Efficacy of Phellinus linteus extract on immunity enhancement: A CONSORT-randomized, double-blind, placebo-controlled pilot trial.

BACKGROUND: Immunity is a major system that defends the human body from the outside. Recently, interest in foods related to immunity has been increasing. METHODS: The purpose of this clinical trial was to determine the safety and efficacy of Phellinus linteus (PL) extract in improving immune function. A total of 30 participants were randomly assigned to 3 groups: the PL1000 group (n = 10) took 1000 mg of PL extract and 1000 mg of dextrin per day; the PL2000 group (n = 10) took 2000 mg of PL extract per day; and the placebo group (n = 10) took 2000 mg of dextrin per day. All participants took 2 capsules twice a day for 8 weeks. We measured their natural killer cell activity and cytokine levels in blood before and after consuming the clinical trial food. Variables were also investigated to evaluate safety, such as adverse reactions, vital signs, and abnormal findings. Student t test or the Mann-Whitney U test, a paired t test or the Wilcoxon signed-rank test, a chi-square test, analysis of variance, and Kruskal-Wallis test were conducted according to the characteristics of the data to compare the differences between each group before and after participants ate the clinical trial food. RESULTS: The natural killer cell activity and interleukin-6 levels of the PL1000 group tended to improve compared to those of the placebo group. Immunoglobulin G1, immunoglobulin G2, and immunoglobulin M levels did not show significant changes, but tended to improve in the PL1000 and PL2000 groups compared to those of the placebo group. Both the Per Protocol and Intention to Treat populations had improved validation parameters. It is safe because no hazards were found in the safety assessment. CONCLUSION: PL extract can help improve immunity. Evidences to conduct the main clinical trial is secured through this pilot study. A future large-scale main trial will be conducted based on this pilot study results.

Efficacy of Liriope platyphylla extract on improving respiratory function: A CONSORT-randomized, double-blind, placebo-controlled pilot trial.

BACKGROUND: The respiratory system is the first line of defense against outside pollutants. Recently, respiratory health has been receiving increasing attention due to the increase in fine dust, which reduces respiratory function and increases incidence of chronic obstructive pulmonary disease, and in coronavirus pandemic, which can cause severe acute respiratory syndrome. METHODS: This clinical pilot trial was designed to secure evidence for a main clinical trial and to confirm the efficacy and safety of Liriope platyphylla (LP) extract for improving respiratory function. We conducted a double-blind randomized placebo-controlled trial with 22 participants from June 30, 2021, to August 25, 2021. The primary outcome was Breathlessness, Cough, and Sputum Scale score. Secondary outcomes included forced vital capacity, forced expiratory volume at 1 second (FEV1), forced expiratory volume at 1 s/forced vital capacity ratio, cough assessment test score, chronic obstructive pulmonary disease assessment test score, peripheral blood mononuclear cell counts (white blood cells, eosinophils, T cells, and B cells), high-sensitivity C-reactive protein level, erythrocyte sedimentation rate, cytokine (interleukin-1ß, interleukin-4, tumor necrosis factor-α, interleukin-6, interleukin-8, interferon-γ, and immunoglobulin E) levels, antioxidant (glutathione peroxidase and superoxide dismutase) levels, and nitric oxide level. RESULTS: A total of 22 participants were randomly assigned to 2 groups: the LP group (n = 11), who took 1000 mg of LP extract per day, and the placebo group, who took 1000 mg of dextrin per day. Participants took 1 capsule twice a day for 4 weeks. For the Breathlessness, Cough, and Sputum Scale, the interaction between group and visit was statistically significant in a blend of analyses of variance. interleukin-8, tumor necrosis factor-α, and interferon-γ levels decreased more in the LP group than in the placebo group. The sample size required for large-scale clinical trials in the future was 50. There were no side effects. CONCLUSION: LP extract can enhance respiratory function. The detailed data we obtained support conducting the future main large-scale clinical trial.

Effects of Phellinus linteus extract on immunity improvement: A CONSORT-randomized, double-blinded, placebo-controlled trial.

