Factors Associated With The Prophylactic Effect of Placebo Injections in Subjects Enrolled in a Study of Botulinum Toxin For Migraine

Cephalalgia ◽  
2007 ◽  
Vol 27 (6) ◽  
pp. 528-534 ◽  
Author(s):  
TJ Schwedt ◽  
JG Hentz ◽  
DW Dodick

We set out to identify predictors for the prophylactic effect of placebo injections in subjects with migraine by post hoc analysis of 81 subjects with episodic migraine receiving single-blind placebo injections in a prospective trial of botulinum toxin. Possible predictors of placebo prophylaxis were compared among placebo responders (PRs) and placebo non-responders (PNRs). There were 34 PRs (42%) and 47 PNRs (58%). Male gender [odds ratio (OR) 5.83, 95% confidence interval (CI) 1.12, 30.14, P = 0.022], a history of opioid use (OR 4.44, 95% CI 1.47, 13.41, P = 0.005) and injections in the neck/shoulders (OR 2.44, 95% CI 0.93, 3.19, P = 0.033) were associated with placebo response. Of subjects with two or more of these signs, 88% were PRs compared with 31% of subjects with one or less. Male gender, opioid use and injections in the neck/shoulders are associated with placebo prophylaxis. These findings may have important implications for the design of future clinical trials and for the clinical management of migraineurs.

2021 ◽  
Vol 17 (1) ◽  
pp. 63-67
Author(s):  
Victoria Simmons, MD ◽  
Sejul Chaudhary, MD ◽  
Karen Hagglund, MS ◽  
R. David Hayward, PhD ◽  
Elango Edhayan, MD

Objective: We examined changes in opioid prescriptions after outpatient laparoscopic cholecystectomy (LC) before and after (1) an educational intervention for surgical residents and (2) subsequent changes in state regulations for handling these prescriptions.Design: A single-institution retrospective review evaluated opioids prescribed on discharge in morphine milligram equivalents (MMEs) over three periods: Period 1, prior to educational intervention (October 1, 2017 to January 31, 2018); Period 2, after intervention and before regulation changes occurred (February 1, 2018 to May 31, 2018); and Period 3, after changes in regulations went into effect (June 1, 2018 to September 30, 2018).Setting: A large urban teaching hospital in Detroit, Michigan. Patients: All adults receiving outpatient LC during one of the study periods. Patients with a history of regular opioid use prior to surgery were excluded. There were 49 patients in Period 1, 57 in Period 2, and 51 in Period 3.Interventions: All general surgery residents participated in an education session focusing on problems related to opioid addiction, prescribing trends, and multimodal pain control options in February 2018.Main outcome measure: Mean MME per patient was compared between time periods.Results: Average MME was reduced from 87.11 in Period 1 to 65.96 in Period 2 to 51.80 in Period 3. Analysis of variance showed MME differed significantly among the periods. Scheffe post hoc t-tests showed MME prescribed during Periods 2 and 3 were each significantly lower than Period 1, whereas Periods 2 and 3 did not differ significantly.Conclusions: MME prescribed after outpatient LC significantly decreased after the educational intervention and remained low after state mandate went into effect.


1970 ◽  
Vol 24 (2) ◽  
pp. 75-78
Author(s):  
MA Hayee ◽  
QD Mohammad ◽  
H Rahman ◽  
M Hakim ◽  
SM Kibria

A 42-year-old female presented in Neurology Department of Sir Salimullah Medical College with gradually worsening difficulty in talking and eating for the last four months. Examination revealed dystonic tongue, macerated lips due to continuous drooling of saliva and aspirated lungs. She had no history of taking antiparkinsonian, neuroleptics or any other drugs causing dystonia. Chest X-ray revealed aspiration pneumonia corrected later by antibiotics. She was treated with botulinum toxin type-A. Twenty units of toxin was injected in six sites of the tongue. The dystonic tongue became normal by 24 hours. Subsequent 16 weeks follow up showed very good result and the patient now can talk and eat normally. (J Bangladesh Coll Phys Surg 2006; 24: 75-78)


