Variation in serum urate levels in the absence of gout and urate lowering therapy

Abstract Background Previous studies have noted significant variation in serum urate (sUA) levels, and it is unknown how this influences the accuracy of hyperuricemia classification based on single data points. Despite this known variability, hyperuricemic patients are often used as a control group in gout studies. Our objective was to determine the accuracy of hyperuricemia classifications based on single data points versus multiple data points given the degree of variability observed with serial measurements of sUA. Methods Data was analyzed from a cross-over clinical trial of urate-lowering therapy in young adults without a gout diagnosis. In the control phase, sUA levels used for this analysis were collected at 2–4 week intervals. Mean coefficient of variation for sUA was determined, as were rates of conversion between normouricemia (sUA ≤6.8 mg/dL) and hyperuricemia (sUA > 6.8 mg/dL). Results Mean study participant (n = 85) age was 27.8 ± 7.0 years, with 39% female participants and 41% African-American participants. Mean sUA coefficient of variation was 8.5% ± 4.9% (1 to 23%). There was no significant difference in variation between men and women, or between participants initially normouricemic and those who were initially hyperuricemic. Among those initially normouricemic (n = 72), 21% converted to hyperuricemia during at least one subsequent measurement. The subgroup with initial sUA < 6.0 (n = 54) was much less likely to have future values in the range of hyperuricemia compared to the group with screening sUA values between 6.0–6.8 (n = 18) (7% vs 39%, p = 0.0037). Of the participants initially hyperuricemic (n = 13), 46% were later normouricemic during at least one measurement. Conclusion Single sUA measurements were unreliable in hyperuricemia classification due to spontaneous variation. Knowing this, if a single measurement must be used in classification, it is worth noting that those with an sUA of < 6.0 mg/dL were less likely to demonstrate future hyperuricemic measurements and this could be considered a safer threshold to rule out intermittent hyperuricemia based on a single measurement point. Trial registration Data from parent study ClinicalTrials.gov Identifier: NCT02038179.

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Variation in Serum Urate Levels in the Absence of Gout and Urate Lowering Therapy: An Analysis Using Data from a Randomized Controlled Trial

10.21203/rs.3.rs-115418/v1 ◽

2020 ◽

Author(s):

Andrew Shaffer ◽

Elizabeth Rahn ◽

Kenneth Saag ◽

Amy Mudano ◽

Angelo Gaffo

Keyword(s):

Coefficient Of Variation ◽

Controlled Trial ◽

Study Participant ◽

Serum Urate ◽

Control Group ◽

Lowering Therapy ◽

Significant Difference ◽

Data Points ◽

Single Data ◽

Using Data

Abstract Background: Previous studies have noted significant variation in serum urate (sUA) levels, and it is unknown how this influences the accuracy of hyperuricemia classification based on single data points. Despite this known variability, hyperuricemic patients are often used as a control group in gout studies. Our objective was to determine the accuracy of hyperuricemia classifications based on single data points versus multiple data points given the degree of variability observed with serial measurements of sUA.Methods: Data was analyzed from a cross-over clinical trial of urate-lowering therapy in young adults without a gout diagnosis. In the control phase, sUA levels used for this analysis were collected at 2-4 week intervals. Mean coefficient of variation for sUA was determined, as were rates of conversion between normouricemia (sUA ≤6.8 mg/dL) and hyperuricemia (sUA >6.8 mg/dL). Results: Mean study participant (n = 85) age was 27.8 ± 7.0 years, with 39% female participants and 41% African-American participants. Mean sUA coefficient of variation was 8.5% ± 4.9% (1% to 23%). There was no significant difference in variation between men and women, or between participants initially normouricemic and those who were initially hyperuricemic.Among those initially normouricemic (n=72), 15% converted to hyperuricemia during at least one subsequent measurement. The subgroup with initial sUA <6.0 (n=54) was much less likely to have future values in the range of hyperuricemia compared to the group with screening sUA values between 6.0-6.8 (n=18) (7% vs 39%, p = 0.0037).Of the participants initially hyperuricemic (n=13), 46% were later normouricemic during at least one measurement.Conclusion: Single sUA measurements were unreliable in hyperuricemia classification due to spontaneous variation. Those with an sUA of <6.0 mg/dL were less likely to demonstrate future hyperuricemic measurements and this could be considered a safer threshold to rule out intermittent hyperuricemia based on a single measurement point.Trial registration: Data from parent study ClinicalTrials.gov Identifier: NCT02038179

