Rainer Stange

Randomised clinical trial: a herbal preparation of myrrh, chamomile and coffee charcoal compared with mesalazine in maintaining remission in ulcerative colitis--a double-blind, double-dummy study.

The herbal treatment with myrrh, dry extract of chamomile flowers and coffee charcoal has anti‐inflammatory and antidiarrhoeal potential and might benefit patients with UC. Aminosalicylates are used as standard treatment for maintaining remission in ulcerative colitis (UC).

Incorporation of n-3 PUFA and γ-linolenic acid in blood lipids and red blood cell lipids together with their influence on disease activity in patients with chronic inflammatory arthritis - a randomized controlled human intervention trial

Background and aimMarine n-3 fatty acids and γ-linolenic acid both have anti-inflammatory effects and may be useful to help treat inflammatory diseases. The effects of these alone or combined were examined in patients with arthritis in a randomized controlled trial.DesignPatients with rheumatoid arthritis or psoriatic arthritis were randomized into four groups in a double-blind, placebo-controlled parallel designed study. Patients received the respective capsules (1: 3.0 g n-3 LC-PUFA/d; 2: 3.2 g γ-linolenic acid/d; 3: 1.6 g n-3 LC-PUFA + 1.8 g γ-linolenic acid/d; 4: 3.0 g olive oil) for a twelve week period. Clinical status was evaluated and blood samples were taken at the beginning and at the end of the period. Differences before and after intervention were tested with paired t-test or with Wilcoxon test for non-normal data distribution.Results60 patients (54 rheumatoid arthritis, 6 psoriatic arthritis) were randomised, 47 finished per protocol. In group 1, the ratio of arachidonic acid (AA)/eicosapentaenoic acid (EPA) decreased from 6.5 ± 3.7 to 2.7 ± 2.1 in plasma lipids and from 25.1 ± 10.1 to 7.2 ± 4.7 in erythrocyte membranes (p ≤ 0.001). There was no significant influence on AA/EPA ratio due to interventions in group 2-4. In group 2, the intake of γ-linolenic acid resulted in a strong rise of γ-linolenic acid and dihomo-γ-linolenic acid concentrations in plasma lipids, cholesteryl esters, and erythrocyte membranes. The combination of n-3 LC-PUFA and γ-linolenic acid (group 3) led to an increase of γ-linolenic acid and dihomo-γ-linolenic acid concentrations in plasma lipids, cholesteryl esters, and erythrocyte mem-branes. This increase was only half of that in group 2.ConclusionsIncorporation of eicosanoid precursor FAs was influenced by an intake of n-3 LC-PUFA and γ-linolenic acid suggesting a possible benefit for therapy of chronic inflammatory diseases.Trial RegistrationClinicalTrials NCT01179971

Effectiveness of Home-Based Cupping Massage Compared to Progressive Muscle Relaxation in Patients with Chronic Neck Pain—A Randomized Controlled Trial

Chronic neck pain is a major public health problem with very few evidence-based complementary treatment options. This study aimed to test the efficacy of 12 weeks of a partner-delivered home-based cupping massage, compared to the same period of progressive muscle relaxation in patients with chronic non-specific neck pain. Patients were randomly assigned to self-directed cupping massage or progressive muscle relaxation. They were trained and asked to undertake the assigned treatment twice weekly for 12 weeks. Primary outcome measure was the current neck pain intensity (0–100 mm visual analog scale; VAS) after 12 weeks. Secondary outcome measures included pain on motion, affective pain perception, functional disability, psychological distress, wellbeing, health-related quality of life, pressure pain thresholds and adverse events. Sixty one patients (54.1±12.7 years; 73.8%female) were randomized to cupping massage (n = 30) or progressive muscle relaxation (n = 31). After treatment, both groups showed significantly less pain compared to baseline however without significant group differences. Significant effects in favor of cupping massage were only found for wellbeing and pressure pain thresholds. In conclusion, cupping massage is no more effective than progressive muscle relaxation in reducing chronic non-specific neck pain. Both therapies can be easily used at home and can reduce pain to a minimal clinically relevant extent. Cupping massage may however be better than PMR in improving well-being and decreasing pressure pain sensitivity but more studies with larger samples and longer follow-up periods are needed to confirm these results. Trial Registration ClinicalTrials.gov NCT01500330

Phase II trial on the effects of Silexan in patients with neurasthenia, post-traumatic stress disorder or somatization disorder.

