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Biomedical subjects

R Saller

Publications and source records attributed to R Saller.

At least 55 records · Page 3Linked to original sources

[Quality of outcome in treating patients with chronic headache within a hospital specialized for migraine. A cohort study with one-year follow-up].

AIMS: To describe characteristics of in-patients with chronic headache syndromes being treated with complementary methods, short-term effects at time of discharge as well as long-term effects covering a catamnesis of 1 year. METHODS: The study was designed as a prospective cohort study with outcome measurements 2 months in advance of admission to the hospital, at admission, and at time of discharge, continued by follow-up queries 2, 6 and 12 months after discharge from the hospital. The parameters for describing the course of headache symptoms were registered by questionnaires and diaries. During the first 6 months in 1996, a total of 424 consecutive patients with migraine or tension-type headache at the 'Migräne-Klinik Königstein' were included. RESULTS: 82.9% of the patients were women, the mean age was 46.3 +/-13.0 years. The median of the duration of the disease was 23 years. At discharge from the hospital there was a marked improvement regarding frequency of headache attacks, intensity of headaches, and concomitant symptoms. 60.5% of the patients were classified as 'responders'. 67.5% responded to follow-up questionnaires. With exception of the duration of headache attacks, a significant improvement regarding the 6-month follow- up compared to base level was observed. Intake of drugs could be diminished and quality of life was improved. Patients suffering from tension-type headache showed smaller effects in general. CONCLUSIONS: Taking into account the mean duration of disease of more than 20 years the results suggest a clinically relevant success from the patients' view regarding the short-term as well as the long-term course. The problem of data loss with follow-up queries and missing comparative data reduce the conclusiveness of the results.

Adult↗

[Dyspeptic pain and phytotherapy--a review of traditional and modern herbal drugs].

Gastrointestinal complaints rank among the most frequently reasons why people asking for medical advice. About 15-30% of the adult patients suffer from different various functional dyspeptic conditions. The therapy of functional gastrointestinal disorders is one of the domains of phytotherapeutic treatments. From ancient times on, bitter herbal drugs played a very important role in the therapy of patients with dyspeptic symptoms. The mechanisms of action of the bitters are not completely understood. But there are indications that they sensorially stimulate at even very small concentrations sensorially the secretion of the stomach as well as the digestive glands and strengthen the smooth musculature of the digestive tract (via the gustatory system, N. vagus and the enteric nervous system). Across the enteral nervous system the strengthened digestive tract seems to stimulate the CNS, leading to a general tonification. At higher dosages bitters probably directly affect the mucous membranes of the stomach and the bowel. Bitters often are combined with essential oils (some volatile oils as aromatic bitters, drug combinations of a volatile oil with a bitter). Essential oils act primarily as spasmolytics, carminatives and local anesthetics. In the last years several controlled studies were carried out with phytotherapeutic combinations (e.g. with Iberis amara, caraway oil, peppermint oil, curcuma extract, ginger extract) in which the herbal drugs proved to be superior compared to placebo and were as effective as prokinetics (studies according to evidence-based medicine). The traditional phytotherapeutic approach is based upon the illness- as well as the patient-related investigations referring to the effectiveness of bitter, acrid- and essential-oil drugs. Such a treatment is supported by a rich amount of various of kinds of individual empirical experience (experience-based phytotherapy). Important traditional medical systems like the Traditional Chinese Medicine, the Ayurvedic Medicine as well as the European 'Humoral Medicine' consider different aspects of the sick human being, like the constitution of the patient (holistic approach), and take qualities of herbal drugs, vegetarian food, and spices into account for therapeutic purposes.

Drugs, Chinese Herbal↗

[Distant healing and clinical research].

Distant healing is one of the most controversially discussed methods of complementary medicine. In the first section this paper outlines the history of spiritual healing and describes some possible definitions and different methods of spiritual healing. Based on a literature search in Medline, EMBASE, Current Contents, Allied and Complementary Medicine Database (AMED) as well as a manual tracking, current distant healing studies (excluding therapeutic touch studies) (n = 16) and some review articles (n = 6) are outlined in the second section. In addition, the randomized clinical double-blind studies (n = 12) are judged as to their formal quality by means of the Jadad Scale and the Internal Validity Scale (IV). Based on the controversially discussed study by Harris et al., some discussion points in the research field of spiritual healing are presented in the third section of this paper. From the evidence contained in the studies of this review article, no firm conclusions about the efficacy or inefficacy of healing can yet be made.

