocol for a cluster randomized trial

Background: Estonia’s aging population faces an increasing burden of non-communicable diseases (NCDs) and a growing population suffers with multiple chronic conditions. These changes have reduced well-being and quality of life for many older Estonians, while increasing the use of high cost specialist and emergency care. In response, the Estonia Health Insurance Fund (EHIF) is working to support primary care physicians to improve care for complex patients with multiple chronic conditions. A new EHIF program, Enhanced Care Management (ECM), trains family physicians to identify complex patients, co-develop proactive care plans with them, and conduct more active outreach and management of these patients. Methods: In this protocol we describe a randomized controlled trial, developed in partnership with EHIF, to evaluate the impact of ECM training for physicians. The RCT enrolled a randomly selected 97 family physicians out of the 786 family physicians practicing in Estonia. Among those physicians’ 6,739 ECM-eligible patients, 2,389 patients were randomly selected for enrolment into the ECM program. Results: Using administrative records, we evaluated the effects of ECM enrolment on: (1) health care utilization; (2) provider management of tracer conditions; and (3) markers of quality of care such as hospital admission for primary health care-sensitive conditions. Conclusions: This protocol presents a pre-specified analysis plan for this evaluation of Estonia’s ECM program. Trial registration: First registered with the American Economics Association, AEARCTR-0003661. Registered May 1, 2019. Retrospective secondary registration with www.clinicaltrials.gov P169891. Registered April 26, 2023.

Do motivational cards really benefit sibling screening of primary open-angle glaucoma probands?

Purpose: To compare the impact of Sibling Motivational Card (SMC) and oral counseling in screening siblings of primary open?angle glaucoma (POAG) probands. Methods: Two hundred and thirty-four newly diagnosed POAG probands were randomized to receive either oral counseling or SMC to motivate their siblings for a glaucoma screening at a tertiary eye care hospital in South India from July 2015 and June 2017. A total of 116 probands were orally counseled with a standard template of dialogs about the importance of family screening to motivate their siblings for a screening. One hundred and eighteen probands were randomized to receive SMC, bearing the details of the proband, sibling, and a message stressing the importance of family screening, in addition to oral counseling. We assessed the response rate in each group. Additionally, we evaluated the prevalence of POAG in the siblings. Results: A total of 95 siblings of 234 POAG probands were screened. The mean age distribution was 53.33 ± 10.9 years (range 28–79 years). The male to female ratio was 3:4. The percentage of siblings screened was more in the oral counseling group (63.2%) than in the SMC group (36.8). About 43 (45%) siblings had some form of glaucoma, and 13.6% had POAG. An additional 22.1% were disk suspects, and 5.2% had ocular hypertension. Conclusion: SMC did not have an additional benefit over the standard oral counseling in promoting sibling screening. Our study stresses the importance of sibling screening in POAG probands. Targeting siblings of POAG probands with oral counseling may offer a relatively inexpensive way of detecting glaucoma

Evaluation of the clinical effect of an artificial intelligence-assisted diagnosis and treatment system for neonatal seizures in the real world: a multicenter clinical study protocol / 中国当代儿科杂志

Neonatal seizures are the most common clinical manifestations of critically ill neonates and often suggest serious diseases and complicated etiologies. The precise diagnosis of this disease can optimize the use of anti-seizure medication, reduce hospital costs, and improve the long-term neurodevelopmental outcomes. Currently, a few artificial intelligence-assisted diagnosis and treatment systems have been developed for neonatal seizures, but there is still a lack of high-level evidence for the diagnosis and treatment value in the real world. Based on an artificial intelligence-assisted diagnosis and treatment systems that has been developed for neonatal seizures, this study plans to recruit 370 neonates at a high risk of seizures from 6 neonatal intensive care units (NICUs) in China, in order to evaluate the effect of the system on the diagnosis, treatment, and prognosis of neonatal seizures in neonates with different gestational ages in the NICU. In this study, a diagnostic study protocol is used to evaluate the diagnostic value of the system, and a randomized parallel-controlled trial is designed to evaluate the effect of the system on the treatment and prognosis of neonates at a high risk of seizures. This multicenter prospective study will provide high-level evidence for the clinical application of artificial intelligence-assisted diagnosis and treatment systems for neonatal seizures in the real world.