2021 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
F Andre ◽  
S Seitz ◽  
P Fortner ◽  
R Sokiranski ◽  
F Gueckel ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Siemens Healthineers Introduction Coronary CT angiography (CCTA) plays an increasing role in the detection and risk stratification of patients with coronary artery disease (CAD). The Coronary Artery Disease – Reporting and Data System (CAD-RADS) allows for standardized classification of CCTA results and, thus, may improve patient management. Purpose Aim of this study was to assess the impact of CCTA in combination with CAD-RADS on patient management and to identify the impact of cardiovascular risk factors (CVRF) on CAD severity. Methods CCTA was performed on a third-generation dual-source CT scanner in patients, who were referred to a radiology centre by their attending physicians. In a total of 4801 patients, CVRF were derived from medical reports and anamnesis. Results The study population consisted of 4770 patients (62.0 (54.0-69.0) years, 2841 males) with CAD (CAD-RADS 1-5), while 31 patients showed no CAD and were excluded from further analyses. Age, male gender and the number of CVRF were associated with more severe CAD stages (all p < 0.001). 3040 patients (63.7 %) showed minimal or mild CAD requiring optimization of CVRF i.e. medical therapy but no further assessment at his time. A group of 266 patients (5.6 %) had a severe CAD defined as CAD-RADS 4B/5. In the multivariate regression analysis, age, male gender, history of smoking, diabetes mellitus and hyperlipidaemia were significant predictors for severe CAD, whereas arterial hypertension and family history of CAD did not reach significance. Of note, a subgroup of 28 patients (10.5 %) with a severe CAD (68.5 (65.5-70.0) years, 26 males, both p = n.s.) had no CVRF. Conclusions CCTA in combination with the CAD-RADS allowed for effective risk stratification of CAD patients. The majority of the patients showed non-obstructive CAD and, thus, could be treated conservatively without the need for further CAD assessment. CVRF out of arterial hypertension and family history had an impact on CAD severity reflected in higher CAD-RADs gradings. Of note, a relevant fraction of patients with CAD did not have any CVRF and, thus, may not be covered by risk stratification models. CAD-RADS n Age (years) Males (%) 1 1453 56.0 (50.0-62.0) 623 (42.9 %) 2 1587 62.0 (55.0-69.0) 918 (57.8 %) 3 1067 66.0 (59.0-71.0) 749 (70.2 %) 4A 397 66.0 (59.0-72.0) 317 (79.8 %) 4B 162 67.0 (61.0-74.0) 139 (85.8 %) 5 104 66.0 (58.5.0-77.0) 95 (91.3 %)


Open Heart ◽  
2021 ◽  
Vol 8 (1) ◽  
pp. e001526
Author(s):  
Elena Tessitore ◽  
David Carballo ◽  
Antoine Poncet ◽  
Nils Perrin ◽  
Cedric Follonier ◽  
...  

ObjectiveHistory of cardiovascular diseases (CVDs) may influence the prognosis of patients hospitalised for COVID-19. We investigated whether patients with previous CVD have increased risk of death and major adverse cardiovascular event (MACE) when hospitalised for COVID-19.MethodsWe included 839 patients with COVID-19 hospitalised at the University Hospitals of Geneva. Demographic characteristics, medical history, laboratory values, ECG at admission and medications at admission were collected based on electronic medical records. The primary outcome was a composite of in-hospital mortality or MACE.ResultsMedian age was 67 years, 453 (54%) were males and 277 (33%) had history of CVD. In total, 152 (18%) died and 687 (82%) were discharged, including 72 (9%) who survived a MACE. Patients with previous CVD were more at risk of composite outcomes 141/277 (51%) compared with those without CVD 83/562 (15%) (OR=6.0 (95% CI 4.3 to 8.4), p<0.001). Multivariate analyses showed that history of CVD remained an independent risk factor of in-hospital death or MACE (OR=2.4; (95% CI 1.6 to 3.5)), as did age (OR for a 10-year increase=2.2 (95% CI 1.9 to 2.6)), male gender (OR=1.6 (95% CI 1.1 to 2.3)), chronic obstructive pulmonary disease (OR=2.1 (95% CI 1.0 to 4.2)) and lung infiltration associated with COVID-19 at CT scan (OR=1.9 (95% CI 1.2 to 3.0)). History of CVD (OR=2.9 (95% CI 1.7 to 5)), age (OR=2.5 (95% CI 2.0 to 3.2)), male gender (OR=1.6 (95% CI 0.98 to 2.6)) and elevated C reactive protein (CRP) levels on admission (OR for a 10 mg/L increase=1.1 (95% CI 1.1 to 1.2)) were independent risk factors for mortality.ConclusionHistory of CVD is associated with higher in-hospital mortality and MACE in hospitalised patients with COVID-19. Other factors associated with higher in-hospital mortality are older age, male sex and elevated CRP on admission.


