Posts Tagged Safety

[Review] Complementary therapies for clinical depression: an overview of systematic reviews – Full Text

Abstract

Objectives

As clinical practice guidelines vary widely in their search strategies and recommendations of complementary and alternative medicine (CAM) for depression, this overview aimed at systematically summarising the level 1 evidence on CAM for patients with a clinical diagnosis of depression.

Methods

PubMed, PsycInfo and Central were searched for meta-analyses of randomised controlled clinical trials (RCTs) until 30 June 2018. Outcomes included depression severity, response, remission, relapse and adverse events. The quality of evidence was assessed according to Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) considering the methodological quality of the RCTs and meta-analyses, inconsistency, indirectness, imprecision of the evidence and the potential risk of publication bias.

Results

The literature search revealed 26 meta-analyses conducted between 2002 and 2018 on 1–49 RCTs in major, minor and seasonal depression. In patients with mild to moderate major depression, moderate quality evidence suggested the efficacy of St. John’s wort towards placebo and its comparative effectiveness towards standard antidepressants for the treatment for depression severity and response rates, while St. John’s wort caused significant less adverse events. In patients with recurrent major depression, moderate quality evidence showed that mindfulness-based cognitive therapy was superior to standard antidepressant drug treatment for the prevention of depression relapse. Other CAM evidence was considered as having low or very low quality.

Conclusions

The effects of all but two CAM treatments found in studies on clinical depressed patients based on low to very low quality of evidence. The evidence has to be downgraded mostly due to avoidable methodological flaws of both the original RCTs and meta-analyses not following the Consolidated Standards of Reporting Trials and Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Further research is needed.

Strengths and limitations of this study

  • This systematic overview included the comprehensive literature search of important complementary and alternative medicine topics defined by the Cochrane Collaboration.
  • The inclusion criteria were restricted to meta-analyses of randomised controlled clinical trials (RCTs) of patients with a clinical diagnosis of depression.
  • The quality of evidence from meta-analyses was assessed according to Grades of Recommendation, Assessment, Development, and Evaluation.
  • There is a possible lack of evidence of newer RCTs, which have not been analysed by the included meta-analyses.

Introduction

Depression is one of the most prevalent psychiatric disorders, with about 25% of women and 12% of men suffering from at least one depressive episode during their lifetime.1–3 According to the criteria for diagnosis recommended by the American Psychiatric Association (APA), depressive disorders can be distinguished by their degree of severity or duration and are also characterised by a high comorbidity and an increase of psychological strain for the affected person.4 It is evident that a strong comorbid connection to several chronic conditions like addictions,5 neurodegenerative diseases6 7 or different psychiatric diseases8–11 exists. This leads depressive disorders as one of the leading causes of disability worldwide.12

The most commonly used treatments for depression are antidepressants, psychotherapy or a combination of drugs and psychotherapy. While both treatment strategies (alone and in combination) have been shown to be effective,13–15 more recent meta-analyses also found high dropout and low remission rates16–21 as well as clinically significant differences between antidepressant drugs and placebos only for patients at the upper end of the very severely depressed category.22 This may lead patients to search for alternatives. Increasing mainstream use of complementary and alternative medicine (CAM) support this trend, particularly for different physical conditions with comorbid affective disorders.23–27 The NIH defines CAM as therapeutic approaches that are usually not included in conventional Western medicine systems.28 CAM therapies used in combination with conventional care are considered as complementary, those used instead of conventional care as alternative practices. Types of CAM approaches include natural products, such as herbs and dietary supplements (vitamins, minerals and probiotics) and mind and body practices, such as yoga, chiropractic and osteopathic manipulation, meditation, relaxation, acupuncture, tai chi, qi gong and hypnotherapy. Practices of traditional healers from Europe (naturopathy and homeopathy), Asia (Ayurveda and traditional Chinese medicine) and other continents are also classified as CAM.28 While some complementary therapies have become a promising adjunct in the standard treatment of depression,29 30 others are known for their possible side effects or interactions with standard drugs.30 Recent clinical practice guidelines, in addition, vary widely in their search strategies and resulting recommendations for CAM treatments. While the American College of Physicians (ACP),31 the American Psychiatric Association (APA)32 and the Canadian Network for Mood and Anxiety Treatments (CANMAT) guideline33 provide a more comprehensive overview and critical appraisal of CAM treatments, the Deutsche Gesellschaft für Psychiatrie und Psychotherapie, Psychosomatik und Nervenheilkunde (DGPPN),34 the National Institute for Health and Care Excellence (NICE),35 and the World Federation of Societies of Biological Psychiatry (WFSBP)36 guidelines mainly focus on St. John’s Wort and light therapy. Possible effects and risks of further CAM therapies are not discussed. Thus, the purpose of this overview is to provide a comprehensive search strategy of relevant CAM terms and systematically summarise the existing level 1 evidence for clinical depression as a basis for further guideline recommendations on the efficacy, effectiveness and safety of CAM therapies.[…]

Continue —-> https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6686993/

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[Guide] Using technology to provide quality remote services – PDF file

Abstract: During the COVID-19 pandemic, employment and day service providers are finding new ways to provide support to people with disabilities. Technology has become an essential tool in doing so. However, before providing remote supports, direct support professionals need to know what the technology options are for each person and develop a plan to provide services remotely. This brief focuses on the various options and technology for delivery of services remotely, and considerations in doing so. Topics covered include access to technology, use of technology, security and safety considerations, family and guardian issues. At the end of the brief are a series of resources that can be helpful in addressing technology related issues.

