[Fasting: the Switch of Life-report on the 18th International Congress of the Medical Association for Fasting and Nutrition (ÄGHE)]. / Fasting: the Switch of Life ­ Tagungsbericht zum 18. Internationalen Kongress der Ärztegesellschaft Heilfasten und Ernährung e. V. (ÄGHE).

The international congress of the German Medical Association for Fasting and Nutrition (ÄGHE e. V.) was held in cooperation with the Maria Buchinger Foundation for the 18th time in June 2019 in Überlingen at Lake Constance. The congress offers a platform for physicians, fasting therapists, and all interested parties to exchange the latest scientific findings in fasting research. "Fasting: the Switch of Life" was the title of the congress, where well-known national and international fasting researchers spoke about health effects of fasting therapies, the indications and contraindications of fasting, and the latest biological, genetic, and neuroscientific findings related to it, such as protein diets and integrative fasting therapies. The religious and spiritual dimension of fasting were also considered in addition to the health-related aspects. Apart from the lectures and case reports, the aim of the congress was to discuss the current developments and challenges in fasting therapy with the participants.

The effects of short-term fasting on quality of life and tolerance to chemotherapy in patients with breast and ovarian cancer: a randomized cross-over pilot study.

BACKGROUND: This pilot trial aimed to study the feasibility and effects on quality of life (QOL) and well-being of short-term fasting (STF) during chemotherapy in patients with gynecological cancer. METHODS: In an individually-randomized cross-over trial patients with gynecological cancer, 4 to 6 planned chemotherapy cycles were included. Thirty-four patients were randomized to STF in the first half of chemotherapies followed by normocaloric diet (group A;n = 18) or vice versa (group B;n = 16). Fasting started 36 h before and ended 24 h after chemotherapy (60 h-fasting period). QOL was assessed by the FACIT-measurement system. RESULTS: The chemotherapy-induced reduction of QOL was less than the Minimally Important Difference (MID; FACT-G = 5) with STF but greater than the MID for non-fasted periods. The mean chemotherapy-induced deterioration of total FACIT-F was 10.4 ± 5.3 for fasted and 27.0 ± 6.3 for non-fasted cycles in group A and 14.1 ± 5.6 for non-fasted and 11.0 ± 5.6 for fasted cycles in group B. There were no serious adverse effects. CONCLUSION: STF during chemotherapy is well tolerated and appears to improve QOL and fatigue during chemotherapy. Larger studies should prove the effect of STF as an adjunct to chemotherapy. TRIAL REGISTRATION: This trial was registered at clinicaltrials.gov: NCT01954836 .

A non-interventional, observational study of a fixed combination of pepsin and amino acid hydrochloride in patients with functional dyspepsia.

BACKGROUND: Functional dyspepsia (FD) is a gastrointestinal disorder characterized by recurrent and diverse symptoms and pathophysiology that remains unexplained following routine clinical investigation. Enzynorm®f is a pharmaceutical preparation comprising fixed amounts of pepsin of biological origin and organically bound acid in the form of amino acid hydrochloride. It is traditionally used as a mild agent to support gastric function and to stimulate the stomach's proteolytic activities in FD. METHODS: In a non-interventional, observational, post-marketing surveillance study, patients with an established diagnosis of FD were treated with a fixed combination of pepsin and amino acid hydrochloride taken as tablets three times daily for 6 weeks. The primary objective of this study was to assess the change in symptoms using the validated Gastrointestinal Symptom Score (GIS©). Secondary objectives included patients' assessment of their gastrointestinal symptoms as well as treatment safety and tolerability. RESULTS: A total of 97 patients (mean age 58.4 ± 13.9 years; 63.2% females) were included in the study, with 72 data having GIS© score data at baseline and at 6 weeks, and 34 also at 3 weeks. The overall GIS© sum score decreased by 4.1 (p < 0.0001) from 11.6 (±4.8) at baseline to 7.4 (± 4.6) reflecting an improvement of clinical symptomatology after 6 weeks of treatment. In a subgroup of 70 patients who had FD meeting the Rome III criteria a GIS© score reduction of ≥50% was observed after 3 weeks treatment in 24% and in 30.8% after 6 weeks. Adverse events were mostly gastrointestinal in nature and consistent with the underlying disease; no unexpected adverse reactions were reported. Twenty-seven patients discontinued the study, mostly because of gastrointestinal symptoms. CONCLUSION: The results of this study support the efficacy of a fixed combination of pepsin and amino acid hydrochloride for the treatment of patients with FD and also suggest good to moderate treatment tolerability. These findings should be further explored in a randomised, placebo-controlled clinical trial. CLINICAL TRIAL REGISTRATION: This study has been retrospectively registered in the ClinicalTrials.gov registry, trial identifier NCT03076411 .

