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Background: The use of Chinese medicinal drugs is becoming more common in Germany. However, the import from China results in aggravated quality controls and potentially jeopardized therapeutic safety. Therefore, in 1999 the Bavarian Department for Agriculture has initiated an interdisciplinary research project to cultivate and analyze important Chinese herbal plants. Currently 16 Bavarian-produced Chinese drugs are in use and distributed to patients by pharmacies. Despite a comparable quality of Bavarian pharmaceutical products, there are concerns remaining as the Bavarian medical drugs have been used for treatment purposes on patients since 2006, without their effect having been compared to the Chinese products. Therefore we performed an observational trial using a parallel group design on patients with chronic rhinosinusitis., Methods: The duration of the trial was 4 weeks. After a 4-week follow-up, the patients were interviewed via telephone. During the trial the patients were given 2 × 50 ml of a decoction of Chinese medicinal herbs, either (a) from Bavarian controlled cultivation (Bavaria group) or (b) from Chinese production (China group). The therapeutic success was evaluated using numerical rating scales., Results: In total, 64 patients completed the observational trial (31 Bavaria group, 33 China group). Both groups showed significant improvements in the main symptom scores of chronic rhinosinusitis as well as in secondary symptoms, such as the overall state of health or the tendency to catch a cold. There were no significant differences between the groups concerning the main symptoms scores. Overall the herbal decoctions had no severe side effects., Conclusion: This observational trial shows that Chinese herbal drugs from Bavarian cultivation are as effective as medicinal herbs imported from China, but the effects of concomitant therapies must be considered as well. The symptom score improvements during the treatment period were obvious and should stimulate further investigation on the efficacy of this herbal formula in the treatment of chronic rhinosinusitis., (© 2015 S. Karger GmbH, Freiburg.)

Introduction: in 2008, we described the documentation system of the ‘Klinik am Steigerwald’. Now, we report on the results gained with this system, especially on the therapeutic success and its sustainability., Patients and Methods: we evaluated 1,972 in-patients treated between 1999 and 2007. 74% of these patients were followed for up to 24 months. The therapeutic success achieved at the time of discharge from hospital was comparable in patients with follow-up and in patients lost to follow-up. Therefore, no relevant bias has to be assumed., Results: at discharge from hospital complaints had improved markedly or somewhat in 62–77% of the patients. 2 years after discharge from hospital between 62 and 85% of the patients said that their complaints had improved as compared to the time before admission. This is also true for progressive diseases and if medication had been reduced. The proportion of days with inability to work decreased from 21.6% before admission to 16.0% at 0–6 months after discharge to 14.0% at 6–12 months after discharge to 11.9% at 18–24 months after discharge from hospital. Special focus is laid on Morbus Crohn /colitis ulcerosa and polyneuropathy which are core areas of the ‘Klinik am Steigerwald’., Conclusion: documentation of the therapeutic success and its sustainability is essential for an evidence based medicine. Assessment of therapeutic success by complaints of patients is according to the idea of quality of life. This holds for modern as well as for traditional medical procedures like e.g., traditional Chinese medicine.

Background: In the 'Klinik am Steigerwald' (Gerolzhofen, Germany), founded in 1996 and providing accommodation for 44 patients, European physicians apply methods of traditional Chinese medicine (TCM)., Objective: To develop an assessment system which is suitable for the evaluation of therapies, can be integrated into daily routine, takes into account the particular therapeutic approach of the hospital, and promotes quality management., Patients and Methods: The hospital admits all kinds of patients with chronic and often therapy-resistant diseases. Patients are primarily treated with Chinese phytotherapy and acupuncture. Methods of classical naturopathy and Western medicine complete the therapeutic range. All admitted patients are to be assessed. Exclusions are made according to a previously determined set of criteria. A written consent is mandatory., Results: The assessment system comprises 3 questionnaires; 2 to be filled in by the patients, and 1 to document the physician's evaluation of the therapeutic success, based on his final consultation of the patient. Between January 2000 and December 2004, 2,021 patients were admitted to the hospital and followed-up until 2006. Of these, 1,609 patients met the inclusion criteria; 1,282 of these, again, agreed to participate in the interviewing process. The questionnaires of 1,110 patients were eligible for analysis. The present paper describes the methods of assessment. Its results are to be published in a future paper., Conclusion: Over the past 7 years, the assessment system has shown to be effective and appropriate to evaluate the type of therapy in question. It is intended to shorten the questionnaires., (Copyright 2008 S. Karger AG, Basel.)

