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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 -
BMJ Open Aug 2017To summarise incidence and prevalence of diabetic ketoacidosis (DKA) in adults with type 1 diabetes (T1D) for the overall patient population and different subgroups... (Review)
Review
OBJECTIVES
To summarise incidence and prevalence of diabetic ketoacidosis (DKA) in adults with type 1 diabetes (T1D) for the overall patient population and different subgroups (age, sex, geographical region, ethnicity and type of insulin administration).
DESIGN
Systematic literature review (SLR).
DATA SOURCES
Medline (via PubMed) and Embase (1 January 2000 to 23 June 2016).
STUDY SELECTION
Peer-reviewed observational studies with reported data on the incidence or prevalence of DKA in T1D adults were included. A single reviewer completed the study screening and selection process and a second reviewer performed an additional screening of approximately 20% of the publications; two reviewers independently conducted the quality assessment; the results were narratively synthesised.
RESULTS
Out of 1082 articles, 19 met the inclusion and exclusion criteria, with two additional studies identified that did not specify the patient age range and are therefore not included in the SLR. Overall, eight studies reported incidence with a range of 0-56 per 1000 person-years (PYs), with one outlying study reporting an incidence of 263 per 1000 PYs. Eleven studies reported prevalence with a range of 0-128 per 1000 people. Prevalence of DKA decreased with increasing age. Subgroup analyses were performed using data from no more than two studies per subgroup. There was a higher prevalence of DKA reported in women, non-whites and patients treated with insulin injections compared with men, whites and patients using continuous subcutaneous insulin infusion pumps, respectively.
CONCLUSIONS
To our knowledge, this is the first SLR on the epidemiology of DKA in T1D adults. Despite an increasing prevalence of T1D in recent years, DKA in adults has been poorly characterised. In an era when the benefit-risk profiles of new antidiabetic therapies are being evaluated, including the potential risk of DKA, there is a clear need to better elucidate the expected rate of DKA among T1D adults.
Topics: Adult; Diabetes Mellitus, Type 1; Diabetic Ketoacidosis; Female; Humans; Hypoglycemic Agents; Infusion Pumps; Injections; Insulin; Male
PubMed: 28765134
DOI: 10.1136/bmjopen-2017-016587 -
JAMA Network Open May 2023Elective induction of labor at 39 weeks of gestation is common. Thus, there is a need to assess maternal labor-related complications and neonatal outcomes associated... (Meta-Analysis)
Meta-Analysis
Comparison of Maternal Labor-Related Complications and Neonatal Outcomes Following Elective Induction of Labor at 39 Weeks of Gestation vs Expectant Management: A Systematic Review and Meta-analysis.
IMPORTANCE
Elective induction of labor at 39 weeks of gestation is common. Thus, there is a need to assess maternal labor-related complications and neonatal outcomes associated with elective induction of labor.
OBJECTIVE
To examine maternal labor-related complications and neonatal outcomes following elective induction of labor at 39 weeks compared with expectant management.
DATA SOURCES
A systematic review of the literature was conducted using the MEDLINE (Ovid), Embase (Ovid), Cochrane Central Library, World Health Organization, and ClinicalTrials.gov databases and registries to search for articles published between database inception and December 8, 2022.
STUDY SELECTION
This systematic review and meta-analysis included randomized clinical trials, cohort studies, and cross-sectional studies reporting perinatal outcomes following induction of labor at 39 weeks vs expectant management.
DATA EXTRACTION AND SYNTHESIS
Two reviewers independently assessed study eligibility, extracted data, and assessed studies for bias. Pooled odds ratios (ORs) and 95% CIs were calculated using a random-effects model. This study is reported per the Preferred Reporting Items for Systematic Reviews and Meta-analyses 2020 guideline, and the protocol was prospectively registered with PROSPERO.
MAIN OUTCOMES AND MEASURES
Maternal outcomes of interest included emergency cesarean section, perineal injury, postpartum hemorrhage, and operative vaginal birth. Neonatal outcomes of interest included admission to the neonatal intensive care unit, low 5-minute Apgar score (<7) after birth, macrosomia, and shoulder dystocia.
