Paul L. Doering

Vitamin C and Vitamin E for Alzheimer's Disease

OBJECTIVE To evaluate the literature on supplemental vitamin C and vitamin E therapy in the prevention and treatment of Alzheimers disease (AD). DATA SOURCES Literature retrieval was accessed through MEDLINE (1966–March 2005) using the key words antioxidants, vitamin C, vitamin E, Alzheimers disease, and dementia. International Pharmaceutical Abstracts (1970–March 2005), Current Contents (1996–March 2005), Cochrane Database of Systematic Reviews (1994–March 2005), and Ebscos Academic Search Elite (1975–March 2005) were searched with the same key words. STUDY SELECTION AND DATA EXTRACTION Articles related to the objective that were identified through PubMed were included. DATA SYNTHESIS Oral supplementation of vitamin C (ascorbic acid) and vitamin E (D-alfa-tocopherol acetate) alone and in combination have been shown to decrease oxidative DNA damage in animal studies in vivo, in vitro, and in situ. Recent results of a prospective observational study (n = 4740) suggest that the combined use of vitamin E 400 IU daily and vitamin C 500 mg daily for at least 3 years was associated with the reduction of AD prevalence (OR 0.22; 95% CI 0.05 to 0.60) and incidence (HR 0.36; 95% CI 0.09 to 0.99). Contradicting this is a previous prospective observational study (n = 980) evaluating the relationship between 4 years of vitamin C and E intake and the incidence of AD, which detected no difference in the incidence of AD during the 4-year follow-up. Recent meta-analysis results suggest that doses of vitamin E ≥400 IU daily for more than one year are associated with increased all-cause mortality. Mega-trial results suggest that vitamin E doses ≥400 IU daily for 6.9 years in patients with preexisting vascular disease or diabetes mellitus increase the incidence of heart failure, with no other outcome benefits noted. CONCLUSIONS In the absence of prospective, randomized, controlled clinical trials documenting benefits that outweigh recently documented morbidity and mortality risks, vitamin E supplements should not be recommended for primary or secondary prevention of AD. Although the risks of taking high doses of vitamin C are lower than those with vitamin E, the lack of consistent efficacy data for vitamin C in preventing or treating AD should discourage its routine use for this purpose.

Optimal management of amiodarone therapy: Efficacy and side effects

Objectives. To review management and dosing guidelines for amiodarone therapy, and discuss the drugs adverse event profile.

FDA Labeling System for Drugs in Pregnancy

OBJECTIVE: To review the current Food and Drug Administration (FDA) pregnancy labeling system, examine the new FDA-proposed pregnancy labeling system for form and content, and provide comments on its suitability for implementation. DATA SOURCES: Data were obtained from the FDAs Web site (www.fda.gov), PubMed, Federal Register, LexisNexis, Physicians Desk Reference (PDR), Drugdex, and Current Contents. STUDY SELECTION: Research and articles involving drugs and pregnancy, drugs and lactation, and the subcommittee meeting of the FDA were included. DATA EXTRACTION: Prospective, case-control studies from pregnancy registries. DATA SYNTHESIS: Currently, only 40% of drugs in the PDR have pregnancy categories listed. The medical profession has resorted to other means to assess pregnancy risk, such as retrospective chart review, case reports, and consultation with experts such as regional drug information centers. CONCLUSIONS: The proposed pregnancy labeling system strives for more clinical usefulness by reliance on human data derived from pregnancy registries. The clinical usefulness of the new labeling remains to be seen.

Discontinuation rates of Helicobacter pylori treatment regimens: a meta-analysis.

We conducted a meta‐analysis to determine what factors in treatment regimens for Helicobacter pylori are associated with increased discontinuation rates. Studies were selected from the 1990–1996 MEDLINE data base, and references in published articles and reviews were obtained. Each article was uniformally abstracted for factors that could potentially affect dropout rates. Drug regimens with high numbers of doses per day had highest dropout rates (p=0.0001). The total dropout rate was lowest for regimens containing a proton pump inhibitor (OR = 0.75, CI 0.57, 0.98). The rate was high in regimens containing a bismuth compound due to side effects (OR = 2.79, CI 1.78, 4.36). The main finding was that drug regimens for eradication of H. pylori that have a high number of doses per day result in higher discontinuation rates than regimens with fewer doses per day.

