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Biomedical subjects

F Singer

Publications and source records attributed to F Singer.

At least 19 recordsLinked to original sources
PubMed2004

[Treatment of osteoarthritis of the knee joint. Efficacy and tolerance to acemetacin slow release in comparison to celecoxib].

OBJECTIVE: The aim of this trial was to compare acemetacin (ACE) with celecoxib (CEL) in terms of tolerability and efficacy in the treatment of osteoarthritis of the knee joint. METHODS: A total of 105 patients (26-64 years old) suffering from primary osteoarthritis (OA) of the knee were enrolled in this international, multicenter, randomized, double blind controlled trial. Fifty three patients were given ACE and 52 CEL. They were treated with either 90 mg bid of slow release ACE or 200 mg bid of CEL for 6 weeks. Additional gastroprotective therapy was not provided. Tolerability was assessed by physical examination, laboratory tests, vital signs and reports of side effects, as well as by patient and physician global assessments. Efficacy parameters comprised pain assessment by visual analogue scale (VAS) and ordinal scale, WOMAC, SF-36 and patient and physician global impressions of efficacy. In addition, acetaminophen consumption was recorded. RESULTS: In 21 ACE (39.6%) and 19 CEL patients (36.5%), the number of side effects totaled 56 (ACE n=29; CEL n=27) (ns). Mean pain reduction at week 6 was highly significant ( P<0.0001) in both groups and amounted to 38.7 mm (+/-20.3) in the ACE group and to 35.1 mm (+/-18.7) in the CEL group (ns). Very similar results were seen with respect to the other efficacy parameters. CONCLUSION: ACE is not inferior to CEL for the short-term treatment of knee OA in terms of tolerability and efficacy.

Adult↗
PubMed2003

Comparison of the efficacy and tolerability of dexibuprofen and celecoxib in the treatment of osteoarthritis of the hip.

CONTEXT: Osteoarthritis (OA) is often treated with nonsteroidal anti-inflammatory drugs (NSAIDs) or selective inhibitors of cyclooxygenase-2 (COX-2). OBJECTIVE: This clinical trial aimed to assess directly the relative therapeutic efficacy of the isolated active enantiomer of ibuprofen, named dexibuprofen (S(+)-ibuprofen) in a special crystal form, and the selective COX-2 inhibitor celecoxib in adults with OA of the hip. Moreover, the hypothesis that the tolerability/safety profile of dexibuprofen is comparable to celecoxib is to be tested. METHODS: The investigation was a randomized, parallel-group, double-blind, active controlled clinical trial, conducted from January 2001 to February 2002 in 4 rehabilitation centers in Austria. 148 inpatients were randomly assigned to dexibuprofen 800 mg or celecoxib 200 mg daily. The primary criterion was the improvement in the Western Ontario and' McMasters osteoarthritis index (WOMAC OA index) after 15 days of therapy. RESULTS: Evaluation of the WOMAC OA index proved that dexibuprofen 400 mg b.i.d. is not inferior to celecoxib 100 mg b.i.d. with the Mann-Whitney estimator equal to 0.5129 and the corresponding lower boundary of the 95% confidence interval equal to 0.4409. The overall incidence of adverse drug reactions was 12.16% in the dexibuprofen group and 13.51% in the celecoxib group. 8.1% of patients on dexibuprofen and 9.5% on celecoxib suffered from gastrointestinal disorders. CONCLUSION: In the presented clinical trial dexibuprofen has at least equal efficacy and a comparable safety/tolerability profile as celecoxib in adult patients suffering from osteoarthritis of the hip.

Adult↗
PubMed2002

[Functional capacity and cartilage oligomeric protein (COMP) in serum of patients with maturity-onset polyarthritis].

