The work is aimed to compare the relative strength of dextroamphetamine and yogic meditation on the performance of 3 different groups of medical students to concentrate on the task to balance on a balance board. Group A subjects were mediators, group B subjects were given orally 5 and 10 mg of dextroamphetamine in a capsule, 1 hr prior to the test. Group C subjects were given same capsule but with lactose in place of the drug (placebo). This last groups served as control for the study. The balance index calculated taking into account their balance time and error score at each trial of 5 min duration showed that the performance of the group B (drug) had declined with overall percentile fall of 40.6% as compared to the performance of the controls (placebo) whereas, the performance of Group A (meditators) went on steadily and progressively increasing throughout the period of 10 trial days with overall percentile rise of 27.8%. The results were conclusive to confirm earlier reports that amphetamine is not of use for improvement of task rather, it deteriorates the task performance. Contrary to that, yogic meditation is of merit to achieve concentration for mental as well as physical task.

INTRODUCTION:Oral intake of vitamins which present antioxidant characteristics can protect living organisms against oxidative damage caused by exposure to ionizing radiation. It was previously reported that administration of high levels of vitamin C can lead to increased DNA damage through production of hydroxyl radicals from hydrogen peroxide by the Fenton reaction. However, our early experiments did not confirm this hypothesis. The main goal of this study was to determine if high doses of Vit C can show life-saving radioprotective effects.

MATERIALS AND METHODS:Phase I: Seventy two male Balb/c mice weighing 20-25g were randomly divided into six groups of 12 animals each. Group I; Vit E for five days, Groups II and III; Vit C and Vit A. Group 4; all three vitamins. Group V; an over-the-counter multivitamin. Group VI; none of the above. Phase II: 120 male BALB/c mice weighing 20-25g were randomly divided into 12 groups of 10 each. Group I; Vit A for five days. Groups II-IV; Vit C 200 mg/kg, 400 mg/kg, 800 mg/kg, respectively. Group V-VII; Vit E at daily doses of 200 iu/kg, 400 iu/kg, 800 iu/kg, respectively. Group VIII and IX; all three vitamins at low and high doses, respectively. Group X; an over-the-counter multivitamin. Group XI; controls group and Group XII; received pure olive oil. All animals (Phases I and II) were exposed to a lethal dose of gamma rays and the survival rates of the animals were monitored and recorded continuously for 16 days after exposure.

RESULTS:Phase I: 14 days after irradiation the survival rate for control group was 33.33%, while the survival rates for the 1st to 5th groups were 45.45%, 81.81%, 50%, 57.14%, and 9.09% , respectively. Phase II: The survival rates in the control group and the group that only received pure olive oil, were 50% and 60%, respectively. Survival rate in the animals received Vit C at daily doses of 200 mg/kg, 400 mg/kg, 800 mg/kg, were 90%, 90% and 90%, respectively. Log rank (Mantel-Cox) test showed statistically significant differences between the survival rates in control irradiated mice (no vitamins) and mice received Vit C at daily doses of 200 mg/kg (P=0.042), 400 mg/kg (P=0.042) and 800 mg/kg (P=0.042).

CONCLUSION:Altogether, findings of this study showed that even high doses of Vit C can show life-saving radioprotective effects. The significant radioprotective effect of Vit C at doses used in this study, opens new horizons in developing non-toxic, cost effective, easily available radioprotectors in life-threatening situations such as exposure to lethal doses of ionizing radiation.  The radioprotective effect of Vit A and Vit E seem to be less efficient compared to that of Vit C.

