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A significant proportion of individuals suffering from post COVID-19 condition (PCC, also known as long COVID) can present with persistent, disabling fatigue similar to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and post-viral fatigue syndromes. There remains no clear pharmacological therapy for patients with this subtype of PCC, which can be referred to as post-COVID fatigue syndrome (PCFS). A low dose of the opioid antagonist naltrexone (ie, low-dose naltrexone (LDN)) has emerged as an off-label treatment for treating fatigue and other symptoms in PCC. However, only small, non-controlled studies have assessed LDN in PCC, so randomised trials are urgently required.
A prospective, randomised, double-blind, parallel arm, placebo-controlled phase II trial will be performed to assess the efficacy of LDN for improving fatigue in PCFS. The trial will be decentralised and open to eligible individuals throughout the Canadian province of British Columbia (BC). Participants will be recruited through the province-wide Post-COVID-19 Interdisciplinary Clinical Care Network (PC-ICCN) and research volunteer platform (REACH BC). Eligible participants will be 19–69 years old, have had a confirmed or physician-suspected SARS-CoV-2 infection at least 3 months prior and meet clinical criteria for PCFS adapted from the Institute of Medicine ME/CFS criteria. Individuals who are taking opioid medications, have a history of ME/CFS prior to COVID-19 or history of significant liver disease will be excluded. Participants will be randomised to an LDN intervention arm (n=80) or placebo arm (n=80). Participants in each arm will be prescribed identical capsules starting at 1 mg daily and follow a prespecified schedule for up-titration to 4.5 mg daily or the maximum tolerated dose. The trial will be conducted over 16 weeks, with assessments at baseline, 6, 12 and 16 weeks. The primary outcome will be fatigue severity at 16 weeks evaluated by the Fatigue Severity Scale. Secondary outcomes will include pain Visual Analogue Scale score, overall symptom severity as measured by the Patient Phenotyping Questionnaire Short Form, 7-day step count and health-related quality of life measured by the EuroQol 5-Dimension questionnaire.
The trial has been authorised by Health Canada and approved by The University of British Columbia/Children’s and Women’s Health Centre of British Columbia Research Ethics Board. On completion, findings will be disseminated to patients, caregivers and clinicians through engagement activities within existing PCC and ME/CFS networks. Results will be published in academic journals and presented at conferences.
by Olivia de Villiers, Claudia Elliot-Wilson, Kevin G. F. Thomas, Patrick L. Semple, Thurandrie Naiker, Michelle Henry, Ian L. Ross
Strong lines of evidence in the neuroscience literature indicate that (a) healthy sleep facilitates cognitive processing, and (b) sleep disruption is associated with cognitive dysfunction. Despite the fact that patients with pituitary disease often display both disrupted sleep and cognitive dysfunction, few previous studies investigate whether these clinical characteristics in these patients might be related. Hence, we explored whether sleep disruption in patients with pituitary disease mediates their cognitive dysfunction. We recruited 18 patients with non-functioning pituitary adenomas (NFPA) and 19 sociodemographically matched healthy controls. They completed the Global Sleep Assessment Questionnaire (thus providing self-report data regarding sleep disruption) and were administered the Brief Test of Adult Cognition by Telephone, which assesses cognitive functioning in the domains of processing speed, working memory, episodic memory, inhibition, and reasoning. We found no significant differences in cognition between patients and controls. Furthermore, spectra of sleep disturbance did not differ significantly between patients and controls. Our data suggest that NFPA patients’ cognition and sleep quality is relatively intact, and that sleep disruption does not mediate cognitive dysfunction. Larger studies should characterize sleep and cognition in patients with NFPA (and other pituitary diseases) to confirm whether disruption of the former mediates impairment in the latter.by Soeurette Policar, Alana Sharp, Joanne Isidor Hyppolite, Gérald Marie Alfred, Eva Steide, Leïnadine Lucien, Naiké Ledan, Matthew Kavanagh
BackgroundFailure to retain people living with HIV (PLHIV) in care remains a significant barrier to achieving epidemic control in Haiti, with as many as 30% lost from care within one year of starting treatment. Community-led monitoring (CLM) is an emerging approach of improving healthcare and accountability to service users, through a cycle of monitoring and advocacy. In 2020, a CLM program was launched in Haiti to identify barriers to retention and advocating for better health services.
MethodsData from the community-led monitoring program in Haiti were analyzed, from a sample of 65 healthcare facilities in the Nord, Artibonite, and Ouest departments collected from April 2021 to February 2022. Qualitative data from six community-based focus groups and 45 semi-structured individual interviews were analyzed.
ResultsConfidentiality and stigmatization emerged as barriers to care, particularly due to the separation of PLHIV from other patients in view of community members. To avoid identification, patients described traveling long distances, with the reimbursement of transportation costs described as being insufficient or unavailable. Costs of non-HIV clinical services were a frequent concern and respondents described a need for clinics to provide food during all patient visits. Stock-outs were a regular challenge; by contrast, treatment literacy did not emerge as a major barrier to retention.
ConclusionsThese findings represent the first instance, to our knowledge, of original data from a community-led monitoring program being published in any country. These findings suggest that improving treatment retention for PLHIV is dependent on improving the acceptability and affordability of healthcare services. Ensuring confidentiality is critical, particularly where stigma is high. Retention could be improved by systematically strengthening patient confidentiality protections throughout the healthcare system, providing patients with sufficient travel compensation and other incentives, and delivering wraparound services provided for free. Addressing these challenges will require ongoing advocacy for community-developed recommendations and solutions.
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