Qigong versus exercise therapy for chronic low back pain in adults--a randomized controlled non-inferiority trial.

BACKGROUND: The value of qigong in the treatment of chronic low back pain is unclear. In a randomized controlled trial, we evaluated whether qigong is non-inferior to exercise therapy in patients with chronic low back pain. METHODS: German outpatients (aged 46.7 ± 10.4) with chronic low back pain [mean visual analogue scale (VAS), 53.9 ± 12.5 mm] were enrolled and randomly allocated in a 1:1 ratio to receive either qigong (64 patients, 12 sessions with 1 × 90 min/week over 3 months) or exercise therapy (63 patients, 12 sessions 1 × 60 min/week). The primary outcome measure was the average pain intensity over the last 7 days on a VAS (0-100 mm, 0 = no pain, 100 = worst imaginable pain, non-inferiority margin = 5 mm) after 3 months. Follow-up was measured after 6 and 12 months. RESULTS: The mean adjusted low back pain intensity after 3 months was 34.8 mm [95% confidence interval (CI) 29.5; 40.2] in the qigong group and 33.1 mm (95% CI 27.7; 38.4) in the exercise group. Non-inferiority of the qigong group compared with the exercise group failed to show statistical significance (p = 0.204). In both groups, 10 patients reported suspected adverse reactions (e.g., muscle soreness, dizziness, pain) the total number was comparable in both groups (qigong n = 40, exercise n = 44). CONCLUSIONS: Qigong was not proven to be non-inferior to exercise therapy in the treatment of chronic low back pain. Its role in the prevention of chronic low back pain might be addressed in further studies.

Mode of action of cupping--local metabolism and pain thresholds in neck pain patients and healthy subjects.

OBJECTIVES: Cupping worldwide has been part of traditional medicine systems and is in the western world used as CAM therapy mainly for treating pain syndromes. The mode of action is up to now unclear. In order to investigate its mechanism we measured in parallel metabolic changes in the tissue under the cupping glass and pressure pain thresholds. DESIGN AND INTERVENTIONS: In 12 volunteers (6 healthy subjects and 6 patients with chronic neck pain) a microdialysis system was implanted subcutaneously on both sides (left and right) above the trapezius muscle. After baseline measures cupping was performed at one randomly selected side (left or right), the other side served as control. Every 20 min during baseline measures and for 280 min after cupping, microdialysis probes for detection of lactate, pyruvate, glucose and glycerin were taken. In addition, pain thresholds were measured before and after cupping with algometry. RESULTS: Cupping resulted in a strong increase of lactate (beginning 160 min after cupping until the end of the measurements) and the lactate/pyruvate ratio, indicating an anaerobe metabolism in the surrounding tissue. Baseline pain thresholds were non-significantly lower in neck pain patients compared to healthy controls and slightly increased immediately after cupping (p<0.05 compared to baseline close to the area of cupping in healthy subjects and on the foot in neck pain patients). After 280 min no more significant changes of pain thresholds were detected. CONCLUSIONS: Cupping induces >280 min lasting anaerobe metabolism in the subcutaneous tissue and increases immediate pressure pain thresholds in some areas.

Chemotherapy-induced peripheral neuropathy in cancer patients: a four-arm randomized trial on the effectiveness of electroacupuncture.

Purpose. Chemotherapy-induced peripheral neuropathy (CIPN) is a common and dose-limiting side effect of cytostatic drugs. Since there are no proven therapeutic procedures against CIPN, we were interested to define the role of electroacupuncture (EA) from which preliminary data showed promising results. Methods. In a randomized trial with a group sequential adaptive design in patients with CIPN, we compared EA (LV3, SP9, GB41, GB34, LI4, LI11, SI3, and HT3; n = 14) with hydroelectric baths (HB, n = 14), vitamin B1/B6 capsules (300/300 mg daily; VitB, n = 15), and placebo capsules (n = 17). The statistical power in this trial was primarily calculated for proving EA only, so results of HB and VitB are pilot data. Results. CIPN complaints improved by 0.8 ± 1.2 (EA), 1.7 ± 1.7 (HB), 1.6 ± 2.0 (VitB), and 1.3 ± 1.3 points (placebo) on a 10-point numeric rating scale without significant difference between treatment groups or placebo. In addition no significant differences in sensory nerve conduction studies or quality of life (EORTC QLQ-C30) were found. Conclusions. The used EA concept, HB, and VitB were not superior to placebo. Since, contrary to our results, studies with different acupuncture concepts showed a positive effect on CIPN, the effect of acupuncture on CIPN remains unclear. Further randomized, placebo controlled studies seem necessary. This trial is registered with DRKS00004448.