A Comparison of Various Types of Patient Instruction in the Proper Administration of Metered Inhalers

The administration technique employed by 42 inpatients using metered inhalers was observed. Proper performance of the six steps recommended by the manufacturer provided the guidelines for correct administration. The degree of compliance with proper technique was defined as the number of steps correctly executed by the patient. The mean number of steps correctly performed was 2.9 out of the possible six (48.3 percent). Twenty-four patients were then randomized into one of three groups. Group 1 received the manufacturers instruction sheet, Group 2 received counseling from a pharmacist, and Group 3 received both the manufacturers instruction sheet and counseling from a pharmacist. There was a significant improvement in the postinstruction technique in Groups 2 and 3, while Group 1 failed to demonstrate any significant improvement. Comparisons were then made among the three groups. No significant difference was found between Group 2 and Group 3. However, both Groups 2 and 3 were found to be significantly different (p < 0.05) from Group 1. This study shows that pharmacist counseling can significantly improve the degree of patient compliance in the administration of metered inhalers.

Bioidentical hormone therapy : a panacea that lacks supportive evidence

Purpose of review In the practice of ‘bioidentical hormone therapy’, it is our belief that pharmacists are compounding bioidentical hormone therapy with the best intentions. These pharmacists are, however, ill informed regarding the lack of scientific underpinning associated with the efficacy and safety of the practice of bioidentical hormone therapy. It is the purpose of this review to systematically examine the scientific rigor of the arguments posed by the proponents of bioidentical hormone therapy, and to differentiate the practice of bioidentical hormone therapy from the legitimate practice of pharmacy compounding. Recent findings Most medical organizations have in essence refuted the bioidentical hormone therapy claims as unsubstantiated. The profession of pharmacy needs to address this issue in an authoritarian, scientific way, outside of the compounding issue. Summary Bioidentical or natural hormones are expected to have similar efficacy and safety profiles as the commercially available hormonal therapies that have been studied in clinical trials, regardless of whether the active principle hormones are compounded by individual pharmacies or manufactured by large companies. Estriol is a weak estrogen that is not Food and Drug Administration approved for use as a prescription drug in the United States; thus, clinical trials are necessary to demonstrate the efficacy and safety profile for estriol. Further, supplementary clinical trials are necessary to determine whether there are efficacy or safety differences between natural progesterone and synthetic progestin, as studies to date are inconclusive.

Predispositions Toward Generic Drug Acceptance

This study examined the predispositions of persons, particularly the elderly poor, toward substituting chemically equivalent generic drugs for more expensive brand name products prescribed by their physicians. The findings suggest that these persons are not prone to choose generic substitutions for brand name drugs.

Effect of Magnesium Citrate on the in Vitro Adsorption of Aspirin by Activated Charcoal

The objective of this study was to determine if magnesium citrate solution given concurrently with activated charcoal would affect charcoals in vitro ability to bind aspirin. Aspirin and charcoal were mixed in simulated gastric fluid and simulated intestinal fluid, and then magnesium citrate solution was added in proportions simulating those encountered clinically. Results indicate that no clinically significant interaction occurs between magnesium citrate and activated charcoal in either fluid, and that these two agents can be given simultaneously without decreasing the binding capacity for aspirin.

Effects of Cocaine on the Human Fetus: A Review of Clinical Studies

The abuse of cocaine in this country has reached epidemic proportions and has generated great concern for the effects of the drug on the fetus when used during pregnancy. Although educational campaigns cite adverse fetal effects as a deterrent to using the drug, there are limited data on which to base a true risk assessment. This paper reviews the published studies of pregnancy outcome in cocaine-abusing mothers, with special focus on structural malformations and other neonatal risks.

Putting an Ecstasy Test Kit to the Test: Harm Reduction or Harm Induction?

Objective. To evaluate the DanceSafe Complete Adulterant Screening Kit for Ecstasy with regard to its accuracy in identifying 3,4‐methylenedioxymeth‐amphetamine (MDMA) and methylenedioxyamphetamine (MDA) derivatives and its ability to detect certain contaminants.