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Purpose: Painful oral mucositis (OM) is a significant toxicity during radiotherapy for head and neck cancers. The aim of this randomized, double-blind, placebo-controlled trial was to test the efficacy of doxepin hydrochloride in the reduction of radiotherapy-induced OM pain., Patients and Methods: In all, 155 patients were randomly allocated to a doxepin oral rinse or a placebo for the treatment of radiotherapy-related OM pain. Patients received a single dose of doxepin or placebo on day 1 and then crossed over to receive the opposite agent on a subsequent day. Pain questionnaires were administered at baseline and at 5, 15, 30, 60, 120, and 240 minutes. Patients were then given the option to continue doxepin. The primary end point was pain reduction as measured by the area under the curve (AUC) of the pain scale using data from day 1., Results: Primary end point analysis revealed that the AUC for mouth and throat pain reduction was greater for doxepin (-9.1) than for placebo (-4.7; P < .001). Crossover analysis of patients completing both phases confirmed that patients experienced greater mouth and throat pain reduction with doxepin (intrapatient changes of 4.1 for doxepin-placebo arm and -2.8 for placebo-doxepin arm; P < .001). Doxepin was associated with more stinging or burning, unpleasant taste, and greater drowsiness than the placebo rinse. More patients receiving doxepin expressed a desire to continue treatment than did patients with placebo after completion of each of the randomized phases of the study., Conclusion: A doxepin rinse diminishes OM pain. Further studies are warranted to determine its role in the management of OM., (© 2014 by American Society of Clinical Oncology.)

The analgesic efficacy of the cyclooxygenase-2 specific inhibitors, valdecoxib and rofecoxib, were evaluated in patients following oral surgery. In a randomized, double-blind, controlled trial, patients experiencing moderate or severe pain received single-dose valdecoxib 40 mg (n=99), rofecoxib 50 mg (n=101), or placebo (n=50) within 4 hours after multiple third molar extraction with bone removal. Onset of action was significantly faster with valdecoxib 40 mg (30 minutes) compared with rofecoxib 50 mg (45 minutes), as measured by pain intensity difference and pain relief scores (P

Although allergic rhinitis is commonly associated most with symptoms of nasal congestion, rhinorrhea, sneezing, and itching, the symptom of sinus pain and pressure often prompts the patient to seek medical attention. The effect of fluticasone propionate on this symptom has not been studied. The purpose of this study was to compare the efficacy and safety of fluticasone propionate aqueous nasal spray to placebo vehicle in the treatment of patients with sinus pain and pressure arising from allergic rhinitis. A multicenter, double-blind, parallel-group trial was conducted in 206 symptomatic patients > or = 12 years with seasonal or perennial allergic rhinitis. Patients were treated for 14 days with either fluticasone propionate aqueous nasal spray, 200 mcg once daily, or placebo vehicle. Patients attended clinic visits and kept diary cards rating sinus pain and pressure (measured as one symptom) and nasal congestion symptoms during the study. Treatment with fluticasone propionate provided significantly greater relief of symptoms of sinus pain and pressure compared with placebo over the entire 14-day treatment period. Nasal congestion scores also were significantly reduced compared with placebo at each time point. Treatments were well tolerated, and the incidence of adverse events attributable to study treatments was similar between groups. Our data indicate that symptoms of sinus pain and pressure and nasal congestion can be significantly reduced in patients with allergic rhinitis when treated with fluticasone propionate aqueous nasal spray, 200 mcg once daily.

The management of chronic orofacial pain has a history of therapeutic misadventures, charismatic-based treatment philosophies, controversies over the correct nomenclature, and a lack of scientific documentation. The dental profession has struggled to develop a systematic approach to nomenclature, treatment, and clinical research through numerous conferences, workshops, and consensus attempts. Despite these efforts, there is no generally accepted agreement on the etiology of chronic orofacial pain, its natural history, the role of occlusion, the need for aggressive treatment, or the effectiveness, safety, and indications for most current practices. These professional differences are often fostered by a lack of appreciation for the difference between clinical observations, which may form the basis for therapeutic innovation, and the need to verify the safety and efficacy of treatments in studies that control for factors that can mimic clinical success. This article describes the use of antidepressants as an example for the treatment of chronic orofacial pain. The treatment arose from the clinical observations of astute clinicians, but was subjected to scientific validation in well-controlled clinical trials.