Attenuation of the Preoperative Stress Response with Midazolam

2000 ◽  
Vol 93 (1) ◽  
pp. 141-147 ◽  
Author(s):  
Zeev N. Kain ◽  
Ferne Sevarino ◽  
Sharon Pincus ◽  
Gerianne M. Alexander ◽  
Shu Ming Wang ◽  
...  
Keyword(s):  
Placebo Group ◽  
Treatment Group ◽  
Global Health ◽  
Outpatient Surgery ◽  
Controlled Trial ◽  
Self Report ◽  
Anesthetic Technique ◽  
Double Blind ◽  
Clinical Recovery ◽  
Sf 36

Background Previously, effects of preoperative sedatives were assessed mainly with respect to preoperative outcomes such as anxiety and compliance. The purpose of this investigation was to evaluate the effects of preoperative sedatives on postoperative psychological and clinical recovery. Methods Patients undergoing general anesthesia and outpatient surgery were enrolled in a double-blind, randomized, placebo-controlled trial. Subjects (n = 55) were randomly assigned to receive either 5 mg intramuscular midazolam (n = 26) or a placebo injection (n = 29) at least 30 min before surgery. The anesthetic technique was controlled. Postoperative anxiety, pain, analgesic consumption, clinical recovery parameters, and global health (SF-36) were evaluated up to 1 month after surgery. Results Surgery length did not differ significantly between the treatment and placebo groups (118 +/- 45 min vs 129 +/- 53 min; P = NS). Throughout the first postoperative week, subjects in the treatment group reported a greater reduction in postoperative pain compared with subjects in the placebo group (F1,50= 3.5; P = 0.035). Moreover, at 1 week, ibuprofen use was reported by less subjects in the treatment group than in the placebo group (0% vs 17.2%; P = 0.026). Subjects in the treatment group also reported a greater reduction in postoperative anxiety throughout the follow-up period (F1,53 = 9.2; P = 0.04). However, global health indexes (SF-36) did not detect any significant differences between the two experimental groups (multivariate F1,45 = 0.44; P = 0.51). Conclusion Subjects treated with midazolam preoperatively self-report improved postoperative psychological and pain recovery. However, the clinical significance of these findings is unclear at the present time.

scholarly journals Ivermectin in combination with doxycycline for treating COVID-19 symptoms: a randomized trial

2021 ◽  
Vol 49 (5) ◽  
pp. 030006052110135
Author(s):  
Reaz Mahmud ◽  
Md. Mujibur Rahman ◽  
Iftikher Alam ◽  
Kazi Gias Uddin Ahmed ◽  
A.K.M. Humayon Kabir ◽  
...  
Keyword(s):  
Placebo Group ◽  
Treatment Group ◽  
Confidence Interval ◽  
Recovery Time ◽  
Controlled Trial ◽  
Hazard Ratio ◽  
Data Repository ◽  
Rt Pcr ◽  
Clinical Recovery ◽  
Number Of Patients

Objective We evaluated whether ivermectin combined with doxycycline reduced the clinical recovery time in adults with COVID-19 infection. Methods This was a randomized, blinded, placebo-controlled trial in patients with mild-to-moderate COVID-19 symptoms randomly assigned to treatment (n = 200) and placebo (n = 200) groups. The primary outcome was duration from treatment to clinical recovery. Secondary outcomes were disease progression and persistent COVID-19 positivity by RT-PCR. Results Among 556 screened patients, 400 were enrolled and 363 completed follow-up. The mean patient age was 40 years, and 59% were men. The median recovery time was 7 (4–10, treatment group) and 9 (5–12, placebo group) days (hazard ratio, 0.73; 95% confidence interval, 0.60–0.90). The number of patients with a ≤7-day recovery was 61% (treatment group) and 44% (placebo groups) (hazard ratio, 0.06; 95% confidence interval, 0.04–0.09). The proportion of patients who remained RT-PCR positive on day 14 and whose disease did not progress was significantly lower in the treatment group than in the placebo group. Conclusions Patients with mild-to-moderate COVID-19 infection treated with ivermectin plus doxycycline recovered earlier, were less likely to progress to more serious disease, and were more likely to be COVID-19 negative by RT-PCR on day 14. Trial Registration ClinicalTrials.gov Identifier: NCT04523831. Data Repository ID Dryad. doi:10.5061/dryad.qjq2bvqf6

scholarly journals Intra-articular Injection of Type I Atelocollagen to Alleviate Knee Pain: A Double-Blind, Randomized Controlled Trial

