Evaluation of Bensal HP for the treatment of diabetic foot ulcers
ABSTRACT The extract of oak bark (QRB7) has been used for years as a topical medication with success. QRB7 is the proprietary oak bark extract in Bensal HP. It is indicated as an external treatment for the inflammation and irritation associated with many common forms of dermatitis, including certain eczematoid conditions. These conditions include complications associated with pyodermas, and in the treatment of insect bites, burns, and fungal infections.
To quantitatively measure the difference in diabetic ulcer size reduction when using Bensal HP versus silver sulfadiazine cream (SSC) for topical treatment as an adjunct to conventional treatment.
Private office of the primary author.
Forty diabetic patients with noncellulitic plantar Wagner grade 1 or 2 ulcers and a minimal ankle brachial index of 0.75 were randomly assigned to either the Bensal HP (QRB7) treatment group or SSC control group for 6 weeks of treatment. In addition to either Bensal HP or SSC, all wounds were cultured and treated with debridement at time 0, 2, 4, and 6 weeks and with off-loading.
The combined wound diameter of the Bensal HP group decreased 72.5% compared to 54.7% for the SSC group. There was a statistical significance between the decreases in wound sizes after 6 weeks of treatment (P = .016). The Cohen effect size for the Bensal HP group was 2.06 compared with 1.03 for the SSC group.
In this tightly controlled 6-week study in which no patients were lost to follow-up, Bensal HP seems to be an effective treatment for properly treated diabetic ulcers, outperforming an identical control group whose only difference was SSC as a medication.
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ABSTRACT: MEDICATION SAFETY Overlooked Renal Dosage Adjustments A retrospective analysis of 647 patients at hospital discharge com-pared required renal dosage adjust-ments to dosage actually prescribed. This study was conducted at VieCuri Medical Centre in Venlo, Netherlands. Patient demographics and renal function data were col-lected, and dosage adjustment needs were assessed via the pharmacy-supported discharge counseling ser-vice. The incidence of inappropriate dosing based on renal function was measured at hospital discharge. Thirty-seven percent of patients evaluated during the study period (237/647) had a creatinine clear-ance less than 51 mL/min/1.73 m 2 ; dosage adjustment was warranted in 23.9% (411/1,718) of prescrip-tions. When dosage adjustment should have been performed, more than 40% of prescriptions (169/411; 41.1%) were inappropri-ate for renal function (9.8% of pre-scriptions overall; 169/1,718). Fur-thermore, 60.4% (102/169) of inappropriate prescriptions pos-sessed the potential for moderate or severe clinical consequences, as evaluated by a panel of two clinical pharmacologists and one nephrolo-gist. Study authors also noted a lack of standardized dosing guidelines for agents requiring renal dosage adjustment. The authors also sug-gested that augmenting medication systems by adding dynamic renal dosing alerts would improve moni-toring. Summary: A comparison of suggested renal dosing and actual dosing at hospital discharge revealed that appropriate prescribing may be overlooked. van Dijk EA, Drabbe NRG, Kruijtbosch M, De Smet PAGM. Drug dosage adjust-ments according to renal function at hos-pital discharge. Ann Pharmacother. 2006;40:1254-1260.Hospital pharmacy 12/1122; 41(7). DOI:10.1310/hpj4311-937
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ABSTRACT: The outcome of management of diabetic foot ulcers is poor and there is uncertainty concerning optimal approaches to management. We have undertaken a systematic review to identify interventions for which there is evidence of effectiveness. A search was made for reports of the effectiveness of interventions assessed in terms of healing, ulcer area or amputation in controlled clinical studies published prior to December 2006. Methodological quality of selected studies was independently assessed by two reviewers using Scottish Intercollegiate Guidelines Network (SIGN) criteria. Selected studies fell into the following categories: sharp debridement and larvae; antiseptics and dressings; chronic wound resection; hyperbaric oxygen (HBO); reduction of tissue oedema; skin grafts; electrical and magnetic stimulation and ultrasound. Heterogeneity of studies prevented pooled analysis of results. Of the 2251 papers identified, 60 were selected for grading following full text review. Some evidence was found to support hydrogels as desloughing agents and to suggest that a systemic (HBO) therapy may be effective. Topical negative pressure (TNP) may promote healing of post-operative wounds, and resection of neuropathic plantar ulcers may be beneficial. More information was needed to confirm the effectiveness and cost-effectiveness of these and other interventions. No data were found to justify the use of any other topically applied product or dressing, including those with antiseptic properties. Further evidence to substantiate the effect of interventions designed to enhance the healing of chronic ulcers is urgently needed. Until such evidence is available from robust trials, there is limited justification for the use of more expensive treatments and dressings.Diabetes/Metabolism Research and Reviews 05/2008; 24 Suppl 1(S1):S119-44. DOI:10.1002/dmrr.825 · 2.97 Impact Factor
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ABSTRACT: Silver-containing treatments are popular and used in wound treatments to combat a broad spectrum of pathogens, but evidence of their effectiveness in preventing wound infection or promoting healing is lacking. To establish the effects of silver-containing wound dressings and topical agents in preventing wound infection and healing of wounds. We searched the Cochrane Wounds Group Specialised Register (6 May 2009); The Cochrane Central Register of Controlled Trials (CENTRAL) (2009 Issue 2); Ovid MEDLINE (1950 to April Week 4 2009); Ovid EMBASE (1980 to 2009 Week 18); EBSCO CINAHL (1982 to April Week 4 2009) and Digital Dissertations (to May 2009) for relevant trials. We contacted manufacturers and distributors. Randomised controlled trials (RCTs) comparing silver-containing wound dressings and topical agents with silver-containing and non silver-containing comparators on uninfected wounds. Two authors independently selected trials, assessed risk of bias, and extracted data. We identified 26 RCTs (2066 patients). Heterogeneity of treatments and outcomes precluded meta-analysis. We grouped results according to wound type, and silver preparation.BurnsThirteen trials compared topical silver (in a variety of formulations - including silver sulphadiazine (SSD) cream) with non-silver dressings. One trial showed fewer infections with silver nitrate when compared with a non-silver dressing, but three trials showed significantly more infection with SSD than with the non-silver dressing.Six trials compared SSD cream with silver-containing dressings. One showed significantly fewer infections with the silver-containing dressing (Hydron AgSD) compared with SSD, the remaining five found no evidence of a difference.One trial compared two silver-containing dressings, and showed a significantly lower infection rate with silver-coated gauze (Acticoat(R)) than with silver nitrate gauze.Other woundsSix trials compared SSD/silver-containing dressings with non-silver dressings (nine dressings in total). Most comparisons (seven) found no significant differences in infection rates; one trial in a variety of wounds exhibited significantly fewer infections with SSD/hydrocolloid, but another, in acute wounds, found significantly more infections with SSD. Only one comparison showed a significant reduction in healing time associated with a silver-containing hydrofibre dressing in diabetic foot ulcers. There is insufficient evidence to establish whether silver-containing dressings or topical agents promote wound healing or prevent wound infection; some poor quality evidence for SSD suggests the opposite.Cochrane database of systematic reviews (Online) 01/2010; 3(3):CD006478. DOI:10.1002/14651858.CD006478.pub2 · 5.94 Impact Factor