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Advances in Therapy Mar 2020Studies assessing the effect of high dose tigecycline on severe infections are limited and remain controversial. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Studies assessing the effect of high dose tigecycline on severe infections are limited and remain controversial.
OBJECTIVES
To assess systematically the effectiveness and safety of high dose tigecycline in the treatment of severe infections.
METHODS
Pubmed, Web of Science, Embase, MEDLINE, Cochrane Library and ClinicalTrials were searched up to February 20, 2019 for studies that compared the effectiveness and safety of high dose tigecycline with standard dose tigecycline or other non-tigecycline-containing regimens in the treatment of severe infections. Rates for all-cause mortality, clinical cure, microbiological eradication and adverse events were analysed.
RESULTS
Ten studies with 593 patients were included. The results indicated that using high dose tigecycline resulted in better outcomes compared with controls with lower all-cause mortality (OR 0.44, 95% CI 0.30-0.66, p < 0.0001), higher clinical cure (OR 3.43, 95% CI 2.09-5.63, p < 0.00001), higher microbiological eradication (OR 2.25, 95% CI 1.44-3.50, p = 0.0003), and without increasing adverse events rates. Subgroup analysis showed that high dose tigecycline reduced all-cause mortality in nosocomial acquired pneumonia (OR 0.39, 95% CI 0.22-0.70, p = 0.002), bloodstream infections (OR 0.19, 95% CI 0.06-0.58, p = 0.004) and mixed infections (OR 0.20, 95% CI 0.07-0.59, p = 0.003), with no statistical differences in complicated intra-abdominal infections (OR 2.04, 95% CI 0.80-5.23, p = 0.14). In carbapenem-resistant pathogens, the microbiological eradication rate in those given high dose tigecycline did not differ from controls (OR 1.07, 95% CI 0.44-2.60, p = 0.87), although mortality was reduced (OR 0.20, 95% CI 0.09-0.45, p = 0.0001). The main limitation of the review is that most of the included studies are observational studies with small sample sizes and high risks of bias.
CONCLUSIONS
High dose tigecycline treatment is effective and safe for severe infections owing to its lower all-cause mortality, higher clinical cure, microbiological eradication and comparable adverse events. However, as a result of the high risks of bias of the included studies, well-designed randomised clinical trials are warranted to establish the effectiveness and safety of high dose tigecycline compared with standard dose tigecycline and other commonly used antibiotics.
Topics: Anti-Bacterial Agents; Drug Resistance, Bacterial; Humans; Infections; Observational Studies as Topic; Severity of Illness Index; Tigecycline
PubMed: 32006240
DOI: 10.1007/s12325-020-01235-y -
Oxidative Medicine and Cellular... 2021Despite evidence of health benefits from kefir administration, a systematic review with meta-analysis on bioactive compounds associated with these benefits is still... (Meta-Analysis)
Meta-Analysis
Despite evidence of health benefits from kefir administration, a systematic review with meta-analysis on bioactive compounds associated with these benefits is still absent in the literature. Kefir is fermented milk resulting from the metabolism of a complex microbiota in symbiosis. Recent researches have investigated the bioactive compounds responsible for the preventive and therapeutic effects attributed to kefir. However, differences in functional potential between industrial and artisanal kefir are still controversial. Firstly, we identified differences in the microbial composition among both types of kefir. Available evidence concerning the action of different bioactive compounds from kefir on health, both from and studies, was subsequently summarized to draw a primary conclusion of the dose and the intervention time for effect, the producer microorganisms, the precursor in the milk, and the action mechanism. Meta-analysis was performed to investigate the statistically significant differences ( < 0.05) between intervention and control and between both types of kefir for each health effect studied. In summary, the bioactive compounds more commonly reported were exopolysaccharides, including kefiran, bioactive peptides, and organic acids, especially lactic acid. Kefir bioactive compounds presented antimicrobial, anticancer, and immune-modulatory activities corroborated by the meta-analysis. However, clinical evidence is urgently needed to strengthen the practical applicability of these bioactive compounds. The mechanisms of their action were diverse, indicating that they can act by different signaling pathways. Still, industrial and artisanal kefir may differ regarding functional potential-OR of 8.56 (95% CI: 2.27-32.21, ≤ .001)-according to the observed health effect, which can be associated with differences in the microbial composition between both types of kefir.
