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ETHNOPHARMACOLOGICAL RELEVANCE: Diabetic sarcopenia (DS), an emerging diabetes complication, poses an increasing challenge to the elderly population. Shenqi paste (SQP) consists of 8 medicine-food homology substances: Astragalus membranaceus (Fisch.) Bge., Codonopsis pilosula (Franch.) Nannf., Polygonatum sibiricum Red., Dioscorea opposita Thunb., Poria cocos (Schw.) Wolf, Eucommia ulmoides Oliv., Hordeum vulgare L., and Ophiopogon japonicus (L.f.) Ker Gawl. SQP has shown potential benefits for sarcopenia in clinical practice. Its efficacy and safety in DS have not been validated in a randomized controlled trial. AIM OF THE STUDY: This study aimed to evaluate the efficacy, safety, and limitations, and provide insights into methods and strategies for utilizing SQP in DS management. MATERIALS AND METHODS: In this randomized, double-blind, placebo-controlled trial, community-dwelling older adults (≥60 years) with DS and spleen-kidney deficiency syndrome were allocated 1:1 to receive either SQP or placebo paste for 12 weeks. Primary outcomes were skeletal muscle mass index (SMI), handgrip strength, and five-time chair stand test (FCST) duration. Secondary outcomes included health-related scales and biochemical indicators. Assessments were conducted at the baseline (T0), week 6 (T1), and week 12 (T2). Safety evaluation included blood routine, liver and kidney function tests. Intention-to-treat analysis was applied to the primary outcomes data from all participants, with per-protocol analysis for sensitivity. Generalized estimating equations with covariate adjustment and t-tests or Wilcoxon rank-sum tests were used for statistical analysis. RESULTS: Of 90 randomized participants, the SQP group showed greater improvements in handgrip strength (T2: interact p < 0.001), SMI (T2: interact p < 0.001), and FCST (T2: interact p < 0.001) versus control. Secondary outcome measures of 74 participants, including frailty, nutrition, physical activity, sleep quality, depression, and TCM syndrome scores, significantly improved (p < 0.05), with significant fasting blood glucose reduction (T2: interact p = 0.018) and C-reactive protein decrease (T2: interact p < 0.001). There was no

Six new polyketides, including three naphthalene-types (1-3) and three γ-lactones-types (4-6), along with 14 known polyketides (7-20), were isolated from a pathogen endophytic fungus Phomopsis sp. XP-8 of Eucommia ulmoides Oliver. Their structures were elucidated by spectrometric analysis using MS and NMR data. The absolute configurations were established using statistical comparative analysis of the experimental ECD data, in conjunction with quantum mechanical calculations. All the compounds and crude extracts were evaluated for their antibacterial activity. Compounds 2, 3, 6, 7, 8, and 10 exhibited moderate inhibition on three gram-positive bacteria, Staphylococcus aureus, Bacillus subtilis, and Bacillus thuringiensis. Synergistic antibacterial interaction experiments showed that compounds 1, 2, 3, 6, 7, 8, and 19 with antibiotics can greatly enhance the inhibition rate against bacteria. The target screening and molecular docking of these compounds were also carried out, with further verification of molecular dynamics, revealing that the compounds exert antibacterial activity by targeting both the Fur-regulated basic protein (FbpB) and drug resistance protein D (EmrD), exhibiting synergy with antibiotics by inhibiting the DNA polymerase III β-subunit resulting in enhanced efficacy.

Duzhong Jiangya Tablet (DJT) composed of Eucommia ulmoides Oliv. and several other traditional Chinese medicines is a Chinese herbal compound, which is clinically used to treat hypertension. The aim of this study was to evaluate the antihypertensive effect of DJT and amlodipine besylate (AB) on the synergistic treatment of spontaneously hypertensive rats (SHRs), and to explore its antihypertensive mechanism. The synergistic therapeutic effect of DJT in combination with AB on SHR was studied using two metabolomics methods based on mass spectrum (MS) and nuclear magnetic resonance. Metabolomics analysis of plasma, urine, liver, and kidney and the combination of orthogonal partial least squares discriminant analysis was performed to expose potential biomarkers. Then, the overall metabolic characteristics and related abnormal metabolic pathways in hypertensive rats were constructed. Blood pressure measurements showed that DJT combined with AB has better effects in treating hypertension than it being alone. A total of 30 biomarkers were identified, indicating that hypertension disrupted the balance of multiple metabolic pathways in the body, and that combined administration restored metabolite levels better than their administration alone. The changes of biomarkers revealed the synergistic therapeutic mechanism of DJT combined with AB, which provided a reference for the combination of Chinese and Western medicines. © 2019 John Wiley & Sons, Ltd.