Cartilage ◽  
2019 ◽  
pp. 194760351986530 ◽  
Author(s):  
Hwa Sung Lee ◽  
Kwang Jun Oh ◽  
Young Wan Moon ◽  
Yong In ◽  
Han Jun Lee ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Placebo Group ◽  
Knee Pain ◽  
Short Form ◽  
Controlled Trial ◽  
Cartilage Defects ◽  
Type I ◽  
Double Blind ◽  
Randomized Controlled ◽  
Sf 36

Objective Collagen disruption is one of the underlying causes of knee pain in patients with osteoarthritis and/or diverse cartilage defects. Atelocollagen is a type of collagen that lacks telopeptides and thus has reduced antigenicity. The intra-articular injection of type I atelocollagen supplements collagen levels in the disrupted articular cartilage. This randomized controlled trial evaluated the effects of the intra-articular injection of atelocollagen for the management of knee pain. Design Two hundred patients with osteoarthritis, chondromalacia, or other cartilage defects were randomly assigned to receive a 3-mL intra-articular injection of atelocollagen (BioCollagen group) or saline (Placebo group). Clinical improvement was evaluated over a 24-week period using the 100-mm visual analogue scale (VAS), the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), and the 36-item Short-Form Health Survey (SF-36). Results VAS scores were significantly better in the BioCollagen group as compared with the Placebo group at 24 weeks. More patients in the BioCollagen group reported exceeding 20% and 40% VAS improvements. The WOMAC and SF-36 scores were also significantly improved from baseline after the intra-articular injection of atelocollagen; although, the differences between the BioCollagen and Placebo groups were not significant. There were no unexpected or severe adverse events reported for either group. Conclusions The results show that an intra-articular injection of atelocollagen effectively alleviates knee pain, as intended. Therefore, the intra-articular injection of atelocollagen can be considered an alternative solution to controlling knee pain due to osteoarthritis and diverse cartilage defects.

scholarly journals Zinc as Adjunct Therapy in Neonatal Sepsis

2020 ◽  
Vol 32 (2) ◽  
pp. 112-116
Author(s):  
Syed Mortaza Ali ◽  
Mujibul Hoque ◽  
Md Manajjir Ali ◽  
Md Noor Uddin Talukder ◽  
Tanjina Chowdhury
Keyword(s):  
Placebo Group ◽  
Neonatal Sepsis ◽  
Recovery Time ◽  
Controlled Trial ◽  
Feeding Tube ◽  
Zinc Homeostasis ◽  
Double Blind ◽  
Adjunct Therapy ◽  
Clinical Recovery ◽  
Pediatric Sepsis

Introduction:Altered zinc homeostasis is an important feature of pediatric sepsis, thus raising the possibility of zinc supplementation as a therapeutic strategy in neonatal sepsis, a major source of morbidity and mortality with few therapeutic options beyond antibiotics. Its objective was to find the role of zinc as adjunct therapy in neonatal sepsis. Materials and Methods: This prospective, randomized double blind placebo controlled trial was conducted in the Department of Paediatrics, Sylhet M A G Osmani Medical College, Sylhet, Bangladesh during January 2013 to December 2014. A total 288 neonates with neonatal sepsis were enrolled. Group allocation to either zinc or placebo group was done by lottery method. Each packet contained 5 mg dispersible zinc sulphate or placebo. One packet dissolved in 2.5 ml expressed breast milk was given orally or through feeding tube. Results: The age of the patients in zinc group and placebo group was 14.40 ± 6.49 days and 15.09 ± 7.18 days respectively. There were 49 (75.6%) male neonates and 16 (24.6%) female neonates in zinc group; while 50 (78.1%) neonates were male and 14 (21.9%) were female in placebo group. Clinical recovery was 61 (93.8%) and failure in 4 (6.2%) patients in zinc group; while clinical recovery was 59 (92.2%) and failure in 5 (7.8%) patients in placebo group. The mean clinical recovery time in zinc group was 104.20 ± 16.61 hours and that of control groups was 111.46 ± 19.43 hours. Conclusion: Oral zinc as adjunct therapy shortens the clinical recovery time. Medicine Today 2020 Vol.32(2): 112-116

scholarly journals Oral Administration ofLactobacillus plantarum299v Reduces Cortisol Levels in Human Saliva during Examination Induced Stress: A Randomized, Double-Blind Controlled Trial

2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Hannah Andersson ◽  
Cecilia Tullberg ◽  
Siv Ahrné ◽  
Kristina Hamberg ◽  
Irini Lazou Ahrén ◽  
...  
Keyword(s):  
Placebo Group ◽  
Treatment Group ◽  
Controlled Trial ◽  
Stress Test ◽  
Controlled Study ◽  
Enzyme Linked Immunosorbent Assay ◽  
Double Blind ◽  
Salivary Iga ◽  
Significant Difference ◽  
Cortisol Levels

