Search

Introduction: Stroke is characterized by high incidence, recurrence rate, and mortality. Patients with acute ischemic stroke (AIS) who are ineligible for acute revascularization therapy require more effective medication treatments. A previous clinical study showed that Ruyi Zhenbao tablets and Baimai ointments might be effective against AIS; however, high-quality clinical evidence supporting their application in AIS is lacking. To explore the efficacy of the two classic Tibetan medicines in the treatment of AIS, a randomized clinical trial will be conducted in patients with AIS who are not eligible for thrombolytic treatment. Methods: A prospective, randomized, multiple-center, double-blinded, placebo-controlled, and parallel-group trial will be conducted. We shall randomize 480 eligible participants to either the intervention or the control group. The distribution ratio of each group will be 1:1:1:1, including 120 patients each in the dual-medication group, the Baimai ointment group, the Ruyi Zhenbao tablet group, and the placebo group. Participants will be treated with medication for 8 weeks, and they will receive three follow-up visits: at 4 weeks (D29), 8 weeks (D56), and 90 days (D90) after commencing treatment. The primary outcome will be D90 change in the simplified Fugl-Meyer score from baseline to posttreatment. The secondary outcomes are as follows: D29 change of simplified Fugl-Meyer score from baseline to posttreatment; proportion of participants whose D29 NIHSS scores decreased by four or more points from baseline D90 proportion of subjects with mRS score of 0–2 (inclusive); D90 proportion of subjects with Barthel index score ≥95; D90 incidence of cardiovascular and cerebrovascular events. Safety endpoint includes mortality within 90 days; proportion of subjects with adverse events/serious adverse events within 90 days. Conclusion: This research protocol lays a solid groundwork for its practical execution. This study is poised to serve as a reference for other Tibetan medicine researchers, contributing to the reduction of stroke-related expenditures globally and, in turn, benefiting a broader population of stroke patients.

Background and purpose: Acupuncture exerts an anti-inflammatory effect and is recommended by the World Health Organization as a complementary therapy for stroke. This study investigated the improvement in neurological function outcome in acute-stage intervention of acute ischemic stroke (AIS), and the anti-inflammatory effect of early acupuncture. Methods: Fifty patients with AIS were randomly assigned to either a control group (CG, 25 patients, received sham acupuncture) or treatment group (TG, 25 patients, received acupuncture treatment). Acupuncture intervention was administered twice a week for a total of 8 sessions over 4 consecutive weeks. The primary outcome was the changes in the National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), and Barthel Index (BI) scores. The secondary outcome was the changes in serum inflammation-related biomarker levels.(ANAIS trial) Results: A total of 35 patients (18 patients in the CG and 17 patients in the TG) completed the trial. The reduction in NIHSS scores was greater in the TG than in the CG between V2 (second assessment administered after acupuncture intervention) and V1 (first assessment administered before acupuncture intervention; 4.33 ± 1.91 vs. 2.68 ± 1.42, p = 0.005) and between V3 (third assessment administered 28 days after last acupuncture intervention) and V1 (6.00 ± 2.53 vs. 3.83 ± 2.31, p = 0.012). The increase in BI scores was greater in the TG than in the CG between V2 and V1 (28.89 ± 15.39 vs. 14.21 ± 19.38, p = 0.016) and between V3 and V1 (39.41 ± 20.98 vs. 25.00 ± 18.47, p = 0.038). Among participants with high inflammation, the increase in serum IL-12p70 level between V2 and V1 was greater in the TG than in the CG (0.20 ± 0.19 vs. −0.14 ± 0.30, pg/mL p = 0.006). Conclusions: Acupuncture improved the neurological function of patients with AIS, and the relationship between acupuncture improving neurological function and anti-inflammatory effect needs further study. In addition, studies with larger sample sizes and longer follow-ups as well as multicenter clinical trials are expected in the future.

Abstract Background Hyperuricemia increases the risk of gout and cardiovascular complications, and how to manage asymptomatic hyperuricemia is controversial. Randomized controlled trials and comparative studies are needed to guide management and treatment. Studies show that Chinese medicine can decrease uric acid through multiple targets, but many of these studies have been conducted in animals because of the lack of a consistent prescription and mechanism. Therefore, we designed this research to study whether Chinese medicine is truly effective and which target is essential by using an approved prescription of a Fuling-Zexie decoction to further guide large sample experiments to determine whether Chinese medicine can reduce the long-term incidence of gout and cardiovascular events. Methods This pilot study is a prospective, double-blinded, randomized, placebo-controlled clinical trial developed from March 2020 to December 2021. Thirty people with asymptomatic hyperuricemia will be recruited and assigned to either the Chinese medicine group or placebo group, and each group will have 15 subjects. During the 12-week observation period, there will be 4 visits. The decline in uric acid is the main outcome measure, and urinary uric acid, inflammatory biomarkers, and other indices that may be involved in lowering uric acid are the secondary outcome measures. Discussion This study will probe the effect of Chinese medicine treatment on hyperuricemia and explore possible therapeutic mechanisms. By performing this trial, we hope to provide evidence and data to support further large clinical studies. Trial registration ChiCTR2000038575 . Registered on September 24, 2020.

Background: Low back pain (LBP) is a prevalent issue that orthopedic surgeons frequently address in the outpatient setting. LBP can arise from various causes, with stiffness in the paraspinal muscles being a notable contributor. The administration of Botulinum toxin type A (BoNT-A) has been found to alleviate back pain by relaxing these stiff muscles. While BoNT-A is approved for use in numerous conditions, a limited number of randomized clinical trials (RCTs) validate its efficacy specifically for treating LBP., Aim: To study the safety and the efficacy of BoNT-A in minimizing pain and improving functional outcomes in patients of chronic LBP (CLBP)., Methods: In this RCT, adults aged 18-60 years with mechanical LBP persisting for at least six months were enrolled. Participants were allocated to either the Drug group, receiving 200 Ipsen Units (2 mL) of BoNT-A, or the Control group, which received a 2 mL placebo. Over a 2-month follow-up period, both groups were assessed using the Visual Analog Scale (VAS) for pain intensity and the Oswestry Disability Index (ODI) for disability at the start and conclusion of the study. A decrease in pain by 50% was deemed clinically significant., Results: The study followed 40 patients for two months, with 20 in each group. A clinically significant reduction in pain was observed in 36 participants. There was a statistically significant decrease in both VAS and ODI scores in the groups at the end of two months. Nonetheless, when comparing the mean score changes, only the reduction in ODI scores (15 in the placebo group vs 16.5 in the drug group, clinically insignificant) was statistically significant ( P = 0.012), whereas the change in mean VAS scores was not significant ( P = 0.45)., Conclusion: The study concludes that BoNT-A does not offer a short-term advantage over placebo in reducing pain or improving LBP scores in CLBP patients., Competing Interests: Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article., (©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.)

