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Endocrinology, Diabetes & Metabolism Jan 2021With increasing numbers of patients with type 2 diabetes mellitus (T2DM) worldwide, the number of associated diabetic foot complications might also increase. This...
AIMS
With increasing numbers of patients with type 2 diabetes mellitus (T2DM) worldwide, the number of associated diabetic foot complications might also increase. This systematic review was performed to summarize published data about risk factors for the diabetic foot (DF) syndrome in order to improve the identification of high-risk patients.
MATERIALS AND METHODS
Six electronic databases were searched for publications up to August 2019 using predefined stringent inclusion and exclusion criteria.
RESULTS
Of 9,476 identified articles, 31 articles from 28 different study populations fulfilled the criteria for our evaluation. The overall quality of the studies was good, and the risk of bias was low. There was large heterogeneity among the studies concerning study protocols and patient populations analysed. A total of 79 risk factors were analysed within this review. The majority of studies described a consistently positive association with different outcomes of interest related to DF for gender, peripheral neuropathy, retinopathy, nephropathy, poor glycaemic control, insulin use, duration of diabetes, smoking and height. For age, hypertension, dyslipidaemia and body mass index, the results remain inconsistent.
CONCLUSION
A most up-to-date literature review resulted in glycaemic control and smoking as the only amenable risk factors with a consistently positive association for DF. Due to the high personal and financial burden associated with DF and the large heterogeneity among included studies, additional longitudinal studies in large patient populations are necessary to identify more modifiable risk factors that can be used in the prediction and prevention of DF complications.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Diabetes Mellitus, Type 2; Diabetic Foot; Female; Glycemic Control; Humans; Male; Middle Aged; Risk Factors; Sex Factors; Smoking; Young Adult
PubMed: 33532615
DOI: 10.1002/edm2.175 -
The Cochrane Database of Systematic... Jan 2017This review is an update of 'Topical capsaicin (high concentration) for chronic neuropathic pain in adults' last updated in Issue 2, 2013. Topical creams with capsaicin... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This review is an update of 'Topical capsaicin (high concentration) for chronic neuropathic pain in adults' last updated in Issue 2, 2013. Topical creams with capsaicin are used to treat peripheral neuropathic pain. Following application to the skin, capsaicin causes enhanced sensitivity, followed by a period with reduced sensitivity and, after repeated applications, persistent desensitisation. High-concentration (8%) capsaicin patches were developed to increase the amount of capsaicin delivered; rapid delivery was thought to improve tolerability because cutaneous nociceptors are 'defunctionalised' quickly. The single application avoids noncompliance. Only the 8% patch formulation of capsaicin is available, with a capsaicin concentration about 100 times greater than conventional creams. High-concentration topical capsaicin is given as a single patch application to the affected part. It must be applied under highly controlled conditions, often following local anaesthetic, due to the initial intense burning sensation it causes. The benefits are expected to last for about 12 weeks, when another application might be made.
OBJECTIVES
To review the evidence from controlled trials on the efficacy and tolerability of topically applied, high-concentration (8%) capsaicin in chronic neuropathic pain in adults.
SEARCH METHODS
For this update, we searched CENTRAL, MEDLINE, Embase, two clinical trials registries, and a pharmaceutical company's website to 10 June 2016.
SELECTION CRITERIA
Randomised, double-blind, placebo-controlled studies of at least 6 weeks' duration, using high-concentration (5% or more) topical capsaicin to treat neuropathic pain.
DATA COLLECTION AND ANALYSIS
Two review authors independently searched for studies, extracted efficacy and adverse event data, and examined issues of study quality and potential bias. Where pooled analysis was possible, we used dichotomous data to calculate risk ratio and numbers needed to treat for one additional event, using standard methods.Efficacy outcomes reflecting long-duration pain relief after a single drug application were from the Patient Global Impression of Change (PGIC) at specific points, usually 8 and 12 weeks. We also assessed average pain scores over weeks 2 to 8 and 2 to 12 and the number of participants with pain intensity reduction of at least 30% or at least 50% over baseline, and information on adverse events and withdrawals.We assessed the quality of the evidence using GRADE and created a 'Summary of findings' table.