Safety and compliance of a complex homeopathic drug (Contramutan N Saft) in the treatment of acute respiratory tract infections: A large observational (non-interventional) study in children and adults focussing on homeopathy specific adverse reactions versus adverse drug reactions.

BACKGROUND: This non-interventional study was performed to generate data on safety and treatment effects of a complex homeopathic drug (Contramutan N Saft). PATIENTS AND METHODS: 1050 outpatients suffering from common cold were treated with the medication for 8days. The study was conducted in 64 outpatient practices of medical doctors trained in CAM. Tolerability, compliance and the treatment effects were assessed by the physicians and by patient diaries. Adverse events were collected and assessed with specific attention to homeopathic aggravation and proving symptoms. Each adverse effect was additionally evaluated by an advisory board of experts. RESULTS: The physicians detected 60 adverse events from 46 patients (4.4%). Adverse drug reactions occurred in 14 patients (1.3%). Six patients showed proving symptoms (0.57%) and only one homeopathic aggravation (0.1%) appeared. The rate of compliance was 84% in average for all groups and the global assessment of the treatment effects attributed to "good" and "very good" in 84.9% of all patients. CONCLUSIONS: The homeopathic complex drug was shown to be safe and effective for children and adults likewise. Adverse reactions specifically related to homeopathic principles are very rare. All observed events recovered quickly and were of mild to moderate intensity.

Echinacea Reduces Antibiotics by Preventing Respiratory Infections: A Meta-Analysis (ERA-PRIMA).

Respiratory tract infections (RTIs) are the leading cause of antibiotic prescriptions, primarily due to the risk for secondary bacterial infections. In this study, we examined whether Echinacea could reduce the need for antibiotics by preventing RTIs and their complications, and subsequently investigated its safety profile. A comprehensive search of EMBASE, PubMed, Google Scholar, Cochrane DARE and clinicaltrials.gov identified 30 clinical trials (39 comparisons) studying Echinacea for the prevention or treatment of RTIs in 5652 subjects. Echinacea significantly reduced the monthly RTI occurrence, risk ratio (RR) 0.68 (95% CI 0.61-0.77) and number of patients with ≥1 RTI, RR = 0.75 [95% CI 0.69-0.81] corresponding to an odds ratio 0.53 [95% CI 0.42-0.67]. Echinacea reduced the risk of recurrent infections (RR = 0.60; 95% CI 0.46-0.80), RTI complications (RR = 0.44; 95% CI 0.36-0.54) and the need for antibiotic therapy (RR = 0.60; 95% CI 0.39-0.93), with total antibiotic therapy days reduced by 70% (IRR = 0.29; 95% CI 0.11-0.74). Alcoholic extracts from freshly harvested Echinacea purpurea were the strongest, with an 80% reduction of antibiotic treatment days, IRR 0.21 [95% CI 0.15-0.28]. An equal number of adverse events occurred with Echinacea and control treatment. Echinacea can safely prevent RTIs and associated complications, thereby decreasing the demand for antibiotics. Relevant differences exist between Echinacea preparations.

