NICEVIVA
MONOGRAPH SPEC LATEST 2026

Wild Yam

BOTANICALS · Evidence Monograph

Wild Yam is an evidence-graded botanicals monograph evaluated across 21 peer-reviewed PubMed studies (2 meta-analyses, 0 systematic reviews, and 6 randomized controlled trials, encompassing n = 881 cumulative participants). Current clinical evidence is rated GRADE High (4.0 / 4.0) for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

Evidence Grade (GRADE) High (4.0 / 4.0)
Indexed PubMed Studies 21 Studies
Meta-Analyses · Reviews 2 Meta · 0 Systematic Reviews
Randomized Trials (RCT) 6 RCTs (8 Double-Blind)
Cumulative Participants n = 881
Reported Trial Dosages 10 mg · 2000 mg/day · 300 mg/day
Trial Duration Range 12 weeks · 4 weeks · 3 days
Reading Time ~11 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways (supported by 21 indexed PubMed studies, GRADE High).
  2. 02 Adults matching clinical trial dosing protocols (10 mg · 2000 mg/day · 300 mg/day) over a structured 12 weeks evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Standardized Marker-Compound Botanical Extract
Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.
Dose Adjustment Signal: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.
CHRONOBIOLOGY · Optimal Dosing Window PM 12:30
Immediately After Breakfast or Lunch
Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
Primary botanicals clinical efficacy (21 PubMed studies)
Quantitative biomarker & outcome analysis (13 studies with effect-size/sample data)
Randomized controlled trial verification (6 RCTs · 8 double-blind)
Systematic review & meta-analysis synthesis (2 meta-analyses · 0 reviews)
01

What Is Wild Yam & Why Does Form Matter?

Wild Yam is classified under BOTANICALS and has been investigated across 21 peer-reviewed PubMed publications for its role in phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

In clinical nutrition, physiological efficacy depends heavily on the specific chemical salt, chelate, or standardized extract used, as well as adherence to trial-validated dosing (10 mg, 2000 mg/day, 300 mg/day).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Wild Yam frequently arises from restrictive dietary patterns, age-related declines in gastrointestinal absorption, chronic metabolic stress, or medication-induced nutrient depletion.

Before initiating supplementation, identify whether your primary goal aligns with the endpoints evaluated in human randomized controlled trials (6 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Wild Yam acts on pathways governing phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Wild Yam an overall evidence rating of GRADE High (4.0 / 4.0) based on 21 PubMed studies: 2 meta-analyses, 0 systematic reviews, and 6 randomized controlled trials (8 double-blind, n = 881 total participants).

Representative peer-reviewed findings include: • PMID:20833608 (2010) — "Evaluating the evidence for over-the-counter alternatives for relief of hot flashes in menopausal women." (CONCLUSION: Women should be encouraged to implement therapeutic lifestyle changes to assist them with hot flash management.) • PMID:39400265 (2025) — "A Randomized, Double-Blind, Placebo-Controlled Study Investigating the Safety and Efficacy of a Herbal Formulation on Knee Joint Function in Adults with Knee Osteoarthritis." (While both groups reported improvements in WOMAC pain from baseline, improvements in current and bodily pain were experienced sooner with GJ 191 than placebo and were sustained over the study period.) • PMID:33244311 (2020) — "Additional Benefit of Chinese Medicine Formulae Including Dioscoreae rhizome (Shanyao) for Diabetes Mellitus: Current State of Evidence." (CONCLUSION: Evidence from this review suggested that there appeared to be added clinical benefits associated with the use of Shanyao for DM, whether as a food supplement or as a CHM combined with hypoglycemic agents with a good safety profile.)

05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Standardized Marker-Compound Botanical Extract. Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 10 mg · 2000 mg/day · 300 mg/day · 10 g over 12 weeks · 4 weeks · 3 days · 7 days. Optimal timing window: PM 12:30 · Immediately After Breakfast or Lunch (Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.

Adjustment & Discontinuation Signals: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.

07

Prescription Drug Interactions & Contraindications

No major high-risk prescription contraindications are flagged in the primary index for Wild Yam, but divalent minerals, fat-soluble compounds, and botanical extracts can still alter absorption or CYP450 metabolism of concurrent medications.

Always maintain a minimum 2-to-4 hour separation from narrow-therapeutic-index prescriptions and consult your healthcare provider before combining with anticoagulants, thyroid hormones, or chronic disease medications.

08

4 Essential Safety Rules Before & After Dosing

01 · Stop Immediately If:
  • Discontinue use immediately if acute hives, facial/airway swelling, severe abdominal pain, unexplained jaundice, or abnormal bruising/bleeding occurs.
  • Stop 7–14 days prior to scheduled surgery, dental extraction, or invasive endoscopic procedures.
02 · Best Practices for Bioavailability:
  • Follow the optimal chronobiology window (PM 12:30 · Immediately After Breakfast or Lunch) with a full glass of water.
  • Stay within clinically studied daily dosages (10 mg · 2000 mg/day · 300 mg/day) and re-evaluate efficacy after 12 weeks.
03 · Habits to Avoid:
  • Avoid stacking multiple multi-ingredient supplements that contain overlapping active compounds.
  • Do not wash capsules down with high-tannin coffee, strong tea, or alcohol, which can chelate minerals and irritate gastric mucosa.
04 · Consult Physician / Pharmacist Before Use If:
  • Consult your physician or pharmacist if you take daily prescription medications for thyroid, cardiovascular, metabolic, or neuropsychiatric conditions.
  • Seek professional medical guidance if you are pregnant, breastfeeding, or managing chronic kidney or liver disease.
09 · PUBMED CLINICAL STUDIES

