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Dermatology and Therapy Aug 2020There is a need to compare efficacy and safety profiles of crisaborole ointment, 2%, versus other topical treatments across randomized clinical trials (RCTs). We...
INTRODUCTION
There is a need to compare efficacy and safety profiles of crisaborole ointment, 2%, versus other topical treatments across randomized clinical trials (RCTs). We performed this review/network meta-analysis to evaluate the comparative efficacy and safety of crisaborole versus other topical pharmacologic therapies for mild-to-moderate atopic dermatitis (AD) among patients aged ≥ 2 years.
METHODS
Searches were conducted in MEDLINE, Embase, the Cochrane Collection Central Register of Clinical Trials, and the Database of Abstracts of Reviews of Effects using Ovid to identify English language articles reporting RCTs of topical anti-inflammatory agents in patients aged ≥ 2 years with mild-to-moderate AD published between inception and 10 March 2020. This review used a prespecified protocol with eligibility criteria for population, interventions, comparisons, outcomes, and study design. Efficacy was evaluated using the Investigator's Static Global Assessment (ISGA) of clear (0) or almost clear (1) and expressed by hazard ratios (HR) with 95% credible intervals.
RESULTS
Patients treated with crisaborole or tacrolimus ointment, 0.1% or 0.03%, versus vehicle alone were significantly more likely to achieve ISGA 0/1 at 28-42 days, with the greatest point estimate observed for the crisaborole comparison (hazard ratio: 2.07; 95% credible interval 1.76 to - 2.36; probability HR above 1 [p better]: 100.0%). Patients were also more likely to achieve ISGA 0/1 with crisaborole than with pimecrolimus cream, 1% (HR: 1.62; 95% credible interval 1.04-2.48; p better: 98.3%). While network meta-analysis for safety was not feasible because of data limitations, crisaborole pivotal studies (AD-301/AD-302) showed crisaborole was well tolerated.
CONCLUSIONS
Crisaborole was shown to be superior to vehicle and pimecrolimus and comparable to tacrolimus, 0.1% or 0.03%, with respect to ISGA 0/1 at 28-42 days in patients aged ≥ 2 years with mild-to-moderate AD. This evaluation of comparative efficacy of crisaborole further supports use of crisaborole as an effective therapeutic option in this population.
PubMed: 32435999
DOI: 10.1007/s13555-020-00389-5 -
The Cochrane Database of Systematic... Feb 2015Pressure ulcers, also known as bedsores, decubitus ulcers and pressure injuries, are localised areas of injury to the skin or the underlying tissue, or both. Dressings... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Pressure ulcers, also known as bedsores, decubitus ulcers and pressure injuries, are localised areas of injury to the skin or the underlying tissue, or both. Dressings are widely used to treat pressure ulcers and there are many different dressing options including hydrogel dressings. A clear and current overview of the current evidence is required to facilitate decision-making regarding dressing use for the treatment of pressure ulcers.
OBJECTIVES
To assess the effects of hydrogel dressings on the healing of pressure ulcers in any care setting.
SEARCH METHODS
We searched the following databases: the Cochrane Wounds Group Specialised Register (searched 19 June 2014); The Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 5); Ovid MEDLINE (1946 to June Week 2 2014); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, 23 June 2014); Ovid EMBASE (1974 to 20 June 2014); and EBSCO CINAHL (1982 to 18 June 2014). There were no restrictions based on language or date of publication.
SELECTION CRITERIA
Published or unpublished randomised controlled trials (RCTs) comparing the effects of hydrogel dressings with alternative wound dressings or no dressing in the treatment of pressure ulcers (stage II or above).
DATA COLLECTION AND ANALYSIS
Two review authors independently performed study selection, risk of bias assessment and data extraction.