Efficacy of myo-inositol in improving pregnancy rate and regulation of menstrual cycle for patients with polycystic ovarian syndrome: A systematic review and meta-analysis

Background@#Polycystic ovarian syndrome (PCOS) is a common, reproductive endocrinopathy associated with ovarian dysfunction, cardiovascular disorders, obesity, and infertility. Myo-inositol is a novel treatment for women with PCOS that claimed to have improved fertility rate in this population. This systematic review and meta-analysis examined the effect of myo-inositol on pregnancy rate, menstrual cycle, and adverse effects from randomized controlled trials (RCTs). @*Methods@#RCTs that evaluated the efficacy of myo-inositol in improving pregnancy rate and regulation of menstrual cycle in women with PCOS. Electronic databases were searched and studies published up to October 24, 2021 were included in the systematic review and meta-analysis. Study selection and assessment of quality were conducted independently by two review authors. @*Results@#Seven studies with 729 patients treated with myo-inositol and 677 patients treated with placebo and/or metformin were included in the analysis. The research groups did not diverge significantly in terms of basic characteristics, such as age, adnexal or uterine pathology, body mass index, and duration of infertility. In the myo-inositol group, regulation of the normal menstrual cycle is at 20%, significantly higher than the metformin group at 12%, (p<0.001). However, there is no significant difference in the pregnancy rate between myoinositol and placebo (p=0.42) and/or metformin (p=0.17). @*Conclusion@#This systematic review and meta-analysis showed that myo-inositol can be an alternative treatment for PCOS in terms of regulation of menses and may improve the success of spontaneous pregnancies. However, additional randomized, double-blind controlled trials with larger sample sizes, low heterogeneity, and uniform inclusion criteria are recommended to establish the effects of myo-inositol on PCOS treatment and pregnancy rate.

Effect of Qingfei Jiangmai Decoction on Content of PM2.5-related Metabolites Mercapturic Acids in Urine / 中国实验方剂学杂志

ObjectiveTo explore the effect of Qingfei Jiangmai decoction （QJD） on the content of mercapturic acids in urine in healthy people amid PM2.5 （particles 2.5 microns or less in size） pollution. MethodA total of 84 healthy students of 18-30 years old in Beijing were recruited and they were randomized into the test group （42 in total， with 1 dropout） and control group （42 in total， with 3 dropouts）. During the pollution， the test group and the control group respectively took QJD granules and placebo for 7 days （1 bag/time， 2 times/day）， and another 7-day intervention with the same drugs was performed at an interval of 4 weeks. The time-activity patterns were recorded during the intervention. On-line solid phase extraction-liquid chromatography/tandem mass spectrometry （SPE-LC-MS/MS） was performed to detect the content of PM2.5-related metabolites S-phenylmercapturic acid （SPMA）， 3-hydroxypropylmercapturic acid （3-HPMA）， 3-hydroxy-1-methylpropylmercapturic acid （HMPMA）， N-acetyl-S-（2-nitrile ethyl）-L-cysteine （CEMA）， and N-acetyl-S-（2-hydroxy ethyl）-L-cysteine （HEMA） in urine before and after intervention. Statistical analysis was followed. ResultThe content of CEMA， HEMA， 3-HPMA， and HMPMA in the test group was all higher after the intervention than before the intervention， with the significant difference in HEMA （P<0.05）. After intervention， content of HEMA and SPMA was significantly higher in the test group than in the control group （P<0.05）， and the difference in HEMA （Z=-3.614， P<0.01） and HMPMA （Z=-1.988， P<0.05） before and after invention in the test group was significantly larger than that in the control group. After the intervention， HEMA in the test group was significantly higher than that in the control group （F=7.597， P<0.01）. ConclusionDuring PM2.5 pollution， QJD can increase the excretion of HEMA， a metabolite of ethylene oxide， in the urine of healthy people in Beijing， and enhance the detoxification process of toxic components in PM2.5， which is of great value in preventing and treating haze-related illnesses.