Dietary interventions have not been effective in the treatment of multiple sclerosis (MS). Here, we show that periodic 3-day cycles of a fasting mimicking diet (FMD) are effective in ameliorating demyelination and symptoms in a murine experimental autoimmune encephalomyelitis (EAE) model. The FMD reduced clinical severity in all mice and completely reversed symptoms in 20% of animals. These improvements were associated with increased corticosterone levels and regulatory T (Treg) cell numbers and reduced levels of pro-inflammatory cytokines, TH1 and TH17 cells, and antigen-presenting cells (APCs). Moreover, the FMD promoted oligodendrocyte precursor cell regeneration and remyelination in axons in both EAE and cuprizone MS models, supporting its effects on both suppression of autoimmunity and remyelination. We also report preliminary data suggesting that an FMD or a chronic ketogenic diet are safe, feasible, and potentially effective in the treatment of relapsing-remitting multiple sclerosis (RRMS) patients (NCT01538355).

Yoga interventions improve obesity-related outcomes including body mass index (BMI), body weight, body fat, and waist circumference, yet it is unclear whether these improvements are due to increased physical activity, increased lean muscle mass, and/or changes in eating behaviors. The purpose of this study is to expand our understanding of the experience of losing weight through yoga. Methods. Semistructured interviews were qualitatively analyzed using a descriptive phenomenological approach. Results. Two distinct groups who had lost weight through yoga responded: those who were overweight and had repeatedly struggled in their attempts to lose weight (55%, n = 11) and those who were of normal weight and had lost weight unintentionally (45%, n = 9). Five themes emerged that differed slightly by group: shift toward healthy eating, impact of the yoga community/yoga culture, physical changes, psychological changes, and the belief that the yoga weight loss experience was different than past weight loss experiences. Conclusions. These findings imply that yoga could offer diverse behavioral, physical, and psychosocial effects that may make it a useful tool for weight loss. Role modeling and social support provided by the yoga community may contribute to weight loss, particularly for individuals struggling to lose weight.

Huntington's disease (HD) is a neurodegenerative disease for which there is no curative treatment available. Given that the endocannabinoid system is involved in the pathogenesis of HD mouse models, stimulation of specific targets within this signaling system has been investigated as a promising therapeutic agent in HD. We conducted a double-blind, randomized, placebo-controlled, cross-over pilot clinical trial with Sativex(®), a botanical extract with an equimolecular combination of delta-9-tetrahydrocannabinol and cannabidiol. Both Sativex(®) and placebo were dispensed as an oral spray, to be administered up to 12 sprays/day for 12 weeks. The primary objective was safety, assessed by the absence of more severe adverse events (SAE) and no greater deterioration of motor, cognitive, behavioral and functional scales during the phase of active treatment. Secondary objectives were clinical improvement of Unified Huntington Disease Rating Scale scores. Twenty-six patients were randomized and 24 completed the trial.After ruling-out period and sequence effects, safety and tolerability were confirmed. No differences on motor (p = 0.286), cognitive (p = 0.824), behavioral (p = 1.0) and functional (p = 0.581) scores were detected during treatment with Sativex(®) as compared to placebo. No significant molecular effects were detected on the biomarker analysis. Sativex(®) is safe and well tolerated in patients with HD, with no SAE or clinical worsening. No significant symptomatic effects were detected at the prescribed dosage and for a 12-week period. Also, no significant molecular changes were observed on the biomarkers. Future study designs should consider higher doses, longer treatment periods and/or alternative cannabinoid combinations.Clincaltrals.gov identifier: NCT01502046.

OBJECTIVE:To determine the feasibility, acceptability and safety of using acupuncture to treat arm lymphoedema in women following treatment for breast cancer.

METHODS:We conducted a randomised controlled trial of acupuncture compared with treatment as usual. Twenty women with stable unilateral intransient lymphoedema present for at least 6 months were recruited from Sydney, Australia. The women received 12 acupuncture treatments administered to body and arm points on the non-lymphoedematous limb over 8 weeks, twice weekly for 4 weeks then once weekly for 4 weeks. Outcome measures included an assessment of interest to participate in the trial, identification of successful recruitment strategies, the appropriateness of eligibility criteria and compliance with treatment attendance. Clinical outcomes were assessed at baseline and 8 weeks and included extracellular fluid, lymphoedema symptoms, well-being and safety.

