A Double-Blind, Randomized, Placebo-Controlled Nutritional Study Using an Insoluble Yeast Beta-Glucan to Improve the Immune Defense System

Purpose: In a placebo-controlled, double-blind, randomized clinical trial, the effect of an insoluble yeast beta-glucan preparation on the incidences of common colds and its effect on common cold symptoms were compared to placebo. Methods: 100 healthy participants with recurring infections were randomly assigned to receive either placebo or yeast beta-glucan (Yestimun?;n = 50 each group) over a period of 26 weeks. The subjects had to document each common cold episode in a diary, and rate 6 predefined infections symptoms on a 3-point rating scale during an infection period, resulting in an infection score. The common cold episodes were confirmed by the investigators. Results: A total of 171 common cold episodes were documented. Of these, 76 were experienced by 38 subjects in the beta-glucan group and 96 were experienced by 48 subjects in the placebo group (p = 0.406). The beta-glucan group had significantly more subjects without incidences of common cold than the placebo group (15.6% vs 2.0%;p = 0.019). During the most intense infection season (first 13 weeks of the study), the beta-glucan group had significantly less infections compared to placebo (p = 0.02). Beta-glucan significantly reduced the typical cold symptoms (“sore throat and/or difficulty swallowing”, “hoarseness and/or cough” and “runny nose”) as opposed to placebo. Conclusion: The present study demonstrates a prophylactic effect of yeast beta-glucan on the occurrence of common colds as opposed to placebo. In addition, when these episodes occurred, they were from the beginning less pronounced and subsided faster.

Effect of <i>Lactobacillus brevis</i>SBC8803 on Gamma-Glutamyl Transferase in Japanese Habitual Drinkers: A Double-Blind, Placebo-Controlled Study

A randomized, double-blind, placebo-controlled clinical trial in Japanese habitual drinkers was conducted to evaluate the efficacy of Lactobacillus brevis SBC8803 to alleviate adverse effect of alcohol. Subjects who drank habitually and had moderately higher levels of gamma-glutamyl transferase (GGT) (50 - 100 IU/L) were enrolled. The levels of transaminases in these subjects were almost within normal levels (aspartate transaminase (AST) <30 IU/L and alanine transaminase (ALT) <40 IU/L). Either the capsules containing placebo (n = 23) or 130 mg (4.0 × 1010 colony-forming units) of live L. brevis SBC8803 (n = 22) per day were administered for the continuous eight weeks (56 days). During the period, the subjects both in test group and placebo groups have kept each drinking behavior as usual. Regarding lipid metabolism, triacylglycerol (TG) levels in the male test group significantly decreased at week 4 as compared with week 0. Biomarkers of hepatocytes-damage;AST and ALT levels showed no significant differences between the pla- cebo and test groups at both weeks 4 and 8. Oxidative stress marker;GGT at weeks 4 was significantly lower in the test group than that in the placebo group (p = 0.017), but not at weeks 8. However, taking a reduced rate of GGT at weeks 8 comparing with that at week 0, that in the test group showed larger value comparing with that in the placebo group. These data about TG and GGT suggest that, although efficacy of L. brevis SBC8803 is limited in this study, intake of the probiotic may alleviate alcoholic influence in lipid metabolism and oxidative stress.

Tolerability of a Proprietary Larch Arabinogalactan Extract: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial in Healthy Subjects

In a placebo-controlled, double-blind, randomized clinical trial, the tolerability of a proprietary larch arabinogalactan preparation (ResistAidTM) was investigated. METHODS: 199 healthy participants were randomly assigned to receive either placebo (n = 98) or an arabinogalactan preparation (n = 101) over a period of 12 weeks. As safety parameters the total number of adverse events, changes in various biochemical and laboratory parameters as well as the global evaluation of tolerability by investigator and subjects compared to placebo were evaluated. RESULTS: In total 16 adverse events were observed in 16 subjects, with no difference between the arabinogalactan and the placebo group (p = 0.935). There were no differences in the mean changes of the measured biochemical and laboratory parameters. The tolerability of the arabinogalactan extract was rated as “very good” or “good” by the investigators for 99% of the subjects and by 98% subjects in self-assessment with no statistical differences to placebo. CONCLUSION: The measured parameters as well as the evaluation of the tolerability by the investigators and the subjects demonstrate a very good tolerance profile of the proprietary arabinogalactan extract with no differences to placebo when taken for 12 weeks.