Perioperative rehabilitation clinical pathway of acetabular fracture in light of the integration of orthopedics and rehabilitation: a prospective randomized control trial / 中国康复理论与实践

ObjectiveTo evaluate the efficacy and safety of a perioperative rehabilitation clinical pathway of acetabular fracture in light of orthopedics rehabilitation team approach. MethodsA prospective randomized control trial was conducted in 82 patients with acetabular fractures who had been admitted from the Emergency Department of Orthopaedic Trauma, Beijing Jishuitan Hospital from June, 2019 to January, 2021. The patients were randomly divided into control group (n = 41) and intervention group (n = 41). The control group was managed routinely, while the intervention group received the rehabilitation clinical pathway, for 24 weeks. The Visual Analogue Score (VAS) of pain, the Barthel Index (BI) and Majeed Pelvic Score were compared. ResultsFinally, 76 patients completed the trial. There was no statistical difference in VAS score between two groups in all periods (|Z| < 1.926, P > 0.05). The BI score was higher in the intervention group than in the control group at discharge, two weeks, six weeks and twelve weeks after operation (|Z| > 2.121, P < 0.05); and no significant difference was found before operation and 24 weeks after operation (|Z| < 1.862, P > 0.05). Majeed Pelvic Score was higher in the intervention group than in the control group two weeks, six weeks, twelve weeks and 24 weeks after operation (|Z| > 2.428, P < 0.05). Six, twelve and 24 weeks after operation, the excellent rate of Majeed Pelvic Score was higher in the intervention group than in the control group (χ2 > 6.136, P < 0.05). ConclusionIn comparison with traditional protocol in acetabular fracture, the perioperative rehabilitation clinical pathway was proved effective and of great safety in the light of the integration of orthopedics and rehabilitation mode for improving the function and activities of daily living of patients.

Perioperative rehabilitation approaches based on the concept of Enhanced Recovery After Surgery for pelvic fractures: a prospective randomized control trial / 中华创伤骨科杂志

Objective:To evaluate the efficacy and safety of perioperative rehabilitation approaches based on the concept of Enhanced Recovery After Surgery (ERAS) for pelvic fractures.Methods:A prospective randomized control trial was conducted to include 114 emergency patients who had been admitted to Department of Orthopaedic Trauma, Beijing Jishuitan Hospital for surgical treatment of pelvic fractures from June 2019 to December 2020. Of them, 57 were assigned into an intervention group according to a random digits table. They were 42 males and 15 females, aged from 18 to 77 years and subjected to management of pelvic fractures with tentative perioperative ERAS approaches which were adjusted at different stages. The other random 57 patients were assigned into a control group. They were 40 males and 17 females, aged from 17 to 70 years and subjected to management of pelvic fractures with conventional rehabilitation approaches which included postoperative in-hospital consultation and guidance by rehabilitation physicians. The 2 groups were compared in terms of Majeed pelvis scores and Barthel indexes at postoperative 2, 6, 12 and 24 weeks, and visual analogue scale (VAS) pain scores and SF36 scores at postoperative 12 and 24 weeks.Results:A total of 105 patients (55 in the intervention group and 50 in the control group) were completely followed up for 151 to 254 d (mean, 177 d). The 2 groups were comparable due to no significant difference between them in the preoperative general data ( P>0.05). The Majeed scores (44±13, 67±16, 86±14 and 98±7) and Barthel indexes (57±13, 79±16, 95±8 and 100±2) at postoperative 2, 6, 12 and 24 weeks in the intervention group were significantly higher than those in the control group [(35±16, 51±16, 73±14 and 91±12) and (45±19, 67±18, 86±12 and 98±4)] (all P<0.05). At postoperative 12 and 24 weeks, the SF-36 scores (129±15 and 141±6) in the intervention group were significantly higher than those in the control group (114±15 and 131±12) ( P<0.05). There was no significant difference in the pain degree between the 2 groups ( P>0.05). Conclusion:In management of pelvic fractures, compared with conventional perioperative rehabilitation approaches, the perioperative ERAS rehabilitation approaches may improve early functional outcomes and thus help the patients restore their activities of daily living earlier.