MAIN RESULTS
We included eight studies, involving 2488 participants, two more studies and 415 more participants than the previous version of this review. Studies were of generally good methodological quality; we judged only one study at high risk of bias, due to small size. Two studies used a placebo control and six used 0.04% topical capsaicin as an 'active' placebo to help maintain blinding. Efficacy outcomes were inconsistently reported, resulting in analyses for most outcomes being based on less than complete data.For postherpetic neuralgia, we found four studies (1272 participants). At both 8 and 12 weeks about 10% more participants reported themselves much or very much improved with high-concentration capsaicin than with 'active' placebo, with point estimates of numbers needed to treat for an additional beneficial outcome (NNTs) of 8.8 (95% confidence interval (CI) 5.3 to 26) with high-concentration capsaicin and 7.0 (95% CI 4.6 to 15) with 'active' placebo (2 studies, 571 participants; moderate quality evidence). More participants (about 10%) had average 2 to 8-week and 2 to 12-week pain intensity reductions over baseline of at least 30% and at least 50% with capsaicin than control, with NNT values between 10 and 12 (2 to 4 studies, 571 to 1272 participants; very low quality evidence).For painful HIV-neuropathy, we found two studies (801 participants). One study reported the proportion of participants who were much or very much improved at 12 weeks (27% with high-concentration capsaicin and 10% with 'active' placebo). For both studies, more participants (about 10%) had average 2 to 12-week pain intensity reductions over baseline of at least 30% with capsaicin than control, with an NNT of 11 (very low quality evidence).For peripheral diabetic neuropathy, we found one study (369 participants). It reported about 10% more participants who were much or very much improved at 8 and 12 weeks. One small study of 46 participants with persistent pain following inguinal herniorrhaphy did not show a difference between capsaicin and placebo for pain reduction (very low quality evidence).We downgraded the quality of the evidence for efficacy outcomes by one to three levels due to sparse data, imprecision, possible effects of imputation methods, and susceptibility to publication bias.Local adverse events were common, but not consistently reported. Serious adverse events were no more common with active treatment (3.5%) than control (3.2%). Adverse event withdrawals did not differ between groups, but lack of efficacy withdrawals were somewhat more common with control than active treatment, based on small numbers of events (six to eight studies, 21 to 67 events; moderate quality evidence, downgraded due to few events). No deaths were judged to be related to study medication.
AUTHORS' CONCLUSIONS
High-concentration topical capsaicin used to treat postherpetic neuralgia, HIV-neuropathy, and painful diabetic neuropathy generated more participants with moderate or substantial levels of pain relief than control treatment using a much lower concentration of capsaicin. These results should be interpreted with caution as the quality of the evidence was moderate or very low. The additional proportion who benefited over control was not large, but for those who did obtain high levels of pain relief, there were usually additional improvements in sleep, fatigue, depression, and quality of life. High-concentration topical capsaicin is similar in its effects to other therapies for chronic pain.
Topics: Administration, Topical; Adult; Analgesics; Capsaicin; Chronic Pain; Diabetic Neuropathies; HIV Infections; Humans; Neuralgia; Neuralgia, Postherpetic; Numbers Needed To Treat; Ointments; Pain, Postoperative; Randomized Controlled Trials as Topic
PubMed: 28085183
DOI: 10.1002/14651858.CD007393.pub4 -
International Wound Journal May 2022This study aims at evaluating the efficacy and safety of ozone therapy for chronic wounds. The Cochrane Library, PubMed, Ovid Embase, Web of Science, and Chinese...
This study aims at evaluating the efficacy and safety of ozone therapy for chronic wounds. The Cochrane Library, PubMed, Ovid Embase, Web of Science, and Chinese Biomedical Literature Database were searched. Randomised controlled trials (RCTs) about participants with chronic wounds were included. Risk of bias assessment was performed by the Cochrane risk-of-bias tool. A randomised-effects model was applied to pool results according to the types of wounds or ulcers. Among 12 included studies, ozone was implemented by topical application (ozone gas bath, ozonated oil, ozone water flushing) and systematic applications including autologous blood immunomodulation and rectal insufflation. The results indicated compared with standard control therapy for diabetic foot ulcers, ozone therapy regardless of monotherapy or combined control treatment markedly accelerated the improvement of the wound area(standardised mean difference(SMD) = 66.54%, 95% confidence interval (CI) = [46.18,86.90], P < .00001) and reduced the amputation rate (risk ration (RR) = 0.36, 95% CI = [0.24,0.54], P < .00001). But there is no improvement in the proportion of participants with completely healed wounds and length of hospital stay. No adverse events associated with ozone treatment have been reported. And the efficacy of ozone therapy for other wound types is still uncertain because of no sufficient studies. More high-quality randomised controlled trials are needed to confirm the efficacy and safety of ozone therapy for chronic wounds or ulcers.
