scholarly journals Antibiotic prophylaxis in acute cholecystectomy revisited: results of a double-blind randomised controlled trial

2020 ◽  
Vol 405 (8) ◽  
pp. 1201-1207
Author(s):  
Gona Jaafar ◽  
Gabriel Sandblom ◽  
Lars Lundell ◽  
Folke Hammarqvist
Keyword(s):  
Antibiotic Prophylaxis ◽  
Acute Cholecystitis ◽  
Controlled Trial ◽  
Study Groups ◽  
Double Blind ◽  
Randomised Study ◽  
Significant Difference ◽  
Preoperative Antibiotic Prophylaxis ◽  
Randomised Controlled ◽  
The Impact

Abstract Purpose Evidence supporting the value of preoperative antibiotic prophylaxis (PAP) in surgery for acute cholecystitis is lacking. This study aimed to shed light on whether PAP in acute cholecystectomy for cholecystitis reduces the postoperative infectious complication (PIC) rate. Secondary outcomes were the prevalence of bacteriobilia, CRP values and leucocyte counts. Methods The study was performed as a single-centre, double-blinded, placebo-controlled, randomised study. Patients with acute cholecystitis amenable for acute laparoscopic cholecystectomy were randomly assigned to either PAP (piperacillin/ tazobactam) or placebo, and the subsequent clinical course was followed. Results A total of 106 patients were enrolled, 16 of whom were excluded due to protocol violation. PIC developed in 22 of the 90 patients included with no significant difference between the PAP and placebo groups (8 patients in the PAP group and 14 in the placebo arm, p = 0.193). The PIC rate was significantly higher in patients with a raised CRP at randomisation and on the day of surgery and in cases of conversion to an open procedure (p = 0.008, 0.004 and 0.017, respectively) but with no differences between the study groups. Conclusion PAP does not affect the risk for PIC in patients with acute cholecystitis. The major risk factors determining PIC in these patients need defining, in particular, the impact of bacteriobilia. Trial registration The study was registered at clinicaltrials.gov (NCT02619149) December 2, 2015.

scholarly journals The Effect of Glycomacropeptide versus Amino Acids on Phenylalanine and Tyrosine Variability over 24 Hours in Children with PKU: A Randomized Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (3) ◽  
pp. 520 ◽  
Author(s):  
Anne Daly ◽  
Sharon Evans ◽  
Satnam Chahal ◽  
Saikat Santra ◽  
Alex Pinto ◽  
...  
Keyword(s):  
Amino Acids ◽  
Controlled Trial ◽  
Target Range ◽  
Blood Spots ◽  
Meal Plan ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Limiting Amino Acids ◽  
The Impact ◽  
Rate Limiting

Introduction: In phenylketonuria (PKU), evidence suggests that casein glycomacropeptide supplemented with rate-limiting amino acids (CGMP-AA) is associated with better protein utilisation and less blood phenylalanine (Phe) variability. Aim: To study the impact of CGMP-AA on blood Phe variability using 3 different dietary regimens in children with PKU. Methods: This was a 6-week randomised controlled cross-over study comparing CGMP-AA vs. Phe-free l-amino acids (l-AA) assessing blood Phe and tyrosine (Tyr) variability over 24 h in 19 children (7 boys) with PKU, with a median age of 10 years (6–16). Subjects were randomised to 3 dietary regimens: (1) R1, CGMP-AA and usual dietary Phe (CGMP + Phe); (2) R2, CGMP-AA − Phe content of CGMP-AA from usual diet (CGMP − Phe); and (3) R3, l-AA and usual dietary Phe. Each regimen was administered for 14 days. Over the last 48 h on days 13 and 14, blood spots were collected every 4 h at 08 h, 12 h, 16 h, 20 h, 24 h, and 04 h. Isocaloric intake and the same meal plan and protein substitute dosage at standardised times were maintained when blood spots were collected. Results: Eighteen children completed the study. Median Phe concentrations over 24 h for each group were (range) R1, 290 (30–580), R2, 220 (10–670), R3, 165 (10–640) μmol/L. R1 vs. R2 and R1 vs. R3 p < 0.0001; R2 vs. R3 p = 0.0009. There was a significant difference in median Phe at each time point between R1 vs. R2, p = 0.0027 and R1 vs. R3, p < 0.0001, but not between any time points for R2 vs. R3. Tyr was significantly higher in both R1 and R2 [70 (20–240 μmol/L] compared to R3 [60 (10–200) μmol/L]. In children < 12 years, blood Phe remained in the target range (120–360 μmol/L), over 24 h, for 75% of the time in R1, 72% in R2 and 64% in R3; for children aged ≥ 12 years, blood Phe was in target range (120–600 μmol/L) in R1 and R2 for 100% of the time, but 64% in R3. Conclusions: The residual Phe in CGMP-AA increased blood Phe concentration in children. CGMP-AA appears to give less blood Phe variability compared to l-AA, but this effect may be masked by the increased blood Phe concentrations associated with its Phe contribution. Reducing dietary Phe intake to compensate for CGMP-AA Phe content may help.