Comparison of standard and tubeless percutaneous nephrolithotomy for renal calculi: a prospective randomized control trial

Background:In the current era of minimally invasive interventions, the mainstay of treatment of renal stones larger than 2cm is percutaneous nephrolithotomy (PCNL). PCNL underwent various evolutionary changes minimizing morbidity to the patients. We prospectively compared the outcome of tubeless PCNL (without nephrostomy drainage tube) to reduce the pain and discomfort caused by tube with standard PCNL in the treatment of renal stones.Methods:In this randomized control trial (RCT), we divided patients satisfying the inclusion criteria of consenting for trial, single access puncture, less than 3 stones each less than 3 cm, operative duration of less than 2 hours into two groups, standard PCNL (group 1) and tubeless PCNL (group 2) with 25 patients each. Randomization and group assignment were done after complete clearance of renal stones.Results:Patient‟s age, gender, sides of stone and stonesize were comparable between two groups (standard versus tubeless PCNL). Postoperative hemoglobin drop, bleeding, pyrexia, urine leak, and blood transfusion requirement did not show a statistically significant difference between the two groups. Analgesic requirement (190mg versus 80 mg of tramadol), operative duration (49.80 min versus 38.60 min), postoperative pain score (6/10 versus 3.64/10-visual analog scale) and duration of hospital stay (68.48 hours versus 41.12 hours) showed statistically significant difference favoring tubeless PCNL.Conclusions: Tubeless PCNL may be a safe, acceptable and effective modality of treatment for renal calculi in carefully selected patients comparing standard PCNL resulting in less operative duration, lower postoperative pain, reduced analgesic requirementand shorter hospital stay

Comparative feasibility of two World Health Organization partographs to predict prolonged labour: a randomized control trial

Background:One of the major causes of maternal mortality is obstructed labor. Identificationof abnormal labor at earliest and timely management can prevent prolonged labor and significantly reduce its sequel. Partograph is a useful tool in hands of labor caregiversto monitor labor course.The study was done to compare feasibility of two WHO partographs a composite partograph including the latent phase with a simplified one without the latent phase to predict prolonged laborin randomized control trial.Methods:A randomized controlled trial, with parallel arm design was conducted. Sample size was calculated as 404 pregnant women .They were randomly categorized in two groups,each group having 202 participants.Results:labor had crossed the alert line in 108 (53.4%) cases monitored by composite partograph and 38(18.8%) cases monitored with simplified partograph. The calculated P value was <0.0001. The odds ratio calculate was 4.95 and 95% confidence interval was 3.16 to 7.76. Labor crossing the action line was found in 16 (7.9%) in composite partograph whereas in simplified partograph, labor had crossed the action line in 18 casesin simplified group. Calculated P value was 0.72 (>0.05). The odds ratio was 0.8793and 95% confidence interval 0.43 to 1.77 which was not significant statistically .Most participants (70%) experienced difficulty with the composite partograph, but no participant reported difficulty while plotting the simplified partograph. Conclusions: WHO simplified partograph was found to be as good as WHO composite partograph in identifying maternal and perinatal outcomes and was more user friendly.

