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Biomedical subjects

R K Fuller

Publications and source records attributed to R K Fuller.

At least 19 recordsLinked to original sources
PubMed1991

Assessment of treatment outcome.

Treatment outcome research consists of two types: controlled clinical trials and in-house program evaluations. Controlled clinical trials are experimental studies designed to test whether or not a treatment is efficacious. In-house program evaluations provide information about the results (outcome) of an individual treatment program. The key components of clinical trials include control groups; randomization procedures; enumeration of those who were screened for inclusion in, those accepted into, and those excluded from the study; a description of the relevant patient characteristics of the sample studied; "double-blinding" for pharmacological studies; raters of treatment effects who are not the therapists for verbal therapies; objective measures of treatment response; follow-up of at least 70% of the original sample; and appropriate statistical analysis of the data collected. In-house program evaluations rarely have control groups or employ randomization. However, a description of the type of patients treated by the program, independent raters, and adequate follow-up of those entering treatment are essential for program evaluation; and the credibility of program evaluation would be enhanced by the use of objective measures of treatment response.

Alcoholism↗
PubMed1988

Validity of self-report in alcoholism research: results of a Veterans Administration Cooperative Study.

The validity of self-report in alcoholism treatment research is controversial. Our recently completed Veterans Administration Cooperative Study evaluating the efficacy of disulfiram treatment for alcoholism provided an opportunity to assess the validity of self-report. To assess treatment response, patients and household contacts were interviewed at seven scheduled points during the 1 year of follow-up. Blood specimens also were obtained from the patients at these times and were analyzed for ethanol. Eighty-eight percent of the patient and/or collateral interviews were obtained at 6 months and 90% at 1 year. The mean number of blood and urine specimens collected per patient was 4.3 and 14.4, respectively. Outcome criteria included continuous abstinence during the year and total number of drinking days. Continuous abstinence: If we had had only the patients' self reports, we would have significantly underestimated the percentage of men who drank. By self-report 58.7% (355/605) relapsed whereas the combination of self report, collaterals' reports, and laboratory tests indicated that 72.4% (438/605) drank (p less than 0.001). Using Bayes' theorem, the conditional probability that a patient is continuously abstinent for 1 year when he so claims is 65%. Total drinking days: Of the 213 patient-collateral pairs each of whom provided all seven scheduled interviews, 46.9% (100/213) agreed on the total number of drinking days during the year.(ABSTRACT TRUNCATED AT 250 WORDS)

Alcohol Drinking↗
PubMed1988

Plasma carnitine in alcoholism.

Carnitine is essential for the beta-oxidation of long-chain fatty acids in the mitochondria and probably has a major role in modulating the acyl-coenzyme A/reduced coenzyme A ratio in the matrix of mitochondria. Plasma carnitine concentrations are elevated in several conditions and reflect changes at the cellular level. We previously had reported elevated plasma carnitine in patients with alcoholic liver disease compared to healthy control subjects. In this study we measured plasma carnitine in a third group, alcoholic patients without overt liver disease. The alcoholic patients (n = 20) had significantly elevated plasma long-chain acylcarnitine (P less than 0.01) compared to 32 healthy men of identical age and significantly lower short-chain (P less than 0.01) and long-chain acylcarnitine (P less than 0.01) than 28 men with alcoholic liver disease. We conclude that alcoholism is another condition in which carnitine homeostasis is altered.

Adult↗
PubMed1987

Psychiatric complications of disulfiram treatment.

The authors studied psychiatric complications of disulfiram use in 605 alcoholic patients. The subjects were assigned to one of three treatment groups: a 250-mg disulfiram group (N = 202), a 1-mg disulfiram group (N = 204) to control for the fear of the alcohol-disulfiram reaction, and a no-disulfiram group (N = 199) to control for the effect of psychotherapy. No significant differences in the incidence of psychiatric complications were found among the three groups. The authors conclude that if psychiatric complications follow disulfiram use, the incidence must be very low with the doses of disulfiram used presently and in the absence of predisposing factors.

Alcoholism↗
PubMed1986

Disulfiram treatment of alcoholism. A Veterans Administration cooperative study.

We conducted a controlled, blinded, multicenter study of disulfiram treatment of alcoholism in 605 men randomly assigned to 250 mg of disulfiram (202 men); 1 mg of disulfiram (204 men), a control for the threat of the disulfiram-ethanol reaction; or no disulfiram (199 men), a control for the counseling that all received. Bimonthly treatment assessments were done for one year. Relative/friend interviews and blood and urine ethanol analyses were used to corroborate patients' reports. There were no significant differences among the groups in total abstinence, time to first drink, employment, or social stability. Among the patients who drank and had a complete set of assessment interviews, those in the 250-mg disulfiram group reported significantly fewer drinking days (49.0 +/- 8.4) than those in the 1-mg (75.4 +/- 11.9) or the no-disulfiram (86.5 +/- 13.6) groups. There was a significant relationship between adherence to drug regimen and complete abstinence in all groups. We conclude that disulfiram may help reduce drinking frequency after relapse, but does not enhance counseling in aiding alcoholic patients to sustain continuous abstinence or delay the resumption of drinking.