International consensus on fasting terminology.

Although fasting is increasingly applied for disease prevention and treatment, consensus on terminology is lacking. Using Delphi methodology, an international, multidisciplinary panel of researchers and clinicians standardized definitions of various fasting approaches in humans. Five online surveys and a live online conference were conducted with 38 experts, 25 of whom completed all 5 surveys. Consensus was achieved for the following terms: "fasting" (voluntary abstinence from some or all foods or foods and beverages), "modified fasting" (restriction of energy intake to max. 25% of energy needs), "fluid-only fasting," "alternate-day fasting," "short-term fasting" (lasting 2-3 days), "prolonged fasting" (≥4 consecutive days), and "religious fasting." "Intermittent fasting" (repetitive fasting periods lasting ≤48 h), "time-restricted eating," and "fasting-mimicking diet" were discussed most. This study provides expert recommendations on fasting terminology for future research and clinical applications, facilitating communication and cross-referencing in the field.

A combination of Tropaeolum majus herb and Armoracia rusticana root for the treatment of acute bronchitis.

BACKGROUND: Tropaeolum majus herb (nasturtium) and Armoracia rusticana root (horseradish) produce three different isothiocyanates as secondary metabolites, which exert antibacterial, anti-inflammatory, and immune-modulatory functions in humans. PURPOSE: Combined in the medicinal product ANGOCIN® Anti-Infekt N, the two natural components demonstrated promising effects against acute bronchitis. STUDY DESIGN: A randomized, two-armed, placebo-controlled, double-blind, phase IV study revealed the healing fostering effect of the two herbal plant components METHODS: This study included 384 patients, with 195 in the treatment and 189 in the placebo group. The 'bronchitis severity score' (BSS) was utilized as primary endpoint. This score sums the ratings for five significant bronchitis symptoms, which are established at the patient's visits to the clinic. RESULTS: Compared to placebo intake, the group of patients treated with the phytomedicine showed statistically significant accelerated healing of bronchitis symptoms after three days of treatment, with reductions in coughing, mucous production, and chest pain. This beneficial effect persisted for the entire duration of treatment until day ten. CONCLUSION: In conclusion, a combination of Tropaeolum majus herb and Armoracia rusticana root promotes an elevated improvement of bronchitis symptomatology.

Echinacea as a Potential Force against Coronavirus Infections? A Mini-Review of Randomized Controlled Trials in Adults and Children.

Echinacea purpurea has been shown to broadly inhibit coronaviruses and SARS-CoV-2 in vitro. This review discusses the available clinical evidence from randomized, blinded and controlled human studies. Two RCTs capturing incidence of viral respiratory tract infections during Echinacea preventative treatment were identified including coronavirus infections. Incidence and/or viral loads were measured by RT-PCR and symptom severity was recorded. In a first study, Jawad et al. collected nasopharyngeal swabs from adults (N = 755) over 4 months of continuous prevention. Overall, 24 and 47 enveloped virus infections occurred, including 21 and 33 coronavirus detections (229E; HKU1; OC43) with Echinaforce® extract (2400 mg daily) and placebo, respectively (p = 0.0114). In a separate study, Ogal et al. administered the same extract (1200 mg) or control for 4 months to children (4-12 years) (N = 203). Echinacea reduced the incidence of enveloped virus infections from 47 to 29 (p = 0.0038) whereas 11 and 13 coronavirus detections (229E, OC43, NL63) were counted (p > 0.05). Respiratory symptoms during coronavirus infections were significantly lower with area-under-curve AUC = 75.8 (+/-50.24) versus 27.1 (+/-21.27) score points (p = 0.0036). Importantly, viral loads in nasal secretions were significantly reduced by 98.5% in the Echinacea group, with Ct-values 31.1 [95% CI 26.3; 35.9] versus 25.0 [95% CI 20.5; 29.5] in the control group (p = 0.0479). Results from clinical studies confirm the antiviral activity found for Echinacea in vitro, embracing enveloped respiratory pathogens and therefore coronaviruses as well. Substantiating results from a new, completed study seem to extrapolate these effects to the prevention of SARS-CoV-2 infections. As hypothesized, the established broad antiviral activity of Echinacea extract appears to be inclusive for SARS-CoV-2.