Stimulation of gastric slow waves with manual acupuncture at acupuncture points ST36 and PC6--a randomized single blind controlled trial.

BACKGROUND: To investigate the effects of stimulated and non-stimulated manual acupuncture at ST36 and PC6 on gastric myoelectrical activity and autonomic function. METHODS: A total of 65 healthy volunteers were randomly assigned to a 1: 1: 2 ratio to receive either 15 min of verum acupuncture (VA) with stimulation followed by 15 min of VA without stimulation (nsVA), or 15 min of nsVA followed by 15 min of VA with stimulation (sVA), or 30 min of sham acupuncture (SA). Measures of autonomic function included electrogastrogram, electrocardiogram, impedance cardiography and assessment of blood pressure, breathing frequency, and electrodermal activity. Outcome parameters were compared between VA and SA, and between sVA and nsVA. The percentage of regular gastric slow waves (normogastria) was defined as the primary outcome. KEY RESULTS: The percentage of normogastria was not significantly different between VA and SA. Differences in secondary outcomes such as power spectrum of gastric slow waves and heart rate variability parameters were pronounced in the comparison of sVA and nsVA. During sVA, the percentage of normogastria was lower (P = 0.005), the percentage of bradygastria was higher (P = 0.003) and power ratio was higher (P < 0.001), systolic blood pressure was lower (P = 0.039) and RMSSD was higher (P < 0.001) as compared with nsVA. CONCLUSIONS & INFERENCES: Our study suggests that manual stimulation of acupuncture needles at ST36 and PC6 affects gastric myoelectrical as well as cardiac activities in healthy volunteers. The effect of stimulation in acupuncture deserves further investigation.

Reporting experiments in homeopathic basic research-description of the checklist development.

The objective of this study was to develop a criteria catalogue serving as a guideline for authors to improve quality of reporting experiments in basic research in homeopathy. A Delphi Process was initiated including three rounds of adjusting and phrasing plus two consensus conferences. European researchers who published experimental work within the last 5 years were involved. A checklist for authors provide a catalogue with 23 criteria. The "Introduction" should focus on underlying hypotheses, the homeopathic principle investigated and state if experiments are exploratory or confirmatory. "Materials and methods" should comprise information on object of investigation, experimental setup, parameters, intervention and statistical methods. A more detailed description on the homeopathic substances, for example, manufacture, dilution method, starting point of dilution is required. A further result of the Delphi process is to raise scientists' awareness of reporting blinding, allocation, replication, quality control and system performance controls. The part "Results" should provide the exact number of treated units per setting which were included in each analysis and state missing samples and drop outs. Results presented in tables and figures are as important as appropriate measures of effect size, uncertainty and probability. "Discussion" in a report should depict more than a general interpretation of results in the context of current evidence but also limitations and an appraisal of aptitude for the chosen experimental model. Authors of homeopathic basic research publications are encouraged to apply our checklist when preparing their manuscripts. Feedback is encouraged on applicability, strength and limitations of the list to enable future revisions.

Reporting experiments in homeopathic basic research (REHBaR)--a detailed guideline for authors.