Complementary Therapies↗

Combined herbal preparation for topical treatment of Herpes labialis.

BACKGROUND: The efficacy of many preparations for topical use in herpes infections have remained rather disappointing. The development of new antiviral drugs, especially herbal preparations, thus remains desirable. In a screening study with plant extracts, a rhubarb root extract and a sage extract showed a promising activity. OBJECTIVE: The efficacy of a combined topical preparation with rhubarb and sage extracts, of a single-agent preparation with sage extract and of a reference treatment was investigated in a double-blind, comparative, randomised trial. PATIENTS AND METHODS: A total of 149 patients participated, and 145 patients (111 female, 34 male) of whom 64 received the rhubarb-sage cream, 40 the sage cream and 41 Zovirax cream could be evaluated by intention-to-treat analysis. The dried rhubarb extract (23 mg/g) is a standardised aqueous- ethanolic extract according to the German Pharmacopoeia (DAB) with 4.0-6.0% hydroxyanthracene derivatives. The dried sage extract (23 mg/g) is an aqueous extract. The reference product was Zovirax cream (Zovirax(R) Creme) with the active ingredient aciclovir (50 mg/g). RESULTS: The mean time to healing in all cured patients was 7.6 days with the sage cream, 6.7 days with the rhubarb-sage cream and 6.5 days with Zovirax cream. There were statistically significant differences in the course of the symptoms. For the parameter 'swelling', at the 1st followup visit there was a significant advantage for Zovirax cream compared to sage cream, and for the parameter 'pain', at the 2nd follow-up visit there was a significant difference in favour of the rhubarb-sage cream compared to the sage cream. CONCLUSION: The combined topical sage-rhubarb preparation proved to be as effective as topical aciclovir cream and tended to be more active than the sage cream.

Acyclovir↗

The use of silymarin in the treatment of liver diseases.

The high prevalence of liver diseases such as chronic hepatitis and cirrhosis underscores the need for efficient and cost-effective treatments. The potential benefit of silymarin (extracted from the seeds of Silybum marianum or milk thistle) in the treatment of liver diseases remains a controversial issue. Therefore, the objective of this review is to assess the clinical efficacy and safety of silymarin by application of systematic approach. 525 references were found in the databases, of which 84 papers were retained for closer examination and 36 were deemed suitable for detailed analysis. Silymarin has metabolic and cell-regulating effects at concentrations found in clinical conditions, namely carrier-mediated regulation of cell membrane permeability, inhibition of the 5-lipoxygenase pathway, scavenging of reactive oxygen species (ROS) of the R-OH type and action on DNA-expression, for example, via suppression of nuclear factor (NF)-kappaB. Pooled data from case record studies involving 452 patients with Amanita phalloides poisoning show a highly significant difference in mortality in favour of silibinin [the main isomer contained in silymarin] (mortality 9.8% vs 18.3% with standard treatment; p < 0.01). The available trials in patients with toxic (e.g. solvents) or iatrogenic (e.g. antispychotic or tacrine) liver diseases, which are mostly outdated and underpowered, do not enable any valid conclusions to be drawn on the value of silymarin. The exception is an improved clinical tolerance of tacrine. In spite of some positive results in patients with acute viral hepatitis, no formally valid conclusion can be drawn regarding the value of silymarin in the treatment of these infections. Although there were no clinical end-points in the four trials considered in patients with alcoholic liver disease, histological findings were reported as improved in two out of two trials, improvement of prothrombin time was significant (two trials pooled) and liver transaminase levels were consistently lower in the silymarin-treated groups. Therefore, silymarin may be of use as an adjuvant in the therapy of alcoholic liver disease. Analysis was performed on five trials with a total of 602 patients with liver cirrhosis. The evidence shows that, compared with placebo, silymarin produces a nonsignificant reduction of total mortality by -4.2% [odds ratio (OR) 0.75 (0.5 - 1.1)]; but that, on the other hand, the use of silymarin leads to a significant reduction in liver-related mortality of-7% [OR: 0.54 (0.3 - 0.9); p < 0.01]. An individual trial reported a reduction in the number of patients with encephalopathy of -8.7% (p = 0.06). In one study of patients with cirrhosis-related diabetes mellitus, the insulin requirement was reduced by -25% (p < 0.01). We conclude that available evidence suggests that silymarin may play a role in the therapy of (alcoholic) liver cirrhosis. Silymarin is has a good safety record and only rare case reports of gastrointestinal disturbances and allergic skin rashes have been published. This review does not aim to replace future prospective trials aiming to provide the 'final' evidence of the efficacy of silymarin.

