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PubMed2005

Power and sample size of therapeutic trials in procedural dermatology: how many patients are enough?

BACKGROUND: Many new devices and therapeutic interventions are continually introduced in cutaneous surgery. The efficacy of these new techniques must be compared with that of preexisting standards so that patients can be appropriately counseled. OBJECTIVES: The purpose of this article is to (1) review methods for estimating sample size and power, (2) estimate the range of sample sizes sufficient to ensure that true differences are not missed in clinical trials of new procedural dermatologic therapies, and (3) consider the reasons why the sample size may be too small in procedural dermatology trials and how this problem can be addressed. METHODS: (1) Selective review of textbooks and other relevant literature, presentation of a brief tutorial describing sample size and power determination for therapeutic clinical trials comparing two groups with continuous outcomes variables; (2) implementation of standard formulae and assumptions to estimate sample size in cutaneous surgery therapeutic trials. RESULTS: Assuming that one group receives a standard surgical intervention and another group undergoes a new technique, to identify a moderate difference in efficacy between groups, at least 50 to 200 subjects will need to be enrolled if conventional strategies are used to reduce the likelihood of finding a difference that does not really exist (Type I error), as well as the likelihood of missing a true difference (Type II error). CONCLUSION: By face validity, it is apparent that most efficacy comparisons in procedural dermatology have low sample size and a concomitant risk of failing to detect actual differences between therapeutic arms. Owing to the limitations that restrict surgeons from frequently performing large randomized controlled trials in procedural dermatology, meta-analyses may be needed to pool the results of smaller studies. When it is critically important that differences between groups be accurately identified, dermatologic surgeons may consider eschewing smaller trials in favor of collaborating on larger trials with an adequate sample size.

Dermatology↗
PubMed2005

Therapeutic potential of wogonin: a naturally occurring flavonoid.

The search for flavonoids with novel therapeutic effects has been intense. Wogonin, as a naturally existing monoflavonoid, has been shown to have therapeutic potential in vitro and in vivo. Methods for its extraction from herbs and its chemical synthesis have been developed. Pharmacokinetic studies have shown a rapid tissue distribution and prolonged plasma elimination phase of wogonin. It has been shown experimentally that wogonin exerts anti-oxidant activity, which may, in part, underlie its antiinflammatory, anti-cancer, antiviral and neuroprotective actions. The recent discovery of its anxiolytic activity suggests a new mechanism of action, involving interaction with the benzodiazepine (BZD) binding site of the GABA(A) receptor and modulation of this receptor activity. Although the safety record of wogonin is remarkable and voluminous literature about its pharmacological effects is available, it has not been used in Western medicine in the form of a pure chemical. In this article we review its therapeutic effects, its sources and pharmacokinetic profile to highlight its therapeutic potential.

Animals↗
PubMedDate not supplied

Evaluation using hoof wall strain gauges of a therapeutic shoe and a hoof cast with a heel wedge as potential supportive therapy for horses with laminitis.

OBJECTIVE: To evaluate using strain gauges, a hoof cast with heel wedge, and a therapeutic shoe with unsupported toe for their effectiveness in redistribution of load from the dorsal hoof wall. STUDY DESIGN: In vitro biomechanical study. SAMPLE POPULATION: Twenty forelimb specimens. METHODS: Rosette strain gauges were placed on the dorsal and lateral hoof wall of 20 normal shaped hooves. Limbs were loaded vertically using a tensile testing machine with a 1 Hz sinusoidally cycling load up to 3000 N during 15 seconds. Mean values of principal strain and direction at 2500 N load were calculated for 3 experimental conditions (unshod, therapeutic shoe with unsupported toe, and hoof cast with heel elevation) and tested by ANOVA (P<.05). RESULTS: Vertical limb loading in an unshod hoof leads to a biaxial compression of the dorsal wall with high longitudinal compression (epsilon2 = -1515 microm/m). Principal strain at the dorsal wall (epsilon2) was decreased by 23% with the therapeutic shoe and by 59% with the hoof cast. On the lateral hoof wall principal strain was unchanged with the shoe, but increased by 34% with the cast. CONCLUSIONS: Strain measurements indicate unloading of the dorsal hoof wall by both methods with the cast being more effective than the shoe. CLINICAL RELEVANCE: The hoof cast with wedge offers substantial unloading of the dorsal wall, but increases load on the quarter. Therefore a hoof cast would likely be most helpful in acute laminitis when palmar structures can still bear load. The therapeutic shoe offers rehabilitation and regrowth of the dorsal wall without increased load on the quarter wall.