BACKGROUND: Immunity protects the body from external threats and prevents the development of cancer. Biological response modifiers extracted from natural sources are being actively studied, and the immunostimulatory and anticancer effects of various types of fungi have been reported. However, there are no previous clinical studies on the immune-enhancing effect of Phellinus linteus (PL). Lactate dehydrogenase cytotoxicity assay is a prerequisite in order to get approval for using PL as a raw material in functional supplements and medicines in Korea. However, due to the absence of precedent clinical trials, the use of PL in supplements has been hindered. but there is no precedent clinical trial using it. We conducted a randomized, double-blinded, placebo-controlled trial to confirm the efficacy and safety of PL extract for the improvement of immunity using the lactate dehydrogenase cytotoxicity assay. METHODS: A total of 98 subjects were enrolled and randomly assigned to 2 groups. Subjects in the PL and placebo groups received 1000 mg of PL extract and 1000 mg of dextrin per day, respectively (one capsule, twice every day for 8 weeks). The primary outcome measured was the activity of natural killer cells. Secondary outcomes were the levels of TNF-α, IFN-γ, IL-1ß, IL-2, IL-6, IL-12, IgG1, IgG2, and IgM. Safety was evaluated using laboratory tests. RESULTS: NK cell activity was significantly increased in the PL group compared to the placebo group (P < .05). Despite the absence of significant changes in secondary outcomes, there was a tendency for improvement in the PL group. PL extract-related adverse outcomes, particularly in liver and renal function, were not observed. CONCLUSION: PL extract may improve immunity and is safe to be consumed orally.

Clinical trial to analyze the effects of oral intake of Phellinus linteus (sanghuang) extract on immune function: a study protocol for a randomized, double-blind controlled trial.

BACKGROUND: As the population of Korea ages, interest in healthcare has increased. In particular, there is an increasing demand for immune-function improvement to prevent infectious diseases. Phellinus linteus (PL) has previously been shown to exert immune-enhancing and anticancer effects. We aim to evaluate whether PL mycelium extract, cultured from the PL KCTC0399BP strain, can increase immune function, as measured using blood-test indicators. This clinical trial protocol is designed as the main trial and is based on the results of a pilot study. METHODS: This clinical trial is a randomized, double-blinded, placebo-controlled trial. Ninety-eight participants are enrolled and randomly divided into two groups: the experimental group (PL 1000 mg) and the control group (placebo). Participants are administered with experimental food or placebo for eight weeks. Blood tests are performed before trial initiation and 8 weeks later, at trial completion. Laboratory evaluation items are as follows: natural killer cell activity, tumor necrosis factor-α, interferon-γ, interleukin (IL)-1ß, IL-2, IL-6, IL-12, immunoglobulin (Ig)G1, IgG2, and IgM. We will mainly use the full analysis dataset to statistically analyze the effectiveness of the treatment. DISCUSSION: This study evaluates the effects of PL extract on immune function and will contribute to knowledge on the value of PL as an immune-function-boosting functional food. TRIAL REGISTRATION: Clinical Research Information Service (CRIS) of Korea CRIS-KCT0005460 . Registered on 12 October 2020.

Effect of Bee Venom on an Experimental Cellular Model of Alzheimer's Disease.

Alzheimer's disease (AD) is a neurodegenerative disease and is characterized by the deposition of the [Formula: see text]-Amyloid peptide ([Formula: see text]A), which causes the inflammation of neurons. Bee venom (BV) elicits a strong anti-inflammatory response, and therefore we conducted an in vitro experiment to study the efficacy of BV in an AD cellular model. To mimic AD, the U87MG cell line was incubated for 168 hours with 2.5 [Formula: see text]M [Formula: see text]A. Changes were confirmed by microscopy, and peptides were measured under stain-free conditions using homo-tomography. Sulforhodamine B analysis was performed to analyze the cell viability. Real-Time quantitative polymerase chain reaction (qPCR) analysis was conducted to analyze mRNA expression levels of pro-inflammatory cytokines (NF-[Formula: see text]B, COX-2, TNF-[Formula: see text], IL-1), and Western blot was performed to measure the Caspase-3 protein levels. BV showed no cytotoxicity at concentrations below 10 [Formula: see text]g/mL. The NF-[Formula: see text]B mRNA levels were not significantly different between the BV group and the control group. The amount of [Formula: see text]A accumulation in the BV group decreased significantly. The mRNA expression levels of COX-2, TNF-[Formula: see text], and IL-1 were significantly reduced using 10 [Formula: see text]g/mL of BV compared to those in the control group. Additionally, Caspase-3 levels were also reduced compared to those of the control group when BV was used at a concentration of 10 [Formula: see text]g/mL. BV could inhibit apoptosis and inflammatory responses in an AD cellular model. In addition, it prevented cell accumulation of [Formula: see text]A, an important pathogenic mechanism in AD.