The efficacy of a modular education program for adult asthmatics was evaluated in a controlled, randomized multicenter trial under outpatient conditions for six months. The education was performed with material (patient handout and PowerPoint slides) of the MASA Program (i.e. a modular outpatient education program for adult asthmatics) according to the contents list of the NASA Program (i.e. a national education program for adult asthmatics). In total, 75 patients of seven asthma specialists were included. The complete data of 53 patients were obtained and evaluated. All patients had been diagnosed with asthma in the year before, most of them (54%) with moderately severe asthma. The patients in the intervention group attended a two-hour teaching program for three times; the control group once received a short introduction to the use of a peak-flow meter, an asthma diary and asthma emergency instructions. Compared to the control group, the intervention group patients showed significantly less mild asthma attacks. The mean requirement for inhalation of short-acting beta-agonists was 0.18 times vs. 1.5 times per week for the intervention and the control group, respectively (p = 0.0062). Another primary outcome was the number of unscheduled asthma-related visits to the doctor within six months. There was a trend to lower numbers in the intervention group, but due to the small number of patients the results did not reach significance. The same applies to the patients' estimation of their quality of life, measured by the SF-36 questionnaire. Patients in the intervention group had a significantly better knowledge about their disease (improvement in the number of correctly answered questions: 6.7 times in the intervention and 5.5 times in the control group; p = 0.0062) and showed a better adherence to their regular medication. In conclusion, this trial proves the quality of the MASA education program and its feasibility in the outpatient setting of a chest physician's practice, and it demonstrates the efficacy of outpatient education programs for asthmatics.

New therapies in rehabilitation medicine have to be evaluated with clinical trials. For drug approval the methodology of clinical trials is standardized world wide and the results of these studies are widely accepted. This standard should be achieved in clinical trials in rehabilitation research, too. One of the standards is the existence of a control group, comparing the effect of the new intervention against controls. In addition, the investigational and control groups must be equal in terms of the structure of possible confounders. Randomisation is the best possibility to distribute the patients to the therapy-groups, confounders will be equally distributed by chance. Other procedures for assignment to the study groups can result in confounding and lead into biased results. In spite of these advantages, randomisation is not generally accepted in rehabilitation research up to now. There are some reservations, mostly ethical, organisational and methodological ones. However, randomised clinical trials should be conducted in rehabilitation research in order to obtain more convincing results. Our intention is to bring some input in this debate and to present basics and practical aspects of randomisation.

For efficient rehabilitation it is important to identify, as early as possible, the patients likely to be successfully returned to work after rehabilitation. The aim of this pilot study was to develop a statistical model for predicting this return as reliably as possible. The model uses only information readily available at the beginning of rehabilitation. A multiple regression analysis with backward elimination was used from a routine data base and identified 8 variables of prognostic value. The model offers a comfortable possibility to predict the probability of return to work of a patient on the basis of routinely registered data. The prognosis was found correct in 68% of those returning to work after rehabilitation (sensitivity) and in 80% of those who did not (specificity). Further work to improve the model for prognosis in rehabilitation research is considered reasonable.

