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PurposeOver half of all cancer patients receiving taxane-, platinum-, or vinca alkaloid-based chemotherapy experience chemotherapy-induced peripheral neuropathy (CIPN), which includes numbness, tingling, pain, cold sensitivity, and motor impairment in the hands and feet. CIPN is a dose-limiting toxicity, potentially increasing mortality. There are no FDA-approved drugs to treat CIPN, and behavioral interventions such as exercise are promising yet understudied. This secondary analysis of our nationwide phase III randomized controlled trial of exercise for fatigue examines (1) effects of exercise on CIPN symptoms, (2) factors that predict CIPN symptoms, and (3) factors that moderate effects of exercise on CIPN symptoms.MethodsCancer patients (N = 355, 56 ± 11 years, 93% female, 79% breast cancer) receiving taxane-, platinum-, or vinca alkaloid-based chemotherapy were randomized to chemotherapy or chemotherapy plus Exercise for Cancer Patients (EXCAP©®). EXCAP is a standardized, individualized, moderate-intensity, home-based, six-week progressive walking and resistance exercise program. Patients reported CIPN symptoms of numbness and tingling and hot/coldness in hands/feet (0–10 scales) pre- and post-intervention. We explored baseline neuropathy, sex, age, body mass index, cancer stage, and cancer type as possible factors associated with CIPN symptoms and exercise effectiveness.ResultsExercise reduced CIPN symptoms of hot/coldness in hands/feet (−0.46 units, p = 0.045) and numbness and tingling (− 0.42 units, p = 0.061) compared to the control. Exercise reduced CIPN symptoms more for patients who were older (p = 0.086), male (p = 0.028), or had breast cancer (p = 0.076).ConclusionsExercise appears to reduce CIPN symptoms in patients receiving taxane-, platinum-, or vinca alkaloid-based chemotherapy. Clinicians should consider prescribing exercise for these patients.Trial registrationClinical Trials.gov, # NCT00924651, http://www.clinicaltrials.gov.

Ayahuasca is a plant concoction containing N,N-dimethyltryptamine (DMT) and certain β-carboline alkaloids from South America. Previous research in naturalistic settings has suggested that ingestion of ayahuasca can improve mental health and well-being; however, these studies were not placebo controlled and did not control for the possibility of expectation bias. This naturalistic observational study was designed to assess whether mental health changes were produced by ayahuasca or by set and setting. Assessments were made pre- and post-ayahuasca sessions in 30 experienced participants of ayahuasca retreats hosted in the Netherlands, Spain, and Germany. Participants consumed ayahuasca (N = 14) or placebo (N = 16). Analysis revealed a main effect of time on symptoms of depression, anxiety, and stress. Compared to baseline, symptoms reduced in both groups after the ceremony, independent of treatment. There was a main treatment × time interaction on implicit emotional empathy, indicating that ayahuasca increased emotional empathy to negative stimuli. The current findings suggest that improvements in mental health of participants of ayahuasca ceremonies can be driven by non-pharmacological factors that constitute a placebo response but also by pharmacological factors that are related to the use of ayahuasca. These findings stress the importance of placebo-controlled designs in psychedelic research and the need to further explore the contribution of non-pharmacological factors to the psychedelic experience.

Background Sepsis, an organ dysfunction caused by deregulated host response to infection, is a major health problem worldwide. Sepsis is associated with high rates of mortality, especially in critically ill patients. Curcumin may improve sepsis through its anti-inflammatory and antioxidant effects. This study aimed to investigate the effects of curcumin-piperine administration in critically ill septic patients. Method This double-blind randomized controlled trial (RCT) conducted on 66 patients with sepsis hospitalized in the intensive care unit (ICU). Patients were randomized to either the intervention group receiving two tablets of curcumin-piperine (each containing 500 mg curcuminoids and 5 mg piperine) ( n  = 33), or the placebo group receiving two matched tablets of placebo ( n  = 33) daily for 7 consecutive days along with enteral feeding. Clinical, laboratory, and biochemical indices were evaluated before and after the intervention. Statistical analyses were performed based on an intention-to-treat method. Result Mortality was observed in 10 patients in the curcumin-piperine group, and 12 patients in the control group. Curcumin-piperine significantly reduced bilirubin-total ( P  = 0.02), bilirubin-direct ( P  = 0.02), pH ( P  < 0.001), C-reactive protein ( P  = 0.04), erythrocyte sedimentation rate ( P  < 0.001), and platelet count ( P  = 0.01) compared with the placebo. A significantly lower reduction was found in red blood cell ( P  = 0.003), hemoglobin ( P  = 0.001), and hematocrit ( P  = 0.002) levels in the intervention vs. placebo group. In addition, mean corpuscular hemoglobin ( P  < 0.001) and mean corpuscular hemoglobin concentration ( P  = 0.001) were significantly higher in the intervention vs. placebo group. Conclusion Curcumin–piperine supplementation over a short period had beneficial effects on some inflammatory and laboratory indices in critically ill patients with sepsis. Trial registration IRCT20150613022681N4; available on: https://en.irct.ir/trial/52661 . Registration date: 2021-01-02, 1399/10/13.

