[Effectiveness of echinacin in therapy of chronic recurrent respiratory disease]. / Nutzenbewertung der Therapie chronisch rezidivierender Atemwegsinfekte mit Echinacin.

PURPOSE: Echinacea purpurea (echinacin) is frequently used in the therapy of chronic recurrent respiratory disease. The aim of this study was to show whether treatment of chronic recurrent respiratory disease with echinacin has a greater benefit in terms of effectiveness than therapy without an immunomodulator. MATERIALS AND METHODS: Frequency, duration of recurrence, resources used and patients' satisfaction was documented in order to assess benefit. In this prospective, non-randomised, multi-centre, nationwide, two-armed health services research study, data of 995 patients (782 echinacin-, 213 standard-cohort) with chronic recurrent respiratory disease were collected. The perspectives of statutory health insurance (SHI), patients and health policy were taken into consideration. RESULTS: The risk of falling ill was 2.3 fold higher and the duration of relapse 1.4 days more compared to the standard-cohort. There was a clinical and economical benefit from the therapy with echinacin for SHI and health policies. In contrast, patients experienced a greater financial burden. Average total costs per patient during the observation period of 3 months amounted to 238.35 in the standard-cohort and to 228.95 in the echinacin-cohort. Results of the intent-to-treat-analysis were reconfirmed in a per-protocol-analysis. CONCLUSION: This health services-research-study taking the therapy of chronic recurrent respiratory disease with echinacin as an example has shown that even non-prescription drugs can have clinical and economic benefits.

Controlled-release oxycodone is better tolerated than intravenous tramadol/metamizol for postoperative analgesia after retinal-surgery.

PURPOSE: We assessed the clinical efficacy and tolerance of controlled-release oxycodone (CRO), comparing it with intravenous tramadol/metamizol combination in this prospective, randomised, double-blind study of 35 ASA physical status I-III patients undergoing retinal-surgery. METHODS: General anaesthesia using remifentanil and propofol was performed for surgery. On arrival in the recovery room patients were randomly allocated to two groups. The controlled-release oxycodone group (CRO Group) received 10 mg CRO. 12 h after the initial dose another 10 mg CRO were administered. Simultaneously with the initial CRO dose, and every 4 h up to 24 h postoperatively, the CRO Group received intravenous isotonic saline infusion. On arrival in the recovery room the tramadol/metamizol group (TM Group) received a placebo tablet, and 12 h later a second placebo. Simultaneously 100 mg tramadol combined with 1 g metamizol were administered intravenously every 4 h until 24 h postoperatively. All patients had access to intravenous opioid rescue medication. RESULTS: The AUC for quality of analgesia was significantly higher in the CRO Group than in the TM Group (p = 0.0023). Patient rated quality of analgesia significantly higher in the CRO Group than in the TM Group 8 h (p = 0.048), 16 h (p = 0.009) and 24 h (p = 0.001) postoperatively. There was no statistical difference in AUC for pain scores between groups (p = 0.205). The CRO Group experienced significantly less nausea than the TM Group (p = 0.012). Six patients in the TM Group in contrast to none in the CRO Group interrupted the study before finishing the study protocol (p = 0.022). CONCLUSIONS: We conclude that CRO administered twice in the first 24 h postoperatively is superior to intravenous tramadol/metamizol for postoperative analgesia after retinal surgery, with fewer adverse events and greater patient satisfaction.

Epidural combination of ropivacaine with sufentanil for postoperative analgesia after total knee replacement: a pilot study.