BACKGROUND AND PURPOSE: Aucubin, the predominant component of Eucommia ulmoides Oliv., has been shown to have profound effects on oxidative stress. As oxidative stress has previously been demonstrated to contribute to acute and chronic myocardial injury, we tested the effects of aucubin on cardiac remodelling and heart failure. EXPERIMENTAL APPROACH: Initially, H9c2 cardiomyocytes and neonatal rat cardiomyocytes pretreated with aucubin (1, 3, 10, 25 and 50 μM) were challenged with phenylephrine. Secondly, the transverse aorta was constricted in C57/B6 and neuronal NOS (nNOS)-knockout mice, then aucubin (1 or 5 mg·kg-1 body weight day-1 ) was injected i.p. for 25 days. Hypertrophy was evaluated by assessing morphological changes, echocardiographic parameters, histological analyses and hypertrophic markers. Oxidative stress was evaluated by examining ROS generation, oxidase activity and NO generation. NOS expression was determined by Western blotting. KEY RESULTS: Aucubin effectively suppressed cardiac remodelling; in mice, aucubin substantially inhibited pressure overload-induced cardiac hypertrophy, fibrosis and inflammation, whereas knocking out nNOS abolished these cardioprotective effects of aucubin. Blocking or knocking down the β3 -adrenoceptor abolished the protective effects of aucubin in vitro. Furthermore, aucubin enhanced the protective effects of a β3 -adrenoceptor agonist in vitro by increasing cellular cAMP levels, whereas treatment with an adenylate cyclase (AC) inhibitor abolished the cardioprotective effects of aucubin. CONCLUSIONS AND IMPLICATIONS: Aucubin suppresses oxidative stress during cardiac remodelling by increasing the expression of nNOS in a process that requires activation of the β3 -adrenoceptor/AC/cAMP pathway. These findings suggest that aucubin could have potential as a treatment for cardiac remodelling and heart failure. © 2018 The British Pharmacological Society.

BACKGROUND: Osteoarthritis (OA) is a major degenerative disease that affects the elderly. The global prevalence of OA is increasing annually. However, current treatments are unable to halt the progress of OA. At present, pharmacological treatments such as non-steroidal anti-inflammatory drugs (NSAIDs) and cyclooxygenase-2 (COX-2) inhibitors control the pain; however, there may be side effects to these medications. We hypothesized that Cortex Eucommiae (CE; Eucommia ulmoides Oliver) extract, which is used as a dietary supplement, may slow down or prevent OA. METHODS: This is a protocol for a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CE extract in subjects with mild OA. One-hundred subjects with mild OA will be recruited and randomly divided in a 1:1 ratio into 2 groups. One group will receive CE extract for 12 weeks and the other group will receive placebo for 12 weeks. Outcomes will be evaluated by using the visual analog scale (VAS), Korean-Western Ontario and McMaster Universities index (K-WOMAC), Korean-Short Form health survey-36 score (KSF-36), and laboratory test results. DISCUSSION: This clinical trial is expected to provide evidence of the efficacy and safety of CE extract as a treatment for mild OA. TRIAL REGISTRATION: Clinical Trials.gov NCT03744611, registered on November 12, 2018, at https://clinicaltrials.gov/ct2/show/NCT03744611.

This study tested whether subcutaneous fat loss is enhanced via application of a popular topical fat loss lotion. Twenty resistance-trained men (mean ± SD age of 26.3 ± 6.3 years and weight of 86.8 ± 11.1 kg) had a topical fat-loss lotion containing Coleus forskholii, Silybin, Eucommia ulmoides leaf, Paullinia cupana seed, caffeine, and black pepper essential oil applied twice daily for 8 weeks to the front and lateral thigh of one of the participant's leg, and a placebo control lotion was applied to the same sites on the other leg. After 8 weeks, there were no significant differences between the placebo and treatment legs for the change in subcutaneous fat thickness of the front thigh (p = 0.73) or for leg fat percentage (p = 0.52). However, there was a slight, yet significant difference in the change in subcutaneous fat thickness of the lateral thigh favoring the treatment leg (-0.42 vs +0.75 mm, p = 0.029), but with this difference disappearing depending on the statistical tests being used. Only 2/19 participants perceived a difference in fat loss in response to each condition. Although the topical lotion tested here resulted in statistically significantly greater subcutaneous fat loss at the lateral but not front thigh, this effect was very small, contingent upon the statistical test being used, and unperceivable by the participants themselves. © 2022 The Authors. Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.

