Standardized Medical Treatment Research Articles

The use of complementary and alternative medicine for functional gastrointestinal disorders among the saudi population

Background and objectiveComplementary and alternative medicine (CAM) is a common practice among patients, who experience functional gastrointestinal disorders (FGID). Among the Saudi population, less is known about CAM use for FGID. Therefore, this study aimed to determine the prevalence of CAM utilization for FGID amongst the Saudi population and determine the types of CAM used for treatment. MethodA cross-sectional study was carried out in Riyadh, Saudi Arabia during February 2023 through social media platforms using questionnaires adopted from the literature. There were three sections in the questionnaire including demographic information, questions to determine the prevalence of CAM use for FGID, the types of FGID, and the types of CAM utilization, and questions on the sources of information about CAM. Multivariable logistic regression was applied to find factors associated with CAM use. All statistical analyses were performed using SPSS version 26. ResultsA total of 828 people participated in this study. The overall prevalence of CAM use for FGID problems was 87.2 %. There were no significant differences in CAM use for FGID problems between men (87.5 %) and women (86.3 %) (P = 0.727). The most commonly used types of CAM for FGID were ginger (73.4 %), chamomile (66.6 %), mint (61.6 %), turmeric (59.0 %), anise (55.5 %), fennel (43.1 %), and Activia yogurt©️ (42.7 %). The most common FGID disorders for utilizing CAM were IBS (29.9 %), followed by constipation (29.8 %), dyspepsia (22.7 %), and bloating (17.0 %). In the multivariable regression, age, gender and employment status did not have an impact on the odds of using CAM. The subjects who had high school, university, and postgraduate education had significant odds ratios of CAM use (OR = 2.73; 95 % CI: 1.22–6.13), (OR = 4.18; 95 % CI: 2.03–8.58), and (OR = 20.85; 95 % CI: 5.51–78.80), respectively, compared to subjects who did not complete high school. Participants who had private insurance had a significant odds ratio (OR = 0.27; 95 % CI: 0.14–0.55) compared to governmental insurance. ConclusionThe use of CAM among the Saudi population is alarmingly high; however, the lack of standardized medical recommendations and treatment options may be the cause. Although there were no significant gender differences, participants with higher educational levels and private insurance coverage were more likely to use CAM for FGID. Patients suffering from FGID and limited access to medical advice and treatment options are vulnerable to being exposed to dubious and incredible information sources. Expanding access to preventative medical services, funding governmental medical websites to provide credible information, educating healthcare professionals about FGID, and conducting more research in safe and effective treatments for FGID is recommended.

Improving cardiovascular control in a hypertensive population in primary care. Results from a staff training intervention

Objective A pilot study to evaluate a staff training intervention implementing a nurse-led hypertension care model. Design and setting Clinical and laboratory data from all primary care centres (PCCs) in the Swedish region Västra Götaland (VGR), retrieved from regional registers. Intervention started 2018 in 11 PCCs. A total of 190 PCCs served as controls. Change from baseline was assessed 2 years after start of intervention. Intervention Training of selected personnel, primarily in drug choice, team-based care, measurement techniques, and use of standardized medical treatment protocols. Patients Hypertensive patients without diabetes or ischemic heart disease were included. The intervention and control groups contained approximately 10,000 and 145,000 individuals, respectively. Main outcome measures Blood pressure (BP) <140/90 mmHg, LDL-cholesterol (LDL-C) <3.0 mmol/L, BP ending on −0 mmHg (digit preference, an indirect sign of manual measuring technique), choice of antihypertensive drugs, cholesterol lowering therapy and attendance patterns were measured. Results In the intervention group, the percentage of patients reaching the BP target did not change significantly, 56%–61% (control 50%–52%), non-significant. However, the percentage of patients with LDL-C < 3.0 mmol/L increased from 34%–40% (control 36%–36%), p = .043, and digit preference decreased, 39%−27% (control 41%−35%), p = 0.000. The number of antihypertensive drugs was constant, 1.63 − 1.64 (control 1.62 − 1.62), non-significant, but drug choice changed in line with recommendations. Conclusion Although this primary care intervention based on staff training failed to improve BP control, it resulted in improved cardiovascular control by improved cholesterol lowering treatment.

