Spinal cordPub Date : 2024-04-08DOI: 10.1038/s41393-024-00987-6
Ahmad M. S. Ali, Mohammad A. Mustafa, Omar M. E. Ali, Conor S. Gillespie, George M. Richardson, Simon Clark, Martin J. Wilby, Christopher P. Millward, Nisaharan Srikandarajah
{"title":"Patient-reported outcomes in Primary Spinal Intradural Tumours: a systematic review","authors":"Ahmad M. S. Ali, Mohammad A. Mustafa, Omar M. E. Ali, Conor S. Gillespie, George M. Richardson, Simon Clark, Martin J. Wilby, Christopher P. Millward, Nisaharan Srikandarajah","doi":"10.1038/s41393-024-00987-6","DOIUrl":"10.1038/s41393-024-00987-6","url":null,"abstract":"Systematic review. Primary Spinal Intradural Tumours (PSITs) are rare pathologies that can significantly impact quality of life. This study aimed to review patient reported outcomes (PROs) in PSITs. A systematic search of Pubmed and Embase was performed to identify studies measuring PROs in adults with PSITs. PRO results were categorised as relating to Global, Physical, Social, or Mental health. Outcomes were summarised descriptively. Following review of 2382 records, 11 studies were eligible for inclusion (737 patients). All studies assessed surgically treated patients. Schwannoma was the commonest pathology (n = 190). 7 studies measured PROs before and after surgery, the remainder assessed only post-operatively. For eight studies, PROs were obtained within 12 months of treatment. 21 PRO measurement tools were used across included studies, of which Euro-Qol-5D (n = 8) and the pain visual/numerical analogue scale (n = 5) were utilised most frequently. Although overall QoL is lower than healthy controls in PSITs, improvements following surgery were found in Extramedullary tumours (EMT) in overall physical, social, and mental health. Similar improvements were not significant across studies of Intramedullary tumours (IMT). Overall QoL and symptom burden was higher in IMT patients than in brain tumour patients. No studies evaluated the effect of chemotherapy or radiotherapy. Patients with PSITs suffer impaired PROs before and after surgery. This is particularly true for IMTs. PRO reporting in PSITs is hindered by a heterogeneity of reporting and varied measurement tools. This calls for the establishment of a standard set of PROs as well as the use of registries.","PeriodicalId":21976,"journal":{"name":"Spinal cord","volume":"62 6","pages":"275-284"},"PeriodicalIF":2.1,"publicationDate":"2024-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.nature.com/articles/s41393-024-00987-6.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140561736","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Duration of detrusor overactivity as an independent predictive factor of upper urinary tract deterioration in patients with traumatic spinal cord injury: results of a retrospective cohort study","authors":"Pratchayapon Kammuang-lue, Sintip Pattanakuhar, Maysa Sermsuk, Chaisiri Angkurawaranon","doi":"10.1038/s41393-024-00988-5","DOIUrl":"10.1038/s41393-024-00988-5","url":null,"abstract":"To determine whether duration of detrusor overactivity (DO) during a cystometric study is an independent predictive factor of upper urinary tract deterioration (UUTD) in patients with traumatic spinal cord injury (TSCI). Retrospective cohort study. A rehabilitation facility in Chiang Mai, Thailand. Data were obtained from medical records of patients who underwent cystometric evaluation at 6–12 months after TSCI. The independent predictor of interest is the duration of DO, which was evaluated by the DO/cystometry ratio (DOratio). Other conventional urodynamic parameters (maximum detrusor pressure, cystometric capacity, bladder compliance, and detrusor-sphincter dyssynergia) and clinical parameters (age, sex, level and severity of injury, comorbidities, bladder emptying method, and history of urinary tract infection) were determined. The outcome was UUTD, which is indicated by chronic kidney disease (GFR < 60 ml/min/1.73 m2), hydronephrosis, and/or vesicoureteral reflux. Multivariable Cox regression analysis was used to determine the independent associations between DOratio and UUTD by adjusting with all other parameters. Medical records of 194 patients with TSCI were included in the study. During a combined total of 1260 follow-up years of those patients, 34 UUTD events were identified, indicating an incidence rate of 27.0 cases per 1000 person-years. After adjusting for all other parameters, a high DOratio (≥0.33) was significantly associated with UUTD (hazard ratio = 3.00 [95% CI: 1.12–7.99], p = 0.025). DOratio may be an independent cystometric predictor of UUTD in patients with TSCI. However, further prospective study is needed prior to applying DOratio as a predictor of UUTD in clinical settings. There was no clinical trial registration since this study is not a clinical trial.","PeriodicalId":21976,"journal":{"name":"Spinal cord","volume":"62 6","pages":"328-335"},"PeriodicalIF":2.1,"publicationDate":"2024-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140561826","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Spinal cordPub Date : 2024-04-04DOI: 10.1038/s41393-024-00981-y
