Conventional Treatment In Patients Research Articles

Assessment of quality of life during long-term treatment of tolvaptan in refractory heart failure: design and rationale of the AQUA-TLV study.

The vasopressin type 2 receptor antagonist tolvaptan (TLV) has recently become available to treat congestion in in-hospital patients with heart failure (HF). However, there is no evidence confirming the long-term efficacy of TLV. The Assessment of Quality of life during long-term treatment of TLV in refractory heart failure (AQUA-TLV) study is a multicenter, open-labeled, randomized, controlled clinical trial that will enroll 100 patients from 18 hospitals in Japan. Patients with HF assigned to New York Heart Association class III or IV, who had a previous history of hospitalization due to congestive HF during the past 1 year and ongoing symptomatic congestion with baseline urine osmolality > 350 mOsm/L regardless of being prescribed daily furosemide ≥ 60 mg are randomized to the conventional diuretics group (50 patients) and TLV add-on group (50 patients), and their quality of life will be assessed using the Minnesota Living with Heart Failure Questionnaire after 6 months of treatment. This study is the first multicenter prospective randomized study in Japan to evaluate the long-term clinical effectiveness of TLV compared with conventional treatment in patients with congestive HF (UMIN Clinical Trial Registry Number: UMIN 000009604).

Novel Neuromuscular Electrical Stimulation System for Treatment of Dysphagia after Brain Injury

The purpose of this study was to compare the effects of a novel neuromuscular electrical stimulation (NMES) to the effects of conventional treatment in patients with dysphagia after brain injury. In total, 26 patients were non-randomly divided into an experimental group (n = 12) and a control group (n = 14). The experimental group received NMES intervention followed by conventional treatment, including thermal-tactile stimulation with intensive repetition of a dry-swallow task. The control group received conventional treatment without NMES. NMES at a fixed pulse duration of 50 μs and a frequency of 50 Hz was delivered over the skin areas above the motor point of the target muscles, i.e., the bilateral geniohyoid, mylohyoid/anterior belly of the digastric, and thyrohyoid muscles, using a high-voltage pulsed-current device. The two groups received 40-min treatments once a day, 5 days per week, for 8 weeks. Outcome, assessed before and 8 weeks after treatment, was evaluated with regard to the videofluoroscopic dysphagia scale (VDS), the anterior and superior displacement of the hyoid bone and larynx, and the functional oral intake scale. Both groups exhibited improvement, but the experimental group exhibited more significant improvement in the displacement of the hyoid bone and larynx, VDS-total score, and VDS-pharyngeal score than the control group did. The results suggest that NMES combined with conventional treatment is superior to conventional treatment alone in patients with dysphagia following treatment for brain injury. Further investigations are necessary to examine the effects of NMES in patients with more varied types of diseases.

Complementary and Conventional Medicine Use Among Youth With Recurrent Headaches

To identify prevalence and patterns of complementary and alternative medicine (CAM) use among youth with recurrent headaches (HA) and evaluate associations with co-occurring health problems and limitations as well as with the use and expenditures for conventional medical care. Variables were constructed for youth aged 10 to 17 by using linked data from the 2007 National Health Interview Survey and the 2008 Medical Expenditures Panel Survey. Bivariate, logistic, and 2-part regression analyses were used. Of the 10.6% of youth experiencing HA, 29.6% used CAM, rising to 41% for the many HA sufferers who also experienced difficulties with emotions, concentration, behavior, school attendance, or daily activities. Biologically based products (16.2%) and mind-body therapies (13.3%) were most commonly used, especially by the 86.4% of youth with HA experiencing at least 1 other chronic condition. Compared with non-CAM users, youth with HA who used CAM also had higher expenditures for and use of most types of conventional care. CAM use is most common among youth with HA experiencing multiple chronic conditions and difficulties in daily functioning. Associations among CAM use, multiple chronic conditions, and higher use of conventional care highlight the need for medical providers to routinely ask about CAM use to meet the complex health needs of their patients and facilitate the optimal integration of care. Research is needed to identify models for coordinating complementary and conventional care within a medical home and to understand the health benefits or risks associated with CAM use in conjunction with conventional treatments for patients with HA.