Topics: Amputation, Surgical; Diabetic Foot; Humans; Ozone; Ulcer; Wound Healing
PubMed: 34612569
DOI: 10.1111/iwj.13687 -
PloS One 2021Cardiac autonomic neuropathy is a common complication of type 2 diabetes mellitus (T2DM), that can be measured through heart rate variability (HRV)-known to be decreased... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Cardiac autonomic neuropathy is a common complication of type 2 diabetes mellitus (T2DM), that can be measured through heart rate variability (HRV)-known to be decreased in T2DM. Physical exercise can improve HRV in healthy population, however results are under debate in T2DM. We conducted a systemic review and meta-analysis to assess the effects of physical exercise on HRV in T2DM patients.
METHOD
PubMed, Cochrane, Embase, and ScienceDirect databases were searched for all studies reporting HRV parameters in T2DM patients before and after exercise training, until September 20th 2020, without limitation to specific years. We conducted random-effects meta-analysis stratified by type of exercise for each of the HRV parameters: RR-intervals (or Normal to Normal intervals-NN), standard deviation of RR intervals (SDNN), percentage of adjacent NN intervals varying by more than 50 milliseconds (pNN50), root mean square of successive RR-intervals differences (RMSSD), total power, Low Frequency (LF), High Frequency (HF) and LF/HF ratio. Sensitivity analyses were computed on studies with the highest quality.
RESULTS
We included 21 studies (9 were randomized) for a total of 523 T2DM patients: 472 had an exercise training and 151 were controls (no exercise). Intervention was endurance (14 studies), resistance (2 studies), endurance combined with resistance (4 studies), and high intensity interval training (HIIT) (4 studies). After exercise training, all HRV parameters improved i.e. an increase in SDNN (effect size = 0.59, 95%CI 0.26 to 0.93), RMSSD (0.62, 0.28 to 0.95), pNN50 (0.62, 0.23 to 1.00), HF (0.58, -0.16 to 0.99), and a decrease in LF (-0.37, -0.69 to -0.05) and LF/HF (-0.52, -0.79 to -0.24). There were no changes in controls. Stratification by type of exercise showed an improvement in most HRV parameters (SDNN, RMSSD, pNN50, LF, HF, LF/HF) after endurance training, whereas mostly LF/HF was improved after both resistance training and HIIT. Supervised training improved most HRV parameters. Duration and frequency of training did not influence the benefits on HRV.
CONCLUSION
Exercise training improved HRV parameters in T2DM patients which may reflect an improvement in the activity of the autonomic nervous system. The level of proof is the highest for endurance training. Supervised training seemed beneficial.
Topics: Diabetes Mellitus, Type 2; Diabetic Neuropathies; Endurance Training; Exercise; Female; Heart; Heart Rate; High-Intensity Interval Training; Humans; Male; Randomized Controlled Trials as Topic; Resistance Training
PubMed: 33999947
DOI: 10.1371/journal.pone.0251863 -
Foot Self-Care Experiences Among Patients With Diabetes: A Systematic Review of Qualitative Studies.Wound Management & Prevention Apr 2020Research that explores foot self-care practices and clinical foot care recommendations for persons with diabetes mellitus is limited.
UNLABELLED
Research that explores foot self-care practices and clinical foot care recommendations for persons with diabetes mellitus is limited.
PURPOSE
The aim of this systematic review was to understand the gaps between the American Diabetes Association clinical recommendations on preventive foot self-care and perceptions of and actions taken by patients with diabetes and diabetic foot ulcers (DFUs).