Echinacea Purpurea For the Long-Term Prevention of Viral Respiratory Tract Infections During Covid-19 Pandemic: A Randomized, Open, Controlled, Exploratory Clinical Study.

SARS-CoV-2 vaccination is effective in preventing severe Covid-19, but efficacy in reducing viral load and transmission wanes over time. In addition, the emergence of novel SARS-CoV-2 variants increases the threat of uncontrolled dissemination and additional antiviral therapies are urgently needed for effective containment. In previous in vitro studies Echinacea purpurea demonstrated strong antiviral activity against enveloped viruses, including SARS-CoV-2. In this study, we examined the potential of Echinacea purpurea in preventing and treating respiratory tract infections (RTIs) and in particular, SARS-CoV-2 infections. 120 healthy volunteers (m,f, 18-75 years) were randomly assigned to Echinacea prevention or control group without any intervention. After a run-in week, participants went through 3 prevention cycles of 2, 2 and 1 month with daily 2,400 mg Echinacea purpurea extract (Echinaforce®, EF). The prevention cycles were interrupted by breaks of 1 week. Acute respiratory symptoms were treated with 4,000 mg EF for up to 10 days, and their severity assessed via a diary. Naso/oropharyngeal swabs and venous blood samples were routinely collected every month and during acute illnesses for detection and identification of respiratory viruses, including SARS-CoV-2 via RT-qPCR and serology. Summarized over all phases of prevention, 21 and 29 samples tested positive for any virus in the EF and control group, of which 5 and 14 samples tested SARS-CoV-2 positive (RR = 0.37, Chi-square test, p = 0.03). Overall, 10 and 14 symptomatic episodes occurred, of which 5 and 8 were Covid-19 (RR = 0.70, Chi-square test, p > 0.05). EF treatment when applied during acute episodes significantly reduced the overall virus load by at least 2.12 log10 or approx. 99% (t-test, p < 0.05), the time to virus clearance by 8.0 days for all viruses (Wilcoxon test, p = 0.02) and by 4.8 days for SARS-CoV-2 (p > 0.05) in comparison to control. Finally, EF treatment significantly reduced fever days (1 day vs 11 days, Chi-square test, p = 0.003) but not the overall symptom severity. There were fewer Covid-19 related hospitalizations in the EF treatment group (N = 0 vs N = 2). EF exhibited antiviral effects and reduced the risk of viral RTIs, including SARS-CoV-2. By substantially reducing virus loads in infected subjects, EF offers a supportive addition to existing mandated treatments like vaccinations. Future confirmatory studies are warranted.

Therapeutic Phlebotomy in Patients with Grade 1 Hypertension: A Randomized-Controlled Trial.

