SEARCH · Search PubMed

Results for “Controlled Clinical Trials as Topic”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

SourceResearch connectionFrom yearThrough year

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 55 records · Page 3Linked to original sources

PubMed1997

Appraisal of the validity of histamine-induced wheal and flare to predict the clinical efficacy of antihistamines.

Antihistaminic drugs have been used successfully for many years in the treatment of allergic diseases. Second-generation antihistamines have fewer sedating side effects than first-generation agents, and the number of newer drugs available for clinical use is growing. Various methods have been used to assess antihistaminic activity, the most popular of which is the epicutaneous histamine-induced wheal and flare. This test relies on the ability of epicutaneously injected histamine to bring about the wheal and flare, a neurovascular response that involves reflex vasodilation (flare) and local swelling caused by plasma extravasation (wheal). Antihistamines have been compared on the basis of their ability to block the histamine-induced wheal and flare in the skin. Results of these trials have been applied to predict the global antiallergic efficacy of various antihistamines. The review has examined the reliability of suppression of the histamine wheal and flare reaction in the skin to predict an antihistamine's clinical efficacy in two common allergic diseases seasonal allergic rhinitis and chronic idiopathic urticaria. Although histamine is one mediator in the allergic response in the skin and nasal mucosa, many other agents are important modulators of the allergic response. In addition, the major structural and functional differences that exist between the nasal mucosa and the skin affect the type of local response. These manifest themselves as differences between the responses to antigen and histamine challenge in the skin and the nose. The allergic responses in these tissues are not simply the consequence of one chemical but are the result of a cascade of interactions among various cells and mediators. The clinical manifestations of these complex interactions obviously cannot be fully replicated by injection of one chemical mediator, histamine, into the outer layer of the skin. Studies with antihistamines have shown that certain drugs, such as cetirizine, are more suppressive than others (loratadine, terfenadine) in controlling the histamine-induced wheal and flare reaction in the skin. When the clinical efficacy of these medications is compared in clinical trials in seasonal allergic rhinitis and chronic idiopathic urticaria, all are equally efficacious in controlling symptoms. Although the histamine-induced wheal and flare reaction can serve as a useful clinical pharmacologic test to assess dose-response relations for an antihistamine, its lack of correlation with clinical responses among antihistamines indicates that this model should not be used to predict or compare clinical efficacies of antihistamines in seasonal allergic rhinitis and chronic idiopathic urticaria.

Allergens↗

PubMed2001

[Gabapentin--yet another antiepileptic agent for the treatment of neuropathic pain?].

Gabapentin is a recently introduced anti-epileptic drug used as an adjuvant in partial and secondarily generalised tonic-clonic seizures. Its mechanism of action has not been fully elucidated, but it seems that gabapentin may regulate voltage-dependent calcium channels, presumably on a spinal level, in the nociceptive system. Two large, controlled clinical trials of painful diabetic neuropathy and postherpetic neuralgia have demonstrated its analgesic efficacy. The adverse effects associated with gabapentin treatment are relatively harmless, mild to moderate in severity, and usually transient, with tolerance developing 2-3 weeks after start of treatment. Gabapentin and tricyclic antidepressants are efficacious in the treatment of painful diabetic neuropathy and postherpetic neuralgia.

Acetates↗

PubMed2005

[The effect of a homeopathic drug on the blood pressure of hypertensive patients--a randomised double-blind controlled parallel group comparative trial].

Pumpan in a dosage of 3 x 10 drops daily over 6 weeks does not differ in its effect on systolic and diastolic blood pressure significantly from placebo. The tolerance was excellent: not one single patient had to be withdrawn from the study due to side effects. Blood lipids (cholesterol, HDL-, LDL-cholesterol and triglyzerides) did not change, neither in the placebo nor in the verum group.

Antihypertensive Agents↗

PubMed1996

[Calcium antagonists in the treatment of hypertension and heart failure. A comment to recently published results of clinical trials].

Several studies have been published recently on the effect of calcium-antagonists in the treatment of hypertension and heart failure. Except for an American case-control study, in which negative results may have been caused by selection bias, other studies show that calcium-antagonists have a positive effect. They appear to reduce cardiovascular complications, lower mortality and slow down the progression of atherosclerosis. However, large trials of adequate design and force are in progress (STOP II, NORDIL, HOT, INSIGHT, ALLHAT). It is hoped that the results of these trials will clarify whether calcium-antagonist are warranted in the treatment of hypertension and associated cardiovascular disease.

Calcium Channel Blockers↗

PubMed1997

[Requirements of patient-oriented clinical-therapeutic research].

Explore the source record for details and available documents.

Clinical Trials as Topic↗

PubMed2001

Natural agents in the prevention of cancer. Part 1: human chemoprevention trials.

