[Adjuvant treatment of knee osteoarthritis with weak pulsing magnetic fields. Results of a placebo-controlled trial prospective clinical trial]. / Adjuvante Behandlung der Gonarthrose mit schwachen pulsierenden Magnetfeldern -- Ergebnisse einer prospektiven, plazebo-kontrollierten vergleichenden Therapiestudie.

PURPOSE: The aim of this study was the objective control of the therapeutic effect of weak pulsing magnetic fields (series of periodically repeating square pulses increasing according to an e-function, frequencies of 10, 20, 30, and 200-300 Hz) by means of a double-blind study on osteoarthritis of the knee. Measured parameters were the Knee Society score, pain sensation, blood count and cardiocirculatory values. METHODS: 36 placebo and 35 verum test persons (all with a knee gap smaller than 3 mm) were exposed daily for 16 minutes over 6 weeks to a low frequency magnetic field (flux densities increasing gradually from 3.4 up to 13.6 microT) encompassing the whole body. The last data collection was made 4 weeks after the end of treatment. RESULTS: Principally, the statistically ensured results exclusively favour the used magnetic field therapy; by far the greatest number of at least significant differences was found at the end of the whole treatment, lasting 6 weeks. In particular, it is striking that all 4 questioned pain scales showed at least significant improvements in favour of the verum collective; also the walking distance was increased. As another confirmed fact, even after 4 weeks without therapy the persistence of several functional and analgesic effects could be documented. CONCLUSIONS: Predominantly, on the one hand, pain relief in osteoarthritis patients was confirmed by a double-blind trial, on the other hand, increases in mobility could be proven. Furthermore, we describe mainly the modes of action of low frequency magnetic energy and 3 physical concepts that are seen as the connecting link between electromagnetic fields coupled into connective tissue and biochemical repair and growth processes in bones and cartilage. Proceeding from the results of this and preceding studies, one has to consider seriously whether this kind of magnetic field application should not be employed as cost-effective and side effect-free alternative or adjuvant form of therapy in the field of orthopaedic disorders.

Impulse magnetic-field therapy for insomnia: a double-blind, placebo-controlled study.

This 4-week double-blind, placebo-controlled study assessed the efficacy of impulse magnetic-field therapy for insomnia. One hundred one patients were randomly assigned to either active treatment (n = 50) or placebo (n = 51) and allocated to one of three diagnostic groups: (1) sleep latency; (2) interrupted sleep; or (3) nightmares. Efficacy endpoints were intensity of sleep latency, frequency of interruptions, sleepiness after rising, daytime sleepiness, difficulty with concentration, and daytime headaches. In the active-treatment group, the values of all criteria were significantly lower at study end (P < .00001). The placebo group also showed significant symptomatic improvement (P < .05), but the differences between groups were highly significant (P < .00001). Seventy percent (n = 34) of the patients given active treatment experienced substantial or even complete relief of their complaints; 24% (n = 12) reported clear improvement; 6% (n = 3) noted a slight improvement. Only one placebo patient (2%) had very clear relief; 49% (n = 23) reported slight or clear improvement; and 49% (n = 23) saw no change in their symptoms. No adverse effects of treatment were reported.

Impulse magnetic-field therapy for migraine and other headaches: a double-blind, placebo-controlled study.

This double-blind, placebo-controlled study assessed the efficacy of 4 weeks of impulse magnetic-field therapy (16 Hz, 5 microTs), delivered through a small device, for different types of headache and migraine. Eighty-two patients were randomly assigned to receive either active treatment or placebo (n = 41 each) and were characterized according to one of seven diagnoses (migraine, migraine combined with tension, tension, cluster, weather-related, posttraumatic, or other). Efficacy was assessed in terms of duration, severity, and frequency of migraine and headache attacks, as well as ability to concentrate. Data for 77 patients were analyzed. In the active-treatment group, all assessed criteria were significantly improved at the end of the study (P < .0001 vs baseline and placebo). Seventy-six percent of active-treatment patients experienced clear or very clear relief of their complaints. Only 1 placebo-patient (2.5%) felt some relief; 8% noted slight and 2% reported significant worsening of symptoms. No side effects were noted.

[Smoking and mortality. Evaluation of statistical analyses of causality]. / Rauchen und Mortalität. Evaluation statistischer Analysen der Kausalität.

Present quantification of "death by smoking" is based on unreliable, biased generalizations of retrospectively collected data. Big samples cannot heal the bias. Not even causality can be derived. Even less possible is an adequate estimate of the degree of the risk of death caused by "smoking" by means of epidemiological methods. The first aim of the paper is a discussion of the difficulties to prove causality with statistical procedures. Defining four variants of excess mortality it is proved that these different definitions are mixed in the current problem discussion. Besides it is difficult, if not impossible, to find appropriate estimates of the degree of dependency considering the necessary complexity of the model.

[Effects of Kneippism, a standardized complex therapy, on pain, quality of life and use of medicines: cohort study with a one-year follow-up]. / Auswirkungen der Kneipp-Kur, einer standardisierten Komplextherapie, auf schmerz, Lebensqualität und medikamentenverbrauch: kohortenstudie mit 1-jahres-follow-up.