RESULTS:Acupuncture was an acceptable intervention in women with upper limb lymphoedema. Compliance with the treatment protocol was high, with nine women completing all 12 treatments. Outcome forms were completed by 17 women at 8 weeks. No major adverse occurrences, as defined by the study protocol, were reported from the acupuncture group although one woman found the needling uncomfortable, and no study participant experienced an increase in swelling of>10%. There was no change in extracellular fluid or any patient-reported outcome measurement.

CONCLUSIONS:Lymphoedema is a persistent symptom experienced by women recovering from breast cancer. Our study suggests that acupuncture may stabilise symptoms and no major safety concerns were identified, so further research is needed.

TRIAL REGISTRATION NUMBER:Australian New Zealand Clinical Trials Registry, http://www.anzctr.org.au ACTRN12612000607875.

OBJECTIVE:To determine the feasibility, acceptability and safety of using acupuncture to treat arm lymphoedema in women following treatment for breast cancer.

METHODS:We conducted a randomised controlled trial of acupuncture compared with treatment as usual. Twenty women with stable unilateral intransient lymphoedema present for at least 6 months were recruited from Sydney, Australia. The women received 12 acupuncture treatments administered to body and arm points on the non-lymphoedematous limb over 8 weeks, twice weekly for 4 weeks then once weekly for 4 weeks. Outcome measures included an assessment of interest to participate in the trial, identification of successful recruitment strategies, the appropriateness of eligibility criteria and compliance with treatment attendance. Clinical outcomes were assessed at baseline and 8 weeks and included extracellular fluid, lymphoedema symptoms, well-being and safety.

RESULTS:Acupuncture was an acceptable intervention in women with upper limb lymphoedema. Compliance with the treatment protocol was high, with nine women completing all 12 treatments. Outcome forms were completed by 17 women at 8 weeks. No major adverse occurrences, as defined by the study protocol, were reported from the acupuncture group although one woman found the needling uncomfortable, and no study participant experienced an increase in swelling of>10%. There was no change in extracellular fluid or any patient-reported outcome measurement.

CONCLUSIONS:Lymphoedema is a persistent symptom experienced by women recovering from breast cancer. Our study suggests that acupuncture may stabilise symptoms and no major safety concerns were identified, so further research is needed.

TRIAL REGISTRATION NUMBER:Australian New Zealand Clinical Trials Registry, http://www.anzctr.org.au ACTRN12612000607875.

BACKGROUND:Thimerosal is a preservative commonly used in ophthalmic solutions, otic drops, and vaccines because of its bactericidal property.

OBJECTIVE:To report a case of a generalized reaction to thimerosal in a patient who received an influenza vaccine.

METHODS:We describe a patient who developed a generalized maculopapular eruption after receiving a thimerosal-containing influenza vaccine. Patch testing was performed to determine if there was an allergy to thimerosal.

RESULTS:Patch testing confirmed a T-cell-mediated sensitivity to thimerosal.

CONCLUSIONS:Physicians need to be aware that thimerosal is found in many products, including vaccinations. Clinicians should also be aware that allergic reactions occur with exposure to thimerosal even in vaccines. To our knowledge, this is the first case report in the literature of a generalized reaction to thimerosalfrom an influenza vaccine.

Coeliac disease is an inflammatory disorder of the small intestine with an autoimmune component and strong heritability. Genetic studies have confirmed strong association to HLA and identified 39 nonHLA risk genes, mostly immune-related. Over 50% of the disease-associated single nucleotide polymorphisms are correlated with gene expression. Most of the coeliac disease-associated regions are shared with other immune-related diseases, as well as with metabolic, haematological or neurological traits, or cancer. We review recent progress in the genetics of coeliac disease and describe the pathways these genes are in, the functional consequences of the associated markers on gene expression and the genes shared between coeliac disease and other traits.