Methodology of clinical studies is highly sophisticated in drug research. But clinical trials are also necessary to demonstrate efficacy and safety of rehabilitation treatment. The call for evidence based medicine has also reached rehabilitation. However, in rehabilitation medicine it is much more difficult to design and conduct clinical trials with a high methodological standard. Among the reasons are: A comparable control group is necessary because spontaneous healing and unspecific measures contribute to therapeutic success, too. But what could "placebo rehabilitation" look like? The masking of therapies (blinded studies) will hardly ever be possible. Therefore, it is more difficult to achieve the same treatment and observation for the treatment and control group. Treatments in rehabilitation take longer to become effective than a drug and maybe the success will disappear after some time. Therefore, long-term trials and follow-ups are necessary. Such studies are expensive, need a strong organisation, and drop-outs are unavoidable. An appropriate outcome variable does not always exist. "Return to work" is an important, reliable and valid variable, but it delivers only one bit of information per patient. As a consequence, smaller progress in rehabilitation can only be demonstrated with large sample sizes. Outcome variables based on time enable studies with reasonable sample sizes. Sometimes it is more difficult to obtain acceptance of randomisation in rehabilitation patients than in acute patients. Some rehabilitation hospitals have only recently begun to take an interest in controlled clinical trials, hence are not so experienced. Nevertheless, controlled clinical trials delivering convincing results are possible in rehabilitation medicine as well. But biometrical consultation is necessary e.g. for study design, study conduction and evaluation. Most important points are the methodology of the study design and its practicability. Especially in these topics rehabilitation physicians and biometrician have to cooperate.

Aim of the Study: The present study assessed the total cost involved in the therapy of nosocomial pneumonia. Cost for patients receiving Imipenem as initial antibiotic therapy was compared with that for patients treated by selected alternative regimens. Secondary objectives included the evaluation of fever days, days of antibiotic therapy, days at ICU and days of overall hospitalisation required for the treatment of the nosocomial pneumonia for both methods of treatment., Methods: A prospective randomised open study involving multiple study sites was conducted. Total cost, efficacy and safety of an initial therapy with Imipenem were compared to results achieved with selected other antibiotic regimens. Altogether 109 patients were enrolled into the study; 85 patients could be assessed., Results: Both treatment methods showed equal clinical efficacy. Total cost of the therapy of nosocomial pneumonia for all patients was in the range between 1,616 DM and 82,141 DM, the arithmetic mean was calculated to be 11,307 DM and the median was found to be 6,507 DM. Imipenem-treated patients incurred lower cost (median 5,649 DM, mean 10,009 DM) than patients treated with other antibiotics (median 9,334 DM, mean 12,701 DM)., Conclusion: The total cost of treatment of nosocomial pneumonia was lower for Imipenem-treated patients than for patients receiving initially other selected antibiotic regimens. The savings are apparently due to a faster recovery of the patients resulting in reduced duration of therapy. The study shows that assessment of cost of therapy per day might be misleading in the economic analysis of antimicrobial chemotherapy.

The efficacy of classic homeopathic therapy is scientifically not well proven. Few of the studies available are acceptable from a scientific point of view. In this paper we will describe a study protocol for a trial of classic homeopathy in chronic headache, which not only is in accordance with currently accepted scientific research standards but also accounts for the special needs of homeopathic therapy. The prescribing practioners are allowed to use any homeopathic drug at any potency or dosage, this enables them to ful fill the homeopathic principle of individuality. At the same time, the study is strictly controlled, randomized and double blind. The prescribing physician sends the homeopathic medication selected for a patient to a notary public, who either forwards it to the patient or substitute placebo, according to the randomization plan. Hence, the trial is not testing a specific drug, but the rationale of individual homeopathic drug selection and the efficacy of the selected drugs in headache patients in general. Patients suffering from chronic headaches for at least 1 year and with headaches at least once a week on average are eligible for the study. Exclusion criteria follow the generally accepted standards and account for the special needs of homeopathic therapy. Data are to be recorded in a patient's diary containing the outcome variables occurrence, duration, intensity of headaches and use of analgesic drugs. After a baseline period of at least 6 weeks the first consultation will take place, with the proper remedy selected and sent to the patient via the notary. After 6 weeks a first follow-up will allow the physician to modify the treatment if necessary. After another 6 weeks the final examination will take place. The duration of the homeopathic treatment, then, is 12 weeks. A total of 100 patients in two groups of 50 are to be treated in the study. The study started in the later part of 1991, and is scheduled to last for 2 1/2 years. We expect a critical discussion of the results from conventional medicine or from homeopathy, depending on the outcome of the study. The study protocol is being published in advance to enable the reviewers of the study to check the original study design and the a priori hypotheses adopted.