Chandrasekaran Jayaraman, Chaithanya Krishna Mummidisetty, Arun Jayaraman, Kimberly Pfleeger, Michelle Jacobson, Melissa Ceruolo, Ellora Sen-Gupta, James Caccese, David Chen
{"title":"Validity and reliability study of a novel surface electromyography sensor using a well-consolidated electromyography system in individuals with cervical spinal cord injury","authors":"Chandrasekaran Jayaraman, Chaithanya Krishna Mummidisetty, Arun Jayaraman, Kimberly Pfleeger, Michelle Jacobson, Melissa Ceruolo, Ellora Sen-Gupta, James Caccese, David Chen","doi":"10.1038/s41393-024-00981-y","DOIUrl":"10.1038/s41393-024-00981-y","url":null,"abstract":"Non-interventional, cross-sectional pilot study. To establish the validity and reliability of the BioStamp nPoint biosensor (Medidata Solutions, New York, NY, USA [formerly MC10, Inc.]) for measuring electromyography in individuals with cervical spinal cord injury (SCI) by comparing the surface electromyography (sEMG) metrics with the Trigno wireless electromyography system (Delsys, Natick, MA, USA). Participants were recruited from the Shirley Ryan AbilityLab registry. Individuals aged 18–70 years with cervical SCI were evaluated with the two biosensors to capture activity on upper-extremity muscles during two study sessions conducted over 2 days (day 1–consent alone; day 2–two data collections in same session). Time and frequency metrics were captured, and signal-to-noise ratio was determined for each muscle group. Test-retest reliability was determined using Pearson’s correlation. Validation of the BioStamp nPoint system was based on Bland-Altmann analysis. Among the 11 participants, 30.8% had subacute cervical injury at C5–C6; 53.8% were injured within 1 year of the study. Results from the test-retest reliability assessment revealed that most Pearson’s correlations between the two sensory measurements were strong (≥0.50). The Bland-Altman analysis found values of the signal-to-noise ratio, frequency, and peak amplitude were within the level of agreement. Signal-to-noise ratios ranged from 7.06 to 22.1. In most instances, the performance of the BioStamp nPoint sensors was moderately to strongly correlated with that of the Trigno sensors in all muscle groups tested. The BioStamp nPoint system is a valid and reliable approach to assess sEMG measures in individuals with cervical SCI. The present study was supported by AbbVie Inc.","PeriodicalId":21976,"journal":{"name":"Spinal cord","volume":"62 6","pages":"320-327"},"PeriodicalIF":2.1,"publicationDate":"2024-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.nature.com/articles/s41393-024-00981-y.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140561731","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Spinal cordPub Date : 2024-04-03DOI: 10.1038/s41393-024-00979-6
Keira E. Tranter, Joanne V. Glinsky, Marsha Ben, Helen Patterson, Lynn Blecher, Jackie Chu, Lisa A. Harvey
{"title":"Using the benefit-harm trade-off method to determine the smallest worthwhile effect of intensive motor training on strength for people with spinal cord injury","authors":"Keira E. Tranter, Joanne V. Glinsky, Marsha Ben, Helen Patterson, Lynn Blecher, Jackie Chu, Lisa A. Harvey","doi":"10.1038/s41393-024-00979-6","DOIUrl":"10.1038/s41393-024-00979-6","url":null,"abstract":"Interviews using the benefit-harm trade-off method and an online survey. To determine the smallest worthwhile effect (SWE) of motor training on strength for people with spinal cord injury (SCI). SCI units, Australia. Forty people with recent SCI who had participated in motor training as part of their rehabilitation program (patient participants) and 37 physiotherapists (physiotherapist participants) working in SCI were recruited. The patient participants underwent an iterative process using the benefit-harm trade-off method to determine the SWE of motor training on strength. The physiotherapist participants were given an online survey to determine the SWE for five different scenarios. Both groups considered