OBJECTIVE: To compare late onset with adult onset rheumatoid arthritis. METHODS: Fifty-eight patients with late onset rheumatoid arthritis (LORA) were compared to 117 patients with adult onset rheumatoid arthritis (AORA) with respect to clinical and functional parameters. Furthermore, in 104 patients serum cartilage oligomeric matrix protein (COMP) was measured. Results were compared by means of ANOVA and possible influences of age, gender and clinical parameters were evaluated by Spearman rank correlation. RESULTS: Except a different distribution in gender (40% males in the LORA group) and a higher ESR, no differences could be found with respect to clinical parameters. However, a significantly higher HAQ score and significantly higher serum-COMP levels could be shown in the LORA group. HAQ scores correlated not only with disease activity parameters (C-reactive protein, disease activity score) but also with the age. Serum-COMP levels did show a correlation with the age as well, but not with disease activity. CONCLUSION: It is concluded that the higher serum-COMP levels in late onset rheumatoid arthritis could be due to concomitant osteoarthritic processes in larger joints, which are not symptomatic. The age dependence of the HAQ score is only weak, but may be the reason why patients with LORA show a worse functional capacity compared to patients with adult onset rheumatoid arthritis.

Activities of Daily Living↗
PubMed2000

Evaluation of the efficacy and dose-response relationship of dexibuprofen (S(+)-ibuprofen) in patients with osteoarthritis of the hip and comparison with racemic ibuprofen using the WOMAC osteoarthritis index.

OBJECTIVE: Treatment with non-steroidal anti-inflammatory drugs is the most common pharmacological therapy of rheumatic diseases. For the symptomatic treatment of painful disorders a dose-response relationship of the NSAID should be a basic requirement, which is difficult to be proven in studies because rheumatic diseases are heterogenous in terms of clinical involvement. The aim of this double-blind randomized trial was to compare the isolated active enantiomer dexibuprofen (S(+)-ibuprofen) with the double dose of racemic ibuprofen and to show a dose-response relationship of dexibuprofen in painful osteoarthritis of the hip. METHODS: 178 patients were randomly assigned to dexibuprofen 600/1,200 mg or racemic ibuprofen 2,400 mg daily. The primary endpoint was the improvement of the WOMAC osteoarthritis index after 15 days of therapy. The analysis was by intention to treat. RESULTS: The evaluation of the WOMAC OA index showed statistically significant equivalence of dexibuprofen 400 mg t.i.d. compared with racemic ibuprofen 800 mg t.i.d. by a Mann-Whitney statistic of 0.578 and the corresponding lower bound of the 95% confidence interval of 0.498. The test for superiority of dexibuprofen was borderline significant with p = 0.055. Dexibuprofen 400 mg t.i.d. and dexibuprofen 200 mg t.i.d. showed a statistically significant dose-response relationship in improving the WOMAC OA index (p = 0.023). Patients suffered from adverse drug reactions, mainly gastrointestinal disorders, 13.34% on dexibuprofen 200 mg, 15.25% on dexibuprofen 400 mg and 16.94% on racemic ibuprofen 800 mg. CONCLUSIONS: The active enantiomer dexibuprofen (S(+)-ibuprofen) proved to be an effective non-steroidal anti-inflammatory drug with a significant dose-response relationship in patients with painful osteoarthritis of the hip. Compared with racemic ibuprofen half of the daily dose of dexibuprofen shows at least equivalent efficacy. In contrast to pharmacokinetic data, the additional administration of R(-)-ibuprofen in form of racemate does not contribute to the clinical efficacy of racemic ibuprofen.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1999

Jet lag: clinical features, validation of a new syndrome-specific scale, and lack of response to melatonin in a randomized, double-blind trial.