MAIN RESULTS
We included eleven studies (523 participants) in this review. Ten studies had two arms and one had three arms that were all relevant to this review. Three studies compared a hydrogel dressing with a basic wound contact dressing; three studies compared a hydrogel dressing with a hydrocolloid dressing; three studies compared a hydrogel dressing with another hydrogel dressing; one study compared a hydrogel dressing with a foam dressing; one study compared a hydrogel dressing with a dextranomer paste dressing and one study compared a hydrogel dressing with a topical treatment (collagenase). Limited data were available for analyses in this review: we conducted no meta-analyses. Where data were available there was no evidence of a difference between hydrogel and alternative treatments in terms of complete wound healing or adverse events. One small study reported that using hydrogel dressings was, on average, less costly than hydrocolloid dressings, but this estimate was imprecise and its methodology was not clear. All included studies were small, had short follow-up times and were at unclear risk of bias.
AUTHORS' CONCLUSIONS
It is not clear if hydrogel dressings are more or less effective than other treatments in healing pressure ulcers or if different hydrogels have different effects, Most trials in this field are very small and poorly reported so that risk of bias is unclear.
Topics: Bandages, Hydrocolloid; Collagenases; Dextrans; Humans; Hydrogels; Ointments; Pressure Ulcer; Randomized Controlled Trials as Topic
PubMed: 25914909
DOI: 10.1002/14651858.CD011226.pub2 -
The Cochrane Database of Systematic... Jul 2018Recurrent corneal erosion is a common cause of disabling ocular symptoms and predisposes the cornea to infection. It may follow corneal trauma. Measures to prevent the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Recurrent corneal erosion is a common cause of disabling ocular symptoms and predisposes the cornea to infection. It may follow corneal trauma. Measures to prevent the development of recurrent corneal erosion following corneal trauma have not been firmly established. Once recurrent corneal erosion develops, simple medical therapy (standard treatment) may lead to resolution of the episode. However, some people continue to suffer when such therapy fails and repeated episodes of erosion develop. A number of treatment and prophylactic options are then available but there is no agreement as to the best option. This review version is an update to the original version published in 2007 and a previous update published in 2012.
OBJECTIVES
To assess the effectiveness and adverse effects of regimens for the prophylaxis of further recurrent corneal erosion episodes, the treatment of recurrent corneal erosion and prophylaxis of the development of recurrent corneal erosion following trauma.
SEARCH METHODS
We searched CENTRAL, which contains the Cochrane Eyes and Vision Trials Register; MEDLINE; Embase; LILACS; the ISRCTN registry; ClinicalTrials.gov and the ICTRP. The date of the search was 14 December 2017.
SELECTION CRITERIA
We included randomised and quasi-randomised trials that compared a prophylactic or treatment regimen with another prophylaxis/treatment or no prophylaxis/treatment for people with recurrent corneal erosion.
DATA COLLECTION AND ANALYSIS
We used standard methods expected by Cochrane. Two authors independently screened search results, extracted data and assessed risk of bias in the included studies using the Cochrane tool for assessing risk of bias. We considered the following outcome measures: resolution of symptoms after treatment; recurrence after complete or partial resolution; symptoms (pain); adverse effects (corneal haze, astigmatism). We graded the certainty of the evidence using GRADE for the three most clinically relevant comparisons.
