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Efficacy of the Whole-Body Cryotherapy as Add-on Therapy to Pharmacological Treatment of Depression-A Randomized Controlled Trial.

ABSTRACT: Introduction:Accumulating evidence indicates the effectiveness of cryogenic temperature interventions in rheumatoid arthritis, ankylosing spondylitis, fibromyalgia, multiple sclerosis, and chronic low back pain. The application of whole-body cryotherapy (WBC) in psychiatric aspects of medicine was also noted. Nevertheless, the exact mechanisms explaining the beneficial effect of WBC on mood disorders remain unclear. The study aimed to assess the efficacy of repetitive short exposure to extremely low temperatures (WBC) on mood, quality of life as well as on biochemical measures among people diagnosed with depressive episode undergoing pharmacological treatment. Materials and Methods:Prospective randomized, double-blind sham-controlled protocol was used. The study enrolled 92 medically stable adults (aged 20-73 years) with a diagnosis of a depressive episode. The participants were randomly allocated and exposed to 10 whole-body cryotherapy (WBC) sessions (-110°C till -160°C [the experimental group (EG)] or to low, but not cryogenic temperatures -50°C [the control group (CG)]. Thirty participants in the EG and 26 in CG completed the whole study. The primary outcome measures were depressive symptoms evaluated with the Beck Depression Inventory-II (BDI-II) as well as the Hamilton Depression Rating Scale (HAM-D 17). The quality of life, quality of sexual life, acceptance of the disease and self-reported mood, vitality, and sleep quality were assessed as secondary outcome measures. The study was registered at Australian New Zealand Clinical Trials Registry (ACTRN12619001600134). Results:The results show evidence for a statistically significant difference in the clinical assessment of depressive symptoms according to HAM-D 17 scale (T4 by group interaction p=0.02), BDI-II (T2 time by group interaction p=0.01), cognitive-affective BDI dimension (T4 by group interaction p=0.00), and somatic BDI dimension (T4 by group interaction p=0.028). Significant improvement was also noticed in life quality (p < 0.05), self-assessed mood (p=0.035), and disease acceptance (p=0.007). There were no statistically significant changes related to sexual satisfaction, self-assessed vitality, and sleep (p > 0.05). Conclusions:Whole-body cryotherapy is a useful method to improve standard pharmacological treatment. The WBC intervention reduces mental health deterioration, especially in mood disorders, such as depression, and can be beneficial for well-being and quality of life.

SUBMITTER: Rymaszewska J

PROVIDER: S-EPMC7296110 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Efficacy of the Whole-Body Cryotherapy as Add-on Therapy to Pharmacological Treatment of Depression-A Randomized Controlled Trial.

Rymaszewska Joanna J Lion Katarzyna M KM Pawlik-Sobecka Lilla L Pawłowski Tomasz T Szcześniak Dorota D Trypka Elżbieta E Rymaszewska Julia E JE Zabłocka Agnieszka A Stanczykiewicz Bartlomiej B

Frontiers in psychiatry 20200609

<h4>Introduction</h4>Accumulating evidence indicates the effectiveness of cryogenic temperature interventions in rheumatoid arthritis, ankylosing spondylitis, fibromyalgia, multiple sclerosis, and chronic low back pain. The application of whole-body cryotherapy (WBC) in psychiatric aspects of medicine was also noted. Nevertheless, the exact mechanisms explaining the beneficial effect of WBC on mood disorders remain unclear. The study aimed to assess the efficacy of repetitive short exposure to e ...[more]