BACKGROUND AND OBJECTIVE: We assessed the analgesic efficacy of postoperative epidural infusions of ropivacaine 0.1 and 0.2% combined with sufentanil 1 microg mL(-1) in a prospective, randomized, double-blinded study. METHODS: Twenty-two ASA I-III patients undergoing elective total-knee replacement were included. Lumbar epidural blockade using ropivacaine 0.75% was combined with either propofol sedation or general anaesthesia for surgery. After surgery, the epidural infusion was commenced. Eleven patients in each group received either an epidural infusion of ropivacaine 0.1% with 1 microg mL(-1) sufentanil (Group 1) or ropivacaine 0.2% with 1 microg mL(-1) sufentanil (Group 2) at a rate of 5-9 mL h(-1). All patients had access to intravenous pirinatrimide (piritramide) via a patient-controlled analgesia (PCA) device. RESULTS: Motor block was negligible for the study duration in both groups. There was no significant difference with the 100 mm visual analogue scale (VAS) scores, with the consumption of rescue analgesia or with patient satisfaction. Patients in Group 1 experienced significantly less nausea (P < 0.05) than those in Group 2. Both treatment regimens provided effective postoperative analgesia with only a minimal use of supplemental opioid PCA. CONCLUSIONS: We recommend the use of ropivacaine 0.1% with 1 microg mL(-1) sufentanil for postoperative analgesia after total knee replacement as it provides efficient pain relief with no motor block of the lower limbs. In addition, compared with 0.2% ropivacaine with sufentanil, the mixture reduces local anaesthetic consumption without compromise in patient satisfaction or VAS scores. Patients even experience less nausea.

[Body weight gain after radioiodine therapy in hyperthyroidism]. / Körpergewichtsentwicklung nach Radioiodtherapie einer Hyperthyreose.

AIM: Analysis and follow up of body weight after radioiodine therapy (RITh) of hyperthyroidism, since excessive weight gain is a common complaint among these patients. METHODS: Therapy and body weight related data of 100 consecutive RITh-patients were retrospectively analysed from the time before up to three years after RITh. All patients suffered from hyperthyroidism (Graves' disease or autonomy), but were adjusted to euthyroid levels after RITh. Patients' data were compared to a control group of 48 euthyroid patients out of the same ambulance and during the same time scale. RESULTS: All patients (RITh and controls) gained weight over the time. There was no statistically significant difference in BMI development over three years between RITh-patients and controls (5.5% resp. 4.9% increase). In the first year after RITh, weight gain of the RITh patients was higher indeed, but lower in the follow up, resulting in the same range of weight gain after three years as the controls. Besides that women showed a slightly higher increase of BMI than men, and so did younger patients compared to elder as well as patients with overweight already before RITh. CONCLUSIONS: An initially distinct increase of body weight after RITh of hyperthyroidism is mainly a compensation of pretherapeutic weight loss due to hyperthyroidism. Presupposing adequate euthyroid adjustment of thyroid metabolism after therapy, RITh is not responsible for later weight gain and adipositas.

[Application of guidelines for the treatment of headache and cancer pain by private practitioners]. / Anwendung von Leitlinien zur Kopf-und Tumorschmerztherapie bei niedergelassenen Artzen.

In a regional pain management network in Cologne, sponsored by the German Ministry of Health, structures of outpatient pain treatment in general practice and the adherence to pain management guidelines were examined. The 3-year project was divided into a 1-year observational period to analyze the present state of outpatient pain management followed by a 2-year period of interventions such as consultations and educational training programs in pain treatment. Eighty physicians with different specializations working in general practice took part in the network. The knowledge of and adherence to the guidelines for the treatment of headache and cancer pain were examined by questionnaire surveys and six simulated patient cases. These investigations were performed yearly from 1997 to 2000. The adherence to the guidelines for the treatment of headache and cancer pain by the physicians participating in the network was low. The levels achieved for simulated cases of headache were higher than for cancer pain. The results of simulated patient cases from the beginning and the end of the project were available for comparison for 28 physicians. Evaluation of the physicians' assessment of the simulated patient cases increased only fractionally and was not significant in headache patients (median change of 0.67) and cancer pain patients (median change of 0.17). The network interventions resulted in a slight improvement in the knowledge of and attitudes to the treatment of headache and cancer pain as judged by simulated patient cases. This improvement, however, did not reach statistical significance. The small number of physicians answering at the beginning and at the end of the project made it difficult to draw a general conclusion on whether the interventions had led to an improvement in outpatient pain management in a larger group of physicians.