Silexan, a novel lavender oil preparation for oral use, has been authorized in Germany for the treatment of states of restlessness during anxious mood. An open-label, exploratory trial was performed to assess the potential of the medicinal product in the treatment of restlessness caused by anxiety as related to several disorders. Outcome measures included the Symptom Checklist-90-Revised (SCL-90-R), von Zerssens Depression Scale (D-S), the 36-item Short Form Health Survey Questionnaire (SF-36), and a sleep diary. 50 male and female patients with neurasthenia (ICD-10 F48.0), post-traumatic stress disorder (PSD; F43.1), or somatization disorder (F45.0, F45.1) were included to receive 1 × 80 mg/day Silexan over 6 weeks; 47 could be analyzed for efficacy as full analysis set. At baseline, patients suffered from restlessness (96%), depressed mood (98%), sleep disturbances (92%), or anxiety (72%). Of those, resp. 62%, resp. 57%, resp.51%, resp. 62% showed improvements during treatment (p < 0.001). For all patients, mean D-S score decreased by 32.7% and SCL-90-R Global Severity Index by 36.4% as compared to baseline, (p < 0.001), while the SF-36 Mental Health Score increased by 48.2% (p < 0.001). Waking-up frequency (p = 0.002), Waking-up duration (p < 0.001) and morning tiredness (p = 0.005) were reduced, while efficiency of sleep (p = 0.018) and mood (p = 0.03) improved. Patients suffering from neurasthenia or PSD showed comparable improvements with most outcomes. The results in this trial justify to further investigate Silexan in disorders with accompanying restlessness caused by sub-threshold anxiety. Adverse reactions, predominantly gastrointestinal complaints, were judged as mild or moderate.