PMID: 32581890

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Project description:BackgroundIndividuals with chronic venous disease (CVeD) frequently experience associated leg pain that may influence disease management self-efficacy.ObjectiveTo evaluate the influence of a cooling intervention on leg pain associated with more severe stages of CVeD and self-efficacy. This was a secondary aim of the trial.DesignRandomized, blinded, comparator-controlled, multisite trial.SettingThree wound clinics and an academic medical research center in the United States of America.Participants276 participants (54.3% female, 46.7% male) with stage 4 and 5 CVeD were randomly assigned by computer generated tables to the cooling intervention group (n = 138) or control group (n = 138).InterventionsParticipants received either a cooling (intervention) leg cuff or placebo cuff (control) to apply topically over the affected skin area. Both groups performed standard of care including wearing compression wraps and elevating legs for 30 min during the intervention. Study visits occurred at baseline, and months 1, 3, 6, and 9.MethodsVisit measures included: Numeric Rating Scale (NRS) for short term pain; VEINES-QOL/Sym questionnaire for long-term pain; and, the Self Efficacy for Managing Chronic Disease Scale (SEMCD-6) for self-efficacy. Data were collected from September 2010 to December 2015 and analyzed using pooled t-tests, Chi-square tests, and mixed effects models. Observed 9-month patient retention rates were 94/138 (68.1%) in the intervention group and 91/138 (65.9%) in the control group. The primary analysis was based on the intention-to-treat principle.ResultsBoth the cooling intervention and control group experienced statistically significant decreases in unadjusted and adjusted mean NRS pain scores of 1.2 (95% CI: (-1.82, -0.64); p < 0.0001) and 1.8 (95% CI: (-2.31, -1.24); p < 0.0001) respectively from baseline, however, no statistically significant differences in change scores were observed between groups. The unadjusted mean VEINES-QOL/Sym pain scores had statistically significant decreases of 0.9 ((95% CI: (-1.07, -0.62) p < 0.0001 cooling)) and 0.8 (95% CI: (-1.09, -0.55) p < 0.0001 - control) points. When adjusting the scores for demographic and clinical features, both cooling and control groups maintained statistically significant decreases (p < 0.001 for both). No statistically significant differences in change scores were observed between groups. The unadjusted and adjusted mean self-efficacy scores had no statistically significant improvements from baseline to month 9 within and between the cooling and control groups.ConclusionsPain was reduced in both groups while self-efficacy did not change. Findings suggest that strictly implemented standard of CVeD care in each study group, with or without cooling, improved pain while there were no effects on self-efficacy.

Project description:BackgroundPatients with major depression disorder presents increased rates of cognitive decline, reduced hippocampal volume, poor sleep quality, hypertension, obesity, suicidal ideation and behavior, and decreased functionality. Although continuous aerobic exercise (CAE) improves some of the aforementioned symptoms, comorbidities, and conditions, recent studies have suggested that performing aerobic exercise with motor complexity (AEMC) may be more beneficial for cognitive decline, hippocampal volume, and functionality. Therefore, this randomized controlled trial will compare the effects of CAE and AEMC on depression score, cognitive function, hippocampal volume, brain-derived neurotrophic factor expression, sleep parameters, cardiovascular risk parameters, suicidal behavior, functionality, and treatment costs in patients with depression.Methods/designSeventy-five medicated patients with depression will be recruited from a Basic Healthcare Unit to participate in this prospective, parallel group, single blinded, superiority, randomized controlled trial. Patients with depression according to DSM-V criteria will be balanced and randomly assigned (based on depression scores and number of depressive episodes) to a non-exercising control (C), CAE, and AEMC groups. The CAE and AEMC groups will exercise for 60 min, twice a week for 24 weeks (on non-consecutive days). Exercise intensity will be maintained between 12 and 14 points of the rating of perceived exertion scale (~?70-80% of the maximum heart rate). The CAE group will perform a continuous aerobic exercise while the AEMC group will perform exercises with progressively increased motor complexity. Blinded raters will assess patients before and after the intervention period. The primary outcome measure will be the change in depression score measured by the Montgomery-Asberg Depression Rating Scale. Secondary outcomes will include measures of cognitive function, hippocampal volume, brain-derived neurotrophic factor expression, sleep parameters, cardiovascular risk parameters, suicidal behavior, functionality, and treatment costs.DiscussionThis study was selected in the call of public policy programs for the Brazilian Unified National Health System - "PPSUS 2015". To our knowledge, this is the first pragmatic trial to test the effect of adding AEMC to the pharmacological treatment of patients with depression and to evaluate the possible reductions in depression symptoms and healthcare costs.Trial registrationBrazilian Clinical Trials Registry (ReBec) - RBR-9zgxzd - Registered on 4 Jan. 2017.

