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Biomedical subjects

L G Madsen

Publications and source records attributed to L G Madsen.

11 recordsLinked to original sources
PubMed2002

Review article: Single subject trials as a research instrument in gastrointestinal pharmacology.

The single subject trial is a randomized controlled trial carried out in the individual patient, and the result obtained is specific to the individual patient and the drug being investigated. This type of trial offers a supplement to traditional parallel group trials, especially in patients with heterogeneous disorders, often characterized by varying treatment responses and/or high placebo response rates. Pooled results from several individual single subject trials could extend the conclusions beyond the individual patient, and help to characterize a subset of responders to a specific treatment or clarify the heterogeneity of the disease. The basic principles of the different single subject trial designs are described. Advantages and limitations are reviewed with a special focus on published trials in functional gastrointestinal disorders. The single subject trial may be a valuable supplement to traditional drug treatment trials, either used as isolated trials in individual patients to determine optimal therapy, or in groups of patients to identify those with a uniform response to treatment. However, the lack of validation and reliability studies limits the value of the single subject trials presented so far.

Anti-Ulcer Agents↗
PubMed2000

[Menetrier's disease. Another Helicobacter pylori associated disease?].

Ménétrier's disease is a rare and poorly outlined disease, diagnosed in patients with giant gastric folds, dyspeptic symptoms and hypoalbuminaemia due to gastrointestinal protein loss. The etiology is unknown, but Ménétrier's disease is often associated with Helicobacter pylori (Hp) infection. Case reports and studies concerning the effect of eradication therapy in patients with Ménétrier's disease were reviewed. It was found that complete normalisation of the gastric mucosa and gastrointestinal protein loss following eradication therapy has been reported in several cases. In conclusion, we recommend patients with Ménétrier's disease to be tested for Hp, and treated with eradication therapy in case of infection.

Adult↗
PubMed2000

The value of alarm features in identifying organic causes of dyspepsia.

The unaided clinical diagnosis of dyspepsia is of limited value in separating functional dyspepsia from clinically relevant organic causes of dyspepsia (gastric and esophageal malignancies, peptic ulcer disease and complicated esophagitis). The identification of one or more alarm features, such as weight loss, dysphagia, signs of gastrointestinal bleeding, an abdominal mass or age over 45 years may help identify patients with a higher risk of organic disease. This review summarizes the frequency of alarm symptoms in dyspeptic patients in different settings (such as the community, primary care and specialist clinics). The prevalence of alarm features in patients diagnosed with upper gastrointestinal malignancy or peptic ulcer disease is described. The probability of diagnosing clinically relevant upper gastrointestinal disease in patients presenting with alarm features and other risk factors is discussed. Alarm features such as age, significant weight loss, use of nonsteroidal anti-inflammatory drugs, signs of bleeding and dysphagia may help stratify dyspeptic patients and help optimize the use of endoscopy resources.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2000

Opioid treatment of painful chronic pancreatitis.

BACKGROUND: Abdominal pain is the dominant symptom in 50-75% of patients with chronic pancreatitis, often requiring opioid analgesics. Fentanyl, a potent synthetic opioid, can be administered percutaneously at a constant dose and is claimed to have fewer systemic side effects. AIM: To evaluate transdermal fentanyl plaster versus sustained release morphine tablets as analgesic treatment of painful chronic pancreatitis. METHODS: In an open randomized crossover trial, 18 patients were included. The treatment period was 4 wk for each drug. All patients had immediate-release morphine tablets as rescue medication. RESULTS: The dosage of transdermal fentanyl had to be increased on average 50% over that indicated by the manufacturer. When this was done and rescue medication was secured, no difference between the two drugs in primary endpoint or patient preference was observed. There was also no difference in the secondary endpoints, pain control, and quality of life. However, skin side effects, mostly mild, occurred in 44% of the patients during treatment with transdermal fentanyl, and the mean daily dose of immediate release morphine was significantly higher during the transdermal fentanyl period than during the sustained-release morphine period (30.7 mg vs. 14.7 mg [p < 0.01]). CONCLUSION: When given in an appropriate dose, transdermal fentanyl might be useful for treatment of some patients with painful chronic pancreatitis, e.g., when tablet ingestion is difficult. However, the dosage often has to be increased above that recommended by the manufacturer. The need of rescue morphine is considerable and skin side effects often occur. Transdermal fentanyl is, therefore, not the ideal first-choice analgesic in patients with painful chronic pancreatitis.

Administration, Cutaneous↗
PubMed1989

[A study of percutaneous absorption of estradiol and progesterone in absolute alcohol in postmenopausal women].

Absorption of solutions containing 17-beta-oestradiol (E2) in absolute alcohol and progesterone (P) in absolute alcohol was investigated in six postmenopausal women. These preparations were applied to the skin of the forearm and the abdomen. 1 mg E2 was applied twice daily to the left forearm (RAS) for 28 days. After an interval of one week, the treatment was continued with 1 mg E2 twice daily for 28 days in the epigastric region (RE). From the 14th to the 28th day, this treatment was supplemented by 10 mg P twice daily partly on the right forearm and partly on the epigastrium. The 24-hour absorptions of E2 and P were investigated: E2 on the first and fourteenth days and P on the fourteenth day in both periods. On days 1, 7, 14, 21 and 28, plasma E2, oestrone (E1) and oestrone sulphate (E1SO4) were investigated for hormone application. Statistically significant absorption of E2 was found after 24 hours (p less than 0.05) and significantly greater absorption from RAS than RE (p less than 0.005). No systematic variation in plasma E2 was found during the period of investigation on RAS or RE. P was not absorbed. No local side effects were registered. It is concluded that E2 dissolved in absolute alcohol is clinically employable for treatment of postmenopausal women but that P is of no value in the dosage employed here. Further investigations of transcutaneous absorption of P are desirable.

Administration, Cutaneous↗
PubMed1989

[Absorption of norethisterone acetate from tablets with normal and coarse particle size].

A clinical randomized double-blind trial with cross-over is presented. The object was to assess the absorption of 1 mg norethisterone acetate from tablets with particles of normal and coarse size. The hypothesis was that the coarse particles would result in retarded absorption. In this trial, eight healthy postmenopausal women with an average age of 72 years participated. The participants received the tablets in the morning with intervals of a week and the plasma concentration (C) was measured throughout 24 hours. The two absorption profiles showed significant differences after 30 minutes (p less than 0.05) with the following values: Tablets with normal particles resulted in C = 31.1 nmol/l while the analogous result with the coarse particles was C = 17.0 nmol/l. It is concluded that the coarse particles resulted in lower plasma concentrations initially.

Aged↗
PubMed1986

[Vasa previa].

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Adult↗
PubMed1985

[Fetal ascites].

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Adult↗