METHODS
PubMed, the Cumulative Index of Nursing and Allied Health Literature, Cochrane Online Library, Psychological Information Database, and Google Scholar were systematically searched for qualitative research literature published in English from January 1, 2001, to October 21, 2016, using the MeSH terms diabetes mellitus, diabetic foot ulcers, foot care, experiences, and perception to examine the experiences of patients with diabetes regarding foot self-care practices. Publications were screened for inclusion according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses, and The Standard for Reporting Qualitative Research was used to appraise trustworthiness and publication bias. Publication details (author, year, title, country in which the study was conducted, and the type of publication), study aims, design (study methodology, method of sampling, and analysis method), and participant details were abstracted to Excel sheets for analysis of foot self-care experiences and to determine common themes (foot self-care issues) among patients with diabetes.
RESULTS
Of the 14 publications identified, 9 (that included 113 patients with diabetes [95 with or history of DFUs and 18 with no DFUs] and 28 health care professionals [14 podiatrists, 8 physicians, and 6 registered nurses]) met the inclusion criteria for analysis. Research included 4 qualitative descriptive design studies, 2 descriptive phenomenology studies, 1 grounded theory study, 1 interpretive phenomenology study, and 1 exploratory qualitative design study. Four (4) studies were found to lack transparency, and 7 studies did not address trustworthiness. The common themes identified were the high clinical and lifestyle burden of DFUs, poor foot self-care knowledge, perception barriers and resistance, adoption of self-management practices, and discordance between patient and provider impressions and expectations.
CONCLUSION
Several barriers to optimal foot care in persons with diabetes with and without foot ulcers were identified and may be explained and addressed by considering the Health Belief Model. Clinical interventions should be individualized to identify and address patient-specific barriers to optimal foot self-care. Future clinical studies are needed to examine the outcomes of individualized interventions.
Topics: Diabetes Mellitus; Diabetic Foot; Humans; Self Care
PubMed: 32294056
DOI: 10.25270/wmp.2020.4.1625 -
European Journal of Vascular and... Aug 2020This review aims to assess the evidence supporting the impact of patient foot care education on self efficacy, self care behaviour, and self care knowledge in... (Review)
Review
OBJECTIVE
This review aims to assess the evidence supporting the impact of patient foot care education on self efficacy, self care behaviour, and self care knowledge in individuals with diabetes.
METHODS
This systematic review was registered prospectively on the PROSPERO database (CRD42019106171). Ovid EMBASE and MEDLINE databases were searched from 1946 to the end of March 2019, using search terms related to the domains diabetic foot, patient education, self efficacy, self care behaviour, and self care knowledge. All included studies were prospective, randomised controlled trials that assessed foot care education interventions in individuals with diabetes and recorded an outcome related to self efficacy, self care behaviour, and/or self care knowledge.
RESULTS
Thirteen randomised controlled trials were included, reporting on a total of 3948 individuals. The risk of bias was high or unclear in 11 of the 13 included studies, and low in two studies. Both the education interventions delivered, and the outcome assessment tools used were heterogenous across included studies: meta-analysis was therefore not performed. Eight of 11 studies identified significantly better foot self care behaviour scores in individuals randomised to education compared with controls. Self efficacy scores were significantly better in education groups in four of five studies reporting this primary outcome. Foot care knowledge was significantly better in intervention vs. control in three of seven studies. In general, studies assessing secondary endpoints including quality of life and ulcer/amputation incidence tended not to identify significant clinical improvements.
CONCLUSION
The available evidence is of inadequate quality to reliably conclude that foot care education has a positive impact on foot self care behaviour and self efficacy in individuals with diabetes. Quality data supporting accompanying benefits on quality of life or ulcer/amputation incidence are also lacking and should be considered as an important outcome measure in future studies.
Topics: Aged; Diabetic Foot; Female; Health Behavior; Health Knowledge, Attitudes, Practice; Humans; Male; Middle Aged; Patient Education as Topic; Quality of Life; Randomized Controlled Trials as Topic; Self Care; Self Efficacy; Treatment Outcome; Wound Healing
PubMed: 32660807
DOI: 10.1016/j.ejvs.2020.03.053 -
Journal of Vascular Surgery Apr 2020Multiple single-center studies have reported significant reductions in major amputations among patients with diabetic foot ulcers after initiation of multidisciplinary...