Aim: Study aim was to investigate the effects of therapeutic phlebotomy on ambulatory blood pressure in patients with grade 1 hypertension. Methods: In this randomized-controlled intervention study, patients with unmedicated hypertension grade 1 were randomized into an intervention group (phlebotomy group; 500 mL bloodletting at baseline and after 6 weeks) and a control group (waiting list) and followed up for 8 weeks. Primary endpoint was the 24-h ambulatory mean arterial pressure between the intervention and control groups after 8 weeks. Secondary outcome parameters included ambulatory/resting systolic/diastolic blood pressure, heart rate, and selected laboratory parameters (e.g., hemoglobin, hematocrit, erythrocytes, and ferritin). Resting systolic/diastolic blood pressure/heart rate and blood count were also assessed at 6 weeks before the second phlebotomy to ensure safety. A per-protocol analysis was performed. Results: Fifty-three hypertension participants (56.7 ± 10.5 years) were included in the analysis (n = 25 intervention group, n = 28 control group). The ambulatory measured mean arterial pressure decreased by -1.12 ± 5.16 mmHg in the intervention group and increased by 0.43 ± 3.82 mmHg in the control group (between-group difference: -1.55 ± 4.46, p = 0.22). Hemoglobin, hematocrit, erythrocytes, and ferritin showed more pronounced reductions in the intervention group in comparison with the control group, with significant between-group differences. Subgroup analysis showed trends regarding the effects on different groups classified by serum ferritin concentration, body mass index, age, and sex. Two adverse events (AEs) (anemia and dizziness) occurred in association with the phlebotomy, but no serious AEs. Conclusions: Study results showed that therapeutic phlebotomy resulted in only minimal reductions of 24-h ambulatory blood pressure measurement values in patients with unmedicated grade 1 hypertension. Further high-quality clinical studies are warranted, as this finding contradicts the results of other studies.

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 AIM: Marine 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. DESIGN: Patients 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. RESULTS: 60 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. CONCLUSIONS: Incorporation 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 REGISTRATION: ClinicalTrials NCT01179971.

Seven-day fasting as a multimodal complex intervention for adults with type 1 diabetes: Feasibility, benefit and safety in a controlled pilot study.

OBJECTIVES: Intermittent as well as prolonged fasting are receiving considerable attention and appear favorable in conditions such as metabolic syndrome, type 2 diabetes, and rheumatic diseases. Fasting for individuals with type 1 diabetes (T1D) is generally considered too risky. However, the ability and possibility to change from carbohydrate- to ketone-based fuel supply might be relevant for individuals with T1D. The aim of this patient-led research was to investigate the feasibility, benefit, and safety of a 7-d multimodal fasting intervention in individuals with T1D. METHODS: This was a non-randomized controlled pilot study, with 20 participants with T1D and 10 without the disease. Data acquisition took place before, after, and 4 mo after the intervention and daily during intervention. RESULTS: Of the individuals with T1D, 19 finished fasting. A mean ß-hydroxybutyrate as representative ketone body increased to 2.8 ± 1.9 mmol/L on day 7; whereas average glucose remained between 4.9 (±1.5) and 7.5 (±2.3) mmol/L (89 ± 27 and 136 ± 40 mg/dL). Mean daily insulin dose was adjusted from 24.4 (3-50) IU on the day before fasting to 7.6 (0-26.7) IU on day 7. Quality of life (WHO-5) normalized from 54 (±4.4) to 68.8 (±15; P = 0.01) after fasting. There was a decrease from before until the follow-up 4 mo later of weight from 77.6 (±20.4) to 76.6 (±20.9) kg (P = 0.023) and for body mass index from 27.68 (±7.04) to 26.74 (±7.15) kg/m2 (P = 0.008). Diastolic blood pressure increased from 69.75 (±11.41) to 75.74 (±8.42) mm Hg (P = 0.028) and stayed in a healthy range on average. Fasting-related side effects were all temporary, and slightly more prevalent in those with type 1 diabetes compared with the reference group. CONCLUSIONS: This study demonstrated the feasibility, benefits, and safety aspects of a 7-d fast in adults with T1D.

Ketosis in patients undergoing medically supervised therapeutic fasting-results from an observational trial.