Mushrooms have become popular sources of natural antitumor, antiviral, antibacterial, antioxidative, and immunomodulatory agents. Golden oyster mushroom, Pleurotus citrinopileatus , is a common mushroom in oriental countries for human consumption. We isolated a functional protein (PCP-3A) from the fresh fruiting body of this mushroom. The isolation procedure included ammonium sulfate fractionation, DEAE-Sepharose CL-6B ion exchange chromatography, and Sephacryl S-300 gel filtration. Electrophoresis demonstrated that PCP-3A is a glycoprotein composed of 10 subunits, each approximately 45.0 kDa in size. In vitro cell study showed that PCP-3A at a concentration about 12.5 microg/mL inhibits the proliferation of human tumor cell line U937, in a time- dependent manner (24, 48, and 72 h). It failed to agglutinate rabbit and human erythrocytes, excluding its possibility from being a lectin. Flow cytometry revealed that it is capable of inhibiting the growth of U937 cells by way of S phase arrest and apoptotic induction. We suggest that PCP-3A is worth further investigating for antitumor use.

BACKGROUND: The 'Mediterranean diet' is considered to exert protective effects on cardiovascular disease, although a wide range of dietary patterns exists among subjects living even in the same Mediterranean country.

OBJECTIVE: To investigate the association between specific dietary patterns and peripheral arterial disease (PAD) in Italian Type 2 diabetes patients.

DESIGN: From a cohort of 944 patients with Type 2 diabetes, 144 patients with PAD were selected, and matched for age and sex with 288 Type 2 diabetic control patients without macrovascular complications. A dietary score was elaborated from a semiquantitative food frequency questionnaire. The higher the final score, the healthier the eating habit.

RESULTS: In multivariate analysis, a higher score was independently associated with a significant reduction in PAD risk [odds ratio (OR) = 0.44; 95% confidence interval (CI) 0.24, 0.83]. Diabetes duration (OR>15 years = 2.49; 95% CI 1.45, 4.25), hypertension (OR = 2.12; 95% CI 1.31, 3.45) and butter consumption (OR = 2.6; 95% CI 1.15, 3.68) were also significantly associated with PAD. The dietary score significantly improved the predictive value of models based on duration of diabetes and hypertension. (LSR = 2.19, DF = 7, P<0.001). The effect of a high dietary score on the risk of PAD was independent of diabetes duration and hypertension.

CONCLUSION: In Italian Type 2 diabetics, a higher dietary score has a protective role against PAD. The use of butter increases the risk of PAD even in patients regularly consuming olive oil. Dietary advice may be helpful for the prevention of PAD in diabetics even in populations traditionally accustomed to a Mediterranean dietary habit.

CONTEXT: The incidence of tendon injuries and tendinopathy has risen substantially in the past decades. OBJECTIVE: To assess the noninferiority of therapy based on the homeopathic preparation Traumeel S ointment (Heel GmbH, Baden-Baden, Germany) compared with treatment based on diclofenac 1% gel in patients with tendinopathies of varying etiology. DESIGN: Nonrandomized, observational study. SETTING: Ninety-five homeopathy and conventional medical practices in Germany. PATIENTS: Three hundred fifty-seven patients aged 18 to 93 years with tendinopathy of varying etiology based on excessive tendon load rather than inflammation. INTERVENTIONS: Traumeel S ointment or diclofenac 1% gel for a maximum of 28 days. MAIN OUTCOME MEASURES: Efficacy was measured on a four-degree scale on pain-related variables, on variables related to motility, and on overall treatment outcome. Tolerability was monitored as adverse events. Compliance was assessed by practitioner and patient on a four-degree scale. RESULTS: The patients groups were comparable at baseline. The changes in summary score of all pain-related variables were -5.3 +/- 2.7 (all values means +/- SD) in the Traumeel group and -5.0 +/- 2.7 in the control group. Changes for all motility-related variables were -4.2 +/- 3.8 with Traumeel and -3.7 +/- 3.4 with control therapy. The summary scores for all clinical variables were reduced by -9.5 +/- 5.7 with Traumeel therapy and by -8.7 +/- 5.4 with diclofenac-based treatment. Homeopathic therapy was noninferior to diclofenac therapy on all variables. For motility-related variables, there was a trend toward superiority of Traumeel. Treatments were well tolerated with no treatment-related adverse events. CONCLUSIONS: The results suggest that Traumeel ointment is an effective alternative to nonsteroidal antiinflammatory drugs therapy for the acute symptomatic treatment of patients with tendinopathy.