Endoscopic airway management of acute upper airway obstruction

The conventional treatment for patients with acute upper airway obstruction is tracheostomy, which is a safe, definitive procedure in most hands. Alternatively, a debulking procedure can be considered but this requires both surgical and anaesthetic skill and expertise. However, where possible, it provides a good alternative with the advantages of removing the cause of obstruction and yielding tissue for histopathological analysis, and avoiding the need for a tracheostomy, with its associated morbidity. We evaluated all patients who presented with acute upper airway obstruction and underwent endoscopic laser debulking surgery performed by the senior author, over a three and a half year period. We recorded patient demographic data, their underlying pathologies, complication rates associated with laser debulking surgery and the conversion to tracheostomy. Thirty patients were identified, including 19 males and 11 females, with a mean age of 57.10±17.20years (19-93years). All patients underwent debulking procedures with carbon dioxide laser under general anaesthetic. All patients had their underlying diagnosis confirmed from their debulking surgery. Twelve patients were found to have benign pathology and 18 had malignant airway obstruction. There were no laser-associated complications. One patient required conversion to emergency tracheostomy, during their debulking surgery. Endoscopic laser assisted debulking surgery has successfully been used to establish a safe airway. It allows obtaining tissue specimens, to confirm the underlying diagnosis, thus avoiding the need for further biopsies under anaesthetic. For all malignant cases, patients were subsequently able to proceed to definitive treatment. It has obviated the need for emergency tracheostomy in almost all of the cases in our patient cohort.

Effects of Constraint-Induced Therapy Combined With Eye Patching on Functional Outcomes and Movement Kinematics in Poststroke Neglect

OBJECTIVE. We investigated the effect of constraint-induced therapy (CIT) plus eye patching (EP), CIT alone, and conventional treatment on functional performance, eye movement, and trunk-arm kinematics in stroke patients with neglect syndrome. METHOD. Twenty-four participants were recruited and randomly allocated to three intervention groups. All participants received intervention 2 hr/day, 5 days/wk, for 3 wk. Outcome measures included the Catherine Bergego Scale, eye movement, and trunk-arm kinematic analysis. RESULTS. The CIT + EP and CIT groups demonstrated larger improvements in functional performance than the control group. The CIT group showed better performance with left fixation points than the CIT+EP group and shorter reaction time than the control group. The CIT + EP group improved more in preplanned control and leftward trunk shift than the other two groups. CONCLUSION. CIT + EP and CIT were more effective interventions than conventional treatment of patients with neglect syndrome in daily functional performance.