Analysis of Variance↗
PubMed2005

Gene transfer for hemophilia: can therapeutic efficacy in large animals be safely translated to patients?

Gene transfer is a novel area of therapeutics in which the active agent is a nucleic acid rather than a protein or small molecule. As early as 1997, investigators reported long-term expression of therapeutic levels of factor IX using gene transfer techniques in hemophilia B mice, and similar data were thereafter reported in mice with hemophilia A. Efforts to translate these results to hemophilic dog models at first yielded only marginally therapeutic levels (1%-2% normal circulating levels), but within the past few years have achieved levels in the range of 10%-20% through multiple different gene transfer strategies. Early phase clinical testing has revealed that many aspects of gene transfer in humans were accurately predicted by studies in hemophilic dogs, but that other aspects were not, and were only appreciated as a result of clinical testing. Studies in the next few years will determine whether the problems identified in preclinical and early phase clinical testing can be solved to develop a therapeutic gene transfer approach to hemophilia.

Adenoviridae↗
PubMed2001

A study of the differential effects of Tomm's questioning styles on therapeutic alliance.

To replicate and extend Dozier's (1992) test of Tomm's hypothesis about the differential effects of questioning styles on therapeutic alliance, an analogue study was conducted. Twenty-eight family triads, each including a son and his parents, viewed four videotaped, simulated family therapy scenarios in which Tomm's four questioning styles were separately portrayed. Participants were asked to identify with the client whose role corresponded to theirs (that is, father, mother, or son) and, on the basis of this, to rate the client's alliance with the therapist. They were also asked to rate the overall alliance between the family and the therapist. Finally, having viewed all four scenarios, they were invited to rate comparatively the quality of the therapeutic alliance across the four questioning styles. Compared with strategic and lineal questioning styles, circular and reflexive questions led to higher ratings of therapeutic alliance on all three measures. The results of this study support Tomm's hypothesis that questioning styles based on circular assumptions lead to a better therapeutic alliance at an individual and systemic level than do questions based on lineal assumptions.

Communication↗
PubMed2002

Outcomes of therapeutic massage for hospitalized cancer patients.

PURPOSE: To examine the effects of therapeutic massage on perception of pain, subjective sleep quality, symptom distress, and anxiety in patients hospitalized for treatment of cancer. ORGANIZING CONSTRUCT: Rogers' Science of Unitary Human Beings and Watson's theory of human caring. METHODS: Quasiexperimental. The sample consisted of 41 patients admitted to the oncology unit at a large urban medical center in the United States for chemotherapy or radiation therapy. Twenty participants received therapeutic massage and 21 received the control therapy, nurse interaction. The outcome variables were measured on admission and at the end of 1 week via the following instruments: a Numerical Rating Scale for pain intensity and Likert-type scale for distress from pain; The Verran Snyder-Halpern Sleep Scale, McCorkle and Young's Symptom Distress Scale, and the Speilberger State Anxiety Inventory. ANOVA and t tests were used to analyze between and within group differences in mean scores and main effects on outcome variables. FINDINGS AND CONCLUSIONS: Mean scores for pain, sleep quality, symptom distress, and anxiety improved from baseline for the subjects who received therapeutic massage; only anxiety improved from baseline for participants in the comparison group. Statistically significant interactions were found for pain, symptom distress, and sleep. Sleep improved only slightly for the participants receiving massage, but it deteriorated significantly for those in the control group. The findings support the potential for massage as a nursing therapeutic for cancer patients receiving chemotherapy or radiation therapy.

Analysis of Variance↗
PubMed1999

Unsuspected infection is infrequent in asymptomatic outpatients with refractory ascites undergoing therapeutic paracentesis.

