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Biomedical subjects

K L Resch

Publications and source records attributed to K L Resch.

At least 55 records · Page 3Linked to original sources

Concept of true and perceived placebo effects.

We often and wrongly equate the response seen in the placebo arm of a clinical trial with the placebo effect. In order to obtain the true placebo effect, other non-specific effects can be identified by including an untreated control group in clinical trials. A review of the literature shows that most authors confuse the perceived placebo effect with the true placebo effect. The true placebo effect is highly variable, depending on several factors that are not fully understood. A distinction between the perceived and the true placebo effects would be helpful in understanding the complex phenomena involved in a placebo response.

Clinical Trials as Topic↗

[Garlic (Allium sativum)--a potent medicinal plant].

A good deal of evidence suggests beneficial effects of the regular dietary intake of garlic on mild hypertension and hyperlipidemia. Garlic seems to have anti-microbial and immunostimulating properties, enhance fibrinolytic activity, and exert favorable effects on platelet aggregation and adhesion. Standardised preparations guarantee exact dosing and minimize the problem of the strong odour of raw garlic. Thus, a traditional folk remedy has established its usefulness for many patients with less severe forms of cardiovascular disease as a medical drug with very few side effects. The available evidence gives rise to the hope that the list of indications may even be considerably extended in the future.

Cardiovascular Diseases↗

[Proving the effectiveness of complementary therapy. Analysis of the literature exemplified by acupuncture].

At present, acupuncture may be considered one of the most popular forms of complementary medicine worldwide. However, in relation to the number of reviews on the subject, comparatively few controlled clinical trials have been reported so far. An analysis of all the controlled clinical trials listed in MEDLINE between 1987 and March 1994 (n = 39) that met certain basic requirements revealed that they addressed a wide variety of diseases and/or symptoms with no major focus (apart from the symptom of pain, which of course is highly complex in nature). In agreement with the findings of other meta-analyses, most of the more recent papers have been found to be still of indifferent quality. Besides the inherent problem that the term acupuncture subsumes within itself a substantial number of different techniques (and even philosophies), an obvious methodological deficit can be observed. Many groups seem to attach too little importance to choosing an appropriate control model, although seminal papers addressing this problem were already published in the early eighties. Similar remarks apply to inadequacies in study design, which should be at least single-blind. In summary, these findings may well help to explain why the effectiveness of acupuncture has still not been definitively demonstrated.

Acupuncture Therapy↗

Forearm bone density and grip strength in women after menopause, with and without estrogen replacement therapy.

Peaking in young adulthood, both bone mass and muscle strength decrease with ageing, but bone loss may accelerate after the menopause and can be delayed by estrogen replacement therapy (ERT). This study was designed to evaluate whether, like bone density, the muscle strength was affected by the onset of menopause and/or ERT. First grip strength (GS) of young female adults (group III; n = 18; age (+/- S.E.M.) 21.8 +/- 0.4 years) was compared to that of postmenopausal women, who were divided into two groups. Group I (n = 22; age 59.6 +/- 1.6 years) was 12.5 +/- 1.7 years after the menopause and received no ERT, and group II (n = 21; age 59.5 +/- 1.1 years) was 8.3 +/- 1.2 years after the menopause and had received ERT for 3.9 +/- 2.3 years at the time of the study. GS of the postmenopausal women was significantly (P < 0.005) lower than that of the young female adults. GS did not differ significantly between both postmenopausal groups. Further analysis revealed a weak negative correlation of years since menopause with forearm bone density (r = -0.37, P < or = 0.023 for group II and III together), but not with GS. It is concluded that the later onset of menopause and estrogen replacement therapy do not seem to have a noticeable influence on muscle strength.

Adult↗

Therapeutic interventions to lower plasma fibrinogen concentration.