Objective. To clarify the effect ofLactobacillus plantarum299v on the salivary cortisol and salivary IgA levels in young adults under examination stress.Design. Forty-one students with an upcoming academic exam were included in a randomized double-blind, placebo-controlled study. The probiotic bacteria or the placebo product was administered in capsules once a day during 14 days. Saliva was collected and a perceived stress test was filled out at each sampling occasion. Saliva was collected for cortisol analysis by Electrochemiluminescence Immunoassay (ECLI) and salivary IgA was analysed by Enzyme-Linked Immunosorbent Assay (ELISA). Abundance of lactobacilli was evaluated by cultivation of saliva on selective medium and identification ofL. plantarum299v was done on randomly selected colonies by a random amplification of polymorphic DNA (RAPD) typing.Results. A significant difference in cortisol levels was found between the treatment group and the placebo group (P<0.05), together with a significant increase in levels of lactobacilli in the treatment group compared with the placebo group (P<0.001). No significant changes were found for salivary IgA.Conclusion. A probiotic bacterium with ability to reduce symptoms of irritable bowel syndrome (IBS) prohibited increased levels of the stress marker cortisol during the examination period. The registration number of the study isNCT02974894, and the study is registered at ClinicalTrials.gov.

scholarly journals The Effect of Protein Supplementation versus Carbohydrate Supplementation on Muscle Damage Markers and Soreness Following a 15-km Road Race: A Double-Blind Randomized Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 858
Author(s):  
Dominique S. M. ten Haaf ◽  
Martin A. Flipsen ◽  
Astrid M. H. Horstman ◽  
Hans Timmerman ◽  
Monique A. H. Steegers ◽  
...  
Keyword(s):  
Placebo Group ◽  
Protein Intake ◽  
Muscle Soreness ◽  
Controlled Trial ◽  
Protein Supplementation ◽  
Group Differences ◽  
Double Blind ◽  
Carbohydrate Supplementation ◽  
Protein Group ◽  
Road Race

We assessed whether a protein supplementation protocol could attenuate running-induced muscle soreness and other muscle damage markers compared to iso-caloric placebo supplementation. A double-blind randomized controlled trial was performed among 323 recreational runners (age 44 ± 11 years, 56% men) participating in a 15-km road race. Participants received milk protein or carbohydrate supplementation, for three consecutive days post-race. Habitual protein intake was assessed using 24 h recalls. Race characteristics were determined and muscle soreness was assessed with the Brief Pain Inventory at baseline and 1–3 days post-race. In a subgroup (n = 149) muscle soreness was measured with a strain gauge algometer and creatine kinase (CK) and lactate dehydrogenase (LDH) concentrations were measured. At baseline, no group-differences were observed for habitual protein intake (protein group: 79.9 ± 26.5 g/d versus placebo group: 82.0 ± 26.8 g/d, p = 0.49) and muscle soreness (protein: 0.45 ± 1.08 versus placebo: 0.44 ± 1.14, p = 0.96). Subjects completed the race with a running speed of 12 ± 2 km/h. With the Intention-to-Treat analysis no between-group differences were observed in reported muscle soreness. With the per-protocol analysis, however, the protein group reported higher muscle soreness 24 h post-race compared to the placebo group (2.96 ± 2.27 versus 2.46 ± 2.38, p = 0.039) and a lower pressure muscle pain threshold in the protein group compared to the placebo group (71.8 ± 30.0 N versus 83.9 ± 27.9 N, p = 0.019). No differences were found in concentrations of CK and LDH post-race between groups. Post-exercise protein supplementation is not more preferable than carbohydrate supplementation to reduce muscle soreness or other damage markers in recreational athletes with mostly a sufficient baseline protein intake running a 15-km road race.

scholarly journals Effects of Fermented Milk Containing Lacticaseibacillus paracasei Strain Shirota on Constipation in Patients with Depression: A Randomized, Double-Blind, Placebo-Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2238
Author(s):  
Xiaomei Zhang ◽  
Shanbin Chen ◽  
Ming Zhang ◽  
Fazheng Ren ◽  
Yimei Ren ◽  
...  
Keyword(s):  
Mental Illness ◽  
Placebo Group ◽  
Rating Scale ◽  
Controlled Trial ◽  
Fermented Milk ◽  
Daily Consumption ◽  
Double Blind ◽  
Tnf Α ◽  
Significant Difference ◽  
Factor Α