Standardized rate of hospitalization for violent injuries among different generations in counties and cities in Taiwan from 2000 to 2015.

This study aimed to understand the distribution of the standardized rate of hospitalization for violent injuries in counties and cities in Taiwan. The ICD-9 diagnosis code N-codes 995.5 (abused child) and 995.8 (abused adult) or E-code E960-E969 (homicide and intentional injury by others) were defined as research cases. The study analyzed the standardized medical treatment rate of children and adolescents aged 0 to 17, adults aged 18 to 64, and older adults over 65 years old suffering from violence for the first time. During the 15-year period, the counties and cities with the highest rate of medical treatment for violent injuries among children (unit: per 105 people) were Pingtung County (33.1 males, 22.9 females), Lienchiang County (8.8 males, 9.8 females), and New Taipei City (8.2 males, 8.8 females). For adults, Pingtung County (73.2 males, 36.8 females), New Taipei City (26.0 males, 14.3 females), and Yunlin County (19.7 males, 7.7 females) registered the highest rates. For older adults, Pingtung County (33.6 persons), New Taipei City (12.5 persons), Yun Lin County (11.2 persons), and Taichung City (9.2 persons) registered the highest rates. The highest rates of older female adults receiving treatment were recorded in Pingtung County (15.1 persons), Yunlin County (9.0 persons), Taichung City (5.5 persons), and New Taipei City (5.1 persons). With the Poisson regression model, the relative risk ratio of seeking medical care owing to violence in Pingtung County (reference: Taipei City) was 25.1 times for children, 20.1 times for adults, and 11.7 times for older adults. The counties and cities with higher rates of violent medical treatment for adults and older adults during the 15-year period were Pingtung County, New Taipei City, and Yunlin County. For children and adolescents, Pingtung County, Lienchiang County, and New Taipei City recorded the highest rates. Pingtung County had the highest risk of sexual violence. These results may be related to the local industrial structure, demographic composition, and other characteristics explained in the text.

How to Dispose of Medical Waste Caused by COVID-19? A Case Study of China.

The rapid increase in novel coronavirus (COVID-19) patients also means a rapid increase in medical waste that could carry the novel coronavirus (SARS-CoV-2). How to safely dispose of medical waste caused by COVID-19 is a huge challenge that needs to be solved urgently. The outbreak of the COVID-19 has led to a significant increase in the daily generation of medical waste in China and has placed a severe test on the Chinese medical waste disposal system. Unlike ordinary wastes and garbage, medical waste that is untreated or incompletely treated will not only cause environmental pollution, but also directly or indirectly cause infections and endanger people’s health. Faced with difficulties, the Chinese government formulated a policy for medical waste management and a response plan for the epidemic, which provides policy guarantee for the standardized disposal of epidemic medical waste. In addition, the government and medical institutions at all levels formed a comprehensive, refined, and standardized medical treatment process system during research and practice. China has increased the capacity of medical waste disposal in various places by constructing new centralized disposal centers and adding mobile disposal facilities. China has achieved good results in the fight against COVID-19, and the pressure on medical waste disposal has been relieved to a certain extent. However, the global epidemic situation is severe. How to ensure the proper and safe disposal of medical waste is related to the prevention and control of the epidemic situation. This study summarizes China’s experience in the disposal of medical waste in the special case of COVID-19 and hopes to provide some reference for other countries in the disposal of medical waste.

A Retrospective Study Comparison Between Stenting and Standardized Medical Treatment for Intracranial Vertebrobasilar Stenosis in a Real-World Chinese Cohort.