INTRODUCTION: Skeletal fluorosis patients face a markedly elevated risk of cardiovascular metabolic abnormalities, including endothelial dysfunction, excessive oxidative stress, and impaired calcium-phosphate metabolism. Current clinical interventions for this condition are limited to symptomatic analgesia and conventional anti-osteoporotic treatments, and lack targeted therapeutic strategies for the "kidney deficiency and blood stasis" pathogenesis of skeletal fluorosis that can synergistically protect both the skeletal and cardiovascular systems. METHODS: This multicenter randomized controlled trial was conducted on 1,480 skeletal fluorosis patients from the China Fluorosis Cohort (CFC), to investigate the synergistic therapeutic effects of three traditional Chinese medicine (TCM) combinations-Ginkgo biloba combined with Epimedium (Drug 1), Xianling Gubao combined with Eucommia ulmoides (Drug 2), and Gusongbao combined with Rosa roxburghii (Drug 3)-in conjunction with lifestyle modifications on cardiovascular metabolic outcomes. RESULTS: Smoking and alcohol consumption were identified as independent risk factors for reduced therapeutic efficacy in skeletal fluorosis patients with comorbid cardiovascular metabolic abnormalities (OR = 2.755, 95% CI: 1.400 -5.421). Among the three TCM combinations, Drug 2 and Drug 3 significantly counteracted these adverse risk factors, reducing the risk of treatment failure by 53.9% (OR = 0.461) and 57.0% (OR = 0.430), respectively. Drug 3 exhibited superior efficacy in reducing diastolic blood pressure (β = -2.263, P = 0.010), while its systolic blood pressure-lowering effect diminished with increasing age. Drug 2 showed synergistic benefits with improved sleep quality (β = 1.596, P = 0.002) and healthy dietary habits (β = -1.180, P = 0.001), which enhanced its antihypertensive effects and led to a significant reduction in low-density lipoprotein cholesterol (LDL-C) levels (P < 0.05). Additionally, the interaction models outperformed the main-effect models, confirming the dynamic synergistic effect between lifestyle interventions and TCM pharmacotherapy. DISCUSSION: These findings highlight the clinical necessity of integrating

Eucommia ulmoides has been used as a food and medicine homologue for a long time in China. We hypothesize that Eucommia ulmoides achieves its health-promoting effects via altering gut microbiota. Here, we investigated the effects of water extract of Eucommia ulmoides bark on caecal microbiota and growth performance, antioxidant activity, and immunity in white-feathered broilers treated for 42 days. A total of 108 one-day-old Cobb white-feathered broilers were randomly assigned to three treatment groups: control diet, 0.75% Eucommia ulmoides diet (EU Ⅰ) and 1.5% Eucommia ulmoides diet (EU Ⅱ). The results showed that EU Ⅱ treatment improved average body weight (ABW), thigh muscle quality and total length of intestines, and decreased the serum total triglycerides and total cholesterol (TC) (p < 0.05). Eucommia ulmoides supplementation increased serum superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), total antioxidant activities and content of immunoglobulins, and reduced levels of malondialdehyde and tumour necrosis factor-α (TNF-α) (p < 0.05). Moreover, the supplementation increased the diversity of caecal microbiota and reduced the pathogenic genera Escherichia Shigella and Helicobacter. The genera Ochrobactrum, Odoribater, Klebsiella, Enterobacter, Georgenia and Bifidobacterium were positively associated with the ABW, total intestinal length, serum levels of GSH-Px, SOD and immunoglobulins (p < 0.001) and negatively associated with the TC and TNF-α (p < 0.01), suggesting an association of the changes of gut microbiota and improvement of broiler health. Meanwhile, Eucommia ulmoides supplementation enriched the Kyoto Encyclopedia of Genes and Genomes pathway of exocrine secretion from the pancreas, circadian entrainment and inhibited lipopolysaccharide biosynthesis. In conclusion, Eucommia ulmoides water extract can be used as a feed additive to improve poultry industry production. © 2024 Wiley‐VCH GmbH. Published by John Wiley & Sons Ltd.