Early surgery for native valve infective endocarditis

Expanded abstractCitationKang DH, Kim YJ, Kim SH, Sun BJ, Kim DH, Yun SC, Song JM, Choo SJ, Chung CH, Song JK, Lee JW, Sohn DW: Early surgery versus conventional treatment for infective endocarditis. N Engl J Med 2012, 366: 2466-2473.BackgroundThe timing and indications for surgical intervention to prevent systemic embolism in infective endocarditis (IE) remain controversial. This trial compares clinical outcomes of early surgery and conventional treatment in patients with IE.MethodsObjectiveTo determine the effect of early surgery (<48 hours) to decrease the rate of death or embolic events as compared with conventional treatment for IE.DesignProspective randomized trial.SettingTwo academic medical centers in Korea.SubjectsAdult patients with left-sided, native-valve IE and a high risk of embolism.InterventionValve repair or replacement with removal of vegetation within 48 hours of random assignment versus no early surgery.OutcomesComposite primary endpoint of in-hospital death and embolic events occurring within 6 weeks after random assignment. Secondary endpoints, at 6 months, included death from any cause, embolic events, recurrence of IE, and repeat hospitalization due to the development of congestive heart failure.ResultsThirty-seven patients were assigned to the early-surgery group (<48 hours), whereas 39 were assigned to conventional therapy. Of the 39 randomly assigned to conventional therapy, 27 patients (77%) underwent surgery during the initial hospitalization and three during follow-up. One patient (3%) in the early-surgery group and nine (23%) in the conventional-treatment group reached the primary endpoint (hazard ratio (HR) 0.10, 95% confidence interval (CI) 0.01 to 0.82; P = 0.03). There was no significant difference in all-cause mortality at 6 months in the early-surgery and conventional-treatment groups (3% and 5%, respectively; HR 0.51, 95% CI 0.05 to 5.66; P = 0.59). The rates of the composite endpoint of death from any cause, embolic events, or recurrence of IE at 6 months were 3% in the early-surgery group and 28% in the conventional-treatment group (HR 0.08, 95% CI 0.01 to 0.65; P = 0.02).ConclusionsEarly surgery in patients with IE and large vegetations significantly reduced the composite endpoint of death from any cause and embolic events by effectively decreasing the risk of systemic embolism.

Combination of Chinese Herbal Medicines and Conventional Treatment versus Conventional Treatment Alone in Patients with Acute Coronary Syndrome after Percutaneous Coronary Intervention (5C Trial): An Open-Label Randomized Controlled, Multicenter Study

Aims. To evaluate the efficacy of Chinese herbal medicines (CHMs) plus conventional treatment in patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI). Methods and Results. Participants (n = 808) with ACS who underwent PCI from thirteen hospitals of mainland China were randomized into two groups: CHMs plus conventional treatment group (treatment group) or conventional treatment alone group (control group). All participants received conventional treatment, and participants in treatment group additionally received CHMs for six months. The primary endpoint was the composite of cardiac death, nonfatal recurrent MI, and ischemia-driven revascularization. Secondary endpoint was the composite of readmission for ACS, stroke, or congestive heart failure. The safety endpoint involved occurrence of major bleeding events. The incidence of primary endpoint was 2.7% in treatment group versus 6.2% in control group (HR, 0.43; 95% CI, 0.21 to 0.87; P = 0.015). The incidence of secondary endpoint was 3.5% in treatment group versus 8.7% in control group (HR, 0.39; 95% CI, 0.21 to 0.72; P = 0.002). No major bleeding events were observed in any participant. Conclusion. Treatment with CHMs plus conventional treatment further reduced the occurrence of cardiovascular events in patients with ACS after PCI without increasing risk of major bleeding.

Additive Complex Ayurvedic Treatment in Patients with Fibromyalgia Syndrome Compared to Conventional Standard Care Alone: A Nonrandomized Controlled Clinical Pilot Study (KAFA Trial)

Background. Fibromyalgia (FMS) is a challenging condition for health care systems worldwide. Only limited trial data is available for FMS for outcomes of complex treatment interventions of complementary and integrative (CIM) approaches. Methods. We conducted a controlled, nonrandomized feasibility study that compared outcomes in 21 patients treated with Ayurveda with those of 11 patients treated with a conventional approach at the end of a two-week inpatient hospital stay. Primary outcome was the impact of fibromyalgia on patients as assessed by the FIQ. Secondary outcomes included scores of pain intensity, pain perception, depression, anxiety, and quality of sleep. Follow-up assessments were done after 6 months. Results. At 2 weeks, there were comparable and significant improvements in the FIQ and for most of secondary outcomes in both groups with no significant in-between-group differences. The beneficial effects for both treatment groups were partly maintained for the main outcome and a number of secondary outcomes at the 6-month followup, again with no significant in-between-group differences. Discussion. The findings of this feasibility study suggest that Ayurvedic therapy is noninferior to conventional treatment in patients with severe FMS. Since Ayurveda was only used as add-on treatment, RCTs on Ayurveda alone are warranted to increase model validity. This trial is registered with NCT01389336.