Background: To date, there has been no consensus regarding the benefits of percutaneous transluminal angioplasty and stenting (PTAS) vs. those of standardized medical treatment (SMT) for patients with symptomatic intracranial vertebrobasilar stenosis (IVBS). The purpose of this retrospective study was to compare the effects of PTAS or SMT on symptomatic IVBS in a real-world Chinese population.Methods: We included 238 patients with ischemic stroke caused by IVBS stenosis who were admitted to Shandong Provincial Hospital Affiliated to Shandong University between September 2012 and May 2018; 62 of these patients were treated with SMT and 176 underwent PTAS. Ischemic stroke in the territory of the responsible artery, hemorrhage, and death within 1 year were recorded as primary endpoints. Secondary endpoints included assessment of stroke severity and the incidence of re-stenosis. The primary endpoint rates were compared between the PTAS and SMT groups at 7 days, 1, 6 months, and 1 year.Results: In the PTAS group, the success rate of stent placement was 98.9%. During the entire trial, except for 7 days, the SMT group had a higher frequency of primary endpoint events than did the PTAS group. The primary endpoint was 17.7% (11/62) vs. 8.6% (15/174) at 1 month (p = 0.049), 29% (18/62) vs. 14.4% (25/174) at 6 months (p = 0.01), and 32.2% (20/62) vs. 17.2% (30/174) at 1 year (p = 0.013). The restenosis rate of the target lesion was 13.8%; 60% were symptomatic restenosis and 40% were asymptomatic restenosis. The rate of severe stroke at 1 year after PTAS was 0%, while that in the SMT group was 9.7%.Conclusions: In a real-world Chinese cohort, PTAS for patients might be superior to SMT, and provide better long-term neurological function recovery and lower disability rate.

The treatment efficacy of nasal polyposis on olfactory functions, clinical scoring systems and inflammation markers.

The aim of this study was to investigate the effect of the medical and the surgical treatment on the olfactory functions, clinical scoring systems and inflammation markers in patients with nasal polyposis. In addition, the secondary aim was to investigate the correlation between those investigated parameters. A total of 30 patients, who completed the standardized medical and surgical treatment and also came to 3months of follow-ups regularly after the surgery, were included in the study. The Sniffin' Sticks olfactory tests, radiological and the endoscopic stagings, liver-expressed chemokine (CCL16) and endothelin (ET) levels and sino-nasal outcome test-22 (SNOT-22) were performed at the initial and at the end of the study. The current study had four major findings: (1) significant improvement in odor functions after treatment was determined; however, the majority of the patients had been already hyposmic. (2) In addition, significant improvement was found in ET and CCL16 levels, SNOT-22 results, and radiologic and endoscopic stagings at the end of the study. (3) However, there was no correlation between the olfactory functions and the investigated parameters. (4) There was a positive correlation between polyp recurrence and ET levels. The standardized medical and surgical treatment provided a significant improvement in the olfactory functions. However, only one patient (3.3%) had become normosmic at the end of the study.

Outcome of Early Tracheostomy in the Management of Grade II (Moderate) Tetanus Patient

The study was carried out in ENT Department ofKEMU, Lahore from December 2012 to November 2015 to assess theoutcome of early tracheostomy in grade II (moderate) tetanus patients.A total of fifty-six adults of both genders, diagnosed as grade II tetanus patients, were included. Clinical characteristics,mode of trauma, incubation period, vaccination status and investigations were recorded. All patients were managed in ICU and early tracheostomy was performed in addition to standardized medical treatment. A total of 86% males with age 32±8.3 years presented the study participants. Results demonstrated thatmost common mode of trauma was road traffic accident, and majority (54%) of patients were never vaccinated. Incubation period noted was 7±1 days. Tracheostomy was performed in 16±3 hours of admission and tracheostomy decannulation was performed in 23±3 days. Patients were discharged in 27±3 days.Weconcludethat early control of airway with tracheostomy in grade II tetanus patients helped in better patient management with early recovery and decreased hospital stay with minimal morbidity.

Anti-tumor necrosis factor alpha therapy (adalimumab) in Rasmussen's encephalitis: An open pilot study.