Background: Duzhong [DZ (Eucommia ulmoides Oliv.)] is regarded as a traditional Chinese medicine with a history dating back more than 2000 years. This herb is considered a nourishing herb in China and is commonly used as a tonic to strengthen muscles and bones, nourish the kidneys and liver, and soothe miscarriages. Moreover, there is evidence that DZ is capable of regulating blood pressure (BP), and several compounds isolated from DZ have been shown to have a BP-lowering effect. Quanduzhong capsules contain an extract of DZ [Eucommia ulmoides Oliv. (Eucommiaceae; Eucommiae cortex)] that is effective in treating hypertension. This multicenter, randomized, double-blind, placebo-controlled clinical trial sought to evaluate the clinical efficacy of Quanduzhong capsules in the treatment of low-to-moderate risk grade 1 hypertension patients. Materials and methods: A total of 60 patients from 3 centers with documented low-to-moderate risk grade 1 hypertension were randomly assigned in a 1:1 ratio to the test group or the control group. After a 1 week lead-in period using sham Quanduzhong capsules, all patients who met the entry criteria (29 cases in the test group and 29 cases in the control group) entered the 4 week test period. The test group took Quanduzhong capsules, and the control group continued to take sham Quanduzhong capsules. The primary endpoints [24-h mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) determined via 24-h ambulatory blood pressure monitoring (ABPM); office SBP and DBP] and secondary endpoints [mean arterial pressure; mean pulse; daytime mean SBP and DBP; nocturnal mean SBP and DBP; SBP and DBP load; area under the blood pressure (BP) curve; morning peak BP; early morning SBP and DBP; smoothness index of SBP and DBP; 24 h BP mean coefficient of variation (CV); percentage of patients with circadian restoration in ABPM; home BP; quality of life evaluated by WHO Quality of Life-BREF questionnaire; grading and quantitative evaluation of hypertension symptoms; values of plasmatic renin activity, angiotensin II, aldosterone, β-2 microglobulin and homocysteine] were assessed following the treatment. Drug-related adverse events a

The effect of Illicium verum extracts (IVE) or Eucommia ulmoides leaf extracts (ELE) on nutrient availability, duodenal and jejunal antioxidant ability of Duroc ×Landrace × Yorkshire (DLY) and Chinese native Licha-black (LCB) piglets was investigated. Ninety-six piglets (48 DLY and 48 LCB respectively) without significant difference in body weight (11.22 ± 0.32 kg) were used in a 2 × 4 factorial design. Animals were randomly allocated to four treatments, and each had four replicates with three DLY and three LCB piglets. Treatments were basal diet (CON) and basal diet with 500 mg/kg IVE, 250 mg/kg ELE and 50 mg/kg chlortetracycline (CHL) respectively. Animals were placed individually for 7-days adaptation following 42-days test. Results showed the significant interaction (p < 0.05) between dietary treatments and pig species in activity of total superoxide dismutase (T-SOD) and glutathione peroxidase (GSH-Px), content of malondialdehyde (MDA), and α-tumour necrosis factor (TNF-α), nuclear factor erythroid 2-related factor 2 (Nrf2) and Nrf2/TNF-α at mRNA and protein level in duodenum and jejunum of DLY and LCB piglets. The IVE and ELE increased (p < 0.05) activity of GSH-Px and T-SOD, and the Nrf2/TNF-α at mRNA and protein level, however, the decreased (p < 0.05) MDA content, and TNF-α at mRNA and protein level in duodenum and jejunum were observed. The CHL decreased (p < 0.05) activity of GSH-Px and T-SOD, TNF-α and Nrf2 at mRNA and protein level in duodenum, but increased (p < 0.05) MDA content and Nrf2/TNF-α in jejunum. DLY piglets had higher (p < 0.05) nutrient digestibility (organic matter, crude protein and gross energy), availability (biological value and net protein utilization), MDA content, and TNF-α at mRNA and protein level in jejunum, and had lower (p < 0.05) activity of GSH-Px and T-SOD, and Nrf2 and Nrf2/TNF-α at mRNA and protein level in duodenum and jejunum than LCB. In conclusion, the 500 mg/kg IVE and 250 mg/kg ELE improved the nutrient availability, and the improvement of antioxidant capacity is realized by activating the Nrf2/TNF-α of duodenum and jejunum. The CHL had adverse effects on antioxidant ability of DLY and LCB piglets. The results sh