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POS0140 URATE-LOWERING THERAPY REDUCES NON-EPISODIC FOOT PAIN IN PATIENTS WHO FAIL TO MEET ACR/EULAR 2015 GOUT CLASSIFICATION CRITERIA: AN EFFECT PREDICTED BY ULTRASOUND

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.1571 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 282.1-282

Author(s):

R. Flood ◽

C. Kirby ◽

Y. Alammari ◽

D. Kane ◽

R. Mullan

Keyword(s):

Early Stage ◽

Serum Urate ◽

Classification Criteria ◽

Disease Classification ◽

Foot Pain ◽

Cross Sectional ◽

Baseline Serum ◽

First Metatarsophalangeal Joint ◽

Lowering Therapy ◽

Significant Difference

Background:Emerging evidence that the joints of asymptomatic hyperuricaemic individuals contain monosodium urate (MSU) deposits and that alternative presentations of foot pain occur in hyperuricaemia suggests that preclinical phases may occur prior to a first episodic gout attack. (1) This case–control study evaluates urate deposition in hyperuricaemic individuals not fulfilling the current gout classification criteria, as well as a potential therapeutic role for urate lowering therapy (ULT).Objectives:To investigate whether ULT reduces non-episodic foot pain in patients who fail to meet ACR/EULAR 2015 gout classification criteria.Methods:Following informed consent, hyperuricaemic individuals with persistent, non-episodic foot pain (n=53) not fulfilling ACR/EULAR 2015 gout classification criteria, were compared with asymptomatic hyperuricaemic controls (n=18). Ultrasound (US) of bilateral first metatarsophalangeal (MTP) joints and features of MSU deposition including double contour (DC) sign, tophus and juxta-articular erosion were recorded. Cases only were treated with febuxostat or allopurinol daily for 6 months. Serum urate, 24-hour and 7-day visual analogue score (VAS) 0–100 mm pain scales and the Manchester Foot Pain and Disability Index (MFPDI) were recorded before treatment and after 3 and 6 months. MTP Ultrasound was repeated after a minimum of 6 months on treatment.Results:53 hyperuricaemic individuals with persistent, non-episodic foot pain not meeting the ACR/EULAR 2015 gout classification criteria were recruited. At baseline MTP US DC sign, erosion and tophus occurred in 62.5%, 20.8% and 49% of cases, respectively. No US features of gout occurred in controls. No significant difference was seen in baseline serum urate between cases (481±14 mg/dL) versus controls (437±14; p=NS). Serum urate in cases fell at 3 months (325±25; p<0.01) and 6 months (248±19; p<0.01). For cases, baseline 24-hour pain VAS (46±3.9) reduced at 3 months (32±4.1; p<0.05) and 6 months (21±5.2; p<0.05) of ULT. The 7-day pain VAS (59±3.9) decreased at 3 months (35±4.5; p<0.05) and 6 months (30±5.3; P<0.05). MFPDI (17±1.4) decreased at 3 month (13±1.8; p=<0.05) and 6 months (11±2.2; p=<0.05). When cases were grouped according to the presence (N=33) or absence (N=18) of DC sign on baseline US, no differences were observed for baseline pain scores. Following ULT however, 24-hour pain VAS were significantly lower in DC positive patients at 3 months (22±4.48 DC positive vs 42±6.14 DC negative; p<0.05) and 6 months (12.±5.4 vs 33±8.4; p<0.05). The 7-day pain VAS were significantly lower in DC positive patients at 3 months (23±4.6 vs 47±6.6; p<0.05) and MFDPI were significantly lower in DC positive patients at 3 months (10±1.9 DC positive vs 19±2.9 DC negative; p<0.05).Conclusion:These findings indicate that persistent, non-episodic foot pain in hyperuricaemia is both associated with US features of MSU deposition and is responsive to ULT. Symptomatic hyperuricaemia occurring prior to episodic gout therefore represents an earlier or alternative disease presentation. Changes to the ACR/ EULAR classification criteria to include non-episodic foot pain in the presence of US features of gout may increase the sensitivity of disease classification at an early stage, leading to improved future treatment strategies and long-term outcomes.References:[1]Stewart S, Dalbeth N, Vandal AC, Rome K. Characteristics of the first metatarsophalangeal joint in gout and asymptomatic hyperuricaemia: A cross-sectional observational study. J Foot Ankle Res. 2015;8(1):1–8.Disclosure of Interests:None declared