Rasmussen's encephalitis (RE) is a severe chronic inflammatory brain disease affecting one cerebral hemisphere and leading to drug-resistant epilepsy, progressive neurologic deficit, and unilateral brain atrophy. Hemispherotomy remains the gold standard treatment but causes permanent functional impairment. No standardized medical treatment protocol currently exists for patients prior to indication of hemispherotomy, although some immunotherapies have shown partial efficacy with functional preservation but poor antiseizure effect. Some studies suggest a role for tumor necrosis factor alpha (TNF-α) in RE pathophysiology. We report an open-label study evaluating the efficacy and the safety of anti-TNF-α therapy (adalimumab) in 11 patients with RE. The primary outcome criterion was the decrease of seizure frequency. The secondary outcome criteria were neurologic and cognitive outcomes and existence of side effects. Adalimumab was introduced with a median delay of 31 months after seizure onset (range 1 month to 16 years), and follow-up was for a median period of 18 months (range 9-54 months). There was a significant seizure frequency decrease after adalimumab administration (from a median of 360 to a median of 32 seizures per quarter, p ≤ 0.01). Statistical analysis showed that adalimumab had a significant intrinsic effect (p < 0.005) independent from disease fluctuations. Five patients (45%) were found to have sustained improvement over consecutive quarters in seizure frequency (decrease of 50%) on adalimumab. Three of these five patients also had no further neurocognitive deterioration. Adalimumab was well tolerated. Our study reports efficacy of adalimumab in terms of seizure frequency control. In addition, stabilization of functional decline occurred in three patients. This efficacy might be particularly relevant for atypical slowly progressive forms of RE, in which hemispherotomy is not clearly indicated. Due to our study limitations, further studies are mandatory to confirm these preliminary results.

Efficacy of ertapenem in severe hidradenitis suppurativa: a pilot study in a cohort of 30 consecutive patients.

Hidradenitis suppurativa (HS) is an inflammatory skin disease typically localized in the axillae and inguinal and perineal areas. In the absence of standardized medical treatment, severe HS patients present chronic suppurative lesions with polymicrobial anaerobic abscesses. Wide surgery is the cornerstone treatment of severe HS, but surgical indications are limited by the extent of lesions. Intravenous broad-spectrum antibiotics may help control HS, but their efficacy is not documented. This study was designed to assess the efficacy of a 6 week course of ertapenem (1 g daily) and of antibiotic consolidation treatments for 6 months (M6) in severe HS. Thirty consecutive patients with severe HS were retrospectively included in this study. The clinical severity of HS was assessed using the Sartorius score, which takes into account the number and severity of lesions. The median (IQR) Sartorius score dropped from 49.5 (28-62) at baseline to 19.0 (12-28) after ertapenem (P < 10(-4)). Five patients were lost to follow-up thereafter. At M6 the Sartorius score further decreased for the 16 patients who received continuous consolidation treatments, since 59% of HS areas reached clinical remission at M6 (i.e. absence of any inflammatory symptoms, P < 10(-4)). Nine patients interrupted or received intermittent consolidation treatments due to poor observance or irregular follow-up. Their Sartorius score stopped improving or returned to baseline. No major adverse event occurred. Ertapenem can dramatically improve severe HS. Consolidation treatments are needed to further improve HS and are mandatory to prevent relapses. Combined with surgery, optimized antibiotic treatments may be promising in severe HS.

4A.07

Objective: The French DENERHTN trial has shown that renal denervation (RDN, Symplicity Catheter) in addition to standardized optimal medical treatment (SOMT) decreases ambulatory BP more (6 mmHg) than the same SOMT alone at 6 months in patients (pts) with resistant hypertension (RH). However, some pts did not respond to RDN or SOMT at 6 months. The aim of the study was to determine the prevalence and characteristics of refractory hypertension (RFH) to more than 5 antihypertensive treatments at 6 months in the 2 groups. Design and method: Pts with RH to > = 3 antihypertensive drugs, including a diuretic, entered a 4-week standardised triple treatment with indapamide 1.5 mg/day, ramipril 10 mg/day (or irbesartan 300 mg/day if cough), and amlodipine (10 mg/day). After 4 weeks, pts with daytime ambulatory SBP/DBP (dASBP/dADBP) > = 135 or 85 mmHg were randomised to the RDN or control group. After randomisation, the SOMT included: spironolactone (25 mg/day), bisoprolol (10 mg/day), prazosin (5 mg/day), and rilmenidine (1 mg/day) sequentially added if home BP (HBP) was > = 135 or 85 mmHg at month 2, 3, 4 and 5. Results: 49/97 pts (50.5%) had RFH at 6 months (RDN: 20/44, 45.5% vs. control: 28/53, 52.8%; p = 0.157). RFH pts were more frequently women, had more frequently OSA, had higher baseline BP values, responded less to any intervention (RDN + SOMT or SOMT alone) despite receiving more antihypertensive treatments, had lower plasma creatinine at baseline. The Morisky adherence score was lower (p = 0.085) at baseline than at 6 months in the RFH group.Conclusions: In conclusion, despite following strictly ESH guidelines for treating patients with RH to a triple therapy, around 50% of the pts have RFH after 6 months follow-up in the DENERHTN trial. Female gender, high BP, low plasma creatinine, and lower adherence at baseline were associated with RFH.