RESULTS
Of the 5827 records identified in the search, 14 studies were eligible for inclusion in this review. These studies reported outcomes for 1 625 899 women birthing a singleton pregnancy. Induction of labor at 39 weeks of gestation was associated with a 37% reduced likelihood of third- or fourth-degree perineal injury (OR, 0.63 [95% CI, 0.49-0.81]), in addition to reductions in operative vaginal birth (OR, 0.87 [95% CI, 0.79-0.97]), macrosomia (OR, 0.66 [95% CI, 0.48-0.91]), and low 5-minute Apgar score (OR, 0.62 [95% CI, 0.40-0.96]). Results were similar when confined to multiparous women only, with the addition of a substantial reduction in the likelihood of emergency cesarean section (OR, 0.61 [95% CI, 0.38-0.98]) and no difference in operative vaginal birth (OR, 1.01 [95% CI, 0.84-1.21]). However, among nulliparous women only, induction of labor was associated with an increased likelihood of shoulder dystocia (OR, 1.22 [95% CI, 1.02-1.46]) compared with expectant management.
CONCLUSIONS AND RELEVANCE
In this study, induction of labor at 39 weeks was associated with improved maternal labor-related and neonatal outcomes. However, among nulliparous women, induction of labor was associated with shoulder dystocia. These results suggest that elective induction of labor at 39 weeks may be safe and beneficial for some women; however, potential risks should be discussed with nulliparous women.
Topics: Infant, Newborn; Pregnancy; Female; Humans; Cesarean Section; Fetal Macrosomia; Cross-Sectional Studies; Shoulder Dystocia; Labor, Induced; Labor, Obstetric; Obstetric Labor Complications; Infant, Newborn, Diseases
PubMed: 37171818
DOI: 10.1001/jamanetworkopen.2023.13162 -
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 -
Age and Ageing Jan 2024Sodium-glucose cotransporter-2 inhibitors (SGLT2Is) reduce cardio-metabolic and renal outcomes in patients with type 2 diabetes (T2D) but their efficacy and safety in... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Sodium-glucose cotransporter-2 inhibitors (SGLT2Is) reduce cardio-metabolic and renal outcomes in patients with type 2 diabetes (T2D) but their efficacy and safety in older or frail individuals remains unclear.
METHODS
We searched PubMed, Scopus, Web of Science, Cochrane CENTRA and Google Scholar and selected randomised controlled trials and observational studies comparing SGLT2Is versus placebo/other glucose-lowering agent for people with frailty or older individuals (>65 years) with T2D and heart failure (HF). Extracted data on the change in HbA1c % and safety outcomes were pooled in a random-effects meta-analysis model.
RESULTS
We included data from 20 studies (22 reports; N = 77,083 patients). SGLT2Is did not significantly reduce HbA1c level (mean difference -0.13, 95%CI: -0.41 to 0.14). SGLT2Is were associated with a significant reduction in the risk of all-cause mortality (risk ratio (RR) 0.81, 95%CI: -0.69 to 0.95), cardiac death (RR 0.80, 95%CI: -0.94 to 0.69) and hospitalisation for heart failure (HHF) (RR 0.69, 95%CI: 0.59-0.81). However, SGLT2Is did not demonstrate significant effect in reducing in the risk of macrovascular events (acute coronary syndrome or cerebral vascular occlusion), renal progression/composite renal endpoint, acute kidney injury, worsening HF, atrial fibrillation or diabetic ketoacidosis.
CONCLUSIONS
In older or frail patients with T2D and HF, SGLT2Is are consistently linked with a decrease in total mortality and the overall burden of cardiovascular (CV) events, including HHF events and cardiac death, but not protective for macrovascular death or renal events. Adverse events were more difficult to quantify but the risk of diabetic ketoacidosis or acute kidney injury was not significantly increase.
Topics: Humans; Aged; Diabetes Mellitus, Type 2; Sodium-Glucose Transporter 2 Inhibitors; Glycated Hemoglobin; Diabetic Ketoacidosis; Sodium-Glucose Transporter 2; Frail Elderly; Heart Failure; Death; Glucose; Sodium
PubMed: 38287703
DOI: 10.1093/ageing/afad254 -
Cardiovascular Diabetology May 2018Exercise training is considered a cornerstone in the management of type 2 diabetes, which is associated with impaired endothelial function. However, the association of... (Meta-Analysis)
Meta-Analysis
BACKGROUND AND AIMS
Exercise training is considered a cornerstone in the management of type 2 diabetes, which is associated with impaired endothelial function. However, the association of exercise training with endothelial function in type 2 diabetes patients has not been fully understood. This meta-analysis aimed to investigate their associations with focus on exercise types.
