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PubMed2004

Comparison of endoscopic procedures vs Lichtenstein and other open mesh techniques for inguinal hernia repair: a meta-analysis of randomized controlled trials.

BACKGROUND: For the scientific evaluation of the endoscopic and open mesh techniques for the repair of inguinal hernia, meta-analyses of randomized controlled trials (RCT) are necessary. The Lichtenstein repair is one of the most common open mesh techniques and therefore of special interest. METHODS: After an extensive search of the literature and a quality assessment, a total of 34 RCT comparing endoscopic procedures both transabdominal preperitoneal (TAPP) and total extraperitoneal (TEP)--with various open mesh repairs were deemed to be suitable for a formal meta-analysis of the relevant parameters. These studies included data for 7,223 patients. Trials that used the Lichtenstein repair for the control group (23 of 34 trials) were analyzed-separately. RESULTS: Significant advantages for the endoscopic procedures compared with the Lichtenstein repair include a lower incidence of wound infection (Peto odds ratio, 0.39; 95% confidence interval, 0.26, 0.61), a reduction in hematoma formation (0.69 [0.54, 0.90]) and nerve injury (0.46 [0.35, 0.61]), an earlier return to normal activities or work (-1.35[-1.72, -0.97]), and fewer incidences of chronic pain syndrome (0.56[0.44, 0.70]). No difference was found in total morbidity or in the incidence of intestinal lesions, urinary bladder lesions, major vascular lesions, urinary retention and testicular problems. Significant advantages for the Lichtenstein repair include in a shorter operating time (5.45[1.18, 9.73]), a lower incidence of seroma formation (1.42[1.13, 1.79]), and fewer hernia recurrences (2.00[1.46, 2.74]). Similar results are seen when endoscopic procedures are compared with other open mesh repairs. However, in this comparison, total morbidity was lower with the endoscopic operations (0.73[0.61, 0.89]). The incidence of seroma formation, chronic pain syndromes, and hernia recurrence was not significantly different. CONCLUSION: Endoscopic repairs do have advantages interms of local complications and pain-associated parameters. For more detailed evaluation further well-structured trials with improved standardization of hernia type, operative technique, and surgeons' experience are necessary.

Digestive System Surgical Procedures↗

PubMed1999

Accuracy of endorectal ultrasound after preoperative radiochemotherapy in locally advanced rectal cancer.

OBJECTIVES: Factors limiting the accuracy of endorectal ultrasound in staging, locally advanced primary rectal cancer after preoperative neoadjuvant radiochemotherapy (RCT) were evaluated. METHODS: Patients (n = 84) with initial locally advanced rectal cancer (uT3/uT4) undergoing R0 resection were investigated after preoperative treatment that combined radiotherapy up to 45 Gy with two cycles of chemotherapy (5-FU and leucovorin on d 1-5 and 22-28). At 4 to 6 weeks after completion of RCT and before tumor resection, preoperative endoluminal ultrasound was performed. RESULTS: The accuracy to predict the depth of tumor infiltration (T-category) was found to correlate with downstaging. The T-category was correctly staged before surgery in 15 of the 51 responders (29%) and in 27 of 33 nonresponders (82%), whereas misinterpretation occurred in 36 of the responders (71%) and in 6 of the nonresponders (18%) (p < 0.001). Neither tumor distance from anal verge nor tumor location correlated with the staging accuracy. Lymph node involvement was correctly assessed in 48 patients (57%). Wall invasion was correctly ascertained in 42 patients (50%), with under estimation in 11 patients (13%) and overestimation in 31 patients (37%). CONCLUSIONS: After radiochemotherapy, endosonography does not provide a satisfactory accuracy for preoperative staging of rectal cancer. New interpretation and diagnostic criteria are needed for the prediction of treatment response.

Adenocarcinoma↗

PubMed2004

Randomized controlled trials on hepato-biliary-pancreatic surgery.

The randomized controlled trial (RCT) plays an important role not only in the performance of evidence-based medicine but also in the establishment of therapeutic guidelines. In this review, I analyzed RCTs on hepato-biliary-pancreatic surgery, particularly on malignant diseases. The number of RCTs on hepato-biliary-pancreatic cancers is smaller than that on other types of cancers. This might be related to their low resectability. In liver surgery, a recent increase in RCTs of operative techniques has almost established a standard transection method. In biliary tract and pancreatic cancers, only a few RCTs have been performed concerning operative strategy. Therefore, many issues should be solved by an adequate RCT observing statements of the Consolidated Standards of Reporting Trials.