A causal link between plasma fibrinogen levels and the risk of cardiovascular disease is now reasonably well established. Therefore the therapeutic lowering of fibrinogen has become a relevant area of research. Several options to achieve this aim have been reported in the literature. Changes in lifestyle can affect the fibrinogen level, of which smoking cessation is by far the most effective; weight or stress reduction or an increase in regular physical activity may have less pronounced effects; dietary changes appear to have even less effect, though a regular, moderate alcohol consumption may result in a small reduction. Many oral drugs have been shown to lower fibrinogen; however, the data should be viewed critically. In particular, the clinical situation in which a drug is administered must be considered and risk:benefit analyses should be performed before a drug is recommended for this indication. Among the oral fibrinogen-lowering drugs, fibrates rank first (e.g. bezafibrate has been reported to reduce increased fibrinogen by as much as 40%, and ticlopidine can induce a reduction of about 15% if fibrinogen was elevated at baseline). Whether concentration within the normal range can be altered by oral medication is less clear. Finally (and obviously), intravenous fibrinolytic agents or heparin-induced extracorporeal low-density lipoprotein precipitation will lower fibrinogen dramatically; yet these procedures are rarely indicated for this purpose alone. All options to lower fibrinogen also have prominent effects on other cardiovascular functions; thus, an intervention trial may not be the most appropriate method of testing the validity of the hypothesis of fibrinogen as a cardiovascular risk factor.

Cardiovascular Diseases↗

Quantification of functional deficits associated with rectus abdominis muscle flaps.

To evaluate the deficits in trunk flexion due to partial or complete unilateral rectus abdominis muscle flap transfer in reconstructive surgery, 27 patients (11 females, 16 males) with rectus abdominis muscle flap transfer dating back at least 3 years, clinically healthy at the time of testing, and 22 controls (10 females and 12 males), comparable in age and body mass index, were compared. For clinical assessment of power of the straight and oblique abdominal muscles, Janda's test of muscle function was used, and torque (in N.m) of isometric trunk flexion at 0, 5, 10, 20, and 30 degrees was determined with the TEF Modular Component, an auxiliary unit of the Cybex 6000. Results were analyzed for males and females separately. Relative torque (N.m/kg) of operated male and female patients was significantly lower (p < 0.05) as compared with controls. Differences were more pronounced in males than in females. Clinically, there were no significant between-group differences in the power of the straight and oblique abdominal muscles. In conclusion, trunk flexion deficits following rectus abdominis muscle flap transfer can be compensated for satisfactorily in most cases, supporting the use of this muscle in reconstructive surgery, if patients are selected carefully.

Abdominal Muscles↗

The "optional cross-over design" for randomized controlled trials.

In order to facilitate the performance of randomized controlled trials (RCT) in situations where no "hard" endpoints can be identified and the patient's subjective impressions about success of failure of a given treatment are paramount, the "optional cross-over design" is suggested. In this design, patients are randomised to receive either active medication or placebo during phase I. At its end the patient may choose to change to the other treatment arm, if therapy was felt to be unsuccessful (= optional cross-over). In phase II, treatment continues as in phase I except for those patients who have chosen the "optional cross-over". Further cross-over points may ensue depending on the particularities of the situation, however, two such options may be adequate for most studies. At the end of the trial period, the numbers of patients in each treatment arm are counted and evaluated statistically. If an optimally successful remedy is being tested, close to 100% of the study population could finish up in the active treatment arm. If, as in most instances, the remedy is not optimally successful, this percentage will be proportionally less. If an ineffective remedy is being tested, the distribution of the total sample within the two treatment arms approaches 50:50%. The "optional cross-over design" seems suited for RCT in areas where the complex, unmeasurable and subjective experience of the patient are considered to represent adequate endpoints.

Cross-Over Studies↗

[Nutrition and osteoporosis: a nutritional analysis of women in postmenopause].

In a cross-sectional study the effects of several nutritional factors on the manifestations of osteoporosis were investigated in 23 postmenopausal women aged 50 to 70 years. Twelve women (group 1) with osteoporosis and eleven healthy control subjects (group 2) were instructed to keep a seven-day nutritional record. Body mass index (BMI) was recorded, and radiological and bone mineral density investigations were undertaken. The daily total energy, protein, fat, carbohydrate, fiber, oxalic acid, calcium, magnesium, phosphorus, sodium, fluoride, zinc, copper, manganese, vitamin C, D, and K intake were analysed within the framework of a nutritional science program. No intergroup differences were observed with regard to total energy intake, nutritional components and BMI; however, age and years since the menopause differed significantly (p < 0.05). The results suggest that the manifestation of osteoporosis in women is influenced to a greater extent by age and years since the menopause than by the distribution of nutritional factors in a normal mixed diet. However, further studies are essential to evaluate the role of dietary composition on the manifestations of osteoporosis.

