Efficacy and Tolerability of the Anti-inflammatory Throat Lozenge Flurbiprofen 8.75mg in the Treatment of Sore Throat : A Randomised, Double-Blind, Placebo-Controlled Study.

OBJECTIVE: This randomised, double-blind, parallel group study compared the efficacy and tolerability of flurbiprofen lozenges (8.75mg or 12.5mg) with demulcent placebo lozenges in the treatment of patients with sore throat due to upper respiratory tract infection. STUDY PARTICIPANTS: A total of 320 patients with objective and subjective evidence of sore throat were randomised to treatment with flurbiprofen 8.75mg (n = 128), flurbiprofen 12.5mg (n = 64) or placebo (n = 128) lozenges. MAIN OUTCOME MEASURES: Efficacy was assessed by changes in subjective ratings scales measuring pain relief, throat soreness and swollen throat at specified intervals over a 6-hour period following administration of a single dose. Tolerability was assessed over a 5-day multiple-dose regimen. RESULTS: Flurbiprofen 8.75mg lozenge was significantly superior to placebo for the primary efficacy variable, total pain relief summed over 15 to 120 minutes (TOTPAR15-120min), and for reducing throat soreness over 2 hours and swollen throat over 2 and 6 hours (p < 0.05). Flurbiprofen 12.5mg treatment was not significantly better than flurbiprofen 8.75mg. There were no significant differences between treatment groups in the incidence of adverse events when reports of taste perversion, which reflects an aspect of patient acceptability rather than tolerability, were removed from the analysis (p = 0.776). CONCLUSIONS: The efficacy and tolerability profile of flurbiprofen 8.75mg lozenges indicated that they provide a convenient treatment for patients with sore throat. Symptomatic relief was rapid, occurring within 15 minutes of administration due to lozenge demulcency, and statistically significant differences between active and placebo lozenges were detected within 30 minutes and sustained over 4 hours.

Economic impact of increased clinical intervention rates in community pharmacy. A randomised trial of the effect of education and a professional allowance.

OBJECTIVE: To determine the economic impact of an interventional programme aimed to increase the rate of clinical interventions undertaken in community pharmacy. STUDY DESIGN AND PERSPECTIVE: A randomised controlled trial of 4 parallel groups of pharmacies, conducted from a government perspective. Economic evaluations were based on savings/costs attributable to healthcare costs avoided, healthcare costs incurred by the pharmacists' actions, change in medication costs, pharmacy time and telephone calls made by the pharmacist. The study was conducted during November and December 1996 and costings were based on 1997 figures. INTERVENTIONS: A professional fee-for-service [10 Australian dollars ($A; $A1 = 6.50 US dollars) per intervention] and education (an intensive 1-week course or advanced education) were implemented in an attempt to increase clinical interventions by the pharmacists. Group A pharmacies (n = 10) served as a control group and received neither education nor remuneration; group B received education and professional remuneration (n = 9); group C had received prior continued education and now received advanced education and professional remuneration (n = 11); and group D received professional remuneration with no education. MAIN OUTCOME MEASURES AND RESULTS: The proactive clinical interventions in group C saved a mean of $A85.35 per 1000 prescriptions [95% confidence interval (CI)-$A157.11 to $A24.95). This was 4 times greater than savings generated by pharmacies in group B (mean savings of $A25.65 per 1000 prescriptions) and 6 times greater than control pharmacies. A sensitivity analysis which extrapolated results to Australian prescription figures showed that the control group was capable of generating savings in the order of $A2.4 million per year while pharmacists in group C would save the healthcare system $A15 million per year. CONCLUSIONS: These results provide the first economic estimates for the provision of clinical interventions in Australian community pharmacies. It is believed that they illustrate the value of pharmaceutical services to the healthcare system and to the Australian community in terms of both quality of care and savings.

Topical antimicrobial prophylaxis in minor wounds.

OBJECTIVE: To evaluate the ability of a novel topical antimicrobial gel containing cetrimide, bacitracin, and polymyxin B sulfate to prevent infections of minor wounds. DESIGN: A clinical trial compared the test preparation with placebo and a povidone iodine antiseptic cream. SETTING: Five primary schools in Sydney, Australia, participated in the study over a 6-week spring/summer school term. SUBJECTS: Children aged 5-12 years with parental consent were eligible for study participation. Accidental injuries occurring at school were treated in a standardized manner by nurses at each site. OUTCOME MEASURES: Wounds were evaluated by the medical practitioner after 3 days of topical treatment. The clinical outcome was classified as resolution or suspected infection. If a clinical infection was suspected, the injury was swabbed for microbiologic evaluation. Growth of a dominant microorganism was classified as a microbiologic infection. RESULTS: Of the 177 injuries treated, there were nine clinical infections. A comparison of these showed a significant difference among treatment groups (p < 0.05). This difference was associated with the test preparation and placebo; the test preparation reduced the incidence of clinical infection from 12.5% to 1.6% (p < 0.05; 95% CI, 0.011 to 0.207). A comparison of microbiologic infections showed no significant differences among treatment groups (p > 0.05). CONCLUSIONS: The novel gel preparation containing cetrimide, bacitracin, and polymyxin B sulfate showed therapeutic action and reduced the incidence of clinical infections in minor accidental wounds. It may be a suitable product for first aid prophylaxis.

Clinical investigation of topical antimicrobials in healthy volunteers.

OBJECTIVE: To evaluate the antibacterial activity, onset of action, and duration of action of four topical antimicrobial gels containing cetrimide, bacitracin, polymyxin B sulfate, and a placebo gel. DESIGN: Multiples (1 x, 2x, 4x, 8x) of minimally inhibitory in vitro drug concentrations were formulated in a gel vehicle. Antibacterial activity was evaluated using a scrub-wash methodology on artificially inoculated skin over an 8-hour study period. SETTING AND PARTICIPANTS: Healthy volunteers with intact forearm skin participated in the study. A standardized culture of Staphylococcus aureus NCTC 6571 was applied to four areas on each forearm, randomly assigned topical treatments were applied, and sites were sampled at predetermined time intervals using a surfactant wash fluid. OUTCOME MEASURES: Recovered bacteria were quantitated, allowing a comparison of antibacterial activity. RESULTS: Two-way and one-way ANOVA and a Scheffe test confirmed significant differences in antibacterial effect between the formulations containing 4 and 8 times the minimally inhibitory in vitro concentrations and placebo (p < 0.05). Duration of action was similar for all preparations; however, onset appeared to be faster with the formulations containing 4 and 8 times minimally inhibitory in vitro concentrations. CONCLUSIONS: The two topical preparations containing 4 and 8 times the minimally inhibitory in vitro concentrations of cetrimide, bacitracin, and polymyxin B sulfate demonstrated significant antibacterial activity and may have potential for further clinical investigations.

Subtalar arthroereisis. Valente procedure.

The Valente procedure is a technically improved version of the original subtalar arthroereisis idea of LeLevre. It involves the control of pronation in a selective type of flatfoot deformity in which the predominant pathology is seen within the subtalar joint. Careful workup is necessary to prevent performing this procedure in flatfeet when other procedures, such as arthrodesis or calcaneal osteotomy, would produce better results. In choosing the proper implant, it is important to allow some pronation of the joint (usually 3 to 4 degrees). Failure to do so can result in complications, such as sinus tarsitis, adductovarus deformity, or dislodging of the implant. The procedure is effective in the treatment of painful flatfoot deformity if the guidelines for patient selection, operative technique, and postoperative care, as presented here, are followed.