Alcoholism↗

Therapy with proteolytic enzymes in rheumatic disorders.

Plant extracts with a high content of proteolytic enzymes have been used in traditional medicine for a long time. Besides herbal proteinases, 'modern' enzyme therapy includes pancreatic enzymes. The therapeutic use of proteolytic enzymes is empirically based, but is also supported by scientific studies. This review provides an overview of preclinical and clinical trials of systemic enzyme therapy in rheumatic disorders. Studies of the use of proteolytic enzymes in rheumatic disorders have mostly been carried out on enzyme preparations consisting of combinations of bromelain, papain, trypsin and chymotrypsin. The precise mechanism of action of systemic enzyme therapy remains unresolved. The ratio of proteinases to antiproteinases, which is affected by rheumatic diseases, appears to be influenced by the oral administration of proteolytic enzymes, probably via induction of the synthesis of antiproteinases or a signal transduction of the proteinase-antiproteinase complex via specific receptors. Furthermore, there are numerous alterations of cytokine composition during therapy with orally administered enzymes resulting from immunomodulatory effects, which might be an indication of the efficacy of enzyme therapy. The results of various studies (placebo-controlled and comparisons with nonsteroidal anti-inflammatory drugs) in patients with rheumatic diseases suggest that oral therapy with proteolytic enzymes produces certain analgesic and anti-inflammatory effects. However, the results are often inconsistent. Nevertheless, in the light of preclinical and experimental data as well as therapeutic experience, the application of enzyme therapy seems plausible in carefully chosen patients with rheumatic disorders.

Clinical Trials as Topic↗

[Herbal remedies in veterinary phytotherapy].

Phytotherapy is based on the use of herbal remedies (phytopharmaceuticals) for therapy and prophylactic measures of illness in humans and animals. Animal owners as well as veterinarians (surgeons) are more and more interested in veterinary phytotherapy. The following review explains fundamentals of veterinary phytotherapy as well as the production, application and possible side-effects of veterinary herbal remedies (veterinary phytopharmaceuticals).

Animal Diseases↗

Immunotherapy of a viral disease by in vivo production of therapeutic monoclonal antibodies.

Continuous and sustained in vivo production of monoclonal antibodies by engineered cells might render long-term antibody-based treatments cost-effective, avoid side effects associated with infusion of massive doses of antibody, and circumvent possible antiidiotypic responses against the therapeutic agent. The FrCasE retrovirus induces a lethal neurodegeneration on infection of newborn mice. We report here that implantation of cellulose sulfate capsules containing cells secreting an ectopic monoclonal antibody neutralizing FrCasE can prevent animals from developing the disease. All treated mice showed reduced or undetectable viremia in addition to a lack of the histopathological lesions characteristic of FrCasE infection. This work paves the way for a novel gene/cell antibody-based immunotherapy of a variety of severe viral and nonviral diseases.

Animals↗

Combined chemotherapy of murine mammary tumors by local activation of the prodrugs ifosfamide and 5-fluorocytosine.

The success of chemotherapeutic intervention is limited because the necessary high local drug doses cannot be achieved without systemic toxicity. Application of suicide genes (SGs) and direct conversion of prodrugs (PDs) to toxic metabolites in situ by SGs may enhance the efficacy of chemotherapy. To evaluate this strategy in two murine breast cancer models, TS/A and GR, we injected cellulose sulfate capsules harboring cat kidney cells expressing the SGs cytosine deaminase and cytochrome P450 2B1 (CYP2B1) intratumorally. The PDs 5-fluorocytosine and ifosfamide were administered in 3-day intervals. The effect of in situ chemotherapy with each PD alone and the combination was analyzed over a period of 100 days. The results reveal that for TS/A tumors, the antitumoral effect mediated by CYP2B1 is more efficient than that of cytosine deaminase, whereas for GR tumors, both systems worked equally well. Furthermore, we find additive toxicity using both SG/PD systems for both TS/A and GR tumors.

Animals↗

[Comparative epidemiological study in patients with rheumatic diseases illustrated in a example of a treatment with non-steroidal anti- inflammatory drugs versus an oral enzyme combination preparation].