Background: Hyperuricemia increases the risk of gout and cardiovascular complications, and how to manage asymptomatic hyperuricemia is controversial. Randomized controlled trials and comparative studies are needed to guide management and treatment. Studies show that Chinese medicine can decrease uric acid through multiple targets, but many of these studies have been conducted in animals because of the lack of a consistent prescription and mechanism. Therefore, we designed this research to study whether Chinese medicine is truly effective and which target is essential by using an approved prescription of a Fuling-Zexie decoction to further guide large sample experiments to determine whether Chinese medicine can reduce the long-term incidence of gout and cardiovascular events.Methods: This pilot study is a prospective, double-blinded, randomized, placebo-controlled clinical trial developed from March 2020 to December 2021. Thirty people with asymptomatic hyperuricemia will be recruited and assigned to either the Chinese medicine group or placebo group, and each group will have 15 subjects. During the 12-week observation period, there will be 4 visits. The decline in uric acid is the main outcome measure, and urinary uric acid, inflammatory biomarkers, and other indices that may be involved in lowering uric acid are the secondary outcome measures.Discussion: This study will probe the effect of Chinese medicine treatment on hyperuricemia and explore possible therapeutic mechanisms. By performing this trial, we hope to provide evidence and data to support further large clinical studies.Trial Registration: ChiCTR2000038575 . Registered on September 24, 2020. [ABSTRACT FROM AUTHOR]

Acupuncture exerts an anti-inflammatory effect and is recommended by the World Health Organization as a complementary therapy for stroke. This study investigated the improvement in neurological function outcome in acute-stage intervention of acute ischemic stroke (AIS), and the anti-inflammatory effect of early acupuncture. Fifty patients with AIS were randomly assigned to either a control group (CG, 25 patients, received sham acupuncture) or treatment group (TG, 25 patients, received acupuncture treatment). Acupuncture intervention was administered twice a week for a total of 8 sessions over 4 consecutive weeks. The primary outcome was the changes in the National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), and Barthel Index (BI) scores. The secondary outcome was the changes in serum inflammation-related biomarker levels.(ANAIS trial) A total of 35 patients (18 patients in the CG and 17 patients in the TG) completed the trial. The reduction in NIHSS scores was greater in the TG than in the CG between V2 (second assessment administered after acupuncture intervention) and V1 (first assessment administered before acupuncture intervention; 4.33 ± 1.91 vs. 2.68 ± 1.42, p = 0.005) and between V3 (third assessment administered 28 days after last acupuncture intervention) and V1 (6.00 ± 2.53 vs. 3.83 ± 2.31, p = 0.012). The increase in BI scores was greater in the TG than in the CG between V2 and V1 (28.89 ± 15.39 vs. 14.21 ± 19.38, p = 0.016) and between V3 and V1 (39.41 ± 20.98 vs. 25.00 ± 18.47, p = 0.038). Among participants with high inflammation, the increase in serum IL-12p70 level between V2 and V1 was greater in the TG than in the CG (0.20 ± 0.19 vs. −0.14 ± 0.30, pg/mL p = 0.006). Acupuncture improved the neurological function of patients with AIS, and the relationship between acupuncture improving neurological function and anti-inflammatory effect needs further study. In addition, studies with larger sample sizes and longer follow-ups as well as multicenter clinical trials are expected in the future. • This is a double-blinded randomized controlled trial to investigate the therapeutic effect of acupuncture treats acute ischemic stroke. • This study also investigated the relationship between effect of acupuncture and its anti-inflammation. • Acupuncture treatment could improve neurologic function and also can reduce inflammation in acute ischemic stroke patients with high inflammation. [ABSTRACT FROM AUTHOR]

Study Objectives: The purpose of this study was to determine the effects of daytime transcranial direct current stimulation (tDCS) on sleep electroencephalogram (EEG) in patients with depression. Methods: The study was a double-blinded, randomized, controlled clinical trial. A total of 37 patients diagnosed with a major depression were recruited; 19 patients (13 females and 6 males mean age 44.79 ± 15.25 years) received tDCS active stimulation and 18 patients (9 females and 9 males; mean age 43.61 ± 11.89 years) received sham stimulation. Ten sessions of daytime tDCS were administered with the anode over F3 and the cathode over F4. Each session delivered a 2 mA current for 30 min per 10 working days. Hamilton-24 and Montgomery scales were used to assess the severity of depression, and polysomnography (PSG) was used to assess sleep structure and EEG complexity. Eight intrinsic mode functions (IMFs) were computed from each EEG signal in a channel. The sample entropy of the cumulative sum of the IMFs were computed to acquire high-dimensional multi-scale complexity information of EEG signals. Results: The complexity of Rapid Eye Movement (REM) EEG signals significantly decreased intrinsic multi-scale entropy (iMSE) (1.732 ± 0.057 vs. 1.605 ± 0.046, P = 0.0004 in the case of the C4 channel, IMF 1:4 and scale 7) after tDCS active stimulation. The complexity of the REM EEG signals significantly increased iMSE (1.464 ± 0.101 vs. 1.611 ± 0.085, P = 0.001 for C4 channel, IMF 1:4 and scale 7) after tDCS sham stimulation. There was no significant difference in the Hamilton-24 (P = 0.988), Montgomery scale score (P = 0.726), and sleep structure (N1% P = 0.383; N2% P = 0.716; N3% P = 0.772) between the two groups after treatment. Conclusion: Daytime tDCS changed the complexity of sleep in the REM stage, and presented as decreased intrinsic multi-scale entropy, while no changes in sleep structure occurred. This finding indicated that daytime tDCS may be an effective method to improve sleep quality in depressed patients. Trial registration This trial has been registered at the ClinicalTrials.gov (protocol ID: TCHIRB-10409114, in progress). [ABSTRACT FROM AUTHOR]

ObjectiveTo explore the effects of daily use of Gerovital H3 (G.H.3.) tablets on relieving mental symptoms and improving health-related quality of life among Chinese older adults population.MethodsIn a randomized, placebo-controlled, double-blinded study, totally 100 eligible participants were randomly allocated into the G.H.3. group or the placebo group, administered either G.H.3. or placebo tablets and were followed up for three months. All of the participants were required to report their subjective feelings about quality of life, low mood, and anxiety by filling out Self-Rating Depression Scale (SDS), Self-Rating Anxiety Scale (SAS) and a 36-item Short-Form Health Survey (SF-36 scale). Physicians were responsible for evaluating the related mental health indications through physical examinations at the baseline and at the end of the intervention period.ResultsParticipants were men and women between 50 and 89 years of age, with a median of 62.53 years. Before the intervention, the demographic characteristics and the baseline SF-36 scores, low mood, and anxiety statuses were comparable (p > 0.05). After the 12-week intervention, the scores of role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), mental health (MH) and health transition (HT), mental composite score (MCS) of the G.H.3. group were higher than the placebo group (p < 0.05), There were no significant differences in other domains in SF-36 and PCS between the two groups(p > 0.05), the scores of SDS and SAS in the G.H.3. group were both lower than the placebo group(p < 0.01), the prevalence rates of low moods in the G.H.3. group and the placebo group were 20.8 % and 34.0 % respectively, no significant difference was found (χ (2) =2.127,p = 0.145), while the prevalence rate of clinical anxiety concerns in the G.H.3. group was 2.1 %, which was significantly lower than the placebo group, 22.0 % (χ (2) =9.040,p < 0.001).ConclusionsPreliminarily use of G.H.3. shows positive effects in supporting mental health and improving general health and well-being while promoting the recovery of cognitive function among older adults. Most of SF-36 domains including PF, RP, BP, GH, VT, RE, MH, and HT, as well as the overall quality of life in MCS might benefit from taking G.H.3. tablets. Average levels of low moods and anxiety concerns were both reduced and the prevalence rate of clinical anxiety concerns were reduced.