OBJECTIVE: Large-volume paracentesis is a safe and effective means of treating patients with refractory ascites. However, there is limited information regarding the need for ascitic fluid studies in asymptomatic outpatients presenting for therapeutic paracentesis. The aim of this prospective study was to define the incidence and natural history of peritoneal fluid infection in asymptomatic outpatients undergoing therapeutic paracentesis. METHODS: Over a 13-month period, 118 therapeutic paracenteses were performed in 29 outpatients with decompensated cirrhosis (Child-Pugh class B = 38%, C = 62%). After a brief medical history and physical examination, ascitic fluid cell count with differential and culture were obtained from all participating subjects. Seven (24%) of the subjects were receiving norfloxacin prophylaxis, accounting for antibiotic coverage during 40% of the procedures performed. The clinical course and outcome of study subjects during a mean follow-up of 137 days was reviewed. RESULTS: All 118 (100%) of the ascitic fluid samples demonstrated absolute neutrophil counts of <250/mm3 (mean = 6.5 +/- 22.5 pmn/mm3). Asymptomatic bacterascites was identified from three of the 118 (2.5%) fluid samples, but all of these subjects spontaneously recovered without treatment or sequelae. During follow-up, six episodes of symptomatic or hospital-associated peritoneal fluid infection were identified in study participants, emphasizing the importance of fluid studies in other clinical settings. CONCLUSIONS: Although further studies are needed, the routine culture of ascitic fluid in asymptomatic outpatients with refractory ascites requiring therapeutic paracentesis may not be necessary when there is a low index of suspicion for occult infection. In circumstances of clinical uncertainty, however, obtaining ascitic fluid cell counts with differential is recommended to insure patient safety.

Adult↗
PubMed2005

'Smart' delivery systems for biomolecular therapeutics.

OBJECTIVE: There is a strong need for drug delivery systems that can deliver biological signals from biomaterials and tissue engineering scaffolds, and a particular need for new delivery systems that can efficiently deliver biomolecules to intracellular targets. Viruses and pathogens have evolved potent molecular machinery that sense the lowered pH gradient of the endosomal compartment and become activated to destabilize the endosomal membrane, thereby enhancing protein or DNA transport to the cytoplasmic compartment. A key feature of many of these biological delivery systems is that they are reversible, so that the delivery systems are not directly toxic. These delivery systems have the ability to change their structural and functional properties and thus display remarkable 'smart' material properties. The objective of this presentation is to review the initial development of smart polymeric carriers that mimic these biological delivery systems and combine similar pH-sensitive, membrane-destabilizing activity for the delivery of therapeutic biomolecules. DESIGN: We have developed new 'smart' polymeric carriers to more effectively deliver and broaden the available types of biomolecular therapeutics. The polymers are hydrophilic and stealth-like at physiological pH, but become membrane-destabilizing after uptake into the endosomal compartment where they enhance the release of therapeutic cargo into the cytoplasm. They can be designed to provide a range of pH profiles and membrane-destabilizing activities, allowing their molecular properties to be matched to specific drugs and loading ranges. A versatile set of linker chemistries is available to provide degradable conjugation sites for proteins, nucleic acids, and/or targeting moieties. RESULTS: The physical properties of several pH-responsive polymers were examined. The activity and pH profile can be manipulated by controlling the length of hydrophobic alkyl segments. The delivery of poly(propyl acrylic acid) (PPAA)-containing lipoplexes significantly enhanced wound healing through the interconnected effects of altered extracellular matrix organization and greater vascularization. PPAA has also been shown to enhance cytoplasmic delivery of a model protein therapeutic. Polymeric carriers displaying pH-sensitive, membrane-destabilizing activity were also examined. The pH profile is controlled by the choice of the alkylacrylic acid monomer and by the ratio of the carboxylate-containing alkylacrylic acid monomer to alkylacrylate monomer. The membrane destabilizing activity is controlled by the lengths of the alkyl segment on the alkylacrylic acid monomer and the alkylacrylate monomer, as well as by their ratio in the final polymer chains. CONCLUSION: The molecular mechanisms that proteins use to sense and destabilize provide interesting paradigms for the development of new polymeric delivery systems that mimic biological strategies for promoting the intracellular delivery of biomolecular drugs. The key feature of these polymers is their ability to directly enhance the intracellular delivery of proteins and DNA, by destabilizing biological membranes in response to vesicular compartment pH changes. The ability to deliver a wide variety of protein and nucleic acid drugs to intracellular compartments from tissue engineering and regenerative scaffolds could greatly enhance control of important processes such as inflammation, angiogenesis, and biomineralization.