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Efficacy and Safety of Intravenous Mesenchymal Stem Cells for Ischemic Stroke

Neurology ◽

10.1212/wnl.0000000000011440 ◽

2021 ◽

pp. 10.1212/WNL.0000000000011440

Author(s):

Jong-Won Chung ◽

Won Hyuk Chang ◽

Oh Young Bang ◽

Gyeong Joon Moon ◽

Suk Jae Kim ◽

...

Keyword(s):

Stem Cells ◽

Mesenchymal Stem Cells ◽

Controlled Trial ◽

Outcome Evaluation ◽

Autologous Serum ◽

Secondary Outcome ◽

Control Group ◽

Link Type ◽

Significant Difference ◽

Major Stroke

ObjectiveTo test whether autologous modified mesenchymal stem cells (MSCs) improve recovery in patients with chronic major stroke.MethodsIn this prospective, open-label, randomized controlled trial with blinded outcome evaluation, patients with severe middle cerebral artery territory infarct within 90 days of symptom onset were assigned, in a 2:1 ratio, to receive preconditioned autologous MSC injections (MSC group) or standard treatment alone (control group). The primary outcome was the score on the modified Rankin Scale (mRS) at 3 months. The secondary outcome was to further demonstrate motor recovery.ResultsA total of 39 and 15 patients were included in the MSC and control groups, respectively, for the final intention-to-treat analysis. Mean age of patients was 68 (range, 28–83) years, and mean interval between stroke onset to randomization was 20.2 (range, 5–89) days. Baseline characteristics were not different between groups. There was no significant difference between the groups in the mRS score shift at 3 months (p = 0.732). However, secondary analyses showed significant improvements in lower extremity motor function in the MSC group compared to the control group (change in the leg score of the Motricity Index, p = 0.023), which was notable among patients with low predicted recovery potential. There were no serious, treatment-related adverse events.ConclusionsIntravenous application of preconditioned, autologous MSCs with autologous serum was feasible and safe in patients with chronic major stroke. MSC treatment was not associated with improvements in the 3-month mRS score, but we did observe leg motor improvement in detailed functional analyses.Classification of evidenceThis study provides Class III evidence that autologous mesenchymal stem cells do not improve 90-day outcomes in patients with chronic stroke.Trial registrationclinicaltrials.gov Identifier: NCT01716481.

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Galphimine-B Standardized Extract versus Alprazolam in Patients with Generalized Anxiety Disorder: A Ten-Week, Double-Blind, Randomized Clinical Trial

BioMed Research International ◽

10.1155/2019/1037036 ◽

2019 ◽

Vol 2019 ◽

pp. 1-9 ◽

Cited By ~ 2

Author(s):

Ofelia Romero-Cerecero ◽

Ana Laura Islas-Garduño ◽

Alejandro Zamilpa ◽

Armando Herrera-Arellano ◽

Enrique Jiménez-Ferrer ◽

...

Keyword(s):

