Biomedical subjects
Publications and source records attributed to J E Bernstein.
A patient with erythema multiforme developed many nevocytic nevi, including a large cluster of such lesions at the sites of healed blisters. The development of eruptive nevocytic nevi in this pattern suggests that cutaneous injury plays a role in their pathogenesis.
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Bullous eruption of diabetes is a cutaneous sign of diabetes mellitus. Patients with this disorder manifest a sudden onset of intraepidermal or subepidermal bullae, which are primarily confined to the extremities and heal within several weeks without scarring. Our patient had severe diabetes and experienced two episodes of bullae associated with intense, ultraviolet light exposure. Negative immunofluorescence, early disappearance of anchoring filaments and half-desmosomes between cell membrane and basal lamina, and the absence of urinary uroporphyrins separate this entity from certain similar-appearing conditions. Cation imbalance, precipitated by renal failure, could be a possible causal factor.
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Participation in human experimental research constitutes a major problem for the geriatric subject. Because there is a high incidence of noncontagious disease in the elderly, they are the group most useful for the study of new therapeutic agents or procedures. However, normal aging processes, often coupled with disease of the central nervous system, render elderly persons less able to comprehend the nature and risks of such studies. These factors permit easy exploitation of geriatric subjects in medical experimentation, with possible exposure to a significant risk of serious drug reactions and unnecessary hospitalization. Recent federal regulations have given "special protections" to children, prisoners, and the mentally infirm in experimental research, to guard against abuse of their human rights. A basic requirement is that informed consent be carefully obtained and documented. Such "special protections" should now be extended to geriatric subjects so that there will be no further exploitation in the course of valid clinical research.
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The class of immunoglobulin (Ig) deposited at the dermal-epidermal junction (DEJ) of the skin in patients with systemic lupus erythematosus (SLE) has been proposed to have prognostic implications. The authors studied disease activity in 51 SLE patients with a positive lupus band. Patients with cutaneous IgM deposits had significantly more severe disease than those with only IgG or with mixed immunoglobulin deposits. While their data suggest an association between IgM deposits, severe disease and a poor prognosis, they urge caution in utilizing Ig deposits as a prognostic indicator.
An 8-week double-blind, multicenter, parallel study compared the safety and efficacy of topical capsaicin and oral amitriptyline in patients with painful diabetic neuropathy involving the feet. Two hundred thirty-five patients were randomized to treatment with either capsaicin cream or amitriptyline capsules. Capsaicin-treated patients received inactive capsules, and amitriptyline-treated patients applied vehicle cream. A visual analogue scale of pain intensity and measurements of interference by pain with functional activities were recorded at onset and at 2-week intervals. A visual analogue scale of pain relief and physicians' global evaluation assessed changes in pain status from baseline. Topical capsaicin and oral amitriptyline produced equal and statistically significant improvements in pain over the course of the study. By the end of week 8, 76% of patients in each group experienced less pain, with a mean reduction in intensity of more than 40%. By the end of the study, the interference with daily activities by pain had diminished significantly (P = .001) in both groups, including improvements in sleeping and walking. No systemic side effects were observed in patients treated with topical capsaicin. Most patients receiving amitriptyline experienced at least one systemic side effect, ranging from somnolence (46%) to neuromuscular (23%) and cardiovascular (9%) adverse effects. Topically applied capsaicin is an equally effective but considerably safer alternative to amitriptyline for relief of the pain of diabetic neuropathy.
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An accepted practice in medical research has been the subordination of individual rights to the benefit of mankind. The Nazi experiments, and other recent abuses, have focused increased attention on the dignity and rights of human research subjects and have led to new regulations to control human experimentation. Central to establishing what constitutes permissible human experimentation are the issues of risk-benefit ratio and informed consent. Evaluating the risk-benefit ratio requires consideration of the nature of the experiment, the likelihood of its success, and the type of subjects to be utilized. Participation in a study requires voluntary "educated" informed consent. Certain categories of subjects, such as children and the mentally handicapped, require special protection in this regard. Finally, formal education in medical ethics and prohibiting publication of unethical studies are likely to prove more effective in curbing unethical experimentation than increasing government regulation.