Biliary Tract Neoplasms↗

PubMed2006

Meta analyses in treatment of spontaneous supratentorial intracerebral haematoma.

BACKGROUND: None of the randomized controlled trials (RCT) on treatment of Intracerebral haematoma (ICH), definitely shows surgery to be beneficial over conservative treatment alone. Systematic reviews that pooled these RCTs were also inconclusive. This systematic review updates previous meta-analyses, using an alternative manner of reviewing with a criteria list constructed specifically for this type of disease and related interventions. METHODS: RCTs and quasi-RCTs (q-RCT) published in English were identified with a systematic literature search. They were evaluated with disease/intervention-specific criteria on comparability between intervention and control group concerning prognostic factors, co-interventions and effect measurement. The resulting selection of studies was compared with those of two earlier systematic reviews. In a meta-analysis selected studies were statistically pooled. FINDINGS: The meta-analysis of surgery versus conservative treatment failed to show a statistically significant reduction in the odds of death (OR: 0.84, 95% CI: 0.67-1.07) in surgically treated patients. CONCLUSIONS: Like previous reviews, our disease/intervention-specific methodological evaluation showed no reduction in mortality. Sensitivity analysis demonstrates that the manner in which studies are methodologically evaluated in a systematic review has a great impact on its conclusions.

Cerebral Hemorrhage↗

PubMed2003

Exploring and enhancing engagement to the psychosocial intervention 'Preparing for Parenthood'.

BACKGROUND: Poor compliance by participants consenting to be randomised to receive both physical and mental health promotion interventions represents a potentially serious threat to external and internal validity of those interventions. Quantitative and qualitative investigation of possible predictors of engagement forms an appropriate basis for efforts to enhance it. METHODS: Eight 'Preparing for Parenthood' intervention courses of a randomized controlled trial (RCT) underpinned a quantitative study. One 'Preparing for Parenthood' (PFP) intervention course, run upon completion of the RCT, formed a qualitative study. All nine courses followed identical procedures to enable clear comparisons. The three factors quantitatively explored with respect to engagement in health promoting behaviours were: locus of control (LOC), psychosocial support, and life events. The qualitative study utilised grounded theory analysis, the participants reflecting upon their experiences of the intervention and/or their reasons for not attending the course; nine interviews were completed. RESULTS: Participants in the quantitative and qualitative studies were divided into three sub-groups: compliant, non-compliant, and refusers. None of the three health promoting variables predicted compliance to a statistically significant degree. However, a variable from the trial analysis was found to reach significance; those women who had had less contact with the National Health Service in the 12 months prior to the baseline assessment were more likely to refuse the invitation to PFP. The qualitative study produced nine main themes that had influenced participant engagement at both the initial recruitment stage and during the course itself. CONCLUSIONS: In combination these findings may contribute to the future design of both effective and acceptable interventions to prevent postnatal depression. One such modified intervention is described and its impact on engagement outlined.

Depression, Postpartum↗

PubMed2004

[Patients with oral squamous cell carcinoma. Long-term survival and evaluation of quality of life-initial results obtained with two treatment protocols in a prospective study].

INTRODUCTION: In patients with oral cancer the treatment has a strong impact on the quality of life. In recent years different therapeutic concepts have been developed, which include preoperative simultaneous 'neoadjuvant' radiochemotherapy (RCT) and one-stage surgery with tumour ablation and reconstruction. Consideration of long-term survival rates yields substantial evidence that mixed-modality treatment including neoadjuvant RCT is superior to adjuvant therapy concepts based on a surgical approach with postoperative radiation. PATIENTS AND METHODS: In this nonrandomised longitudinal prospective study quality of life was evaluated in two groups made up of a total of 53 patients with squamous cell carcinoma of the oral cavity, 26 of whom underwent neoadjuvant radiochemotherapy with subsequent surgical resection while the remaining 27 received surgical treatment first and then postoperative radiotherapy. The quality-of-life core questionnaire (QLQ C-30) and the head and neck cancer module (H&N 35) of the European Organisation for Research and Treatment of Cancer (EORTC) were used. Long-term survival was estimated according to the Kaplan-Meier test. RESULTS: Postoperatively both groups showed a marked reduction in quality of life, especially in restricted chewing, swallowing and speaking. One year later their quality of life had improved substantially, though without quite reaching the preoperative quality-of-life scores. Both groups showed specific impairments in the symptom scales. With adjustment for the fact that the patients were not randomised, long-term survival was 78% in the neoadjuvant treatment group and 50% in the adjuvant treatment group. CONCLUSION: Temporary limitations in the quality of life can be expected after tumour treatment of the kinds presented here for oral cancer. Neoadjuvant therapy concept is more aggressive and might result in longer disease-free survival. The primary goal should be eradication of the tumour. Nevertheless preservation or reconstruction of a maximum of function is essential for a high level of quality of life. Combined-modality treatments seem to be superior to any kind of monotherapy and should therefore be preferred.