BACKGROUND: Reporting experiments in basic research in homeopathy is an important issue as comprehensive description of what exactly was done is required. So far, there is no guideline for authors available, unlike criteria catalogues common in clinical research. METHODS: A Delphi Process was conducted, including a total of five rounds, three rounds of adjusting and phrasing plus two consensus conferences. European researchers who published experimental work within the last five years were involved. RESULTS: A checklist of 23 items was obtained and supplemented with detailed examples emphasizing what each item implies. Background, objectives and possible hypotheses should be given in the part 'introduction'. Special emphasis is put on the 'materials and methods' section, where a detailed description of chosen controls, object of investigation, experimental setup, replication, parameters, intervention, allocation, blinding, and statistical methods is required. The section 'results' should present sufficient details on analysed data, descriptive as well as inferential. Authors should discuss their results and give an interpretation in the context of current evidence. CONCLUSION: A guideline for Reporting Experiments in Homeopathic Basic Research (REHBaR) was compiled to be applied by authors when preparing their manuscripts, and to be used by scientific journals in the reviewing process. Furthermore the guideline is a commitment to a certain minimum quality level needed in basic research, e.g. blinding and randomisation. Feedback is encouraged on applicability, strength and limitations of the list to enable future revisions.

Artichoke leave extract for chronic hepatitis C - a pilot study.

BACKGROUND: Artichoke leave extracts (ALE) have hepatoprotektive properties and are used by patients with chronic liver disease. Effects in patients with chronic hepatitis C are unclear. METHODS: 17 patients with chronic hepatitis C and persistently elevated aminotransferase levels were treated for 12 weeks with 3200mg standardized ALE per day. Primary outcome parameter was the rate of alanine aminotransferase (ALT) normalisation after 12 weeks. Secondary parameters were the course of ALT, aspartate aminotransferase and gamma glutamyltransferase levels, quantitative HCV RNA, subjective symptoms frequently associated with chronic hepatitis C (fatigue, discomfort upper abdomen, joint problems) and safety. RESULTS: None of the patients had normalized ALT levels after 12 weeks of treatment. There was no significant change of aminotransferase levels or viral load compared to baseline levels. Fatigue and joint problems significantly improved after 4 weeks of treatment. However, after 12 weeks, there was no significant difference to baseline. Tolerability of ALE was rated as good to excellent. Severe side effects did not occur. CONCLUSION: ALE seem not to be effective to improve aminotransferase levels in patients with chronic hepatitis C.

Homeopathic treatment of patients with psoriasis--a prospective observational study with 2 years follow-up.

Design Prospective multicentre observational study. Objective To evaluate details and effects of homeopathic treatment in patients with psoriasis in usual medical care. Methods Primary care patients were evaluated over 2 years using standardized questionnaires, recording diagnoses and complaints severity, health-related quality of life (QoL), medical history, consultations, all treatments, and use of other health services. Results Forty-five physicians treated 82 adults, 51.2% women, aged 41.6 +/- 12.2 (mean +/- SD) years. Patients had psoriasis for 14.7 +/- 11.9 years; 96.3% had been treated before. Initial case taking took 127 +/- 47 min. The 7.4 +/- 7.4 subsequent consultations (duration: 19.4 +/- 10.5 min) cumulated to 169.0 +/- 138.8 min. Patients received 6.0 +/- 4.9 homeopathic prescriptions. Diagnoses and complaints severity improved markedly with large effect sizes (Cohen's d= 1.02-2.09). In addition, QoL improved (SF-36 physical component score d = 0.26, mental component score d = 0.49), while conventional treatment and health service use were considerably reduced. Conclusions Under classical homeopathic treatment, patients with psoriasis improved in symptoms and QoL.

The conclusions on the effectiveness of homeopathy highly depend on the set of analyzed trials.

OBJECTIVE: Shang's recently published meta-analysis on homeopathic remedies (Lancet) based its main conclusion on a subset of eight larger trials out of 21 high quality trials (out of 110 included trials). We performed a sensitivity analysis on various other meaningful trial subsets of all high quality trials. STUDY DESIGN: Subsets were defined according to sample size, type of homeopathy, type of publication, and treated disease/condition. For each subset, we estimated the overall odds ratios (ORs) from random effect meta-analyses. RESULTS: All trials were highly heterogeneous (I2=62.2%). Homeopathy had a significant effect beyond placebo (OR=0.76; 95% CI: 0.59-0.99; p=0.039). When the set of analyzed trials was successively restricted to larger patient numbers, the ORs varied moderately (median: 0.82, range: 0.71-1.02) and the P-values increased steadily (median: 0.16, range: 0.03-0.93), including Shang's results for the eight largest trials (OR=0.88, CI: 0.66-1.18; P=0.41). Shang's negative results were mainly influenced by one single trial on preventing muscle soreness in 400 long-distance runners. CONCLUSIONS: The meta-analysis results change sensitively to the chosen threshold defining large sample sizes. Because of the high heterogeneity between the trials, Shang's results and conclusions are less definite than had been presented.