Abnormal metabolism serves a critical role in the development and progression of different types of malignancies including glioblastoma (GBM), and may therefore serve as a promising target for treatment of cancer. Preclinical studies have indicated that a ketogenic diet (KD) may exhibit beneficial effects in patients with GBM; however, the underlying mechanisms remain incompletely understood. The aim of the present study was to evaluate the effects of a KD on glioma stem‑like cells (GSCs), by culturing patient‑derived primary GSCs as well as a GSC cell line in glucose‑restricted, β‑hydroxybutyrate‑containing medium (BHB‑Glow) which was used to mimic clinical KD treatment. GSCs cultured in BHB‑Glow medium exhibited reduced proliferation and increasedapoptosis compared with cells grown in the control medium. Furthermore, decreased expression of stem cell markers, diminished self‑renewal in vitro, and reduced tumorigenic capacity in vivo, providing evidence that the stemness of GSCs was compromised. Mechanistically, culturing in BHB‑Glow medium reduced glucose uptake and inhibited glycolysis in GSCs. Furthermore, culturing in the BHB‑Glow medium resulted in morphological and functional disturbances to the mitochondria of GSCs. These metabolic changes may have reduced ATP production, promoted lactic acid accumulation, and thus, increased the production of reactive oxygen species (ROS) in GSCs. The expression levels and activation of mammalian target of rapamycin, hypoxia‑inducible factor 1 and B‑cell lymphoma 2 were decreased, consistent with the reduced proliferation of GSCs in BHB‑Glow medium. ROS scavenging reversed the inhibitory effects of a KD on GSCs. Taken together, the results demonstrate that treatment with KD inhibited proliferation of GSCs, increased apoptosis and attenuated the stemness in GSCs by increasing ROS production.

OBJECTIVES:Chemotherapy is one of the major treatments of cancer. However, the emergence of resistance to chemotherapeutic agents is still a major obstacle in the successful management of resistant tumors. Therefore, development of new mechanisms to overcome drug resistance is essential and may be further developed into effective therapies that can flip the switch from drug resistance to susceptibility. The aim of this study was to evaluate a combination consisting of a ketogenic diet and melatonin to determine whether it would inhibit cisplatin- and vincristine-resistant breast cancer.

METHODS:In the in vitro part of the study, drug-resistant cell lines were treated with melatonin and real-time polymerase chain reaction was used to measure levels of gene expression involved in apoptosis and resistance. On the protein level, the activity of caspase-3 and the level of vascular endothelin growth factor protein were determined. In the in vivo part, tumor-bearing mice received one of the following treatments: ketogenic diet, melatonin, combination of melatonin and ketogenic diet, vehicle, or chemotherapy.

RESULTS:Successful inhibition of resistant cell lines was achieved by melatonin. This inhibition was mediated by induction of apoptosis, inhibition of angiogenesis, and downregulation of resistance genes. A synergistic anticancer effect was observed between melatonin and the ketogenic diet against resistant breast tumors inoculated in mice with a cure rate of 70%.

CONCLUSIONS:The combination of melatonin and a ketogenic diet represents a promising option to overcome drug resistance in cancer chemotherapy. However, further testing on the protein level using flow cytometry is important to better understand the mechanisms of action.