Adult↗

PubMed2004

Randomized controlled trial of the efficacy of adjuvant immunochemotherapy and adjuvant chemotherapy for colorectal cancer, using different combinations of the intracutaneous streptococcal preparation OK-432 and the oral pyrimidines 1-hexylcarbamoyl-5-fluorouracil and uracil/tegafur.

BACKGROUND: We investigated the efficacy and safety of adjuvant immunochemotherapy and adjuvant chemotherapy for colorectal cancer, using different combinations of the intracutaneous streptococcal preparation OK-432 and the oral pyrimidines 1-hexylcarbamoyl-5-fluorouracil (carmofur, HCFU) and uracil/tegafur (UFT). METHODS: Patients with stage II, III, or IV (Dukes' B, C) colorectal cancer were enrolled and randomly assigned to one of three groups: an immunochemotherapy group (mitomycin C [MMC] + 5-fluorouracil [5-FU] + HCFU + OK-432), a chemotherapy group (MMC + 5-FU + HCFU), and a control group (surgery alone) for those with colon cancer (study 1); and an immunochemotherapy group (MMC + 5-FU + UFT + OK-432), a chemotherapy group (MMC + 5-FU + UFT), and a control group (surgery alone) for those with rectal cancer (study 2). RESULTS: A total of 760 patients with colon cancer and 669 patients with rectal cancer were entered into this randomized clinical trial (RCT). The incidence of side-effects was in the order of: immunochemotherapy group >> chemotherapy group >> control group in both the cohort of patients with colon cancer and the cohort with rectal cancer. In particular, the frequency of leucopenia and skin disorders was significantly higher than control groups. There were no severe adverse events such as death related to the adjuvant therapy. In both the colon cancer and rectal cancer cohorts, no significant difference in the 5-year survival rate and disease-free survival rate was noted among the three groups. CONCLUSION: The results of an RCT demonstrated that the combination of MMC + 5-FU + HCFU + OK-432 for colon cancer and that of MMC + 5-FU + UFT + OK-432 for rectal cancer could not prolong the survival of patients with surgically resected colorectal cancer, but that both combinations were well tolerated as adjuvant therapy. We investigated the efficacy and safety of adjuvant immunochemotherapy and adjuvant chemotherapy for colorectal cancer, using different combinations of the intracutaneous streptococcal preparation OK-432 and the oral pyrimidines 1-hexylcarbamoyl-5-fluorouracil (carmofur, HCFU) and uracil/tegafur (UFT).

Administration, Oral↗

PubMed2004

Hormonal treatment of acne: review of current best evidence.

BACKGROUND: Recent controlled clinical trials have demonstrated the efficacy of various hormonal preparations, including oral contraceptives, in treatment of acne. OBJECTIVE: The goal of this article is to evaluate the best current evidence on the efficacy of hormonal treatment of acne. METHODS: English-language controlled clinical trials of systemic hormonal treatment of acne were sought by search of references of general dermatology texts, reviews on acne, drug product monographs, and computer-assisted search of MEDLINE, CINAHL, and COCHRANE databases between 1970 and 2003 using the key words hormonal, oral contraceptive, acne, spironolactone, cyproterone, flutamide, and therapy. For each agent, studies fulfilling the highest level of evidence were selected for further evaluation. RESULTS: The literature search recovered two placebo-controlled random controlled trials (RCTs) each of ethinyl estradiol 0.035 mg and norgestimate and ethinyl estradiol 20 microg and leonorgestrel 100 microg, three active-comparator RCTs of ethinyl estradiol 0.035 mg and cyproterone acetate 2 mg, one active comparator RCT of ethinyl estradiol 30 mug and drosperinone 3 mg, three small placebo-controlled RCTs of spironolactone, and one active-comparator RCT of flutamide. CONCLUSIONS: The efficacy of Tri-Cyclen and Alesse in acne is supported by high-quality RCTs (level A evidence). Evidence for the efficacy of Diane-35, spironolactone, and flutamide is derived from lower-quality RCTs (level B evidence). Results from a population-based epidemiological study suggests that Diane-35 is the most effective of these oral contraceptives in the treatment of acne (level B evidence; epidemiological study).