Impact of Rosuvastatin in Systolic Heart Failure among elderly patients- A randomized control clinical trial

Background: Patients with systolic heart failure have generally been excluded from statin trials. Acute coronary events are uncommon in this population, and statins have theoretical risks in these patients. Objective: To evaluate the impact of Rosuvastatin in patient of Systolic Heart Failure. Materials and methods: A randomized controlled clinical trial was conducted among 500 patients of at least 60 years of age with New York Heart Association class II, III, or IV ischemic, systolic heart failure. The patients were randomly allocated to accept 10 mg of rosuvastatin or placebo per day. The primary composite outcome was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. Epi-info was used for analysis. Results: As compared with the placebo group, patients in the rosuvastatin group had decreased levels of low-density lipoprotein cholesterol (P<0.001) and of high-sensitivity C-reactive (P<0.001). During a median follow-up of 30 months, the primary outcome occurred in 500 patients in the rosuvastatin group and 700 in the placebo group (hazard ratio, 0.92; 95% confidence interval (CI), 0.83 to 1.02; P = 0.12. There were no significant differences between the two groups in the coronary outcome or death from cardiovascular causes. No excessive episodes of muscle-related or other adverse events occurred in the rosuvastatin group. Conclusions: Rosuvastatin did not reduce the primary outcome or the number of deaths from any cause in older patients with systolic heart failure, although the drug did reduce the number of cardiovascular hospitalizations.

Proceed with Caution When Using Real World Data and Real World Evidence

Clinical studies can be conducted to gather real world evidence (RWE) not available from randomized controlled trials, providing new information and knowledge. Although the concept of RWE emerged relatively recently, numerous clinical studies are utilizing it. However, many researchers are engaging in trial and error that may not overcome the various biases that occur in electronic medical record (EMR)-based RWE studies. While RWE can reflect the real world, there are still limitations to its acceptance. There are many hurdles in using RWE and solutions must be explored. Results based on RWE may be overestimated and it can be difficult to derive good quality results. This paper discusses data quality management, direct chart review, sample size, study design, and the interpretation of EMR-based RWE. More specifically, this paper shares the experience of the various hurdles that occur when conducting RWE studies and discusses the easy-to-false errors. RWE is still in the developmental stage and numerous aspects of RWE use remain unclear. Nonetheless, despite its many limitations, increasing use of RWE is still anticipated. This will require continued experience and effort in using RWE, as well as upgrading RWE research through the accumulation of information on such experiences and efforts.

Treatment of Uncomplicated Recurrent Urinary Tract Infection with Chinese Medicine Formula: A Randomized Controlled Trial / 中国结合医学杂志

OBJECTIVE@#To evaluate Chinese medicine (CM) formula Bazheng Powder () as an alternative therapeutic option for female patients with recurrent urinary tract infection (RUTI).@*METHODS@#A randomized double-blinded trial was performed. Eligible female patients with RUTI were recruited from one hospital and two community health centers. By using a blocked randomization scheme, participants were randomized to receive a CM formula (10 herbs) for 4 weeks or antibiotics for 1 week, followed by 3 weeks of placebo. Clinical cure rate and microbiological cure and recurrence after treatment were evaluated.@*RESULTS@#A total 122 eligible patients were enrolled, with 61 cases in each group. The clinical cure rate by the intentto- treatment approach was 90.2% for the CM group and 82.0% for the antibiotics group (P>0.05). Bacteria were cleared from 88.5% (54/61) of patients in the CM group and 82.0% (50/61) in the antibiotics group. The recurrence rate in recovered patients at the 6-month follow-up was 9.1% (5/61) and 14.0 (7/61) in the CM and antibiotics groups, respectively (P>0.05).@*CONCLUSION@#CM formula Bazheng Powder is a good alternative option for RUTI treatment. (Registration No. NCT01745328).