ObjectiveTo explore the effects of daily use of Gerovital H3 (G.H.3.) tablets on relieving mental symptoms and improving health-related quality of life among Chinese older adults population.MethodsIn a randomized, placebo-controlled, double-blinded study, totally 100 eligible participants were randomly allocated into the G.H.3. group or the placebo group, administered either G.H.3. or placebo tablets and were followed up for three months. All of the participants were required to report their subjective feelings about quality of life, low mood, and anxiety by filling out Self-Rating Depression Scale (SDS), Self-Rating Anxiety Scale (SAS) and a 36-item Short-Form Health Survey (SF-36 scale). Physicians were responsible for evaluating the related mental health indications through physical examinations at the baseline and at the end of the intervention period.ResultsParticipants were men and women between 50 and 89 years of age, with a median of 62.53 years. Before the intervention, the demographic characteristics and the baseline SF-36 scores, low mood, and anxiety statuses were comparable (p > 0.05). After the 12-week intervention, the scores of role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), mental health (MH) and health transition (HT), mental composite score (MCS) of the G.H.3. group were higher than the placebo group (p < 0.05), There were no significant differences in other domains in SF-36 and PCS between the two groups(p > 0.05), the scores of SDS and SAS in the G.H.3. group were both lower than the placebo group(p < 0.01), the prevalence rates of low moods in the G.H.3. group and the placebo group were 20.8 % and 34.0 % respectively, no significant difference was found (χ (2) =2.127,p = 0.145), while the prevalence rate of clinical anxiety concerns in the G.H.3. group was 2.1 %, which was significantly lower than the placebo group, 22.0 % (χ (2) =9.040,p < 0.001).ConclusionsPreliminarily use of G.H.3. shows positive effects in supporting mental health and improving general health and well-being while promoting the recovery of cognitive function among older adults. Most of SF-36 domains including PF, RP, BP, GH, VT, RE, MH, and HT, as well as the overall quality of life in MCS might benefit from taking G.H.3. tablets. Average levels of low moods and anxiety concerns were both reduced and the prevalence rate of clinical anxiety concerns were reduced.

Background: Hydroxyethyl starch (HES) solutions are used for volume therapy to treat hypovolemia due to acute blood loss and to maintain hemodynamic stability. This study was requested by the European Medicines Agency (EMA) to provide more evidence on the long-term safety and efficacy of HES solutions in the perioperative setting.Methods: PHOENICS is a randomized, controlled, double-blind, multi-center, multinational phase IV (IIIb) study with two parallel groups to investigate non-inferiority regarding the safety of a 6% HES 130 solution (Volulyte 6%, Fresenius Kabi, Germany) compared with a crystalloid solution (Ionolyte, Fresenius Kabi, Germany) for infusion in patients with acute blood loss during elective abdominal surgery. A total of 2280 eligible patients (male and female patients willing to participate, with expected blood loss ≥ 500 ml, aged > 40 and ≤ 85 years, and ASA Physical status II-III) are randomly assigned to receive either HES or crystalloid solution for the treatment of hypovolemia due to surgery-induced acute blood loss in hospitals in up to 11 European countries. The dosing of investigational products (IP) is individualized to patients' volume needs and guided by a volume algorithm. Patients are treated with IP for maximally 24 h or until the maximum daily dose of 30 ml/kg body weight is reached. The primary endpoint is the treatment group mean difference in the change from the pre-operative baseline value in cystatin-C-based estimated glomerular filtration rate (eGFR), to the eGFR value calculated from the highest cystatin-C level measured during post-operative days 1-3. Further safety and efficacy parameters include, e.g., combined mortality/major post-operative complications until day 90, renal function, coagulation, inflammation, hemodynamic variables, hospital length of stay, major post-operative complications, and 28-day, 90-day, and 1-year mortality.Discussion: The study will provide important information on the long-term safety and efficacy of HES 130/0.4 when administered according to the approved European product information. The results will be relevant for volume therapy of surgical patients.Trial Registration: EudraCT 2016-002162-30 . ClinicalTrials.gov NCT03278548. [ABSTRACT FROM AUTHOR]

Abstract Background One of the most serious secondary manifestations of Cardiovascular Disease (CVD) is coronary atherosclerosis. This study aimed to evaluate whether aged garlic extract (AGE) can influence coronary artery calcification (CAC) and to predict the individual effect of AGE using a standard process for data mining (CRISP–DM). Method This was a single-center parallel randomized controlled study in a university hospital in Europe. Patients were randomized, in a double-blind manner, through a computer-generated randomization chart. Patients with a Framingham risk score ≥ 10 after CT scan (n = 104) were randomized to an intake of placebo or AGE (2400 mg daily) for 1 year. Main outcome measures were changes in CAC score and secondary outcome measures changes in blood pressure, fasting blood glucose, blood lipids and inflammatory biomarkers. Result 104 patients were randomized and 46 in the active group and 47 in the placebo group were analyzed. There was a significant (p

Introduction: Stroke is characterized by high incidence, recurrence rate, and mortality. Patients with acute ischemic stroke (AIS) who are ineligible for acute revascularization therapy require more effective medication treatments. A previous clinical study showed that Ruyi Zhenbao tablets and Baimai ointments might be effective against AIS; however, high-quality clinical evidence supporting their application in AIS is lacking. To explore the efficacy of the two classic Tibetan medicines in the treatment of AIS, a randomized clinical trial will be conducted in patients with AIS who are not eligible for thrombolytic treatment., Methods: A prospective, randomized, multiple-center, double-blinded, placebo-controlled, and parallel-group trial will be conducted. We shall randomize 480 eligible participants to either the intervention or the control group. The distribution ratio of each group will be 1:1:1:1, including 120 patients each in the dual-medication group, the Baimai ointment group, the Ruyi Zhenbao tablet group, and the placebo group. Participants will be treated with medication for 8 weeks, and they will receive three follow-up visits: at 4 weeks (D29), 8 weeks (D56), and 90 days (D90) after commencing treatment. The primary outcome will be D90 change in the simplified Fugl-Meyer score from baseline to posttreatment. The secondary outcomes are as follows: D29 change of simplified Fugl-Meyer score from baseline to posttreatment; proportion of participants whose D29 NIHSS scores decreased by four or more points from baseline D90 proportion of subjects with mRS score of 0-2 (inclusive); D90 proportion of subjects with Barthel index score ≥95; D90 incidence of cardiovascular and cerebrovascular events. Safety endpoint includes mortality within 90 days; proportion of subjects with adverse events/serious adverse events within 90 days., Conclusion: This research protocol lays a solid groundwork for its practical execution. This study is poised to serve as a reference for other Tibetan medicine researchers, contributing to the reduction of stroke-related expenditures globally and, in turn, benefiting a broader population of stroke patients., Competing Interests: All the authors have completed the ICMJE uniform disclosure form. The authors declare no conflicts of interest., (© 2024 The Author(s). Published by S. Karger AG, Basel.)

