Randomized, placebo-controlled study of cetirizine and loratadine in children with seasonal allergic rhinitis.

BACKGROUND: Pharmacologic treatment is a mainstay of allergy therapy and many caregivers use over-the-counter antihistamines for the treatment of seasonal allergic rhinitis (SAR) symptoms in children. OBJECTIVE: To assess the efficacy and safety of cetirizine 10 mg syrup versus loratadine 10 mg syrup versus placebo syrup in a randomized double-blind study of children, ages 6-11 years, with SAR. METHODS: This randomized, double-blind, parallel-group, placebo-controlled study was conducted at 71 U.S. centers during the spring tree and grass pollen season. After a 1-week placebo run-in period, qualified subjects were randomized to once-daily cetirizine 10 mg (n = 231), loratadine 10 mg (n = 221), and placebo (n = 231) for 2 weeks. The primary efficacy end point was change from baseline in the subject's mean reflective total symptom severity complex (TSSC) score over 14 days. RESULTS: Children treated with cetirizine experienced significantly greater TSSC score reductions versus children treated with placebo over 14 days (least square mean change, -2.1 versus -1.6; p = 0.006). The differences in TSSC score improvement over 14 days between the cetirizine versus loratadine groups (-2.1 versus -1.8; p = 0.124) and between the loratadine versus placebo groups (-1.8 versus -1.6; p = 0.230) were not statistically significant. Predominant adverse events in the cetirizine, loratadine, and placebo groups were headache (3.5, 3.6, and 3.1%, respectively) and pharyngitis (3.5, 2.7, and 3.5%, respectively). Somnolence was reported in three subjects (1.3%) treated with cetirizine and in none of the other subjects. CONCLUSION: Cetirizine 10 mg was statistically significantly more efficacious than placebo in the treatment of SAR symptoms in children ages 6-11 years. Symptom improvement was not significantly different between the loratadine 10 mg and placebo groups.

Subacute knee pain and swelling in a healthy male: a case of Brodie's abscess.

Osteomyelitis is an inflammatory process of the bone caused by an infection. The key to successful management is early recognition and treatment, as complications can arise if interventions are not done in a timely manner. Subacute or chronic osteomyelitis is associated with avascular necrosis of bone requiring surgical debridement and antibiotic therapy. Here, we describe a case illustrating an uncharacteristic presentation of knee pain ending with multiple surgical debridements in a healthy male.

Female Runner With Painful Left Thigh Swelling: A Case of May-Thurner Syndrome.

We discuss a case of a female runner who presented with burning left groin and thigh pain and positional swelling after a long run. The workup revealed May-Thurner syndrome. May-Thurner syndrome anatomy is a common anatomical variant present in approximately 20% of the population. Compression of the iliac vein may result in venous stasis in the lower limb with a predisposition to deep venous thrombosis. We identify 4 reported cases of May-Thurner syndrome in female runners and review the importance of diagnosis and appropriate treatment of this condition. LEVEL OF EVIDENCE: V.

Assessment of Different Cetirizine Dosing Strategies on Seasonal Allergic Rhinitis Symptoms: Findings of Two Randomized Trials.

BACKGROUND: Cetirizine has been shown to be effective for relief of seasonal allergic rhinitis (SAR) symptoms. Allergic rhinitis symptoms have been reported to have circadian variations, with symptoms tending to be most bothersome overnight and in the morning. OBJECTIVE: To evaluate the effects of different cetirizine dosing schedules in comparison to twice daily (BID) chlorpheniramine and placebo on SAR symptoms at 12 and 24 hours postdose. METHODS: Study 1 subjects received cetirizine 10-mg once daily in the morning (QAM), cetirizine 10-mg once daily at bedtime (QHS), cetirizine 5-mg twice daily, or placebo. Study 2 subjects received cetirizine 5-mg QAM, cetirizine 10-mg QHS, chlorpheniramine 8-mg BID, or placebo. The primary end point was total symptom severity complex (TSSC); TSSC was the sum of symptom severity ratings averaged over the 2-week study period. Post hoc analyses of reflective symptom severity assessed in the morning (TSSCAM) and in the evening (TSSCPM) were conducted to evaluate cetirizine's effects at 12 and 24 hours postdose. RESULTS: In study 1, subject- and investigator-assessed TSSC was significantly lower in all cetirizine groups versus placebo (P ≤ .003). In study 2, subject-assessed TSSC was significantly lower in all cetirizine groups versus placebo (P ≤ .04) and was numerically lower for investigator-assessed TSSC. Post hoc analyses demonstrated that cetirizine significantly improved TSSCAM at 12 and 24 hours postdose versus placebo in both studies regardless of dosing schedule. TSSCPM significantly improved at 12 and 24 hours postdose in all study 1 cetirizine groups versus placebo. In study 2, versus placebo, TSSCPM significantly improved at 12 hours postdose in cetirizine 5-mg QAM group and numerically improved at 24 hours postdose in cetirizine 10-mg QHS group. CONCLUSION: Regardless of dosing regimen, cetirizine demonstrates effective 24-hour relief of SAR symptoms, particularly on TSSCAM, which assesses overnight and early morning symptom control.