Easy and effective test to evaluate tear-film stability for self-diagnosis of dry eye syndrome: blinking tolerance time (BTT).

BACKGROUND: The tear film breakup time (tBUT) is a clinical evaluation of evaporative dry eye disease assessed by instilling topical fluorescein into the eyes. In the present study, we introduce a new diagnostic test, blinking tolerance time (BTT), for self-evaluation of tear-film stability. We compared the results with the tBUT and validated the BTT test for self-assessment of tear film instability. METHODS: This was a prospective controlled study involving 212 eyes of 106 participants 20-79 years of age. A total of 114 eyes of 57 dry eye patients and 98 eyes of 49 healthy subjects were included in the study. All patients and subjects were administered the following tests to diagnose dry eye disease: Ocular Surface Disease Index, BTT, tBUT, slit-lamp examination, corneal stain score, and Schirmer I test (without anesthesia). Patients and subjects were instructed not to blink for as long possible after reset blinking. The time interval between the reset blink and the next blink was measured. The mean of 3 tBUT values in both the right and left eyes was defined as tBUTBE. Correlations between the BTT and tBUTBE were also evaluated. To evaluate the diagnostic efficacy of the BTT and tBUT tests, receiver operating characteristic (ROC) curves were generated to obtain a cutoff score, and the sensitivities of the tests against the specificity at all possible thresholds were plotted. RESULTS: Spearman's correlation analysis revealed a significant weakly positive correlation between BTT and tBUTBE (r = 0.447; p = 0.000). The intraclass correlation coefficient (ICC) of the tBUT was 0.679 (95% confidence interval [CI]: 0.575-0.765) and the ICC of the BTT was 0.904 (95% CI: 0.867-0.932). The area under the ROC curve did not significantly differ between the tBUTBE (0.678) and BTT (0.628, p = 0.641). When the cutoff value of the BTT test was set to 8.1 s, the sensitivity was 63.3% and the specificity was 56.1%. CONCLUSION: The BTT test is a simple, inexpensive, and effective method for self-diagnosing dry eye that can also be used in the clinical setting.

A clinical pilot study to evaluate the efficacy of oral intake of phellinus linteus (sanghuang) extract on knee joint and articular cartilage: Study protocol clinical trial (SPIRIT Compliant).

BACKGROUND: Knee osteoarthritis (KOA) is the most common form of degenerative arthritis. We used Phellinus linteus (PL), which has been well-known anti-inflammatory function. In this study, we will evaluate if PL extract improves symptoms with KOA. METHODS: This study will be an 8-week single-center randomized controlled double-blind clinical trial. Total of 24 subjects with KOA will be enrolled and they will be divided into 3 groups, PL 1,000 mg, PL 1,500 mg and placebo. Subjects will be followed up every 4 weeks with efficacy and safety at the 2nd and 3rd visits. All subjects should maintain a dosage schedule for this protocol. The primary outcome will be assessed with the Korean version of the Western Ontario and McMasters Universities. And the secondary outcomes will be measured using the visual analog scale, quality of life scale (EQ-5D-3L), ESR, C-reactive protein, and C-telopeptide of type-II collagen. Statistical analysis will be performed on the principle of full analysis set. DISCUSSION: This study has inclusion and exclusion criteria and a well-controlled intervention. This clinical trial is the first step to assess the efficacy and safety of PL in patients with KOA. This study will make an important contribution to the literature and aid follow-up research into the use of PL in KOA.