In the HIV study of the German Red Cross blood banks the overall rate has remained constantly low, with less than two Western blot positive donors in 100,000 donors since 1987. However, the rate of HIV positivity tends to increase in male first time and in male repeat blood donors. Despite this fact, the overall rate stays constant since the number of young first time donors has decreased with increasing donations by women. Therefore the blood banks once again have to take newly intensified but also sophisticated measures to guarantee further as well a sufficient number of blood products as their HIV safety.

From the multicenter study of the Red Cross Blood Banks in the FRG HIV-antibody prevalences and incidences are documented since July 1985. Constantly low prevalences and incidences since 1987 of less than 2 Western blot (Wb)-positive donors and less than 1 Wb-positive donor per 100,000 donors respectively confirm our estimate of the rest risk of an HIV-infection by blood products of 1:500,000 to 1:3 million donations. In the epidemiologic details there seems to be a trend to an increase of the incidence in male repeat blood donors. The modes of HIV-infection in blood donors have changed to an increasing number of infections acquired in heterosexual contacts to persons at risk.

A computer program specifically designed for surgical data retrieval was tested for longer than one year. By using the information contained in operation reports, with this program statistical analysis may be achieved. The reports are generated and printed using a personal computer running MS-DOS. Entering data does not cause any additional effort for the secretary. The selection of requested data is possible with any combination of criteria, and the resultant information is displayed on the computer terminal screen or printed on the computer printer. A combination of terms is used instead of a numeric code for data entry allowing far greater selectivity, with a reduced risk of data loss due to wrong numeric code entry.

The incidence of hepatitis (B and non-A, non-B) was determined in a prospective multicentre study of 1100 hospital patients during 12 months without or after surgery and with or without transfusion. The incidence was 3.6% (4 of 111 patients) after surgery and transfusion, and 0.5% (5 of 989) without transfusion - with or without surgery. The incidence of hepatitis B was significantly higher in the transfused group, while non-A, non-B hepatitis had the same incidence in all three groups. Hepatitis was clinically manifest in only three of the nine patients. The remaining six silent ones were uncovered by a careful prospective follow-up plan. Thus the incidence of hepatitis in this study was higher than has been reported in retrospective series. However, the absolute number of cases is small and the confidence limits thus rather wide: the incidence of non-A, non-B hepatitis must be interpreted with caution.

Regional chemotherapy with floxuridine was undertaken in 50 patients (32 men and 18 women, mean age 57 years) with colorectal carcinoma with metastases only to the liver. In 25 patients (group I) the drug (0.2 mg/kg) was administered exclusively intraarterially into the hepatic artery, while in the remaining 25 (group II) it was given both intraarterially (0.21 mg/kg) and intravenously (0.09 mg/kg) via the inferior vena cava. The remission rate in group I was 56% (14 of 25), in group II it was 64% (16 of 25). It was subsequently discovered that 4 of the 25 in group II already had extrahepatic metastases at the time of implantation of the infusion catheter. The difference in remission rate between the two groups is not significant. Extrahepatic tumour recurrence occurred after a median period of 16 months in 17 patients of group I (68%) and six of 21 of group II (29%, P less than 0.01). Over an observation period of 34 months the survival rates of the two groups were not significantly different. However, these results suggest that over a longer period a higher survival rate is to be expected for the intraarterially plus intravenously treated group.

Until now the therapy of pollinosis with Galphimia glauca was based on individual experience. We performed a randomized, controlled, multicenter, and double-blind clinical trial to verify the effectiveness of the Galphimia glauca D4 therapy of patients with pollinosis. The average time of observation was 51/2 weeks. Galphimia was found to be more effective than placebo at a 1% level of significance. Therapeutic success was given in 34/41 (= 83%) of the patients with Galphimia and in 21/45 (= 47%) of the control patients.