Topics: Animals; Anti-Infective Agents; Antineoplastic Agents; Biological Products; Fermentation; Humans; Immunomodulating Agents; Kefir; Milk
PubMed: 34745425
DOI: 10.1155/2021/9081738 -
European Journal of Internal Medicine May 2022To evaluate the evidence concerning the effectiveness of antiseptic barrier caps vs. manual disinfection in preventing central line-associated bloodstream infection... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
To evaluate the evidence concerning the effectiveness of antiseptic barrier caps vs. manual disinfection in preventing central line-associated bloodstream infection (CLABSI).
METHODS
The protocol of this systematic review and meta-analysis was pre-registered in PROSPERO (CRD42021259582). PubMed, Cochrane Library and Web of Science databases were searched from 2011 to 2021. Randomized-controlled trials (RCT) and observational studies on hospitalized patients of any age were included.
RESULTS
Fourteen studies were included. Compared with manual disinfection, antiseptic barrier caps significantly reduced CLABSI rate per 1000 line-days (Standardized Mean Difference [SMD]: -0.02; 95%CI: -0.03 to -0.01) and number of CLABSI per patient (RR: 0.60; 95%CI: 0.41-0.89). Subgroup analysis showed that antiseptic barrier caps were more effective in reducing CLABSI rate per 1000 line-days in ICU (SMD: -0.02; 95%CI: -0.03 to -0.01) and non-ICU patients (SMD: -0.03; 95%CI: -0.05 to -0.01), adults (SMD: -0.02; 95%CI: -0.04 to -0.01), as in observational studies (SMD: -0.02; 95%CI: -0.02 to -0.01). Antiseptic barrier caps also significantly reduce CLABSI risk in ICU patients (RR: 0.65, 95%CI: 0.42-1.00), adults (RR: 0.50, 95%CI: 0.29-0.86), and observational studies (RR: 0.54; 95%CI: 0.32-0.91). No differences were found when only children or RCTs were taken into account. Median cost savings amongst studies were $21,890 [IQR 16,350-45,000] per CLABSI.
CONCLUSIONS
Antiseptic barrier caps appear to be effective in reducing CLABSI. The real-world impact needs to be confirmed by RCTs.
Topics: Adult; Anti-Infective Agents, Local; Catheter-Related Infections; Child; Humans; Sepsis
PubMed: 35151542
DOI: 10.1016/j.ejim.2022.01.040 -
The Cochrane Database of Systematic... Nov 2022Typhoid and paratyphoid (enteric fever) are febrile bacterial illnesses common in many low- and middle-income countries. The World Health Organization (WHO) currently... (Review)
Review
BACKGROUND
Typhoid and paratyphoid (enteric fever) are febrile bacterial illnesses common in many low- and middle-income countries. The World Health Organization (WHO) currently recommends treatment with azithromycin, ciprofloxacin, or ceftriaxone due to widespread resistance to older, first-line antimicrobials. Resistance patterns vary in different locations and are changing over time. Fluoroquinolone resistance in South Asia often precludes the use of ciprofloxacin. Extensively drug-resistant strains of enteric fever have emerged in Pakistan. In some areas of the world, susceptibility to old first-line antimicrobials, such as chloramphenicol, has re-appeared. A Cochrane Review of the use of fluoroquinolones and azithromycin in the treatment of enteric fever has previously been undertaken, but the use of cephalosporins has not been systematically investigated and the optimal choice of drug and duration of treatment are uncertain.
