Design of clinical trials for chronic diseases: implications for periodontal disease

In order to make effective use of the statistical theory of design of clinical trials for chronic diseases such as periodontal disease, certain issues must be considered. Any clinical trial requires that the disease definition be well-specified; that patient eligibility be explicit; that the observation times be explicit; that the duration and endpoint of therapy be specified; that the duration of subsequent followup observation be specified; and that the unit of observation (e.g., tooth, set of teeth, patient) be defined. In a chronic disease, the potential biases that can readily be introduced by self-selection of patients who enter the trial and/or who return for subsequent observation become more important, because subjects are required to remain on treatment and/or observation for prolonged periods. Further, the cyclical nature of some chronic diseases may require special attention to baseline definitions of active disease and disease outcome. These issues are illustrated with examples from clinical trials of hypertension, breast cancer screening, and Polycythemia Vera. Implications for periodontal disease are discussed.     

Canine serum keratan sulfate and hyaluronate concentrations. Relationship to age and osteoarthritis

Elevated serum levels of keratan sulfate (KS) and hyaluronate (HA) in patients with osteoarthritis (OA) have been reported. We measured KS and HA in dogs to determine if there was an elevation of these serum glycosaminoglycans in a canine model of OA. A single intraarticular injection of 1 mg of chymopapain into a shoulder joint increased serum KS by tenfold, and HA by less than twofold, in 24 hours. Serum KS and HA levels were 3-5-fold higher in dogs younger than 2 months of age than in older dogs. Serum KS and HA concentrations and synovial fluid KS concentrations were unrelated to spontaneous cartilage degeneration in 1-year-old dogs. Higher KS levels in synovial fluid correlated with higher KS levels in serum (r = 0.54, P less than 0.025). The mean KS concentration in sera of older dogs (greater than 3 years old) with OA was 37% higher than that in disease-free controls, but the difference between the groups was not statistically significant. Thus, elevated levels of serum KS and HA do not appear to have clinical significance in this model of OA.     

Misdiagnosis of hysteria

The diagnosis of hysteria is often incorrect and must be made with great caution. A retrospective study demonstrates that an erroneous diagnosis of hysteria is most likely to be given to females, the psychiatrically ill, patients who embellish and patients who present plausible psychogenic explanations for their illness. Movement disorders and paralysis are the neurologic disorders most frequently mislabeled as hysteria.     

Cervical lesions of branchial origin

A brief review of the developmental background of the lateral cervical sinuses, fistulas, cysts and auricles has been presented. In all likelihood they are of branchial cleft origin. Surgical excision is the recommended treatment as shown in the cases described.     

Second‐degree atrioventricular block (Mobitz Type I) in an adolescent with anorexia nervosa: Intrinsic or acquired conduction abnormality

Anorexia nervosa (AN) can cause both functional and structural cardiac complications, including a variety of different conduction abnormalities. This is the first case report of symptomatic diurnal second‐degree atrioventricular (AV) block (Mobitz Type I) in an adolescent with AN. We present a 12‐year‐old girl with AN, restrictor sub‐type who reported cardiac symptoms during weight gain, at the time of the initial diagnosis of AV block. Second‐degree AV block (Mobitz Type I) is discussed as a possible complication of the AN, as well as being an intrinsic conduction system disease. © 2009 by Wiley Periodicals, Inc. Int J Eat Disord 2009