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Clinical Trials
Published in Abhaya Indrayan, Research Methods for Medical Graduates, 2019
Blinding is easier said than done. Some features of blinding are given in Box 4.2. There are situations where blinding is not possible. For assessing outcomes such as quality of life, readmissions, and falls after hip surgery, blinding is just not possible if one maneuver is keeping patients in hospital for a specified number of days, and the other is early discharge and home rehabilitation. In most surgical interventions, the control has to be another kind of surgery, and not a “placebo.” Sham surgery may be unethical because it exposes a patient to surgical risks. In either case, it is extremely difficult to enforce blinding in a surgical trial. The patient can be kept blind after proper consent, but the surgeon definitely knows. However, mechanisms can be developed that all assessments subsequent to the operation are done by another surgeon who does not know whether the patient belongs to the test surgery or the control surgery.
Simulations of epidemics
Published in Ann H. Kelly, Frédéric Keck, Christos Lynteris, The Anthropology of Epidemics, 2019
Frédéric Keck, Guillaume Lachenal
The standardisation of epidemic scenarios, which is stressed by the organisers of simulations as a way to mitigate the threat of panic by producing automatised behaviours, leads us to propose a hypothesis on the emergence of these epidemic scenarios. It is striking that simulation has also developed during the twentieth century in surgery as a technique to intervene in patients’ bodies with standardised gestures to control human emotions in the confrontation with disease. Epidemiology and surgery were fostered by the experience of the First World War, but it is only at the end of the century with the possibilities opened by digitalization to follow a disease in the globe or in the body on a screen that simulate invaded hospitals as a technique of disease management. Sham surgery has developed as a fake medical intervention that mimics the therapeutic effects and could be considered as an equivalent of placebo in clinical trials. Since surgeons and hospital managers have to take difficult decisions faced with unpredictable diseases, the aim of simulations is to reduce the uncertainty by producing in the individual body and in the collective team standardised habits. The military origins of this idea are obvious, although we have little documentation so far on the transfer of simulation techniques from the army to public health.
Placebo and nocebo
Published in Harald Breivik, William I Campbell, Michael K Nicholas, Clinical Pain Management, 2008
Luana Colloca, Damien G Finniss, Fabrizio Benedetti
An emergent view among researchers and ethicists argues that not only is the use of sham surgery ethical, but that it should also be mandatory when conducting trials to evaluate the effectiveness of surgical procedures.147 There are, however, some opponents to placebo surgery who emphasize the role of evidence-based medicine.148
Dexmedetomidine inhibits inflammatory response and oxidative stress through regulating miR-205-5p by targeting HMGB1 in cerebral ischemic/reperfusion
Published in Immunopharmacology and Immunotoxicology, 2021
Jun-jun Yang, Yan-Hong Zhao, Ke-Wen Yin, Xiao-qing Zhang, Jianhui Liu
For establishment of cerebral I/R injury model, the middle cerebral artery occlusion (MCAO) method was performed. Briefly, rats were anesthetized with intraperitoneal injection of anesthesia by 3% pentobarbital (50 mg/kg). Occlusion for the middle cerebral artery was performed for 120 min, and body temperature was maintained within 37 ± 0.5 °C with a heating pad. Then the reperfusion was conducted by removing the occlusion. The ischemia and reperfusion induction were monitored by a laser-doppler flowmetry (Moor Instruments, Devon, UK). For sham surgery, similar procedure was performed without occlusion. The Longa’s neurological function score [22] was used to measure the neurological function after 24 h of the surgery and mice with scores 1–4 were chosen for further experiments. For DEX treatment, animals received intravenous injection of 10 μg/kg DEX at 30 min before occlusion. HE staining was performed to observe the brain tissues.
Erzhi pills ameliorate cognitive dysfunction and alter proteomic hippocampus profiles induced by d -galactose and Aβ1–
40 injection in ovariectomized Alzheimer’s disease model rats
Published in Pharmaceutical Biology, 2021
Yongyan Xie, Bo Yan, Min Hou, Maofu Zhou, Chao Liu, Mengsheng Sun, Kun He, Cong Fang, Yaohui Chen, Liping Huang
Rats were anesthetized with intraperitoneal injections of 10% chloral hydrate (3.0 mL/kg). Bilateral ovariectomy (Huang et al. 2018) was performed using sterile surgical techniques. A small incision was made in the region between the hip and the last rib on each abdominal side. The fallopian tubes were clamped and ligated, and the ovaries and fat tissue around the ovaries were excised. The muscle and skin layers were then sutured. Sham surgery was performed in the same way but without ligation of the fallopian tubes and resection of the ovaries. After surgery, all rats were injected intramuscularly with penicillin sodium (50,000 U, for 3 days) to fight infection. All rats were fed a soy-free diet to exclude the effects of phytosterols in the diet. Two days after surgery, the exfoliated vaginal epithelial cell smear technique was used to evaluate the success of the ovariectomy. If keratinocytes were not detected in five consecutive day smears, which suggested successful ovariectomy, ovariectomized rats were randomly divided into four groups (n = 13 per group), labelled the ‘model’, ‘estradiol valerate’, ‘Erzhi pills high-dose’, and ‘Erzhi pills low-dose’ groups. In addition, sham-operated rats were selected for the sham-operated group (n = 13).
Trimetazidine ameliorates hindlimb ischaemic damage in type 2 diabetic mice
Published in Annals of Medicine, 2021
Yan Yang, Qinqin Xu, Tao Li, Shiying Shao
Seven-week-old male db/db (C57BLKS/J-leprdb/leprdb) mice (Model Animal Research Centre of Nanjing University, Nanjing, China) were fed with a standard chow diet ad libitum and had free access to drinking water. Fasting blood glucose levels were measured every 3 d. Mice with blood glucose above 16.7 mmol/L were underwent left femoral artery ligation (FAL) as previously reported [22]. Briefly, after anesthesia, the femoral artery was isolated and ligated with 5-0 silk sutures at proximal and distal places (keeping the same distance in all mice). After FAL, mice were given TMZ (10 mg/kg, Sigma-Aldrich, St. Louis, MO, TMZ group, n = 10) or an equal volume of saline solution (saline group, n = 10) by intragastric administration every day for 2 weeks. Sham surgery was performed by passing the suture underneath the femoral artery without ligation (Control group, n = 10). All animal care and experimental procedures were approved by the Institutional Animal Care and Use of Committee of Tongji Medical College of Huazhong University of Science & Technology.