Get this Document: https://covid19.communityinclusion.org/pdf/TO36_COVID_F.pdf

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[ARTICLE] A protocol of systematic review and meta-analysis of acupuncture for drug resistant epilepsy – Full Text

Abstract

Background:

This study aims to appraise the effectiveness and safety of acupuncture for drug resistant epilepsy (DRE).

Methods:

We will search all potential randomized controlled trials (RCTs) of acupuncture for patients with DRE from their origin to March 1, 2020: MEDLINE, EMBASE, Cochrane Library, CINAHL, Scopus, WANGFANG, and Chinese Biomedical Literature Database. We will not apply any restrictions to the language and publication date. All RCTs investigating the effectiveness and safety of acupuncture for patients with DRE will be included. Study quality will be appraised by Cochrane risk of bias, and statistical analysis will be scrutinized by RevMan 5.3 software. Whenever possible, a narrative summary to describe study quality and content of the evidence will be performed.

Results:

This study will provide summarize high quality evidence and will utilize a variety of outcome measurements to verify effectiveness and safety of acupuncture for DRE.

Conclusion:

The results of this study will seek to explore the effectiveness and safety of acupuncture for DRE.

1 Introduction

Epilepsy is a chronic neurological disease that is caused by a variety of factors.[1,2] It is characterized by recurrent, episodic and temporary neurological function impairments because of the excessive discharge of brain neurons.[3] Epidemiological studies reported the prevalence rate of epilepsy is about 1%.[4] Despite numerous antiepileptic drugs are available for the management of epilepsy, there are more than 30% patients progressing to drug-resistant epilepsy (DRE),[5] which causes increasing morbidity and mortality.[6–8]

Acupuncture has been utilized in treating a variety of disorders, such as pain, allergic rhinitis, post-stroke spastic hemiplegia, fertilization, cardiac arrhythmia, migraine, perimenopausal depressive disorder, overactive bladder, uterine fibroids, urinary incontinence, hiccups, and epilepsy.[9–31] Although published systematic reviews assessed the effectiveness and safety of acupuncture for the treatment of patients with epilepsy,[27,30] no study has specifically addressed its efficacy and safety for the treatment of patients with DRE. In addition, an increasing number of clinical trials focus on acupuncture in treating DRE.[32–46] Thus, this systematic review will specifically investigate the effectiveness and safety of acupuncture in treating DRE.

[…]

 

Continue —-> A protocol of systematic review and meta-analysis of acupunc… : Medicine

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[ARTICLE] A new lower limb portable exoskeleton for gait assistance in neurological patients: a proof of concept study – Full Text

Abstract

Background

Few portable exoskeletons following the assist-as-needed concept have been developed for patients with neurological disorders. Thus, the main objectives of this proof-of-concept study were 1) to explore the safety and feasibility of an exoskeleton for gait rehabilitation in stroke and multiple sclerosis patients, 2) to test different algorithms for gait assistance and measure the resulting gait changes and 3) to evaluate the user’s perception of the device.

Methods

A cross-sectional study was conducted. Five patients were recruited (4 patients with stroke and 1 with multiple sclerosis). A robotic, one-degree-of-freedom, portable lower limb exoskeleton known as the Marsi Active Knee (MAK) was designed. Three control modes (the Zero Force Control mode, Mode 1 and Mode 3) were implemented. Spatiotemporal gait parameters were measured by the 10-m walking test (10MWT), the Gait Assessment and Intervention Tool (G.A.I.T.) and Tinetti Performance Oriented Mobility Assessment (gait subscale) before and after the trials. A modified QUEST 2.0 questionnaire was administered to determine each participant’s opinion about the exoskeleton. The data acquired by the MAK sensors were normalized to a gait cycle, and adverse effects were recorded.

Results

The MAK exoskeleton was used successfully without any adverse effects. Better outcomes were obtained in the 10MWT and G.A.I.T. when Mode 3 was applied compared with not wearing the device at all. In 2 participants, Mode 3 worsened the results. Additionally, Mode 3 seemed to improve the 10MWT and G.A.I.T. outcomes to a greater extent than Mode 1. The overall score for the user perception of the device was 2.8 ± 0.4 95% CI.

Conclusions

The MAK exoskeleton seems to afford positive preliminary results regarding safety, feasibility, and user acceptance. The efficacy of the MAK should be studied in future studies, and more advanced improvements in safety must be implemented.

Background

In 2015, neurological disorders accounted for 16.8% of the total deaths worldwide and 10.2% of the global disability-adjusted life-years (DALYs) [1]. These numbers have increased since 1990 due to growing size of the population and aging, and they are expected to continue to increase. By 2030, it is estimated that the population affected by neurological diseases will include as many as 1.136 million people [2]. In Spain, between 6.7–7.5 million people are affected by neurological diseases [3]. The total direct and indirect cost related to neurological diseases was 10.9 million euros in 2004 in this country [34].

Neurological diseases cause functional disturbances, including gait disabilities, that affect patients’ ability to perform activities of daily living [1]. Between 50 and 60% of patients with stroke still have some degree of motor impairment after a conventional rehabilitation period [5]. In multiple sclerosis (MS) patients, gait impairment is a major contributor to social, personal and economic burdens [6]. Thus, gait impairment is one of the main problems in patients with stroke or MS [78].