Leitlinien zur Fastentherapie

Jahreszeitlich bedingte Schwankungen im Nahrungsangebot prägten in der Evolution den Stoffwechsel aller Lebewesen. Die Fähigkeit, sich diesen Schwankungen durch Depotbildung und deren Mobilisierung anzupassen, ist von jeher Bedingung für das Überleben, insbesondere für das menschliche Überleben. Fasten ist die Fähigkeit, für eine begrenzte Zeit den Bedarf an Makround Mikronährstoffen bei ausbleibender oder minimaler Nahrungsaufnahme über den Verdauungstrakt ohne gesundheitliche Nachteile aus körpereigenen Reserven zu decken. Hinzu kommen eine relative Bedarfsminderung sowie verschiedene Sparmechanismen (z. B. Umstellung des ZNS auf Fettverbrennung, Rückgang der Verdauungsund Assimilationsvorgänge, die dieser äusseren Verknappung entgegensteuern: einerseits um den Zellstoffwechsel jederzeit ausreichend mit Energie zu versorgen, andererseits um die Zellerneuerung aufrecht zu erhalten. Aus dieser biologischen Fähigkeit entwickelten sich Fastenkulturen mit religiös-spiritueller oder medizinisch-therapeutischer Zielsetzung. Die Integration des Fastens in die Medizin gelang bei uns über die Klassische Naturheilkunde, deren unverzichtbaren Bestandteil es heute darstellt. Als Fastenmethoden haben sich vor allem das Heilfasten nach Dr. med. Otto Buchinger (Buchinger, 1935) und die Therapie nach Dr. med. F.X. Mayr (Mayr, 1921) durchgesetzt. Otto Buchinger entwickelte aus rudimentären Ansätzen ein multidisziplinäres Konzept für eine stationäre Fastentherapie, in der Physio-, Bewegungsund Ernährungstherapie mit einem gesundheitspädagogischen Programm verbunden sind (Fahrner, 1991). Die Integration der Psychotherapie erfolgte später. Auch Aspekte der religiösen Fastentradition sind heute Bestandteil des therapeutischen Fastens: zu der physischen traten die psycho-soziale und die spirituelle Dimension hinzu. Diese Leitlinien wurden von einem Expertengremium erstellt und werden von ihm gemeinsam getragen. Ihr Ziel ist die Beschreibung des Therapieverfahrens und die Feststellung von Standards zu Zwecken der ärztlichen Fortund Weiterbildung, der Orientierung bei qualitätssichernden Massnahmen in Klinik und Praxis sowie der weiteren wissenschaftlichen Erforschung der klinischen Effekte der Methode. Auch sollen sie einen Beitrag zur methodisch korrekten Durchführung des Fastens in den zahlreichen Einrichtungen leisten, die das Fasten zu präventiv-medizinisch und/oder religiös-spirituell motivierten Zielsetzungen anbieten. Für das ärztlich betreute Fasten dienten bislang seit 1978 Angebote im Rahmen der Weiterbildung zur Erlangung der Zusatzbezeichnung Naturheilverfahren der Sicherung eines Wissensstandards. Hierbei ist auch die Fastenselbsterfahrung ein erwünschter Bestandteil. Seit 1996 können ÄrztInnen im Rahmen eines Curriculums zum Erwerb des Weiterbildungszertifikates «Fastenärztin/Fastenarzt» der Ärztegesellschaft Heilfasten und Ernährung e. V. eine ausgewiesene Qualifikation erwerben. Im nicht-ärztlich betreuten Fasten werden seit 1986 von mehreren Einrichtungen FastenleiterInnen ausgebildet. Diese Ausbildung dient auch der Kooperation mit FastenärztInnen.

Fasting Therapy - an Expert Panel Update of the 2002 Consensus Guidelines

Fasting for medical purpose (fasting therapy) has a long tradition in Europe and is established as a defined therapeutic approach in specialized fasting hospitals or within clinical departments for integrative medicine. In 2002, the first guidelines for fasting therapy were published following an expert consensus conference; here we present a revised update elaborated by an expert panel. Historical aspects and definitions, indications, methods, forms, and accompanying procedures of fasting as well as safety and quality criteria of fasting interventions are described. Fasting has shown beneficial effects in various chronic diseases with highest level of evidence for rheumatic diseases. Preliminary clinical and observational data and recently revealed mechanisms of fasting and caloric restriction indicate beneficial effects of fasting also in other chronic conditions such as metabolic diseases, pain syndromes, hypertension, chronic inflammatory diseases, atopic diseases, and psychosomatic disorders. Fasting can also be applied for preventing diseases in healthy subjects. In order to guarantee successful use of fasting and to ensure adherence of all safety and quality standards it is mandatory that all interventions during fasting are guided/accompanied by physicians/therapists trained and certified in fasting therapy.

In-Patient Treatment of Fibromyalgia: A Controlled Nonrandomized Comparison of Conventional Medicine versus Integrative Medicine including Fasting Therapy