To establish the safety and efficacy of an oral enzyme-combination product (OE; Phlogenzym, containing trypsin, bromelain and rutin) in the treatment of rheumatic diseases a retrolective cohort study with parallel groups was undertaken as an epidemiological study, in which the enzyme combination was compared with non steroidal anti-inflammatory drugs (NSAID). Data of 3326 patients treated for rheumatic diseases between January 1993 and the end of March 1995 were registered by 380 physicians. From the patient file age, gender, indication for treatment (diagnostic group), anamnestic data (especially pre-treatment), complaints at the beginning and end of treatment, treatment duration, prescribed drugs (OE, NSAID), additional treatment and adverse events were transferred into case report forms (CRFs). The quality of the data was monitored and additionally checked by internal and external quality audits. Included in the efficacy analysis were 2139 patients which were treated either only with OE or only with NSAID and could be classified unambiguously into one of the following diagnostic groups: joint diseases, spinal diseases, rheumatic soft tissue diseases. As clinically relevant and reliably evaluable criterion freedom from rheumatic complaints at the end of treatment was considered. For evaluation of safety the documented adverse events of all patients were considered. Two thirds of the OE patients received the recommended dose of 6 tablets/day, taken for 23 to 35 days. The respective mean values for NSAID patients were 16 to 25 days, and the patients were treated with the recommended symptomatically effective doses of NSAID. As the allocation of the compared treatment options (OE or NSAID) to the patients was not randomized, a mixing of treatment effects with other factors cannot be excluded. For adjustment of these confounding factors two methods were applied: a) logistic regression of the relative ratio of the main criterion and all confounding factors and b) stratification of data according to the propensity score i.e. the probability of a treatment with OE. Both methods yielded similar results: A 50% higher success rate can be expected in total for OE than for NSAID at comparable initial and treatment situations (95% confidence interval with logistic regression = 1.218-1.96, with stratification according to propensity score = 1.16-1.84). As significant negative indicators for response age over 50 years, pre-treatment with antirheumatic or analgetic drugs, treatment duration more than 30 days and joint diseases or fibromyalgias could be revealed. Since there was no interaction between these indicators and the type of treatment also in patients presenting with these indicators a treatment success (freedom from symptoms) with OE can be expected with a higher probability than with NSAID. OE were well tolerated showing much less adverse events when compared with conventional doses of NSAID.

Adult↗

Analgesic efficacy of the serial application of a sulfurated mud bath at home.

The purpose of this randomized controlled trial was to evaluate the analgesic efficacy of a series of applications of sulfurated mud baths in outpatients suffering from back pain. Within 2 weeks 13 patients took 6 sulfurated mud baths (group A) and 12 patients 6 tap water baths (group B) at home. Before the bath and over 48 h after starting the 1st and the 6th bath, pain intensity was evaluated by the patients according to a visual analogue scale (VAS). The main outcome parameter was the weighted (for time of observation) sum of pain intensity (SPI) after the 6th bath. The mean SPI in group A was 741 mm x h (95% CI 594-864 mm x h) and in group B 1,112 mm x h (95% CI 929-1,252 mm x h) (p = 0.009), suggesting a significantly stronger analgesic effect of a series of sulfurated mud baths than of a series of tap water baths.

Adult↗

Systemic enzyme therapy in oncology: effect and mode of action.

Plant extracts with a high content of proteolytic enzymes have been used for a long time in traditional medicine. Besides proteolytic enzymes from plants, 'modern' enzyme therapy additionally includes pancreatic enzymes. The therapeutic use of proteolytic enzymes is partly based on scientific studies and is partly empirical. The aim of the current review is to provide an overview of clinical trials of systemic enzyme therapy in oncology, and to discuss the evidence for their possible mechanisms of action. Clinical studies of the use of proteolytic enzymes in oncology have mostly been carried out on an enzyme preparation consisting of a combination of papain, trypsin and chymotrypsin. This review of these studies showed that enzyme therapy can reduce the adverse effects caused by radiotherapy and chemotherapy. There is also evidence that, in some types of tumours, survival may be prolonged. The beneficial effect of systemic enzyme therapy seems to be based on its anti-inflammatory potential. However, the precise mechanism of action of systemic enzyme therapy remains unsolved. The ratio of proteinases to antiproteinases, which is increasingly being used as a prognostic marker in oncology, appears to be influenced by the oral administration of proteolytic enzymes, probably via an induction of the synthesis of antiproteinases. Furthermore, there are numerous alterations of cytokine composition during therapy with orally administered enzymes, which might be an indication of the efficacy of enzyme therapy. Effects on adhesion molecules and on antioxidative metabolism are also reviewed.