Young man with sudden severe hip pain secondary to femoral neck stress fracture.

Femoral neck stress fractures have been described in military recruits and athletes. Early recognition and aggressive treatment are important, as femoral neck stress fractures have a high potential for complications and even uncomplicated fractures require an extensive course of rehabilitation. Tension-side (superolateral) stress fractures of the femoral neck are at high risk for complications such as displacement, non-union and avascular necrosis, and need to be treated surgically, while compression-side (inferomedial) fractures can be treated conservatively. We describe a case illustrating a typical presentation of insidious hip pain culminating in sudden onset of severe hip pain in a healthy young man. We perform a literature review of studies showing epidemiology, treatment algorithms and rehabilitation.

Neuroleptic malignant syndrome secondary to aripiprazole initiation in a clozapine-intolerant patient.

PURPOSE: A case of neuroleptic malignant syndrome (NMS) secondary to aripiprazole in a schizophrenic patient previously managed with clozapine is reported. SUMMARY: A 42-year-old Caucasian woman with a history of schizophrenia (chronic paranoid type) arrived at the emergency department (ED) with a chief complaint of altered mental status and oliguria. The patient was previously managed with clozapine for 14 years, which was well tolerated until the patient developed urinary retention. As a result, clozapine was gradually discontinued over several weeks. Aripiprazole 30 mg orally once daily was initiated four days before her arrival at the ED. Approximately four days after starting aripiprazole therapy, the patient began experiencing tremors, confusion, and rigidity. Physical examination revealed poor inspiratory effort, diffuse abdominal tenderness, and decreased muscle strength. Initial blood work confirmed acute renal failure and leukocytosis. The patient developed both hypokalemia and hypomagnesemia; her urine myoglobin level was suggestive of rhabdomyolysis. In light of her fever, encephalopathy, autonomic instability, elevated creatine kinase levels, and muscle rigidity, a diagnosis of NMS was made. Supportive care in the form of cooling blankets, electrolyte management, and blood pressure control was provided to the patient. Bromocriptine was also initiated to restore her dopamine balance. Twenty days after the initial presentation, the patient was initiated on paliperidone 3 mg orally at bedtime, which was slowly increased to 9 mg over several weeks. Follow-up evaluation demonstrated no signs or symptoms of NMS. Laboratory test values were also within normal limits. CONCLUSION: A 42-year-old Caucasian woman with schizophrenia who could no longer tolerate therapy with clozapine developed NMS secondary to the initiation of aripiprazole.

Back contouring in weight loss patients.

BACKGROUND: Body contouring in the post-bariatric surgery patient has focused predominantly on the resulting tissue excesses of the abdomen, breasts, and arms. The back, however, has not received the same attention and, although the skin folds on the back may sometimes be improved by addressing the previously mentioned areas, the result is usually unsatisfactory and leaves the patient with significant residual excess. METHODS: The senior author (B.S.) has developed a classification system and surgical treatment for the excess back tissue that eliminates these folds. RESULTS: Modifications of the senior author's techniques of mammaplasty/mastopexy and circumferential abdominoplasty, in addition to direct excision, are used to improve the contour of the back. CONCLUSIONS: Contouring of the back roll deformities seen in post-bariatric surgery patients requires a systematic approach. With this approach, the authors have been able to achieve uniform patient satisfaction with low morbidity. Although patients are left with additional scarring, this tradeoff is accepted by nearly all patients for the dramatic improvement in body contour.

A primary protocol for the management of ear keloids: results of excision combined with intraoperative and postoperative steroid injections.

