Hydroxychloroquine safety in Covid-19 vs non-Covid-19 patients: analysis of differences and potential interactions.

BACKGROUND: The use of hydroxychloroquine (HCQ) in the first COVID-19 epidemic wave raised safety concerns. RESEARCH DESIGN AND METHODS: Adverse reactions (ADR) suspected to be induced by HCQ and submitted to the Spanish Pharmacovigilance Database were studied. A disproportionality analysis was performed to determine adverse effects reported in non-Covid and Covid patients. To explore potential drug-drug interactions, Omega (Ω) statistics was calculated. RESULTS: More severe cases were reported when used in COVID-19. Main differences in frequency were observed in hepatobiliary, skin, gastrointestinal, eye, nervous system and heart ADRs. During the COVID-19 pandemic, high disproportionality in reports was found for Torsade de Pointes/QT prolongation with a ROR (-ROR) of 132.8 (76.7); severe hepatotoxicity, 18.7 (14.7); dyslipidaemias, 12.1 (6.1); shock, 9.5 (6.9) and ischemic colitis, 8.9 (2.6). Myopathies, hemolytic disorders and suicidal behavior increased their disproportionality during the pandemic. Disproportionality was observed for neoplasms, hematopoietic cytopaenias and interstitial lung disease in the pre-COVID-19 period. Potential interactions were showed between HCQ and azithromycin, ceftriaxone, lopinavir and tocilizumab. CONCLUSIONS: The use of HCQ during the Covid-19 pandemic changed its ADRs reporting profile. Of particular concern during the pandemic were arrhythmias, hepatotoxicity, severe skin reactions and suicide, but not ocular disorders. Some signals identified would require more detailed analyses.

Does the Addition of Pain Neurophysiology Education to a Therapeutic Exercise Program Improve Physical Function in Women with Fibromyalgia Syndrome? Secondary Analysis of a Randomized Controlled Trial.

Therapeutic exercise (TE) is one of the most investigated approaches for the management of FMS. Pain neurophysiology education (PNE) helps toward understanding the pain condition, leading to maladaptive pain cognitions and coping strategies in patients with chronic pain. Our study aimed to assess the effects of therapeutic exercise and pain neurophysiology education versus TE in isolation on fatigue, sleep disturbances, and physical function in the short term and at three months of follow-up in women with fibromyalgia syndrome (FMS). A single-blind randomized controlled trial was carried out. A total of 32 women with FMS referred from medical doctors and fibromyalgia association were randomized in 2 groups: PNE + TE group or TE group. Fatigue and sleep disturbances (Visual Analog Score) and physical function (Senior Fitness Test) were assessed before, after intervention, and at three months of follow-up. Significant improvements were achieved in the Timed Up and Go test (p = 0.042) and Arm Curl test (p = 0.043) after intervention and on handgrip in the non-dominant side at three months of follow-up (p = 0.036) on the PNE + TE group. No between-groups differences were found for fatigue, sleep disturbances, and the rest of test included in the Senior Fitness Test. In conclusion, these results suggest that PNE + TE appears to be more effective than TE in isolation for the improvement of physical function (Timed Up and Go test and Arm Curl test) in women with FMS in the short term.

Therapeutic Exercise and Pain Neurophysiology Education in Female Patients with Fibromyalgia Syndrome: A Feasibility Study.

BACKGROUND: We compared the effects of therapeutic exercise (TE) combined with pain neurophysiology education (PNE) to those of TE in isolation on pain intensity, general fibromyalgia impact, mechanical pain sensitivity, pain catastrophizing, psychological distress and quality of life in women with fibromyalgia syndrome (FMS). METHODS: A feasibility study with a 3 month follow-up was designed. Thirty-two patients with FMS were randomly assigned to PNE + TE group (n = 16) or to TE group (n = 16). Both groups received 30 sessions of TE (3 per week), and the PNE + TE group received eight face-to-face educational sessions. The measuring instruments used were the visual analogue scale, a standard pressure algometer, the Revised Fibromyalgia Impact Questionnaire, the Pain Catastrophizing Scale, the Hospital Anxiety and Depression Scale and the Health Assessment Questionnaire. RESULTS: The PNE + TE group showed a statistically significant decrease on pain intensity compared to TE group at short term (p = 0.015). No between-groups differences were found for mechanical pain sensitivity, general fibromyalgia impact, pain catastrophizing, psychological distress or quality of life (p > 0.05). CONCLUSIONS: The combination of PNE and TE was more effective than TE for reducing pain intensity in the short-term. No differences were found for psychological distress, pain catastrophizing and quality of life after the intervention or at 3 months of follow-up.