Homeopathic arnica therapy in patients receiving knee surgery: results of three randomised double-blind trials.

OBJECTIVES: We investigated the effectiveness of homeopathic Arnica montana on postoperative swelling and pain after arthroscopy (ART), artificial knee joint implantation (AKJ), and cruciate ligament reconstruction (CLR). DESIGN: Three randomised, placebo-controlled, double-blind, sequential clinical trials. SETTING: Single primary care unit specialised in arthroscopic knee surgery. PARTICIPANTS: Patients suffering from a knee disease that necessitated arthroscopic surgery. INTERVENTIONS: Prior to surgery, patients were given 1 x 5 globules of the homeopathic dilution 30x (a homeopathic dilution of 1:10(30)) of arnica or placebo. Following surgery, 3 x 5 globules were administered daily. PRIMARY OUTCOME MEASURES: The primary outcome parameter was difference in knee circumference, defined as the ratio of circumference on day 1 (ART) or day 2 (CLR and AKJ) after surgery to baseline circumference. RESULTS: A total of 227 patients were enrolled in the ART (33% female, mean age 43.2 years;), 35 in the AKJ (71% female, 67.0 years), and 57 in the CLR trial (26% female; 33.4 years). The percentage of change in knee circumference was similar between the treatment groups for ART (group difference Delta=-0.25%, 95% CI: -0.85 to 0.41, p=0.204) and AKJ (Delta=-1.68%, -4.24 to 0.77, p=0.184) and showed homeopathic arnica to have a beneficial effect compared to placebo in CLR (Delta=-1.80%, -3.30 to -0.30, p=0.019). CONCLUSIONS: In all three trials, patients receiving homeopathic arnica showed a trend towards less postoperative swelling compared to patients receiving placebo. However, a significant difference in favour of homeopathic arnica was only found in the CLR trial.

Autologous whole blood injections to patients with chronic urticaria and a positive autologous serum skin test: a placebo-controlled trial.

BACKGROUND: Patients with chronic urticaria (CU) frequently exhibit positive skin test reactions to autologous serum (ASST). Therapies aimed at inducing tolerance to circulating histamine-releasing factors in ASST+ CU patients, e.g. by treatment with autologous whole blood (AWB), have not yet been tested. OBJECTIVE: To test whether ASST+ CU patients can benefit from repeated low-dose intramuscular injections of AWB. METHODS: We characterized CU severity and duration, anti-Fc(epsilon)RI and anti-IgE expression, use of antihistamines, and quality of life in 56 CU patients (ASST+: 35, ASST-: 21) and assessed the therapeutic effects of 8 weekly AWB injections in a randomized, placebo-controlled, single-blind, parallel-group trial. RESULTS: Numbers, size, intensity, and/or duration of CU symptoms, quality of life, as well as expression of anti-Fc(epsilon)RI or anti-IgE were similar in ASST+ and ASST- CU patients. However, CU in ASST+ patients was of longer duration and required markedly more antihistaminic medication. Interestingly, ASST+ patients, but not ASST- patients, showed significantly (1) reduced CU activity, (2) decreased use of antihistamines, and (3) improved quality of life after AWB treatment. Placebo treatment was ineffective in both groups, but differences of AWB and placebo treatment responses did not achieve statistical significance in either group, most likely due to the limited number of patients treated. CONCLUSION: Our findings suggest that ASST+ CU is clinically different from other CU subforms and that ASST+ CU patients can benefit from AWB therapy.

Mistletoe treatment induces GM-CSF- and IL-5 production by PBMC and increases blood granulocyte- and eosinophil counts: a placebo controlled randomized study in healthy subjects.