Actuarial Analysis↗
PubMed1985

Effect of parenteral amino acids on human pancreatic exocrine secretion.

Parenteral administration of amino acids has been utilized for the nutritional support of patients with a variety of gastrointestinal disorders including protracted pancreatitis and pancreatic fistulae. However, the effect of parenteral amino acid administration alone on human pancreatic secretion has not been studied. We have studied the short-term effect of parenteral administration of amino acids on pancreatic exocrine secretion in seven healthy men. A double-lumen tube was placed in the duodenum and polyethylene glycol was perfused into the proximal duodenum at the rate of 10 ml/min. A second double-lumen tube was placed in the stomach and bromsulfthalein was perfused into the cardia. Samples of duodenal contents were aspirated and gastric contents recovered during one hour of intravenous saline infusion followed by two hours of an amino acid mixture infusion. Hourly outputs of protein and pancreatic enzymes were determined, correcting for duodenogastric reflux based on concentrations of both markers in the samples. Despite an average increase of 72% in the plasma concentration of the infused amino acids, the outputs of protein, trypsin and amylase did not change significantly during amino acid infusion; the output of lipase decreased significantly during amino acid infusion. Two subjects were given intravenous secretin and cholecystokinin following amino acids; this resulted in increased outputs of protein, trypsin, and amylase in both. We conclude that the parenteral administration of amino acids to healthy young men does not stimulate pancreatic enzyme secretion as measured by the method using duodenal marker perfusion at the rate of 10 ml/min.

Adult↗
PubMed1985

Immune complexes and complement abnormalities in patients with cystic fibrosis. Increased mortality associated with circulating immune complexes and decreased function of the alternative complement pathway.

Serum samples from 139 patients with cystic fibrosis (CF) were tested for complement abnormalities and circulating immune complexes (CIC). We found no consistent changes in whole complement activity. However, we found CIC in 29% of these patients and decreased activity of the alternative complement pathway (ACP) in 36%. During 5 yr of observation, mortality was much higher in patients whose sera contained CIC (p less than 0.001) or decreased ACP activity (p less than 0.01). Of patients with both abnormalities, 31% died; however, no deaths occurred in patients with normal ACP activity and negative tests for CIC (p less than 0.001). During a subsequent 2.5-yr period, 55% of patients greater than or equal to 21 yr old with both findings died. In contrast, no deaths occurred in older patients lacking this combination (p = 0.0062). Circulating immune complexes but not decreased ACP activity were an independent risk factor for death. Our findings support the hypothesis that humoral immune mechanisms may contribute to morbidity and mortality in CF.

Adolescent↗
PubMed1984

Veterans Administration cooperative study of disulfiram in the treatment of alcoholism: study design and methodological considerations.

Disulfiram treatment of alcoholism has been difficult to evaluate in controlled studies because the study design must contend with problems unique to this drug. The therapeutic effect may be a result of the patient's fear of the disulfiram-ethanol reaction rather than a direct pharmacological effect on the craving for alcohol. Good outcome may not be directly related to compliance with the drug regimen; a patient may remain abstinent even if he does not take his medication. The Veterans Administration Cooperative Study "Disulfiram in the Treatment of Alcoholism," is a multicenter, randomized, blinded, controlled clinical trial designed to evaluate the efficacy of disulfiram while addressing these issues. Two control groups are used. The members of one control group will not receive disulfiram and will be told they are not receiving disulfiram. The members of the other control group will be given disulfiram and will be told they are receiving disulfiram; however, the dose of their disulfiram will be measured by doing pill counts and obtaining urine specimens at each clinic visit and measuring urinary diethylamine, a metabolite of disulfiram, and riboflavin (a medication marker).

Adolescent↗
PubMed1983

The metabolic fate of double-labeled disulfiram.

The metabolic fate of disulfiram labeled with both 14C and 35S was studied in the rat. After administration of 50 mg of 14C, 35S-disulfiram dissolved in corn oil to rats by stomach tube, 95% of the radioactivity was recovered in urine, feces, and expired air at 144 hr. The major portion of the excreted radioactivity was in urine (75 +/- 6%). Feces and expired air contained 13 +/- 2% and 6 +/- 5% of the body organs or carcass. Pretreatment of rats with unlabeled disulfiram for 20 days prior to administration of 14C, 35S-disulfiram led to more rapid catabolism of the drug and more rapid excretion of radioactivity in the urine during the first 12 hr after dosing.

Animals↗
PubMed1981

An evaluation of the efficacy of nasogastric suction treatment in alcoholic pancreatitis.