scholarly journals Ligilactobacillus salivarius PS2 Supplementation during Pregnancy and Lactation Prevents Mastitis: A Randomised Controlled Trial

2021 ◽  
Vol 9 (9) ◽  
pp. 1933
Author(s):  
Esther Jiménez ◽  
Susana Manzano ◽  
Dietmar Schlembach ◽  
Krzysztof Arciszewski ◽  
Rocio Martin ◽  
...  
Keyword(s):  
Placebo Group ◽  
Post Partum ◽  
Controlled Trial ◽  
Late Pregnancy ◽  
Probiotic Strain ◽  
Study Groups ◽  
Rank Test ◽  
Double Blind ◽  
Pregnancy And Lactation ◽  
Randomised Controlled

Mastitis is considered one of the main reasons for unwanted breastfeeding cessation. This study aimed to investigate the preventive effect of the probiotic strain Ligilactobacillus salivarius PS2 on the occurrence of mastitis in lactating women. In this multicountry, multicenter, randomized, double-blind, placebo-controlled trial, 328 women were assigned to the probiotic or the placebo group. The intervention started from the 35th week of pregnancy until week 12 post-partum. The primary outcome was the incidence (hazard) rate of mastitis, defined as the presence of at least two of the following symptoms: breast pain, breast erythema, breast engorgement not relieved by breastfeeding, and temperature > 38 °C. The probability of being free of mastitis during the study was higher in the probiotic than in the placebo group (p = 0.022, Kaplan–Meier log rank test) with 9 mastitis cases (6%) vs. 20 mastitis cases (14%), respectively. The hazard ratio of the incidence of mastitis between both study groups was 0.41 (0.190–0.915; p = 0.029), indicating that women in the probiotic group were 58% less likely to experience mastitis. In conclusion, supplementation of L. salivarius PS2 during late pregnancy and early lactation was safe and effective in preventing mastitis, which is one of the main barriers for continuing breastfeeding.

scholarly journals Effect of a single preoperative dose of oral antibiotic to reduce the incidence of surgical site infection following below-knee dermatological flap and graft repair

2019 ◽  
pp. 28-35 ◽  
Author(s):  
Helena Rosengren ◽  
Clare Heal ◽  
Petra Buettner
Keyword(s):  
Surgical Site Infection ◽  
Antibiotic Prophylaxis ◽  
Controlled Trial ◽  
Study Groups ◽  
High Dose ◽  
Antibiotic Administration ◽  
Oral Antibiotic ◽  
Site Infection ◽  
Double Blind

Background: Surgical site infection (SSI) rates for below-knee dermatological surgery are unacceptably high, particularly following complex flap and graft closures. The role of antibiotic prophylaxis for these surgical cases is uncertain. Objective: To determine whether SSI following complex dermatological closures on the leg could be reduced by antibiotic prophylaxis administered as a single oral preoperative dose. Methods: A total of 115 participants were randomized to 2 g of oral cephalexin or placebo 40-60 minutes prior to surgical incision in a prospective, randomized, double-blind, placebo-controlled trial at a primary care skin cancer clinic in North Queensland, Australia. Results: Overall 17/55 (30.9%) controls and 14/55 (25.5%) intervention participants developed infection (P = 0.525). There was no difference between the study groups in adverse symptoms that could be attributed to high-dose antibiotic administration (P = 1).

scholarly journals A double-blind, randomised, controlled trial of protein supplementation to enhance exercise capacity in COPD during pulmonary rehabilitation: a pilot study

2021 ◽  
pp. 00077-2021
Author(s):  
Abdulelah M. Aldhahir ◽  
Yousef S. Aldabayan ◽  
Jaber S. Alqahtani ◽  
Heidi A. Ridsdale ◽  
Colette Smith ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Exercise Capacity ◽  
Pulmonary Rehabilitation ◽  
Controlled Trial ◽  
Protein Supplementation ◽  
High Protein ◽  
Double Blind ◽  
Meaningful Improvement ◽  
Significant Difference ◽  
Randomised Controlled

