Multicenter, Prospective, Controlled Double-Blind Study Comparing Fib-19-01, A Phytotherapy Treatment, To A Dietary Supplement And To Conventional Care In Patients Suffering From Fibromyalgia.
Altern Ther Health Med. 2019 Jul;25(4):46-53
Authors: Barmaki M, Maindet-Dominici C, Nizard J, Baron D, Russ I, Fardellone P, Ginies P, Marc JF, Conrozier T, Bertin P
Background: Current therapeutic modalities for fibromyalgia (FM) do not provide satisfactory results and new approaches have to be explored.
Objectives: To assess efficacy and safety of adding a phytotherapy treatment (Fib-19-01) to the current therapeutic regimen in patients with FM.
Methods: Double-blind controlled trial: women with active FM (Fibromyalgia Index Questionnaire FIQ > 40) were randomised to receive Fib-19-01 or a food supplement (FS) undistinguishable from Fib-19-01 or no supplementary treatment (NoST). All continued the conventional therapy throughout the 6 month follow-up. Primary endpoint: change in FIQ between Day 0 and month 6 (M6). Secondary Criteria: variation over time FIQ ( repeated measurements), change in Pichot fatigue scale, Pittsburgh Sleep Quality Index (PSQI), SF-12 and Hospital Anxiety and Depression (HAD) scales.
Results: 100 patients (Intent-To-Treat population) were analyzed. FIQ decreased significantly only in the Fib-19-01 group (P < .001) at both week 12 and 24. Improvement was higher for Fib-19-01 (-13.4 ± 18.9) than in the 2 other groups (-5.5 ± 15.6 and -5.6 ± 11.3) despite there was no statistical between-group difference at week 24 in FIQ score (P = .08 and P = .09 respectively). Analysis of variance in repeated measurements of FIQ showed a significant difference between Fib-19-01 and FS throughout the follow-up period (P = .03). Fib-19-01 was superior to both FS and NoST for Pichot scale decrease over time: -4.6 (range -6.9; -2.28), -0.29 (-2.7; 2.1) and -0.72 (-3.1; 1.66) (P = .013 and 0.023 respectively), mental and social SF12 [+8.1 (range 3.5; 12.6), -0.27(range -5.3; 4.8 ) and -0.02 (range -5.0; 4.9 ) P = .02 and 0.018)],HAD depression [-2.0 (range -3.3; -0.7), +0.5 (range -0.9; 1.9 ) and +0.71 (range -0.7; 2.1) P = .013 and 0.007]. No significant difference was found between FS and NoST groups for any outcome. All treatments were well and similarly tolerated.
Conclusions: In patients with FM taking conventional therapy, Fib-19-01 has a therapeutic effect on fatigue, emotion and social life, and depression associated with the disease.
PMID: 31202211 [PubMed - in process]
The Endocannabinoid System and its Modulation by Cannabidiol (CBD).
Altern Ther Health Med. 2019 Jun;25(S2):6-14
Authors: Corroon J, Felice JF
The endocannabinoid system (ECS) is an extensive endogenous signaling system with multiple elements, the number of which may be increasing as scientists continue to elucidate its role in human health and disease. The ECS is seemingly ubiquitous in animal species and is modulated by diet, sleep, exercise, stress, and a multitude of other factors, including exposure to phytocannabinoids, like Cannabidiol (CBD). Modulating the activity of this system may offer tremendous therapeutic promise for a diverse scope of diseases, ranging from mental health disorders, neurological and movement disorders, pain, autoimmune disease, spinal cord injury, cancer, cardiometabolic disease, stroke, TBI, osteoporosis, and others.
PMID: 31202198 [PubMed - in process]
The role of dispositional mindfulness in a stress-health pathway among Parkinson's disease patients and caregiving partners.
Qual Life Res. 2019 Jun 14;:
Authors: Hicks A, Phillips K, Siwik C, Salmon P, Litvan I, Jablonski ME, Filoteo JV, Kayser K, Sephton SE
PURPOSE: Parkinson's disease (PD) patients and their caregivers experience significant distress that impacts physical, emotional and social functioning in the patient, and in turn, has a significant impact on the caregiver. Lower levels of stress have been associated with a better prognosis in PD. The quality of dispositional mindfulness-innate present moment, non-judgmental awareness-has consistently been associated with less perceived stress, greater well-being, and better physical health in both clinical and healthy populations. To date, associations of mindfulness with distress, depression, sleep problems, and other variables that define health-related quality of life have not been examined in the context of PD patient/caregiver dyads.