Due to the extent that gait impairment affects patients, gait rehabilitation is considered a key aspect of physical rehabilitation [9,10,11,12,13,14]. Currently, there is a growing interest in determining which characteristics of training should be involve in gait rehabilitation, as therapies are currently based on repetitive and intensive training and functional and feedback-based interventions [15,16,17]. These characteristics are aligned with the use of exoskeletons in gait rehabilitation. In recent years, this technology has been widely used in stroke and MS studies [18,19,20,21,22,23,24].

To the best of our knowledge, few portable exoskeletons that are lightweight and have the capability to execute or modify gait assistance algorithms have been developed, and a high degree of customization can be allowed by following the assist-as-needed concept [25] for gait assistance in stroke and MS patients. The exoskeleton evaluated in this study is a single-limb exoskeleton with actuation at the knee level (Fig. 1). Thus, the main objectives of this study were 1) to explore the safety and feasibility of the exoskeleton developed by the research team for gait rehabilitation in stroke and MS patients as a proof of concept, 2) to test different algorithms for gait assistance and measure the resulting gait changes and 3) to evaluate the user’s perception of the device.

figure1

Fig. 1 Marsi Active Knee (MAK) exoskeleton, by Marsi Bionics

 

[…]

Continue —-> A new lower limb portable exoskeleton for gait assistance in neurological patients: a proof of concept study | Journal of NeuroEngineering and Rehabilitation | Full Text

 

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[ARTICLE] Adaptive Treadmill-Assisted Virtual Reality-Based Gait Rehabilitation for Post-Stroke Physical Reconditioning—a Feasibility Study in Low-Resource Settings – Full Text

Abstract

Objectives: Individuals with chronic stroke suffer from heterogeneous functional limitations, including cardiovascular dysfunction and gait disorders (associated with increased energy expenditure) besides psychological factors, e.g., motivation. To recondition their cardiovascular endurance and gait, rehabilitation exercises with gradually increasing exercise intensity suiting their individualized capabilities need to be offered. In principal accordance, here we (i) implemented an adaptive Virtual Reality (VR)-based treadmill-assisted platform sensitive to energy expenditure, (ii) investigated its safety and feasibility of use and (iii) examined the implications of gait exercise with this platform on cardiac and gait performance along with energy expenditure, clinical measures (to estimate physical reconditioning of subjects with stroke) and their views on community ambulation capabilities. Methods: Ten able-bodied subjects volunteered in a study to ensure its safety and feasibility of use. Nine subjects with chronic stroke underwent physical reconditioning over multiple exposures using our platform. We investigated the patients’ cardiac and gait performance prior and post exposure to our platform along with studying the clinical relevance of gait parameters in estimating their physical reconditioning. We collected the patients’ feedback. Results: We found statistical improvement in the gait parameters and reduction in energy expenditure during overground walk following ~1 month of gait exercise with our platform. They reported that the VR-based tasks were motivating. Conclusion: Results show that this platform can pave the way towards implementing home-based individualized exercise platform that can monitor one’s cardiac and gait performance capabilities while offering an adaptive and progressive gait exercise environment within safety thresholds suiting one’s exercise capabilities.

Physiological Cost Index sensitive Adaptive Response Technology (PCI-ART) for post-stroke physical reconditioning. Note: PCI- Physiological Cost Index; SST-Single Support Time; AL- Affected limb; UAL- Unaffected limb.

Physiological Cost Index sensitive Adaptive Response Technology (PCI-ART) for post-stroke physical reconditioning. Note: PCI- Physiological Cost Index; SST-Single Support Time; AL- Affected limb; UAL- Unaffected limb. 

SECTION I.

Introduction

Neurological disorders, such as stroke is a leading cause of disability with a prevalence rate of 424 in 100,000 individuals in India [1]. Often, these patients suffer from functional disabilities, heterogeneous physical deconditioning along with deteriorated cardiac functioning [2], [3] and a sedentary lifestyle immediately following stroke [4]. A deconditioned patient requires reconditioning of his/her cardiac capacity and ambulation capabilities that can be achieved through individualized rehabilitation [5]. This needs to be done under the supervision of a clinician who can monitor one’s functional capability, cardiac capacity and gait performance thereby recommending an appropriate dosage of the gait rehabilitation exercise intensity to the patient along with feedback. Such gait rehabilitation is crucial since about 80% of these patients have been reported to suffer from gait-related disorders [6] along with more energy expenditure than able-bodied individuals [7] often accompanied with reduced cardiac capacity [2], [4]. However, given the low doctor-to-patient ratio [8], lack of rehabilitation facilities and patients being released early from rehabilitation clinics followed by home-based exercise [9], particularly in developing countries like India, availing individualized rehabilitation services becomes difficult. Again, undergoing home-based exercises under clinician’s one-on-one supervision becomes difficult given the restricted healthcare resources, thereby limiting the rehabilitation outcomes [10]. Again, given the restricted healthcare resources, getting a clinician visiting the homes for delivering therapy sessions to patients is often costly causing the patients to miss the expert inputs on the exercise intensity suiting his/her exercise capability along with motivational feedback from the clinician [11]. This necessitates the use of a complementary technology-assisted rehabilitation platform that can be availed by the patient at his/her home [12] following a short stay at the rehabilitation clinic [13]. Again, it is preferred that this platform be capable of offering individualized gait exercise while varying the dosage of exercise intensity (based on the patient’s exercise capability) along with motivational feedback [14]. Additionally, exercise administered by this platform can be complemented with intermediate clinician-mediated assessments of rehabilitation outcomes, thereby reducing continuous demands on the restricted clinical resources. Thus, it is important to investigate the use of such technology-assisted gait exercise platforms that are capable of offering exercise based on one’s individualized capability along with motivational feedback.

