Untreated Control Arm Research Articles

SOLAR (BRACHIORADIAL) PRURITUS?RESPONSE TO CAPSAICIN CREAM

Background. Solar (brachioradial) pruritus is an enigmatic condition affecting the lateral aspects of the arm(s) and is primarily seen in Caucasian people living in the tropics or subtropics. Methods. Over a 5-year period we prospectively evaluated 68 patients with solar pruritus seen in an outpatient dermatology clinic. Clinical, biochemical, and microscopic and ultramicroscopic studies were performed. An open-label trial of capsaicin cream application was initiated in 15 patients. Results. An almost equal number of men and women were seen with an average age of 44 years. Brown-eyed and blue-eyed patients were seen with equal frequency. Most patients (86%) had outdoor occupations or avocations. The pruritus was intense, usually bilateral (72%) and invariably affected the lateral (as opposed to medial) aspects of the arm(s) in the absence of primary lesions. The most commonly affected area was the elbow area superficial to the brachioradialis and extensor carpi longus muscles, but extension of the pruritus to include the forearm and/or upper arm was common. Biopsy specimens (stained with hematoxylin and eosin) were normal or showed mild actinic elastosis in 15 patients tested. Ultramicroscopy showed myelin sheath splitting in all four patients studied. This is a nonspecific finding that may also be found in diabetic or alcoholic neuropathy. Ten of thirteen patients completing the capsaicin-cream study found significant relief (itching much improved or gone) after 3 weeks compared with the untreated control arm. Conclusions. The cause of solar pruritus remains unknown, but circumstantial evidence implicates chronic exposure to solar radiation. Capsaicin may offer relief to these patients, but the patients need to be cautioned about the burning sensation that occurs with capsaicin cream.

Quality, Evolution, and Clinical Implications of Randomized, Controlled Trials on the Treatment of Lung Cancer

A review of 150 published randomized trials on the treatment of lung cancer showed serious methodological drawbacks. Handling of withdrawals (only 7 trials had no dropouts), a priori estimates of sample size (only 9 trials specified the required number of patients), blinding of randomization (only 22 trials had a satisfactory procedure), and information on eligible nonrandomized patients (only 13 studies reported it precisely) were areas of major concern. Although trial quality improved over time both in<i>design/execution</i>(study size estimation and analysis by prognostic factors became more frequent) and<i>reporting</i>(information on patients' characteristics and side effects were more thoroughly reported), their evolution was inconsistent. For non—small-cell lung cancer—despite the persistent lack of proof of efficacy of any active treatment—an untreated control arm was prematurely abandoned and a wide variety of tested regimens prevailed even in better-quality studies. Slightly more promising is the picture for small-cell lung cancer, where research indicates somewhat more reliable—though limited—progress. While clinical research in lung cancer has contributed little to defining the best standard care, we conclude that its heterogeneity makes it unlikely that quantitative meta-analysis of existing trials will be constructive. (<i>JAMA</i>. 1989;262:2101-2107)