MAIN RESULTS
We included eight randomised and two quasi-randomised controlled trials in the review, encompassing 505 participants. Seven studies were from Europe (Germany, Sweden and the UK), two from East Asia (Hong Kong and Japan) and one from Australia. Nine of the studies examined treatments for episodes of recurrent corneal erosions and one study considered prophylaxis to prevent development of recurrent corneal erosions after injury. Two of the nine treatment studies also enrolled participants in a study of prophylaxis to prevent further episodes of recurrent corneal erosions. The studies were poorly reported; we judged only one study low risk of bias on all domains.Two studies compared therapeutic contact lens with topical lubrication but one of these studies was published over 30 years ago and used a therapeutic contact lens that is no longer in common use. The more recent study was a two-centre UK study with 29 participants. It provided low-certainty evidence on resolution of symptoms after treatment with similar number of participants in both groups experiencing resolution of symptoms at four months (risk ratio (RR) 0.97, 95% confidence interval (CI) 0.62 to 1.53). There was very low-certainty evidence on recurrence after partial or total resolution at seven months' follow-up (RR 1.07, 95% CI 0.07 to 15.54). There was no evidence of an important difference in pain score (score of 3 in the contact lens group and score of 2 in the topical lubrication group, low-certainty evidence) and no adverse effects were reported. The older study, using a contact lens no longer in common use, found an increased risk of pain and complications with the contact lens compared with hypromellose drops and paraffin ointment at night.A single-centre, Australian study, with 33 participants, provided low-certainty evidence of an increased risk of recurrence with phototherapeutic keratectomy compared with alcohol delamination but with wide confidence intervals, compatible with increased or decreased risk (RR 1.27, 95% CI 0.48 to 3.37). Time to recurrence was similar in both groups (6.5 and 6 months, low-certainty evidence). On average people receiving phototherapeutic keratectomy reported less pain but confidence intervals included no difference or greater pain (mean difference (MD) -0.70, 95% CI -2.23 to 0.83, low-certainty evidence). No adverse effects were reported.A 48-participant study in Hong Kong found recurrences were less common in people given diamond burr superficial keratectomy after epithelial debridement compared with sham diamond burr treatment after epithelial debridement (RR 0.07, 95% CI 0.01 to 0.50, moderate-certainty evidence). The study did not report pain scores but adverse effects such as corneal haze (RR 0.92, 95% CI 0.06 to 13.87, low-certainty evidence) and astigmatism (0.88 versus 0.44 dioptres, moderate-certainty evidence) were similar between the groups.A study comparing transepithelial versus subepithelial excimer laser ablation in 100 people found low-certainty evidence of a small increased risk of recurrence of corneal erosion at one-year follow-up in people given the transepithelial compared with subepithelial technique, however, the confidence intervals were wide and compatible with increased or decreased risk (RR 1.20, 95% CI 0.58 to 2.48, low-certainty evidence). Other outcomes were not reported.Other treatment comparisons included in this review were only addressed by studies published two decades or more ago. The results of these studies were inconclusive: excimer laser ablation (after epithelial debridement) versus no excimer laser ablation (after epithelial debridement), epithelial debridement versus anterior stromal puncture, anterior stromal puncture versus therapeutic contact lens, oral oxytetracycline and topical prednisolone (in addition to 'standard therapy') versus oral oxytetracycline (in addition to 'standard therapy') versus 'standard therapy'.
AUTHORS' CONCLUSIONS
Well-designed, masked, randomised controlled trials using standardised methods are needed to establish the benefits of new and existing prophylactic and treatment regimes for recurrent corneal erosion. Studies included in this review have been of insufficient size and quality to provide firm evidence to inform the development of management guidelines. International consensus is also needed to progress research efforts towards evaluation of the major effective treatments for recurrent corneal erosions.
Topics: Anti-Bacterial Agents; Contact Lenses; Corneal Diseases; Corneal Injuries; Debridement; Eye Infections; Glucocorticoids; Humans; Keratectomy; Lubricant Eye Drops; Pain Measurement; Prednisolone; Randomized Controlled Trials as Topic; Recurrence; Secondary Prevention; Tetracycline
PubMed: 29985545
DOI: 10.1002/14651858.CD001861.pub4 -
Archives of Oral Biology Mar 2021This systematic review evaluated the effect of phytotherapeutics in the treatment and prevention of 5-fluorouracil (5-FU)-induced oral mucositis (OM) in animal models. (Review)
Review
OBJECTIVES
This systematic review evaluated the effect of phytotherapeutics in the treatment and prevention of 5-fluorouracil (5-FU)-induced oral mucositis (OM) in animal models.