Researchers have explored the use of technology-assisted solutions to offer rehabilitative gait exercises to these patients, along with presenting motivational feedback [15]–[16][17][18][19][20][21][22][23][24]. Specifically, investigators have used Virtual Reality (VR) coupled with a treadmill (having a limited footprint and making it suitable for home-based settings) while delivering individualized feedback [15] to the patient during exercise. Again, VR can help to project scenarios that can make the exercise engaging and interactive for a user [16]–[17][18][19]. In fact, Finley et al. have shown that the visual feedback offered by VR provides an optical flow that can induce changes in the gait performance (quantified in terms of gait parameters, e.g., Step Length, Step Symmetry, etc.) of such patients during treadmill-assisted walk [20]. Further, Jaffe et al. have reported positive implications of VR-based treadmill-assisted walking exercise on the gait performance of individuals with stroke [23], leading to improvement in their community ambulation [24]. These studies have shown the efficacy of the VR-based treadmill-assisted gait exercise platform to contribute towards gait rehabilitation of individuals suffering from stroke. Though promising, none of these platforms are sensitive to one’s individualized exercise capability and thus, in turn, could not decide an optimum dosage of exercise intensity suiting one’s capability, e.g., cardiac capacity and ambulation capability. This is particularly critical for individuals with stroke since they possess diminished exercise ability along with deteriorated cardiac functioning [2], [4].

From literature review, we find that after stroke, treadmill-assisted cardiac exercise programs can lead to one’s improved fitness and exercise capability [25]. For example, researchers have presented studies on Moderate-Intensity Continuous Exercise and High-Intensity Interval Training in which exercise protocols are individualized by a clinician based on one’s cardiac capacity while contributing to effective gait rehabilitation [26]–[27][28][29]. Though promising, these have not offered a progressive and adaptive exercise environment in which the dosage of exercise intensity is varied based on one’s cardiac capacity in real-time. Thus, the choice of optimum dosage of exercise intensity that can be individualized in real-time for a patient, still remains as inadequately explored [4]. For deciding the optimal dosage of rehabilitative exercise intensity, clinicians often refer to the guidelines recommended by the American College of Sports Medicine (ACSM) [30]. These guidelines suggest thresholds to decide the intensity of the exercise based on one’s metabolic energy consumption in terms of oxygen intake, heart rate, etc. Deciding the dosage of exercise intensity is crucial, particularly for individuals with stroke since their energy requirements have been reported to be 55-100% higher than that of their able-bodied counterparts [7]. Specifically, higher energy requirement often limits the capabilities of these patients and challenges their rehabilitation outcomes. This can be addressed if the technology-assisted gait exercise platform can offer individualized exercise (maintaining the safe exercise thresholds) based on the energy expenditure of the patients acquired in real-time during the exercise.

The energy expenditure can be defined as the cost of physical activity [4] and it is often expressed in terms of oxygen consumption or heart rate [31]. Thus, investigators have monitored the oxygen consumption and heart rate to estimate the energy expenditure of individuals with stroke during their walk [31], [32]. However, monitoring oxygen consumption during exercise requires a cumbersome setup [31], making it unsuitable for home-based rehabilitation. On the other hand, one’s heart rate (HR) can be monitored using portable solutions [33] that can be integrated with a treadmill in home-based settings. Researchers have explored treadmill-assisted gait exercise platforms that are sensitive to the user’s heart rate. For example, researchers have offered treadmill training to subjects with stroke in which some of them varied treadmill speed to achieve 45%-50% [34], while others varied speed to achieve 85% to 95% [35], [36] of one’s age-related maximum heart rate. Again, Pohl et al. have offered treadmill-assisted exercise to subjects with stroke while ensuring that the user’s heart rate settled to the respective resting-state heart rate [37]. Again of late, there had been advanced treadmills, available off-the-shelf, that can monitor one’s heart rate and vary the treadmill speed to maintain the user’s heart rate at a predefined level [38], [39]. Though one’s heart rate is an important indicator that needs to be considered during treadmill-assisted exercise, one’s walking speed while using the treadmill also offers important information on one’s exercise capability. This is because gait rehabilitation aims to improve one’s community ambulation that is related to one’s walking speed [40]. Thus, it would be interesting to explore the composite effect of one’s walking speed along with working and resting-state heart rates during treadmill-assisted gait exercise to study one’s energy expenditure, quantified in terms of a proxy index, namely Physiological Cost Index (PCI) [31].