Background: One of the most serious secondary manifestations of Cardiovascular Disease (CVD) is coronary atherosclerosis. This study aimed to evaluate whether aged garlic extract (AGE) can influence coronary artery calcification (CAC) and to predict the individual effect of AGE using a standard process for data mining (CRISP–DM). Method: This was a single-center parallel randomized controlled study in a university hospital in Europe. Patients were randomized, in a double-blind manner, through a computer-generated randomization chart. Patients with a Framingham risk score ≥ 10 after CT scan (n = 104) were randomized to an intake of placebo or AGE (2400 mg daily) for 1 year. Main outcome measures were changes in CAC score and secondary outcome measures changes in blood pressure, fasting blood glucose, blood lipids and inflammatory biomarkers. Result: 104 patients were randomized and 46 in the active group and 47 in the placebo group were analyzed. There was a significant (p < 0.05) change in CAC progression (OR: 2.95 [1.05–8.27]), blood glucose (OR: 3.1 [1.09–8.85]) and IL-6 (OR 2.56 [1.00–6.53]) in favor of the active group. There was also a significant (p = 0.027) decrease in systolic blood pressure in the AGE group, from a mean of 148 (SD: 19) mmHg at 0 months, to 140 (SD: 15) mmHg after 12 months. The AGE Algorithm, at a selected probability cut-off value of 0.5, the accuracy score for CAC progression was 80%, precision score of 79% and recall score 83%. The score for blood pressure was 74% (accuracy, precision and recall). There were no side-effects in either group. Conclusions: AGE inhibits CAC progression, lowers IL–6, glucose levels and blood pressure in patients at increased risk of cardiovascular events in a European cohort. An algorithm was made and was used to predict with 80% precision which patient will have a significantly reduced CAC progression using AGE. The algorithm could also predict with a 74% precision which patient will have a significant blood pressure lowering effect pressure using AGE. Trial registration: Clinical trials , retrospectively registered (1/32019). [ABSTRACT FROM AUTHOR]

Ethnopharmacological relevance: Shuganjianpi Therapy (SGJP), Jianpi Therapy (JP), Shugan Therapy (SG), Jianpiwenshen Therapy (JPWS), and Shuganjianpiwenshen Therapy (SGJPWS), consisting of formulas from Chinese herbal medicine (CHM), have been tremendously applied to irritable bowel syndrome (IBS). However, it remains uncertain when exploring the preferable option among different CHM therapies for diarrhea-predominant irritable bowel syndrome (IBS-D). Aim of the study : To compare and rank the efficacy and safety of different CHM therapies for IBS-D. Materials and methods: We searched randomized, double-blinded, placebo-controlled trials through mainstream databases from their inception to October 31, 2022. Eligible randomized controlled trials (RCTs) applied one of the CHM therapies as the experimental group and placebo as the control group. Two authors independently extracted data into a form and evaluated the quality of the retrieved articles by the Cochrane Risk of Bias Tool. At least one of the following outcomes was assessed: Serotonin, Neuropeptide Y (NPY), Incidence of Adverse Events (AE), and Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) with its subscales of Severity of Abdominal Pain (SAP), Frequency of Abdominal Pain (FAP), Severity of Abdominal Distension (SAD), Dissatisfaction with Bowel Habits (DBH), and Interference with Quality of Life (IQOL). A Bayesian network meta-analysis on a random-effect model was conducted using R 4.2.2 software. Results: 1367 records were retrieved from databases in an initial search. Fourteen studies involving six interventions with 2248 participants were identified. Provided pairwise comparisons, the surface under the cumulative ranking curve (SUCRA) ranking, and cluster analysis, JPWS was the best option for ameliorating clinical symptoms simultaneously, which included IBS-SSS, SAP, FAP, SAD, DBH, and IQOL. As for AE, JPWS contributed to fewer adverse events than others as well. In respect of serum indicators, we noticed the dominance of SGJP in regulating both serotonin and NPY. Conclusions: JPWS and SGJP were the most prominent CHM therapies for IBS-D in terms of clinical symptoms, including abdominal pain, distension, bowel habits, and improvement of quality of life. The effect of JP and SG for IBS-D required further investigation. As a potential candidate, SGJP may well treat IBS-D by mediating dysmotility, visceral hypersensitivity, and the gut-brain axis with an increase of NPY and a reduction of serotonin. For safety, JPWS was ideal for the fewest adverse events in the treatment of IBS-D. On account of a small sample size and possible geographical publication bias, more double-blinded and placebo-controlled trials with larger samples worldwide would be necessary for strengthening current evidence. [Display omitted] [ABSTRACT FROM AUTHOR]

Selenium (Se) compounds have demonstrated anticancer properties in both preclinical and clinical studies, with particular promise in combination therapy where the optimal form and dose of selenium has yet to be established. In a phase I randomised double-blinded study, the safety, tolerability and pharmacokinetic (PK) profiles of sodium selenite (SS), Se-methylselenocysteine (MSC) and seleno-l-methionine (SLM) were compared in patients with chronic lymphocytic leukaemia and a cohort of patients with solid malignancies. Twenty-four patients received 400 μg of elemental Se as either SS, MSC or SLM for 8 weeks. None of the Se compounds were associated with any significant toxicities, and the total plasma Se AUC of SLM was markedly raised in comparison to MSC and SS. DNA damage assessment revealed negligible genotoxicity, and some minor reductions in lymphocyte counts were observed. At the dose level used, all three Se compounds are well-tolerated and non-genotoxic. Further analyses of the pharmacodynamic effects of Se on healthy and malignant peripheral blood mononuclear cells will inform the future evaluation of higher doses of these Se compounds. The study is registered under the Australian and New Zealand Clinical Trials Registry No: ACTRN12613000118707. [ABSTRACT FROM AUTHOR]

Hyposmia is one of the earliest and the most common symptoms in Parkinson's disease (PD). The benefits of hydrogen water on motor deficits have been reported in animal PD models and PD patients, but the effects of hydrogen gas on PD patients have not been studied. We evaluated the effect of inhalation of hydrogen gas on olfactory function, non-motor symptoms, activities of daily living, and urinary 8-hydroxy-2′-deoxyguanine (8-OHdG) levels by a randomized, double-blinded, placebo-controlled, crossover trial with an 8-week washout period in 20 patients with PD. Patients inhaled either ~1.2–1.4% hydrogen-air mixture or placebo for 10 minutes twice a day for 4 weeks. Inhalation of low dose hydrogen did not significantly influence the PD clinical parameters, but it did increase urinary 8-OHdG levels by 16%. This increase in 8-OHdG is markedly less than the over 300% increase in diabetes, and is more comparable to the increase after a bout of strenuous exercise. Although increased reactive oxygen species is often associated with toxicity and disease, they also play essential roles in mediating cytoprotective cellular adaptations in a process known as hormesis. Increases of oxidative stress by hydrogen have been previously reported, along with its ability to activate the Nrf2, NF-κB pathways, and heat shock responses. Although we did not observe any beneficial effect of hydrogen in our short trial, we propose that the increased 8-OHdG and other reported stress responses from hydrogen may indicate that its beneficial effects are partly or largely mediated by hormetic mechanisms. The study was approved by the ethics review committee of Nagoya University Graduate School of Medicine (approval number 2015-0295). The clinical trial was registered at the University Hospital Medical Information Network (identifier UMIN000019082). [ABSTRACT FROM AUTHOR]