2021 ◽  
pp. 232020682110065
Author(s):  
Deniz Erdil ◽  
Nilsun Bagis ◽  
Hakan Eren ◽  
Melike Camgoz ◽  
Kaan Orhan

Aim: Bruxism is defined as the involuntary recurrent masticatory muscle activity characterized by gnashing, grinding, clenching of teeth, and/or pushing the mandible. Factors creating its etiology are peripheral (morphological) or central (physiopathological and physiological), and exogenous. Recently, among physiological factors, depression and bruxism were considered to be related. A definitive treatment method does not exist for bruxism; however, botulinum toxin-A (BT-A) application is an up-to-date and effective way of treatment. The present study is aimed to evaluate the levels of depression in bruxism patients treated with BT-A application. Materials and Methods: A total of 25 individuals (23 females and 2 males) who were diagnosed as bruxism patients were included in the study. 25 U of BT-A for each masseter muscle was injected into the patients. Patients were prospectively observed for a possible change in depression levels by using Beck’s Depression Inventory. The inventory was implemented before and six months after the BT-A application. Depression levels before and six months after the injection were compared. A paired t-test was used to compare “before” and “after” treatment values. One-way analysis of variance and post-hoc Tukey tests were used to evaluate the change in Beck’s Depression Inventory scores according to age groups. Results: The mean total score was 7.80 ± 8.10 before the treatment and 7.16 ± 6.52 six months after the treatment. The decrease in the mean score was not statistically significant ( P > .05). Conclusion: In conclusion, despite the decrease in the mean Beck’s Depression Inventory scores, a statistically significant decrease in the depression levels of patients was not observed.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 340.1-341
Author(s):  
N. Ziade ◽  
J. El-Hajj ◽  
J. Rassi ◽  
S. Hlais ◽  
C. López-Medina ◽  
...  

Background:In patients with spondyloarthritis (SpA), root joint diseases (RJD), i.e. hip or shoulder involvement, may be associated with a distinct disease phenotype compared to those with other affected joints. The ASAS-PerSpA study (PERipheral involvement in SPondyloArthritis) [1], offers a unique opportunity to study the phenotypes of patients with RJD in a global cohort.Objectives:Primary objective was to compare the clinical characteristics of SpA patients with and without RJD. Secondary objectives were to compare the prevalence of RJD across the different SpA subtypes and the different regions of the world, compare the severity of axial disease as well as the disease burden in SpA patients with and without RJD.Methods:This is a post-hoc analysis of the ASAS-PerSpA study, which included 4,465 patients with any subtype of SpA (axial SpA (axSpA), peripheral SpA (pSpA), psoriatic arthritis (PsA), inflammatory bowel disease associated SpA (IBD-SpA), reactive arthritis (ReA) and Juvenile SpA (Juv-SpA)) according to the rheumatologist’s diagnosis. RJD was defined as a positive answer by the investigator to the following question: “Do you consider that the patient has ever suffered from RJD (e.g. hip, shoulder) related to SpA?” In case of a positive answer, a potential specific treatment (e.g. Total Articular Replacement) was investigated. The patient’s characteristics were compared between those with and without RJD involvement, using Chi-2 or Fisher exact test for the categorical variables and t-test for the continuous variables. Two separate multivariable stepwise binary logistic regression analyses were conducted to identify factors associated with the dependent variables “hip involvement” and “shoulder involvement”.Results:RJD occurred in 1,503 patients (33.7%), with more prevalent hip (24.2%) than shoulder (13.2%) involvement. The prevalence of RJD as a group was the highest in Juv-SpA (52.7%), followed by pSpA (44.3%) and axSpA (33.9%). The highest prevalence of RJD was found in Asia and the lowest in Europe and North America. Among patients with hip involvement, 6.0% had a history of hip replacement (highest in the Middle East and North Africa and Latin America); among patients with shoulder involvement, 0.8% had a history of shoulder replacement. Hip had a distinct pattern of associations compared to shoulder involvement (Figure 1). Hip involvement was significantly associated with the SpA main diagnosis (highest in pSpA, lowest in PsA), younger age at first SpA symptom, lower prevalence of family history of psoriasis, positive HLA-B27, occiput-to-wall distance>0, and treatment with cs-DMARDs and b-DMARDs. Shoulder involvement was associated with the SpA main diagnosis (highest in Juv-SpA and pSpA, lowest in axSpA), older age at first SpA symptom, higher prevalence of enthesitis, dactylitis, tender joints count, IBD, occiput-to-wall distance>0, EQ5D score and treatment with cs-DMARDs.Conclusion:Hip involvement was more prevalent than shoulder involvement in patients with SpA, and had a distinct phenotype resembling axial disease whereas shoulder involvement was mostly associated with features of peripheral disease. Hip and shoulder involvement should be analyzed separately in future studies rather than under the RJD entity.References:[1]Lopez-medina, C. et al. Prevalence and Distribution of Peripheral Musculoskeletal Manifestations in Axial Spondyloarthritis, Peripheral Spondyloarthritis and Psoriatic Arthritis: Results of the International, Cross-sectional ASAS-PerSpA Study. RMD Open; 2021;7:e001450.Disclosure of Interests:None declared