Systematic review and meta‐analysis of studies involving telehome monitoring‐based telenursing for patients with chronic obstructive pulmonary disease

This systematic review evaluated the effects of telehome monitoring-based telenursing (THMTN) on health outcomes and use of healthcare services and compared them with the effects of conventional treatment in patients with severe and very severe chronic obstructive pulmonary disease (COPD). An extensive published work search of several databases was performed in May and October 2011. Randomized controlled trials and non-randomized controlled clinical trials were evaluated. Parameters included hospitalization rate, number of visits to the emergency department, exacerbations, mean number of hospitalizations, mean duration of bed days of care, mortality, and health-related quality of life by the duration of THMTN and COPD severity. A random effects model was applied. Risk ratio and mean difference were calculated. Heterogeneity was assessed using the I(2) statistic. Nine original articles involving 550 participants were identified in the meta-analysis. THMTN decreased hospitalization rates, emergency department visits, exacerbations, mean number of hospitalizations, and mean duration of bed days of care in severe and very severe COPD patients. Hospitalization rates and emergency department visits were comparable between patients undergoing THMTN of different durations. In addition, THMTN had no effect on mortality. THMTN significantly decreases the use of healthcare services; however, it does not affect mortality in severe and very severe COPD patients.

The ASTIS Trial: First Results

This article discusses the first results from the Autologous Stem Cell Transplantation International Scleroderma trial [ASTIS; ISRCTN54371254], an international, investigator-initiated, open-label Phase 3 trial that suggests that hematopoietic stem cell transplantation results in better long-term event-free and overall survival compared with conventional treatment for patients with poor prognosis, early diffuse, cutaneous systemic sclerosis.

Early Surgery versus Conventional Treatment for Infective Endocarditis

BackgroundThe timing and indications for surgical intervention to prevent systemic embolism in infective endocarditis remain controversial. We conducted a trial to compare clinical outcomes of early surgery and conventional treatment in patients with infective endocarditis.MethodsWe randomly assigned patients with left-sided infective endocarditis, severe valve disease, and large vegetations to early surgery (37 patients) or conventional treatment (39). The primary end point was a composite of in-hospital death and embolic events that occurred within 6 weeks after randomization.ResultsAll the patients assigned to the early-surgery group underwent valve surgery within 48 hours after randomization, whereas 30 patients (77%) in the conventional-treatment group underwent surgery during the initial hospitalization (27 patients) or during follow-up (3). The primary end point occurred in 1 patient (3%) in the early-surgery group as compared with 9 (23%) in the conventional-treatment group (hazard ratio, 0.10; 95% confidence interval [CI], 0.01 to 0.82; P=0.03). There was no significant difference in all-cause mortality at 6 months in the early-surgery and conventional-treatment groups (3% and 5%, respectively; hazard ratio, 0.51; 95% CI, 0.05 to 5.66; P=0.59). The rate of the composite end point of death from any cause, embolic events, or recurrence of infective endocarditis at 6 months was 3% in the early-surgery group and 28% in the conventional-treatment group (hazard ratio, 0.08; 95% CI, 0.01 to 0.65; P=0.02).ConclusionsAs compared with conventional treatment, early surgery in patients with infective endocarditis and large vegetations significantly reduced the composite end point of death from any cause and embolic events by effectively decreasing the risk of systemic embolism. (EASE ClinicalTrials.gov number, NCT00750373.)