A psychosocial analysis of women planning birth outside hospital.

Most of the women requesting out-of-hospital delivery considered delivery a natural process, not an illness requiring hospital care. The women cited freedom of choice concerning the delivery, less anxiety in the home than in the hospital environment, a more personal relationship with the midwife, and, as far as possible, making do without medical equipment. The interviewed women were a selected collective regarding age, parity, socioeconomic status and obstetric risk profile. Nonetheless, the results suggest ways that in-hospital obstetrics can be adapted to meet the requirements of pregnant women. Individualized, family-oriented obstetrics with judicious use of medical technology should be possible in the clinical setting.

Comparison of continuous epidural infusion of ropivacaine and sufentanil with intravenous patient-controlled analgesia after total hip replacement.

We assessed the efficacy of an epidural infusion of ropivacaine 0.1% and sufentanil 1 microg x ml(-1), comparing it with intravenous patient-controlled analgesia using piritramide in this prospective, randomised, double-blind study of 24 ASA physical status I-III patients undergoing elective total hip replacement. Lumbar epidural block using ropivacaine 0.75% was combined with either propofol sedation or general anaesthesia for surgery. Epidural infusion and patient-controlled analgesia were started after surgery. Twelve patients received an epidural infusion of ropivacaine 0.1% and sufentanil 1 microg x ml(-1) at a rate of 5-9 ml x h(-1) and an intravenous patient-controlled analgesia device loaded with saline. Eleven patients received an epidural infusion of saline at the same rate and intravenous piritramide via the patient-controlled analgesia device. Motor block was negligible in both groups. The epidural ropivacaine group had significantly lower visual analogue pain scores at rest 4 h after surgery (p < 0.01), and on movement 4 h (p < 0.01) and 8 h (p < 0.05) after surgery, than the intravenous piritramide group. The piritramide group experienced significantly more adverse events than the epidural group (p < 0.001), especially hypotension (p < 0.01) and vomiting (p < 0.05). Patients in the epidural ropivacaine group were more satisfied with the pain management (p < 0.05). We conclude that the epidural infusion of ropivacaine 0.1% and sufentanil 1 microg x ml(-1) is superior to intravenous opioid by patient-controlled analgesia in preventing pain after total hip replacement, with fewer adverse effects and greater patient satisfaction.

[Deficits in the treatment of chronic pain. 2. Possibilities for improvement through the Pain Therapy Ambulant Network (STAN)]. / Defizite in der Therapie chronischer Schmerzen (Teil 2). Möglichkeiten zur Verbesserung durch das Schmerztherapeutische ambulante Netzwerk (STAN).

In a regional pain management network in Cologne, the pain clinic of the department of anaesthesiology and the departments of psychosomatic medicine and of informatics, statistics and epidemiology have been cooperating with the regional board of physicians and more than 80 general practitioners since 1996. The program is sponsored by the German Ministry of Health. In this network, guidelines for the management of chronic pain have been implemented for outpatient care in the last three years. Results from the first year confirm the high level of distress of patients with chronic pain. Consultation and education offered by the coordinating office and in training courses were accepted by the practitioners in variable degrees. Some physicians requested consultations frequently while including only a few patients in the study documentation, while other physicians requested consultations rarely and assessed many patients. Participating physicians were also asked to provide analgesic regimens for constructed case reports with chronic headache or cancer pain. The evaluation of these prescriptions showed poor adherence to analgesic guidelines.

[Deficits in the treatment of chronic pain (I)]. / Defizite in der Therapie chronischer Schmerzen (Teil 1).

Pain management by general practitioners often is inadequate. Guidelines for pain management are either not observed or not known at all. Opioids are not prescribed adequately. Differential diagnoses influencing the therapeutic regimen such as drug-induced headache are not sufficiently known. Monotherapies with analgesic drugs are enforced for patients with chronic lower back pain in spite of low efficacy. Improving pain management can be difficult for the general practitioner having no special knowledges or support from pain specialists. However, the general practitioner should remain the patient-coordinator for the patient with chronic pain. Networks with general practitioners and specialised units in the hospital may offer possibilities for improvement of pain management deficits.