BackgroundPulmonary rehabilitation (PR) is a cost-effective management strategy in chronic obstructive pulmonary disease (COPD) which improves exercise performance and health-related quality of life. Nutritional supplementation may counter malnutrition and enhance PR outcomes but rigorous evidence is absent. We aimed to investigate the effect of high protein-supplementation (Fortisip Compact Protein, FCP) during PR on exercise capacity.MethodsA double-blind randomised controlled trial comparing FCP with preOp (a carbohydrate control supplement) in COPD patients participating in a PR programme. Participants consumed the supplement twice a day during PR and attended twice-weekly PR sessions, with pre- and post-PR measurements including the incremental shuttle walk test (ISWT) at 6-weeks as the primary outcome. Participants’ experience using supplements was assessed.ResultsSixty-eight patients were recruited; (FCP: 36 and control: 32). The trial was stopped early due to COVID-19. Although statistical significance was not reached, there was the suggestion of a clinically meaningful difference in ISWT at 6 weeks favouring the intervention group (intervention: 342 m±149; n=22 versus control: 305 m±148; n=22, p=0.1). Individuals who achieved an improvement in ISWT had larger mid-thigh circumference at baseline (responder: 62 cm±4 versus non-responder: 55 cm±6; p=0.006). 79% were satisfied with the taste and 43% would continue taking the FCP.ConclusionAlthough the data did not demonstrate a statistically significant difference in ISWT, high protein supplementation in COPD during PR may result in a clinically meaningful improvement in exercise capacity and was acceptable to patients. Large, adequately powered studies are justified.

scholarly journals Impact of Epley manoeuvre on self-perceived disability: A randomised controlled trial in primary care

2020 ◽  
Author(s):  
Ricard Carrillo Muñoz ◽  
Jose Luis Ballve Moreno ◽  
Ivan Villar Balboa ◽  
Yolanda Rando Matos ◽  
Oriol Cunillera Puertolas ◽  
...  
Keyword(s):  
Primary Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Perceived Disability ◽  
Randomised Controlled ◽  
The Impact

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513

Managing irritable bowel syndrome: The impact of micro-physiotherapy

2017 ◽  
Vol 14 (2) ◽  
Author(s):  
Daniel Grosjean ◽  
Patrice Benini ◽  
Pierre Carayon
Keyword(s):  
Irritable Bowel Syndrome ◽  
Holistic Approach ◽  
Study Groups ◽  
Control Group ◽  
Double Blind Study ◽  
Self Healing ◽  
Double Blind ◽  
Significant Difference ◽  
Irritable Bowel ◽  
The Impact

AbstractBackgroundIrritable bowel syndrome (IBS) has a complex pathology, high prevalence and large impact on patients’ quality of life. As conventional therapy may yield unsatisfactory results, a more holistic approach may be desirable. The current study assessed the effect of micro-physiotherapy on the severity of IBS symptoms.MethodsIn a double-blind study, 61 recurrent IBS patients were randomised to two sessions of micro-physiotherapy or sham micro-physiotherapy. Inclusion criteria were the presence of ≥1 IBS symptom from abdominal pain, constipation, diarrhoea or bloating. Exclusion criteria were previous major intestinal surgery and the presence of chronic diseases. The mean patient age was 53.5±15.3 years. Micro-physiotherapy consisted of micro-palpatory examination to identify osteopathic lesions, followed by micro-massage to stimulate self-healing. The control group underwent a sham procedure. The presence and severity of symptoms was assessed at baseline and at 1-month follow-up by the same gastroenterologist.ResultsTwo patients did not complete the study. There was a significant difference in percentage of patients that improved after the first session, at 74 % for the micro-physiotherapy group and 38 % for the sham group, respectively (p=0.005). After the second session, the initial improvement was maintained in both groups, although with no further gains, and the differences between the study groups remained significant (p=0.007).ConclusionsMicro-physiotherapy significantly improves IBS symptoms and should be explored further for use in mainstream healthcare.

scholarly journals 630. Emergence of Colistin Resistance in the OVERCOME Trial: Impact of Combination Therapy with Meropenem

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S418-S419
Author(s):  
Jason M Pogue ◽  
Michael J Rybak ◽  
Kyle Stamper ◽  
Dror Marchaim ◽  
Visanu Thamlikitkul ◽  
...  
Keyword(s):  
Infection Type ◽  
Therapeutic Option ◽  
Controlled Trial ◽  
Severity Of Illness ◽  
Controlled Study ◽  
Independent Contractor ◽  
Double Blind ◽  
Resistance Development ◽  
Significant Difference ◽  
The Impact