BACKGROUND/AIM: Medically supervised fasting has long tradition and broad acceptance in some European countries. The exact amount to which ketone bodies are produced as well as their possible contribution to beneficial effects in this procedure are open. METHODS: Open-label observational trial with in-patients undergoing medically supervised fasting with supplementation of approximately 40 g/d carbohydrates as part of an established routine care. Daily finger-stick blood samples for measurement of glucose and ß-hydroxybutyrate. Descriptive analysis for all data. RESULTS: Complete sets of data of 17 patients (5 m, mean age 63.1) could be evaluated. Mean concentrations of ß-hydroxybutyrate rose continuously to a mean maximum of 3.6 mmol/L with an individual maximum of 5.1 mmol/L, while glucose decreased within normal range. Two patients with type 2 diabetes produced significantly less ß-hydroxybutyrate. Courses for ß-hydroxybutyrate and glucose showed a weak inverse correlation, while no serious adverse effects could be observed. CONCLUSION: Medically supervised fasting with definite small amounts of carbohydrates by fluid intake may lead to limited increases of ketone bodies in their biopositive range, as known e.g. from epileptology or sports medicine. Clinical consequences deserve further research.

Effects of dietary protein-load and alkaline supplementation on acid-base balance and glucose metabolism in healthy elderly.

BACKGROUND/OBJECTIVES: Metabolism is controlled by macro- and micronutrients. Protein-rich diets should lead to latent acidosis at tissue level with further negative implications. Food supplements with alkaline salts are available and popular pretending to prevent these changes. SUBJECTS/METHODS: Within a randomised double-blind placebo-controlled trial we tested the hypotheses that (1) a 4-week protein-rich diet induces a latent tissue acidosis and (2) an alkaline supplement can compensate this. Acid-base balance and important metabolic parameters were determined before and after 4 weeks of supplementation by peripheral blood samples, indirect calorimetry and muscle microdialysis before and after a protein-rich test meal. RESULTS: Fourty volunteers were randomised 1:1 to either verum or placebo supplements. Protein-rich diet by itself did not significantly affect acid-base balance. Alkaline supplementation increased plasma bicarbonate concentration without changing pH. Postprandial increases in serum glucose and insulin tended to be lower for verum vs. placebo. Resting and postprandial energy metabolism, and carbohydrate and fat oxidation did not differ significantly before and after supplementation in both groups. In muscle, postprandial glucose uptake and aerobic glucose oxidation were significantly higher for verum. In addition, verum significantly increased serum magnesium concentrations. CONCLUSIONS: Four weeks of protein-rich diet did not significantly influence acid-base balance. However, alkaline supplementation improved systemic and tissue acid-base parameters and oxidative glucose metabolism.

Short-term fasting accompanying chemotherapy as a supportive therapy in gynecological cancer: protocol for a multicenter randomized controlled clinical trial.

BACKGROUND/OBJECTIVES: A few preliminary studies have documented the safety and feasibility of repeated short-term fasting in patients undergoing chemotherapy. However, there is a lack of data from larger randomized trials on the effects of short-term fasting on quality of life, reduction of side effects during chemotherapy, and a possible reduction of tumor progression. Moreover, no data is available on the effectiveness of fasting approaches compared to so-called healthy diets. We aim to investigate whether the potentially beneficial effects of short-term fasting can be confirmed in a larger randomized trial and can compare favorably to a plant-based wholefood diet. METHODS: This is a multicenter, randomized, controlled, two-armed interventional study with a parallel group assignment. One hundred fifty patients, including 120 breast cancer patients and 30 patients with ovarian cancer, are to be randomized to one of two nutritional interventions accompanying chemotherapy: (1) repeated short-term fasting with a maximum energy supply of 350-400 kcal on fasting days or (2) repeated short-term normocaloric plant-based diet with restriction of refined carbohydrates. The primary outcome is disease-related quality of life, as assessed by the functional assessment of the chronic illness therapy measurement system. Secondary outcomes include changes in the Hospital Anxiety and Depression Score and as well as frequency and severity of chemotherapy-induced side effects based on the Common Terminology Criteria of Adverse Events. Explorative analysis in a subpopulation will compare histological complete remissions in patients with neoadjuvant treatments. DISCUSSION/PLANNED OUTCOMES: Preclinical data and a small number of clinical studies suggest that repeated short-term fasting may reduce the side effects of chemotherapy, enhance quality of life, and eventually slow down tumor progression. Experimental research suggests that the effects of fasting may partly be caused by the restriction of animal protein and refined carbohydrates. This study is the first confirmatory, randomized controlled, clinical study, comparing the effects of short-term fasting to a short-term, plant-based, low-sugar diet during chemotherapy on quality of life and histological tumor remission. TRIAL REGISTRATION: ClinicalTrials.gov NCT03162289 . Registered on 22 May 2017.