OBJECTIVES
To evaluate the effectiveness of cephalosporins for treating enteric fever in children and adults compared to other antimicrobials.
SEARCH METHODS
We searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL, MEDLINE, Embase, LILACS, the WHO ICTRP and ClinicalTrials.gov up to 24 November 2021. We also searched reference lists of included trials, contacted researchers working in the field, and contacted relevant organizations.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) in adults and children with enteric fever that compared a cephalosporin to another antimicrobial, a different cephalosporin, or a different treatment duration of the intervention cephalosporin. Enteric fever was diagnosed on the basis of blood culture, bone marrow culture, or molecular tests.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Our primary outcomes were clinical failure, microbiological failure and relapse. Our secondary outcomes were time to defervescence, duration of hospital admission, convalescent faecal carriage, and adverse effects. We used the GRADE approach to assess certainty of evidence for each outcome.
MAIN RESULTS
We included 27 RCTs with 2231 total participants published between 1986 and 2016 across Africa, Asia, Europe, the Middle East and the Caribbean, with comparisons between cephalosporins and other antimicrobials used for the treatment of enteric fever in children and adults. The main comparisons are between antimicrobials in most common clinical use, namely cephalosporins compared to a fluoroquinolone and cephalosporins compared to azithromycin. Cephalosporin (cefixime) versus fluoroquinolones Clinical failure, microbiological failure and relapse may be increased in patients treated with cefixime compared to fluoroquinolones in three small trials published over 14 years ago: clinical failure (risk ratio (RR) 13.39, 95% confidence interval (CI) 3.24 to 55.39; 2 trials, 240 participants; low-certainty evidence); microbiological failure (RR 4.07, 95% CI 0.46 to 36.41; 2 trials, 240 participants; low-certainty evidence); relapse (RR 4.45, 95% CI 1.11 to 17.84; 2 trials, 220 participants; low-certainty evidence). Time to defervescence in participants treated with cefixime may be longer compared to participants treated with fluoroquinolones (mean difference (MD) 1.74 days, 95% CI 0.50 to 2.98, 3 trials, 425 participants; low-certainty evidence). Cephalosporin (ceftriaxone) versus azithromycin Ceftriaxone may result in a decrease in clinical failure compared to azithromycin, and it is unclear whether ceftriaxone has an effect on microbiological failure compared to azithromycin in two small trials published over 18 years ago and in one more recent trial, all conducted in participants under 18 years of age: clinical failure (RR 0.42, 95% CI 0.11 to 1.57; 3 trials, 196 participants; low-certainty evidence); microbiological failure (RR 1.95, 95% CI 0.36 to 10.64, 3 trials, 196 participants; very low-certainty evidence). It is unclear whether ceftriaxone increases or decreases relapse compared to azithromycin (RR 10.05, 95% CI 1.93 to 52.38; 3 trials, 185 participants; very low-certainty evidence). Time to defervescence in participants treated with ceftriaxone may be shorter compared to participants treated with azithromycin (mean difference of -0.52 days, 95% CI -0.91 to -0.12; 3 trials, 196 participants; low-certainty evidence). Cephalosporin (ceftriaxone) versus fluoroquinolones It is unclear whether ceftriaxone has an effect on clinical failure, microbiological failure, relapse, and time to defervescence compared to fluoroquinolones in three trials published over 28 years ago and two more recent trials: clinical failure (RR 3.77, 95% CI 0.72 to 19.81; 4 trials, 359 participants; very low-certainty evidence); microbiological failure (RR 1.65, 95% CI 0.40 to 6.83; 3 trials, 316 participants; very low-certainty evidence); relapse (RR 0.95, 95% CI 0.31 to 2.92; 3 trials, 297 participants; very low-certainty evidence) and time to defervescence (MD 2.73 days, 95% CI -0.37 to 5.84; 3 trials, 285 participants; very low-certainty evidence). It is unclear whether ceftriaxone decreases convalescent faecal carriage compared to the fluoroquinolone gatifloxacin (RR 0.18, 95% CI 0.01 to 3.72; 1 trial, 73 participants; very low-certainty evidence) and length of hospital stay may be longer in participants treated with ceftriaxone compared to participants treated with the fluoroquinolone ofloxacin (mean of 12 days (range 7 to 23 days) in the ceftriaxone group compared to a mean of 9 days (range 6 to 13 days) in the ofloxacin group; 1 trial, 47 participants; low-certainty evidence).