Data exist in the scientific literature showing reduction in the risk of tumor occurrence achieved by the use of nutritional and other natural materials. However, many trials that have attempted to prevent cancer occurrence with nutritional supplementation have found no effect or even increased tumor incidence. Several factors appear to be responsible for these disparate data, including the forms of nutrients used and the types of cancer being studied. In addition, combinations of nutrients have often been found to be more effective than single nutrient interventions. Appropriate use of supplemental nutrition, along with attention to pertinent dietary and lifestyle risk factors, comprise for the average person perhaps the best presently available strategy for prevention of the common types of malignancy.

Chemoprevention↗

PubMed2003

Curative ablation for atrial fibrillation: what clinical trials do we need to establish efficacy.

In contrast to other supraventricular tachycardias, curative treatment of atrial fibrillation, although increasingly available and rapidly evolving, is neither as effective nor the first choice. Until recently, the unavailability of nonsurgical curative treatment may have fueled a debate on the relative importance of restoring sinus rhythm versus controlling the ventricular rate during atrial fibrillation. Recent randomized trials (PIAF, AFFIRM, and RACE) using very limited atrial fibrillation burden assessment show that pharmacologic ventricular rate control is much safer and possibly more effective than pharmacologic restoration of sinus rhythm. A clinical trial comparing a truly curative treatment of atrial fibrillation-such as catheter ablation targeting pulmonary vein isolation-with pharmacologic treatment is required. It should focus on reliable efficacy parameters, use vigilant assessment of safety, and, most importantly, be structured to provide all-important prognostic information on long-term outcome. Atrial fibrillation burden is a theoretically robust efficacy parameter, but accurate quantification over a sufficiently long period of monitoring will require technologically innovative noninvasive rhythm monitoring devices.

Anti-Arrhythmia Agents↗

PubMed1994

Anorexia and cachexia in advanced cancer patients.

Cachexia is a frequent and devastating complication of advanced cancer. Current understanding of the pathophysiology of this syndrome implicates tumour induced metabolic changes and immune responses. Clinical manifestation include anorexia, chronic nausea, asthenia and change in body image. Aggressive nutritional intervention has not been shown to be of benefit. Patients and families should be counselled about the goals of nutritional intake. In selected cases, enteral nutrition may be appropriate. Pharmacological management should first be directed at correcting nausea. Agents of potential usefulness in the treatment of anorexia include corticosteroids, megestrol acetate, cyproheptadine, hydrazine sulphate and dronabinol. Future research should further address pathophysiology, symptomatic and metabolic effects of interventions and interactions with other syndromes of terminal cancer.

Adrenal Cortex Hormones↗

PubMed1999

[Intensified insulin treatment is cost-effective].

Both the Diabetes Control and Complications Trial (DCCT) in USA/Canada, and Stockholm Diabetes Intervention Study (SDIS) showed intensified insulin treatment and reduced glycaemia to prevent complications in patients with insulin-dependent (type I) diabetes mellitus. In the DCCT, the intensified treatment was considered cost-effective. In the SDIS, investigation of the direct increase in costs due to the intensified insulin treatment showed the saving in direct costs due to the reduction in photocoagulation requirements, and in the prevalence of renal insufficiency and of amputation, to correspond to 10 years' intensive insulin treatment. Thus, as intensified insulin treatment in type I diabetes reduces direct suffering at a low cost, it may be regarded as 'evidence-based' and mandatory.

Canada↗

PubMed1995

Risperidone: review and assessment of its role in the treatment of schizophrenia.

OBJECTIVE: To review pharmacologic, pharmacokinetic, therapeutic, and safety information for the antipsychotic agent risperidone and to evaluate its place in the treatment of schizophrenia. DATA SOURCES: MEDLINE and Exerpta Medica databases; Janssen Pharmaceuticals; Food and Drug Administration Psychopharmacology Advisory Committee; PJB Publications; published articles and abstracts; unpublished research reports and abstracts. STUDY SELECTION: In vivo animal studies (pharmacology); volunteer studies (pharmacokinetics); clinical case reports, open clinical studies, and controlled clinical studies (clinical efficacy and adverse effects; long-term studies; studies in special populations. DATA EXTRACTION: Relevant data were extracted from published and unpublished source documents, evaluated, and summarized in tables for comparative review. Abstracts were used in 6 of 8 pharmacokinetic studies, 4 of 8 open clinical studies, and 2 of 9 controlled clinical studies. Use of abstracts limits the extent of data extracted. DATA SYNTHESIS: Risperidone is an effective treatment for positive symptoms of schizophrenia and may be effective for negative symptoms. Efficacy in treatment-resistant patients is inconclusive. In patients in whom low-to-moderate dosage is effective, there should be fewer and less severe adverse effects with risperidone than with haloperidol. Optimal dosage for schizophrenia appears to be 6 mg/d. Although data are limited, risperidone may be toxic on overdose. CONCLUSIONS: Risperidone is a useful addition to the antipsychotic drug armamentarium, but it should be viewed as an atypical antipsychotic agent. It is reasonable to consider a trial of risperidone in treatment-resistant schizophrenic patients prior to the use of clozapine and as a first-line treatment for newly diagnosed patients with schizophrenia.