OBJECTIVE: The goals of this study were to validate a new rating scale for measuring severity of jet lag and to compare the efficacy of contrasting melatonin regimens to alleviate jet lag. METHOD: This was a randomized, double-blind trial of placebo and three alternative regimens of melatonin (5.0 mg at bedtime, 0.5 mg at bedtime, and 0.5 mg taken on a shifting schedule) for jet lag. The subjects were 257 Norwegian physicians who had visited New York for 5 days. Jet lag ratings were made on the day of travel from New York back to Oslo (6 hours eastward) and for the next 6 days in Norway. The main outcome measures were scale and item scores from a new, syndrome-specific instrument, the Columbia Jet Lag Scale, that identifies prominent daytime symptoms of jet lag distress. RESULTS: There was a marked increase in total jet lag score in all four treatment groups on the first day at home, followed by progressive improvement over the next 5 days. However, there were no significant group differences or group-by-time interactions. In addition, there was no group effect for sleep onset, time of awakening, hours slept, or hours napping. Ratings on a summary jet lag item were highly correlated with total jet lag scores (from a low of r = 0.54 on the day of travel to a high of r = 0.80 on day 3). The internal consistency of the total jet lag score was high on each day of the study. CONCLUSIONS: The use of melatonin for preventing jet lag needs further study.

Aerospace Medicine↗
PubMed1999

[From acute to chronic pain (in rheumatic diseases)].

Pain and functional restriction are the main factors leading the patient to the physician. For these patients quality of life is reduced a lot. Pain is a subjective experience and it cannot be objectivated easily. Pain experience lasting more than 3 to 6 months is considered to be chronic. Its causes are individually different and encompass the peripheral nociception, biochemical changes of the neurotransmitters in the spinal range and events in the subcortical and cortical region. For a successful treatment, the proper understanding of the perception and experience of pain is a preliminary condition for the physician and the patient.

Acute Disease↗
PubMed1997

Differences in pain medication use in stroke patients with aphasia and without aphasia.

BACKGROUND AND PURPOSE: While individuals with stroke are known to experience pain for a variety of reasons including premorbid conditions and stroke-specific sequelae, there are some groups of individuals with stroke, who because of aphasia, are unable to express their pain. This study investigated whether there exists an association between severity of aphasia and overall pain medication use as indicated (1) by the proportion of individuals medicated according to aphasia severity and (2) by the dosage of pain medication used according to aphasia severity. METHODS: The study involved a retrospective chart review of 207 charts of patients with stroke admitted to the Jewish Rehabilitation Hospital (JRH), Laval, Canada. Patients were classified into three groups according to level of expressive aphasia: those without aphasia, those with mild-to-moderate aphasia, and those severe aphasia. Information on medications used primarily for pain management was elicited for the first 21 days and the last 5 days of hospitalization. Any substitution, increase, elimination, or addition of pain medication during hospitalization was also monitored. RESULTS AND CONCLUSIONS: While the findings indicate that pain medication prescriptions were similar for all patients, a significantly smaller number of individuals with aphasia received pro re nata (prn) "as required" pain medication when compared with those without aphasia, for the first 21 days and for the last 5 days of hospitalization at the JRH. Similarly, when daily dose was monitored for the same time periods, individuals with aphasia were found to have received less medication for pain than those without aphasia.

Aged↗
PubMed1996

[Drug therapy of activated arthrosis. On the effectiveness of an enzyme mixture versus diclofenac].

Clinical efficacy of the antiphlogistic potency of enzymes (Wobenzym, 4 x 7 capsules/day) vs. Diclofenac-Na (2 x 50 mg capsules/day) on patients (n = 80) suffering from osteoarthritis of the knee in an acute phase was evaluated. The study design was double blind according to the GCP-guidelines. The treatment period lasted 28 days and was followed by a treatment-free controll-period of another 28 days. There was equal status of age, sex, duration and impact of osteoarthritis in both groups. The clinical parameters as pain at rest, on motion, on walking, at night and pain tenderness showed a significant improvement (p < 0.05) after the treatment period, with tendency to relapse in the following observation period. No significant difference between both treatment-groups could be seen. No changes in laboratory findings were observed. The global-assessment (physician's and patient's score) of efficacy and tolerability in both groups were mostly stated as "very good" and "good". Adverse events were reported as: Wobenzym: total 14 patients: gastrointestinal complaints (obstipation, vomiting, meteorism), allergic rash once and dizziness twice, 6 of these patients discontinued by that reasons. Diclofenac: total 11 patients: gastrointestinal complaints (epigastrical pain, upset stomach, meteorism), dizziness, 3 of these discontinued. All of these vanished after intake was stopped. Summarizing up it could be demonstrated that both evaluated drugs showed equal clinical potency. So it might be assumed that Wobenzym can be used as an alternative substance in treatment of acute painful osteoarthritis.