METHODS
Databases were searched up to January 2018 for studies evaluating the influences of exercise training with durations ≥ 8 weeks on endothelial function assessed by flow-mediated dilation (FMD) among type 2 diabetes patients or between type 2 diabetics and non-diabetics. Data were pooled using random-effects models to obtain the weighted mean differences (WMDs) and 95% confidence intervals (CIs).
RESULTS
Sixteen databases were included. Exercise training resulted in an overall improvement in FMD by 1.77% (95% CI 0.94-2.59%) in type 2 diabetes patients. Specifically, both aerobic and combined aerobic and resistance exercise increased FMD by 1.21% (95% CI 0.23-2.19%) and 2.49% (95% CI 1.17-3.81%), respectively; but resistance exercise only showed a trend. High-intensity interval aerobic exercise did not significantly improve FMD over moderate-intensity continuous exercise. Notably, the improvement in FMD among type 2 diabetes patients was smaller compared with non-diabetics in response to exercise training (WMD - 0.72%, 95% CI - 1.36 to - 0.08%) or specifically to aerobic exercise (WMD - 0.65%, 95% CI - 1.31 to 0.01%).
CONCLUSIONS
Exercise training, in particular aerobic and combined exercise, improves endothelial function in type 2 diabetes patients, but such an improvement appears to be weakened compared with non-diabetics. Trial registration PROSPERO CRD42018087376.
Topics: Aged; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Endothelium, Vascular; Exercise Therapy; Exercise Tolerance; Female; Humans; Male; Middle Aged; Recovery of Function; Treatment Outcome; Vasodilation
PubMed: 29720185
DOI: 10.1186/s12933-018-0711-2 -
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 -
Cardiovascular Diabetology Mar 2022We conducted a systematic review and meta-analysis of the cardiovascular, kidney, and safety outcomes of sodium-glucose cotransporter 2 inhibitors (SGLT2i) among... (Meta-Analysis)
Meta-Analysis
BACKGROUND
We conducted a systematic review and meta-analysis of the cardiovascular, kidney, and safety outcomes of sodium-glucose cotransporter 2 inhibitors (SGLT2i) among patients with diabetic kidney disease (DKD).
METHODS
We searched electronic databases for major randomized placebo-controlled clinical trials published up to September 30, 2021 and reporting on cardiovascular and kidney outcomes of SGLT2i in patients with DKD. DKD was defined as chronic kidney disease in individuals with type 2 diabetes. Random-effects meta-analysis models were used to estimate pooled hazard ratios (HR) and 95% confidence intervals (CI) for clinical outcomes including major adverse cardiovascular events (MACE: myocardial infarction [MI], stroke, and cardiovascular death), kidney composite outcomes (a combination of worsening kidney function, end-stage kidney disease, or death from renal or cardiovascular causes), hospitalizations for heart failure (HHF), deaths and safety events (mycotic infections, diabetic ketoacidosis [DKA], volume depletion, amputations, fractures, urinary tract infections [UTI], acute kidney injury [AKI], and hyperkalemia).
RESULTS
A total of 26,106 participants with DKD from 8 large-scale trials were included (median age: 65.2 years, 29.7-41.8% women, 53.2-93.2% White, median follow-up: 2.5 years). SGLT2i were associated with reduced risks of MACE (HR 0.83, 95% CI 0.75-0.93), kidney composite outcomes (HR 0.66, 95% CI 0.58-0.75), HHF (HR 0.62, 95% CI 0.55-0.71), cardiovascular death (HR 0.84, 95% CI 0.74-0.96), MI (HR 0.78, 95% CI 0.67-0.92), stroke (HR 0.76, 95% CI 0.59-0.97), and all-cause death (HR 0.86, 95% CI 0.77-0.96), with no significant heterogeneity detected. Similar results were observed among participants with reduced estimated glomerular filtration rate (eGFR: < 60 mL/min/1.73m). The relative risks (95% CI) for adverse events were 3.89 (1.42-10.62) and 2.50 (1.32-4.72) for mycotic infections in men and women respectively, 3.54 (0.82-15.39) for DKA, and 1.29 (1.13-1.48) for volume depletion.
CONCLUSIONS
Among adults with DKD, SGLT2i were associated with reduced risks of MACE, kidney outcomes, HHF, and death. With a few exceptions of more clear safety signals, we found overall limited data on the associations between SGLT2i and safety outcomes. More research is needed on the safety profile of SGLT2i in this population.