DESIGN
A search was performed in PubMed/Medline, CENTRAL (The Cochrane Library), EMBASE, and Web of Science, including studies published up to January 2020. Only articles investigating the chemoinduction of OM by 5-FU in animal models were included. Eligibility was evaluated and data were extracted from the eligible studies following the predefined PICO questions. The Cochrane Collaboration Risk of Bias Assessment tool was used to evaluate the quality of the included studies.
RESULT
A total of 503 articles were retrieved and 13 were included. The hamster was the animal model used in all included studies. The treatment method ranged from the topical application of ointment (n = 3), gel (n = 5) and extract (n = 3) to the oral ingestion of the phytotherapeutics (n = 3). Chamomilla recutita L. (n = 3) and Pistacia atlantica (n = 3) were the most used therapeutic agents. Although all studies were classified as high risk of bias, all of them reported promising results regarding the use of phytotherapeutics in the management of OM, including lower clinical and histopathological scores as well as healing, anti-inflammatory, antimicrobial, and antioxidant activities.
CONCLUSION
Despite the high risk of bias of the studies, phytotherapy is a promising alternative for the treatment of 5-FU-induced OM, showing interesting results in terms of tissue healing and anti-inflammatory, antimicrobial and antioxidant activity.
Topics: Animals; Anti-Infective Agents; Anti-Inflammatory Agents; Antioxidants; Cricetinae; Fluorouracil; Matricaria; Phytotherapy; Pistacia; Plant Preparations; Stomatitis
PubMed: 33485111
DOI: 10.1016/j.archoralbio.2020.104998 -
Global Advances in Health and Medicine Sep 2014Systematic review of the literature. (Review)
Review
STUDY DESIGN
Systematic review of the literature.
OBJECTIVE
To evaluate whether an integrated approach that includes different Complementary and Alternative Medicine (CAM) therapies combined or CAM therapies combined with conventional medical care is more effective for the management of low back pain (LBP) than single modalities alone.
SUMMARY OF BACKGROUND DATA
LBP is one of the leading causes of disability worldwide, yet its optimal management is still unresolved.
METHODS
The PRISMA Statement guidelines were followed. The Cochrane Back Review Group scale was used to rate the quality of the studies found.
RESULTS
Twenty-one studies were found that met the inclusion criteria. The CAM modalities used in the studies included spinal manipulative therapy, acupuncture, exercise therapy, physiotherapy, massage therapy, and a topical ointment. Twenty studies included acupuncture and/or spinal manipulative therapy. Nine high quality studies showed that integrative care was clinically effective for the management of LBP. Spinal manipulative therapy combined with exercise therapy and acupuncture combined with conventional medical care or with exercise therapy appears to be promising approaches to the management of chronic cases of LBP.
CONCLUSIONS
There is support in the literature for integrated CAM and conventional medical therapy for the management of chronic LBP. Further research into the integrated management of LBP is clearly needed to provide better guidance for patients and clinicians.
PubMed: 25568825
DOI: 10.7453/gahmj.2014.043 -
Scientific Reports Apr 2020Flap necrosis is a common complication after mastectomy, and nitroglycerin (NTG) ointment has been used successfully to treat it. However, it is not clear whether... (Meta-Analysis)
Meta-Analysis
Flap necrosis is a common complication after mastectomy, and nitroglycerin (NTG) ointment has been used successfully to treat it. However, it is not clear whether topical NTG can completely prevent the occurrence of flap necrosis after breast cancer surgery, and it is also unclear whether this treatment may cause side effects. Three randomized controlled trials (RCTs) and two retrospective cohort studies (RCSs) were included in our investigation. This meta-analysis was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We found that NTG significantly reduced the rates of mastectomy flap necrosis, full-thickness flap necrosis, and debridement as well as the rate of early complications other than flap necrosis. However, there was no significant difference in drug-related adverse reactions, explantation, superficial flap necrosis, infection, hematoma or seroma between the NTG and placebo groups.