Effectiveness of randomized control trial of mobile phone messages on control of fasting blood glucose in patients with type-2 diabetes mellitus in a Northern State of India

Limited availability of randomized control trial warranted the conduct of a present study to demonstrate the effectiveness of mobile phone-based short message services (SMSs) on reduction in mean fasting blood glucose (FBG) in patients with type-2 diabetes mellitus. A total of 955 patients were recruited from primary and secondary health-care facilities and randomized to intervention (479) and control (476) group. Messages were delivered to patients for 12 months tailoring to their recent FBG values. SMS included information to maintain the desired FBG levels and next due date for FBG assessment. Patients were statistically similar for their age, socioeconomic status, smoking, and alcohol use. After the intervention, an average FBG declined from 163.7 to 152.8 mg/dl (P = 0.019) in intervention and from 150.5 to 149.2 mg/dl (P = 0.859) in control group. Adjusted for the baseline FBG, the intervention was found to be significantly effective (odds ratio: 1.7; 95 confidence interval: 1.2–2.6).

Comparison of the outcomes of home based and supervised individually designed exercise programme amongst the patients in chronic phase after guillain barre syndrome: study protocol for a randomized control trial

Background: Guillain barre syndrome (GBS) is an immune mediated polyneuropathy characterized by progressive weakness and variety of symptoms including muscle paralysis, autonomic dysfunction and respiratory involvement that affect one or two persons in 100,000 population. Although immunotherapies including therapeutic plasma exchange (TPE), immunoglobulins (IVIg) and corticosteroids are the available beneficial modes of treatment, the residual symptoms are disabling and long lasting and require long term rehabilitation. Observational studies and RCT on multi-disciplinary care has proven exercises to be an answer to residual long lasting disability. Supervised individually designed exercise prescription after physiotherapy assessment may play a major role in minimizing disability.Methods: The present study is an open-level, parallel, superiority randomized control trial with blinding of outcome assessors to evaluate the results of the individually designed exercise programme over home based exercise programme. 74 adult referred GBS patients will be recruited and randomize in two groups either to receive 12 weeks individually designed exercise programme or home based exercise programme. The primary outcome shall be assessed as functional independence in activities of daily living and secondary outcomes shall be evaluated in terms of muscle strength, fatigue, pain, and quality of life at baseline, six months and twelve months duration.Conclusions: This is the first randomized control trial to compare the effect of supervised individually designed exercise over home based exercise programme on pwGBS.Trial registration: Currently the trial is ethically approved, prospectively registered CTRI/2016/08/007150 and in the process of recruiting its first subjects.

Real-world Evidence versus Randomized Controlled Trial: Clinical Research Based on Electronic Medical Records

Real-world evidence (RWE) and randomized control trial (RCT) data are considered mutually complementary. However, compared with RCT, the outcomes of RWE continue to be assigned lower credibility. It must be emphasized that RWE research is a real-world practice that does not need to be executed as RCT research for it to be reliable. The advantages and disadvantages of RWE must be discerned clearly, and then the proper protocol can be planned from the beginning of the research to secure as many samples as possible. Attention must be paid to privacy protection. Moreover, bias can be reduced meaningfully by reducing the number of dropouts through detailed and meticulous data quality management. RCT research, characterized as having the highest reliability, and RWE research, which reflects the actual clinical aspects, can have a mutually supplementary relationship. Indeed, once this is proven, the two could comprise the most powerful evidence-based research method in medicine.

Efectividad de las intervenciones psicológicas basadas en el modelo transteórico (MTT) del cambio para el control metabólico de pacientes diabéticos / Effectiveness of psychological interventions based on the transtheoretical model (MTT) of change for metabolic control of diabetic patients