Validation of the German version of the Brief Pain Inventory.

The Brief Pain Inventory is a comprehensive instrument for pain assessment and has been validated in several languages. A validated German version was not available until now. From March to May 1995 all outpatients of the pain clinic of the Department of Anesthesiology completed a questionnaire with the German versions of the Brief Pain Inventory (BPI) and the SF-36 quality-of-life questionnaire. The BPI was repeated after the consultation. The physician assessed the performance status score of the Eastern Cooperative Oncology Group (ECOG). The questionnaire was completed by 151 patients. Forty-two patients were excluded from evaluation for methodological reasons, so 109 patients were evaluated. As in the original version of the BPI, factor analysis showed a common factor for pain intensity and a second factor for pain-related interference with function. The comparative fit index of 0.86 confirmed this model. Responses before and after consultation correlated closely for the sum scores of the pain intensity items (Perarson correlation r = 0.976) as well as for the interference with function items (r = 0.974). Pain intensity in the BPI correlated with bodily pain in the SF-36 (r = 0.585). Sum scores of the pain interference items were higher in patients with deteriorated ECOG performance status, whereas sum scores of the intensity items were not changed. Validity and reliability of the German BPI were comparable to the original version. The BPI may be advantageous for palliative care patients, as it places only a small burden on the patient and offers easy criteria for evaluation. However, further research is needed to differentiate the impact of pain-related and disease-related interference with function on the BPI, and to find an algorithm for the evaluation of the BPI when values are missing.

Long-term treatment with growth hormone has no persisting effect on lipoprotein(a) in patients with Turner's syndrome.

Treatment with recombinant human GH (rhGH), alone or in combination with the anabolic steroid oxandrolone (OX), has been recommended for girls with Turner's syndrome to improve final height. Several cardiovascular risk factors have been described in patients with Turner's syndrome, but the effect of therapy with rhGH and OX on lipoprotein(a) [Lp(a)] has not been investigated. Lp(a) serum levels and apolipoprotein(a) phenotypes were determined in 46 girls with Turners syndrome (aged 6-15 yr) during treatment with different combinations of rhGH and OX for 24-36 months (median, 27 months). Lp(a) serum levels showed little variation during 30 months of treatment in all treatment groups. Lp(a) levels showed no significant change in 25 patients receiving only rhGH and in 21 patients receiving rhGH and OX in combination. Treatment effects were independent of apolipoprotein(a) phenotypes and were not influenced by pubertal status. These data indicate that long term administration of rhGH has no significant impact on serum Lp(a) levels in girls with Turner's syndrome.

[Autologous blood transfusion in the Federal Republic of Germany--results of a questionnaire in 1993. 2. The use of autologous transfusion in the old and new federation]. / Autologe Bluttransfusion in der Bundesrepublik Deutschland--Ergebnisse einer Umfrage aus dem Jahre 1993. Teil 2: Die Verbreitung autologer Transfusionsverfahren in den alten und neuen Bundesländern.