Fibromyalgia poses a challenge for therapy. Recent guidelines suggest that fibromyalgia should be treated within a multidisciplinary therapy approach. No data are available that evaluated multimodal treatment strategies of Integrative Medicine (IM). We conducted a controlled, nonrandomized pilot study that compared two inpatient treatment strategies, an IM approach that included fasting therapy and a conventional rheumatology (CM) approach. IM used fasting cure and Mind-Body-Medicine as specific methods. Of 48 included consecutive patients, 28 were treated with IM, 20 with CM. Primary outcome was change in the Fibromyalgia Impact Questionnaire (FIQ) score after the 2-week hospital stay. Secondary outcomes included scores of pain, depression, anxiety, and well being. Assessments were repeated after 12 weeks. At 2 weeks, there were significant improvements in the FIQ (P < 0.014) and for most of secondary outcomes for the IM group compared to the CM group. The beneficial effects for the IM approach were reduced after 12 weeks and no longer statistically significant with the exception of anxiety. Findings indicate that a multimodal IM treatment with fasting therapy might be superior to CM in the short term and not inferior in the mid term. Longer-term studies are warranted to assess the clinical impact of integrative multimodal treatment in fibromyalgia.

Randomised controlled trial with medical leeches for osteoarthritis of the knee

OBJECTIVES To evaluate the possible efficacy of medical leeches (Hirudo medicinalis) in the treatment of patients with active osteoarthritis of the knee. DESIGN Unblinded, randomised controlled trial with outpatients in a crossover design with single interventions of either leeches or transcutaneous electrical nerve stimulation (TENS) as comparator. MAIN OUTCOME MEASURES Change in Lequesnes combined index for pain and function and change (L.I.) and overall assessment of complaints by visual analog scale (VAS). Cross-over at day 42, with further observation period of 21 days. RESULTS 52 out of 72 screened patients were randomised (intent to treat) to initial treatment with either eight leeches (group 1: 27 patients) or TENS (group 2: 25 patients). Due to phase effects, confirmatory evaluation had to be restricted to the first period. Between days 0 and 21, we observed highly significant (p<0.001) improvements for means of Lequesnes index from 12.07 to 9.37 and for VAS from 5.89 to 4.16 cm for leeches, but no significant differences for TENS. Effect size as group difference was -2.50 for L.I. (95% confidence interval -3.88 to -1.11), resp. -1.86 cm for VAS (95% confidence interval -2.85 to -0.87 cm). 12 patients (5 group 1, 7 group 2) did not finish the trial, mostly due to non-compliance (6). No serious adverse effects were observed. CONCLUSIONS Single leech therapy showed significant, relevant and sustaining effects, comparable to other trials with leeches. The method deserves further research, esp. into mechanisms of possible specific effects and optimization of dosing by number of leeches and possible repeats.

Unkontrollierte klinische Studie zur Wirksamkeit ambulanten Heilfastens bei Patienten mit Arthrose