A standardized treatment regimen for patients with severe haemophilia A undergoing orthopaedic or trauma surgery: a single centre experience.

Recommendations on the administration of clotting factor concentrates in patients with severe haemophilia undergoing surgery are usually determined by monitoring target clotting factor levels. In this retrospective cohort study, we enrolled patients with severe haemophilia A who underwent major orthopaedic or trauma surgery. We wanted to evaluate the feasibility and the safety of a standardized medical treatment procedure. Further on, we wanted to assess whether our standardized treatment regimen enables surgical procedures in certain situations in which measuring clotting factor VIII (FVIII) activity is not available. We created a standardized medical treatment procedure that included a medical protocol and close cooperation with the Haemophilic Treatment Centre. Thirteen surgical procedures in nine patients were examined. The feasibility and safety of this standardized treatment concept were assessed by identifying perioperative complications and by means of a questionnaire. Depending on the surgery, the amount of FVIII administered within the first 10 days ranged between 653 and 1027 units/kg body weight. No allogeneic blood transfusion was required. The measurement of FVIII activity was performed repeatedly in five patients. In all patients activated partial thromboplastin time monitoring was performed during the hospital stays. The surgeons and patients were satisfied with our treatment concept and adhered to the medical regimen protocol. By means of a detailed, standardized medical protocol and by ensuring close cooperation between the patient, the surgeons and the Haemophilic Treatment Centre, we could show that elective and emergency operations can be safely performed even in situations in which FVIII activity could not be monitored.

Commentary on "clinical characteristics and adequate treatment of familial adenomatous polyposis combined with desmoid tumors".