Objective: To compare the efficacy of the compuLsive Exercise Activity theraPy (LEAP) programme integrated with manualized cognitive behavioral therapy for anorexia nervosa (CBT‐AN) compared to CBT‐AN alone. Method: Seventy‐eight adults were randomized to CBT‐AN, delivered with or without eight embedded sessions of LEAP, for a total of 34 individual outpatient sessions. Participants were assessed at baseline, the end of the first phase of CBT‐AN (which included LEAP), mid‐therapy, end of therapy, and at 3 and 6 months follow‐up. Linear mixed effects modelling was used for comparing trajectories over time by group in primary outcomes of pathological exercise cognitions and secondary outcomes of exercise frequency, BMI, eating disorder (ED) symptoms, AN stage of change, anxiety/depression, and health related quality of life. Results: There were significant improvements over time in all outcomes. There were no significant differences between treatment groups in primary outcome measures. Fidelity and end‐of‐treatment participant satisfaction were satisfactory across both conditions. Discussion CBT‐AN and LEAP added to CBT‐AN resulted in improved attitudes and beliefs toward exercise and general improvements in BMI and ED psychopathology in people with AN. [ABSTRACT FROM AUTHOR]

Checkpoint inhibitors are effective in recurrent/metastatic nasopharyngeal cancer (R/M NPC). RATIONALE-309 (NCT03924986) randomized 263 treatment-naive R/M NPC patients to tislelizumab or placebo every 3 weeks (Q3W), plus chemotherapy (Q3W for 4–6 cycles). At interim analysis, progression-free survival (PFS) was significantly longer with tislelizumab-chemotherapy versus placebo-chemotherapy (hazard ratio: 0.52; 95% confidence interval: 0.38, 0.73; p < 0.0001). PFS benefit for tislelizumab-chemotherapy versus placebo-chemotherapy was observed regardless of programmed death-ligand 1 expression. PFS after next line of treatment and overall survival showed favorable trends for tislelizumab-chemotherapy versus placebo-chemotherapy. The safety profile was similar between arms. Gene expression profiling (GEP) identified immunologically "hot" tumors, and showed an activated dendritic cell (DC) signature was associated with tislelizumab-chemotherapy PFS benefit. Our results support that tislelizumab-chemotherapy should be considered as first-line treatment for R/M NPC, and GEP and activated DC signature results may help identify patients who might benefit most from immunochemotherapy treatment. [Display omitted] [Display omitted] • First-line tislelizumab plus chemotherapy improves PFS, PFS2, and OS • The combination shows a manageable safety profile in patients with R/M NPC • Efficacy is observed irrespective of EBV level and PD-L1 expression • Patients with high levels of activated dendritic cell signature may benefit most from treatment Yang et al. demonstrate the efficacy and safety of tislelizumab plus chemotherapy (gemcitabine-cisplatin) in treatment-naive patients with recurrent/metastatic nasopharyngeal cancer. Compared with placebo-chemotherapy, tislelizumab-chemotherapy extends progression-free survival, irrespective of PD-L1 expression, as well as progression-free survival after next line of treatment, with a tolerable safety profile. [ABSTRACT FROM AUTHOR]

Background: Although tyrosine kinase inhibitors (TKIs) are still recommended as the standard therapy in renal cell carcinoma (RCC), the high frequency of adverse events is a weakness of this therapy. Because royal jelly (RJ) possesses anti-inflammatory and antioxidant properties, we assessed its protective effects on TKI-induced toxicities in RCC patients. Methods: We enrolled 33 patients with advanced RCC who were assigned to start TKI therapy in combination with a randomized, double-blinded, placebo-controlled RJ trial consisting of a placebo group with 17 subjects and an RJ group with 16 subjects. Results: Fatigue and anorexia frequencies in the RJ group were significantly lower than in the placebo group (p = 0.003 and 0.015, respectively). A statistically significant correlation between RJ and fatigue or anorexia was detected in sunitinib-treated patients. The dose reduction- or discontinuation-free periods were significantly longer (p = 0.013) in the RJ group than in the placebo group. Furthermore, similar observations were made in sunitinib-treated patients (p = 0.016). Conclusions: Our clinical trial showed that RJ exerted protective effects against TKI-induced fatigue and anorexia and lowered TKI dose reduction or discontinuation. Hence, RJ is beneficial for maintaining the quality of life and medication compliance in TKI-treated RCC patients.

This study investigated the impact of the improvement of insomnia on the blood pressure levels of hypertensive patients. A total of 402 patients with a diagnosis of insomnia and hypertension were selected and randomly divided into two groups. The treatment group (202 cases) received standard anti-hypertensive treatment with Estazolam, and the control group (200 cases) received standard anti-hypertensive treatment with placebo. The sedentary diastolic and systolic blood pressures were measured before the treatment and every 7 days during the experiment. To assess the sleep quality and anxiety and depression levels of patients, the scores of the Pittsburgh Sleep Quality Index, the Hamilton Anxiety Rating Scale and the Hamilton Depression Scale-17 were reported at the same time points. At the conclusion of the experiment, the Pittsburgh Sleep Quality Index, Hamilton Anxiety Rating Scale and Hamilton Depression Scale-17 scores of the treatment group were significantly lower than those of the control group ( P < 0.001). The insomnia treatment efficacy of Estazolam in the treatment group was 67.3%, significantly higher than that (14.0%) of the control ( P < 0.001). The blood pressure of the treatment group showed significant improvement throughout the experiment. By Day 28, the decrease of sedentary diastolic and systolic blood pressures in the treatment group was significantly greater than that of the control (sedentary systolic blood pressure: 10.5 ± 3.9 versus 3.4 ± 2.5 mmHg; sedentary diastolic blood pressure: 8.1 ± 3.6 versus 2.7 ± 2.1 mmHg, P < 0.001), and the compliance rate of goal blood pressure (< 140/90 mmHg) was 74.8% with Estazolam, compared with 50.5% with placebo ( P < 0.001). Thus, the current findings indicated that the improvement of insomnia can significantly help lower blood pressure in hypertensive patients. [ABSTRACT FROM AUTHOR]

Background: Intra-articular inflammation resulting in lameness is a common health problem in horses. Exogenous intra-articular hyaluronic acid has been shown to provide an analgesic effect and reduce pain in equine and human osteoarthritis. High molecular weight non-animal stabilized hyaluronic acid (NASHA) has gained popularity in the treatment of human arthritic conditions due to its long-acting pain-relieving effects. The aim of this study was to compare the response to treatment of lameness localized in the equine metacarpophalangeal joint injected with non-animal stabilized hyaluronic acid (NASHA) and placebo (saline). Twenty-seven clinically lame horses with a positive response to diagnostic intra-articular anaesthesia of the metacarpophalangeal joint and with no, or at most mild, radiographic changes in this joint were included in the study. Horses in the treatment group (n = 14) received 3 mL of a NASHA product intra-articularly, and those in the placebo group (n = 13) received an equivalent volume of sterile 0.9 % saline solution. Results: The change in the lameness score did not significantly differ between NASHA and placebo groups (P = 0.94). Scores in the flexion test improved more in the NASHA group compared with placebo (P = 0.01). The changes in effusion and pain in flexion were similar (P = 0.94 and P = 0.27, respectively) when NASHA and placebo groups were compared. A telephone interview follow-up of the owners three months post-treatment revealed that 14 of the 21 horses (67 %) were able to perform at their previous level of exercise. Conclusions: In the present study, a single IA NASHA injection was not better than a single saline injection for reducing lameness in horses with synovitis or mild osteoarthritis. However, the results of this study indicate that IA NASHA may have some beneficial effects in modifying mild clinical signs but more research is needed to evaluate whether the positive effect documented ie. reduced response in the flexion test is a true treatment effect. [ABSTRACT FROM AUTHOR]