OBJECTIVE
Multiple single-center studies have reported significant reductions in major amputations among patients with diabetic foot ulcers after initiation of multidisciplinary teams. The purpose of this study was to assess the association between multidisciplinary teams (ie, two or more types of clinicians working together) and the risk of major amputation and to compile descriptions of these diverse teams.
METHODS
We searched PubMed, Scopus, Cumulative Index to Nursing and Allied Health, and Cochrane Central Register of Controlled Trials from inception through May 24, 2019 for studies reporting the association between multidisciplinary teams and major amputation rates for patients with diabetic foot ulcers. We included original studies if ≥50% of the patients seen by the multidisciplinary team had diabetes, they included a control group, and they reported the effect of a multidisciplinary team on major amputation rates. Studies were excluded if they were non-English language, abstracts only, or unpublished. We used the five-domain Systems Engineering Initiative for Patient Safety Model to describe team composition and function and summarized changes in major amputation rates associated with multidisciplinary team care. A meta-analysis was not performed because of heterogeneity across studies, their observational designs, and the potential for uncontrolled confounding (PROSPERO No. 2017: CRD42017067915).
RESULTS
We included 33 studies, none of which were randomized trials. Multidisciplinary team composition and functions were highly diverse. However, four elements were common across teams: teams were composed of medical and surgical disciplines; larger teams benefitted from having a "captain" and a nuclear and ancillary team member structure; clear referral pathways and care algorithms supported timely, comprehensive care; and multidisciplinary teams addressed four key tasks: glycemic control, local wound management, vascular disease, and infection. Ninety-four percent (31/33) of studies reported a reduction in major amputations after institution of a multidisciplinary team.
CONCLUSIONS
Multidisciplinary team composition was variable but reduced major amputations in 94% of studies. Teams consistently addressed glycemic control, local wound management, vascular disease, and infection in a timely and coordinated manner to reduce major amputation for patients with diabetic foot ulcerations. Care algorithms and referral pathways were key tools to their success.
Topics: Amputation, Surgical; Diabetic Foot; Humans; Limb Salvage; Patient Care Team
PubMed: 31676181
DOI: 10.1016/j.jvs.2019.08.244 -
Diabetes/metabolism Research and Reviews Mar 2020Offloading interventions are commonly used in clinical practice to heal foot ulcers. The aim of this updated systematic review is to investigate the effectiveness of...
BACKGROUND
Offloading interventions are commonly used in clinical practice to heal foot ulcers. The aim of this updated systematic review is to investigate the effectiveness of offloading interventions to heal diabetic foot ulcers.
METHODS
We updated our previous systematic review search of PubMed, EMBASE, and Cochrane databases to also include original studies published between July 29, 2014 and August 13, 2018 relating to four offloading intervention categories in populations with diabetic foot ulcers: (a) offloading devices, (b) footwear, (c) other offloading techniques, and (d) surgical offloading techniques. Outcomes included ulcer healing, plantar pressure, ambulatory activity, adherence, adverse events, patient-reported measures, and cost-effectiveness. Included controlled studies were assessed for methodological quality and had key data extracted into evidence and risk of bias tables. Included non-controlled studies were summarised on a narrative basis.
RESULTS
We identified 41 studies from our updated search for a total of 165 included studies. Six included studies were meta-analyses, 26 randomised controlled trials (RCTs), 13 other controlled studies, and 120 non-controlled studies. Five meta-analyses and 12 RCTs provided high-quality evidence for non-removable knee-high offloading devices being more effective than removable offloading devices and therapeutic footwear for healing plantar forefoot and midfoot ulcers. Total contact casts (TCCs) and non-removable knee-high walkers were shown to be equally effective. Moderate-quality evidence exists for removable knee-high and ankle-high offloading devices being equally effective in healing, but knee-high devices have a larger effect on reducing plantar pressure and ambulatory activity. Low-quality evidence exists for the use of felted foam and surgical offloading to promote healing of plantar forefoot and midfoot ulcers. Very limited evidence exists for the efficacy of any offloading intervention for healing plantar heel ulcers, non-plantar ulcers, and neuropathic ulcers with infection or ischemia.