Biocompatible Materials↗
PubMedDate not supplied

An analysis of the nursing diagnosis ineffective management of therapeutic regimen compared to noncompliance and Orem's self-care deficit theory of nursing.

The authors compare the nursing diagnosis ineffective management of therapeutic regimen with that of noncompliance and with Orem's concept of self-care deficit. The article describes how the diagnosis of ineffective management of therapeutic regimen is more comprehensive than noncompliance. A question of patient autonomy is raised considering how the patient manages his or her therapeutic regimen. The major conclusion is that the nursing diagnosis of ineffective management of therapeutic regimen is based on continuous interaction between patient and nurse. The authors recommend that noncompliance be eliminated as a nursing diagnosis.

Humans↗
PubMedDate not supplied

Aperture size to therapeutic volume relation for a multielement ultrasound system: determination of applicator adequacy for superficial hyperthermia.

Three-dimensional acoustic and thermal models were developed to simulate superficial hyperthermia treatments using a new multielement planar ultrasonic system. Typical power density and steady-state temperature distributions are presented. A parametric study was performed to determine the relationship between therapeutic volume (volume at and above 42 degrees C) and aperture size (number of active elements). The parameters investigated were: maximum allowable temperature, skin surface temperature, blood perfusion (thermal diffusion length), acoustic absorption, and frequency. Results showed that this device produces well distributed sound beams with lateral dimensions comparable to the aperture size. These simulated results were in agreement with experimental measurements. The simulated temperature distributions were uniform at each depth across the applicator's aperture. The main heating characteristics found were: (1) the therapeutic volume was directly proportional to the aperture size; (2) the lateral dimensions of the therapeutic volume were independent of the parameters studied and remained practically constant with depth for several centimeters, with a very rapid increase near the skin surface and a very rapid fall off at depth; and (3) therapeutic penetration was strongly dependent on maximum allowable temperature, frequency, and acoustic absorption; and weakly dependent on blood perfusion and skin surface temperature. These heating characteristics are new in commercial systems for superficial hyperthermia. Despite the well-distributed beams, it was found that in order to produce adequate hyperthermia with this device the lateral dimensions of tumors must be smaller than the applicator's active aperture and that thermal depth coverage must be monitored during treatments. Guidelines for aperture selection and thermometry strategies are discussed.

Acoustics↗
PubMed1990

Therapeutic efficacy of granulocyte colony-stimulating factor alone and in combination with antibiotics against Pseudomonas aeruginosa infections in mice.

The therapeutic efficacy of granulocyte colony-stimulating factor (G-CSF) against an experimental intramuscular infection induced by Pseudomonas aeruginosa in mice was confirmed. Bacterial growth in the infected thigh muscle was suppressed by G-CSF treatment. The change in the number of peripheral blood polymorphonuclear leukocytes (PMN) after bacterial challenge was investigated. The results showed that G-CSF could stimulate stronger defense mechanisms after stimulation by bacterial challenge. In the G-CSF-treated group, more clusters of matured PMN were observed in the infected thigh muscle 6 h after bacterial challenge. Next, the correlation between the number of PMN in the blood at the time of infection and the therapeutic efficacy of antibiotics was investigated. The therapeutic efficacy of ceftazidime, a beta-lactam antibiotic, was affected by the number of blood PMN at the time of infection. In particular, a decrease of peripheral blood PMN at the time of infection resulted in a dramatic decrease in the efficacy of ceftazidime. The reduction in leukopenia by G-CSF remarkably strengthened the therapeutic effect of antibiotics in mice.

Animals↗
PubMed1997

Therapeutic intragastric vaccination against Helicobacter pylori in mice eradicates an otherwise chronic infection and confers protection against reinfection.