OBJECTIVE: Various immunological effects have been reported during application of mistletoe preparations. Because these data are heterogeneous, we performed a placebo controlled study to investigate (1) effects on peripheral granulocyte and eosinophil counts, (2) related cytokine levels and (3) whether effects are related to mistletoe lectin (ML). METHODS: 43 volunteers were randomized to receive the mistletoe plant extract Iscador Quercus spezial (IQ), purified ML, IQ which was depleted from ML, or placebo subcutaneously twice per week for 8 weeks. Weekly, differential blood count and every four weeks spontaneous and IQ- and ML-induced cytokine production by peripheral blood mononuclear cells (PBMC) were analyzed. RESULTS: Leukocyte-, granulocyte-, and eosinophil counts were significantly higher during treatment in the IQ- and ML-groups than in the placebo group. Furthermore, a significant increase of antigen-induced production of GM-CSF, IL-5 and IFNgamma by PBMC was observed in the IQ- and ML-group but not in the groups receiving ML-depleted IQ or placebo. Severe side effects did not occur in any of the subjects. CONCLUSIONS: Treatment with IQ or ML stimulates the production of GM-CSF, IL-5 and IFNgamma by PBMC, and this is accompanied by an increase of eosinophil- and granulocyte-counts. These observations may, therefore, open rational therapeutic indications for mistletoe extracts.

Oral silymarin for chronic hepatitis C - a retrospective analysis comparing three dose regimens.

To investigate the effects of silymarin on aminotransferase levels in patients with chronic hepatitis C, a standardized treatment with 420mg, 840mg or 1260mg per day was performed in patients of our clinic, who were not eligible for treatment with pegylated interferon and ribavirin. Aminotransferase levels were determined before, at 3-6 week intervals during and at the end of treatment. Predefined inclusion criteria for the retrospective analysis were persistently elevated alanine aminotransferase (ALT) levels (at least 6 months prior to and at beginning of the treatment) and treatment duration of at least three weeks. Liver cirrhosis CHILD B or C, interferon therapy within the last three months before treatment with silymarin, alcohol use >30 g/d, coinfection with hepatitis B virus or other severe diseases were exclusion criteria. According to these criteria 40 patients (13 with 420mg, 20 with 840mg and 7 with 1260mg silymarin per day) were eligible for the analysis. The mean treatment period was 125 +/- 78 days. ALT, aspartate aminotransferase and gamma glutamyltransferase levels did not change significantly from baseline in any group and there were no differences between the treatment groups. Bilirubin and prothrombine time were normal in all but one patient and remained unchanged. Silymarin therapy had no side effects. Silymarin at the doses used, does not improve elevated aminotransferases in patients with chronic hepatitis C.

Patients' assessments of the effectiveness of homeopathic care in Norway: a prospective observational multicentre outcome study.

OBJECTIVE: To evaluate the patient reported effects of homeopathic care 6 months after first consultations. METHODS: Prospective uncontrolled observational multicentre outcome study. All patients visiting 80 homeopaths all over Norway for the first time in eight different time periods from 1996 to 1998 were approached. Patients wrote down their main complaint and scored its impact on daily living on a 100 mm Visual Analogue Scale (VAS) at the first consultation. Six months later they were asked to score again. The homeopaths recorded treatments given for up to two follow-up consultations. MAIN OUTCOME MEASURE: Predefined as a reduction of at least 10 mm in the VAS score between the first consultation and follow-up. RESULT: Patients 1097 were recruited, 654 completed the follow-up questionnaire. The main complaint improved by at least 10mm on the VAS for 71% (95% confidence interval 67-74%) of patients. The average reduction was 32mm (95% CI 30-35 mm). Fifty-one per cent (95% CI 48-55%) of the patients had an improvement in their general well being of more than 10 mm. The mean reduction in the whole group was 14mm (95% CI 12-16 mm). The proportion of patients using conventional medication reduced from 39% to 16%. Regression analysis showed that lower age and higher baseline score were predictors of better outcome. CONCLUSION: In this study, seven out of ten patients visiting a Norwegian homeopath reported a meaningful improvement in their main complaint 6 months after the initial consultation.