Acne Vulgaris↗

PubMed2006

Thermal biofeedback for primary Raynaud's phenomenon: a review of the literature.

The clinical presentation of primary Raynaud's phenomenon (RP) derives from various pathogenic triggers. The use of thermal biofeedback (TBF) may be of benefit in reducing the severity and frequency of attacks. This article summarizes the relevant research regarding the pathophysiology of primary RP and mechanism of TBF for RP. Systematic reviews of the efficacy of TBF for RP and treatment guidelines for clinicians are provided. The panel concludes that the level of evidence for TBF efficacy is categorized as Level IV: efficacious. The rationale, based on three randomized controlled trials conducted in independent laboratories, demonstrated "superiority or equivalence" of treatments that include TBF. However, randomly controlled trials (RCT) with positive clinical outcomes tended to be small. A large RCT with negative results did not effectively teach handwarming skills. Procedures for reviewing and rating of the levels of evidence of efficacy of studies was based on the Template for Developing Guidelines for the Evaluation of the Clinical Efficacy of Psychophysiological Interventions developed by the joint task force of the AAPB and the Society for Neuronal Regulation (SNR).

Biofeedback, Psychology↗

PubMed2006

Analysis of randomized controlled trials on hepatopancreatic surgery.

The randomized controlled trial (RCT) is an important research method, providing the highest evidence and playing a pivotal role in the performance of evidence-based medicine. However, RCTs on hepatopancreatic surgery have been performed less frequently than RCTs in other fields. Therefore, this review analyzes the characteristics of RCTs on hepatic and pancreatic surgery to propose a breakthrough. We retrieved studies performed via a MEDLINE search to identify prospective RCTs on hepatopancreatic surgery in the last decade. Eligible RCTs were analyzed using the following items: study design, publication year, geographical area, sample size, multicenter study, and impact factor. Studies comparing surgical technique or methods have composed the majority of the RCTs involving hepatectomy and pancreatectomy. About half of the RCTs on hepatectomy have been performed in East Asia, whereas most of the RCTs on pancreatectomy were undertaken in Western countries. The average sample number of RCT on hepatectomy is significantly smaller than those in other fields. Moreover, multicenter studies are less frequently performed on hepatectomy compared with pancreatectomy. Promoting the organization of multicenter studies would be the best way to increase the number and sample size of RCTs on hepatectomy. Adequate RCTs observing the Consolidated Standards of Reporting Trials statements are necessary to obtain reliable evidence.

Bibliometrics↗

PubMed2005

Changes in quality of life in chronic psychiatric patients: a comparison between EuroQol (EQ-5D) and WHOQoL.

It has often been postulated that simple, short questionnaires are unable to reflect complex changes in well-being of individuals with chronic psychiatric disorders. To investigate these assumptions we included two recently developed instruments to measure quality of life (the WHOQoL-Bref and the EuroQoL EQ-5D) in a randomised control trial (RCT) in which two treatment conditions were compared. Aims of the study were to assess the sensitivity and validity of these quality of life (QoL)-instruments, to establish their relationship and to examine the predictors of changes in QoL. Subjective changes in QoL were measured on three assessments waves in a period of 18 months and compared to objective changes in psychopathology and social functioning in a sample of 76 chronic schizophrenic patients who participated in the RCT. Results indicated that both WHOQoL-Bref and EuroQoL EQ-5D are capable of detecting changes in QoL over time in physical and psychological well-being. The instruments partly measure the same aspects of QoL, indicated by 50% common variance on total scores. Reduction of positive psychotic symptoms appeared to be the most important factor in improving QoL. The weighted TTO-score of EuroQoL-5D, which is often used as an index in economic evaluations of health care, did however not correspond with these changes, which indicates that it is less sensitive to changes in social and psychological well-being. It's use as the core measure in (economic) health evaluation in the field of psychiatry therefore seems less appropriate.

