7 research outputs found
Responding to the Needs of Early Career Physicians and Fellows in Headache Medicine: Career Planning, Getting Involved, and Considerations in Building a Headache Center
Effect of Suboccipital Release on Pain Perception and Autonomic Reflex Responses to Ischemic and Cold Pain
Introduction: In 2012, approximately 19 million adults in the U.S. used some form of manipulative treatment as part of their overall healthcare. Suboccipital release (SOR) is a commonly used manual medicine technique of the head and neck. SOR and related techniques are also used to treat pain from tension-type and migraine headaches. The clinical effects of SOR are purported to be mediated via the autonomic nervous system, but similar to many manual techniques, the neurophysiological data in this area are sparse. Thus, the effects and mechanisms of SOR are unclear and not well understood. Objective: This study aimed to determine the effects of SOR on the cardiovascular system during cold pain and ischemic pain. Methods: 16 healthy subjects (8 women, 8 men) experienced ischemic (forearm post-exercise muscle ischemia; PEMI) and cold (hand cold pressor test; CPT) pain. Beat-to-beat heart rate (HR; ECG), mean arterial blood pressure (MAP; finger photoplethysmography), baroreflex sensitivity (transfer function analysis), and pain perception were measured. SOR or a sham (modified yaw; 30 cycles/min) was performed in the final minute of pain. To probe potential mechanisms and interactions between manual treatment and a prototypic analgesic, oral aspirin (967 mg) was given 60 min prior to testing to reduce prostaglandin synthesis. Results: PEMI increased MAP by 23±2 and 20±2 mmHg; no differences occurred with the addition of SOR or yaw. PEMI modestly elevated HR during ischemia, followed by a significant reduction from baseline with SOR (-3±2 bpm) and yaw (-4±2 bpm); no differences were observed between treatment and sham. CPT increased MAP (SOR=11±1, yaw=9±2 mmHg) and HR (SOR=10±2, yaw=8±3 bpm) prior to SOR and yaw. Neither treatment nor sham blunted MAP increased (SOR=25±2, yaw=22±2 mmHg) with CPT; both decreased HR (SOR=-3±2, yaw=-2±2 bpm) from baseline. PEMI and CPT caused increased pain without treatment modulation. SOR decreased baroreflex sensitivity in the 0.05-0.15 Hz range and increased it in the 0.15-0.35 Hz range compared to yaw. Aspirin slightly attenuated pain but did not alter cardiovascular changes to PEMI and did not interact with SOR or yaw. These data indicate that “hands-on” interventions during acute pain and SOR post-pain have the capacity to modulate certain pain-induced autonomic effects. Conclusion: The primary findings of this study are that acute hypertensive conditions caused by experimental pain were not modulated by SOR, but HR responses were decreased during both SOR and a “hands-on” sham technique. The changes in BP and blood flow due to pain were not altered by the SOR treatment. However, baroreflex sensitivity was altered in both the low and high frequency ranges during the recovery period after experimentally induced pain, regardless of the type of pain. These data indicate that “hands-on” interventions during acute pain and SOR post-pain have the capacity to modulate certain pain-induced autonomic effects
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Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial
We aimed to assess the efficacy and safety of two neutralising monoclonal antibody therapies (sotrovimab [Vir Biotechnology and GlaxoSmithKline] and BRII-196 plus BRII-198 [Brii Biosciences]) for adults admitted to hospital for COVID-19 (hereafter referred to as hospitalised) with COVID-19.
In this multinational, double-blind, randomised, placebo-controlled, clinical trial (Therapeutics for Inpatients with COVID-19 [TICO]), adults (aged ≥18 years) hospitalised with COVID-19 at 43 hospitals in the USA, Denmark, Switzerland, and Poland were recruited. Patients were eligible if they had laboratory-confirmed SARS-CoV-2 infection and COVID-19 symptoms for up to 12 days. Using a web-based application, participants were randomly assigned (2:1:2:1), stratified by trial site pharmacy, to sotrovimab 500 mg, matching placebo for sotrovimab, BRII-196 1000 mg plus BRII-198 1000 mg, or matching placebo for BRII-196 plus BRII-198, in addition to standard of care. Each study product was administered as a single dose given intravenously over 60 min. The concurrent placebo groups were pooled for analyses. The primary outcome was time to sustained clinical recovery, defined as discharge from the hospital to home and remaining at home for 14 consecutive days, up to day 90 after randomisation. Interim futility analyses were based on two seven-category ordinal outcome scales on day 5 that measured pulmonary status and extrapulmonary complications of COVID-19. The safety outcome was a composite of death, serious adverse events, incident organ failure, and serious coinfection up to day 90 after randomisation. Efficacy and safety outcomes were assessed in the modified intention-to-treat population, defined as all patients randomly assigned to treatment who started the study infusion. This study is registered with ClinicalTrials.gov, NCT04501978.
Between Dec 16, 2020, and March 1, 2021, 546 patients were enrolled and randomly assigned to sotrovimab (n=184), BRII-196 plus BRII-198 (n=183), or placebo (n=179), of whom 536 received part or all of their assigned study drug (sotrovimab n=182, BRII-196 plus BRII-198 n=176, or placebo n=178; median age of 60 years [IQR 50–72], 228 [43%] patients were female and 308 [57%] were male). At this point, enrolment was halted on the basis of the interim futility analysis. At day 5, neither the sotrovimab group nor the BRII-196 plus BRII-198 group had significantly higher odds of more favourable outcomes than the placebo group on either the pulmonary scale (adjusted odds ratio sotrovimab 1·07 [95% CI 0·74–1·56]; BRII-196 plus BRII-198 0·98 [95% CI 0·67–1·43]) or the pulmonary-plus complications scale (sotrovimab 1·08 [0·74–1·58]; BRII-196 plus BRII-198 1·00 [0·68–1·46]). By day 90, sustained clinical recovery was seen in 151 (85%) patients in the placebo group compared with 160 (88%) in the sotrovimab group (adjusted rate ratio 1·12 [95% CI 0·91–1·37]) and 155 (88%) in the BRII-196 plus BRII-198 group (1·08 [0·88–1·32]). The composite safety outcome up to day 90 was met by 48 (27%) patients in the placebo group, 42 (23%) in the sotrovimab group, and 45 (26%) in the BRII-196 plus BRII-198 group. 13 (7%) patients in the placebo group, 14 (8%) in the sotrovimab group, and 15 (9%) in the BRII-196 plus BRII-198 group died up to day 90.
Neither sotrovimab nor BRII-196 plus BRII-198 showed efficacy for improving clinical outcomes among adults hospitalised with COVID-19.
US National Institutes of Health and Operation Warp Spee