We evaluated the efficacy of nasogastric suction for alcohol-related pancreatitis by performing a randomized, controlled study. Twenty-one patients with pancreatitis associated with alcohol ingestion received either nasogastric suction or nothing by mouth in addition to intravenous fluids and meperidine as needed. Twenty patients completed the treatment to which they were assigned. There were no statistically significant differences between the group that received nasogastric suction and the group that did not in duration of abdominal pain, anorexia, abdominal tenderness, ileus, presence of abdominal masses, or elevated serum amylase and lipase activities and the ratio of the renal clearance of amylase to creatinine; or the number of meperidine injections requested per subject. Patients receiving nasogastric suction complained of significantly longer duration of nausea and vomiting. We conclude that nasogastric suction is not effective in the treatment of uncomplicated alcoholic pancreatitis.

Abdomen↗
PubMed1980

The metabolism of 14C-disulfiram by the rat.

After administration of 14C-disulfiram to rats by stomach tube, we found that 87% of the radioactivity was excreted in urine and 7% in feces. Greater than 80% of the radioactivity was excreted by 48 hr. Small but measurable radioactivity was excreted in urine up to 144 hr after administration. Total recovery of radioactivity at 144 hr was 95% of the ingested dose with less than 1% in organs, blood, and carcass; the remainder was in urine and feces. Studies on specific radioactivity showed that diethylamine, a major urinary metabolite of disulfiram, is excreted in the urine undiluted with endogenous diethylamine. Pretreatment of rats with unlabeled disulfiram leads to a more rapid catabolism of the radioactive drug and more rapid excretion of radioactivity in the urine. Further, pretreatment appears to induce formation of a glucuronide conjugate of a disulfiram metabolite.

Animals↗
PubMed1980

Life-table analysis of abstinence in a study evaluating the efficacy of disulfiram.

Data from a study evaluating the efficacy of disulfiram for the treatment of alcoholism were analyzed by life-table methods. Previous analysis by more commonly used statistical tests showed a trend favoring disulfiram treatment, but the results were not statistically significant. Life-table methods are the appropriate techniques for analyzing longitudinal studies because they evaluate response to treatment over time rather than at one point in time. Analysis of our data using these methods revealed that disulfiram, combined with medical care and counseling, was superior to medical care and counseling alone in 128 men followed for 1 yr. This report demonstrates: (A) the advantage of life-table methods for evaluating treatment outcome data in alcoholism studies; and (B) the importance of disulfiram treatment in alcoholic patients similar to those we studied.

Actuarial Analysis↗
PubMed1979

Disulfiram for the treatment of alcoholism. An evaluation in 128 men.

One hundred twenty-eight alcoholic men were assigned randomly to receive either a regular dose of disulfiram (250 mg), a pharmacologically inactive dose (1 mg), or no disulfiram. There were no statistically significant differences among the three treatment groups in total abstinence, percentage of drinking days, days worked, family stability (living with same relative), or percent of scheduled appointments kept. However, 21% of those who received the regular dose of disulfiram and 25% who received the pharmacologically inactive dose remained abstinent, whereas only 12% of those who received no disulfiram did so. These results indicate that disulfiram may be of limited value in the treatment of alcoholism, fear of the disulfiram-ethanol reaction is important in preventing drinking, and patients willing to take disulfiram are more likely to be abstinent if given the drug. We also found that complete abstinence correlated significantly with compliance and obtaining employment.

Adult↗
PubMed1977

An optimal diuretic regimen for cirrhotic ascites. A controlled trial evaluating safety and efficacy of spironolactone and furosemide.

Previous studies demonstrated the effectiveness of diuretics in mobilizing fluid, but frequent complications occur with their use in treating ascites. To develop an effective but safe regimen for treatment of cirrhotic ascites, a two-part crossover study was done. Subjects with life-threatening complications of cirrhosis were excluded. In part one it was demonstrated that a six-day diuretic regimen with dietary sodium restriction of 10 mEq/day is safe and more effective than sodium restriction alone. In part two the duration of diuretic therapy was safely extended from six to nine days with mobilization of significantly more fluid. Careful selection of subjects, use of diuretics in modest dosages for brief periods of time, and daily monitoring of subjects were important for the success of this study.

Ascites↗
PubMed1976

Method for the detection of diethylamine, a metabolite of disulfiram, in urine.

Disulfiram is a drug used in the treatment of chronic alcoholism in man. Accurate assessment of patient compliance is important in this treatment. This paper describes a method for the detection and quantitative analysis of diethylamine, a metabolite of disulfiram, in urine. The method involves conversion of the water-soluble diethylamine in the urine to a derivative, N,N-diethyl-3,5-dinitrobenzamide, that is soluble in an organic solvent. This derivative is extracted from urine with diethyl ether and then subjected to thin-layer chromatography. A spectrophotometric procedure is used for quantification. This method provides a means of determining whether or not a patient is taking his prescribed disulfiram.

Benzamides↗