Probiotics have been shown to benefit patients with constipation and depression, but whether they specifically alleviate constipation in patients with depression remains unclear. The aim of this study was to investigate the effect of Lacticaseibacillus paracasei strain Shirota (LcS), formerly Lactobacillus casei strain Shirota, on constipation in patients with depression with specific etiology and gut microbiota and on depressive regimens. Eighty-two patients with constipation were recruited. The subjects consumed 100 mL of a LcS beverage (108 CFU/mL) or placebo every day for 9 weeks. After ingesting beverages for this period, we observed no significant differences in the total patient constipation-symptom (PAC-SYM) scores in the LcS group when compared with the placebo group. However, symptoms/scores in item 7 (rectal tearing or bleeding after a bowel movement) and items 8–12 (stool symptom subscale) were more alleviated in the LcS group than in the placebo group. The Beck Depression Index (BDI) and Hamilton Depression Rating Scale (HAMD) scores were all significantly decreased, and the degree of depression was significantly improved in both the placebo and LcS groups (p < 0.05), but there was no significant difference between the groups. The LcS intervention increased the beneficial Adlercreutzia, Megasphaera and Veillonella levels and decreased the bacterial levels related to mental illness, such as Rikenellaceae_RC9_gut_group, Sutterella and Oscillibacter. Additionally, the interleukin (IL)-1β, IL-6, and tumor necrosis factor-α (TNF-α) levels were significantly decreased in both the placebo and LcS groups (p < 0.05). In particular, the IL-6 levels were significantly lower in the LcS group than the placebo group after the ingestion period (p < 0.05). In conclusion, the daily consumption of LcS for 9 weeks appeared to relieve constipation and improve the potentially depressive symptoms in patients with depression and significantly decrease the IL-6 levels. In addition, the LcS supplementation also appeared to regulate the intestinal microbiota related to mental illness.

scholarly journals Tranexamic acid for acute intracerebral haemorrhage growth based on imaging assessment (TRAIGE): a multicentre, randomised, placebo-controlled trial

2021 ◽  
pp. svn-2021-000942
Author(s):  
Jingyi Liu ◽  
Ximing Nie ◽  
Hongqiu Gu ◽  
Qi Zhou ◽  
Haixin Sun ◽  
...  
Keyword(s):  
Placebo Group ◽  
Tranexamic Acid ◽  
Intracerebral Haemorrhage ◽  
Intracranial Haemorrhage ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intracerebral Haematoma ◽  
Spot Sign ◽  
Double Blind ◽  
Risk Of Death

BackgroundStudies show tranexamic acid can reduce the risk of death and early neurological deterioration after intracranial haemorrhage. We aimed to assess whether tranexamic acid reduces haematoma expansion and improves outcome in intracerebral haemorrhage patients susceptible to haemorrhage expansion.MethodsWe did a prospective, double-blind, randomised, placebo-controlled trial at 10 stroke centres in China. Acute supratentorial intracerebral haemorrhage patients were eligible if they had indication of haemorrhage expansion on admission imaging (eg, spot sign, black hole sign or blend sign), and were treatable within 8 hours of symptom onset. Patients were randomly assigned (1:1) to receive either tranexamic acid or a matching placebo. The primary outcome was intracerebral haematoma growth (>33% relative or >6 mL absolute) at 24 hours. Clinical outcomes were assessed at 90 days.ResultsOf the 171 included patients, 124 (72.5%) were male, and the mean age was 55.9±11.6 years. 89 patients received tranexamic acid and 82 received placebo. The primary outcome did not differ significantly between the groups: 36 (40.4%) patients in the tranexamic acid group and 34 (41.5%) patients in the placebo group had intracranial haemorrhage growth (OR 0.96, 95% CI 0.52 to 1.77, p=0.89). The proportion of death was lower in the tranexamic acid treatment group than placebo group (8.1% vs 10.0%), but there were no significant differences in secondary outcomes including absolute intracranial haemorrhage growth, death and dependency.ConclusionsAmong patients susceptible to haemorrhage expansion treated within 8 hours of stroke onset, tranexamic acid did not significantly prevent intracerebral haemorrhage growth. Larger studies are needed to assess safety and efficacy of tranexamic acid in intracerebral haemorrhage patients.