Anxiety Disorder ◽

Generalized Anxiety Disorder ◽

Daytime Sleepiness ◽

Control Treatment ◽

Control Group ◽

Generalized Anxiety ◽

Therapeutic Success ◽

Link Type ◽

Significant Difference ◽

Experimental Group

Galphimine-B (G-B), a compound isolated from Galphimia glauca, has been shown to possess important anxiolytic activity. In this study, we evaluated the effectiveness and tolerability of a G-B standardized extract (experimental treatment) that was administered daily for 10 weeks in patients with moderate or severe Generalized Anxiety Disorder (GAD). Alprazolam was used as control treatment and administered under the same conditions. A total of 167 patients were included. At the start of the study, the severe anxiety condition prevailed, with an average on the Hamilton Anxiety Scale of 35.1 ± 8.8 and 35.8 ± 8.1 points in the control and experimental groups, respectively. After the 10 weeks of administration, the average was reduced in the control group to 4.6 ± 6.5 points and in the experimental group to 3.5 ± 5.5 points. Therapeutic success in the control group was 85.7% and in the experimental group, 92.0%. A high proportion of patients (22.2%) treated with Alprazolam manifested daytime sleepiness, while in the group treated with the G-B standardized extract, daytime sleepiness was found in 4.7%. In conclusion, a G-B standardized extract demonstrated therapeutic effectiveness in patients with GAD, without exhibiting significant difference with Alprazolam, but showing fewer cases of daytime sleepiness. The trial was registered at http://clinicaltrials.gov by identifier: NCT03702803.

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Acceptance and commitment therapy on perceived stress and psychological flexibility of psychiatric nurses: a randomized control trial

BMC Nursing ◽

10.1186/s12912-021-00763-4 ◽

2021 ◽

Vol 20 (1) ◽

Author(s):

Seyyed Arman Hosseini Zarvijani ◽

Ladan Fattah moghaddam ◽

Samaneh Parchebafieh

Keyword(s):

Acceptance And Commitment Therapy ◽

Perceived Stress ◽

Psychological Flexibility ◽

Control Group ◽

Link Type ◽

Commitment Therapy ◽

Acceptance And Commitment ◽

Significant Difference ◽

The Impact ◽

Experimental Group

Abstract Background Nursing in psychiatric wards is considered a highly stressful career due to the type of patients and the problem of communicating with them. Finding appropriate solutions to overcome this stress can improve the general health of nurses and improve their quality of work. The aim was to investigate the impact of Acceptance and Commitment Therapy (ACT) on the perceived stress (PS) and psychological flexibility (PF) of nurses in psychiatric wards. Methods A total of 70 nurses of Razi Psychiatric Center of Tehran were randomly selected and divided into two experimental and control groups of 35. In addition to routine interventions, the experimental group was provided with eight 2-h sessions of ACT training, whereas the control group only received routine interventions. Prior to the intervention sessions and a month after the last session, demographic information, PS scale, and Acceptance and Action Questionnaire (2nd Edition) were completed in both groups. Results There was a significant difference regarding the PS level (P = 0.002) and PF (P = 0.001) in the control and experimental groups; the experimental group showed lower PS and higher PF. Conclusions ACT can lead to reduced PS and improved PF, which can be considered as a solution to empower nurses working in psychiatric wards. Trial registration This was registered in Iranian Registry of Clinical Trials (IRCT) (clinical trial code: IRCT20180506039557N1. Registered 2018-10-31. Retrospectively registered, https://en.irct.ir/trial/31040

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Update on the Clinical Effect of Acupuncture Therapy in Patients with Gouty Arthritis: Systematic Review and Meta-Analysis

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2016/9451670 ◽

2016 ◽

Vol 2016 ◽

pp. 1-14 ◽

Cited By ~ 2

Author(s):

Wei-wei Lu ◽

Jin-ming Zhang ◽

Zheng-tao Lv ◽

An-min Chen

Keyword(s):

Acupuncture Therapy ◽

Clinical Effect ◽

Web Of Science ◽

Meta Analysis ◽

Gouty Arthritis ◽

Serum Urate ◽

Control Group ◽

Pharmacological Treatments ◽

Significant Difference ◽

Collection Form

Objective. The aim of this study is to evaluate the clinical efficacy and safety of acupuncture therapy in the treatment of acute gouty arthritis.Methods. A literature search of PubMed, EMBASE, ISI Web of Science, CENTRAL, and CNKI was conducted from the inception date of each database up to October 2015. Two investigators screened each article independently and were blinded to the findings of the other reviewer. Data was extracted according to the predetermined collection form. Meta-analysis was performed.Results. We analyzed data from 28 RCTs involving 2237 patients with gouty arthritis. Compared with conventional pharmacological treatments acupuncture was more effective in rendering patients free from symptoms after 24 hours, lowering serum urate, alleviating pain associated with gouty arthritis, and decreasing the ESR; regarding CRP, no statistically significant difference was found. In addition, the frequency of adverse events in acupuncture treatment was lower than that in control group.Conclusion. Based on the findings of our study, we cautiously suggest that acupuncture is an effective and safe therapy for patients with gouty arthritis. However, the potential beneficial effect of acupuncture might be overstated due to the methodological deficiency of included studies. High quality RCTs with larger scale are encouraged.