CONCLUSION
Strong evidence supports the use of non-removable knee-high offloading devices (either TCC or non-removable walker) as the first-choice offloading intervention for healing plantar neuropathic forefoot and midfoot ulcers. Removable offloading devices, either knee-high or ankle-high, are preferred as second choice over other offloading interventions. The evidence bases to support any other offloading intervention is still weak and more high-quality controlled studies are needed in these areas.
Topics: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Foot; Disease Management; Evidence-Based Medicine; Humans; Practice Guidelines as Topic; Practice Patterns, Physicians'; Prognosis
PubMed: 32176438
DOI: 10.1002/dmrr.3275 -
The Cochrane Database of Systematic... May 2021The World Health Organization (WHO) recommends that people of all ages take regular and adequate physical activity. If unable to meet the recommendations due to health...
BACKGROUND
The World Health Organization (WHO) recommends that people of all ages take regular and adequate physical activity. If unable to meet the recommendations due to health conditions, international guidance advises being as physically active as possible. Evidence from community interventions of physical activity indicate that people living with medical conditions are sometimes excluded from participation in studies. In this review, we considered the effects of activity-promoting interventions on physical activity and well-being in studies, as well as any adverse events experienced by participants living with inherited or acquired neuromuscular diseases (NMDs). OBJECTIVES: To assess the effects of interventions designed to promote physical activity in people with NMD compared with no intervention or alternative interventions.
SEARCH METHODS
On 30 April 2020, we searched Cochrane Neuromuscular Specialised Register, CENTRAL, Embase, MEDLINE, and ClinicalTrials.Gov. WHO ICTRP was not accessible at the time.
SELECTION CRITERIA
We considered randomised or quasi-randomised trials, including cross-over trials, of interventions designed to promote physical activity in people with NMD compared to no intervention or alternative interventions. We specifically included studies that reported physical activity as an outcome measure. Our main focus was studies in which promoting physical activity was a stated aim but we also included studies in which physical activity was assessed as a secondary or exploratory outcome.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane procedures.
MAIN RESULTS
The review included 13 studies (795 randomised participants from 12 studies; number of participants unclear in one study) of different interventions to promote physical activity. Most studies randomised a minority of invited participants. No study involved children or adolescents and nine studies reported minimal entry criteria for walking. Participants had one of nine inherited or acquired NMDs. Types of intervention included structured physical activity support, exercise support (as a specific form of physical activity), and behaviour change support that included physical activity or exercise. Only one included study clearly reported that the aim of intervention was to increase physical activity. Other studies reported or planned to analyse the effects of intervention on physical activity as a secondary or exploratory outcome measure. Six studies did not report results for physical activity outcomes, or the data were not usable. We judged 10 of the 13 included studies at high or unclear risk of bias from incomplete physical activity outcome reporting. We did not perform a meta-analysis for any comparison because of differences in interventions and in usual care. We also found considerable variation in how studies reported physical activity as an outcome measure. The studies that reported physical activity measurement did not always clearly report intention-to-treat (ITT) analysis or whether final assessments occurred during or after intervention. Based on prespecified measures, we included three comparisons in our summary of findings. A physical activity programme (weight-bearing) compared to no physical activity programme One study involved adults with diabetic peripheral neuropathy (DPN) and reported weekly duration of walking during and at the end of a one-year intervention using a StepWatch ankle accelerometer. Based on the point estimate and low-certainty evidence, intervention may have led to an important increase in physical activity per week; however, the 95% confidence interval (CI) included the possibility of no difference or an effect in either direction at three months (mean difference (MD) 34 minutes per week, 95% CI -92.19 to 160.19; 69 participants), six months (MD 68 minutes per week, 95% CI -55.35 to 191.35; 74 participants), and 12 months (MD 49 minutes per week, 95% CI -75.73 to 173.73; 70 participants). Study-reported effect estimates for foot lesions and full-thickness ulcers also included the possibility of no difference, a higher, or lower risk with intervention. A sensor-based, interactive exercise programme compared to no sensor-based, interactive exercise programme One study involved adults with DPN and reported duration of walking over 48 hours at the end of four weeks' intervention using a t-shirt embedded PAMSys sensor. It was not possible to draw conclusions about the effectiveness of the intervention from the very low-certainty evidence (MD -0.64 hours per 48 hours, 95% CI -2.42 to 1.13; 25 participants). We were also unable to draw conclusions about impact on the Physical Component Score (PCS) for quality of life (MD 0.24 points, 95% CI -5.98 to 6.46; 35 participants; very low-certainty evidence), although intervention may have made little or no difference to the Mental Component Score (MCS) for quality of life (MD 5.10 points, 95% CI -0.58 to 10.78; 35 participants; low-certainty evidence). A functional exercise programme compared to a stretching exercise programme One study involved adults with spinal and bulbar muscular atrophy and reported a daily physical activity count at the end of 12 weeks' intervention using an Actical accelerometer. It was not possible to draw conclusions about the effectiveness of either intervention (requiring compliance) due to low-certainty evidence and unconfirmed measurement units (MD -8701, 95% CI -38,293.30 to 20,891.30; 43 participants). Functional exercise may have made little or no difference to quality of life compared to stretching (PCS: MD -1.10 points, 95% CI -5.22 to 3.02; MCS: MD -1.10 points, 95% CI -6.79 to 4.59; 49 participants; low-certainty evidence). Although studies reported adverse events incompletely, we found no evidence of supported activity increasing the risk of serious adverse events.