AUTHORS' CONCLUSIONS
Based on very low- to low-certainty evidence, ceftriaxone is an effective treatment for adults and children with enteric fever, with few adverse effects. Trials suggest that there may be no difference in the performance of ceftriaxone compared with azithromycin, fluoroquinolones, or chloramphenicol. Cefixime can also be used for treatment of enteric fever but may not perform as well as fluoroquinolones. We are unable to draw firm general conclusions on comparative contemporary effectiveness given that most trials were small and conducted over 20 years previously. Clinicians need to take into account current, local resistance patterns in addition to route of administration when choosing an antimicrobial.
Topics: Child; Adult; Humans; Adolescent; Paratyphoid Fever; Typhoid Fever; Cephalosporins; Azithromycin; Ceftriaxone; Cefixime; Fluoroquinolones; Anti-Bacterial Agents; Chloramphenicol; Anti-Infective Agents; Monobactams; Ciprofloxacin; Ofloxacin; Recurrence; Pakistan
PubMed: 36420914
DOI: 10.1002/14651858.CD010452.pub2 -
The Ocular Surface Oct 2019We conducted a systematic review and meta-analysis to evaluate the efficacy of different treatment for Demodex blepharitis. Parameters studied were mites count,... (Meta-Analysis)
Meta-Analysis
PURPOSE
We conducted a systematic review and meta-analysis to evaluate the efficacy of different treatment for Demodex blepharitis. Parameters studied were mites count, improvement of symptoms and mites' eradication, stratified on type of treatments and mode of delivery of treatments (local or systemic).
METHOD
The PubMed, Cochrane Library, Embase, ClinicalTrials.gov, Google scholar and Science Direct databases were searched for studies reporting an efficacy of treatments for Demodex blepharitis.
RESULTS
We included 19 studies (14 observational and 5 randomized clinical trials), for a total of 934 patients, 1741 eyes, and 13 different treatments. For mites count, eradication rate, and symptoms improvement, meta-analysis included fifteen, fourteen and thirteen studies, respectively. The overall effect sizes for efficiency of all treatments, globally, were 1.68 (95CI 1.25 to 2.12), 0.45 (0.26-0.64), and 0.76 (0.59-0.90), respectively. Except usual lid hygiene for mites count, Children's Hospital of Eastern Ontario ointment (CHEO) for both eradication rate and symptoms, and CHEO, 2% metronidazole ointment, and systemic metronidazole for eradication rate, all treatments were efficient. Stratified meta-analysis did not show significant differences between local and systemic treatments (1.22, 0.83 to 1.60 vs 2.24, 1.30 to 3.18 for mites count; 0.37, 0.21 to 0.54 vs 0.56, 0.06 to 0.99 for eradication rate; and 0.77, 0.58 to 0.92 vs 0.67, 0.25 to 0.98 for symptoms improvement).
CONCLUSION
We reported the efficiency of the different treatments of Demodex blepharitis. Because of less systemic side effects, local treatments seem promising molecules in the treatment of Demodex blepharitis.
Topics: Animals; Anti-Infective Agents, Local; Antiparasitic Agents; Blepharitis; Eye Infections, Parasitic; Humans; Ivermectin; Metronidazole; Miotics; Mite Infestations; Mites; Pilocarpine; Tea Tree Oil
PubMed: 31229586
DOI: 10.1016/j.jtos.2019.06.004 -
American Journal of Infection Control Jul 2023Reliable and safe venous access is crucial for patients using central venous catheters (CVC). However, such CVCs carry a risk for central line-associated bloodstream... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Reliable and safe venous access is crucial for patients using central venous catheters (CVC). However, such CVCs carry a risk for central line-associated bloodstream infections (CLABSIs). Antiseptic barrier caps (ABCs) are a novel tool in the armamentarium for CVC disinfection. Our aim was to review the efficacy and safety of ABCs.