Xi-Feng-Hua-Shi granules for diarrhea-predominant irritable bowel syndrome:protocol for a randomized,double-blind,placebo-controlled multi-center clinical trial

Background:Irritable bowel syndrome(IBS)is a common functional bowel disorder that can severely affect the quality of life of patients.Limited drugs have been reported for modern medical IBS treatment.The advantages of traditional Chinese medicine(TCM)treatment are gradually becoming prominent.Xi-Feng-Hua-Shi granules have been clinically used for diarrhea-predominant IBS(IBS-D)treatment for many years in TCM practice.Thus,this study aimed to further verify the effectiveness and safety of Xi-Feng-Hua-Shi(XFHS)granules in IBS-D treatment through a randomized,double-blind,placebo-controlled multi-center clinical trial and provide high-quality evidence for its effectiveness and safety in treatment,as well as provide a basis for clinical rational drug use and explore new clinical IBS-D treatment plans.Methods:A randomized,double-blind,placebo-controlled multi-center clinical trial will be performed in 23 hospitals.A total of 300 participants will be randomly divided into the experimental group(prescribed with XFHS granules)and the control group(prescribed with the placebo granules),with 150 participants in each group.The appearance,shape,color,and taste of the placebo granules are the same as those of XFHS granules.All participants will receive a 4-week treatment and a 6-month follow-up.The primary outcome is the overall clinical efficacy;the secondary outcomes are the IBS-Symptom Severity Score(IBS-SSS),TCM Syndrome Evaluation,and the IBS-Quality of Life(IBS-QoL)score,mental state assessment,and recurrence rate.Outcome measures(including primary and secondary outcome measures)are collected at baseline,as well as 2,4,16,and 28 weeks post-intervention.Discussion:This randomized,placebo-controlled,multi-center trial may provide high-quality evidence for the clinical XFHS granule efficacy in IBS-D treatment.Additionally,this study will conduct safety evaluations to provide a basis for clinical rational drug use.

Effects of Depth of Needle Insertion with Risperidone Long-Acting Injectable in Persons with Schizophrenia: A Randomized Double-Blind Study

In some cases, if the insertion depth is shallower than expected, intramuscular (IM) injection of risperidone long-acting injectable (RLAI) may not penetrate the muscle fascia. However, if needle insertion depth is deeper than anticipated, needle penetration may cause damage to nerves, arteries and veins. Few clinical studies were done to evaluate the depth of needle length insertion reaching the intended gluteal muscle. The aim of this study was to evaluate the suitable depth of injecting RLAI. Twenty-six patients with schizophrenia were treated with RLAI, and randomly divided into two groups: 50 mm needle inserted group (Group-D, deep insertion, n = 13) and 20 mm needle insertion group (Group-S, shallow insertion, n = 13). For Group-S, the needle length was marked with a spacer at exactly 20 mm. Injections were performed by the psychiatrist or nurse, alternating between the two gluteal sites by double-cross method every two weeks. Clinical psychotic symptoms and injection site reactions were recorded throughout the study period. Experienced psychologists who were blinded from the needle-length experimental variable evaluated patients’ psychotic symptoms using the Positive and Negative Syndrome Scale (PANSS) every two weeks. The plasma 9-hydroxyrisperidone (9-OH-RIS) concentrations were measured every two weeks;comparison data were determined on the 8th week and the 14th week. No significant difference was observed in 9-OH-RIS concentrations, psychotic symptoms, injection site skin reactions of subjects in both groups. However, in Group-D, injection site adverse reactions were confirmed in two subjects (15%). In Group-S, injection site reactions were confirmed in six subjects (46%). Although effective 9-OH-RIS concentrations were obtained with the insertion using both depth, it was concluded that the 50 mm insertion length was more suitable for dorsogluteal IM injections in adult patients with schizophrenia as demonstrated by the incidence of local adverse skin reactions.