A randomized, double-blind, placebo-controlled trial on the efficacy and tolerability of sertraline in Iranian veterans with post-traumatic stress disorder

2011 ◽  
Vol 41 (10) ◽  
pp. 2159-2166 ◽  
Author(s):  
Y. Panahi ◽  
B. Rezazadeh Moghaddam ◽  
A. Sahebkar ◽  
M. Abbasi Nazari ◽  
F. Beiraghdar ◽  
...  
Keyword(s):  
Placebo Group ◽  
Post Traumatic Stress Disorder ◽  
Traumatic Stress ◽  
Stress Disorder ◽  
Controlled Trial ◽  
Post Traumatic Stress ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Post Traumatic ◽  
The Mean

BackgroundUnlike civilian post-traumatic stress disorder (PTSD), the efficacy of sertraline for the treatment of combat-related PTSD has not yet been proven. The present study aimed to evaluate the clinical efficacy of sertraline against combat-related PTSD in a randomized, double-blind, placebo-controlled trial.MethodSeventy Iranian veterans of the Iran–Iraq war who met the DSM-IV criteria for diagnosis of PTSD were randomized to receive either flexibly dosed sertraline (50–200 mg/day) (n=35, completers=32) or placebo (n=35, completers=30) for 10 weeks. Efficacy was evaluated by the Impact of Event Scale – Revised (IES-R) and the Clinical Global Impression scale – Severity (CGI-S) and Improvement (CGI-I) ratings. Responder criteria were defined as a ⩾30% reduction in the IES-R total score plus a CGI-I rating of ‘much’ or ‘very much’ improved.ResultsOn both intention-to-treat (ITT) and per protocol (completer) methods of analysis, the mean reductions in the IES-R total and subscale (re-experiencing/intrusion, avoidance/numbing and hyperarousal) scores (p<0.001) and also in the CGI-S score (p<0.01) were significantly greater in the sertraline group than in the placebo group. For the CGI-I, the mean endpoint score was significantly lower in the sertraline group than in the placebo group (p⩽0.001). The number of responders in the sertraline group was significantly higher than in the placebo group (44% v. 3%, p⩽0.001). Sertraline was well tolerated, with a 6% discontinuation rate as a result of adverse reactions.ConclusionsThe results of this study suggest that sertraline can be an effective, safe and tolerable treatment for combat-related PTSD in Iranian veterans.

Value of Whole-Body Washing With Chlorhexidine for the Eradication of Methicillin-ResistantStaphylococcus aureus:A Randomized, Placebo-Controlled, Double-Blind Clinical Trial

2007 ◽  
Vol 28 (9) ◽  
pp. 1036-1043 ◽  
Author(s):  
C. Wendt ◽  
S. Schinke ◽  
M. Württemberger ◽  
K. Oberdorfer ◽  
O. Bock-Hensley ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Treatment Group ◽  
Solution Treatment ◽  
University Hospital ◽  
Whole Body ◽  
Double Blind ◽  
Antiseptic Solution ◽  
Double Blind Clinical Trial ◽  
Double Blinded

Background.Whole-body washing with antiseptic solution has been widely used as part of eradication treatment for colonization with methicillin-resistantStaphylococcus aureus(MRSA), but evidence for the effectiveness of this measure is limited.Objective.To study the efficacy of whole-body washing with chlorhexidine for the control of MRSA.Design.Randomized, placebo-controlled, double-blinded clinical trial.Setting.University Hospital of Heidelberg and surrounding nursing homes.Patients.MRSA carriers who were not treated concurrently with antibiotics effective against MRSA were eligible for the study.Intervention.Five days of whole-body washing with either 4% chlorhexidine solution (treatment group) or with a placebo solution. All patients received mupirocin nasal ointment and chlorhexidine mouth rinse. The outcome was evaluated 3, 4, 5, 9, and 30 days after treatment with swab samples taken from several body sites.Results.Of 114 patients enrolled in the study (56 in the treatment group and 58 in the placebo group), 11 did not finish treatment (8 from the treatment group and 3 from the placebo group [P= .02]). At baseline, the groups did not differ with regard to age, sex, underlying condition, site of MRSA colonization, or history of MRSA eradication treatment. Eleven patients were MRSA-free 30 days after treatment (4 from the treatment group and 7 from the placebo group [P= .47]). Only groin-area colonization was significantly better eradicated by the use of chlorhexidine. The best predictor for total eradication was a low number of body sites positive for MRSA. Adverse effects were significantly more frequent in the treatment group than in the placebo group (any symptom, 71% vs 33%) but were reversible in most cases.Conclusion.Whole-body washing can reduce skin colonization, but it appears necessary to extend eradication measures to the gastrointestinal tract, wounds, and/or other colonized body sites if complete eradication is the goal.Trial Registration.ClinicalTrials.gov identifier: NCT00266448.

Sign in / Sign up

Export Citation Format

Share Document