Topics: Breast Neoplasms; Female; Humans; Mammaplasty; Mammary Glands, Human; Mastectomy; Middle Aged; Necrosis; Nitroglycerin; Ointments; Patient Safety; Seroma; Surgical Flaps; Treatment Outcome; Vasodilator Agents
PubMed: 32317705
DOI: 10.1038/s41598-020-63721-1 -
The Cochrane Database of Systematic... Jan 2010Central venous catheters (CVC) continue to play a prominent role in haemodialysis vascular access with 46% to 70% of patients commencing haemodialysis via a CVC. CVC... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Central venous catheters (CVC) continue to play a prominent role in haemodialysis vascular access with 46% to 70% of patients commencing haemodialysis via a CVC. CVC access is associated with catheter-related infections, increased patient hospitalisations and death due to infection. A variety of interventions are used to prevent CVC infection.
OBJECTIVES
To evaluate the benefits and harms of prophylactic topical antimicrobials, topical antiseptics, medicated and non-medicated dressings on infectious complications among haemodialysis patients with CVC.
SEARCH STRATEGY
We searched the Cochrane Renal Group's specialised register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and reference lists of articles without language restriction.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) and quasi-RCTs investigating any intervention that prevented infectious complications among haemodialysis patients with CVC. We excluded antimicrobial impregnated CVC or CVC using locking solutions with antimicrobial properties.
DATA COLLECTION AND ANALYSIS
Two authors assessed study quality and extracted data. Dichotomous outcomes were expressed as risk ratios (RR) with 95% confidence intervals (CI) and continuous outcomes as mean differences (MD).
MAIN RESULTS
Ten studies (786 patients) were included. Mupirocin ointment reduced the risk of catheter-related bacteraemia (RR 0.17, 95%CI 0.07 to 0.43) and had a significant effect on catheter-related infections caused by S. aureus. The risk of catheter-related bacteraemia was reduced by polysporin (RR 0.40, 95%CI 0.19 to 0.86) and povidone-iodine ointment (RR 0.10, 95%CI 0.01 to 0.72). Subgroup analysis suggested mupirocin (RR 0.12, 95%CI 0.01 to 2.13) and povidone-iodine ointment (RR 0.84, 95%CI 0.24 to 2.98) had no effect on all-cause mortality while polysporin ointment showed a significant reduction (RR 0.22, 95%CI 0.07 to 0.74). Mortality related to infection was not reduced by mupirocin, polysporin or povidone-iodine ointment. Topical honey did not reduce the risk of exit site infection (RR 0.45, 95%CI 0.10 to 2.11) or catheter-related bacteraemia (RR 0.80, 95%CI 0.37 to 1.73). Transparent polyurethane dressing compared to dry gauze dressing did not reduce the risk of CVC or exit site infection, or catheter-related bacteraemia.
AUTHORS' CONCLUSIONS
Mupirocin ointment appears effective in reducing the risk of catheter-related bacteraemia. Insufficient reporting on mupirocin resistance was noted and needs to be considered in future studies. A lack of high quality data on the routine use of povidone-iodine ointment, polysporin ointment and topical honey warrant larger RCTs. Insufficient data were available to determine which dressing type (transparent polyurethane or dry gauze dressing) has the lowest risk of catheter-related infections.