the SWE of a physiotherapy intervention involving an additional 12 h of motor training for 10 weeks on top of usual care. They were required to estimate the smallest improvement in strength (points on the Total Motor Score of the International Standards for Neurological Classification of SCI) to justify the effort and associated costs, risks or inconveniences of the motor training. The median (interquartile range) smallest improvement in strength that patient and physiotherapist participants deemed worth the effort and associated costs, risks or inconveniences of the motor training was 3 (1–5) points, and 9 (7–13) points, respectively. People with recent SCI are willing to devote 12 h a week for 10 weeks to motor training in addition to their usual care to gain small changes in strength. Physiotherapists wanted to see greater improvements to justify the intervention.","PeriodicalId":21976,"journal":{"name":"Spinal cord","volume":"62 6","pages":"314-319"},"PeriodicalIF":2.1,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.nature.com/articles/s41393-024-00979-6.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140561733","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Spinal cordPub Date : 2024-04-03DOI: 10.1038/s41393-024-00989-4
Auwal Bello Hassan, Auwal Abdullahi, Musa Sani Danazumi
{"title":"A response to “Toward a better understanding and terminology of transcutaneous spinal cord stimulation”","authors":"Auwal Bello Hassan, Auwal Abdullahi, Musa Sani Danazumi","doi":"10.1038/s41393-024-00989-4","DOIUrl":"10.1038/s41393-024-00989-4","url":null,"abstract":"","PeriodicalId":21976,"journal":{"name":"Spinal cord","volume":"62 6","pages":"273-274"},"PeriodicalIF":2.1,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140561734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Spinal cordPub Date : 2024-04-02DOI: 10.1038/s41393-024-00985-8
Marsha Ben, Federica Tamburella, Matteo Lorusso, Joanne V. Glinsky, Keira E. Tranter, Giorgio Scivoletto, Lynn Blecher, Anneliese Harris, Giovanni Galeoto, Joshua Wan, Lisa A. Harvey
{"title":"A therapist-administered self-report version of the Walking Index for Spinal Cord Injury II (WISCI): a psychometric study","authors":"Marsha Ben, Federica Tamburella, Matteo Lorusso, Joanne V. Glinsky, Keira E. Tranter, Giorgio Scivoletto, Lynn Blecher, Anneliese Harris, Giovanni Galeoto, Joshua Wan, Lisa A. Harvey","doi":"10.1038/s41393-024-00985-8","DOIUrl":"10.1038/s41393-024-00985-8","url":null,"abstract":"To develop a self-report version of the Walking Index for Spinal Cord Injury II (WISCI II) and to test its reliability and validity. Psychometric study. Spinal cord injury (SCI) rehabilitation centres in Australia and Italy. Eighty people with SCI were recruited from a sample of convenience. Two self-report versions of the WISCI II were developed. Both versions were administered in English at the Australian site, and in Italian at the Italian site through an online platform. The format of the first self-report version (SR-V1) was similar to the original face-to-face WISCI II. The second self-report version (SR-V2) had more questions, but each question required participants to focus on one aspect of walking at a time. Participants completed SR-V1 and SR-V2 with assistance from research physiotherapists on two separate occasions, three to seven days apart. The original WISCI II was then administered through a face-to-face assessment by an independent physiotherapist. The intra-rater reliability and validity of SR-V1 and SR-V2 were determined with intraclass correlation coefficients (ICC) and percent close agreements. The data from the Australian and Italian sites were pooled. The validity and reliability of the two self-report versions were very similar, with SR-V2 performing slightly better than SR-V1. The ICC (95% confidence interval) of SR-V2 was 0.87 (0.81–0.92). The ICC reflecting the agreement between the self-report and the face-to-face WISCI was 0.89 (0.84–0.93). Both versions of the self-report WISCI II provide a reasonable substitute for a face-to-face assessment although therapists preferred SR-V2.","PeriodicalId":21976,"journal":{"name":"Spinal cord","volume":"62 6","pages":"307-313"},"PeriodicalIF":2.1,"publicationDate":"2024-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.nature.com/articles/s41393-024-00985-8.