Background Migraine is a highly prevalent neurological disorder related to severe, unilateral headache and symptoms such as vomiting, nausea, and photophobia. Growing evidence implicates oxidative stress and inflammation as key contributors to migraine pathophysiology, exacerbating symptoms and related mental health conditions. Mixodin is a novel bioactive formulation derived from natural compounds, including curcumin, piperine, and gingerol, which are well-established for their anti-inflammatory and antioxidant properties. While each component has shown potential in alleviating migraine-related symptoms, the combined therapeutic efficacy remains unclear. This study investigates whether the combined natural compounds in mixodin provide synergistic benefits in migraine management by targeting multiple underlying mechanisms. This study aims to examine the effects of mixodin supplementation on clinical symptoms, mental health, quality of life (QOL), inflammatory, and oxidative stress factors in patients with migraine. Methods This study is a randomized, double-blind, placebo-controlled clinical trial involving 60 patients diagnosed with migraine by a neurologist according to the ICHD-3 criteria. Eligible participants, aged 20 to 60 years, will be randomly assigned to one of two groups. The intervention group ( n  = 30) will receive two mixodin capsules daily for 8 weeks, each containing 300 mg of curcumin, 7.5 mg of gingerol, and 3.75 mg of piperine. The control group ( n  = 30) will receive two placebo capsules daily for the same duration. The primary outcome will be the clinical symptoms of migraine, including the frequency, severity, and duration of migraine attacks reported by patients. Secondary outcomes will include serum levels of high-sensitivity C-reactive protein (hs-CRP), calcitonin gene-related peptide (CGRP), total antioxidant capacity (TAC), total oxidant status (TOS), malondialdehyde (MDA), superoxide dismutase (SOD), nitric oxide (NO), and assessments of mental health status and QOL. Discussion This clinical trial aims to evaluate the effects of mixodin supplementation on inflammatory markers, oxidative stress, migraine-related symptoms, mental health, and QOL in patients with migraine. The results may suggestion insights into underlying mechanisms and support the development of evidence-based clinical guidelines that incorporate anti-inflammatory and antioxidant strategies to enhance therapeutic outcomes in migraine management. Trial registration Iranian Registry of Clinical Trials ( www.irct.ir ) (ID: IRCT20241009063312N1). Registration date: 2024–12–15. Trial status The protocol is Version 2.0, March 01, 2025. Recruitment began November 11, 2024, and is anticipated to be completed by June 22, 2025.

This study evaluates the effects of oral supplementation of curcumin alone and curcumin plus piperine on body composition, phase angle, and functional capacity in patients with mild to moderate inflammatory bowel disease (IBD). Patients with a diagnosis of IBD, aged 18 years or older with intact kidney and liver function, were into three groups: placebo, curcumin (1000 mg/day), and curcumin plus piperine (1000 mg/day + 10 mg/day). Anthropometric markers, body composition, phase angle (via tetrapolar bioelectrical impedance analysis), and hand-grip strength were assessed before and after the 12-week supplementation period. Statistical analyses included Chi-square test (χ²) and generalized estimating equation (GEE) adjusted for age. Of the 58 patients who started the study, 51 completed it. Initially, obesity was prevalent according to BMI (43.1%) and body fat percentage (62.7%), while 86.3% exhibited muscle depletion based on fat-free mass (FFM). Post-intervention, the curcumin plus piperine group showed a significant reduction in muscle depletion, with improvements in FFM (χ², p  = 0.019; GEE, p  = 0.049) and phase angle (χ², p  = 0.028) compared to the placebo group. In conclusion, our findings indicate that curcumin plus piperine significantly improves body composition by increasing muscle mass in patients with mild to moderate IBD, suggesting its potential as an adjuvant therapy. Trial registration : This trial was registered at ensaiosclinicos.gov.br as RBR89q4ydz on July 20, 2023. Website https://ensaiosclinicos.gov.br/ .