We commend Jung et al. [1] on their noteworthy effort to describe the clinicopathological features, risk factors, and outcomes of familial adenomatous polyposis (FAP) patients with desmoid tumors (DTs). In this regard, we would like to stress a particular and disturbing aspect of this disease, which is the potentially ambiguous role of surgery towards young FAP patients with colorectal cancer (CRC). In fact, in these patients, the post-surgical development of massive intra-abdominal DTs represents a fatal event in the vast majority of cases, as discussed in more detail hereafter. Recently, we performed total proctocolectomy in a 28-year-old nulliparous FAP-girl (APC mutation 3′ to codon 3238) who developed a cancerous polyp of the rectum. The patient did well after the intervention until, after 6 months, she developed a pregnant looking abdomen, even though she was not pregnant. A computed tomography scan showed a solid mass of the mesentery measuring 28 cm×21 cm, which occupied the entire abdominal cavity encasing the superior mesenteric vessels and both common iliac arteries: a radiological diagnosis of giant mesenteric DT was notched (Fig. 1). Due to the irresectable nature of the lesion, the patient was referred to a specialized center for intestinal and multivisceral transplantation, but, during evaluation she became rapidly aggravated until death. Fig. 1. Coronal (A) and sagittal (B) view of the stage IV intra-abdominal desmoid tumor occupying the entire abdominal cavity and encasing vital vascular structures Despite being extremely rare in the general population, intra-abdominal DTs (also known as mesenteric fibromatosis) represent the most frequent cause of death in patients affected with FAPhaving undergone total proctocolectomy [2]. Although histologically benign and clinically non-metastasizing, these monoclonal myofibroblastic proliferations can show a highly aggressive local behavior, achieving massive size, infiltrating major vessels and causing severe complications, such as bowel ischemia and obstruction, fistulae with peritonitis, bleeding and venousthromboembolism [2]. Young nulliparous women using contraceptives with history of colectomy are at higher risk of development [2]. Pathobiology is poorly understood: consequently, their behavior is unpredictable and there is no standardized medical orsurgical treatment [1]. A valuable measure in management of this kind of lesion was provided in 2005 by Church et al. [3] who proposed a clinical staging system based on tumorsize, growth and the presence ofsymptoms and complications. While stage I, II, and III are amenable to several modalities of treatment (antiestrogens, nonsteroidal anti-inflammatory drugs,selective tyrosine kinase inhibitor, chemotherapy, and surgical resection),stage IV tumors (larger than 20 cm, rapidly growing and severely symptomatic such as our case) are characterized by higher morbidity and mortality rates: indeed, any medical treatmentseemsto be in vain astoo much time is required for any type of benefit and surgical resection is often impossible for the encasement of vital vessels [1]. Currently, advanced unresectable mesenteric DTs are the fourth most common indication for intestinal transplant intervention worldwide [4]. However, not all of these patients arrive at transplantation (as in our case) and the 5-year survival rate does not exceed 70% [2]. Greater knowledge of giant inoperable mesenteric DTs is needed, and, in particular, young FAP patients should be thoroughly informed on the risk of this ominous event when undergoing colectomy for CRC and carefully followed-up.

Renal Denervation Improves Systolic Ambulatory BP in Resistant Hypertension

Systolic daytime ambulatory blood pressure (BP) was significantly decreased by renal denervation plus standardized medical treatment with the Symplicity catheter compared with standardized medical treatment alone in patients with confirmed resistant hypertension. This article presents 6-month data from the multicenter Renal Denervation in Hypertension study [DENER-HTN; NCT01570777].

Hemicraniectomy and Durotomy Upon Deterioration From Infarction-Related Swelling Trial

Hemicraniectomy and Durotomy Upon Deterioration From Infarction-Related Swelling Trial (HeADDFIRST) was a randomized pilot study to obtain information necessary to design a Phase III trial to evaluate the benefit of surgical decompression for brain swelling from large supratentorial cerebral hemispheric infarction. All patients with stroke were screened for eligibility (age 18-75 years, National Institutes of Health Stroke Scale≥18 with Item 1a<2 [responsive to minor stimulation], and CT demonstrating unilateral, complete middle cerebral artery territory infarction by specific imaging criteria). All enrolled patients were treated using a standardized medical treatment protocol. Those with both≥4 mm of pineal shift and deterioration in level of arousal or ≥7.5 mm of anteroseptal shift within 96 hours of stroke onset were randomized to continued medical treatment only or medical treatment plus surgery. Death at 21 days was the primary outcome measure. Among 4909 screened patients, only 66 (1.3%) patients were eligible for HeADDFIRST. Forty patients were enrolled, and 26 patients developed the requisite brain swelling for randomization. All who failed to meet randomization criteria were alive at 21 days. Mortality at 21 and 180 days was 40% (4/10) in the medical treatment only and 21% (3/14) and 36% (5/14) in the medical treatment plus surgery arms, respectively. HeADDFIRST randomization criteria effectively distinguished low from high risk of death from large supratentorial cerebral hemispheric infarction. Lower mortality in the medical treatment only group than in other published trials suggests a possible benefit to standardizing medical management. These results can inform the interpretation of recently completed European trials concerning patient selection and medical management. This trial was not registered because enrollment began before July 1, 2005.