Topics: Adult; Aged; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Diabetic Ketoacidosis; Diabetic Nephropathies; Female; Heart Failure; Humans; Kidney; Male; Myocardial Infarction; Sodium-Glucose Transporter 2 Inhibitors; Stroke
PubMed: 35321742
DOI: 10.1186/s12933-022-01476-x -
Clinical Oral Implants Research Oct 2018his review evaluated implant survival in geriatric patients (≥75 years) and/or the impact of systemic medical conditions. (Meta-Analysis)
Meta-Analysis
OBJECTIVES
his review evaluated implant survival in geriatric patients (≥75 years) and/or the impact of systemic medical conditions.
MATERIALS AND METHODS
Systematic literature searches were performed to identify studies reporting on geriatric subjects with dental implants and on implant patients who had any of the seven most common systematic conditions among geriatric patients. Meta-analyses were performed on the postloading implant survival rates. The impact of systemic medical conditions and their respective treatment was qualitatively analyzed.
RESULTS
A total of 6,893 studies were identified; of those, 60 studies were included. The fixed-effects model revealed an overall implant survival of 97.3% (95% CI: 94.3, 98.7; studies = 7) and 96.1% (95% CI: 87.3, 98.9; studies = 3), for 1 and 5 years, respectively. In patients with cardiovascular disease, implant survival may be similar or higher compared to healthy patients. High implant survival rates were reported for patients with Parkinson's disease or diabetes mellitus type II. In patients with cancer, implant survival is negatively affected, namely by radiotherapy. Patients with bone metastases receiving high-dose antiresorptive therapy (ART) carry a high risk for complications after implant surgery. Implant survival was reported to be high in patients receiving low-dose ART for treatment of osteoporosis. No evidence was found on implant survival in patients with dementia, respiratory diseases, liver cirrhosis, or osteoarthritis.
CONCLUSIONS
Implant prostheses in geriatric subjects are a predictable treatment option with a very high rate of implant survival. The functional and psychosocial benefits of such intervention should outweigh the associated risks to common medical conditions.
Topics: Age Factors; Aged; Aged, 80 and over; Alveolar Bone Loss; Bone Density Conservation Agents; Cardiovascular Diseases; Dementia; Dental Implantation, Endosseous; Dental Implants; Dental Restoration Failure; Diabetes Complications; Diabetes Mellitus, Type 2; Humans; Lung Diseases; Neoplasm Metastasis; Neoplasms; Osteoporosis; Parkinson Disease; Radiotherapy; Risk Factors; Survival Analysis; Xerostomia
PubMed: 30328186
DOI: 10.1111/clr.13288 -
The Cochrane Database of Systematic... Jun 2017People with diabetes are at high risk for developing foot ulcers, which often become infected. These wounds, especially when infected, cause substantial morbidity. Wound... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
People with diabetes are at high risk for developing foot ulcers, which often become infected. These wounds, especially when infected, cause substantial morbidity. Wound treatments should aim to alleviate symptoms, promote healing, and avoid adverse outcomes, especially lower extremity amputation. Topical antimicrobial therapy has been used on diabetic foot ulcers, either as a treatment for clinically infected wounds, or to prevent infection in clinically uninfected wounds.
OBJECTIVES
To evaluate the effects of treatment with topical antimicrobial agents on: the resolution of signs and symptoms of infection; the healing of infected diabetic foot ulcers; and preventing infection and improving healing in clinically uninfected diabetic foot ulcers.
SEARCH METHODS
We searched the Cochrane Wounds Specialised Register, CENTRAL, Ovid MEDLINE, Ovid MEDLINE (In-Process & Other Non-Indexed Citations), Ovid Embase, and EBSCO CINAHL Plus in August 2016. We also searched clinical trials registries for ongoing and unpublished studies, and checked reference lists to identify additional studies. We used no restrictions with respect to language, date of publication, or study setting.
SELECTION CRITERIA
We included randomised controlled trials conducted in any setting (inpatient or outpatient) that evaluated topical treatment with any type of solid or liquid (e.g., cream, gel, ointment) antimicrobial agent, including antiseptics, antibiotics, and antimicrobial dressings, in people with diabetes mellitus who were diagnosed with an ulcer or open wound of the foot, whether clinically infected or uninfected.
DATA COLLECTION AND ANALYSIS
Two review authors independently performed study selection, 'Risk of bias' assessment, and data extraction. Initial disagreements were resolved by discussion, or by including a third review author when necessary.