Of a total of 5.6 million blood donations by 1.6 million German Red Cross donors between July, 1985 and December, 1987 tested for HIV antibodies 210 were found to be positive in at least one Western blot. Calculated per quarter, the prevalence (for first-time donors) of 10 per 100,000 in 1985 decreased to 4 per 100,000 in 1986, while the incidence (for multiple donors) was a constant 2 per 100,000 for each quarter in 1987. This indicates that new HIV infections were rare in blood donors and there was no exponential increase. Further analysis revealed that over 90% of those with confirmed Western blot positive results were members of risk groups or their direct contacts. The age and sex distribution conformed to the known pattern for AIDS cases in the Federal Republic of Germany. The data demonstrate that there is at present no indication of a rapid spread of HIV infections transmitted heterosexually among blood donors.

To assess the function of the thyroid gland in premature infants of different gestational ages during the first month of life we determined simultaneously TSH, T4, T3, and rT3 serum concentrations in 116 preterm infants (gestational ages 31st to 38th week) during each of the first 30 days of life. The serum concentrations of TSH, T3, and rT3 changed significantly during this period. The TSH and rT3 values were highly increased on the first day and decreased thereafter. The T3 values, however, increased significantly during this period. During the first month of life the T4 values remained roughly unchanged independent of the age of the children. There was no significant influence on serum concentrations of thyroid hormones by gestational age. The 65 preterm infants with adaptational disorders showed no difference in their patterns of TSH and thyroid gland activity during the first month of life compared with 51 healthy premature infants. From the 4th to the 6h day of life -- a recommended period for the screening of congenital hypothyroidism -- the differences of TSH values measured were insignificant (16-18 muU/ml). The T4 values on these days remained all above 6.8 microgram/dl.

In a controlled randomized double-blind trial carried out by 47 physicians in private practice with totally 152 patients with sinusitis the therapeutic success of the following homeopathic drug preparations was investigated: Group A: combination of luffa operculata D4, kalium bicromicum D4 and cinnabaris D3. Group B: combination of kalium bicromicum D4 and cinnabaris D3. Group C: luffa operculata D4. Group D: placebo. Criteria for the therapeutic result were headache, blocked nasal breathing, trigeminal tenderness, reddening and swelling of nasal mucosa and postnasal secretion. There was no remarkable difference in the therapeutic success among the investigated homeopathic drug combinations nor between the active drugs and placebo. Averaged over all four groups 81% of the patients with acute sinusitis and 67% of the patients with chronic sinusitis recovered. In the literature comparable therapeutic results are reported for antibiotic therapy, decongestant nose drops and for the drainage of nasal cavities.

The clinical application of electroretinography has been limited until now by the lack of standardisation, especially of stimulus conditions. Normal values for the electroretinographic response parameters can only be used if patients are examined under the conditions which were given for the examination of healthy subjects. It is shown in this paper that the inexpensive apparatus designed by Kooijman and Damhof (1981) can be calibrated by any user simply and at justifiable expense. Normal values for the amplitudes and peak times for the a- and b-wave are presented. The normal range of the values has been defined with regard to the frequency distribution. According to the authors' results, methods of descriptive statistics in skewed distributions are mainly necessary at low stimulus intensities. The descriptive methods for normal distributions were regularly applied at higher stimulus intensities. In general, however, ERG parameters are normally distributed as shown by the distribution of the residuals between the linear regression of the parameter to the logarithm of the corneal illuminance and the measured values. The influence of age on the amplitude was calculated according to the results of Lehnert and Wünsche (1966) and the lower limits of the normal range are given for four age groups. The data presented here may be used as normal values provided that the simple calibration methods are applied. Thus electroretinography is no longer a method merely for the laboratory, but can be used in clinics and offices as well. However, a prerequisite is that the physician has sufficient experience in ophthalmological electrophysiology.