Chronic Disease↗

PubMed2026

Sutureless versus renorrhaphy in robot-assisted off-clamp partial nephrectomy: a systematic review and meta-analysis.

BACKGROUND: The necessity of routine parenchymal renorrhaphy during off-clamp robot-assisted partial nephrectomy (RAPN) remains uncertain. This study aimed to compare perioperative, functional, safety, and oncological outcomes between sutureless and conventional renorrhaphy. METHODS: We conducted a systematic review and meta-analysis following PRISMA 2020 guidelines. Comparative studies evaluating sutureless versus conventional renorrhaphy during purely off-clamp RAPN were included. Trifecta achievement was the primary outcome. Random-effects models were used for pooled analyses, with subgroup analysis according to study design. RESULTS: Four studies involving 787 patients, including one randomized controlled trial (RCT) and three propensity score-matched (PSM) studies, were included. The overall pooled estimate showed no statistically significant difference in Trifecta achievement (RR 1.17, 95% CI 0.97-1.41), with substantial heterogeneity (I² = 86.5%). The PSM studies favored the sutureless approach (RR 1.26, 95% CI 1.05-1.52), whereas the RCT yielded an RR of 0.97 (95% CI 0.92-1.04) and met the prespecified noninferiority criterion without demonstrating superiority. The sutureless approach was associated with a smaller perioperative eGFR decline (MD - 3.89, 95% CI - 6.16 to - 1.62), while no significant difference was observed in eGFR at 3 months. No statistically significant differences were identified in major complications, blood transfusion, or positive surgical margins; urinary and vascular complications were sparsely reported. CONCLUSIONS: In selected patients undergoing purely off-clamp RAPN, randomized evidence supports the noninferiority of a strategy that omits routine parenchymal renorrhaphy while permitting clinically necessary selective repair, but does not demonstrate superiority. Favorable estimates from PSM studies remain vulnerable to intraoperative treatment-selection bias. Current evidence is insufficient to determine whether omission of renorrhaphy affects urinary complications, long-term renal function, or oncological outcomes. REGISTRATION: This systematic review was registered prospectively in PROSPERO (CRD420261435995).

Humans↗

PubMed2001

Acknowledgment of uncertainty: a fundamental means to ensure scientific and ethical validity in clinical research.

Recognition of the importance of uncertainty in the design of randomized, controlled trials (RCT) has reached the status of a principle. The "uncertainty principle," or less ambiguously, equipoise, holds that a patient should be enrolled in an RCT only if there is substantial uncertainty about which of the trial treatments would benefit the patient most. In fact, the "uncertainty principle" addresses the most important issue of a clinical trial--the choice of an adequate comparative control. Studies in which intervention and control group are believed to be non-equivalent violate the uncertainty principle. Therefore, one would expect that both editors and authors would be particularly careful to include a statement concerning prior beliefs of the investigator(s) about the uncertainty of the treatments that are reported. However, we found no evidence of such a policy in the randomized, controlled trials we examined. We also show that there is a predictable relationship between the uncertainty principle, that is, the moral principle upon which trials are based, and the ultimate outcomes of clinical trials. We postulate that about 50% of innovations are successful, leading to the conclusion that preserving the ethics of clinical research may be the best investment strategy available.

Ethics, Professional↗

PubMed2006

Conservative treatment with transurethral resection, neoadjuvant chemotherapy followed by radiochemotherapy in stage T2-3 transitional bladder cancer.