Topics: Apitherapy; Bacitracin; Bacteremia; Catheter-Related Infections; Catheterization, Central Venous; Drug Combinations; Gramicidin; Humans; Mupirocin; Polymyxin B; Povidone-Iodine; Randomized Controlled Trials as Topic; Renal Dialysis; Staphylococcal Infections
PubMed: 20091610
DOI: 10.1002/14651858.CD006894.pub2 -
Lasers in Medical Science Mar 2014More than just a cosmetic concern, onychomycosis is a prevalent and extremely difficult condition to treat. In older and diabetic populations, severe onychomycosis may... (Meta-Analysis)
Meta-Analysis
More than just a cosmetic concern, onychomycosis is a prevalent and extremely difficult condition to treat. In older and diabetic populations, severe onychomycosis may possibly serve as a nidus for infection, and other more serious complications may ensue. Many treatment modalities for the treatment of onychomycosis have been studied, including topical lacquers and ointments, oral antifungals, surgical and chemical nail avulsion, and lasers. Due to their minimally invasive nature and potential to restore clear nail growth with relatively few sessions, lasers have become a popular option in the treatment of onychomycosis for both physicians and patients. Laser or light systems that have been investigated for this indication include the carbon dioxide, neodymium-doped yttrium aluminum garnet, 870/930-nm combination, and femtosecond infrared 800-nm lasers, in addition to photodynamic and ultraviolet light therapy. This systematic review will discuss each of these modalities as well as their respective currently published, peer-reviewed literature.
Topics: Aluminum; Humans; Laser Therapy; Lasers, Gas; Neodymium; Onychomycosis; Photochemotherapy; Photosensitizing Agents; Phototherapy; Titanium; Ultraviolet Therapy; Yttrium
PubMed: 23179307
DOI: 10.1007/s10103-012-1232-y -
Journal of the American Academy of... Jun 2018Multiple placebo-controlled trials have assessed locally applied topical nitrate preparations in treating Raynaud's phenomenon (RP). (Meta-Analysis)
Meta-Analysis
BACKGROUND
Multiple placebo-controlled trials have assessed locally applied topical nitrate preparations in treating Raynaud's phenomenon (RP).
OBJECTIVES
The objective of this meta-analysis was to assess the effects of local topical nitrates in primary and secondary RP with respect to a combined end point integrating parameters of digital blood flow and clinical severity.
METHODS
A systematic review was performed using MEDLINE, Embase, and the Cochrane library. Only trials comparing locally applied topical nitrates with placebo comparators were included. Studies were appraised for bias by 2 independent reviewers.
RESULTS
A total of 7 placebo-controlled trials including 346 patients were used in the meta-analysis; 4 trials used nitroglycerin ointments, 2 used the nitroglycerin gel vehicle MQX-503, and 1 used compounded nitrite. The meta-analysis results supported a moderate-to-large treatment effect in RP (standardized mean difference [SMD] = 0.70; 95% CI, 0.35-1.05; P < .0001). Subgroup analyses showed a large treatment effect in secondary RP (SMD = 0.95; 95% CI, 0.25-1.65; P = .008) and moderate effect in primary RP (SMD = 0.45; 95% CI, 0.05-0.85; P = .03).
LIMITATIONS
Limitations include the inclusion of multiple topical nitrate preparations and integration of different outcomes assessments.
CONCLUSION
Local topical nitrates have significant efficacy in the treatment of both primary and secondary RP.
Topics: Administration, Topical; Controlled Clinical Trials as Topic; Female; Humans; Male; Nitrates; Patient Safety; Prognosis; Raynaud Disease; Severity of Illness Index; Treatment Outcome
PubMed: 29408338
DOI: 10.1016/j.jaad.2018.01.043 -
The Cochrane Database of Systematic... Feb 2017Pressure ulcers are common in clinical practice and pose a significant health problem worldwide. Apart from causing suffering to patients, they also result in longer... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Pressure ulcers are common in clinical practice and pose a significant health problem worldwide. Apart from causing suffering to patients, they also result in longer hospital stays and increase the cost of health care. A variety of methods are used for treating pressure ulcers, including pressure relief, patient repositioning, biophysical strategies, nutritional supplementation, debridement, topical negative pressure, and local treatments including dressings, ointments and creams such as bacitracin, silver sulphadiazine, neomycin, and phenytoin. Phenytoin is a drug more commonly used in the treatment of epilepsy, but may play an important role in accelerating ulcer healing.