BACKGROUND: Keloids of the ear are a challenging problem, with many treatment modalities advocated. The primary determinant in choosing a treatment protocol should be a low recurrence rate. Most reports in the literature suffer from small numbers of patients and inadequate follow-up. METHODS: This study presents a retrospective analysis of 64 patients representing 92 ear keloids treated between 1982 and 1997. The treatment protocol consisted of excision with an intraoperative and two postoperative steroid injections. All patients were treated by a single physician. Long-term follow-up was obtained at a minimum of 5 years. RESULTS: Protocol success was achieved in 74 of 92 keloids (80 percent) excised. Prior excision of the keloid was significantly associated with protocol failure (p = 0.0068). Keloid recurrence was seen in 10 of 43 (23 percent). Statistically significant differences were noted in keloids that had undergone prior excision as compared with those presenting for initial treatment. These differences included growth rate (p = 0.0026), protocol failure (p = 0.0149), and total postoperative steroid injections administered (p = 0.0104). CONCLUSIONS: The primary protocol presented for the treatment of ear keloids produces durable results, with an acceptably low recurrence rate. Stratification of keloids based on an assessment of aggressiveness may allow for a more informed choice in their optimal treatment.

Pulsed magnetic fields accelerate cutaneous wound healing in rats.

BACKGROUND: Previous studies of pulsed magnetic fields have reported enhanced fracture and chronic wound healing, endothelial cell growth, and angiogenesis. This study characterizes the biomechanical changes that occur when standard cutaneous wounds are exposed to radiofrequency pulsed magnetic fields with specific dosage parameters, in an attempt to determine whether return to functional tensile strength could be accelerated in wound healing. METHODS: There were two study phases and a total of 100 rats. In phase 1, wounds were exposed to a 1.0-G pulsed magnetic field signal in clinical use for wound repair for 30 minutes twice daily for 21 or 60 days. Phase 2 was a prospective, placebo-controlled, double-blind trial in which rats were treated for 30 minutes twice daily with three different low-amplitude signals (0.02 to 0.05 G), configured assuming a Ca binding transduction pathway, for 21 days. A midline, 8-cm, linear skin incision was made on the rat dorsum. Tensile strength was determined by measuring the point of rupture of the wound on a standard tensiometer loaded at 0.45 mm/second. RESULTS: The mean tensile strength of treated groups in phase 1 was 48 percent (p < 0.001) greater than that of controls at 21 days; there was no significant difference at 60 days. In phase 2, the treated groups showed 18 percent (not significant), 44 percent, and 59 percent (p < 0.001) increases in tensile strength over controls at 21 days. CONCLUSION: The authors successfully demonstrated that exposing wounds to pulsed magnetic fields of very specific configurations accelerated early wound healing in this animal model, as evidenced by significantly increased wound tensile strength at 21 days after wounding.

Limited myocardial muscle necrosis model allowing for evaluation of angiogenic treatment modalities.

The currently accepted model for creating infarcted cardiac tissue in a rat model involves ligation of the left anterior descending artery (LAD), either proximally or at the bifurcation level. This procedure requires significant technical expertise and, even in skilled hands, commonly results in a 30% to 60% animal mortality. The authors propose a new model for creating a limited area of myocardial muscle necrosis that can be effectively studied. It involves a distal electrocautery occlusion of the LAD terminal branches and coagulation of the surrounding muscle. The model is consistently reproducible and decreases the morbidity of the study animals. It provides a cardiac muscle necrosis model not dependent on survival, while allowing study of the post injured state of the muscle and surrounding scar. This allows researchers to evaluate neovascularization and healing of the scar and peri-necrotic muscle, to assess improving blood flow with treatment by techniques designed to improve and stimulate angiogenesis, and to measure the outcome of stem-cell transplants for potential clinical use.

Pulsed magnetic field therapy increases tensile strength in a rat Achilles' tendon repair model.

PURPOSE: To examine the effect of pulsing electromagnetic fields on the biomechanic strength of rat Achilles' tendons at 3 weeks after transection and repair. METHODS: This noninvasive modality was tested in a prospective, randomized, double-blinded, placebo-controlled study to evaluate the effect of a specific noninvasive radiofrequency pulsed electromagnetic field signal on tendon tensile strength at 21 days post transection in a rat model. RESULTS: In the animals receiving PMF exposure, an increase in tensile strength of up to 69% was noted at the repair site of the rat Achilles' tendon at 3 weeks after transection and repair compared with nonstimulated control animals. CONCLUSIONS: The application of electromagnetic fields, configured to enhance Ca(2+) binding in the growth factor cascades involved in tissue healing, achieved a marked increase of tensile strength at the repair site in this animal model. If similar effects occur in humans, rehabilitation could begin earlier and the risk of developing adhesions or rupturing the tendon in the early postoperative period could be reduced.