Coping strategies and the request for a consultation on complementary and alternative medicine -- a cross-sectional survey of patients in a psychosomatic and three medical departments of a german university hospital.

OBJECTIVE: To identify factors, predicting which patients of a large German university hospital request for a consultation on complementary and alternative medicine (CAM). PATIENTS AND METHODS: 350 patients of 3 medical and a psychosomatic department of the University Hospital Freiburg were consecutively surveyed with respect to their coping strategies, health locus of control, anxiety, depression, and the request for a consultation on CAM. Predicting factors were identified via logistic regression models. RESULTS: The request for a CAM consultation was primarily determined by an active coping strategy (odds ratio 1.66, 95% confidence interval 1.27-2.17, p = 0.0002) and a low Karnofsky index (odds ratio 0.79, 95% confidence interval 0.62-0.99, p = 0.0417). Anxiety, depression or internal health locus of control correlated with each other but could not be proved as independent factors for the request for a CAM consultation. CONCLUSION: Patients of a university hospital with an active disease coping have a need for information about CAM.

Diagnoses and treatment in homeopathic medical practice.

BACKGROUND: Despite increasing interest in complementary medicine worldwide, there has been no systematic large-scale documentation of medical homeopathic care. OBJECTIVE: We therefore conducted a prospective cohort study aimed at characterizing patients seeking homeopathic care and their treatment. PATIENTS AND METHODS: From September 1997 to June 1999, patients of all age groups who were visiting a homeopathic care center for the first time were included consecutively in the study and followed up for 24 months. Diagnostic procedures and prescriptions were documented using specific case report forms. MAIN OUTCOME MEASURES: Diagnoses (ICD-9), medical history, consultations, and prescriptions. RESULTS: A total of 3,981 patients were included in the study, 2,851 adults (29% men, mean age 42.5 +/- 13.1 years; 71% women, 39.9 +/- 12.4 years) and 1,130 children (52% boys, 6.5 +/- 3.9 years; 48% girls, 7.0 +/- 4.3 years). Almost all patients suffered from chronic conditions for 10.3 +/- 9.8 (adults) and 4.3 +/- 3.7 years (children). The most frequent diagnoses were allergic rhinitis in adult males, headache in adult females, and atopic dermatitis in children (both genders). The typical homeopathic initial consultations took 117 +/- 43 minutes for adults and 86 +/- 36 minutes for children, not varying much between primary diagnoses. In the observed 2 years the patients had on average 8.6 +/- 9.3 (adults) and 8.9 +/- 9.6 (children) consultations, approximately 50% each by telephone and face-to-face. Physicians most often prescribed the classical 'great' remedies (like sepia, sulfur, natrium mur., lycopodium), but in total, nearly 600 different homeopathic remedies were used. CONCLUSIONS: Our study provides a wealth of data on the medical practice of classical homeopathy. In terms of treatment, polychrests are used frequently, although it should be noted that a large proportion of patients received 'small remedies' instead. Most patients are treated for chronic diseases. The present results will, in concert with follow-up outcome analysis, aid in determining the effectiveness of medical homeopathic practice.

Pretreatment with thyroxine (10-(8) parts by weight) enhances a 'curative' effect of homeopathically prepared thyroxine (10-(13)) on lowland frogs.

We studied the influence of a moderate homeopathically prepared thyroxine dilution (final concentration in the basin water 10-(13) parts by weight) on the metamorphosis of lowland Rana temporaria which had been hyperstimulated with thyroxine. Two groups of animals were pretreated by immersing them in a molecular thyroxine dilution (10-(8) parts by weight). This pretreatment speeds up development, as is well known. In accordance with the homeopathic/isopathic idea of detoxication or cure, the same hormone was then diluted and agitated in successive steps for further treatment. This homeopathically prepared dilution was administered at 24-hour intervals to one of the groups. An analogously prepared blank solution was used for the control group. Our hypothesis, which was derived from earlier studies, was that animals treated with the test solution would metamorphose more slowly than the control animals, i.e. that the homeopathically prepared thyroxine would have a 'curative' effect. In this new series of experiments this hypothesis was examined by 3 independent researchers. In the experiments carried out by 2 of the 3 researchers the number of animals that reached the four-legged stage at defined points in time was smaller in the group treated with homeopathically prepared thyroxine. In the third laboratory no difference was found between the groups. However, the overall inhibiting effect was statistically significant and more pronounced than in earlier, less promising studies and in parallel experiments in which nonprestimulated animals had been used. Other studies carried out by the 3 researchers involved animals from highland biotopes, where the natural environment probably induces a greater sensitivity towards thyroxine or higher thyroxine levels. These animals reacted to the homeopathically prepared thyroxine with a slowing down of metamorphosis, even when they had not been prestimulated with a molecular dose of the hormone. This effect was observed in all 3 laboratories and is consistent with the results of previous studies.