Abstract Background Colistin (COL) remains an important therapeutic option for carbapenem-resistant (CR) Gram-negative bacilli (GNB). COL is often utilized in combination with meropenem (MEM), in part due to concerns regarding the development of COL resistance with monotherapy. We recently completed a randomized controlled trial comparing outcomes in patients receiving COL + placebo to those receiving COL + MEM; herein we present data on the emergence of COL resistance in this trial. Methods OVERCOME was an international, multicenter, randomized, double-blind, placebo-controlled study comparing COL and COL + MEM for the treatment of bloodstream infection and/or pneumonia due to CR GNB. Subjects were included in the modified intent to treat population (mITT) if their enrollment pathogen had a COL MIC ≤2 mg/L, as determined by broth microdilution (BMD). Daily blood and/or respiratory samples were obtained in patients per protocol until two consecutive negatives were obtained or the end of study treatment. All subsequent isolates were evaluated for COL resistance via BMD, defined as MIC ≥ 4 mg/L. Results Of the 425 patients in the mITT population, 380 (191 COL; 189 COL + MEM) were evaluable for the endpoint of COL resistance development. The median age of the cohort was 70, 38% were female, 47% were white, and 45% were Asian. 70% had an index infection of pneumonia, 68% were in the intensive care unit at the onset of their infection, and A. baumannii was the most common pathogen (78% of patients). Baseline characteristics, infection type, severity of illness, and index pathogen were similar amongst treatment arms. No significant difference in resistance development was seen between the COL and COL + MEM groups overall (12% vs. 8%; p = 0.31), or in any subgroup (Table). In patients with A. baumannii, there was a trend towards decreased resistance development with COL + MEM (13.3% vs 7.5%; p = 0.13). Conclusion We were unable to identify a significant difference in resistance emergence between treatment arms, but given the low incidence of this outcome, were underpowered to do so. The impact of COL + MEM on preventing emergence of COL resistance in A. baumannii warrants further clinical study. Disclosures Jason M Pogue, PharmD, BCPS, BCIDP, Merck (Consultant)QPex (Consultant)Shionogi (Consultant)Utility Therapeutics (Consultant)VenatoRX (Consultant) Michael J. Rybak, PharmD, MPH, PhD, Paratek Pharmaceuticals (Research Grant or Support) Emmanuel Roilides, MD, PhD, FIDSA, FAAM, FESCMID, Merck Sharp & Dohme Corp. (Consultant, Grant/Research Support) Matthew Sims, MD, PhD, Astra Zeneca (Independent Contractor)Diasorin Molecular (Independent Contractor)Epigenomics Inc (Independent Contractor)Finch (Independent Contractor)Genentech (Independent Contractor)Janssen Pharmaceuticals NV (Independent Contractor)Kinevant Sciences gmBH (Independent Contractor)Leonard-Meron Biosciences (Independent Contractor)Merck and Co (Independent Contractor)OpGen (Independent Contractor)Prenosis (Independent Contractor)Regeneron Pharmaceuticals Inc (Independent Contractor)Seres Therapeutics Inc (Independent Contractor)Shire (Independent Contractor)Summit Therapeutics (Independent Contractor)

Synbiotic supplementation is not effective on breast milk selenium concentrations and growth of exclusively breast fed infants: a pilot study

2019 ◽  
Vol 89 (1-2) ◽  
pp. 73-79 ◽  
Author(s):  
Leila Nikniaz ◽  
Reza Mahavi ◽  
Alireza Ostadrahimi ◽  
Zeinab Nikniaz ◽  
Sharare Taghipour
Keyword(s):  
Pilot Study ◽  
Breast Milk ◽  
Graphite Furnace ◽  
Controlled Trial ◽  
Study Groups ◽  
Z Score ◽  
Double Blind ◽  
Significant Difference ◽  
The Mean ◽  
Synbiotic Supplementation

Abstract. In this randomized, double-blind, placebo-controlled trial, 57 lactating mothers were randomly allocated into two groups to receive a daily supplement of synbiotic (n = 30) which contained different probiotic strains (2.0 × 108 CFU) and fructooligosaccharide (394 mg) or a placebo (n = 27) for 30 days. Dietary intake was collected from lactating women by 24-hour recall method. Breast milk selenium contents were determined by atomic absorption spectrometry with graphite furnace. Weight for age Z-score (WAZ) and Height for age Z-score (HAZ) were evaluated for infants. Data analyses were assessed using nutritionist IV, Epi Info and SPSS software and presented as mean ± sd or SEM. The total mean breast milk selenium levels were 50.1 ± 16.1 mcg L−1. At the baseline, the mean breast milk selenium concentrations in the synbiotic and placebo groups were 51.7 ± 20.2 and 48.5 ± 12.1 mcg L−1. The mean breast milk selenium levels increased and decreased in the symbiotic and placebo groups respectively, which were not significant (p > 0.05). Also, comparison of the changes in breast milk selenium concentration showed no significant difference between the two study groups after the intervention. At the baseline, the mean WAZ and HAZ of infants whose mothers’ milk selenium was more than 60 mcg/l was significantly (P < 0.05) higher than for others. In this pilot study, no significant effect was observed by synbiotic supplementation, however, for concise conclusion, more human studies with higher doses of supplements and longer duration of supplementation are needed to determine the effects of synbiotic supplementation on breast milk selenium contents and infants’ growth.