Chronic infection of the gastroduodenal mucosae by the gram-negative spiral bacterium Helicobacter pylori is responsible for chronic active gastritis, peptic ulcers, and gastric cancers such as adenocarcinoma and low-grade gastric B-cell lymphoma. The success of eradication by antibiotic therapy is being rapidly hampered by the increasing occurrence of antibiotic-resistant strains. An attractive alternative approach to combat this infection is represented by the therapeutic use of vaccines. In the present work, we have exploited the mouse model of persistent infection by mouse-adapted H. pylori strains that we have developed to assess the feasibility of the therapeutic use of vaccines against infection. We report that an otherwise chronic H. pylori infection in mice can be successfully eradicated by intragastric vaccination with H. pylori antigens such as recombinant VacA and CagA, which were administered together with a genetically detoxified mutant of the heat-labile enterotoxin of Escherichia coli (referred to as LTK63), in which the serine in position 63 was replaced by a lysine. Moreover, we show that therapeutic vaccination confers efficacious protection against reinfection. These results represent strong evidence of the feasibility of therapeutic use of VacA- or CagA-based vaccine formulations against H. pylori infection in an animal model and give substantial preclinical support to the application of this kind of approach in human clinical trials.

Animals↗
PubMed2001

Combined phototherapeutic keratectomy and therapeutic contact lens for recurrent erosions in bullous keratopathy.

AIMS: To evaluate the therapeutic effects of excimer laser phototherapeutic keratectomy (PTK) combined with therapeutic contact lens for painful recurrent corneal erosions (RCE) secondary to bullous keratopathy (BK) not suitable for penetrating keratoplasty. METHODS: Excimer laser PTK was performed prospectively in eight eyes with painful RCE due to BK visually expecting no benefit from penetrating keratoplasty. After mechanical removal of the epithelium, the corneas were ablated with 50 pulses in the central 6.5 mm zone (ablation rate 0.25 microm per pulse) and another 200 pulses for polishing the periphery. After PTK, therapeutic contact lenses were applied for 3 months. The mean follow up period after PTK was 10.9 months (ranging from 6 to 15 months). RESULTS: All patients experienced relief of their pain symptoms after the epithelium healed. Only one patient complained of occasional stinging pain with intermittent recurrence of small bullae. He refused a second treatment because the pain was much less than that before the surgery and quite tolerable. No infection or other complications were noted. CONCLUSION: PTK with deeper ablation and adjunctive therapeutic contact lens is an easy to perform and effective treatment with less recurrence rate for patients with BK and poor visual potential.

Aged↗
PubMed2003

Therapeutic penetrating keratoplasty in severe fungal keratitis using cryopreserved donor corneas.

AIMS: To investigate whether cryopreserved donor cornea could be used for therapeutic penetrating keratoplasty (PKP) to eradicate the infection, obviate complications, and preserve anatomical integrity in severe fungal keratitis. METHODS: In this retrospective, consecutive case series, 45 eyes of 45 patients with severe fungal keratitis, which exhibited anterior chamber collapse, corneal perforation, and/or large suppurative corneal infiltrate, received therapeutic PKP after removal of the infected corneal tissue, irrigation of the anterior chamber by 0.2% fluconazole solution, iris dissection of fibrinoid membrane, and iridectomy and therapeutic PKP using corneas cryopreserved at -20 degrees C. RESULTS: Among 45 eyes, 39 eyes (86.7%) were successfully eradicated the fungal infection without recurrence and maintained their anatomical integrity without any complication. Four of 45 eyes (8.9%) showed postoperative rise of intraocular pressure, of which three were controlled with subsequent antiglaucoma surgeries, whereas one eye needed additional antiglaucoma medications. Two of 45 eyes (4.4%) were enucleated because of uncontrollable fungal infection and secondary retinal detachment, respectively. 23 eyes received subsequent optical PKP and, among them, 21 maintained clear corneal grafts and two suffered from graft failure due to allograft rejections. CONCLUSION: Cryopreserved donor corneas are effective substitutes in therapeutic PKP to control severe fungal corneal infection and preserve the global integrity, and may offer additional advantages over conventional PKP in reducing allograft rejection, eradicating fungal infection during the postoperative period, and improving the success of optical PKP for visual rehabilitation.

Administration, Oral↗
PubMed1998

Eradication of chronic Helicobacter pylori infection by therapeutic vaccination.