New Anticoagulants in the Treatment of VTE

Low molecular weight heparins (LMWHs) and vitamin K antagonists make up the cornerstone of therapy for patients with venous thromboembolism (VTE) but have drawbacks making their use difficult in daily practice. Current research focuses on the development of new anticoagulant drugs that could be administered orally at a fixed dose, with fewer food and drug interactions and no need for monitoring or dose adjustment. Several new drugs are tested in noninferiority trials, either as a single-drug approach treatment (e.g., rivaroxaban or apixaban), or after an initial course of LMWH (e.g., dabigatran or edoxaban). Published clinical trials demonstrate that rivaroxaban and dabigatran are noninferior to conventional treatment in patients with VTE. Several issues remain challenging for physicians, such as the lack of antidote and of routinely available monitoring tests. To what extent new anticoagulant drugs will change clinical practice is not yet well defined. They may facilitate outpatient management of VTE. They might also improve the risk-benefit balance of prolonged anticoagulation and therefore modify the optimal duration of anticoagulation in VTE patients.

ECMO criteria for influenza A (H1N1)-associated ARDS: role of transpulmonary pressure

To assess whether partitioning the elastance of the respiratory system (E (RS)) between lung (E (L)) and chest wall (E (CW)) elastance in order to target values of end-inspiratory transpulmonary pressure (PPLAT(L)) close to its upper physiological limit (25 cmH(2)O) may optimize oxygenation allowing conventional treatment in patients with influenza A (H1N1)-associated ARDS referred for extracorporeal membrane oxygenation (ECMO). Prospective data collection of patients with influenza A (H1N1)-associated ARDS referred for ECMO (October 2009-January 2010). Esophageal pressure was used to (a) partition respiratory mechanics between lung and chest wall, (b) titrate positive end-expiratory pressure (PEEP) to target the upper physiological limit of PPLAT(L) (25 cmH(2)O). Fourteen patients were referred for ECMO. In seven patients PPLAT(L) was 27.2 ± 1.2 cmH(2)O; all these patients underwent ECMO. In the other seven patients, PPLAT(L) was 16.6 ± 2.9 cmH(2)O. Raising PEEP (from 17.9 ± 1.2 to 22.3 ± 1.4 cmH(2)O, P = 0.0001) to approach the upper physiological limit of transpulmonary pressure (PPLAT(L) = 25.3 ± 1.7 cm H(2)O) improved oxygenation index (from 37.4 ± 3.7 to 16.5 ± 1.4, P = 0.0001) allowing patients to be treated with conventional ventilation. Abnormalities of chest wall mechanics may be present in some patients with influenza A (H1N1)-associated ARDS. These abnormalities may not be inferred from measurements of end-inspiratory plateau pressure of the respiratory system (PPLAT(RS)). In these patients, titrating PEEP to PPLAT(RS) may overestimate the incidence of hypoxemia refractory to conventional ventilation leading to inappropriate use of ECMO.

Dimethyl Sulfoxide–Sodium Bicarbonate Infusion for Palliative Care and Pain Relief in Patients With Metastatic Prostate Cancer

ABSTRACTProstate cancer (adenocarcinoma of the prostate) is the most widespread cancer in men. It causes significant suffering and mortality due to metastatic disease. The main therapy for metastatic prostate cancer (MPC) includes androgen manipulation, chemotherapy, and radiotherapy and/or radioisotopes. However, these therapeutic approaches are considered palliative at this stage, and their significant side effects can cause further decline in patients’ quality of life and increase non–cancer-related morbidity/mortality. In this study, the authors have used the infusion of dimethyl sulfoxide–sodium bicarbonate (DMSO-SB) to treat 18 patients with MPC. The 90-day follow-up of the patients having undergone the proposed therapeutic regimen showed significant improvement in clinical symptoms, blood and biochemistry tests, and quality of life. There were no major side effects from the treatment. In searching for new and better methods for palliative treatment and pain relief, this study strongly suggested therapy with DMSO-SB infusions could provide a rational alternative to conventional treatment for patients with MPC.