In 1993, we conducted a postal survey to assess the use of autologous blood transfusion (ABT) in the Federal Republic of Germany after reunification. The results of this survey have already been reported in a previous paper, but without differentiation between the "old" and "new" states (former West Germany and former German Democratic Republic, respectively). In the present study, the data of our 1993 survey were further analysed to see if there were differences in the use of ABT between the "old" and "new" states. METHODS. The study is based on data of a 1993 postal survey of German hospitals. Details concerning the performance of the survey have been reported in a previous paper. Briefly, questionnaires were mailed to the anaesthesia departments of 400 randomly selected hospitals in the "old" states and 284 hospitals in the "new" states of the Federal Republic of Germany. The questionnaires contained 36 questions related to general information on the hospital and the use of ABT; 305 completed questionnaires were returned from the "old" states and 197 from the "new" states, response rates of 76% and 69%, respectively. For the present investigation, the responses of the hospitals of the "old" and "new" states were analysed separately. Frequency distributions of categorical variables were analysed by the chi-square test. Because of multiple testing, statistical significance was attained only at the 0.05% level (P < or = 0.0005). RESULTS. There were no significant differences between the "old" and "new" states with respect to hospital size by number of beds, percentage of general and specialised hospitals, and percentage of operations requiring blood transfusion. In both the "old" and "new" states, 9% of the responding hospitals maintained a hospital-based transfusion service, while the other depended on regional blood banks. Preoperative autologous blood donation (PABD) was performed at least "rarely" in 85% and 71% (P = 0.0001), and "mostly" in 20% and 10% (P = 0.0014) of the hospitals in the "old" and "new" states, respectively. Uniformly, the principal uses of PABD were for orthopaedic and cardiac surgery. In 62% and 27% (P < 0.0001) of those hospitals that reported performing PABD, the autologous blood service was run by the anaesthesia department. Preoperative plasmapheresis was performed in 14% and 8% (P = 0.008), and isovolaemic haemodilution in 82% and 56% (P < 0.0001) of the hospitals in the "old" and "new" states, respectively. Automated autotransfusion devices (cell savers) were available in 38% and 19% (P < 0.0001) of the hospitals, respectively. Simple collection devices for perioperative blood salvage were used in 17% and 15% (P = 0.24) of the hospitals in the "old" and "new" states, respectively. CONCLUSION. We conclude that ABT is more widely used in the "old" than the "new" states of the Federal Republic of Germany. ABT is regarded as a desirable alternative to homologous blood transfusion, and in the interest of equal standards of medical care throughout the nation, the use of ABT should be further promoted, especially in the "new" states of the Federal Republic of Germany.

[Trends in autologous blood transfusion in the old states of the Federal Republic of Germany, 1989-1993. 1. A panel study of 143 hopitals]. / Die Entwicklung der autologen Bluttransfusion in den alten Bundesländern der Bundesrepublik Deutschland von 1989 bis 1993. Teil 1: Eine Verlaufsbeobachtung an 143 Krankenhäusern.

Increased perception of the risks of homologous blood transfusion has focused substantial interest on autologous blood transfusion (ABT). To evaluate the role of ABT in the Federal Republic of Germany (FRG), we conducted postal surveys of German hospitals in 1989 and 1993. In the present study, the responses of 143 hospitals in the "old" federal states (former West Germany) that replied to both of our surveys were analysed. The objective was to examine trends in ABT practice in the FRG from 1989 to 1993. The study was restricted to the "old" federal states because data for the "new" federal states (former German Democratic Republic) were not available for that period. METHODS. Data presented in this study were obtained by postal surveys of German hospitals in 1989 and 1993. Because of German reunification (3 October 1990), only hospitals in the "old" federal states were surveyed in 1989, while hospitals in both the "old" and "new" states were included in 1993. Four hundred randomly selected hospitals in the "old" federal states were included in both surveys, 143 of which responded to both. The completed questionnaires of these 143 hospitals were analysed. In addition, to estimate the magnitude of positive selection bias, the data provided by these 143 hospitals were compared with data provided by another set of 162 hospitals in the "old" federal states that replied to the 1993 but not to the 1989 survey. RESULTS. There were no significant changes from 1989 to 1993 in the 143 hospitals with respect to hospital size by number of beds and spectrum of surgical specialties. The proportion of hospitals that performed preoperative autologous blood donation grew by 20% (from 74% to 89%) and the proportion that used this technique regularly ("frequently" and "mostly") rose by 80% (from 25% to 45%). The percentage of hospitals that performed preoperative plasmapheresis had more than doubled (from 8% to 19%). The proportion that used acute isovolaemic haemodilution grew by 32% (from 62% to 82%), while those doing so regularly ("frequently" and "mostly") increased by only 17% (from 23% to 27%). The fraction of hospitals equipped with cell-washing devices grew by 29% (from 35% to 45%). General transfusion practice, as measured by acceptance of postoperative haemoglobin levels of less than 10.0 g/dl, had changed but little. CONCLUSIONS. Although the 143 hospitals are not representative on a national level, the findings of our study allow some conclusions on general trends in the "old" states of the FRG. The potential for ABT has substantially grown in the "old" states from 1989 to 1993, although more consistent advantage of this potential could be taken.