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140561706","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Long-term trends and risk factors of tracheostomy and decannulation in patients with cervical spinal cord Injury","authors":"Lianjun Gao, Wei Gao, Hongwei Liu, Changbin Liu, Feng Yang, Qimin Wang, Weichao Zhao, Zhaohui Tong","doi":"10.1038/s41393-024-00968-9","DOIUrl":"10.1038/s41393-024-00968-9","url":null,"abstract":"Retrospective study. To investigate the risk factors of tracheostomy and decannulation after cervical spinal cord injury (CSCI) and their epidemiological changes over the past 8 years in Beijing Bo’ai Hospital, China Rehabilitation Research Center (CRRC), China. Beijing Bo’ai Hospital, CRRC. We reviewed 8 years of patient data (2013.1.1 to 2020.12.31) at CRRC, focusing on those hospitalized and diagnosed with CSCI. We analyzed changes in demographic and clinical data’s trends. Logistic regression analysis was used to determine factors impacting tracheostomy and decannulation. Finally, 1641 CSCI patients met the inclusion criteria. Over the past 8 years, the proportion of tracheostomized patients with CSCI was 16.3%, and the proportion of successfully decannulated of tracheostomized patients with TCSCI was 77.9%. We found that Traumatic (OR = 1.8, 95% CI = 1.06, 3.22; p = 0.046), Motor level of injury (C5–C8) (OR = 0.32, 95% CI = −1.91,−0.34; p = 0.005), AIS = A/B/C (OR = 22.7/11.1/4.2, 95% CI = 12.16,42.26/5.74,21.56/2.23,7.89; p < 0.001/p < 0.001/p < 0.001), age > 56 (OR = 1.6, 95% CI = 1.04, 2.32; p = 0.031) were the risk factors for tracheostomy. By analyzing the risk factors of decannulation failure in tracheostomized patients with TCSCI through multivariable logistic regression, statistically significant differences were found in age > 45 (OR = 4.1, 95% CI = 1.44, 11.81; p = 0.008), complete injury (OR = 2.7, 95% CI = 1.26, 5.95; p = 0.011), facet dislocation (OR = 2.8, 95% CI = 1.13,7.07; p = 0.027). Recent years have witnessed shifts in the epidemiological characteristics of CSCI. Identifying the factors influencing tracheostomy and decannulation in CSCI can aid in improving patient prognosis.","PeriodicalId":21976,"journal":{"name":"Spinal cord","volume":"62 6","pages":"300-306"},"PeriodicalIF":2.1,"publicationDate":"2024-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140330133","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Spinal cordPub Date : 2024-03-28DOI: 10.1038/s41393-024-00973-y
Thomas Anand Augustine, Henry Prakash M, Suceena Alexander, Mahasampath Gowri S
{"title":"Assessment of renal function in persons with motor complete spinal cord injury—cystatin C as an accurate single marker","authors":"Thomas Anand Augustine, Henry Prakash M, Suceena Alexander, Mahasampath Gowri S","doi":"10.1038/s41393-024-00973-y","DOIUrl":"10.1038/s41393-024-00973-y","url":null,"abstract":"Observational cohort. To show that Cystatin C is an accurate single marker to estimate GFR in motor complete persons with SCI. To assess if Cystatin C is an accurate for estimating GFR in persons with SCI with no preserved motor power. To study if use of Serum creatinine for estimation of GFR in this population significantly overestimates GFR, thereby inaccurate. Tertiary care hospital and Medical College, Vellore, South India. 30 persons with SCI (ASIA A and B) fulfilling the inclusion criteria were recruited. Serum Creatinine and Serum Cystatin C values were obtained, and eGFR was calculated based on available formulae. 24-h urine for urine creatinine clearance-based eGFR was used as a reference value. Analysis with a Bland-Atman plot showed that eGFR estimated with Serum Cystatin C was more accurate than Serum Creatinine, using 24-h urine creatinine as a reference value. eGFR using Serum Creatinine significantly overestimated GFR by over 50.6%. Estimated GFR using Serum Cystatin C showed a meager mean difference of 0.5% from the reference 24-h urine creatinine clearance (mean difference of –2.56%). Serum Cystatin C is a much more accurate marker for estimating GFR in SCI, compared to serum Creatinine which overestimates GFR.","PeriodicalId":21976,"journal":{"name":"Spinal cord","volume":"62 6","pages":"295-299"},"PeriodicalIF":2.1,"publicationDate":"2024-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140313476","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Spinal cordPub Date : 2024-03-22DOI: 10.1038/s41393-024-00977-8
Reed Handlery, Kaci Handlery, Dana Kahl, Lyndsie Koon, Elizabeth W. Regan