The Relevance of Complementary and Integrative Medicine in the COVID-19 Pandemic: A Qualitative Review of the Literature.

Background: During the COVID-19 pandemic people are facing risks of adverse health effects due to the restrictions implemented such as quarantine measures, reduced social contact, and self-isolation. In this qualitative review, we collected data on potential preventive and therapeutic health benefits of Complementary and Integrative Medicine (CIM) that might be useful during the COVID-19 pandemic. We have reviewed the scientific literature to summarize CIM practices that could be beneficial for improving physical and mental health and well-being of the population under the current pandemic circumstances. It must be noted that this review is not SARS-CoV-2 specific and we explicitly do not intend to make any SARS-CoV-2 specific health claims in this article. Methods and Findings: A qualitative, non-systematic literature review was conducted in Medline to identify literature describing preventive and therapeutic CIM approaches for strengthening mental and physical health. For a variety of CIM approaches clinical evidence was identified, indicating beneficial effects. CIM approaches include specific dietary measures and selected micronutrients, physical activity, techniques from Mind-Body Medicine, single botanicals or botanical compounds, and spending time in nature among others. The effects of CIM measures on conditions like obesity and hypertension are of special relevance here, as these conditions are considered as risk factors for a severe course of COVID-19. Moreover, a possibly direct effect of CIM approaches on immune functions and clinical parameters in respiratory tract infections, such as influenza, were identified. The findings of this review could be helpful for clinicians, patients, and the general population during the current pandemic when discussing and/or considering CIM options. Conclusions: CIM offers a variety of preventive and therapeutic options for strengthening physical and mental resilience, which could also be useful in the current COVID-19 pandemic. The evidence of CIM approaches with a potential benefit in the COVID-19 pandemic in different areas is worth to be analyzed. While this qualitative review has several obvious limitations, it might serve as useful starting point for further research on this topic.

Partial Body UV Exposure in Chronic Kidney Disease and Extrarenal Vitamin D Metabolism.

BACKGROUND/AIM: Exposure of the skin to sunshine is the major natural source of vitamin D. In order to imitate this natural production of vitamin D for patients with chronic kidney disease, hemodialysis patients were exposed three times a week to radiation of the front part of both legs to normalize the vitamin D status. PATIENTS AND METHODS: Partial body UVB irradiation was performed during the routine dialysis session. Twenty-two patients took part, with a mean age of 61.7 (range=35-81) years. RESULTS: Serum levels of 25(OH)D3 and 1,25(OH)2D3 increased into the mid normal range. Intact parathyroid hormone decreased by 25% and osteocalcin by 45%. 24-Hour blood-pressure monitoring demonstrated decreases in systolic and diastolic blood pressure. CONCLUSION: Partial body exposure to UVB radiation normalized not only the serum level of 25(OH)D3, but also that of 1,25(OH)2D3, which resulted in a significant decrease in parathyroid hormone, osteocalcin levels, and also in blood pressure. Sunshine imitating UVB exposure utilizes the capacity of the skin to convert extrarenally vitamin D3 to 25(OH)D3 and 1,25(OH)2D3.

A nonrandomized controlled clinical pilot trial on 8 wk of intermittent fasting (24 h/wk).