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AB0889 SARCOPENIA AND HIP FRACTURE IN GERIATRIC POPULATION

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.5440 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1749.3-1749

Author(s):

K. Boskovic ◽

S. Pantelinac ◽

S. Tomasevic-Todorovic ◽

T. Spasojevic ◽

D. Simic-Panic ◽

...

Keyword(s):

Quality Of Life ◽

Body Composition ◽

Hip Fracture ◽

Muscle Mass ◽

Hip Fractures ◽

Control Group ◽

Link Type ◽

Significant Difference ◽

Experimental Group

Background:Sarcopenia is a loss of skeletal muscle mass, muscle strength, and function, with an impact on the quality of life, increased risk of bone loss and fracture, which is associated with normal aging.Objectives:To determine the effect of sarcopenia on the recovery of patients after hip fracture, their fitness, functionality, and quality of lifeMethods:A prospective study had 60 patients with hip fractures of both sexes,> 65 years of age (70.8), in the experimental group of patients with sarcopenia and the control group without sarcopenia. All anthropometric measurements were performed: BMI (kg / m2), waist circumference, the volume of the upper arm and lower leg muscle mass, handgrip force (kg) - dynamometry. The following questionnaires were used to assess functionality, mobility, and quality of life: Health assessment questionnaire (HAQ), Harrison hip score (HHS), Sarcopenia and Quality of life (SarQol)Results:Muscle mass (BMI) was significantly lower in the experimental group patients (p <0.005) compared to the control group. The clamp strength measured by the dynamometer was significantly lower in patients with hip fractures (p <0.005) compared to the control group. About 2/3 of the subjects with sarcopenia and hip fracture have a severe and complete physical disability. There was a significant difference in all domains of quality of life between subjects with hip fractures and the control group due to the presence of sarcopenia (p <0.005).Conclusion:The presence of sarcopenia indicates consequently reduced functionality and a degree of disability in patients with hip fractures, slows recovery and increases the need for mobility aids, thus extending hospital stay and patient recovery.References:[1]He H, Liu Y, Tian Q, Papasian CJ, Hu T, Deng HW. Relationship of sarcopenia and body composition with osteoporosis. Osteoporos Int. 2016 Feb; 27(2):473–82.https://doi.org/10.1007/s00198-015-3241-8PMID: 26243357[2]Oliveira A, Vaz C. The role of sarcopenia in the risk of osteoporotic hip fracture. Clin Rheumatol. 2015 Oct; 34(10):1673–80.https://doi.org/10.1007/s10067-015-2943-9PMID: 25912213[3]Tarantino U, Piccirilli E, Fantini M, Baldi J, Gasbarra E, Bei R. Sarcopenia and fragility fractures: molecular and clinical evidence of the bone-muscle interaction. J Bone Joint Surg Am. 2015 Mar 4; 97(5):429–37.https://doi.org/10.2106/JBJS.N.00648PMID: 25740034 Benichou O, Lord SR. Rationale for Strengthening Muscle to Prevent Falls and Fractures: A Review of the Evidence. Calcif Tissue Int. 2016 Jun; 98(6):531–45.https://doi.org/10.1007/s00223-016-0107-9PMID: 26847435[4]Hirschfeld HP, Kinsella R, Duque G. Osteosarcopenia: where bone, muscle, and fat collide. Osteoporos Int. 2017 Oct; 28(10):2781–2790.https://doi.org/10.1007/s00198-017-4151-8PMID: 28733716[5]Rantanen T, Volpato S, Ferrucci L, Heikkinen E, Fried LP, Guralnik JM. Handgrip strength and causespecific and total mortality in older disabled women: exploring the mechanism. J Am Geriatr Soc. 2003 May; 51(5):636–41.https://doi.org/10.1034/j.1600-0579.2003.00207.xPMID: 12752838[6]Syddall H, Cooper C, Martin F, Briggs R, Aihie Sayer A. Is grip strength a useful single marker of frailty? Age Ageing. 2003 Nov; 32(6):650–6.https://doi.org/10.1093/ageing/afg111PMID: 14600007[7]Chen LK, Liu LK, Woo J, Assantachai P, Auyeung TW, Bahyah KS, et al. Sarcopenia in Asia: consensus report of the Asian Working Group for Sarcopenia. J Am Med Dir Assoc. 2014 Feb; 15(2):95–101.https://doi.org/10.1016/j.jamda.2013.11.025PMID: 24461239[8]Wehren LE, Hawkes WG, Hebel JR, Orwig DL, Magaziner J. Bone mineral density, soft tissue body composition, strength, and functioning after hip fracture. J Gerontol A Biol Sci Med Sci. 2005 Jan; 60 (1):80–4.https://doi.org/10.1093/gerona/60.1.80PMID: 15741287Disclosure of Interests:None declared