Animals↗

[Quality management and research. A pragmatic concept for evaluation and optimization of complementary medicine within the framework of hospital and practitioner relations].

Objective of the concept "Quality Management and Research" is to evaluate and optimize Complementary Medicine (CM) within everyday-practice in a network of hospitals and practitioners. In a step by step-strategy the concept should give information about quality on the levels of structure, process and outcome for and about patients and providers. Therefore special profiles of quality should be determined. In a next step preinterventionally defined goals of therapies have to be proofed for being achieved at admission or at the end of the intervention. To enable decision-making for patients, physicians and insurance companies profiles of quality should be compared within the specialized network and/or with mainstream providers. Asking for high evidence it is necessary to conduct randomized controlled trials (RCTs). A main interest of the program is to integrate the concept into routine practice of the network and to build up a data-collection-centre at the university in order to improve the providing system and to create new tools for practice-based medical research.

Complementary Therapies↗

[Herbal drugs of foreign cultures and medical systems exemplified by Indian incense. Considerations regarding social and insurance medicine expert assessment].

Increase preparations are being used with increasing frequency in Western medicine. In experimental investigations, an anti-inflammatory effect has been shown. Clinical observations relate to increase applications in rheumatoid arthritis, malignant brain tumors, inflammatory bowel diseases and asthma bronchiale. A relevant clinical effect of increase preparations has not been ascertained. In Germany, the registration of increase preparation H 15 as a drug has been withheld by the federal drug registration office (former "Bundesgesundheitsamt"). Health funds may reimburse costs for increase preparations in exceptional cases only.

Anti-Inflammatory Agents↗

Injection of encapsulated cells producing an ifosfamide-activating cytochrome P450 for targeted chemotherapy to pancreatic tumors.

The prognosis of pancreatic cancer is poor, and current medical treatment is mostly ineffective. The aim of this study was to design a new treatment modality in an animal model system. We describe here a novel treatment strategy employing a mouse model system for pancreatic carcinoma. Embryonal kidney epithelial cells were genetically modified to express the cytochrome P450 subenzyme 2B1 under the control of a cytomegalovirus (CMV) immediate early promoter. This CYP2B1 gene converts ifosfamide to its active cytotoxic compounds, phosphoramide mustard, which alkylates DNA, and acrolein, which alkylates proteins. The cells were then encapsulated in a cellulose sulphate formulation and implanted into preestablished tumors derived from a human pancreatic tumor cell line. Intraperitoneal administration of low-dose ifosfamide to tumor bearing mice that received the encapsulated cells results in partial or even complete tumor ablation. Such an in situ chemotherapy strategy utilizing genetically modified cells in an immunoprotected environment may prove useful for solid tumor therapy in man.

Animals↗

A double-blind randomised trial to investigate three different concentrations of a standardised fresh plant extract obtained from the shoot tips of Hypericum perforatum L.

The aim of this randomised double-blind multi-centre parallel group comparative study was to investigate the efficacy and tolerability of a new standardised fresh-plant extract obtained from the shoot tips of St. John's wort (Hypericum perforatum L.) in the treatment of mild to moderate depression. 348 out-patients (259 female, 89 male) with mild to moderate depression were recruted by 12 psychiatrc specialty practices and 26 general practices. The patients took during 6 weeks 3 times a day 1 tablet of a Hypericum preparation standardised to either 0.17 mg (114 patients), 0.33 mg (115 patients), or 1 mg (119 patients) total hypericin per day (Hyperiforce). The main outcome measure was the Hamilton Psychiatric Rating Scale for Depression; additional measures were the Hospital Anxiety and Depression Scale and the Clinical Global Impression. At the end of treatment, a reduction in the average Hamilton Depression score from an initial 16-17 to 8-9, i.e. a relative reduction of about 50%, was observed in all groups (280 patients, par protocol analysis). The response rates were 62%, 65% and 68%, respectively (348 patients, intention to treat analysis). Overall, the intergroup comparison revealed no significant differences. Tolerability was excellent, with mild adverse reactions probably causally related to the treatment occurring in only 7 of the 348 patients (2%). This Hypericum preparation is effective in all three doses and is well tolerated.

Adult↗