Capsule of alkaloids from the leaf of Alstonia scholaris (L.) R.Br. (Apocynaceae) (CALAS) is a new investigational botanical drug (No. 2011L01436) for bronchitis, post-infectious cough and asthma. To observe the clinical safety and tolerability of CALAS. Subjects were assigned to eight cohorts, and each received randomly CALAS or placebo in one of single ascending dose (SAD) of 8, 40, 120, 240, 360, 480, or in one of multiple ascending dose (MAD) of 40 or 120 mg, three times daily for 7 days. Each cohort contained two placebo subjects. Sixty-two enrolled volunteers completed the study and no serious adverse events and clinically significant changes in vital signs, electrocardiography, and upper abdominal Doppler ultrasonography were observed. The ratios of treatment-emergent adverse events (TEAEs) were reported in 11/46 (23.91%) of CALAS groups and 3/16 (18.75%) of the placebo group (p > 0.05), respectively, based on the results of SAD and MAD. All TEAEs were mild, transient, and disappeared without any intervention. The TEAEs possibly related to CALAS treatment were as followings: hiccups (4/46: 8%), dry mouth and nausea (3/46: 6%), increased sleep (2/46: 4%), abdominal distension (1/46: 2%), bilirubin elevated (1/46: 2%). CALAS is safe and well-tolerated with no unexpected or clinically relevant safety concerns up to a single dose of 360 mg and three times daily for 7 days up to 120 mg in healthy Chinese volunteers, supporting further Phase II studies.

K-601 is an herbal formulation for influenza consisting of Lonicera japonica , Isatis indigotica , Rheum palmatum , Phellodendron chinense and Scutellaria baicalensis . In this work, we characterized the chemical constituents in K-601, identified the absorbed compounds and determined their pharmacokinetics in 6 Chinese and African volunteers by liquid chromatography with time-of-flight mass spectrometry. Similarity evaluation for chromatographic fingerprint of nine different batches showed values above 0.983. Totally, 50 components were identified in K-601. Then, 15 major prototype compounds and 17 metabolites were identified in human plasma. Major metabolic pathways included glucuronidation, sulfation, methylation, demethylation and reduction. The pharmacokinetics of the most abundant prototype compounds, berberine, jatrorrhizine, palmatine and magnoflorine were determined. Significant pharmacokinetic differences were observed between the African and Chinese subjects. The AUC s of the African is about 4–10 fold higher than that of the Chinese for the three benzylisoquinoline alkaloids. Magnoflorine, an aporphine alkaloid, was absorbed better in the Chinese than in the African. The biotransformation of K-601 by human intestinal microflora was also investigated. The major reactions included hydroxylation, methylation, demethylation, acetylation and reduction. Glucuronidation and sulfation were not observed with fecal flora. These results may be important and useful in linking data from pharmacological assays and clinical effects.

PURPOSE: Coffee consumption has been reported to decrease oxidative damage in peripheral white blood cells (WBC). However, effects on the level of spontaneous DNA strand breaks, a well established marker of health risk, have not been specifically reported yet. We analyzed the impact of consuming a dark roast coffee blend on the level of spontaneous DNA strand breaks. METHODS: Healthy men (n = 84) were randomized to consume daily for 4 weeks either 750 ml of fresh coffee brew or 750 ml of water, subsequent to a run in washout phase of 4 weeks. The study coffee was a blend providing high amounts of both caffeoylquinic acids (10.18 ± 0.33 mg/g) and the roast product N-methylpyridinium (1.10 ± 0.05 mg/g). Before and after the coffee/water consumption phase, spontaneous strand breaks were determined by comet assay. RESULTS: At baseline, both groups exhibited a similar level of spontaneous DNA strand breaks. In the intervention phase, spontaneous DNA strand breaks slightly increased in the control (water only) group whereas they significantly decreased in the coffee group, leading to a 27 % difference within both arms (p = 0.0002). Food frequency questionnaires indicated no differences in the overall diet between groups, and mean body weight during the intervention phases remained stable. The consumption of the study coffee substantially lowered the level of spontaneous DNA strand breaks in WBC. CONCLUSION: We conclude that regular coffee consumption contributes to DNA integrity.