Objetivo: Evaluar el rol de las intervenciones basadas en el Modelo Transteórico (MTT) para mejorar el autocuidado de pacientes con diabetes mellitus tipo 1 ó tipo 2 (DM1, DM2). Metodología: Se realizó una búsqueda (mayo 2017), en las bases de datos Pubmed, Academic Search Complete y PsycInfo, utilizando términos en inglés relacionados con Glucose Metabolic Disorder, Motivational Interviewing y Randomized Control Trial. Criterios de inclusión: pacientes diabéticos, mayores de 18 años, estudios realizados en atención primaria y cuyo resultado primario fuere el control glicémico. La selección de estudios fue realizada de forma independiente por MP y LR, resolviendo discrepancias con CC. Los resultados son presentados en base al protocolo PRISMA. Resultados: Se identificaron 455 estudios, en base a título y resumen se seleccionaron 68, de los cuales 8 cumplían con los criterios de inclusión. Los participantes presentaban entre 53 y 64 años de edad. No se encontraron estudios con población con DM1. No se encontraron resultados significativos para el control metabólico. Sin embargo, cuatro de los estudios demostraron que el MTT fue efectivo para aumentar la actividad física y dos reportaron mejorar la adherencia al tratamiento farmacológico y mitigar las barreras percibidas para la toma de medicamentos. Conclusiones: Intervenciones psicológicas basadas en el MTT para el cambio de estilo de vida de los pacientes con DM2, favorecen el autocuidado de la enfermedad a través de la adherencia al tratamiento farmacológico y actividad física. No existe evidencia que sugiera que estas intervenciones impacten directamente en el control metabólico. (AU)

Objetive: To establish the role of health behavior interventions based on the Transtheorical Model (TTM), in the treatmentand management of type 1 and type diabetes mellitus (DM1, DM2). Methods: The databases Pubmed, Academic Search Complete and PsycInfo were searched for studies published before May 2017, with the Mesh terms Glucose Metabolic Disorder, Transtheoretical Model. Randomized controlled trials were analyzed. Inclusion criteria: adults with DM1 or DM2, studies conducted in primary care services, glycemic control as primary outcome. Study selection and inclusion was conducted by MP and LR, solving discrepancies with CC. Results :are presented according to the PRISMA statement. Results: 455 studies were initially identified from the selected databases. 68 studies were identified through title and abstract, and analyzed in detail. 8 studies fulfilled inclusion criteria. Participant's age ranged from 53 to 64 years old. There were no studies conducted with DM1patients. There were no significant results for glycemic control. Nonetheless, 4 studies showed that TTM is effective in increasing physical activity and 2 studies showed a significant improvement in treatment adherence and lower psychological limitations to pharmacological adherence. Conclusions: Health behavior interventions based on the TTM for lifestyle changes, have a positive impact in the self-management of patients with type 2 diabetes mellitus. (AU)

Bromelain and cardiovascular risk factors in diabetes: An exploratory randomized, placebo controlled, double blind clinical trial / 中国结合医学杂志

<p><b>OBJECTIVE</b>To assess whether the dietary supplement (bromelain) has the potential to reduce plasma fibrinogen and other cardiovascular disease (CVD) risk factors in patients with diabetes.</p><p><b>METHODS</b>This randomized placebo controlled, double blind, parallel design, efficacy study was carried out in China and investigated the effect of 12 weeks of bromelain (1,050 mg/day) on plasma fibrinogen. This randomized controlled trial (RCT) recruited 68 Chinese diabetic patients [32 males and 36 females; Han origin, mean age of 61.26 years (standard deviation (SD), 12.62 years)] with at least one CVD risk factor. Patients were randomized into either bromelain or placebo group. While bromelain group received bromelain capsule, the placebo group received placebo capsule which consisted inert ingredient and has no treatment effect. Subjects were required to take 1,050 mg (3×350 mg) of either bromelain or starch-filled placebo capsules, two to be taken (2×350 mg) after breakfast and another (350 mg) after dinner, daily for 12 weeks. Plasma fibrinogen, CVD risk factors and anthropometric indicators were determined at baseline and at 12 weeks.</p><p><b>RESULTS</b>The change in the fibrinogen level in the bromelain group at the end of the study showed a mean reduction of 0.13 g/L (standard deviation (SD) 0.86g/L) compared with the mean reduction of 0.36 g/L (SD 0.96 g/L) for the placebo group. However, there was no significant difference in the mean change in fibrinogen between the placebo and bromelain groups (mean difference=0.23g/L (SD 0.22 g/L), =0.291). Similarly, the difference in mean change in other CVD risk factors (blood lipids, blood pressure), blood glucose, C-reactive protein and anthropometric measures between the bromelain and placebo groups was also not statistically significant. Statistical differences in fibrinogen between bromelain and placebo groups before the trial despite randomization may have influenced the results of this study.</p><p><b>CONCLUSION</b>This RCT failed to show a beneficial effect in reducing fibrinogen or influencing other selected CVD risk factors but suggests other avenues for subsequent research on bromelain.</p>