Objective: To explore the effects of daily use of Gerovital H3 (G.H.3.) tablets on relieving mental symptoms and improving health-related quality of life among Chinese older adults population.Methods: In a randomized, placebo-controlled, double-blinded study, totally 100 eligible participants were randomly allocated into the G.H.3. group or the placebo group, administered either G.H.3. or placebo tablets and were followed up for three months. All of the participants were required to report their subjective feelings about quality of life, low mood, and anxiety by filling out Self-Rating Depression Scale (SDS), Self-Rating Anxiety Scale (SAS) and a 36-item Short-Form Health Survey (SF-36 scale). Physicians were responsible for evaluating the related mental health indications through physical examinations at the baseline and at the end of the intervention period.Results: Participants were men and women between 50 and 89 years of age, with a median of 62.53 years. Before the intervention, the demographic characteristics and the baseline SF-36 scores, low mood, and anxiety statuses were comparable (p > 0.05). After the 12-week intervention, the scores of role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), mental health (MH) and health transition (HT), mental composite score (MCS) of the G.H.3. group were higher than the placebo group (p < 0.05), There were no significant differences in other domains in SF-36 and PCS between the two groups(p > 0.05), the scores of SDS and SAS in the G.H.3. group were both lower than the placebo group(p < 0.01), the prevalence rates of low moods in the G.H.3. group and the placebo group were 20.8 % and 34.0 % respectively, no significant difference was found (χ (2) =2.127,p = 0.145), while the prevalence rate of clinical anxiety concerns in the G.H.3. group was 2.1 %, which was significantly lower than the placebo group, 22.0 % (χ (2) =9.040,p < 0.001).Conclusions: Preliminarily use of G.H.3. shows positive effects in supporting mental health and improving general health and well-being while promoting the recovery of cognitive function among older adults. Most of SF-36 domains including PF, RP, BP, GH, VT, RE, MH, and HT, as well as the overall quality of life in MCS might benefit from taking G.H.3. tablets. Average levels of low moods and anxiety concerns were both reduced and the prevalence rate of clinical anxiety concerns were reduced. [ABSTRACT FROM AUTHOR]

Objective: To evaluate cosmesis, body image, pain, and quality of life (QoL) after single-port laparoscopic cholecystectomy (SPLC) versus conventional 4-port laparoscopic cholecystectomy (4PLC). Background: The impact of SPLC on improving cosmesis, body image, pain, and QoL has not been evaluated in double-blinded randomized controlled trials (RCT). This approach therefore remains controversial. Methods: Between October 2011 and February 2014, 110 patients from 2 centers were randomly assigned to SPLC (n=55) or 4PLC (n=55). Primary endpoints were a validated cosmesis (3-24 points) and body image (5-20 points) score after 3 and 12 months. Secondary endpoints included operative duration, postoperative pain, complications, QoL, and length of hospital stay. Patients, physicians, and nurses were blinded until the seventh postoperative day. Results: Demographics were equally distributed between both groups (mean age: 46 years, SD: 14, 62 females, 34 males). The SPLC-group showed superior mean cosmesis and body image compared with the 4PLC-group at 12-weeks (21 vs 16, P<0.001 and 5 vs 6, P=0.013, respectively) and at 1-year (24 vs 16, P<0.001 and 5 vs 6, P<0.017, respectively). Operation duration was longer in the SPLC-group (mean 101 vs 90 minutes, p=0.031). Although postoperative pain was less in the SPLC-group (mean VAS 1 vs 2, p=0.005), there were no differences in complications, and length of hospital-stay. Conclusions: This is the first multicenter double-blinded RCT reporting superior short- and long-term cosmetic and body image, postoperative pain, and QoL in SPLC compared with 4PLC. Although cost-effectiveness is still a subject of ongoing debate, SPLC should be offered to patients undergoing surgery for benign gallbladder disease. [ABSTRACT FROM AUTHOR]

Abstract: Complex regional pain syndrome (CRPS) is a severe chronic pain condition that most often develops following trauma. The pathophysiology of CRPS is not known but both clinical and experimental evidence demonstrate the important of the NMDA receptor and glial activation in its induction and maintenance. Ketamine is the most potent clinically available safe NMDA antagonist that has a well established role in the treatment of acute and chronic pain. This randomized double-blind placebo controlled trial was designed to evaluate the effectiveness of intravenous ketamine in the treatment of CRPS. Before treatment, after informed consent was obtained, each subject was randomized into a ketamine or a placebo infusion group. Study subjects were evaluated for at least 2weeks prior to treatment and for 3months following treatment. All subjects were infused intravenously with normal saline with or without ketamine for 4h (25ml/h) daily for 10days. The maximum ketamine infusion rate was 0.35mg/kg/h, not to exceed 25mg/h over a 4h period. Subjects in both the ketamine and placebo groups were administered clonidine and versed. This study showed that intravenous ketamine administered in an outpatient setting resulted in statistically significant (p <0.05) reductions in many pain parameters. It also showed that subjects in our placebo group demonstrated no treatment effect in any parameter. The results of this study warrant a larger randomized placebo controlled trial using higher doses of ketamine and a longer follow-up period. [Copyright &y& Elsevier]

Summary: Background & aims: Diacylglycerol oil has been shown to lower postprandial and fasting serum triacylglycerol levels and reduce body fat. The aim of this study was to investigate the effect of diacylglycerol oil on risk factors of type 2 diabetes mellitus (DM) and cardiovascular disease in type 2 DM patients. Methods: This was a double-blind controlled parallel study with 127 type 2 DM patients (aged 40–65) recruited in Hangzhou, China. All subjects consumed triacylglycerol oil in the lead-in period (14 days), then they were randomly divided into two groups and consumed diacylglycerol or triacylglycerol oil with a similar fatty acid composition (25g/day) for 120 days. Blood samples were collected on days 0, 60 and 120 and risk factors of type 2 DM and cardiovascular disease and biochemical parameters were measured by standard methods. Results: There were a total of 112 subjects who completed the study. Diet intake did not differ significantly between groups. Body weight, BMI, waist circumference, HOMA-IR, serum insulin and leptin levels were significantly reduced from baseline in the diacylglycerol oil group but not in the triacylglycerol oil group. Serum glucose was also significantly improved in patients with higher glucose levels at baseline (>7.00mmol/L) in the diacylglycerol oil group. Parameters of liver and kidney functions and essential fatty acids in serum phospholipids did not differ between groups. Conclusions: Diacylglycerol oil consumption improved biomarkers and anthropometric parameters of type 2 DM compared with triacylglycerol oil. No adverse reactions were observed with diacylglycerol oil consumption for type 2 DM patients. Diacylglycerol oil has an equivalent bioavailability as triacylglycerol oil in relation to providing essential fatty acids. [Copyright &y& Elsevier]