Birth rates in the United States have recently fallen. Birth rates per 1000 females aged 25-29 fell from 118 in 2007 to 105 in 2015. One factor may involve the vaccination against the human papillomavirus (HPV). Shortly after the vaccine was licensed, several reports of recipients experiencing primary ovarian failure emerged. This study analyzed information gathered in National Health and Nutrition Examination Survey, which represented 8 million 25-to-29-year-old women residing in the United States between 2007 and 2014. Approximately 60% of women who did not receive the HPV vaccine had been pregnant at least once, whereas only 35% of women who were exposed to the vaccine had conceived. For married women, 75% who did not receive the shot were found to conceive, while only 50% who received the vaccine had ever been pregnant. Using logistic regression to analyze the data, the probability of having been pregnant was estimated for females who received an HPV vaccine compared with females who did not receive the shot. Results suggest that females who received the HPV shot were less likely to have ever been pregnant than women in the same age group who did not receive the shot. If 100% of females in this study had received the HPV vaccine, data suggest the number of women having ever conceived would have fallen by 2 million. Further study into the influence of HPV vaccine on fertility is thus warranted.

Walking within nature (Green Exercise) has been shown to immediately enhance mental well-being but less is known about the impact on physiology and longer lasting effects. Heart rate variability (HRV) gives an indication of autonomic control of the heart, in particular vagal activity, with reduced HRV identified as a risk factor for cardiovascular disease. Night-time HRV allows vagal activity to be assessed whilst minimizing confounding influences of physical and mental activity. The aim of this study was to investigate whether a lunchtime walk in nature increases night-time HRV. Participants (n = 13) attended on two occasions to walk a 1.8 km route through a built or a natural environment. Pace was similar between the two walks. HRV was measured during sleep using a RR interval sensor (eMotion sensor) and was assessed at 1-2 h after participants noted that they had fallen asleep. Markers for vagal activity were significantly greater after the walk in nature compared to the built walk. Lunchtime walks in nature-based environments may provide a greater restorative effect as shown by vagal activity than equivalent built walks. Nature walks may improve essential recovery during night-time sleep, potentially enhancing physiological health.

BACKGROUND AND AIMS:The Mediterranean diet, which is palatable and easily achievable, has been associated with lower all-cause and cardiovascular disease (CVD) incidence and mortality. Data on heart failure (HF) and stroke types are lacking. The aim was to examine a Mediterranean diet in relation to incidence of myocardial infarction (MI), HF and stroke types in a Swedish prospective cohort.

METHODS:In a population-based cohort of 32,921 women, diet was assessed through a self-administered questionnaire. The modified Mediterranean diet (mMED) score was created based on high consumption of vegetables, fruits, legumes, nuts, whole grains, fermented dairy products, fish and monounsaturated fat, moderate intakes of alcohol and low consumption of red meat, on a 0-8 scale. Relative risks (RR) with 95% confidence intervals (CI), adjusted for potential confounders, were estimated by Cox proportional hazards regression models.

RESULTS:During 10 y of follow-up (1998-2008), 1109 MIs, 1648 HFs, 1270 ischemic strokes and 262 total hemorrhagic strokes were ascertained. A high adherence to the mMED score (6-8), compared to low, was associated with a lower risk of MI (RR: 0.74, 95% CI: 0.61-0.90, p = 0.003), HF (RR: 0.79, 95% CI: 0.68-0.93, p = 0.004) and ischemic stroke (RR: 0.78, 95% CI: 0.65-0.93, p = 0.007), but not hemorrhagic stroke (RR: 0.88, 95% CI: 0.61-1.29, p = 0.53).

CONCLUSIONS:Better adherence to a Mediterranean diet was associated with lower risk of MI, HF and ischemic stroke. The Mediterranean diet is most likely to be beneficial in primary prevention of all major types of atherosclerosis-related CVD.

AIMS:The aim of the study was to evaluate the effect of a Mediterranean diet (MedDiet), enhanced with extra virgin olive oil (EVOO) and nuts, on a composite of adverse maternofoetal outcomes of women with normoglycemia during pregnancy.

METHODS:This was a sub-analysis of the St Carlos gestational diabetes mellitus Prevention Study. Only normoglycemic women were analysed (697). They were randomized (at 8-12th gestational weeks) to: standard-care control group (337), where fat consumption was limited to 30% of total caloric intake; or intervention group (360), where a MedDiet, enhanced with EVOO and pistachios (40-42% fats of total caloric intake) was recommended. The primary outcome was a composite of maternofoetal outcomes (CMFOs): at least having 1 event of emergency C-section, perineal trauma, pregnancy-induced hypertension and preeclampsia, prematurity, large-for-gestational-age and small-for gestational-age.