METHOD
A literature search was conducted using MedLine, EMBASE, Cochrane library, and CINAHL. Primary aim was to compare CLABSI rates in patients using ABCs versus standard care. Secondary aims included efficacy of ABCs in relevant subgroups (age, ABC brand, clinical setting), safety, compliance, and costs. Fifteen studies were included in the meta-analysis.
RESULTS
In total, 391 CLABSIs in 273,993 catheter days occurred in the intervention group versus 620 CLABSIs in 284,912 days in the standard care group, resulting in a risk ratio of 0.65 (95%CI 0.55-0.76; P < .00001). Subgroup analyses showed similar effects, except for nonintensive care unit. In general, ABCs were safe, highly appreciated by patients and caregivers, and cost-effective, while compliance was easy to monitor. In most studies, a substantial risk of bias was observed.
CONCLUSION
In conclusion, while available evidence suggests that ABCs are effective, safe, easy in use, and cost-effective. However, due to the poor methodological quality of most available studies, more robust data should justify their use at this point.
Topics: Humans; Catheter-Related Infections; Central Venous Catheters; Disinfection; Anti-Infective Agents, Local; Sepsis; Catheterization, Central Venous
PubMed: 36116679
DOI: 10.1016/j.ajic.2022.09.005 -
International Journal of Nursing Studies Mar 2022Chlorhexidine and povidone-iodine are the most common disinfectants used in preoperative skin preparation. However, there is no consistent conclusion regarding the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Chlorhexidine and povidone-iodine are the most common disinfectants used in preoperative skin preparation. However, there is no consistent conclusion regarding the prevention of surgical site infection (SSI) and bacterial culture data.
OBJECTIVE
To assess the efficacy of chlorhexidine and povidone-iodine in the prevention of postoperative SSI and relevant bacterial data.
DESIGN
Systematic Review and Meta-Analysis SETTINGS: N/A PARTICIPANTS: N/A METHOD: Literature relevant to "skin antisepsis" and "surgical site infections" was retrieved from PUBMED, Web of Science, EMBASE, CINHAL and CNKI. The incidence of SSI was the primary outcome, while the secondary outcome was bacterial data from the infected incision. All data were analyzed with Revman 5.3 and Stata Statistical Software.
RESULTS
A total of 36 studies were identified in this study, which included 16,872 participants. This study revealed that chlorhexidine is superior to povidone-iodine in the prevention of postoperative SSI (risk ratio [RR], 0.73; 95% confidence interval [CI], 0.61-0.87; p = 0.019, I = 39%). Further meta-regression analysis revealed that the effect of chlorhexidine was directly associated with the type of incision, but failed to differentiate between the subgroups divided according to the type of incision. With respect to bacteria colonization, the most common bacteria for chlorhexidine arm were propionibacterium's, while the most common bacteria for the iodine arm were staphylococci species.
CONCLUSION
In comparison to povidone-iodine, chlorhexidine showed better results in preventing postoperative SSI.
Topics: Anti-Infective Agents, Local; Chlorhexidine; Humans; Iodine; Preoperative Care; Surgical Wound Infection
PubMed: 35121520
DOI: 10.1016/j.ijnurstu.2021.104059 -
The Journal of Antibiotics Sep 2020Ivermectin proposes many potentials effects to treat a range of diseases, with its antimicrobial, antiviral, and anti-cancer properties as a wonder drug. It is highly...