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A single-centre experience of febuxostat as a second-line urate-lowering therapy

Malaysian Family Physician ◽

10.51866/oa0892 ◽

2021 ◽

Vol 16 (1) ◽

pp. 50-55

Author(s):

Swee Gaik Ong ◽

Hui Jen Ding

Keyword(s):

Serum Creatinine ◽

Significant Proportion ◽

Serum Urate ◽

Oxidase Inhibitor ◽

Equal Proportion ◽

Second Line ◽

Cross Sectional ◽

Xanthine Oxidase Inhibitor ◽

Lowering Therapy ◽

Significant Difference

Introduction: The purpose of this study was to describe the local experience in terms of drug efficacy and safety using a new xanthine oxidase inhibitor, febuxostat, as a second-line urate lowering therapy (ULT) in gout patients with normal renal function and chronic kidney disease. Methods: This cross-sectional study included all gout patients who attended the rheumatology clinic from January 2013 to June 2018 and had received febuxostat as a second-line ULT. Analysis focused on the proportion of gout patients who achieved target serum urate (sUA) of <360 μmol/L, duration taken to achieve target sUA, and febuxostat dosage at achievement of target sUA. Safety assessments included comparison of serum creatinine, estimated glomerular filtration rate (eGFR), and serum alanine aminotransferase (ALT) at baseline, at achievement of target sUA, and at 12-monthly intervals. Results: Majority (90.9%) of patients achieved target sUA. Median duration required to achieve target sUA was 5.5 months with IQR (interquartile range) of 8.5. Five (22.7%) patients achieved target sUA within one month of therapy with febuxostat 40 mg per day. Eleven (55%) patients achieved target sUA within six months and 16 (80%) by 12 months. Equal proportion of patients achieved target sUA with febuxostat 40 mg per day and 80 mg per day, respectively. There was no significant difference in the changes in serum creatinine level, eGFR and ALT from baseline and at achievement of target sUA, nor at 12-monthly intervals throughout the duration of febuxostat therapy. Apart from three patients who developed hypersensitivity reactions to febuxostat, no other adverse events were reported. Conclusion: A significant proportion of gout patients with CKD managed to achieve target sUA with a lower dose of febuxostat at 40 mg per day and it is reasonable to maintain this dose for up to six months before considering dose escalation.

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Normobaric oxygen therapy strategies in the treatment of postcraniotomy pneumocephalus

Journal of Neurosurgery ◽

10.3171/jns/2008/108/5/0926 ◽

2008 ◽

Vol 108 (5) ◽

pp. 926-929 ◽

Cited By ~ 43

Author(s):

Pankaj A. Gore ◽

Harvinder Maan ◽

Steve Chang ◽

Alan M. Pitt ◽

Robert F. Spetzler ◽

...