Given that there are no existing studies that have used a treadmill-assisted gait exercise platform deciding the dosage of exercise intensity based on one’s PCI estimated in real-time during exercise, it might be interesting to explore the use of such an individualized gait exercise platform for individuals with stroke. Thus, we wanted to extend a treadmill-assisted gait exercise platform by making it adaptive to one’s individualized PCI. Additionally, we wanted to augment this platform with VR-based user interface to offer visual feedback to the user undergoing gait exercise. We hypothesized that such a gait exercise platform can recondition a patient’s exercise capability in terms of cardiac and gait performance to achieve improved community ambulation. The objectives of our research were three-fold, namely to (i) implement a novel PCI-sensitive Adaptive Response Technology (PCI-ART) offering VR-based treadmill-assisted gait exercise, (ii) investigate the safety and feasibility of use of this platform among able-bodied individuals before applying it to subjects with stroke and (iii) examine implications of undergoing gait exercise with this platform on the patients’ (a) cardiac and gait performance along with energy expenditure, (b) clinical measures estimating the physical reconditioning and (c) views on their community ambulation capabilities.

The rest of the paper is organized as follows: Section II presents our system design. Section III explains the experiments and procedures of this study. Section IV discusses the results. In Section V, we summarize our findings, limitations, and scope of future research.[…]

Continue —-> Adaptive Treadmill-Assisted Virtual Reality-Based Gait Rehabilitation for Post-Stroke Physical Reconditioning—a Feasibility Study in Low-Resource Settings – IEEE Journals & Magazine

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[WEB SITE] Is Stem Cell Therapy Effective?

Is stem cell therapy safe and effective?

Find out if the therapy is beneficial for a specific disease,
how and why it works and what the treatment involves

This article is written by Eremin Ilya – Vice Director for Science and Research at Swiss Medica clinic.

Swiss Medica specializes in the most cutting edge stem cell therapies for 8 years. Their head office is based in Switzerland and they have treatment centers in Russia, Moscow and Serbia, Belgrade.
As a result, patients have seen a halt in the progression and/or symptoms of a vast array of diseases, such as arthritis, diabetes, multiple sclerosis, autism, Parkinson’s and other hard to treat diseases.

What are stem cells?
Stem cells are the unique types of cells that are able to replicate itself and to launch the regeneration processes. Stem cells are circulating into the body and looking for damaged areas to repair them. They are also able to put out the inflammation.

This helps to eliminate the cause of the disorders, to reduce its symptoms or even to get a full recovery, depends on the initial condition. And the most important, stem cell treatment is a gentle way of healing that is safe and side-effect free in most cases.

When you undergo cell-based treatment, you get 100+ million viable stem cells in one dose. Cells are harvested from the patient’s body and then cultivated to this quantity. Donated stem cells can be also used for immediate treatment.

Not for all cases, but there is a high percentage of getting health improvements that can be reached in variety diseases.

 

What are the expected results?
Using stem cells in therapy helps to reduce symptoms and can even stop or reverse the progression of some diseases, mostly autoimmune and/or diseases associated with tissue damage. These types of cells trigger the healing process and help to:

– relieve inflammation;
– reduce pain;
– repair wounds and damaged tissues;
– stimulate the formation of neurons and new blood vessels;
– restore lost functions;
– eliminate the signs of aging.

Depending on the patient’s condition, we use cell products based on autologous (patient’s own) or donor cells. Activated stem cells can be administered in several ways, depending on the purpose of the therapy, the disease, and the patient’s condition (IV, intrathecal, intramuscular, retrobulbar or local injection).

 

It is important to understand that stem cells are not a guaranteed cure for every disease.The patient may be denied stem cell procedures for various reasons. The effectiveness of the therapy for a particular disease depends on multiple factors: duration of the illness, age of the patient, the existence of chronic conditions, hereditary predisposition, lifestyle, etc.

Applying only stem cells for some cases may be not enough. Cell therapy works more effectively when combined with other therapeutic methods that help decrease inflammation, restore mobility, activate the tissue repair process

 

How do stem cells work?
The main therapeutic effect of stem cells is their ability to produce cytokines and growth factors in the intercellular space. These special chemicals are able to activate the regenerative functions of distant cells and promote tissue recovery. This mechanism is called paracrine regulation.

Cytokines help block the signals of inflammation in various diseases, including autoimmune processes [1]. An important feature of these signal molecules is that their concentrations may be regulated by inflammation and may be strictly limited by the stage of tissue regeneration. We can boost the production of cytokines using cell products based on stromal cells, leading to improved function of the damaged tissue.

When stem cells are introduced into a patient’s body during therapy, they circulate in the blood system until they are attracted to proteins secreted around inflamed or damaged tissue. Stem cells then rush to that injured area and start producing:
– various growth factors (promoting tissue recovery);
– chemokines (helping cells to migrate);
– adhesion molecules (regulating cell interactions at the molecular level).

How the procedure is carried out?
First, the patient undergoes a full examination to determine the current state of health. Then specialist makes a conclusion about the appropriateness and expected effects of therapy.
Next, the question is whether self-sourced or donor stem cells will be used. In the first case, the biopsy is performed and stromal cells are isolated from the patient’s own biomaterial. Then the harvested cells are cultivated to the required volume. Usually, this takes 3-4 weeks depending on the proliferative potential of the MMSCs. After that, the cultivated cells can be used for therapy or stored in a cryobank for an unlimited period of time. In the case of donor cells, the cell product can be used immediately in the initial treatment.

The use of cell products is carried out under medical supervision. The volume of cell mass required for treatment is calculated depending on the patient’s body weight. Before use, a test for sterility and infectious/bacteriological safety is carried out. Then a passport of the cell product is drawn up. This passport indicates the name of the cell product, the source of cells, date of extraction, cells characteristics, description of final product formulation, etc.