{"title":"High intensity functional training for people with spinal cord injury & their care partners","authors":"Reed Handlery, Kaci Handlery, Dana Kahl, Lyndsie Koon, Elizabeth W. Regan","doi":"10.1038/s41393-024-00977-8","DOIUrl":"10.1038/s41393-024-00977-8","url":null,"abstract":"Non-randomized clinical trial. Examine the feasibility, physical and psychosocial effects of a high intensity functional training (HIFT) exercise program for people with spinal cord injury (pSCI) and their care partners (CPs). Community fitness center in a Medically Underserved Area (Fort Smith, USA.) A single-group design with three assessment points (before the program, at midpoint (13 weeks), and post-program (25 weeks) was used to examine the effects of up to 49 HIFT sessions over 25-weeks. Sessions were 60 to 75 min in duration and adapted to the abilities of participants. Feasibility measures included recruitment, retention, attendance, safety and fidelity (exercise intensity rated via session-Rating of Perceived Exertion (RPE). Physical measures included cardiovascular endurance, anaerobic power, and muscular strength. Psychosocial measures included perceived social support for exercise, exercise self-efficacy and health-related quality of life. Fourteen pSCI (7 with paraplegia and 7 with tetraplegia, 2 females) and 6 CPs (4 females) were included (median age = 60) (IQR = 15.8). Recruitment rates were 40% for pSCI and 32% for CPs. On average, participants attended 73% (22%) of exercise sessions with a median session-RPE of 5 (IQR = 1). Retention rates were 83% and 67% for pSCI and CPs, respectively. For pSCI and their CPs, large effect sizes were observed for cardiovascular endurance, anaerobic power, muscular strength, and social support for exercise. For pSCI and their CPs, HIFT appears feasible and potentially leads to improvements in physical and psychosocial health for both groups.","PeriodicalId":21976,"journal":{"name":"Spinal cord","volume":"62 7","pages":"357-366"},"PeriodicalIF":2.1,"publicationDate":"2024-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.nature.com/articles/s41393-024-00977-8.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140194546","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Spinal cordPub Date : 2024-03-22DOI: 10.1038/s41393-024-00983-w
Samford Wong, Shashivadan P. Hirani, Alastair Forbes, Naveen Kumar, Ramaswamy Hariharan, Jean O’Driscoll, Ravi Sekhar, Ali Jamous
{"title":"Lactobacillus casei Shirota probiotic drinks reduce antibiotic associated diarrhoea in patients with spinal cord injuries who regularly consume proton pump inhibitors: a subgroup analysis of the ECLISP multicentre RCT","authors":"Samford Wong, Shashivadan P. Hirani, Alastair Forbes, Naveen Kumar, Ramaswamy Hariharan, Jean O’Driscoll, Ravi Sekhar, Ali Jamous","doi":"10.1038/s41393-024-00983-w","DOIUrl":"10.1038/s41393-024-00983-w","url":null,"abstract":"This was a sub-group analysis of a multicentre, randomised, placebo-controlled, double-blind trial (ECLISP trial) To assess the efficacy of a probiotic containing at least 6.5 × 109 live Lactobacillus casei Shirota (LcS) in preventing antibiotic associated diarrhoea (AAD) in patients with spinal cord injury (SCI) who consumed proton pump inhibitor (PPI) regularly. LcS or placebo was given once daily for the duration of an antibiotic course and continued for 7 days thereafter. The trial was registered with ISRCTN:13119162. Three SCI centres (National Spinal Injuries Centre, Midland Centre for Spinal Injuries and Princess Royal Spinal Cord Injuries Centre) in the United Kingdom Between November 2014, and November 2019, 95 eligible consenting SCI patients (median age: 57; IQ range: 43-69) were randomly allocated to receive LcS (n = 50) or placebo (n = 45). The primary outcome is the occurrence of AAD up to 30 days after finishing LcS/placebo. The LcS group had a significantly lower incidence of AAD at 30 days after finishing the antibiotic course (28.0 v 53.3%, RR: 95% CI: 0.53, 0.31–0.89; z = 2.5, p = 0.01). Multivariate logistic regression analysis identified that LcS can reduce the risk of AAD at 30 days (OR: 0.36, 95% CI 0.13, 0.99, p < 0.05). No intervention-related adverse events were reported during the study. LcS has the potential to prevent AAD in what could be considered a defined vulnerable group of SCI patients on regular PPI. A confirmatory, randomised, placebo-controlled study is needed to confirm this apparent therapeutic success to translate it into appropriate clinical outcomes. Yakult Honsha Co., Ltd.","PeriodicalId":21976,"journal":{"name":"Spinal cord","volume":"62 5","pages":"255-263"},"PeriodicalIF":2.2,"publicationDate":"2024-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.nature.com/articles/s41393-024-00983-w.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140194547","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}