METHODS: We investigated the impact of dispositional mindfulness in a stress-health model among eighteen dyads consisting of PD patients and their caregivers.
RESULTS: Multilevel linear modeling (actor-partner interdependence models) revealed significant associations between dispositional mindfulness and stress appraisal, interpersonal support, depressive symptoms, sleep, and health-related quality of life (HRQOL) within both dyadic partners. As expected, results demonstrated significant associations of distress with interpersonal support, depressive symptoms, sleep and HRQOL for both PD patients and caregivers.
CONCLUSIONS: Dispositional mindfulness was associated with reduced distress and its downstream clinical consequences. These results support an ameliorative role for dispositional mindfulness among PD patients and caregivers, as a protective factor against psychosocial burdens imposed on couples related to disease and caregiving. Findings suggest future studies should explore mindfulness training as a therapeutic option.
PMID: 31201728 [PubMed - as supplied by publisher]
Palliative care assessment of dry mouth: what matters most to patients with advanced disease?
Support Care Cancer. 2019 Jun 14;:
Authors: Fleming M, Craigs CL, Bennett MI
PURPOSE: Dry mouth is a highly prevalent and significant symptom in patients with advanced progressive diseases. It is a poorly understood area of research, and currently, there is no standardised outcome measure or assessment tool for dry mouth.
METHODS: To assess responses to self-reported dry mouth questions, the impact of dry mouth, methods used to reduce symptoms and relevance of the questionnaire. A cross-sectional multisite study of 135 patients with advanced progressive disease experiencing dry mouth. Participants were located in the inpatient, day care, outpatient or community setting.
RESULTS: The majority (84.4%) of patients rated their dry mouth as moderate or severe using the verbal rating scale (VRS). Seventy-five percent (74.7%) had a numeric rating scale (NRS) score of 6 or more for dry mouth severity. Patients reported that dry mouth interfered most with talking and was the most important function to assess (median score 6 out of 10) followed by eating (median 5) and taste (median 5). Taking sips of drink was the most common and most effective self-management strategy. Over half of patients (54.6%) also reported impact on swallow and sleep and associated dryness of lips, throat and nasal passages.
CONCLUSIONS: This study highlights the severity of dry mouth in advanced disease. Important factors when assessing patients with dry mouth should include the functional impact on day-to-day activities including talking, dysphagia and sleep. Simple considerations for patients include provision of drinks and reviewing medications. This study could be used to develop a standardised assessment tool for dry mouth to use in clinical practice.
PMID: 31201546 [PubMed - as supplied by publisher]
A RR interval based automated apnea detection approach using residual network.
Comput Methods Programs Biomed. 2019 Jul;176:93-104
Authors: Wang L, Lin Y, Wang J
BACKGROUND AND OBJECTIVE: Apnea is one of the most common conditions that causes sleep-disorder breathing. With growing number of patients worldwide, more and more patients suffer from complications of apnea. But most of them stay untreated due to the complex and time-consuming polysomnography (PSG) diagnosis method. Effective and precise diagnosis support system using electrocardiograph (ECG) is required. In this paper, we propose an approach using residual network to detect apnea based on RR intervals (intervals between R-peaks of ECG signal).
METHODS: In our model, we apply residual network to represent information carried by RR intervals. Moreover, we proposed a novel perspective, called dynamic autoregressive representation, to provide interpretation of representing the RR intervals by convolutional layers.
RESULTS: This approach is tested for per-segment apnea detection using publicly available dataset on Physionet. 30 overnight recordings are used for training and 5 for testing. We achieve a good result of 94.4% accuracy, 93.0% sensitivity and 94.9% specificity. This result outperform other prevalent methods based on RR intervals. This model also shows its good adaptivity while using ECG-derived respiration signal (EDR) in experiments. Its extensiveness is evaluated and compared in experiments. The proposed model is also compared with deep neural networks using original ECG signals for apnea detection, and it achieves better result using fewer input samples.
CONCLUSIONS: We develop a deep residual network to detect apnea on low-sample-rate RR intervals. The result suggests a possibility of representing RR intervals by neural network. The model showed strong adaptivity when using EDR input.
PMID: 31200916 [PubMed - in process]