Efficacy and Safety of Bushen Huoxue Herb versus Celecoxib in the Treatment of Knee Osteoarthritis:A Me-ta-analysis / 中国药房

OBJECTIVE:To systematically review the efficacy and safety of Bushen huoxue herb and celecoxib in the treat-ment of knee osteoarthritis, and provide evidence-based reference for clinical treatment. METHODS:Retrieved from CNKI, CBM,VIP and Wanfang Database,Medline,PubMed and Cochrane Library,randomized controlled trials (RCT) about Bushen huoxue herb(test group)and celecoxib(control group)in the treatment of knee osteoarthritis were collected. Meta-analysis was per-formed by using Rev Man 5.3 software after data extraction and quality evaluation. RESULTS:Totally 15 RCTs were included,in-volving 1 129 patients. Results of Meta-analysis showed,the total effective rate [RR=1.09,95%CI(1.04,1.14),P0.05;Lysholm:MD=2.32,95%CI(-1.95,6.58),P>0.05;WOMAC:MD=-2.87,95%CI(-6.38,0.64), P>0.05] and the incidence of adverse reactions in 2 groups[RR=0.49,95%CI(0.22,1.09),P=0.08]. CONCLUSIONS:Bushen huoxue herb shows better efficacy and analgesic effect than celecoxib in the treatment of knee osteoarthritis,and is similar to cele-coxib in terms of improving knee function score and safety.

Effects of low molecular weight heparin on patients with AECOPD:a meta-analysis / 军事医学

Objective To estimate the effect of low molecular weight heparin (LMWH) combined with conventional treatment on patients with acute exacerbation of chronic obstructive pulmonary disease(AECOPD).Methods Literature on randomized control trials( RCTs) with AECOPD treated by LMWH combined with conventional methods was collected in PubMed.The studies were selected according to inclusive and exclusive criteria.The data were extracted,the quality was assessed, and meta-analysis was conducted with RevMan 5.2 software.Results There were twelve RCTs including 879 patients with AECOPD in the current study.The results of meta-analysis showed that:①LMWH could obviously improve PaO2 and PaCO2 of patients with AECOPD as compared with the control group.②There was no statistically significant difference between the LMWH-treated group and control group in the improvement of FEV1 or hematocrit.Conclusion LMWH can significantly improve arterial blood gas analysis in AECOPD, but does not improve FEV1 or hematocrit.

Progress in evidence-based medicine for the treatment of optic neuritis / 中华实验眼科杂志

Optic neuritis is a common optic neuropathy,which typically presents with sudden loss of vision.Visual deficit of optic neuritis varies in severity and generally can be improved spontaneously over several-month duration.The most convincing eight evidences from level Ⅰ and Ⅱ evidence of evidence-based medicine( EBM ) about the treatment of all the optic neuritis were collected by searching theCochrane Controlled TrialsRegister (CENTRAL),MEDLINE,EMBASE and reference lists of identified trial reports since the last decade.At present,the latest findings showed that there is no conclusive evidence of benefit in terms of recovery to normal visual acuity,visual field or contrast sensitivity with either intravenous or oral corticosteroids at the doses evaluated in trials included in this review.Either no treatment or intravenous corticosteroid therapy followed by oral corticosteroids is appropriate,and intravenous corticosteroid may benefit the patient in terms of faster recovery to normal vision.There may be of different treatment of optic neuritis in China compared to Western countries due to geographical,racial and genetic background that may cause different etiology and clinical features of optic neuritis.Therefore,in China,it is imperative to carry out a large randomized control trial(RCT) of optic neuritis as soon as possible to get the best evidence for the management of optic neuritis patients.