BACKGROUND: Inpatient as well as outpatient cure in a spa environment with commonly 3- to 4-week duration features a combination of different treatments customized according to the needs of the individual patient. The physiological rationale and the mode of action are widely accepted. However, firm quantitative evidence of the clinical effectiveness is incomplete. OBJECTIVE: To document the effects of a well standardized complex therapeutic regimen (Kneippism) on pain, quality of life, and drug consumption during therapy and with 1-year follow up. STUDY DESIGN: Prospective cohort study with assessments at the beginning, during, and at the end of treatment and with follow-up investigations 3, 6, and 12 months thereafter. SETTING: Four spa clinics in Bad Wörishofen, Southern Bavaria. PATIENTS: 363 patients (248 outpatients, mean duration of therapy 23.3 days, and 115 inpatients, mean duration of therapy 27.4 days), one half between 40 and 60 years old above 60 years of age, predominantly suffering from musculoskeletal and/or cardiovascular diseases. INTERVENTION: Custom-tailored combination of therapies comprising of hydro-, kinesi-, and phytotherapy, dietetics, 'ordnungstherapie', and continued disease-specific standard treatment, if necessary. MAIN OUTCOME MEASURE: Pain, patients' self-rating, (IRES questionnaire), medication. RESULTS: The monitored dimensions of pain improved significantly during treatment and remained at that level essentially for the complete follow up interval. The same was true for various dimensions of reported subjective complaints as well as for drug consumption. CONCLUSION: When estimating the clinical relevance of a complex therapeutic regimen such as a cure of 3- to 4-week duration, the question of the impact of the specific effect of single components is secondary to the question of the overall relevance of that therapeutic concept. The findings of this study point at potential long-term effects of at least 1-year duration.

[Effect of adjuvant immunoglobulin therapy on infections in patients in an surgical intensive care unit. Results of a randomized controlled study]. / Einfluss einer adjuvanten Immunglobulintherapie auf Infektionen bei Patienten einer operativen Intensiv-Therapie-Station.

A randomized controlled clinical trial was conducted on the effects of immunoglobulin in therapy for infections in 104 intensive care patients. At the first sign of infection, one group of 50 patients received an i.v. preparation of immunoglobulin (4 X 100 ml) combined with antibiotics. The other 54 control patients received antibiotics alone. The most common infections in these patients were pneumonia, septicemia, peritonitis and wound sepsis. Infections were significantly seldom the cause of death, especially in patients with high-risk surgery who had been treated with immunoglobulin (p less than or equal to 0.05). Likewise ventilation time in the high-risk surgery group averaged only 5.5 days for those receiving immunoglobulin as opposed to 12.7 days in controls (p less than or equal to 0.01). Whereas the control group, in particular patients with pneumonia, remained in intensive care an average of 21.5 days, those receiving immunoglobulin stayed only 14.8 days (p less than or equal to 0.01). In general, patients treated with immunoglobulin recovered more rapidly from infections than did controls (p less than or equal to 0.01).

Multivariate analysis of the serum-cerebrospinal fluid-protein-relation for the diagnosis of neurological diseases of the central nervous systems.

In a population comprising 197 patients, serum and CSF proteins were assayed using the radial immunodiffusion technique devised by Mancini. Multiple discriminants analysis was applied to investigate whether the measured CSF/serum protein relations and their ratios could be regarded as an indicator of specific neurological diseases. One significant finding was that the slope angle alpha of the regression line between the serum/CSF relation and molecular weight may represent an important indicative parameter. A small angle is suggestive of enhanced permeability of the BBB, a large angle of a correspondingly lowered permeability. Further, the analyses demonstrated that the combined use of several predictors can markedly improve differential diagnosis. The study also demonstrates the potential of a statistical analytic technique that is still rarely applied in medicine.

[Diagnosis of central nervous system diseases. Multivariate analysis of the serum-cerebrospinal fluid- protein relation]. / Zur Diagnose von Erkrankungen des zentralen Nervensystems. Multivariate Analyse der Serum-Liquor-Protein-Relation.

In a population comprising 197 patients serum and CSF proteins were assayed using the radial immunodiffusion technique devised by Mancini. Multiple discriminant analysis was applied to investigate whether the measured CSF/serum protein relations and their ratios could be regarded as an indicator of specific neurologic diseases. One significant finding was that the slope angle alpha of the regression line between the serum/CSF relation and molecular weight may represent an important indicative parameter. A small angle is suggestive of enhanced permeability of the blood-brain barrier, a large angle of a correspondingly lowered permeability. Further, the analyses demonstrated that the combined use several predictors can markedly improve differential diagnosis. The study also demonstrates the potential of a statistical analytic technique that is still rarely applied in medicine.

[Immunoglobulins in bacterial and viral meningitis. Results of a controlled randomized clinical study of intravenous and intrathecal application]. / Immunglobuline bei bakteriellen und viralen Meningitiden. Ergebnisse einer kontrollierten randomisierten klinischen Studie intravenöser und intrathekaler Applikation.

The efficacy of additional intravenous and intrathecal immunoglobulin (Ig) therapy was investigated in a randomized clinical trial with 68 patients divided with the aid of a list of random numbers into two groups according to their infection. The group of bacterial infections of the CNS included 29 patients and the group of virus infections of the CNS 39 patients. The statistical evaluation of patients with bacterial infections and of those with virus infections was done separately. Group 1 received 10 g Ig each as a short infusion on two consecutive days. Patients with bacterial infections received in addition on every second day and patients with viral infections on every fifth day 500 mg of the same preparation by intrathecal injection. In contrast to this, a control group received the usual therapy only, principally antibiotics for purulent meningitis. The following characteristics were investigated and compared as variable criteria of the course of the disease and consequently of the efficacy of the additional therapy with Ig: CSF cell count, CSF protein, pyrexia, general condition, paralyses, neuropsychological defects, vigilance and EEG recording. As overall criteria of the course of the disease the length of stay in hospital and the rise in temperature were considered. The results of the statistical analysis showed a statistically significant superiority for the Ig-treatment which was most marked in the regression of the CSF pleocytosis, total CSF protein and pyrexia. For the subjectively graded clinical evaluations such as general condition, disturbances of vigilance, transient paralyses, neuropsychological defects and EEG tracings the statistical significance still applied, even if not so pronounced as for the previously mentioned criteria.