Project description:Objective: We assessed the efficacy, safety, and tolerability of cannabidivarin (CBDV) as add-on therapy in adults with inadequately controlled focal seizures. Materials and Methods: One hundred and sixty-two participants (CBDV n=81; placebo n=81) were enrolled. After a 4-week baseline, participants titrated from 400 to 800 mg CBDV twice daily (b.i.d.) (or placebo) over 2 weeks, followed by 6 weeks stable dosing (at 800 mg b.i.d.) and a 12-day taper period. The primary endpoint was the change from baseline in focal seizure frequency during the 8-week treatment period. Secondary endpoints included additional efficacy measures relating to seizures, physician- and participant-reported outcomes, change in the use of rescue medication, cognitive assessments, and safety. Results: Median baseline focal seizure frequencies were 17-18 per 28 days in both groups, and similar reductions in frequency were observed in the CBDV (40.5%) and placebo (37.7%) groups during the treatment period (treatment ratio [% reduction] CBDV/placebo: 0.95 [4.6]; confidence interval: 0.78-1.17 [-16.7 to 21.9]; p=0.648). There were no differences between the CBDV and placebo groups for any seizure subtype. There were no significant treatment differences between CBDV and placebo groups for any of the secondary efficacy outcome measures. Overall, 59 (72.8%) of participants in the CBDV group and 39 (48.1%) in the placebo group had ≥1 treatment-emergent adverse event (AE); the 3 most common were diarrhea, nausea, and somnolence. The incidence of serious AEs was low (3.7% in the CBDV group vs. 1.2% in the placebo group). There was little or no effect of CBDV on vital signs, physical examination, or electrocardiogram findings. Elevations in serum transaminases (alanine aminotransferase or aspartate aminotransferase) to levels >3×upper limit of normal occurred in three participants taking CBDV (two discontinued as a result) and one taking placebo; however, none met the criteria for potential Hy's Law cases. Conclusion: It is likely the 40.5% seizure reduction with CBDV represents an appropriate pharmacological response in this population with focal seizures. The placebo response was, however, high, which may reflect the participants' expectations of CBDV, and a treatment difference from placebo was not observed. CBDV was generally well tolerated. Clinical Trial Registration number: NCT02365610.

Project description:INTRODUCTION:Cutaneous warts are common skin lesions, caused by human papillomavirus. For years, liquid nitrogen is the cryogen of choice for wart treatment. Alternatively, several cryogenic devices for home treatment are commercially available. The present trial assessed efficacy and safety of a novel nitrous oxide-based cryogenic device for home use (EndWarts Freeze® in Europe, Compound W® Nitro-Freeze in the USA). METHODS:This investigator-blinded, controlled, randomized study compared the nitrous oxide device (test product) with a dimethylether propane-based product (Wartner®; comparator 1). Subjects with common or plantar warts (50/50 ratio) were randomized into two groups (n = 58, test product; n = 40, comparator 1). Sequentially, an extra treatment arm (n = 40) was added to compare with a dimethylether-based product with metal nib (Wortie®; comparator 2). Main objective implied comparison of the percentage cured subjects after one to maximum three treatments. Efficacy and safety was evaluated by a blinded investigator. RESULTS:After a maximum of three applications, a significantly (p = 0.001) higher cure rate of 70.7% (Intention-to-Treat analysis) was observed with test product versus 46.2% (comparator 1) and 47.5% (comparator 2). Almost three times more subjects were cured after 1 test product application (29.3%), versus comparator 1 (10.4%) and comparator 2 (12.5%). Reported side effects were transient and typical of cryotherapy. All treatments were well-tolerated. CONCLUSION:The superior cure rates for the test product versus two comparators can be explained by its design. Combination of nitrous oxide (cooling agent), the specific activation method (holding the liquid coolant in the cap), and skin-conforming polyurethane foam, results in higher cooling efficiency (- 80 °C) and more effective wart freezing. This trial demonstrated that the nitrous oxide device is a safe, user-friendly and effective wart treatment for home use, comparing favourably to dimethylether (propane) devices with higher freezing temperature, regardless of the applicator type. FUNDING:Oystershell Laboratories. TRIAL REGISTRATION:Clinicaltrials.gov identifier, NCT03129373.

Dataset Information

Efficacy of the Whole-Body Cryotherapy as Add-on Therapy to Pharmacological Treatment of Depression-A Randomized Controlled Trial.

Publications

Efficacy of the Whole-Body Cryotherapy as Add-on Therapy to Pharmacological Treatment of Depression-A Randomized Controlled Trial.

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