Eucommia ulmoides is traditional Chinese medicine, and it possesses several potential bioactivities, such as anti-inflammatory, antioxidant and immune regulatory activities. This study was conducted to determine the effects of dietary Eucommia ulmoides leaf extracts (ELE) on growth performance, antioxidant capacity and intestinal function of weaned piglets. Two hundred crossbred (Duroc × Landrace × Yorkshire) piglets with an average initial weight of 12.96 ± 0.28 kg were randomly allotted to five treatments: C0 (basal diet), C1 (basal diet + antibiotics) and basal diet supplemented with increasing levels of ELE (0.2, 0.3 or 0.4 g/kg of feed). The results showed that ELE or antibiotics supplementation remarkably decreased diarrhoea rate and 0.3 g/kg ELE increased average daily gain compared with C0 (p < .05). 0.3 g/kg ELE increased alkaline phosphatase (AKP) levels and total antioxidant capacity (T-AOC) in serum and liver, as well as increased the content of serum albumin and total protein (TP) compared with the C0 (p < .05). The lipase activity of duodenum content and trypsin activity of jejunum content were improved fed diets containing 0.3 g/kg ELE compared with C0 (p < .05). The 0.3 g/kg ELE treatments have a higher villus height of the duodenum and jejunum compared with the C0 (p < .05). These results suggested that ELE supplementation had beneficial effects on antioxidant and intestinal function in weaned piglets, which also could increase growth performance and decreased diarrhoea rate. Accordingly, ELE is a potential alternative to antibiotics. © 2020 Blackwell Verlag GmbH.

Plant extracts are considered to be an effective alternative to antibiotics in response to weaning stress in piglets. This study evaluated the effect of Illicium verum extracts (IVE) or Eucommia ulmoides leaf extracts (ELE) on growth performance, serum and liver antioxidant ability of nursery piglets, as well as the difference of IVE and ELE on Duroc × Landrace × Yorkshire (DLY) and Chinese native Licha-black (LCB) piglets. A total of 96 nursery piglets (48 DLY and 48 LCB piglets) with an average body weight of 11.22 ± 0.32 kg were randomly divided into four treatments in a 2 × 4 factorial design. Each treatment had four replicates with 3 DLY and 3 LCB piglets per replicate respectively. Treatments included: basal diet, basal diet + 500 mg/kg IVE, basal diet + 250 mg/kg ELE and basal diet + 50 mg/kg chlortetracycline (CHL). All piglets were housed individually for the 42 days trial period after 7 days adaptation. Results showed that there were significant interactions (p < .05) between piglets species and dietary treatments in average daily gain (ADG) and feed efficiency, serum and hepatic glutathione peroxidase (GSH-Px) and malondialdehyde (MDA), hepatic integral optical density (IOD) of α-tumour necrosis factor (TNF-α), hepatic relative mRNA expressions of nuclear factor erythroid 2-related factor 2 (Nrf2)/TNF-α and protein expression of TNF-α. Regardless of piglets species, supplementation with IVE and ELE increased (p < .05) ADG and feed efficiency, T-SOD and GSH-Px in serum and liver, hepatic IOD of Nrf2, hepatic mRNA and protein expression of Nrf2/TNF-α. However, CHL treatment resulted in lower (p < .05) serum GSH-Px and hepatic mRNA and protein expression of Nrf2/TNF-α, and higher hepatic MDA and IOD of TNF-α. Compared to LCB, DLY piglets had higher (p < .05) ADG and feed efficiency, serum and hepatic MDA, and protein expression of TNF-α, but lower (p < .05) ADFI, liver index, serum and hepatic GSH-Px, hepatic IOD of TNF-α, mRNA expressions of Nrf2/TNF-α were observed. In conclusion, Illicium verum (500 mg/kg) and Eucommia ulmoides leaf (250 mg/kg) extracts can increase the growth performance and antioxidant ability of DLY and LCB piglets, while chlortetr