Ivermectin proposes many potentials effects to treat a range of diseases, with its antimicrobial, antiviral, and anti-cancer properties as a wonder drug. It is highly effective against many microorganisms including some viruses. In this comprehensive systematic review, antiviral effects of ivermectin are summarized including in vitro and in vivo studies over the past 50 years. Several studies reported antiviral effects of ivermectin on RNA viruses such as Zika, dengue, yellow fever, West Nile, Hendra, Newcastle, Venezuelan equine encephalitis, chikungunya, Semliki Forest, Sindbis, Avian influenza A, Porcine Reproductive and Respiratory Syndrome, Human immunodeficiency virus type 1, and severe acute respiratory syndrome coronavirus 2. Furthermore, there are some studies showing antiviral effects of ivermectin against DNA viruses such as Equine herpes type 1, BK polyomavirus, pseudorabies, porcine circovirus 2, and bovine herpesvirus 1. Ivermectin plays a role in several biological mechanisms, therefore it could serve as a potential candidate in the treatment of a wide range of viruses including COVID-19 as well as other types of positive-sense single-stranded RNA viruses. In vivo studies of animal models revealed a broad range of antiviral effects of ivermectin, however, clinical trials are necessary to appraise the potential efficacy of ivermectin in clinical setting.
Topics: Animals; Antiviral Agents; Betacoronavirus; Cell Line; DNA Viruses; Disease Models, Animal; Global Health; Humans; Ivermectin; Molecular Structure; RNA Viruses; SARS-CoV-2
PubMed: 32533071
DOI: 10.1038/s41429-020-0336-z -
Pharmacological Research Jan 2021Ivermectin is a macrolide antiparasitic drug with a 16-membered ring that is widely used for the treatment of many parasitic diseases such as river blindness,...
Ivermectin is a macrolide antiparasitic drug with a 16-membered ring that is widely used for the treatment of many parasitic diseases such as river blindness, elephantiasis and scabies. Satoshi ōmura and William C. Campbell won the 2015 Nobel Prize in Physiology or Medicine for the discovery of the excellent efficacy of ivermectin against parasitic diseases. Recently, ivermectin has been reported to inhibit the proliferation of several tumor cells by regulating multiple signaling pathways. This suggests that ivermectin may be an anticancer drug with great potential. Here, we reviewed the related mechanisms by which ivermectin inhibited the development of different cancers and promoted programmed cell death and discussed the prospects for the clinical application of ivermectin as an anticancer drug for neoplasm therapy.
Topics: Animals; Antineoplastic Agents; Antiparasitic Agents; Cell Death; Humans; Ivermectin; Molecular Targeted Therapy; Neoplasms; Signal Transduction
PubMed: 32971268
DOI: 10.1016/j.phrs.2020.105207 -
The Cochrane Database of Systematic... Mar 2021Leg ulcers are open skin wounds that occur below the knee but above the foot. The majority of leg ulcers are venous in origin, occurring as a result of venous... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Leg ulcers are open skin wounds that occur below the knee but above the foot. The majority of leg ulcers are venous in origin, occurring as a result of venous insufficiency, where the flow of blood through the veins is impaired; they commonly arise due to blood clots and varicose veins. Compression therapy, using bandages or stockings, is the primary treatment for venous leg ulcers. Wound cleansing can be used to remove surface contaminants, bacteria, dead tissue and excess wound fluid from the wound bed and surrounding skin, however, there is uncertainty regarding the effectiveness of cleansing and the best method or solution to use.
OBJECTIVES
To assess the effects of wound cleansing, wound cleansing solutions and wound cleansing techniques for treating venous leg ulcers.
SEARCH METHODS
In September 2019 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.
SELECTION CRITERIA
We considered randomised controlled trials (RCTs) comparing wound cleansing with no wound cleansing, or RCTs comparing different wound cleansing solutions, or different wound cleansing techniques.
DATA COLLECTION AND ANALYSIS
We screened studies for their appropriateness for inclusion, assessed their risk of bias using the Cochrane 'Risk of bias' tool, and used GRADE methodology to determine the certainty of evidence. Two review authors undertook these tasks independently, using predetermined criteria. We contacted study authors for missing data where possible.