Adjuvants, Immunologic↗
PubMed1996

[Evaluation of 2 questionnaires with reference to their suitability for self-evaluation of patients with gonarthrosis. A contribution to quality assurance in rheumatology].

Questionnaires are useful instruments to evaluate disability and handicap in patients suffering from rheumatic diseases. Most of the used questionnaires require a time consuming interview with the attending physician or medical health personnel. Two (Larson and Lequesne) well established questionnaires are available for osteoarthritis(OA)-patients. Since it would be desirable to have reliable patients self reporting questionnaires, we have tested the utility and validity of these questionnaires by comparing the results of patients self reports with the results obtained by medical health personnel (4 occupational- and physiotherapists) in the same patients (n = 52). The analysis of the questionnaires revealed that results obtained by the Larson technique gave very different (p < 0.01) global and detail scores as assessed by patients or medical staff. This difference of assessments was not influenced by the stage of arthrosis as defined by x-ray. The Lequesne questionnaires gave essentially similar results, with a significant difference between assessment of disease severity by patients in comparison to results obtained by medical staff. The results obtained by the 4 members of the medical staff did not differ significantly from each other. From our study it is concluded that neither the Larson nor the Lequesne questionnaire can be recommended for scientific use as a reliable patients self reporting evaluation of disease severity in osteoarthritis.

Activities of Daily Living↗
PubMed1995

Rationale for the use of alendronate in osteoporosis.

Bisphosphonates are being used in disorders associated with accelerated resorption of bone, particularly Paget's disease of bone and the bone disease of malignancy. Their undoubted biological efficacy and relatively low apparent toxicity make them attractive candidates for the management of osteoporosis. The bisphosphonate alendronate has many characteristics which suggest that it is suitable for use in osteoporosis. It is a potent inhibitor of osteoclast-mediated bone resorption with no adverse effect on the mineralization of bone. Earlier studies have shown it to be one of the most active bisphosphonates in Paget's disease and the hypercalcemia of malignancy. In common with other bisphosphonates tested thus far, alendronate appears to inhibit bone loss in a variety of experimental models of osteoporosis. Long-term studies are needed to determine its steady-state effects on bone mass in man. Most data indicate that alendronate is capable at least of decreasing the rate of bone loss, and might even induce increments in bone mass for many years. Since the experimental studies show that the increase in bone mass observed with alendronate is associated with an increase in bone strength, its use is likely to decrease the frequency of fractures. However, direct clinical evidence for this requires the outcome of well-designed long-term prospective studies.

Alendronate↗
PubMed1995

A multicenter trial of low dose gallium nitrate in patients with advanced Paget's disease of bone.

Gallium nitrate is a potent antiresorptive drug that has been extensively tested in patients with accelerated bone turnover. We have evaluated the effects of this new agent in a pilot multicenter trial of 49 patients with advanced Paget's disease of bone. Patients were randomized to receive 0.05, 0.25, or 0.5 mg/kg.day gallium nitrate administered by sc injection in two 14-day cycles. Serum alkaline phosphatase, fasting 2-h urinary hydroxyproline and N- telopeptide collagen cross-links excretion, and quality of life were assessed every 2 weeks for 12 weeks. The group mean alkaline phosphatase activity at baseline was 854 +/- 100 (+/- SEM) IU/L. The mean changes from baseline to week 12 in serum alkaline phosphatase were +0.5%, -24%, and -31%, respectively, for the three doses tested. The differences for each of the higher dose levels (0.25 and 0.5 mg/kg.day) was statistically significant (P < or = 0.05), and nearly half of the patients treated with the 0.5 mg/kg.day dose achieved a 50% or more reduction in enzyme activity. The nadir value in hydroxyproline excretion occurred at 10 weeks, with mean changes of +9%, -10%, and -17% for the 0.05, 0.25, and 0.5 mg/kg.day doses, respectively; the difference was significant only at the 0.5 mg/kg.day level (P < 0.01). Urinary collagen cross-link excretion showed a significant decrease at the 0.25 and 0.5 mg/kg.day doses. We also observed a definite, but nonsignificant, trend for improved quality of life in patients treated at the highest drug dose. Minor discomfort at the injection site was frequently reported, but did not lead to interruption of therapy. Our results in these patients who had received moderate to extensive prior therapies with other drugs show that cyclical, low dose, sc administration of gallium nitrate is safe and effective for treating patients with advanced Paget's disease of bone.