Age Factors↗

[Functional deficits following transfer of rectus abdominis muscle].

Functional deficits after raising of a rectus abdominis muscle flap in reconstructive surgery were evaluated retrospectively in 27 patients (11 female, 16 male) and compared to 22 healthy control individuals. To test the torque of trunk flexion, the Cybex 6000 (TEF modular component) was used and subjects tested in a defined position allowing isolated sagittal flexion. For the rectus and oblique abdominal muscles, the Janda muscle function test was applied. For comparison of patients and controls, the Man and Whitney test was applied, and subgroup analyses were performed for men and women, respectively. The peak torque (relative to bodyweight) was significantly lower in patients as compared to controls, the differences being greater in men than in women, whereas clinical examination did not reveal a significant difference between either group. After autologous transplantation of the rectus abdominis muscle flap, compensation is obviously restricted to a certain degree, although the remaining deficit does not seem to represent a handicap in normal life. Thus the use of rectus abdominis muscle flaps in reconstructive surgery may be beneficial for the patient, provided the indication is precise and long-term control is possible.

Adult↗

[Clinical trials--methodological gold standard or naive reductionism?].

The methodological concept of the randomized controlled clinical trial is a relatively recent invention. It is widely accepted to be the only means of conclusively establishing a cause effect relationship between a given therapeutic intervention and an observed outcome. There are, however, numerous pitfalls. Ethical concerns and/or practical problems can seriously affect both proper randomisation as well as the use of a placebo treatment as the control intervention. Sometimes blinding of the patients or the therapist may be difficult or even impossible, depending on the availability of a similar treatment without the specific therapeutic effect, whereas a satisfactory investigator blinding can be achieved in most instances. Practical problems can be minimised by adapting the trial design to the given clinical situation. The fact that a number of drawbacks exist, must, however, not be used as an argument to abstain from performing such studies--simply because there is no better alternative.

Bias↗

[Treatment of hypertension--the value of non-drug measures].

METHOD: To investigate the usefulness of non-pharmacological measures in the treatment of essential hypertension, 91 subjects comprising patients attending a physical-medical department and the inhabitants of an old people's home, were asked to complete a questionnaire. RESULTS: Almost all patients were receiving drug therapy (n = 89); in two-thirds treatment had been initiated when the diagnosis was first established. Although two-thirds were well informed about non-pharmacological measures (physical exercise, sodium restricted diet, reduced caloric intake, changes in dietary habits), more than one-half of the patients had neither been informed about, nor instructed in the use of, any of these alternatives by their general practitioners. Some 40% were aware of the benefit of relaxation techniques, but only one in six practiced them. CONCLUSIONS: Although this study revealed a high level of knowledge of non-pharmacological anti-hypertensive therapy, the care-providing doctors clearly attach more importance to prescribing drugs. In view of the potential value of alternative forms of treatment, greater consideration of this point by the physician would be desirable.

Aged↗

Geographical variations in plasma viscosity and relation to coronary event rates.