Genome-wide Profiling in AML Patients Relapsing after Allogeneic Hematopoietic Cell Transplantation

Molecular pathogenesis of relapse after allogeneic hematopoietic cell transplantation is poorly understood. Data regarding relapse mechanisms after transplantation is scarcely available. We investigated genomic aberrations (GAs) in 21 patients undergoing related and unrelated HLA-matched transplantation in leukemic blasts before transplant and at relapse after transplantation. We found a higher number of GAs after transplantation, suggesting increased genomic instability during relapse. Two of 21 patients showed a large homozygous region spanning the whole HLA-locus on chromosome 6p in the relapse sample. In both patients sequence-based HLA typing of the blasts revealed a loss of the patient-specific allele at the mismatched locus leading to homozygosity for the HLA haplotype shared by the patient and the donor. In addition, GAs were found in critical regions such as 12p13, 13q12.2, and 17p13. Our results suggest that escape from immunologic surveillance may be a relevant mechanism of relapse after transplantation in patients with GAs on chromosome 6p. A combination of continuous immunologic pressure mediated by donor T cells and clonal evolution of myeloid leukemia may result in acquired GAs after transplantation.

Stem Cell Transplantation for Ischemic Stroke

Studies in animal models of ischemic stroke have shown that stem cells transplanted into the brain can lead to functional improvement. However, to date, evidence for the benefits of stem cell transplantation in patients with ischemic stroke is lacking. Our objective was to assess the efficacy and safety of stem cell transplantation compared with conventional treatments in patients with ischemic stroke. We searched the Cochrane Stroke Group Trials Register (last searched February 2010), the Cochrane Central Register of Controlled Trials (CENTRAL; The …

Fast track surgery versus conventional recovery strategies for colorectal surgery

In recent years the Enhanced Recovery after Surgery (ERAS) postoperative pathway in (ileo-)colorectal surgery, aiming at improving perioperative care and decreasing postoperative complications, has become more common. We investigated the effectiveness and safety of the ERAS multimodal strategy, compared to conventional care after (ileo-)colorectal surgery. The primary research question was whether ERAS protocols lead to less morbidity and secondary whether length of stay was reduced. To answer the research question we entered search strings containing keywords like "fast track", "colorectal and surgery" and "enhanced recovery" into major databases. We also hand searched references in identified reviews concerning ERAS. We included published randomised clinical trials, in any language, comparing ERAS to conventional treatment in patients with (ileo-) colorectal disease requiring a resection. RCT's including at least 7 ERAS items in the ERAS group and no more than 2 in the conventional arm were included. Data of included trials were independently extracted by the reviewers. Analyses were performed using "REVMAN 5.0.22". Data were pooled and rate differences as well as weighted mean differences with their 95% confidence intervals were calculated using either fixed or random effects models, depending on heterogeneity (I(2)). 4 RCTs were included and analysed. Methodological quality of included studies was considered low, when scored according to GRADE methodology. Total numbers of inclusion were limited. The trials included in primary analysis reported 237 patients, (119 ERAS vs 118 conventional). Baseline characteristics were comparable. The primary outcome measure, complications, showed a significant risk reduction for all complications (RR 0.50; 95% CI 0.35 to 0.72). This difference was not due to reduction in major complications. Length of hospital stay was significantly reduced in the ERAS group (MD -2.94 days; 95% CI -3.69 to -2.19), and readmission rates were equal in both groups. Other outcome parameters were unsuitable for meta-analysis, but seemed to favour ERAS. The quantity and especially quality of data are low. Analysis shows a reduction in overall complications, but major complications were not reduced. Length of stay was reduced significantly. We state that ERAS seems safe, but the quality of trials and lack of sufficient other outcome parameters do not justify implementation of ERAS as the standard of care. Within ERAS protocols included, no answer regarding the role for minimally invasive surgery (i.e. laparoscopy) was found. Furthermore, protocol compliance within ERAS programs has not been investigated, while this seems a known problem in the field. Therefore, more specific and large RCT's are needed.