Corneal collagen cross‐linking as treatment for infectious and noninfectious corneal melting in cats and dogs: results of a prospective, nonrandomized, controlled trial

UV-A/Riboflavin cross-linking of corneal collagen fibers (CXL) is a highly promising therapy for corneal melting in humans. A prospective interventional, nonrandomized, controlled study was conducted to compare the stabilizing effect of CXL treatment on melting keratitis in dogs and cats and the complication rate of CXL to those of standardized intensive medical treatment. Forty-nine eyes with melting keratitis were included in the study between October 2009 and October 2012. All eyes were treated according to the same medical treatment protocol. Nineteen eyes were CXL-treated, and 30 eyes were not. Follow-up included slit-lamp examination, fluorescein staining, ulcer size measurement, stromal stability evaluation, photographic documentation, and documentation of complications. Five of 19 eyes in the CXL group and 9/30 eyes in the control group required rescue stabilization due to continued melting. Seven of the nine control group corneas stabilized after rescue CXL treatment. At initial presentation, the ulcers in the canine CXL group were significantly deeper and larger than in the control group. Ulcer deepening during follow-up was more pronounced in the canine control group than in the canine CXL group. CXL treatment-related complications were not observed. Based on the similar failure rates in the control and CXL treatment groups despite the poorer initial situation in the CXL group, the tendency for the ulcers in the control group to deepen and the stabilization of all corneas receiving CXL rescue treatment, we believe that CXL has its place as an adjunctive therapy for melting keratitis in veterinary ophthalmology.

DiaSurg 2 trial - surgical vs. medical treatment of insulin-dependent type 2 diabetes mellitus in patients with a body mass index between 26 and 35 kg/m2: study protocol of a randomized controlled multicenter trial - DRKS00004550

BackgroundType 2 diabetes mellitus (T2DM) is a disease with high prevalence, associated with severe co-morbidities as well as being a huge burden on public health. It is known that glycemic control decreases long-term morbidity and mortality. The current standard therapy for T2DM is medical treatment. Several randomized controlled trials (RCTs) performed in obese patients showed remission of T2DM after bariatric surgery. Recent RCTs have shown bariatric procedures to produce a similar effect in non-morbidly and non-severely obese, insulin-dependent T2DM patients suggesting procedures currently used in bariatric surgery as new therapeutical approach in patients with T2DM. This study aims at investigating whether Roux-en-Y gastric bypass (RYGB) is an efficient treatment for non-severely obese T2DM patients in terms of preventing long-term complications and mortality.MethodsThe DiaSurg 2 trial is a multicenter, open randomized controlled trial comparing RYGB including standardized medical treatment if needed to exclusive standardized medical treatment of T2DM (control group). The primary endpoint is a composite time-to-event endpoint (cardiovascular death, myocardial infarction, coronary bypass, percutaneous coronary intervention, non-fatal stroke, amputation, surgery for peripheral atherosclerotic artery disease), with a follow-up period of 8 years. Insulin-dependent T2DM patients aged between 30 and 65 years will be included and randomly assigned to one of the two groups. The experimental group will receive RYGB and, if needed, standardized medical care, whereas the control group will receive exclusive standardized medical care, both according to the national treatment guidelines for T2DM. Statistical analysis is based on Cox proportional hazards regression for the intention-to-treat population. Assuming a loss to follow-up rate of 20%, 200 patients will be randomly allocated to the comparison groups. A total sample size of n = 400 is sufficient to ensure 80% power in a two-tailed significance test at alpha = 5%.DiscussionThe DiaSurg2 trial will yield long-term data (8 years) on diabetes-associated morbidity and mortality in patients with insulin-dependent T2DM receiving either RYGB or standardized medical care.Trial registrationThe trial protocol has been registered in the German Clinical Trials Register DRKS00004550.

Abstract WP283: Medical Treatment Matters: Using Headdfirst Results To Enhance The Lessons From The European Hemicraniectomy Trials For Stroke