Adult↗
PubMed1995

[Physical and occupational therapy considerations in osteoarthrosis].

A lot of facts have to be kept in mind discussing the etiology of osteoarthritis. Thus the therapeutic approach to it depends on its etiology. Different treatments as exercise- and occupational therapy, ergonomics and orthopaedics have to be considered. In this paper especially the range of motion-and occupational therapies are discussed focused on their therapeutic goal for the patients. The goal of them is based upon the activities of daily life, functional capacity and considerations about minimizing further cartilage damage. Details are demonstrated for example in a patient suffering from osteoarthritis of the hip. Other physical treatments and also the spa-treatment are discussed in relation to osteoarthritis "disease".

Activities of Daily Living↗
PubMed1994

Hereditary hyperphosphatasia: 20 year follow-up and response to disodium etidronate.

We provide a 20 year follow-up of a family with three siblings affected by hereditary hyperphosphatasia (HH). An iliac crest bone biopsy was performed on one of the siblings following double-tetracycline labeling, with results reported quantitatively in a standard histomorphometric format. Biochemical parameters of disease activity were monitored in the patient before and after treatment with oral etidronate disodium, 20 mg/kg/day taken for 5 weeks. Biochemical evidence of intense disease activity continued 20 years after the initial diagnosis of HH in the sibling studied. His bone biopsy specimen also revealed extremely high bone turnover but low cancellous bone volume and osteoclasts unlike those found in Paget's disease. Treatment with etidronate disodium resulted in a temporary 40% reduction in serum alkaline phosphatase and 24 h urine hydroxyproline excretion, with reduction in serum osteocalcin from two times the upper limit of normal to a subnormal level. We conclude that disease activity in HH can continue unabated for two decades. Our bone biopsy finding of low cancellous bone volume, the consistent lack of pagetic-looking osteoclasts in our and other studies, plus the clinical features of HH (childhood onset and extremely diffuse disease with gross skeletal deformation) serve to distinguish HH from Paget's disease. Bisphosphonates may be of value in treating HH.

Adult↗
PubMed1994

Characteristics of a two-site immunoradiometric assay for human skeletal alkaline phosphatase in serum.

This two-site IRMA includes specific monoclonal antibodies for measuring skeletal alkaline phosphatase (B-ALP) in human serum. Assay calibration is based on mass units (micrograms per liter) and was established with purified B-ALP from a human osteosarcoma cell line, SAOS-2. Precision studies demonstrated intra- and interassay CVs of 3-5% and 5-7%, respectively. Relative reactivity studies showed that the assay has a sevenfold preference for detecting B-ALP compared with the liver isoenzyme in serum. The normal reference interval for 478 healthy adults was 5-22 micrograms/L. Method comparison studies showed good correlation between this B-ALP assay (y) and commercially available electrophoretic methods (x) (y = 0.3540x + 20.5, R2 = 0.929) in a pagetic population. Temporal profiles for total ALP, this IRMA B-ALP assay, and B-ALP by electrophoresis in three pagetic patients were parallel. We conclude that this assay demonstrates good analytical performance and would be useful for the clinical assessment of metabolic bone disorders.

Adult↗