When the cell product is ready for use, it can be administered in several ways, depending on the purpose of therapy, the disease, and the patient’s condition:

  • IV drip;
  • Intramuscularly;
  • Intrathecal (spinal tap);
  • Retrobulbar (in the eye area);
  • Locally (cutaneous covering, joint, cavernous bodies of the penis, etc.).

What are the indications, contraindications and side effects?

Treatment with cell products is usually appealed in cases where the standard therapy of the underlying disease is not adequately effective or is associated with complications.

Before therapy, it is necessary to exclude contraindications for cell treatment, including:
– Previous bad experience with cell products;
– Any acute infectious disease;
– Cancer or a precancerous condition;
– Stroke or transient ischemic attack in the last 3 months;
– Deviations of some indicators in blood tests;
– Mental disorders and addictions;
– Contraindications to anesthesia and/or high risk of bleeding and/or pathological processes in the area of the proposed biopsy (does not exclude the possibility of using donor cell products);
– Pregnancy and lactation, and some others.

Along with the expected improvements in cell therapy, unwanted side effects are rare and include allergic and pyrogenic posttransfusion reactions (short-term fever), which are both easily managed.

In a majority of cases, it is possible to decline the manifestations of the disease, weaken pain symptoms, and correct the function that was affected. The therapies generally improve the standard of living.

Safety of stem cell therapy
The procedures are usually well tolerated in the majority of patients. Clinical trial results confirmed the safety of local injections and treatment with MMSCs from the perspective of tumor formation after a follow-up period [6]. Individual intolerance (short-term fever), while rare, cannot be excluded. Swiss Medica specialists will monitor your condition for safer and more beneficial results. [2], [3].
When it comes to improvement?
It usually takes a few weeks or months until transplanted cells start to fully take effect, although the first improvements can be felt in the days after administration. Often, reduced pain, enhanced mobility of affected joints, improved energy and activity, improved indicators of diagnostic tests can be realized relatively quickly.

Transplanted stem cells are active for 3 months on average, 6 months as a maximum. After this period, the stem cells are no longer active, but the processes started by them continue. A complex effect is possible where not only the manifestations of the underlying disease are reduced, but also the general condition of the patient is improved.

Your doctor may recommend you to seek a second consultation after 3 and/or 6 months after cell introduction in order to assess the effectiveness of the therapy. To achieve a greater and more persistent effect, the therapy can be repeated after a recommended period of time. […]

 

For more visit site —->  Swiss Medica Article – Is Stem Cell Therapy Effective?

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[HelpGuide] Helping Someone with PTSD

Helping a Loved One While Taking Care of Yourself

Women embracingWhen someone you care about suffers from post-traumatic stress disorder (PTSD), it can leave you feeling overwhelmed. The changes in your loved one can worry or even frighten you. You may feel angry about what’s happening to your family and relationship, or hurt by your loved one’s distance and moodiness. But it’s important to know  that you’re not helpless. Your support can make all the difference for your partner, friend, or family member’s recovery. With your help, your loved one can overcome PTSD and move on with their life.

Living with someone who has PTSD

PTSD can take a heavy toll on relationships. It can be hard to understand your loved one’s behavior—why they are less affectionate and more volatile. You may feel like you’re walking on eggshells or living with a stranger. You may have to take on a bigger share of household tasks, deal with the frustration of a loved one who won’t open up, or even deal with anger or disturbing behavior. The symptoms of PTSD can also lead to job loss, substance abuse, and other problems that affect the whole family.

It’s hard not to take the symptoms of PTSD personally, but it’s important to remember that a person with PTSD may not always have control over their behavior. Your loved one’s nervous system is “stuck” in a state of constant alert, making them continually feel vulnerable and unsafe. This can lead to anger, irritability, depression, mistrust, and other PTSD symptoms that your loved one can’t simply choose to turn off. With the right support from friends and family, though, your loved one’s nervous system can become “unstuck” and they can finally move on from the traumatic event.

Helping someone with PTSD tip 1: Provide social support

It’s common for people with PTSD to withdraw from friends and family. While it’s important to respect your loved one’s boundaries, your comfort and support can help the person with PTSD overcome feelings of helplessness, grief, and despair. In fact, trauma experts believe that face-to-face support from others is the most important factor in PTSD recovery.

Knowing how to best demonstrate your love and support for someone with PTSD isn’t always easy. You can’t force your loved one to get better, but you can play a major role in the healing process by simply spending time together.

Don’t pressure your loved one into talking. It can be very difficult for people with PTSD to talk about their traumatic experiences. For some, it can even make them feel worse. Instead, let them know you’re willing to listen when they want to talk, or just hang out when they don’t. Comfort for someone with PTSD comes from feeling engaged and accepted by you, not necessarily from talking.

Do “normal” things with your loved one, things that have nothing to do with PTSD or the traumatic experience. Encourage your loved one to participate in rhythmic exercise, seek out friends, and pursue hobbies that bring pleasure. Take a fitness class together, go dancing, or set a regular lunch date with friends and family.

Let your loved one take the lead, rather than telling him or her what to do. Everyone with PTSD is different but most people instinctively know what makes them feel calm and safe. Take cues from your loved one as to how you can best provide support and companionship.

Manage your own stress. The more calm, relaxed, and focused you are, the better you’ll be able to help your loved one.

Be patient. Recovery is a process that takes time and often involves setbacks. The important thing is to stay positive and maintain support for your loved one.