EFFECT OF ADDED DIETARY CALCIUM ON ESOPHAGEAL EPITHELIAL-CELL PROLIFERATION IN SUBJECTS AT HIGH RISK FOR ESOPHAGEAL CANCER: A DOUBLE-BLIND INTER-VENTION STUDY

A randomized double-blind intervention trial was carried determine whether oral calcium supplementation could lower the proliferation of epithelial cells of the esophagus. 41 subjects identified with precancerous lesions by histopathology were randomized to receive oral supplementation of their conventional diets with 0.6 g of calcium as calcium carbonate or placebo. Both at the entry to the study and at the end of the treatment, seven months later, the subjects were examined, with an emphasis on the frequency and distribution of proliferating epithelial cells of the esophagus. Patterns of cell proliferation was defined by dividing the esophageal epithelium into cell columns oriented perpendicularly to the basal cell layer and by comparing the numbers and fractions of tritiated thymidine-labeled epithelial cells in the various cell columns and cell compartments.Before dietary supplementation with calcium, the profile of proliferating epithelial cells in the esophageal compartments in calcium group is similar to that in the placebo group, which is comparable to that previously observed in subjects with high risk for esophageal cancer. Seven months after supplementation having been started, in calcium group, proliferation was significantly reduced and the profile of the esophageal columns approached to that previously observed in subjects at low risk for esophageal cancer, however, in the placebo group, the proliferation and profile maintain at the same level as that before supplementation. Our findings indicate that oral calcium supplementation induces a more quiescent equilibrium in epithelial-cell proliferation in the esophageal mucosa of the subjects at high-risk for esophageal cancer, similar to that observed in subjects at low risk.

Evaluation of the Potential Inhibitory Activity of A Combination of L.Acidophilus,L.Rhamnosus and L.Sporogenes on Helicobacter Pylori：A Randomized Double-Blind Placebo-Controlled Clinical Trial

Objective： To investigate whether three strains of probiotics, L. acidophilus, L. rhamnosus, and L. sporogenes, had significant inhibitive effects on Helicobacter pylori（H. pylori）. Methods： This is a 4-week, randomly assigned, parallel-group, doubled-blind, and placebo-controlled study. Fifty patients with a positive H. pylori infection urea breath test（△UBT） result 〉 10% and without ulcer symptoms were randomized into a treatment group and a placebo group by a computer generated allocation sheet with 1：1. These subjects took one capsule of probiotics or placebo twice daily. The primary measurement was the change in △UBT values. Results： The △UBT values during the 4-week treatment period and the 2-week follow-up period were not significantly different between the treatment group and the placebo group, indicating that the inhibitive effects on H. pylori were comparable between both groups. The monocyte count（%） was 5.77±1.11 in the treatment group versus 5.09±1.12 in the placebo group（P=0.044）, and the basophile count was 0.55±0.32 in the treatment group versus 0.36±0.23 in the placebo group（P=0.024） at week 2 of the treatment period, both of which reached statistical significance. The monocyte count was 5.75±1.26 in the treatment group and 4.72±0.99 in the placebo group at the end of the follow-up period（P=0.003）. Conclusions： There was no significant inhibitive effects of the three probiotic strains（L. acidophilus, L. rhamnosus, and L. sporogenes） on H. pylori. Probiotics can not play the same role as antibiotics in the eradication of H. pylori, the role of probiotics is likely to be important as adjuvant to the triple or quadruple therapy for H. pylori, especially in resistance cases.

Botulinum toxin type A for treating chronic low back pain:A double blinded randomized control study

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.

Evaluation of the effect of acupuncture on hand pain,functional deficits and health-related quality of life in patients with rheumatoid arthritis--A study protocol for a multicenter,double-blind,randomized clinical trial

BACKGROUND： Rheumatoid arthritis（RA） is a systemic inflammatory disease characterized by functional disability and pain. Although acupuncture is widely used, until now Western acupuncture studies on RA have not shown conclusive positive results. Acupuncture is regarded as a reflex therapy that has effects on the human autonomic nervous system. By establishing a traditional Chinese medicine（TCM） diagnosis first, the practitioner is able to choose acupoints according to the state of each individual patient.METHODS/DESIGN： We are interested if acupuncture, using a classical diagnostic procedure to allocate acupoints to the patient according to the Shang Han Lun theory, can be effective in relieving pain, improving hand function and increasing health-related quality of life in RA.The authors intend to harmonize TCM diagnosis according to clinical and genetic profiles. Patients with the TCM diagnosis of a so-called Turning Point syndrome will be followed up in a randomized, prospective, double-blind, placebo-controlled, multicenter and three-armed parallel-group study with a standardized treatment in order to optimize potential therapeutic effects of acupuncture on pain, strength and muscle function of patients with RA as well as the influence on inflammation and quality of life.DISCUSSION： The findings of this study will provide important clinical information about the feasibility and efficacy of acupuncture treatment for RA patients. In addition, it will explore the feasibility of further acupuncture research.TRIAL REGISTRATION NUMBER： Clinical Trials.gov Identifier NCT02553005.