MAIN RESULTS
We included four studies with a total of 254 participants. All studies included comparisons between different types of cleansing solutions, and three of these reported our primary outcomes of complete wound healing or change in ulcer size over time, or both. Two studies reported the secondary outcome, pain. One study (27 participants), which compared polyhexamethylene biguanide (PHMB) solution with saline solution for cleansing venous leg ulcers, did not report any of the review's primary or secondary outcomes. We did not identify any studies that compared cleansing with no cleansing, or that explored comparisons between different cleansing techniques. One study (61 participants) compared aqueous oxygen peroxide with sterile water. We are uncertain whether aqueous oxygen peroxide makes any difference to the number of wounds completely healed after 12 months of follow-up (risk ratio (RR) 1.88, 95% confidence interval (CI) 1.10 to 3.20). Similarly, we are uncertain whether aqueous oxygen peroxide makes any difference to change in ulcer size after eight weeks of follow-up (mean difference (MD) -1.38 cm, 95% CI -4.35 to 1.59 cm). Finally, we are uncertain whether aqueous oxygen peroxide makes any difference to pain reduction, assessed after eight weeks of follow-up using a 0 to 100 pain rating, (MD 3.80, 95% CI -10.83 to 18.43). The evidence for these outcomes is of very low certainty (we downgraded for study limitations and imprecision; for the pain outcome we also downgraded for indirectness). Another study (40 participants) compared propyl betaine and polihexanide with a saline solution. The authors did not present the raw data in the study report so we were unable to conduct independent statistical analysis of the data. We are uncertain whether propyl betaine and polihexanide make any difference to the number of wounds completely healed, change in ulcer size over time, or wound pain reduction. The evidence is of very low certainty (we downgraded for study limitations and imprecision). The final study (126 participants) compared octenidine dihydrochloride/phenoxyethanol (OHP) with Ringer's solution. We are uncertain whether OHP makes any difference to the number of wounds healed (RR 0.96, 95% CI 0.53 to 1.72) or to the change in ulcer size over time (we were unable to conduct independent statistical analysis of available data). The evidence is of very low certainty (we downgraded for study limitations and imprecision). None of the studies reported patient preference, ease of use of the method of cleansing, cost or health-related quality of life. In one study comparing propyl betaine and polihexanide with saline solution the authors do not report any adverse events occurring. We are uncertain whether OHP makes any difference to the number of adverse events compared with Ringer's solution (RR 0.58, 95% CI 0.29 to 1.14). The evidence is of very low certainty (we downgraded for study limitations and imprecision).
AUTHORS' CONCLUSIONS
There is currently a lack of RCT evidence to guide decision making about the effectiveness of wound cleansing compared with no cleansing and the optimal approaches to cleansing of venous leg ulcers. From the four studies identified, there is insufficient evidence to demonstrate whether the use of PHMB solution compared with saline solution; aqueous oxygen peroxide compared with sterile water; propyl betaine and polihexanide compared with a saline solution; or OHP compared with Ringer's solution makes any difference in the treatment of venous leg ulcers. Evidence from three of the studies is of very low certainty, due to study limitations and imprecision. One study did not present data for the primary or secondary outcomes. Further well-designed studies that address important clinical, quality of life and economic outcomes may be important, based on the clinical and patient priority of this uncertainty.
Topics: Aged; Anti-Infective Agents, Local; Betaine; Bias; Biguanides; Confidence Intervals; Detergents; Disinfectants; Ethylene Glycols; Female; Humans; Hydrogen Peroxide; Imines; Male; Middle Aged; Pain Measurement; Pyridines; Randomized Controlled Trials as Topic; Ringer's Solution; Saline Solution; Varicose Ulcer; Wound Healing
PubMed: 33734426
DOI: 10.1002/14651858.CD011675.pub2