Keyword(s):

Study Participant ◽

Neurological Deficits ◽

Ct Scans ◽

Control Group ◽

Time Interval ◽

Control Groups ◽

Normobaric Oxygen ◽

Significant Difference ◽

The Mean ◽

And Control

Object Postsurgical pneumocephalus is an unavoidable sequela of craniotomy. Sufficiently large volumes of intracranial air can cause headaches, lethargy, and neurological deficits. Supplemental O2 to increase the rate of absorption of intracranial air is a common but unsubstantiated neurosurgical practice. To the authors' knowledge, this is the first prospective study to examine the efficacy of this therapy and its effect on the rate of pneumocephalus absorption. Methods Thirteen patients with postoperative pneumocephalus that was estimated to be ≥ 30 ml were alternately assigned to breathe 100% O2 using a nonrebreather mask (treatment group) or to breathe room air (control group) for 24 hours. Head computed tomography (CT) scans without contrast enhancement were obtained at the beginning and end of treatment or control therapy. A neuroradiologist blinded to the type of treatment used software to calculate the 3D volume of the pneumocephalus from the CT scans. The percentage of pneumocephalus absorption was calculated for each study participant. Results There was no statistically significant difference between the treatment and control groups regarding the mean initial pneumocephalus volume or time interval between CT scans. There was a significant difference (p = 0.009) between the mean rate of pneumocephalus volume reduction in the treatment (65%) and control groups (31%) per 24 hours. No patient suffered adverse effects related to treatment. Conclusions Administration of postsurgical supplemental O2 through a nonrebreather mask significantly increases the absorption rate of postcraniotomy pneumocephalus as compared with breathing room air.

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Comparing the effects of self-selected MUsic versus predetermined music on patient ANXiety prior to gynaecological surgery: the MUANX randomized controlled trial

Trials ◽

10.1186/s13063-021-05511-2 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

D. Reynaud ◽

N. Bouscaren ◽

V. Lenclume ◽

M. Boukerrou

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Preoperative Anxiety ◽

Control Group ◽

Gynaecological Surgery ◽

Patient Anxiety ◽

Randomized Controlled ◽

Link Type ◽

Significant Difference

Abstract Background Anxiety is frequently observed in the preoperative setting. The negative impact of preoperative anxiety is well known. In the context of gynaecological surgery, anxiety is exacerbated by the fact that the intervention can have catastrophic repercussions on a woman’s body image, sexuality, and psycho-affective well-being. Music listening is increasingly used as an alternative therapy for minimizing preoperative anxiety. Personal preferences, familiarity, and popularity may be key elements for an optimal relaxation response to music. This study aimed to determine whether listening to self-selected music decreases preoperative anxiety in women scheduled to undergo gynaecologic surgery compared with predetermined music from an application (MUSIC CARE®). Methods The MUANX study was a single-blind, monocentric, parallel, superiority, randomized controlled trial. A total of 174 women were included and randomized in two groups between August 2017 and September 2018. Patients in the intervention group listened to the personal music playlist that they had created before being hospitalized. Patients in the control group listened to the predetermined playlist on the MUSIC CARE® application. All patients received standard nursing care and listened to 20 min of music 1 h before surgery. Anxiety scores were assessed before and after the music session using Spielberger’s State-Trait Anxiety Inventory (STAI). Results The mean age of the 171 evaluated patients was 41.5 years (SD = 10.0 years). Before the music session, the STAI state anxiety score was similar in the control group (M = 38.8, SD = 11.9) and the intervention group (M = 39.0, SD = 13.1). After the music session, this score had significantly decreased in both the control group (M = −7.2, SD = 9.0) and the intervention group (M = −5.5, SD = 6.6), with no significant difference in score reduction between groups. Physiological parameters were unchanged after the music session. No significant differences in postoperative measurements (pain intensity, hospitalization duration) were observed between the two groups. Conclusion Self-selected music is as effective as predetermined music for reducing patient anxiety before gynaecological surgery. As it has no side effects and is easily applicable in gynaecological surgical services, this non-drug intervention may be proposed by healthcare professionals in the management of preoperative anxiety. Trial registration The MUANX trial (MUsic therapy on ANXiety) is registered at the US National Institutes of Health (ClinicalTrials.gov) #NCT03226834. Registered on 24 July 2017. https://clinicaltrials.gov/ct2/show/NCT03226834?term=muanx&draw=2&rank=1

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