A PROSPECTIVE STUDY TO EVALUATE THE SAFETY AND EFFICACY USING REMOVING BLOOD STASIS HERBALS FOR PATIENTS WITH INTRACRANIAL HEMORRHAGE OF HYPERACUTE STAGE AND RELATIVE FACTORS OF HEMATOMA ENLARGEMENT(A MULTICENTER PROSPECTIVE RANDOMIZED DOUBLE-BLIND PLACEBO

The aim was to investigate whether using a removing blood stasis method in hyperacute intracranial hemorrhage stage can lead to hematoma enlargement and its clinical efficacy.A multicenter retrospective randomized double-blind placebo-controlled clinical study.We recruited patients aged 18 years or older and presenting at less than 6 h from symptom onset in 8 research centers.All the patients

Inter-Toe Cracks: A Cosmetic Response versus Excipient. Efficacy and Tolerance Evaluation

A randomized, monocentric, double-blind, intra-individual excipient-controlled comparative study was performed to evaluate the efficacy and tolerance of an active peptide (laminin 5 fragment [LN-5]) formulated in cosmetic balm, versus excipient in inter-toe cracks. Two products were tested on 10 healthy volunteers. Each of them suffered from this particular superficial wound characterized by a peeling off a skin tab between at least two inter-toe spaces. The duration of this study belonged of 28 days with an intermediate visit to D14. Initial and outcome evaluation was performed using a 4-grade-scale depending on the severity of the inter-toe cracks. Tolerance and healing were assessed using macrophotographs. At D14 and D 28, the difference of cure between the 2 treatments was in favor of the peptide active product. The clinical score showed a best efficiency of the active compared with the excipient;indeed a significant difference between D28 and D0 was observed for the active ingredient. Active product repairs more quickly inter-toes cracks than the excipient and we noted the complete disappearance of the “severe” and “moderate” stages from the 14th day. This study showed clearly a fast (in 14 days) and beneficial effect of the application of LN-5 compared with the excipient, on the cutaneous repair of inter-toes cracks. Since LN-5 fragment is capable of producing immediate biological activity and reinforcing the dermal-epidermal junction, it can accelerate tissue repair.

USE OF CHRONOLITHOTHERAPY FOR BETTER INDIVIDUAL HEALTHCARE AND WELFARE

Man＇s innate clocks functioning allows to understand WHEN and WHY therapies are efficient. Vigil chronotypes determination and respect allows to avoid scholars＇ failure. Performances depend on chronotypes and time changes. Both minimal and maxima/durations of night sleep cycles result from interactions between endogenous and exogenous clocks. Our ecoexotope is structured by solar, lunar and terrestrial rhythms which are synchronisers for endophysiotope clocks. Man night sleep changes depend on lunar cycles entrainment. Sleep analyses point to circa-annual solar rhythms used as controls to evidence circa-monthly lunar ones. To evidence physiological responses individual longitudinal records are used. To evidence lithotherapeutic effects, stimuli responses are tested according to a double-blind placebo-controlled survey. WHAT mineral to chose？, WHY？, HOW to treat？, WHEN？ Compared with controls, jadeite or nephrite enhances night sleep quality with a 15 fold decrease of awakenings and urinations. The highest placebo effect was below 4 fold increase. Depending on minerals and trace elements, properties change. The mineral crystal structure is evidenced to have an action. The contact area with the skin is a limiting factor. Placebo effects are greater during the day phase. Red jasper treatment enhances the number and intensity of diurnal physical working. Minerals act in a dose-dependent manner and in synergy. Hematite sole gives a placebo effect, but increases the effect of serpentinite by a 15 fold value. Within a clocks network, the latency phase of the whole is shorter than the shortest latency phase of each clock, enhancing the system reactivity.