AUTHORS' CONCLUSIONS
We found a lack of evidence relating to children, adolescents, and non-ambulant people of any age. Many people living with NMD did not meet randomised controlled trial eligibility criteria. There was variation in the components of supported activity intervention and usual care, such as physical therapy provision. We identified variation among studies in how physical activity was monitored, analysed, and reported. We remain uncertain of the effectiveness of promotional intervention for physical activity and its impact on quality of life and adverse events. More information is needed on the ITT population, as well as more complete reporting of outcomes. While there may be no single objective measure of physical activity, the study of qualitative and dichotomous change in self-reported overall physical activity might offer a pragmatic approach to capturing important change at an individual and population level.
Topics: Bias; Exercise; Health Promotion; Humans; Muscle Stretching Exercises; Neuromuscular Diseases; Outcome Assessment, Health Care; Quality of Life; Randomized Controlled Trials as Topic; Resistance Training; Time Factors; Walking
PubMed: 34027632
DOI: 10.1002/14651858.CD013544.pub2 -
Scientific Reports Jan 2021Studies have suggested that hyperbaric oxygen therapy (HBOT) is effective in the healing of diabetic foot ulcer (DFU); however, there is a lack of consensus. Therefore,... (Meta-Analysis)
Meta-Analysis
Studies have suggested that hyperbaric oxygen therapy (HBOT) is effective in the healing of diabetic foot ulcer (DFU); however, there is a lack of consensus. Therefore, to assess the efficacy of HBOT on diabetic foot ulcer among diabetic patients, controlled clinical trials were searched through PubMed, EMBASE, Clinical key, Ovid Discovery, ERMED, Clinical Trials.gov databases for randomized controlled trials (RCTs) and other sources until 15 September 2020. Studies that evaluated the effect of HBOT on diabetic foot ulcer, complete healing, amputation, adverse events, ulcer reduction area, and mortality rate were included. Of 1984 study records screened, 14 studies (768 participants) including twelve RCTs, and two CCTs were included as per inclusion criteria. The results with pooled analysis have shown that HBOT was significantly effective in complete healing of diabetic foot ulcer (OR = 0.29; 95% CI 0.14-0.61; I = 62%) and reduction of major amputation (RR = 0.60; 95% CI 0.39-0.92; I = 24%). Although, it was not effective for minor amputations (RR = 0.82; 95% CI 0.34-1.97; I = 79%); however, less adverse events were reported in standard treatment group (RR = 1.68; 95% CI 1.07-2.65; I = 0%). Nevertheless, reduction in mean percentage of ulcer area and mortality rate did not differ in HBOT and control groups. This review provides an evidence that hyperbaric oxygen therapy is effective as an adjunct treatment measure for the diabetes foot ulcers. These findings could be generalized cautiously by considering methodological flaws within all studies.
Topics: Amputation, Surgical; Controlled Clinical Trials as Topic; Diabetic Foot; Humans; Hyperbaric Oxygenation; Publication Bias; Risk; Treatment Outcome; Wound Healing
PubMed: 33500533
DOI: 10.1038/s41598-021-81886-1