2021 ◽  
pp. 193864002199849
Author(s):  
Sumit Patel ◽  
Lauren Baker ◽  
Jose Perez ◽  
Ettore Vulcano ◽  
Jonathan Kaplan ◽  
...  

Background Nonunion is a postoperative complication after ankle arthrodesis (AA), which leads to increased morbidity and revision rates. Previous studies have identified risk factors for nonunion following AA, but no meta-analysis has been performed to stratify risk factors based on strength of evidence. Methods Abstracts and full-text articles were screened by 2 independent reviewers. Relevant data were extracted from the included studies. Random effects meta-analyses were summarized as forest plots of individual study and pooled random effect results. Results Database search yielded 13 studies involving 987 patients were included, and 37 potential risk factors for nonunion. Meta-analysis found 5 significant risk factors for nonunion post-AA. Strong evidence supports male gender (OR: 1.96; 95% CI: 1.13-3.41), smoking (OR: 2.89; 95% CI: 1.23-6.76), and history of operative site infection prior to arthrodesis (OR: 2.40; 95% CI: 1.13-5.09) as predictors for nonunion following AA. There was moderate evidence supporting history of open injury (OR: 5.95; 95% CI: 2.31-15.38) and limited evidence for preoperative avascular necrosis (OR: 13.16; 95% CI: 2.17-79.61) as possible risk factors for nonunion. Conclusion The results of our meta-analysis suggest that male gender, smoking, and history of operative site infection have strong evidence and that history of open injury and avascular necrosis also have evidence as risk factors for nonunion. Surgeons should be cognizant of these risks when performing AA and closely follow up with patients with the aforementioned risk factors to ensure postoperative success. Levels of Evidence: Level V: Systematic review of cohort and case-control studies


2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Katie Kanter ◽  
Ryan Gallagher ◽  
Feyisope Eweje ◽  
Alexander Lee ◽  
David Gordon ◽  
...  

Abstract Background The incidence of opioid-related overdose deaths has been rising for 30 years and has been further exacerbated amidst the COVID-19 pandemic. Naloxone can reverse opioid overdose, lower death rates, and enable a transition to medication for opioid use disorder. Though current formulations for community use of naloxone have been shown to be safe and effective public health interventions, they rely on bystander presence. We sought to understand the preferences and minimum necessary conditions for wearing a device capable of sensing and reversing opioid overdose among people who regularly use opioids. Methods We conducted a combined cross-sectional survey and semi-structured interview at a respite center, shelter, and syringe exchange drop-in program in Philadelphia, Pennsylvania, USA, during the COVID-19 pandemic in August and September 2020. The primary aim was to explore the proportion of participants who would use a wearable device to detect and reverse overdose. Preferences regarding designs and functionalities were collected via a questionnaire with items having Likert-based response options and a semi-structured interview intended to elicit feedback on prototype designs. Independent variables included demographics, opioid use habits, and previous experience with overdose. Results A total of 97 adults with an opioid use history of at least 3 months were interviewed. A majority of survey participants (76%) reported a willingness to use a device capable of detecting an overdose and automatically administering a reversal agent upon initial survey. When reflecting on the prototype, most respondents (75.5%) reported that they would wear the device always or most of the time. Respondents indicated discreetness and comfort as important factors that increased their chance of uptake. Respondents suggested that people experiencing homelessness and those with low tolerance for opioids would be in greatest need of the device. Conclusions The majority of people sampled with a history of opioid use in an urban setting were interested in having access to a device capable of detecting and reversing an opioid overdose. Participants emphasized privacy and comfort as the most important factors influencing their willingness to use such a device. Trial registration NCT04530591.


2016 ◽  
Vol 38 (5) ◽  
pp. 1081-1089.e4 ◽  
Author(s):  
Christian A. Bannister ◽  
James G. Orr ◽  
Alan V. Reynolds ◽  
Mark Hudson ◽  
Peter Conway ◽  
...  

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