The clinical curative effect of the treatment to severe allergic purpura children through procaine

Objective To observe the clinical curative effect of the treatment to severe allergic purpura children through procaine deveangeorge. Methods From May 2007 to February 2010, 32 patients hospitalized children with severe allergic purpura were randomly divided into two groups:A group (observation group)16 cases were offered conventional treatment(adrenal cortical hormone, antihistamines, improve blood capillary brittleness medicine, antibiotics or disease-resistant poison, etc comprehensive treatment) + procaine treatment.Group B(control group) 16 cases were offered conventional treatment. The clinical effect of two groups were observed. Results Two graps in illness recovery time, the length of time, recurrence rate and effective time,there were significant differences in general, used for treatment of abdominal pain, had blood in one' s stool for intractable main symptom, conventional therapies patients is preferred. Conclusion There is better clinical curative effect of the treatment to severe allergic purpura children through procaine devean george with conventional treatment especially to those with intractable abdominal pain, and having blood in one' s stool as the main symptoms of conventional treatment in patients. Key words: Procaine; Deveangeorge; Serious; Allergic purpura; Children

Stem cell transplantation for ischemic stroke

Studies in animal models of ischemic stroke have shown that stem cells transplanted into the brain can lead to functional improvement. However, to date, evidence for the benefits of stem cell transplantation in ischemic stroke patients is lacking. To assess the efficacy and safety of stem cell transplantation compared with conventional treatments in patients with ischemic stroke. We searched the Cochrane Stroke Group Trials Register (last searched February 2010), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2009, Issue 3), MEDLINE (1966 to August 2008), EMBASE (1980 to August 2008), Science Citation Index (1900 to August 2008), and BIOSIS (1926 to August 2008). We handsearched potentially relevant conference proceedings, screened reference lists, and searched ongoing trials and research registers (last searched November 2008). We also contacted individuals active in the field and stem cell manufacturers (last contacted December 2008). We included randomized controlled trials (RCTs) recruiting patients with ischemic stroke, in any phase of the disease, and an ischemic lesion confirmed by computerized tomography or magnetic resonance imaging scan. We included all types of stem cell transplantation regardless of cell source (autograft, allograft, or xenograft; embryonic, fetal, or adult; from brain or other tissues), route of cell administration (systemic or local), and dosage. The primary outcome was efficacy (assessed as combined functional outcome or disability and dependency) at longer follow-up (minimum six months). Secondary outcomes included post-procedure safety outcomes (death, worsening of neurological deficit, infections and neoplastic transformation). Two review authors independently extracted data and assessed trial quality. We contacted study authors for additional information. We identified three very small RCTs. Two are still awaiting classification because only subgroups of patients could be included in this meta-analysis and additional unpublished data are needed. The third trial randomized 30 patients to intravenous transplantation of autologous mesenchymal stem cell (10 participants) or reference group (20 participants) (five participants, initially randomized to the intervention group, refused the treatment and were allocated to the reference group) and found a statistically non-significant functional improvement in treated patients at longer follow-up. No adverse cell-related events were reported. No large trials of stem cell transplantation have been performed in ischemic stroke patients and it is too early to know whether this intervention can improve functional outcome. Large, well-designed trials are needed.

First Report of Successful Stem Cell Transplantation in a Patient With Sickle Cell Hemoglobin D Disease

Sickle cell hemoglobin D disease is a rare variant of sickle cell disease. Affected patients suffer from episodes of acute exacerbation of clinical course with a wide range of manifestations such as acute chest syndrome, stroke, painful vaso-occlusive crises, acute sequestration crises, joint necrosis, organ failure, infections, and temporary aplastic crises, collectively called sickling crises. Conventional treatments for patients with sickle cell disease include hydroxyurea therapy and prophylactic red blood cell transfusion. However, morbidity and mortality rates remain high with these remedies. In this article, we report hematopoietic stem cell transplantation as an alternative treatment in children with high-risk factors. According to our knowledge and an extensive review of the literature, stem cell transplantation in sickle cell hemoglobin D disease previously has not been reported in any published study and our patient is the first case.