Objectives This study aims to investigate the efficacy of curcumin-piperine co-supplementation on disease duration, severity and clinical symptoms, and inflammatory mediators in patients with coronavirus (COVID-19). Trial design This is a randomized, placebo-controlled, double-blind, parallel arm clinical trial. Participants All patients aged 20-75 years with the diagnosis of Covid-19 based on the PCR test. The exclusion criteria will include an age less than 20 and more than 75 years, current use of warfarin or other anticoagulant drugs, and the presence of sensitivity to herbal products such as turmeric and pepper. This study will be conducted in academic hospitals affiliated to Isfahan University of Medical Sciences, Isfahan, Iran. Intervention and comparator Fifty outpatients will be randomly allocated in a ratio of 1:1 to receive a capsule of curcumin-piperine containing 500 mg curcumin plus 5 mg piperine or matching placebo containing 505 mg maltodextrin twice a daily, after lunch and dinner, over a period of 2 weeks. Similarly, 50 inpatients who are admitted to hospital wards excluding intensive care unit (ICU) will be randomly assigned in a ratio of 1:1 to receive a capsule curcumin-piperine or matching placebo (provided by the Sami Labs company) twice a daily, after lunch and dinner, over a period of 2 weeks. Main outcomes The main outcomes of this study are the efficacy of curcumin-piperine on coronavirus disease’s clinical symptoms, duration, severity, and inflammatory mediators after 2 weeks of curcumin-piperine co-supplementation. Randomisation Randomization sequences will be generated with the use of a random-number table with a permuted block design (block size of 4) and stratification according to the gender variable (male vs. female). These sequences will be prepared by an independent statistician and will be kept in opaque, sealed, numbered envelopes which will be opened only at the time of enrollment. The allocation ratio in intervention and control groups is 1:1. Researchers and all patients will be unaware of the study-group assignment until the completion of data analyses. Blinding (masking) This study is a double-blind clinical trial (participant, researcher). The curcumin-piperine and placebo supplements are packaged in similar numbered drug containers, and the researcher and all patients will be unaware of the study assignment until the end of the study. Numbers to be randomised (sample size) The calculated total sample size is 100 patients, with 25 patients in each group. Trial Status The protocol is Version 2.0, May 24, 2020. Recruitment began May 4, 2020, and is anticipated to be completed by April 19, 2021. Trial registration This trial has been registered by the title of “Effect of curcumin-piperine co-supplementation on disease duration, severity and clinical signs, and inflammatory factors in patients with coronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial study” in the Iranian Registry of Clinical Trials (IRCT) with code “IRCT20121216011763N46”, https://www.irct.ir/trial/47529 . The registration date is May 4, 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1 ). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Postoperative nausea and vomiting (PONV) frequently occur in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) under general anesthesia. Glycopyrronium bromide, an anticholinergic medication, is believed to not only relieve gastrointestinal spasms but also effectively prevent PONV. To compare the incidence of nausea and vomiting and the effect of relieving spasm between patients administered glycopyrronium bromide and those given anisodamine hydrobromide following endoscopic retrograde cholangiopancreatography (ERCP). This is a monocentric prospective study. Patients eligible for ERCP were randomly assigned to two groups. One group received 0.2 mg glycopyrronium bromide (Group G) intravenously, while the other group received 10 mg anisodamine hydrobromide (Group A) intramuscularly for anesthesia induction. The study assessed duodenal motility during ERCP and the incidence of PONV within 24 hours. The study included 130 patients. Nausea and vomiting within 24 hours post-surgery occurred in nine patients (13.8%) in Group G and 19 patients (29.2%) in Group A, with statistical significance (relative risk (RR), 0.47; 95% confidence interval (CI) [0.02-0.29];  = 0.033). Vomiting specifically was observed in three patients (4.6%) in Group G and 12 patients (18.5%) in Group A, showing statistical significance (RR 0.25; 95% CI [0.03-0.25];  = 0.028). There was no significant difference in duodenal peristalsis between the groups (Group G: 10.9 ± 3.1 times/min; Group A: 11.6 ± 3.1 times/min;  = 0.174). For patients undergoing ERCP under general anesthesia, a subcutaneous injection of 0.2 mg glycopyrronium bromide significantly reduces PONV and provides similar anti-spasmodic effects to 10 mg intramuscular anisodamine hydrobromide.