OBJECTIVE: The aim of the study was to evaluate whether intermittent fasting (IF) is an effective preventive measure, and whether it is feasible for healthy volunteers under every day conditions. METHODS: A nonrandomized controlled clinical trial on IF was performed with healthy volunteers over a period of 8 wk, and a subsequent 4-mo follow-up. Outcomes were assessed at baseline, after 8 wk, and after 6 mo. Volunteers who were not interested in fasting served as a control group. Participants in the fasting group were asked to continue their regular nutritional habits on the nonfasting days, whereas the control group maintained their habitual nutrition throughout the whole period. Outcomes included changes of metabolic parameters (insulin, glucose, insulin resistance, insulin-like growth factor-1, brain-derived neurotropic factor, lipids, liver enzymes, hemoglobin A1c) and coagulation markers; bioelectrical impedance analysis; body mass index; abdominal girth; blood pressure; general quality of life (five-item World Health Organization Well-Being Index [WHO-5] questionnaire), as well as mood and anxiety (Hospital Anxiety and Depression Scale [HADS], Profile of Mood States, Flourishing-Scale, visual analog scale, Likert scales). The intervention consisted of a fasting day, which was repeated every week for 8 wk, with abstinence from solid food between 00:00 and 23:59 at minimum and a maximum caloric intake of 300 kcal on each fasting day. A per-protocol analysis was performed. P < 0.05 was considered significant. RESULTS: Thirty-six volunteers were included; 22 allocated themselves to the fasting group, and 14 to the control group. Thirty-three data sets were included in the final analysis. Although significant in-group changes were observed in both groups for a number of outcomes after 8 wk and 6 mo, no significant between-group differences were observed for any outcome other than overall body fat mass after 8 wk as well as for the HADS total score and the WHO-5 total score after 6 mo, all in favor of the fasting group. However, none of the between-group differences were clinically relevant. CONCLUSIONS: We did not find any clinically relevant differences between groups in this controlled clinical pilot trial of 8 wk of IF in healthy volunteers. Further clinical research in this field is warranted to further analyze mechanisms and effects of IF.

The Effectiveness of Leech Therapy in Chronic Low Back Pain.

BACKGROUND: Leech therapy has been found to be effective in the treatment of a number of chronic musculoskeletal pain syndromes. Leeches are also often used empirically to treat chronic low back pain, but data from clinical trials have been lacking to date. We therefore conducted the first randomized trial of leech therapy for chronic low back pain. METHODS: Patients with chronic low back pain were randomized to receive either a single session of local treatment with 4-7 leeches or four weekly sessions of exercise therapy (1 hour each) led by a physical therapist. The primary endpoint was a change in average back pain intensity, as measured using a 100-mm visual analog scale (VAS), after 28 days. Secondary end- points included functional impairment (Roland-Morris Disability Questionnaire, Hannover Functional Ability Questionnaire), quality of life (Short-Form Health Questionnaire [SF 36]), pain perception (pain perception scale = Schmerzempfindungsskala [SES]), depressivity (Center for Epidemiological Studies Depression Scale [CES-D]), and analgesic consumption (questionnaire/ diary). Trial visits took place before treatment and on days 28 ± 3 and 56 ± 5 after the start of treatment; the overall duration of the trial was 56 ± 5 days. RESULTS: The mean low back pain score improved from 61.2 ± 15.6 before treatment to 33.1 ± 22.4 on day 28 in the leech ther- apy group (n = 25) and from 61.6 ± 14.8 to 59.8 ± 16.7 in the exercise therapy group (n = 19) (group difference -25.2; 95% con- fidence interval [-41.0; -9.45]; p = 0.0018). Significant benefits of leech therapy were also found at both time points with respect to physical impairment and function as well as physical quality of life. The patients' expectations from treatment were higher in the leech therapy group but did not significantly affect the findings. CONCLUSION: A single session of leech therapy is more effective over the short term in lowering the intensity of pain over the short term and in improving physical function and quality of life over the intermediate term (4 weeks and 8 weeks, respectively). The limitations of this trial are the lack of blinding and the small number of patients. Leech therapy appears to be an effective treat- ment for chronic low back pain.