RESULTS:Crude relative risk showed that the intervention was associated with a significant reduction in the risk of CMFOs (0.48 [0.37-0.63]; p = 0.0001), with a number-needed-to-treat = 5. Risk of urinary tract infections, emergency C-sections, perineal trauma, large-for-gestational-age and small-for gestational age new-borns were also significantly reduced.

CONCLUSION:A MedDiet, enhanced with EVOO and nuts, was associated with a risk reduction of CMFOs in over 50% in normoglycemic pregnant women. Therefore, it might be a potentially adequate diet for pregnant women.

TRIAL REGISTRATION:Identifier ISRCTN84389045. The study was registered on September 27, 2013. Last edited on September 26, 2018.

OBJECTIVE: 1) To assess the efficacy of homeopathic prepared Galphimia glauca compared to placebo in the treatment of pollinosis. 2) To estimate the corresponding overall success rate of Galphimia glauca. Meta-analysis of clinical trials. STUDY SELECTION: 7 randomized double-blind placebo-controlled trials and 4 not placebo-controlled trials (1 randomized and controlled, 1 prospective uncontrolled, 2 retrospective uncontrolled) performed by our study group between 1980 and 1989. An additional MEDLINE search revealed no further trials on this topic. Exclusion and inclusion criteria were identical over all trials. In total, 1038 ambulatory patients that suffered from acute pollinosis (752 in placebo-controlled trials) entered the analysis. MAIN OUTCOME MEASURES: Relative frequency and relative risk for showing noticeable and soothing relief in ocular symptoms as assessed by the patient. The overall rate of improved eye-symptoms is about 1.25 (CI: 1.09 to 1.43) times higher in the verum than in the placebo group. Verum success rate is estimated by 79.3% (CI: 74.1% to 85.0%). Across the single studies the results were highly comparable except for the study run in 1985. A significant superiority of Galphimia glauca over placebo is demonstrated. Estimates of verum success rates are comparable with those of conventional antihistaminics, but no side effects occurred. As not all of the single studies were analyzed by intention to treat analysis the results may be biased.

OBJECTIVES:To study the effects of both balneotherapy and mud-bath therapy treatments in patients affected by primary fibromyalgia (FM) using rheumatological, psychiatric, biochemical and proteomic approaches.

METHODS:Forty-one FM patients (39 females, 2 males), who fulfilled the American College of Rheumatology criteria received a 2-week thermal therapy programme consisting of therapy once daily for 6 days/week. Twenty-one patients received mud-bath treatment, while the other twenty balneotherapy. Pain, symptoms, and quality of life were assessed. Oxytocin, brain-derived neurotrophic factor (BDNF), ATP and serotonin transporter levels during therapy were assayed. Comparative whole saliva (WS) proteomic analysis was performed using a combination of two-dimensional electrophoresis (2DE) and mass spectrometry techniques.

RESULTS:We observed a reduction in pain, FIQ values and improvement of SF36 in both groups of patients treated with mud-bath or balneotherapy. The improvement of the outcome measures occurred with different timing and duration in the two spa treatments. A significant decrease in BDNF concentrations was observed either after balneotherapy or mud-bath therapy when assayed after twelve weeks, while no significant change in oxytocin levels, ATP levels and serotonin transporter were detected. Significant differences were observed for phosphoglycerate mutase1 (PGAM1) and zinc alpha-2-glycoprotein 1 (AZGP1) protein expression.

CONCLUSIONS:Our results showed that the thermal treatment might have a beneficial effect on the specific symptoms of the disease. In particular, while balneotherapy gives results that in most patients occur after the end of the treatment but which are no longer noticeable after 3 months, the mud-bath treatment gives longer lasting results.