Educate yourself about PTSD. The more you know about the symptoms, effects, and treatment options, the better equipped you’ll be to help your loved one, understand what they are going through, and keep things in perspective.

Accept (and expect) mixed feelings. As you go through the emotional wringer, be prepared for a complicated mix of feelings—some of which you’ll never want to admit. Just remember, having negative feelings toward your family member doesn’t mean you don’t love them.

Tip 2: Be a good listener

While you shouldn’t push a person with PTSD to talk, if they do choose to share, try to listen without expectations or judgments. Make it clear that you’re interested and that you care, but don’t worry about giving advice. It’s the act of listening attentively that is helpful to your loved one, not what you say.

A person with PTSD may need to talk about the traumatic event over and over again. This is part of the healing process, so avoid the temptation to tell your loved one to stop rehashing the past and move on.

Some of the things your loved one tells you might be very hard to listen to, but it’s important to respect their feelings and reactions. If you come across as disapproving or judgmental, they are unlikely to open up to you again.

Communication pitfalls to avoid

Don’t…

  • Give easy answers or blithely tell your loved one everything is going to be okay
  • Stop your loved one from talking about their feelings or fears
  • Offer unsolicited advice or tell your loved one what they “should” do
  • Blame all of your relationship or family problems on your loved one’s PTSD
  • Invalidate, minimize, or deny your loved one’s traumatic experience
  • Give ultimatums or make threats or demands
  • Make your loved one feel weak because they aren’t coping as well as others
  • Tell your loved one they were lucky it wasn’t worse
  • Take over with your own personal experiences or feelings

Tip 3: Rebuild trust and safety

Trauma alters the way a person sees the world, making it seem like a perpetually dangerous and frightening place. It also damages people’s ability to trust others and themselves. If there’s any way you can rebuild your loved one’s sense of security, it will contribute to their recovery.

Express your commitment to the relationship. Let your loved one know that you’re here for the long haul so they feel loved and supported.

Create routines. Structure and predictable schedules can restore a sense of stability and security to people with PTSD, both adults and children. Creating routines could involve getting your loved one to help with groceries or housework, for example, maintaining regular times for meals, or simply “being there” for the person.

Minimize stress at home. Try to make sure your loved one has space and time for rest and relaxation.

Speak of the future and make plans. This can help counteract the common feeling among people with PTSD that their future is limited.

Keep your promises. Help rebuild trust by showing that you’re trustworthy. Be consistent and follow through on what you say you’re going to do.

Emphasize your loved one’s strengths. Tell your loved one you believe they’re capable of recovery and point out all of their positive qualities and successes.

Encourage your loved one to join a support group. Getting involved with others who have gone through similar traumatic experiences can help some people with PTSD feel less damaged and alone.

Tip 4: Anticipate and manage triggers

A trigger is anything—a person, place, thing, or situation—that reminds your loved one of the trauma and sets off a PTSD symptom, such as a flashback. Sometimes, triggers are obvious. For example, a military veteran might be triggered by seeing his combat buddies or by the loud noises that sound like gunfire. Others may take some time to identify and understand, such as hearing a song that was playing when the traumatic event happened, for example, so now that song or even others in the same musical genre are triggers. Similarly, triggers don’t have to be external. Internal feelings and sensations can also trigger PTSD symptoms.

Common external PTSD triggers

  • Sights, sounds, or smells associated with the trauma
  • People, locations, or things that recall the trauma
  • Significant dates or times, such as anniversaries or a specific time of day
  • Nature (certain types of weather, seasons, etc.)
  • Conversations or media coverage about trauma or negative news events
  • Situations that feel confining (stuck in traffic, at the doctor’s office, in a crowd)
  • Relationship, family, school, work, or money pressures or arguments
  • Funerals, hospitals, or medical treatment

Common internal PTSD triggers

  • Physical discomfort, such as hunger, thirst, fatigue, sickness, and sexual frustration
  • Any bodily sensation that recalls the trauma, including pain, old wounds and scars, or a similar injury
  • Strong emotions, especially feeling helpless, out of control, or trapped
  • Feelings toward family members, including mixed feelings of love, vulnerability, and resentment

Talking to your loved one about PTSD triggers

Ask your loved one about how they may have coped with triggers in the past in response to an action that seemed to help (as well as those that didn’t). Then you can come up with a joint game plan for how you will respond in future.

Decide with your loved one how you should respond when they have a nightmare, flashback, or panic attack. Having a plan in place will make the situation less scary for both of you. You’ll also be in a much better position to help your loved one calm down.

How to help someone having a flashback or panic attack

During a flashback, people often feel a sense of disassociation, as if they’re detached from their own body. Anything you can do to “ground” them will help.

  • Tell your loved one they’re having a flashback and that even though it feels real, the event is not actually happening again
  • Help remind them of their surroundings (for example, ask them to look around the room and describe out loud what they see)
  • Encourage them to take deep, slow breaths (hyperventilating will increase feelings of panic)
  • Avoid sudden movements or anything that might startle them
  • Ask before you touch them. Touching or putting your arms around the person might make them feel trapped, which can lead to greater agitation and even violence

Tip 5: Deal with volatility and anger

PTSD can lead to difficulties managing emotions and impulses. In your loved one, this may manifest as extreme irritability, moodiness, or explosions of rage.