Tear film break-up time was measured on 6 consecutive workdays in 6 subjects without eye disease selected at random. The reasons for the wide range of scatter in the values measured were investigated by variance component estimation. It was found that intraindividual variance is by far the most important factor influencing the overall variance of the measured values. Therefore, caution is called for when judging the stability of the precorneal tear film by the tear film break-up time in healthy individuals.

Between 1971 and 1978 the diagnosis of isolated ventricular septal defect was made in 149 patients. Most of these defects were small. In the majority of cases the diagnosis was made clinically. Spontaneous closure was assumed when, all other cardiac findings being normal, the heart murmur had disappeared. This took place in 50 of the 149 cases (34%) during the period of observation. Closure rate was independent of sex and birth rate, but related to size of defect and age of patient at time of diagnosis. Closure rate was 53% for small defects, 15% for larger ones. Because of the limited period of observation the reported spontaneous closure rate is less than the true one, estimated at 70-75% up to the age of nine years.

A randomized and controlled study was undertaken to test whether substitution with factor XIII concentrates influences the clinical course in patients with acute leukaemia and acquired factor XIII deficiency (less than or equal to 60%). A control group of 31 patients was compared with a factor XIII-treated group of 29 patients. Partial factor XIII deficiency was successfully corrected by substitution. On the other hand, there was no statistically significant difference between the two patient groups in the frequency and severity of bleeding complications, transfusion requirements, and the number of remissions. Undesirable side-effects as a result of substitution treatment were not observed.

Ulrich and Ulrich's method of oculo-oscillodynamography (OODG) is a relatively new method which enables the systolic retinal, systolic ciliary, and systolic ocular perfusion pressure or respectively blood pressure to be measured. The results obtained by the present authors are in good agreement with those of Ulrich and Ulrich (n = 30). The intraocular pressure values obtained with this method correlate somewhat less well with the systemic blood pressure than is the case with suction cup ophthalmodynamometry. However, the correlation coefficients are sufficiently high to permit their application in ophthalmological diagnosis. The results presented here indicate that the diastolic ocular pressure should be determined by applying the formoscillatory criterion. The positive intercept in the regression equations can be explained by the assumption that the regression is curvilinear at systemic blood pressure values which are generally not encountered in humans in whom OODG is of diagnostic importance. It is suggested that the linear regression is a sufficiently exact model at the systemic blood pressures most frequently measured. Normal OODG values can be read off easily from the diagrams published here.

Diclofenac is superior to other nonsteroid anti-inflammatory drugs (NAD) with respect to its antiphlogistic properties, as demonstrated in laboratory animal experiments. The antiphlogistic action of diclofenac eyedrops versus placebo eyedrops in the prophylaxis of cystoid macular edema (CME) and postoperative inflammatory symptoms was therefore tested in a prospective randomized double-blind study. A total of 179 patients with intracapsular cataract operations and Choyce Mark IX anterior chamber lens implantation received 2 drops 5 times preoperatively and 1 drop 5 times postoperatively until they were discharged, and then subsequently for 6 months they used 1 drop of diclofenac or placebo eyedrops 3 times. To evaluate the CME, fluorescence angiography was carried out on all patients on the day of discharge, 6 weeks later, and after 6 months following the operation. The patients who completed the study according to plan numbered 112. With diclofenac eyedrops, significantly less CME occurred in comparison with treatment with placebo eyedrops (p = 0.03). Visual acuity improved faster and the postoperative inflammatory symptoms receded more quickly in the diclofenac group.

In 30 healthy volunteers the tear-film break-up times of both eyes were determined, comparing one eye with a cut-off filter (customarily used in fluorescein angiography (Schott OG 530, thickness 3 mm] with the common method, not using this filter, in the other eye. By using the filter the variance of observed break-up times is decreased, and the time elapsing after the administration of the dye no longer influences the break-up time significantly. The filter described here is therefore recommended for determining the tear-film break-up time.