PURPOSE: Organ preservation has been investigated in patients (p) with infiltrating transitional cell carcinoma (TCC) of the bladder over the past decade as an alternative to radical cystectomy. This is a trimodal schedule study, including transurethral resection of bladder tumor (TURB), neoadjuvant chemotherapy and concomitant radiochemotherapy (RTC). PATIENTS AND METHODS: From April 1996 until August 2005, 29 evaluable patients (p) with T2-T3NXM0 bladder cancer were enrolled. After a transurethral resection of bladder tumor (TURB), we administered 2 cycles of induction chemotherapy with CMV (15 p) or Gemcitabine-Cisplatin (14 p) followed by radiotherapy 45 Gy 1.8 Gy/fraction and two cycles of concomitant cisplatin 70 mg/m(2). 2-3 weeks later, a cystoscopy with tumor-site biopsy was performed. If complete histological response, p were treated with consolidation radiotherapy until 64.8 Gy. For p with residual or recurrent tumor, cystectomy was performed. RESULTS: We included 28 men and 1 women (median age 63, range 39-72 years) with PS (ECOG) 0-1. The stage was: 21 p T2; 6 p T3a; and 2 p T3b. Toxicity was higher in CMV compared with Gem- Cis: grade (3/4) neutropenia 4/15 (26%) vs 1/14 (7%); febrile neutropenia 3/15 (20%) vs 1/14 (7%); grade (3/4) trombocytopenia 2/15 (13%) vs 1/14 (7%). Toxicities with concomitant RCT were low-moderate: urocystitis (26%) and enteritis (18%). RESPONSE: microscopically complete TURB was obtained in 20 p (69%), but not in 9 p (31%) (7 microscopic, and 2 macroscopic residual tumor). We found a complete histologic response after induction RCT in 25 p (86%). After a median follow-up of 69.4 months (m) (range: 8-97.7), there were 8 deaths, with a overall survival of 72%. Furthermore 14 of 29 p (48%) were alive with intact bladder, and median survival time with intact bladder was 63.6 m (50.1-77.2); were predictive of best outcome T2 stage vs T3 (p < 0.0001), and complete histologic resection in initial TURB vs residual tumor (p = 0.0004). CONCLUSIONS: Combined treatment provide high response rates and can be offered as an alternative option to radical cystectomy in selected patients with TCC. Patients with T2 stage and complete histologic resection in initial TURB had the best outcome.

Adult↗

PubMed2026

Efficacy and Safety of Psychedelic Microdosing on Psychological Outcomes in Healthy Adults: A Systematic Review and Meta-analysis.

BACKGROUND: Psychedelic microdosing has gained increasing popularity for enhancing mood and cognition, yet its effects on psychological outcomes in healthy adults remain unclear. We aim to evaluate the efficacy and safety of psychedelic microdosing on psychological outcomes in healthy/non-clinical adult population. METHODS: This review was registered in the International Prospective Register of Systematic Reviews (PROSPERO; CRD420251035294). We searched Embase, MEDLINE, and PsycINFO from inception to February 2026 for original studies in healthy adults using sub-hallucinogenic psychedelic doses on separate days. We included randomized studies, nonrandomized prospective studies, cross-sectional studies, and observational longitudinal designs and stratified meta-analyses by design. Random-effects models were used; safety in randomized controlled trials (RCTs) was pooled as risk differences (RDs). Risk of bias was assessed using the Joanna Briggs Institute (JBI) critical appraisal tools appropriate for each study design. RESULTS: 24 studies (3,681 participants) met inclusion criteria, 6 contributed to meta-analyses. RCTs of psilocybin and LSD microdosing showed subjective and neurophysiological effects but minimal impact on cognition, creativity, or sustained mood. Psilocybin altered EEG and speech with little behavioral change, while LSD caused transient mood and minor physiological effects without lasting cognitive or personality benefits. Observational studies indicated mood and personality improvements, likely influenced by expectancy or lifestyle factors. Meta-analyses included two parallel RCTs (3 comparisons; n = 117) and three non-RCT studies (n = 1,013). Adverse event analyses included two RCTs (4 comparisons; n = 109). RCTs showed no clear evidence of immediate symptom reduction: depressive symptoms (SMD = -0.19; 95% CI -0.56, 0.19; I2 = 0%), anxiety (SMD = -0.20; 95% CI -1.11, 0.71; I2 = 82.3%),and stress (SMD = 0.02; 95% CI -0.39, 0.43; I2 = 0%). Non-RCT within-arm estimates were imprecise and heterogeneous for depressive symptoms (SMCC -0.33; 95% CI -0.75, 0.08) and anxiety (SMCC -0.29; 95% CI-0.84, 0.26). Exploratory pooling across all designs suggested decreases in depressive symptoms and stress, while anxiety remained uncertain. Adverse event risks were similar between treatment and control. CONCLUSIONS: Microdosing does not show consistent immediate benefits for depressive, anxiety, or stress symptoms in healthy adults, and evidence from RCTs remains inconclusive. Although improvements were observed in some studies, these effects were not significantly different from placebo. Larger, well-designed RCTs are needed to clarify the efficacy and safety of psychedelic microdosing beyond placebo.