MAIN RESULTS
We found 22 trials that met our inclusion criteria with a total of over 2310 participants (one study did not report number of participants). The included studies mostly had small numbers of participants (from 4 to 317) and relatively short follow-up periods (4 to 24 weeks). At baseline, six trials included only people with ulcers that were clinically infected; one trial included people with both infected and uninfected ulcers; two trials included people with non-infected ulcers; and the remaining 13 studies did not report infection status.Included studies employed various topical antimicrobial treatments, including antimicrobial dressings (e.g. silver, iodides), super-oxidised aqueous solutions, zinc hyaluronate, silver sulphadiazine, tretinoin, pexiganan cream, and chloramine. We performed the following five comparisons based on the included studies: Antimicrobial dressings compared with non-antimicrobial dressings: Pooled data from five trials with a total of 945 participants suggest (based on the average treatment effect from a random-effects model) that more wounds may heal when treated with an antimicrobial dressing than with a non-antimicrobial dressing: risk ratio (RR) 1.28, 95% confidence interval (CI) 1.12 to 1.45. These results correspond to an additional 119 healing events in the antimicrobial-dressing arm per 1000 participants (95% CI 51 to 191 more). We consider this low-certainty evidence (downgraded twice due to risk of bias). The evidence on adverse events or other outcomes was uncertain (very low-certainty evidence, frequently downgraded due to risk of bias and imprecision). Antimicrobial topical treatments (non dressings) compared with non-antimicrobial topical treatments (non dressings): There were four trials with a total of 132 participants in this comparison that contributed variously to the estimates of outcome data. Evidence was generally of low or very low certainty, and the 95% CIs spanned benefit and harm: proportion of wounds healed RR 2.82 (95% CI 0.56 to 14.23; 112 participants; 3 trials; very low-certainty evidence); achieving resolution of infection RR 1.16 (95% CI 0.54 to 2.51; 40 participants; 1 trial; low-certainty evidence); undergoing surgical resection RR 1.67 (95% CI 0.47 to 5.90; 40 participants; 1 trial; low-certainty evidence); and sustaining an adverse event (no events in either arm; 81 participants; 2 trials; very low-certainty evidence). Comparison of different topical antimicrobial treatments: We included eight studies with a total of 250 participants, but all of the comparisons were different and no data could be appropriately pooled. Reported outcome data were limited and we are uncertain about the relative effects of antimicrobial topical agents for each of our review outcomes for this comparison, that is wound healing, resolution of infection, surgical resection, and adverse events (all very low-certainty evidence). Topical antimicrobials compared with systemic antibiotics : We included four studies with a total of 937 participants. These studies reported no wound-healing data, and the evidence was uncertain for the relative effects on resolution of infection in infected ulcers and surgical resection (very low certainty). On average, there is probably little difference in the risk of adverse events between the compared topical antimicrobial and systemic antibiotics treatments: RR 0.91 (95% CI 0.78 to 1.06; moderate-certainty evidence - downgraded once for inconsistency). Topical antimicrobial agents compared with growth factor: We included one study with 40 participants. The only review-relevant outcome reported was number of ulcers healed, and these data were uncertain (very low-certainty evidence).
AUTHORS' CONCLUSIONS
The randomised controlled trial data on the effectiveness and safety of topical antimicrobial treatments for diabetic foot ulcers is limited by the availability of relatively few, mostly small, and often poorly designed trials. Based on our systematic review and analysis of the literature, we suggest that: 1) use of an antimicrobial dressing instead of a non-antimicrobial dressing may increase the number of diabetic foot ulcers healed over a medium-term follow-up period (low-certainty evidence); and 2) there is probably little difference in the risk of adverse events related to treatment between systemic antibiotics and topical antimicrobial treatments based on the available studies (moderate-certainty evidence). For each of the other outcomes we examined there were either no reported data or the available data left us uncertain as to whether or not there were any differences between the compared treatments. Given the high, and increasing, frequency of diabetic foot wounds, we encourage investigators to undertake properly designed randomised controlled trials in this area to evaluate the effects of topical antimicrobial treatments for both the prevention and the treatment of infection in these wounds and ultimately the effects on wound healing.
Topics: Administration, Topical; Anti-Bacterial Agents; Bacterial Infections; Bandages, Hydrocolloid; Diabetic Foot; Foot Ulcer; Humans; Incidence; Intercellular Signaling Peptides and Proteins; Randomized Controlled Trials as Topic; Wound Healing
PubMed: 28613416
DOI: 10.1002/14651858.CD011038.pub2