Plasma viscosity is reported to be predictive of coronary heart disease (CHD) and stroke. To find out whether regional differences in CHD event rates correlate with differences in plasma viscosity, we compared plasma viscosity in a high-risk area for CHD (Glasgow Multinational Monitoring of Trends and Determinants in Cardiovascular Disease [MONICA] and Scottish Heart Health Study population surveys, 1985/86; n = 1166) and in a lower-risk area (MONICA Augsburg survey, 1984/85; n = 3258) in men and women aged 25-64 years. Mean plasma viscosity (37 degrees C) was 1.261 (SD 0.067) mPa s in Augsburg and 1.327 (0.093) mPa s in the west of Scotland for men, and 1.248 (0.066) mPa s and 1.318 (0.087) mPa s, respectively, for women. The unadjusted difference of the means between the west of Scotland and Augsburg was 0.066 (95% CI from weighted regression 0.058-0.073) mPa s for men and 0.070 (0.062-0.078) mPa s for women. Adjustment for age, smoking behaviour, total and high-density-lipoprotein cholesterol, systolic and diastolic blood pressure, and body-mass index had no effect on these differences. Age-standardised coronary event rates in 1985-87 were at least two times higher among men, and four times higher among women, in MONICA Glasgow than in MONICA Augsburg. This large geographical difference in plasma viscosity might partly explain the differences in CHD event rates between these populations. Further studies are needed on the determinants of plasma viscosity, and on its potential roles in atherosclerosis, thrombosis, and ischaemia.

Adult↗

Continuous microwave enhances the healing process of septic and aseptic wounds in rabbits.

Evidence indicates that local application of continuous microwave (CM) has positive effects, for instance, on skin grafts and white blood cells. To investigate the role of CM on local wound healing under different conditions (septic and aseptic), a study was performed in an animal model. Seventy-two rabbits were randomly assigned to four groups of 18 each: group 1 and group 2 consisted of animals with aseptic wounds, and group 3 and group 4 consisted of animals with infected wounds. In the medial third of the dorsolateral body of each animal a wound was prepared under local anesthesia. Animals of groups 1 and 3 received CM treatment, and those of groups 2 and 4 served as controls. The treatment consisted of an irradiation with CM (fixed frequency 37 GHz, power flow density 1 mW/cm2) for 30 min once per day for 5 (group 1) or 7 days (group 3). No other conservative or surgical methods were applied. Aseptic wounds were covered with a sterile dressing. Infected wounds of controls (group 4) were irrigated with 10% NaCl once a day. Measurements were visual analysis, planimetric, bacterial, and immunological tests. The wound surface of treated animals with aseptic wounds became dry and plicated faster, the daily decrease of the wound surface area being more than twice as large as that in the control group (group 2, P < 0.05). Complete epithelization and adhesion of wounds appeared around Day 19 (95% Cl, 18.3 to 20.1) in group 3 and around Day 31 (95% Cl, 29.5 to 32.7) in group 4.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗

[Possibilities and limits of CO2 balneotherapy].

CO2 baths are considered an integral feature of balneotherapy. Natural springs containing a concentration of CO2 probably sufficient to be clinically effective (> 1 g/l) as well as artificially enriched baths are applied. Phenomena like a marked erythema (at concentrations above 0.5 g/l) imply clinical efficacy beyond unspecific effects of baths (water immersion, thermal effects). Prolonged effects are postulated to exceed "direct" effects, thus forming the rationale for serial applications of CO2-baths. CO2 is believed to cause an acute induction of local vasodilation and a shift of the O2 binding curve, resulting in a facilitation of the delivery of O2 to the tissue. A positive impact of CO2-baths on the flow properties of blood has been reported. A wide variety of indications is mentioned in the literature, while clear evidence from controlled trials exists only for a minority of them, mainly for chronic circulatory disturbances based on atherosclerotic diseases such as peripheral arterial occlusive disease, trophic ulceration, microangiopathies of various origins, and mild hypertension. Some evidence supports the idea that CO2 baths might represent an efficient therapeutic means in the rehabilitation of coronary heart disease, myocardial infarction and stroke, and in the treatment of chronic venous insufficiency, certain inflammatory diseases, and functional disturbances.

Balneology↗

[Critical evaluation of ultrasound therapy].

Low dose ultrasound has been available for the treatment of various diagnoses since more than half a century. The literature offers a great number of reports with differing results. This review aims at providing a survey of clinical trials investigating low dose ultrasound therapy. Hence there are only few placebo-controlled trials published on the subject. There is some evidence for low dose ultrasound to be effective in the treatment of ulcus cruris and epicondylitis humeri lateralis. For other indications the effectiveness of this therapy lacks of controlled clinical studies and thus no clear conclusion can be drawn at present.

Humans↗