Introduction: HeADDFIRST was a randomized trial to evaluate the benefit of surgical decompression for brain swelling from large supratentorial cerebral hemispheric infarction (LSCHI). Subsequently, several similar European trials have been completed. Several unique aspects about HeADDFIRST findings provide specific lessons about patient selection and the significance of medical management to outcome, particularly in the context of these trials. Methods: All patients were screened for eligibility (age 18-75, NIHSS &gt; 18, and CT demonstrating at least compete MCA territory infarction by specific imaging criteria). Those without exclusions and consented were treated by a standardized medical treatment protocol. Those with &gt; 4 mm of pineal shift or &gt; 7.5 mm of anteroseptal shift within 96 hours of stroke onset were randomized to the medical treatment only (MTO) or surgical + medical treatment (SMT) arms with struct adherence. Results: 40 patients were registered, and 26 developed the requisite brain swelling for randomization. All of those consented who failed to develop the degree of brain swelling required for randomization survived. The 180-day mortality was 40% and 35.7% in the MTO and SMT arms, respectively. From the pooled meta-analysis of the European trials’ the 12-month mortality was 71% and 22% in the medical and surgical arms. Conclusion: 1. HeADDFIRST medical treatment outcomes were profoundly better than the European trials, suggesting some significance to our medical treatment protocol differences and the strict adherence. 2. HeADDFIRST randomization criteria accurately differentiates between survivors vs. those with a high risk of non-survival with LSCHI.

Analysis on standardized emergency treatments to 69 eases of blunt abdominal injury

Objective To analyze the clinical features and the clinical diagnostic measurements of blunt abdominal injury in order to regulate the treatment of blunt abdominal injury and improve the diagnosis and treatment level. Methods The retrospective analysis was carried out to of clinical data and treatment results of the 69 patients with blunt abdominal injury.Results Among 69 patients with blunt abdominal injury, 62 routine emergency surgery, conservative treatment in 7 cases, rescue cure in 64 cases, 92.8% survival rate, before and after surgery and 5 died. Conclusion Quick assessment to the injury, early comprehensive examination conducting, developing treatment plans, early anti-shock therapy and surgery, prevention of multiple organ failure and the standardized emergency medical treatment can significantly improve the success rate of treatment of blunt abdominal injury. Key words: Blunt injury; Injury assessmeng Comprehensive examination; Standardized treatment

A Controlled Study of Sorbent Suspension Dialysis in Chronic Liver Disease and Hepatic Encephalopathy

To investigate the role of extracorporeal detoxification in cirrhotic patients with advanced hepatic encephalopathy not responding to medical treatment, 20 patients were randomized to receive six hours of additional sorbent dialysis or ongoing standardized medical treatment. Following treatment, the clinical stage of encephalopathy remained unchanged in both groups. Abnormal sensory evoked potentials improved following sorbent dialysis (N70 latency, 128 ms before versus 110 ms after treatment, P<0,05; cervico-cranial transmission, 7.7 ms versus 6.8 ms, P<0.01) indicating improvement in important aspects of cerebral function. In contrast, brain function remained unchanged following medical treatment (N70 latency, 114 ms versus 113 ms; cervico-cranial transmission, 7.7 ms versus 7.2 ms, P=NS, respectively). Serum benzodiazepine levels decreased significantly after sorbent dialysis but not after medical treatment. Biocompatibility of sorbent dialysis was limited and clinical complications occurred in a proportion of patients. In conclusion, a six-hour treatment with sorbent suspension dialysis did not ameliorate the clinical stage of HE but improved neurophysiologic function in cirrhotic patients who had not responded to conventional medical treatment.

Die Wirksamkeit psychotherapeu-tischer Maßnahmen bei Morbus Crohn - Ergebnisse einer randomisierten, multizentrischen Studie1 -

In a prospective multicenter study of Crohn disease patients, the influence of psychotherapy on the course of the disease and on psychosocial variables (anxiety, depression, life satisfaction and data of the PSKB) was studied. Psychodynamic oriented psychotherapy was provided in addition to a standardized medical treatment and took place during the first year of the two-year observation period. 108 of 488 patients were recruited and randomly assigned to the psychotherapy and the control group. 84 patients completed the somatic and 81 the psychosocial follow up. 23% of the control group and 30% of the psychotherapy group showed episode-free courses, 29% and 17% respectively underwent surgery (worst outcome group). The ranking and comparisons of the disease course showed no significant difference (p = 0.125) between psychotherapy and control group. The psychosocial variables also showed no differences between these groups. Subjectively, the patients report favourable effects to psychotherapy.