REPRINTED WITH PERMISSION OF IASP – Pain assessment in advanced dementia. Validity of the German PAINAD – a prospective double-blind randomised placebo-controlled trial

Ból ◽  
2019 ◽  
Vol 19 (4) ◽  
pp. 34-49
Author(s):  
Albert Lukas ◽  
Ulrich Hagg-Grün ◽  
Benjamin Mayer ◽  
Thomas Flscher ◽  
Matthias Schuler
Keyword(s):  
Pain Assessment ◽  
Controlled Trial ◽  
The Elderly ◽  
Study Groups ◽  
Advanced Dementia ◽  
Double Blind ◽  
Observation Instrument ◽  
Significant Difference ◽  
Pain Recognition ◽  
Pain In The Elderly

Pain in combination with dementia is a common condition that makes pain recognition significantly more difficult. This results in undertreatment of pain in those suffering from dementia. The Pain Assessment in Advanced Dementia (PAINAD) scale currently represents one of the best approaches to pain detection in dementia. In a pilot study, strong inter-rater and retest reliability of the German version (PAINAD-G) was proven. However, the available data concerning the validity of this instrument were insufficient. The aim of the study was to validate the PAINAD-G scale by a double-blind randomised placebo-controlled trial in people with advanced dementia expected to be in pain. A second aim was to examine whether other observational tools (BISAD5 Observation Instrument for Assessing Pain in the Elderly with Dementia) (German: Beobachtungsintrument fur das Schmerzassessment bei alten Menschen mit Demenz, Checklist of Nonverbal Pain Indicators, Algoplus) were also able to demonstrate a significant difference between the study groups. Surprisingly, the study revealed no difference in „pain reduction” between those treated by oxycodone compared with those treated by placebo. Equally, none of the other 3 observational tools were able to demonstrate a significant difference between the study groups. However, correlations among the 4 observational tools were mostly moderate to high. A number of possible reasons for this observation, such as difficulties regarding sensitivity to change/responsiveness, consistence of the fundamental construct, influence of the early onset study, and efficacy of the analgesic in advanced dementia are discussed.

scholarly journals SettleIN: Using a Manualised Intervention to Facilitate the Adjustment of Older Adults with Dementia Following Placement into Residential Care

2020 ◽  
Vol 17 (7) ◽  
pp. 2606
Author(s):  
Caroline A Saint-Bryant ◽  
Judy Murrill ◽  
Janine K Hayward ◽  
Kayleigh-Marie Nunez ◽  
Aimee Spector
Keyword(s):  
Quality Of Life ◽  
Residential Care ◽  
Controlled Trial ◽  
Care Home ◽  
Post Intervention ◽  
Significant Difference ◽  
New Residents ◽  
Randomised Controlled ◽  
The Impact

The authors examined the feasibility of delivering an adapted version of SettleIN, a manualised staff-led programme designed to facilitate adjustment to care for new residents with dementia. The effects of SettleIN on resident adjustment, mood and quality of life were also investigated. A pilot randomised controlled trial was conducted. Nineteen new residents with dementia and 21 staff participants were recruited. Residents were randomly assigned to receive the SettleIN programme or residential care as usual. Resident quality of life, mood and overall adjustment were measured at baseline and post-intervention, in week seven. Interviews were conducted with staff in week seven to explore intervention feasibility. Despite medium to large effect sizes, there was no significant difference in mean change scores between the two conditions, with regards to quality of life, psychological wellbeing or overall adjustment outcomes. Qualitative feedback indicated that SettleIN was not feasible across all areas, with problems around recruitment and practicality. However, SettleIN was deemed feasible in terms of retention and acceptability among staff. The majority of staff felt that SettleIN was beneficial for residents but that organisational and programme factors impacted upon intervention feasibility. Further exploration of organisational barriers is needed in order to reduce the impact of such factors on care home research.

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