Antipsychotic Agents↗

PubMed2003

Concepts in the treatment of bipolar disorder.

OBJECTIVE: Concepts in the treatment of bipolar disorder are discussed considering clinical practice. METHOD: Results of the Multicenter Study of Long-term Treatment of Affective and Schizoaffective Psychoses (MAP) study, a controlled maintenance trial, are interpreted with respect to treatment concepts. RESULTS: The spectrum of patients diagnosed as bipolar has become more heterogeneous. It now comprises subtypes requiring differentiated treatment. The MAP study confirms that prophylactic efficacy of lithium seems to be specific to classic manic-depressive illness, whereas carbamazepine might be more efficacious in non-classic bipolar patients. With respect to clinical practice, treatment evaluation should also consider anti suicidal effects, inter-episodic morbidity and compliance. In these respects, results are in favour of lithium. Furthermore, data indicate that adherence to lithium clearly depends on illness concepts. This encourages efforts to supplement pharmacotherapy by psychoeducation and psychotherapy. CONCLUSION: With the broadening of diagnostic criteria, the treatment of bipolar disorder has become more complex. Patients need an integrated approach, including differentiated mood-stabilizing pharmacotherapy and psychotherapeutic measures.

Affect↗

PubMed2005

Topical glyceryl trinitrate application in the treatment of chronic supraspinatus tendinopathy: a randomized, double-blinded, placebo-controlled clinical trial.

BACKGROUND: Topical glyceryl trinitrate therapy has previously demonstrated short-term pain reduction in patients with supraspinatus tendinopathy. HYPOTHESIS: Topical glyceryl trinitrate improves outcome measures in patients with supraspinatus tendinopathy. STUDY DESIGN: Randomized controlled clinical trial; Level of evidence, 1. METHODS: Fifty-three patients (57 shoulders) were recruited, and the authors completed a prospective, randomized, double-blinded, placebo-controlled clinical trial of continuous topical glyceryl trinitrate treatment (1.25 mg/24-h glyceryl trinitrate). RESULTS: The glyceryl trinitrate group had significantly reduced shoulder pain with activity, at night, and at rest at week 24 (P = .03); reduced internal rotation impingement at week 24 (P = .02); increased range of motion in abduction and internal rotation at week 24 (P = .04); and increased force at weeks 12 and 24 with supraspinatus muscle testing (P = .001), external rotation (P = .04), internal rotation (P = .01), adduction (P = .04), and subscapularis pushoff (P = .01). Forty-six percent of patients on glyceryl trinitrate patches were asymptomatic with activities of daily living at 6 months compared with 24% of patients with tendon rehabilitation alone (P = .007, chi(2) analysis). Mean effect size for all outcome measures was 0.26. DISCUSSION: Topical glyceryl trinitrate treatment significantly improved pain scores, range of motion, internal rotation impingement, muscular force, and patient outcomes in patients with supraspinatus tendinopathy. Topical glyceryl trinitrate should be included as part of nonsurgical management of chronic tendinopathies.

Administration, Topical↗

PubMed1983

Septic complications after appendicectomy for perforated appendicitis. A controlled clinical trial metronidazole and topical ampicillin.

A prospective, controlled trial of antibiotic therapy was carried out in 90 patients with perforated appendicitis. One randomly selected group received systemic metronidazole, started peroperatively, plus locally instilled ampicillin. The other group, also randomly selected, received only local ampicillin. There was no statistically significant difference in the overall frequency of postoperative septic complications (wound infection or intra-abdominal abscess) between the two groups, but wound infections were significantly fewer in the patients given metronidazole. There was no intergroup difference in hospitalization time. Treatment with systemic metronidazole and local ampicillin is recommended in patients operated on for perforated appendicitis.

Adolescent↗

PubMed1980

Controlled clinical trial of oral and topical diethylcarbamazine in treatment of onchocerciasis.

In a double-blind controlled clinical trial comparing the safety and efficacy of oral diethylcarbamazine citrate (DEC) with topical DEC for the treatment of onchocerciasis twenty men with moderate skin-snip microfilarial counts received daily therapy for 1 week, then weekly therapy for the rest of 6 months. The number of microfilariae per skin snip dropped quickly to 2% of initial levels and remained at low levels in those receiving oral DEC, and to 20% of initial levels in patients treated with DEC lotion. Side-effects in both groups included lymphadenopathy, fever, pruritus, rash, proteinuria, and chorioretinitis; they were commoner with topical DEC.

Administration, Oral↗

PubMed1974