BACKGROUND: A tea made from Eucommia ulmoides leaves and bark is part of the Japanese diet. Eucommia is an herbal medicine that, by increasing nitric oxide, reduced blood pressure (BP) in rats and humans in an uncontrolled clinical trial. OBJECTIVE: A controlled clinical trial was conducted to evaluate an aqueous bark extract of Eucommia standardized to eight percent pinoresinol di-beta-D-glucoside (PG) for BP reduction in humans. METHODS: Study 1: Twenty-four healthy adult subjects with a BP between 120-160/80-100 mmHg were randomized to Eucommia extract 500 mg three times daily for eight weeks. Automatic 24-hour ambulatory blood pressure monitoring (24-h ABPM) was utilized at baseline and after eight weeks. Study 2: The effect of the Eucommia extract on isoproterenol-stimulated lipolysis was evaluated in a human fat cell assay to determine whether Eucommia was a beta-adrenergic blocker. Study 3: Thirty healthy adult subjects with a BP between 120-160/80-100 mmHg were randomized to 1 g Eucommia extract three times daily for two weeks with 24-h ABPM at baseline and after two weeks. RESULTS: Study 1: There was no toxicity or any difference in BP between the two groups. Study 2: Eucommia at 0.5% w/v reduced isoproterenol-stimulated lipolysis from 2.67 to 1.4 times the buffer control (P<0.001). Study 3: The Eucommia extract was well-tolerated and reduced BP by an average of 7.5/3.9 mmHg (P<0.008). CONCLUSION: The standardized Eucommia extract reduced BP and has beta-adrenergic blocking activity. Eucommia may be an appropriate nutraceutical intervention for prehypertension.

OBJECTIVE: This study aimed to compare the efficacy and safety of a multibotanical (Nutrafem) with those of placebo for the treatment of menopausal vasomotor symptoms. METHODS: In this phase III, double-blind, randomized, placebo-controlled study, 159 postmenopausal women experiencing at least 21 vasomotor symptoms per week were treated with Nutrafem (Bionutra Pte Ltd, Singapore) or a matched placebo for 12 weeks. Treatment outcome was evaluated by the change from baseline in the average weekly number of vasomotor symptoms. RESULTS: At the end of the study, Nutrafem reduced the number of vasomotor symptoms by 46% from baseline, and this is significantly superior to placebo (26% from baseline; P = 0.020). Forty-three percent of women taking Nutrafem experienced an at least 50% reduction in the number of symptoms compared with 6% of women taking placebo (P = 0.021; number needed to treat = 2.7). There were no group differences in adverse events, laboratory values, and gynecological data. CONCLUSIONS: Nutrafem is an effective botanical treatment for vasomotor symptoms in postmenopausal women.

NASH is a common condition with a rising incidence. There is progression to cirrhosis in some cases and the potential for mortality or requirement of liver transplantation. Currently, there is no approved therapy for NASH. The natural compound YHK has both anti-inflammatory and antifibrotic properties, and can lead to improvement in transaminases in viral hepatitis. Improvement in transaminases may correlate with improved histology in NASH and hence may impact on the natural history. We sought to determine the effects of YHK on NASH. We performed a randomized, double-blind, placebo-controlled pilot study to determine the effects of YHK on transaminases and on quality of life (QoL) in patients with biopsy-confirmed NASH and a persistently abnormal ALT or AST. Eight patients were randomized to YHK or placebo for 8 weeks. The ALT and AST were measured at baseline and weeks 4, 8, and 12. SF-36 surveys were serially completed. All five patients in the YHK group but none in the placebo group had a marked decrease in ALT at both week 4 and week 8 compared to baseline. After discontinuing YHK the ALT returned toward baseline at week 12. The mean decrease in ALT compared to baseline was significantly greater in the YHK group than in the placebo group at both week 4 (-42.8+/-23.2 vs. -6.3+/-6.7 U/L; P=0.036) and week 8 (-45.4+/-23.4 vs. 6.0+/-24.6 U/L; P=0.036). There was also a nonsignificant decrease in AST in the YHK group compared to placebo. QoL was not affected and no severe adverse events were reported. In this controlled pilot study we found the novel nutraceutical agent YHK to be effective at reducing ALT values in patients with NASH. YHK is well tolerated. Further studies are justified to assess the impact of YHK in the natural history of NASH.