People suffering from PTSD live in a constant state of physical and emotional stress. Since they usually have trouble sleeping, it means they’re constantly exhausted, on edge, and physically strung out—increasing the likelihood that they’ll overreact to day-to-day stressors. For many people with PTSD, anger can also be a cover for other feelings such as grief, helplessness, or guilt. Anger makes them feel powerful, instead of weak and vulnerable. Others try to suppress their anger until it erupts when you least expect it.

Watch for signs that your loved one is angry, such as clenching jaw or fists, talking louder, or getting agitated. Take steps to defuse the situation as soon as you see the initial warning signs.

Try to remain calm. During an emotional outburst, try your best to stay calm. This will communicate to your loved one that you are “safe,” and prevent the situation from escalating.

Give the person space. Avoid crowding or grabbing the person. This can make a traumatized person feel threatened.

Ask how you can help. For example: “What can I do to help you right now?” You can also suggest a time out or change of scenery.

Put safety first. If the person gets more upset despite your attempts to calm him or her down, leave the house or lock yourself in a room. Call 911 if you fear that your loved one may hurt himself or others.

Help your loved one manage their anger. Anger is a normal, healthy emotion, but when chronic, explosive anger spirals out of control, it can have serious consequences on a person’s relationships, health, and state of mind. Your loved one can get anger under control by exploring the root issues and learning healthier ways to express their feelings.

Tip 6: Take care of yourself

Letting your family member’s PTSD dominate your life while ignoring your own needs is a surefire recipe for burnout and may even lead to secondary traumatization. You can develop your own trauma symptoms from listening to trauma stories or being exposed to disturbing symptoms like flashbacks. The more depleted and overwhelmed you feel, the greater the risk is that you’ll become traumatized.

In order to have the strength to be there for your loved one over the long haul and lower your risk for secondary traumatization, you have to nurture and care for yourself.

Take care of your physical needs: get enough sleep, exercise regularly, eat properly, and look after any medical issues.

Cultivate your own support system. Lean on other family members, trusted friends, your own therapist or support group, or your faith community. Talking about your feelings and what you’re going through can be very cathartic.

Make time for your own life. Don’t give up friends, hobbies, or activities that make you happy. It’s important to have things in your life that you look forward to.

Spread the responsibility. Ask other family members and friends for assistance so you can take a break. You may also want to seek out respite services in your community.

Set boundaries. Be realistic about what you’re capable of giving. Know your limits, communicate them to your family member and others involved, and stick to them.

Support for people taking care of veterans

If the person you’re caring for is a military veteran, financial and caregiving support may be available. In the U.S., visit VA Caregiver Support to explore your options, or call Coaching into Care at (888) 823-7458. For families of military veterans in other countries, see the section below for online resources.

Authors: Melinda Smith, M.A., and Lawrence Robinson. Last updated: June 2019.

via Helping Someone with PTSD – HelpGuide.org

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[Abstract] Efficacy and Safety of High-frequency Repetitive Transcranial Magnetic Stimulation for Post-Stroke Depression:A Systematic Review and Meta-Analysis

Abstract

Objective

To summarize and systematically review the efficacy and safety of high frequency repetitive transcranial magnetic stimulation (HF-rTMS) for depression in stroke patients.

Data Sources

Six databases (Wanfang, CNKI, PubMed, Embase, Cochrane Library, and Web of Science) were searched from inception until November 15, 2018.

Study Selection

Seventeen randomized controlled trials were included for meta-analysis.

Data Extraction

Two independent reviewers selected potentially relevant studies based on the inclusion criteria, extracted data, and evaluated the methodological quality of the eligible trials using the Physiotherapy Evidence Database (PEDro).

Data Synthesis

We calculated the combined effect size (standardized mean difference [SMD] and odds ratio [OR]) for the corresponding effects models. Physiotherapy Evidence Database scores ranged from 7 to 8 points (mean = 7.35). The study results indicated that HF-rTMS had significantly positive effects on depression in stroke patients. The effect sizes of the SMD ranged from small to large (SMD = −1.01; 95% confidence interval [95% CI], −1.36 to −0.66; P < .001; I2 = 85%; n = 1053), and the effect sizes of the OR were large (response rates: 58.43% VS 33.59%; OR = 3.31; 95% CI, 2.25 to 4.88; P < .001; I2 = 0%; n = 529; remission rates: 26.59% VS 12.60%; OR = 2.72; 95% CI, 1.69 to 4.38; P < .001; I2 = 0%; n = 529). In terms of treatment side-effects, the HF-rTMS group was more prone to headache than the control group (OR = 3.53; 95% CI, 1.85 to 8.55; P < .001; I2 = 0%; n = 496).

Conclusions

HF-rTMS is an effective intervention for post-stroke depression, although treatment safety should be further verified via large sample multi-center trials.

via Efficacy and Safety of High-frequency Repetitive Transcranial Magnetic Stimulation for Post-Stroke Depression:A Systematic Review and Meta-Analysis – Archives of Physical Medicine and Rehabilitation

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[Slideshow] Comparing the Safety of Antiepilepsy Drugs in Pregnancy

Comparing the Safety of Antiepilepsy Drugs in Pregnancy

Mar 26, 2018

What are the risks of birth defects and perinatal outcomes for infants exposed to various AEDs in utero?

Source: http://www.neurologytimes.com/slideshows/comparing-safety-antiepilepsy-drugs-pregnancy

 

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