Perennial allergic rhinitis (PAR) often causes sleep disturbances and associated daytime somnolence, thus resulting in a poor quality of life. Various clinical interventions in patients suffering from the disorder seek to improve symptoms and quality of life. Additional studies are needed to establish whether the alleviation of PAR symptoms, particularly the reduction of congestion, will improve sleep quality and reduce daytime somnolence. This study seeks to determine whether treatment with montelukast is more effective than placebo in reducing nasal congestion and sleep disturbances, resulting in reduced daytime somnolence and fatigue in patients with PAR. Thirty-one subjects were enrolled in a double-blinded, placebo-controlled study using Balaam's design. Patients were treated with montelukast or placebo. Collected subjective data included a daily diary recording nasal symptoms, sleep issues, and daytime fatigue, the Functional Outcomes of Sleep Questionnaire, the Epworth Sleepiness Scale, Juniper's Rhinoconjunctivitis Quality of Life Questionnaire, the Rhinitis Severity Scale, the Calgary Sleep Apnea Quality of Life Index, and Trail Making tests. Subjects treated with montelukast, compared with placebo, showed a statistically significant improvement in daytime somnolence (p = 0.0089) and daytime fatigue (p = 0.0087), with both factors improving with montelukast and worsening with placebo. In a small cohort of subjects, montelukast, when compared with placebo, improved the symptoms of PAR and reduced the fatigue and daytime somnolence associated with the disorder. [ABSTRACT FROM AUTHOR]

OBJECTIVE. Our hypothesis was that infants with perinatal brain injury fail to thrive in the first postnatal year because of increased energy and protein requirements from deficits that accumulated during neonatal intensive care. Our aim was to assess whether dietary energy and protein input was a rate-limiting factor in brain and body growth in the first year after birth. METHODS. We conducted a prospective, double-blind and randomized, 2-stage group sequential study and controlled for gestation, gender, and brain lesion. Neonates with perinatal brain damage were randomly allocated to receive either a high -(120% recommended average intake) or average (100% recommended average intake) energy and protein diet. The study began at term and continued for 12 months. Three-day dietary diaries estimated energy and protein intake. The primary outcome measure was growth of occipitofrontal circumference. Other measures were growth of axonal diameters in the corticospinal tract, which were estimated by using transcranial magnetic stimulation, weight gain, and length. RESULTS. The study was terminated at the first analysis when the 16 subjects had completed the protocol, because the predetermined stopping criterion of >1 SD difference in occipitofrontal circumference at 12 months' corrected age in those receiving the higher-energy and -protein diet had been demonstrated. Axonal diameters in the corticospinal tract, length, and weight were also significantly increased. CONCLUSIONS. These data support our hypothesis that infants with significant perinatal brain damage have increased nutritional requirements in the first postnatal year and suggest that decreased postnatal brain growth may exacerbate their impairment. There are no measures of cognitive ability at 12 months of age, and whether there will be any improvement in the status of these children, therefore, remains to be shown. [ABSTRACT FROM AUTHOR]

This study aimed to compare the efficacy of intrathecal nalbuphine and buprenorphine as an adjuvant to heavy bupivacaine (0.5%) for spinal anesthesia in lower limb orthopedic surgeries to improve the quality of spinal anesthesia (onset, duration, and side effects) and prolongation of postoperative analgesia. Sixty patients were recruited into this single-centered, double-blinded, hospital-based, prospective, comparative study conducted in 2017-2018. They were randomly and equally (n = 30) allocated into two groups: nalbuphine group which received 0.5 mL (0.8 mg) of nalbuphine with 3 mL of heavy (0.5%) hyperbaric bupivacaine and buprenorphine group which received 0.5 mL (60 mg) of buprenorphine with 3 mL of heavy hyperbaric bupivacaine. Intraoperatively, onset and duration of blockade (motor and sensory), and time for first dose of rescue analgesia were recorded in both groups at regular intervals. Heart rate, blood pressure, Visual Analogue Scale score and side effects were also recorded postoperatively for 12 hours. The demographic parameters, time of onset of sensory block and motor block, and duration of motor block were comparable between nalbuphine and buprenorphine groups. The duration of sensory block in the buprenorphine group was longer than in the nalbuphine group. Time to the first dose of rescue analgesia was delayed in buprenorphine group as compared to nalbuphine group. In both groups maximum patients achieved maximum height of sensory block at 90 minutes. There were significant differences in the mean heart rate and blood pressure between buprenorphine and nalbuphine groups. Nalbuphine group patients achieved a Visual Analogue Scale score > 4 earlier as compared to buprenorphine group. Few side effects were observed in both groups. Intrathecal buprenorphine is a better adjuvant to 0.5% bupivacaine in the spinal anesthesia for lower limb orthopedic surgeries, as it provides longer sensory block and delayed administration of first dose of rescue analgesia with negligible side-effects. The study was approved by Institutional Ethics Committee of Krishna Institute of Medical Sciences (approval number: KIMSDU/IEC/03/2017) on November 23, 2017.

• The study supports the beneficial effect of Kaixinsan, a TCM formula, in mild and moderate depressive disorder without ADR • Depressive individuals were found with adverse plasma lipid patterns • KXS treatment might improve patients' lipid profile especially on apolipoproteins Traditional Chinese medicine (TCM) KaiXinSan (KXS) has been used to treat depressed patients for a long time, but its potential underlying mechanisms have not been fully understood. KXS could mitigate symptoms of patients with atypical depression at least partly via regulating lipid equilibrium. Patients meeting DSM-IV criteria for mild or moderate depression were assigned into placebo (N = 68) or KXS 3.2 g/day (N = 66) groups in a randomized, double-blinded, placebo-controlled, parallel clinical trial to investigate the anti-depressive efficacy of KXS and its association with serum lipid profile. The HAMD score and SDS score at 8 weeks were significantly improved in KXS-treated patients the N-BACK accuracy rate was also increased after 8 weeks of KXS treatment compared with baseline. These results indicated that KXS not only improved the specific symptoms of depression, but also had a beneficial effect on cognitive function related working memory. More importantly, KXS treatment improved patients' lipid profile by reducing the ratios of LDL/HDL and ApoB/ApoA1 (p < 0.05), as well as ApoC3 level. Moreover, subgroup analysis found that HAMD score was significantly higher in patients with high lipid profile than in those with normal lipid profile, and lipid improvement after 8 weeks of KXS treatment was more obvious in depressed patients with high lipid profile than with normal lipid profile. KXS could mitigate symptoms of patients with minor and modest depression at least partly via regulating lipid equilibrium. Its might shed light that KXS may likely contributes to depressed patients with other cardio-metabolic diseases. Image, graphical abstract [ABSTRACT FROM AUTHOR]