Humans↗

PubMed1992

Thromboelastogram fails to predict postoperative hemorrhage in cardiac patients.

To determine the clinical usefulness of the thromboelastogram in the prediction of postoperative hemorrhage in cardiac patients, we related the results of routine coagulation tests (RCTs) and thromboelastography with the amount of chest tube drainage postoperatively in 101 patients requiring cardiopulmonary bypass. Our data indicated that there was no correlation between RCT results and thromboelastographic variables. No single variable of RCTs and thromboelastography correlated well with the amount of chest tube drainage postoperatively. Before the onset of cardiopulmonary bypass, the most frequent abnormalities detected by thromboelastograms were fibrinolysis and hypocoagulability resulting from factor deficiency. Hypercoagulability detected by thromboelastograms occurred in 13% of patients after cardiopulmonary bypass and usually was not detected by RCTs. The incidence of false-negative thromboelastograms and RCT results in patients who had excessive hemorrhage of unknown cause was 46% and 52%, respectively. The incidence of fibrinolysis as detected by thromboelastograms was similar before and after bypass, but only 2 of the 18 patients with fibrinolysis had excessive hemorrhage postoperatively. Our results indicate that neither RCTs nor thromboelastography predicts the likelihood of excessive hemorrhage in patients after cardiopulmonary bypass. The thromboelastographic results should be interpreted cautiously because of the high rate of unreliable results.

Blood Coagulation Tests↗

PubMedDate not supplied

The role of clinical drug trial methodology with respect to studies of new drugs. Clinical trials of timolol.

The use of the Randomized Clinical Trial (RCT) to assess the safety and efficacy of a new drug or treatment can provide a clear evaluation of the relative benefits and risks of the new therapy as compared to the longer-established treatment methodology. In some cases, such as insulin, the benefits are immediately apparent; in other cases, such as photocoagulation for proliferative diabetic retinopathy, the consensus is not so easily obtained, and the clinical trial can supply the answer. Furthermore, the RCT provides the opportunity to identify adverse reactions, in particular those which present with a seemingly unrelated or unexpected set of symptoms. In conducting clinical trials of timolol, researchers must be alert for beta-adrenergic antagonist effects, such as were seen with practolol, and should be especially careful to note early, mild reactions which may be the forerunners of later, more severe or irreversible adverse effects.

Diabetic Retinopathy↗

PubMed1991

Poly(vinyl alcohol)-heparin hydrogels as sensor catheter membranes.

Poly(vinyl alcohol)-heparin hydrogels with varying water content were synthesized for use as sensor catheter membranes. Films were cast from aqueous mixtures of poly(vinyl alcohol) (PVA), a photosensitive cross-linker p-diazonium diphenyl amine polymer (PA), glutaraldehyde (GA) and heparin. After drying, the films were cross-linked by successive UV irradiation and heat treatment. To get an indication about the cross-linking density of the networks, the water content of the hydrogels was measured after equilibration in water. Hydrogels from PVA, PA, GA and heparin, with a water content of 35-95%, could be obtained if the components were dissolved in saline instead of water. The release of heparin from PVA-heparin or PVA-PA-heparin hydrogels was studied using different receiving phases. The cumulative amount of released heparin appeared to be dependent on the initial water content of the hydrogels and the composition of the receiving phase. For the PVA-PA-heparin hydrogels as well as the PVA-heparin hydrogels the cumulative amount of released heparin in water was about six times higher than in a Tris buffer. Using Tris buffer as receiving phase PVA-PA-heparin hydrogels with water contents of 53, 61 or 71% released heparin for at least 3 wk. The cumulative amount of released heparin increased with initial water content of these hydrogels. Recalcification times (RCT) of plasma exposed to PVA-PA-heparin hydrogels (water content 53%), which released heparin at a low rate (2 micrograms/cm2 per day), were markedly prolonged compared with the RCT values for PVA-PA hydrogels without heparin.(ABSTRACT TRUNCATED AT 250 WORDS)

Albumins↗