OBJECTIVES
To assess the effects of topical phenytoin on the rate of healing of pressure ulcers of any grade, in any care setting.
SEARCH METHODS
In September 2016, we searched the following electronic databases to identify relevant randomized clinical trials: the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library); Ovid MEDLINE; Ovid Embase; and EBSCO CINAHL Plus. We handsearched conference proceedings from the European Pressure Ulcer Advisory Panel, European Wound Management Association and the Tissue Viability Society for all available years. We searched the references of the retrieved trials to identify further relevant trials. We also searched clinical trials registries to identify ongoing and unpublished studies. There were no restrictions with respect to language, date of publication or study setting.
SELECTION CRITERIA
We included all randomized controlled trials (RCTs) addressing the effects (both benefits and harms) of topical phenytoin on the healing of pressure ulcers of any grade compared with placebo or alternative treatments or no therapy, irrespective of blinding, language, and publication status.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected studies, extracted information on participants, interventions, methods and results and assessed risk of bias using Cochrane methodological procedures. For dichotomous variables, we calculated the risk ratio (RR) with 95% confidence interval (CI). For continuous variables, we calculated the mean difference with 95% CI. We rated the quality of the evidence by using Grading of Recommendations, Assessment, Development and Evaluation approach (GRADE).
MAIN RESULTS
Three small RCTs met our inclusion criteria and included a total of 148 participants. These compared three treatments with topical phenytoin: hydrocolloid dressings, triple antibiotic ointment and simple dressings. In the three RCTs, 79% of participants had grade II ulcers, and 21% of participants had grade I ulcers; no participants had grade III or IV ulcers. Two RCTs had a high risk of bias overall and the other RCT was at unclear risk of bias due to poor reporting. Two RCTs had three intervention arms and the other had two intervention arms.Two studies compared topical phenytoin with hydrocolloid dressing (84 participants analysed). The available data suggest that hydrocolloid dressings may improve ulcer healing compared to topical phenytoin (39.3% ulcers healed for phenytoin versus 71.4% ulcers healed for hydrocolloid dressings (RR 0.55, 95% CI 0.33 to 0.92; 56 participants, 1 study; low quality evidence). We downgraded the evidence twice: once due to serious limitations (high risk of bias) and once due to the small sample size and small number of events. Two studies compared topical phenytoin with simple dressings (81 participants analysed). From the available data, we are uncertain whether topical phenytoin improves ulcer healing compared to simple dressings (39.3% ulcers healed for phenytoin versus 29.6% ulcers healed for the simple dressing (RR 1.33, 95% CI 0.63 to 2.78; 55 participants, 1 study; very low quality evidence). This evidence was downgraded once due to serious limitations (high risk of bias) and twice due to the low number of outcome events and resulting wide CI which included the possibility of both increased healing and reduced healing. We therefore considered it to be insufficient to determine the effect of topical phenytoin on ulcer healing. One study compared topical phenytoin with triple antibiotic ointment, however, none of the outcomes of interest to this review were reported. No adverse drug reactions or interactions were detected in any of the three RCTs. Minimal pain was reported in all groups in one trial that compared topical phenytoin with hydrocolloid dressings and triple antibiotic ointment.
AUTHORS' CONCLUSIONS
This review has considered the available evidence and the result shows that it is uncertain whether topical phenytoin improves ulcer healing for patients with grade I and II pressure ulcers. No adverse events were reported from three small trials and minimal pain was reported in one trial. Therefore, further rigorous, adequately powered RCTs examining the effects of topical phenytoin for treating pressure ulcers, and to report on adverse events, quality of life and costs are necessary.
Topics: Administration, Topical; Anti-Bacterial Agents; Bandages; Bandages, Hydrocolloid; Dermatologic Agents; Humans; Ointments; Phenytoin; Pressure Ulcer; Randomized Controlled Trials as Topic
PubMed: 28225152
DOI: 10.1002/14651858.CD008251.pub2