Chronic infection of the gastroduodenal mucosae by the gram-negative spiral bacterium Helicobacter pylori is responsible for chronic active gastritis, peptic ulcers, and gastric cancers such as adenocarcinoma and low-grade B-cell lymphoma. The success of eradication by antibiotic therapy is being rapidly hampered by the increasing occurrence of antibiotic-resistant strains. An attractive alternative approach to combat this infection is represented by the therapeutic use of vaccines. In the present work, we have exploited the mouse model of persistent infection by mouse-adapted H. pylori strains that we have developed to assess the feasibility of the therapeutic use of vaccines against infection. We report that an otherwise chronic H. pylori infection in mice can be successfully eradicated by intragastric vaccination with H. pylori antigens such as recombinant VacA and CagA, which were administered together with a genetically detoxified mutant of the heat-labile exterotoxin of Escherichia coli (referred to as LTK63), in which the serine in position 63 was replaced by a lysine. Moreover, we show that therapeutic vaccination confers efficacious protection against reinfection. These results represent strong evidence of the feasibility of therapeutic use of VacA- or CagA-based vaccine formulations against H. pylori infection in an animal model and give substantial preclinical support to the application of this kind of approach in human clinical trials.

Animals↗
PubMed1997

Endothelin in heart failure: a promising therapeutic target?

The results of early acute haemodynamic studies with anti-endothelin agents are promising. Much still needs to be done, however, before endothelin antagonism is established as a therapeutic strategy in heart failure. We need to know, for example, whether the haemodynamic effects of anti-endothelin drugs are sustained. We need to ensure that there is no reflex activation of other neuroendocrine systems and, preferably, to demonstrate neuroendocrine suppression. Characterisation of the renal actions of endothelin receptor antagonists will also be important. Perhaps the most pressing issue in the development of these agents is elucidation of the role of the endothelial ETB receptor in heart failure. It is now clearly shown that vascular smooth muscle ETB receptors can mediate vasoconstriction in human blood vessels and that these receptors may be particularly important in heart failure. The effect of selective ETB receptor blockade in humans in vivo is not currently known, however, and whether endothelial ETB receptors might tonically offset ETA and ETB receptor mediated smooth muscle contraction remains conjectural. This question is directly relevant to whether selective ETA or non-selective ETA and ETB receptor antagonism might be the better therapeutic strategy in heart failure. ECE inhibition may become another therapeutic option in due course, but at present no specific and selective inhibitors of the enzyme have been developed. The recent demonstration that the selective ETA receptor antagonist BQ-123 improves long term survival in rats with heart failure induced by myocardial infarction suggests that anti-endothelin strategies may hold great therapeutic promise in heart failure.

Aspartic Acid Endopeptidases↗
PubMed2002

Embryonic stem cell production through therapeutic cloning has fewer ethical problems than stem cell harvest from surplus IVF embryos.

Restrictions on research on therapeutic cloning are questionable as they inhibit the development of a technique which holds promise for successful application of pluripotent stem cells in clinical treatment of severe diseases. It is argued in this article that the ethical concerns are less problematic using therapeutic cloning compared with using fertilised eggs as the source for stem cells. The moral status of an enucleated egg cell transplanted with a somatic cell nucleus is found to be more clearly not equivalent to that of a human being. Based on ethical considerations alone, research into therapeutic cloning should be encouraged in order to develop therapeutic applications of stem cells.

Bioethics↗
PubMed2002

Computer automated prediction of potential therapeutic and toxicity protein targets of bioactive compounds from Chinese medicinal plants.

Understanding the molecular mechanism and pharmacology of bioactive compounds from Chinese medicinal plants (CMP) is important in facilitating scientific evaluation of novel therapeutic approaches in traditional Chinese medicine. It is also of significance in new drug development based on the mechanism of Chinese medicine. A key step towards this task is the determination of the therapeutic and toxicity protein targets of CMP compounds. In this work, newly developed computer software INVDOCK is used for automated identification of potential therapeutic and toxicity targets of several bioactive compounds isolated from Chinese medicinal plants. This software searches a protein database to find proteins to which a CMP compound can bind or weakly bind. INVDOCK results on three CMP compounds (allicin, catechin and camptotecin) show that 60% of computer-identified potential therapeutic protein targets and 27% of computer-identified potential toxicity targets have been implicated or confirmed by experiments. This software may potentially be used as a relatively fast-speed and low-cost tool for facilitating the study of molecular mechanism and pharmacology of bioactive compounds from Chinese medicinal plants and natural products from other sources.

Animals↗