Ziel: Untersuchung der Wirksamkeit ambulanten Heilfastens auf Schmerz, Befindlichkeit und Gelenkfunktion bei Patienten mit Arthrose. Patienten und Methoden: Prospektive, unkontrollierte Pilotstudie. 30 Patienten (22 Frauen, 8 MÄnner), Kellgren-Stadien I–III, mit Fingergelenks- (N = 10), Cox- (N = 8) und Gonarthrose (N = 12) unterzogen sich einer 2-wÖchigen ambulanten Fastenintervention nach Buchinger mit 3 Entlastungstagen, 8 Fastentagen (300 kcal) und 4 Aufbautagen sowie Followup nach 4 und 12 Wochen. Bewertungskriterien: Globale SchmerzintensitÄt (Visuelle Analogskala, VAS); Anlauf-, Belastungs-, Ruheschmerz (VAS); Druckschmerzschwelle (DSS); Gelenkfunktion (Neutral-Null-Durchgangsmethode); Gesundheitsbezogene LebensqualitÄt (SF-36, bestehend aus Physical Component Score und Mental Component Score); Western Ontario and McMasters Universities Arthrose-Index (WOMAC); painDETECT©-Fragebogen (Pfizer); Analgetika-Konsum; KÖrpergewicht, Body-Mass-Index (BMI), Bauchumfang, Blutdruck, Puls sowie umfangreiche serologische Parameter. Ergebnisse: Signifikante Schmerzreduktion, Befindlichkeits- und Gelenkfunktionsverbesserung sowie signifikante Reduktion von KÖrpergewicht und BMI, Abnahme des Bauchumfangs im Fasten-und gesamten Studienzeitraum, Analgetikaverbrauch konnte reduziert werden. Entgleisungen autonomer bzw. metabolisch-serologischer Parameter wurden nicht beobachtet. Schlussfolgerung: Heilfasten unter Ärztlicher Aufsicht kann die Symptomatik bei Patienten mit moderater Arthrose positiv beeinflussen. Kontrollierte Studien mit hÖheren Fallzahlen mÜssen dies konsolidieren.OBJECTIVE To study the efficacy of fasting therapy according to Buchinger on pain, state of health, and articular function in patients with osteoarthritis. PATIENTS AND METHODS Uncontrolled pilot study in which 30 patients (22 women, 8 men) with osteoarthritis (Kellgren stages I-III) of the hand (N = 10), hip (N = 8) and knee (N = 12) underwent ambulant fasting therapy according to Buchinger for 2 weeks with 3 pre-fast days, 8 fast days (300 kcal) and 4 re-feed days as well as follow-up 4 and 12 weeks afterwards. ASSESSMENT CRITERIA: Global intensity of pain (visual analogue scale, VAS); joint pain with activity, with start of walking, at rest (VAS); pressure pain threshold; articular function; health-related quality of life (SF-36 including Physical Component Score and Mental Component Score); Western Ontario and McMasters Universities Arthrose Index (WOMAC); painDETECT-questionnaire (Pfizer); analgesics; weight; body mass index (BMI); waist circumference; blood pressure; pulse and a variety of serological parameters. RESULTS Pain, state of health, and articular function improved significantly; significant reduction in weight, BMI, and waist circumference during fasting and over the complete course of the study; analgesics could be reduced. No abnormalities in autonomous, metabolic, or blood parameters were observed. CONCLUSION Medically supervised fasting can have a positive impact on the symptoms of patients with moderate osteoarthritis. This finding must be consolidated by controlled studies that include higher numbers of patients.

Cholesterol reduction using psyllium husks – Do gastrointestinal adverse effects limit compliance? Results of a specific observational study

PURPOSE Despite known cholesterol lowering effects the use of psyllium husk (Plantaginis ovatae testa) in Germany for hypercholesterolemia is limited compared to their use as a laxative. To investigate whether use in hypercholesterolemia is limited due to adverse effects on the gastrointestinal system, a prospective observational study was conducted. METHODS Sixty-two outpatients with documented hypercholesterolemia and complaints of constipation were identified from an academic clinical center. Treatment with 3.5g psyllium husk preparation administered three times daily was initiated and patients were monitored at weekly intervals. Gastrointestinal symptoms were quantified using a validated Nepean Dyspepsia Index modified to identify both upper and lower abdominal symptoms. Diaries and study medication records were used to evaluate compliance. RESULTS Fifty-four of 62 patients enrolled in the study completed the study protocol with 4 subjects discontinuing due to adverse reactions associated with psyllium husks. Total cholesterol was significantly decreased from 252+/-39mg/dl before treatment to 239+/-37mg/dl after 3 weeks of treatment. Similarly, low density lipoprotein (LDL)-cholesterol decreased from 174+/-34 to 162+/-31mg/dl during the study. Triglycerides and high density lipoprotein (HDL) were unchanged. Gastrointestinal symptoms were rated lower at the end than at the beginning of the study. In week 1 most of the patients reported gastrointestinal symptoms and also gastrointestinal adverse reactions, which however, showed a decrease from week 1 to weeks 2 and 3 in the diaries. Patient response to study medication was positive for patients completing the study. CONCLUSIONS Psyllium husk preparations may be a therapeutic option for patients with mild to moderately elevated cholesterol levels. Adverse gastrointestinal symptoms associated with the preparation appear to be transient in some of the patients. Compliance may be optimized with adequate patient counseling.