Effects of short-term modified fasting on sleep patterns and daytime vigilance in non-obese subjects: results of a pilot study.

BACKGROUND: Periodically repeated short-term fasting is a frequently practised tradition worldwide. Empirical reports suggest that during fasting periods the quality of sleep and daytime performance are improved. The effects of a home-based 1-week modified fasting on sleep patterns and daytime vigilance and performance were analysed in 15 healthy non-obese volunteers. METHODS: Sleep was measured by polysomnography before and after a 7-day fasting period; sleep inventories with assessment of daytime performance were collected throughout the observation period. Blood samples and urine were drawn at the beginning and at the end of fasting. RESULTS: 13 subjects (12 females, 1 male; age 41.2 +/- 13.4 years; BMI 23.9 +/- 4.2 kg/m(2)) completed the fasting period; weight decreased from 66.5 +/- 11.7 kg to 63 +/- 11.9 kg. Compared to baseline, a significant decrease in arousals, a decrease in periodic leg movements (PLM) and a non-significant increase in REM sleep were observed at the end of fasting. Subjective sleep ratings showed a fasting-induced increase in global quality of sleep, daytime concentration, vigour and emotional balance. Clinical laboratory tests showed a decrease in serum magnesium; urinary melatonin excretion decreased moderately. CONCLUSION: This open pilot study demonstrates that along with a decrease in sleep arousals a 1-week fasting period promotes the quality of sleep and daytime performance in non-obese subjects. The observed decrease in PLM might point to a nutritional modification of brain dopaminergic functions. In terms of evolutionary development, an improved daytime performance during periods of food deprivation could have been beneficial for the success in search for food.

Effects of one week juice fasting on lipid metabolism: a cohort study in healthy subjects.

OBJECTIVE: We investigated the effects of a popular modified juice fasting program on lipid metabolism. VOLUNTEERS AND METHODS: 5 healthy, nonobese, male volunteers fasted for 8 days. Daily energy intake was limited to 150-300 kcal/d solely as carbohydrates (vegetable and fruit drinks). Physical activity was maintained as before. At baseline, on days 2, 3, and 8 during fasting, and on days 2 and 8 after fasting, serum lipids, lipoproteins, and insulin were investigated. RESULTS: Juice fasting resulted in bi-phasic changes: Until day 2 and 3 triacylglycerols (TG), very low-density lipoprotein apolipoprotein B (VLDL apo B), and insulin decreased by 52, 51, and 65% respectively, while nonesterified fatty acids (NEFA), low-density lipoprotein (LDL) apo B, and LDL cholesterol increased by 363, 38, and 35%. Between day 3 and 8 NEFA increased; TG and insulin increased as well, but remained below baseline values, and LDL cholesterol normalized. After 8 days juice fasting significant changes (p < 0.05) compared to the baseline were found only for free cholesterol (-10%), phospholipids (-14%), apo AI (-9%), apo AII (-11%), insulin (-42%), C-peptide (-57%), and NEFA (+535%, p = 0.0001). Total cholesterol decreased by 9% (n.s.) after 8 days. One week after the ending of fasting all parameters returned to normal. CONCLUSION: Contrary to total fasting and fasting with limited physical activity, 8 days juice fasting without limitation of physical activity results in a decrease of free cholesterol and an only initial increase of LDL cholesterol. After 8 days insulin, TG, and VLDL are still lower than at baseline, however, they have increased compared to the initial phase, probably counterregulatory to a further increase of NEFA.