[The role of autologous blood transfusion in the the Federal Republic of Germany. Results of a 1993 questionnaire. 1. The reunited Germany]. / Gegenwärtiger Stand der autologen Bluttransfusion in der Bundesrepublik Deutschland. Ergebnisse einer Umfrage aus dem Jahre 1993 Teil 1: Gesamtes Bundesgebiet.

UNLABELLED: The objective of the study was to evaluate the role of autologous blood transfusion in current clinical practice in the Federal Republic of Germany after reunification. METHODS: Questionnaires were sent to the anaesthesia departments of 684 German hospitals in January 1993. The sample consisted of 400 randomly selected hospitals from the former West Germany ("old federal states") and 284 hospitals from the former German Democratic Republic ("new federal states"). Only hospitals with more than 25 surgical beds were included in the study. The questionnaire contained 36 questions related to (1) general information on the hospital, (2) preoperative autologous blood donation (PABD), (3) preoperative plasmapheresis, (4) isovolaemic haemodilution, (5) perioperative blood salvage, and (6) general management of blood transfusion. RESULTS: A total of 502 completed questionnaires (73%) were returned, 305 from hospitals in the "old federal states" and 197 from hospitals in the former German Democratic Republic. Nine per cent of the responding hospitals were running their own transfusion services, and 56% were located in the vicinity of a regional blood bank. The overall proportion of surgical procedures requiring perioperative blood transfusion ranged from 1% to 90% (median 10%). PABD was performed "not at all" in 18%, "rarely" in 20% "occasionally" in 27%, "frequently" in 17%, and "mostly" in 16% of the responding hospitals. The principal use of PABD was in orthopaedic surgery and cardiac surgery (83% and 70% of the departments in question, respectively). In more than 50% of the hospitals reporting, the PABD service was run by the anaesthesia department. Patients not meeting the established criteria for homologous blood donors were accepted for autologous blood donation "frequently" and "mostly" in 20% and 12% of the hospitals, respectively, but at most "occasionally" in 63% of the hospitals. Preoperative plasmapheresis was performed in 12% of the responding hospitals. Autologous fresh frozen plasma predominantly was used for volume replacement, and for prevention of coagulation disorders when major blood loss was anticipated. Isovolaemic haemodilution was performed "not at all" in 28%, "rarely" in 19%, "occasionally" in 28%, "frequently" in 16%, and "mostly" in 8% of the responding hospitals. The reasons most frequently invoked for not performing haemodilution were "too time consuming" and "too little blood-saving effect". Cell separators for perioperative blood salvage were available in 30% of the responding hospitals. Of the other hospitals not equipped with cell-washing devices, 11% performed perioperative blood salvage of unprocessed blood by means of simple collection devices. Some 80% of those hospitals using intraoperative autotransfusion devices also performed blood salvage postoperatively. The principal use of perioperative blood salvage was in cardiac surgery, orthopaedics, and vascular surgery (90%, 54%, and 54% of departments, respectively). Some 48% of the responding anaesthetists "mostly" considered haemoglobin levels of 8-10 g/dl acceptable in patients without cardiopulmonary disease, but only 18% did so in patients with cardiopulmonary disease. CONCLUSIONS: Although available in the majority of hospitals surveyed, the simple techniques of both PABD and isovolaemic haemodilution are unduly neglected in routine clinical practice. The consistent use of both of these techniques, and the careful weighing up of the indication for every single blood transfusion, would not only effectively reduce homologous blood transfusions, but also enable even small hospitals to run successful autologous transfusion programmes without expensive cell-washing and plasmapheresis devices.