Background: The use of drugs to attenuate the haemodynamic response to laryngoscopy and endotracheal intubation is the standard of care during elective surgery. Current evidence is conflicting concerning the best agent and optimal dose for this purpose. In the majority of cases, fentanyl is widely utilized to attenuate haemodynamic responses. Ketamine, an established available drug, has been scarcely studied in this regard at low doses and against varying doses of other common agents., Objective: To compare the overall occurrence of hypertension and tachycardia immediately pre-intubation (post-induction) until 10 minutes post intubation between the study group receiving fentanyl at 1.0 µg/kg and the other receiving ketamine at 0.5 mg/kg, to compare the occurrence of post-induction hypotension and the occurrence of neuropsychiatric phenomena during emergence between the two groups., Methods: One hundred and eight ASA I and II patients aged 18-65 years scheduled for elective surgery under general anaesthesia were randomized into two groups: Control group: received fentanyl 1.0 µg/kg intravenously. Intervention group: received ketamine 0.5 mg/kg intravenously. General anaesthesia was standardized in both groups. The patients and physicians administering anaesthesia were blinded to the study. Haemodynamic responses were evaluated by determining heart rate and blood pressure immediately before laryngoscopy and at 2.5, 5, 7.5 and 10 minutes. Neuropsychiatric phenomena were assessed upon recovery from anaesthesia., Results: One hundred and eight ASA I and II patients scheduled to undergo elective surgery were included in this study, 54 participants (50%) in the fentanyl arm and 54 (50%) in the ketamine arm. Baseline demographic characteristics were similar between the groups. There were more hypertensive episodes in the ketamine arm (11%) compared to the fentanyl arm (1.85%), but not achieving statistical significance: Fisher's exact test, p=0.06. There was no significant difference in the number of episodes of tachycardia between the Ketamine group 7/54 (13%) and the fentanyl group, 6/54 (11%); x2=0.05, p=0.82. Hypotensive episodes were more common in those who received Fentanyl, 41/54 (76%), compared to ketamine recipients, 21/54 (39%), X2=16.9, p<0.001. The use of Ketamine was associated with less episodes of hypotension, adjusted odds ratio = 0.18 (95% confidence interval 0.07, 0.45)., Conclusion: We conclude, based upon findings in this study group, that there is no difference in the occurrence of hypertension with the use ketamine at 0.5 mg/kg in combination with Propofol at 2.0 mg/kg. In this regard, ketamine provides a viable alternative to fentanyl at 1.0 µg/kg for attenuating the pressor response to laryngoscopy and endotracheal intubation. Additionally, our results suggest that ketamine may protect against post-induction (pre-laryngoscopy) hypotension., (© 2019 Ongewe et al.)

Hyposmia is one of the earliest and the most common symptoms in Parkinson's disease (PD). The benefits of hydrogen water on motor deficits have been reported in animal PD models and PD patients, but the effects of hydrogen gas on PD patients have not been studied. We evaluated the effect of inhalation of hydrogen gas on olfactory function, non-motor symptoms, activities of daily living, and urinary 8-hydroxy-2'-deoxyguanine (8-OHdG) levels by a randomized, double-blinded, placebo-controlled, crossover trial with an 8-week washout period in 20 patients with PD. Patients inhaled either ~1.2-1.4% hydrogen-air mixture or placebo for 10 minutes twice a day for 4 weeks. Inhalation of low dose hydrogen did not significantly influence the PD clinical parameters, but it did increase urinary 8-OHdG levels by 16%. This increase in 8-OHdG is markedly less than the over 300% increase in diabetes, and is more comparable to the increase after a bout of strenuous exercise. Although increased reactive oxygen species is often associated with toxicity and disease, they also play essential roles in mediating cytoprotective cellular adaptations in a process known as hormesis. Increases of oxidative stress by hydrogen have been previously reported, along with its ability to activate the Nrf2, NF-κB pathways, and heat shock responses. Although we did not observe any beneficial effect of hydrogen in our short trial, we propose that the increased 8-OHdG and other reported stress responses from hydrogen may indicate that its beneficial effects are partly or largely mediated by hormetic mechanisms. The study was approved by the ethics review committee of Nagoya University Graduate School of Medicine (approval number 2015-0295). The clinical trial was registered at the University Hospital Medical Information Network (identifier UMIN000019082)., Competing Interests: Conflicts of interest There is no conflict of interest.

Background: Although tyrosine kinase inhibitors (TKIs) are still recommended as the standard therapy in renal cell carcinoma (RCC), the high frequency of adverse events is a weakness of this therapy. Because royal jelly (RJ) possesses anti-inflammatory and antioxidant properties, we assessed its protective effects on TKI-induced toxicities in RCC patients. Methods: We enrolled 33 patients with advanced RCC who were assigned to start TKI therapy in combination with a randomized, double-blinded, placebo-controlled RJ trial consisting of a placebo group with 17 subjects and an RJ group with 16 subjects. Results: Fatigue and anorexia frequencies in the RJ group were significantly lower than in the placebo group ( p = 0.003 and 0.015, respectively). A statistically significant correlation between RJ and fatigue or anorexia was detected in sunitinib-treated patients. The dose reduction- or discontinuation-free periods were significantly longer ( p = 0.013) in the RJ group than in the placebo group. Furthermore, similar observations were made in sunitinib-treated patients ( p = 0.016). Conclusions: Our clinical trial showed that RJ exerted protective effects against TKI-induced fatigue and anorexia and lowered TKI dose reduction or discontinuation. Hence, RJ is beneficial for maintaining the quality of life and medication compliance in TKI-treated RCC patients.

Clinical trials are the backbone of modern day medicine. Randomized, double-blinded, placebo-controlled studies are critical for advancement in medicine and dermatology. Skin conditions such as psoriasis and atopic dermatitis are among the most common health problems in the United States. Clinical trials can provide treatments that not only offer objective improvements in clinical disease status but also subjective improvements in the quality of life of patients who are afflicted with the disease. In this article, we discuss the processes and resources of a clinical trials unit and the challenges that can be encountered during the study process. It is critical to engage in clinical trials to treat patients most effectively with new and innovative therapies that are rooted in trial-validated, evidence-based medicine.

Background: Glomerular filtration rate (GFR) declines during long-term dialysis treatment. In peritoneal dialysis, blockade of the renin-angiotensin-aldosterone system reduces GFR decline. Observational studies suggest that similar treatment may preserve kidney function in hemodialysis (HD)., Study Design: A multicenter, randomized, placebo-controlled, double-blinded trial, with 1-year follow-up., Setting & Participants: Adult HD patients with urine output >300mL/24h, HD vintage less than 1 year, and cardiac ejection fraction >30%. Patients were included from 6 HD centers., Intervention: Patients were randomly assigned to placebo or the angiotensin II receptor blocker irbesartan, 300mg daily. Target systolic blood pressure (BP) was 140mm Hg., Outcomes & Measurements: Primary outcomes were change in GFR measured as the mean of creatinine and urea renal clearance together with urine volume. Secondary outcomes were change in albuminuria, renin-angiotensin II-aldosterone hormone plasma levels, and time to anuria., Results: Of 82 patients randomly assigned (41 patients in each group), 56 completed 1 year of treatment. The placebo and irbesartan groups were comparable at baseline in terms of sex balance (26 vs 30 men), mean age (62 vs 61 years), median HD vintage (137 vs 148 days), mean HD time (10 vs 11h/wk), median urine volume (1.19 vs 1.26L/d), and mean GFR (4.8 vs 5.7mL/min/1.73m(2)). The target BP level was reached in both groups and BP did not differ significantly between groups over time. Adverse-event rates were similar. GFR declined by a mean of 1.7 (95% CI, 1.2-2.3) and 1.8 (95% CI, 1.1-2.4) mL/min/1.73m(2) per year in the placebo and irbesartan groups, respectively. Mean difference (baseline values minus value at 12 months) between groups was -0.0 (95% CI, -0.8 to 0.8). In each group, 4 patients became anuric., Limitations: GFR decline rates were lower than expected, reducing the power., Conclusions: At equal BP levels, we found that irbesartan treatment did not affect the decline in GFR or urine volume significantly during 1 year of treatment in HD patients. Irbesartan treatment was used safely in the studied population., (Copyright © 2014 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)