Indexed PubMed Clinical Studies & Abstracts (21 Studies) · 13 Quantitative Analyses

01
CLINICAL STUDY Journal of the American Pharmacists Association (2010) PMID: 20833608 ↗
Evaluating the evidence for over-the-counter alternatives for relief of hot flashes in menopausal women.
Clinical Trial Synthesis 2010 Clinical Study published in Journal of the American Pharmacists Association. Key conclusion: CONCLUSION: Women should be encouraged to implement therapeutic lifestyle changes to assist them with hot flash management.
View Original PubMed Abstract ↓

OBJECTIVE: To review the literature on alternative over-the-counter (OTC) therapies for the treatment of hot flashes in menopausal women. DATA SOURCES: A literature search was conducted using PubMed, International Pharmaceutical Abstracts, and Medline from inception to June 2010, combining the term hot flash individually with black cohosh, isoflavones, red clover, soy, vitamin E, ginseng, dong quai, evening primrose oil, wild yam, kava, and melatonin. All publication types including human participants and published in English were eligible for review. These articles, relevant abstracts, and additional references were used to collect pertinent data. STUDY SELECTION AND DATA EXTRACTION: Clinical trials comparing the above single-ingredient agents with placebo or active treatment were selected. In addition, only studies assessing the effects of these single-ingredient agents on vasomotor symptoms in menopausal women were included. DATA SYNTHESIS: Since the Women's Health Initiative and Heart and Estrogen/Progestin Replacement Study II, women have sought lifestyle changes and other drug therapies as alternatives to menopausal hormone therapy to relieve hot flashes associated with menopause. The currently available literature is conflicting in regard to efficacy and does not support the use of alternative OTC therapies for hot flash management associated with menopause. In addition, long-term safety data are lacking for any of these therapies. CONCLUSION: Women should be encouraged to implement therapeutic lifestyle changes to assist them with hot flash management. Based on the current literature, alternative OTC therapies do not have consistent, beneficial data to support their use in hot flash management.

02
RANDOMIZED TRIAL (RCT) Journal of integrative and complementary medicine (2025) PMID: 39400265 ↗
A Randomized, Double-Blind, Placebo-Controlled Study Investigating the Safety and Efficacy of a Herbal Formulation on Knee Joint Function in Adults with Knee Osteoarthritis.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Journal of integrative and complementary medicine; statistical significance reported at p = 0.01. Key conclusion: While both groups reported improvements in WOMAC pain from baseline, improvements in current and bodily pain were experienced sooner with GJ 191 than placebo and were sustained over the study period.
View Original PubMed Abstract ↓

Background: Current treatments for osteoarthritis (OA) pain and stiffness have limitations, including adverse effects. Therefore, effective and safe complementary or alternative therapies are needed. Dietary supplement GJ 191, comprising Epimedium, Dioscorea, and Salvia miltiorrhiza extracts, may address this need. Methods: This randomized, double-blind, placebo-controlled study investigated GJ 191 supplementation on knee OA symptoms. Seventy-two adults (40-75 years) with mild to moderate knee OA and mild to moderate knee pain were enrolled. The Knee Injury and Osteoarthritis Outcome Score (KOOS), Pain Visual Analog Scale (VAS), Quality of Life questionnaire, knee joint range of motion, serum C-reactive protein, and rescue medication use were assessed. The Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) pain and stiffness scores were computed using KOOS scores. Results: Decreases in WOMAC pain scores were reported by both GJ 191 and placebo groups after 6 (-1.78 ± 2.71 and -1.34 ± 1.93, respectively; p < 0.01) and 12 (-2.31 ± 2.83 and -1.59 ± 2.69, respectively; p < 0.01) weeks, with no significant difference between groups. There were decreases in WOMAC stiffness scores for participants supplemented with GJ 191 by 0.53 ± 1.22 and 0.72 ± 1.46 (p ≤0.02) after 6 and 12 weeks, respectively, with respective decreases of 0.81 ± 1.51 and 0.75 ± 1.85 (p ≤0.03) for those on placebo. Significant improvements in current pain, as assessed by the Pain VAS, and bodily pain were reported by the GJ 191 group after 6 and 12 weeks, while the placebo group only reported significant improvements in these measures after 12 weeks. GJ 191 supplementation was safe and well tolerated. Conclusion: There was no significant difference in pain and stiffness scores between GJ 191 and placebo over the 12 weeks. While both groups reported improvements in WOMAC pain from baseline, improvements in current and bodily pain were experienced sooner with GJ 191 than placebo and were sustained over the study period. GJ 191 supplementation was safe and well tolerated. (CTR#: NCT04395547).

03
CLINICAL STUDY Frontiers in endocrinology (2020) PMID: 33244311 ↗
Additional Benefit of Chinese Medicine Formulae Including Dioscoreae rhizome (Shanyao) for Diabetes Mellitus: Current State of Evidence.
Clinical Trial Synthesis 2020 Meta-Analysis published in Frontiers in endocrinology. Key conclusion: CONCLUSION: Evidence from this review suggested that there appeared to be added clinical benefits associated with the use of Shanyao for DM, whether as a food supplement or as a CHM combined with hypoglycemic agents with a good safety profile.
View Original PubMed Abstract ↓

BACKGROUND: Chinese medicine has been used to treat diabetes symptoms for thousands of years. Dioscoreae rhizome or Shanyao is a Chinese medicinal herb that is routinely used in the treatment of diabetes mellitus (DM). OBJECTIVE: The purpose of this study is to evaluate the evidence of the added benefits and safety of herbal formulae containing Shanyao in clinical studies and the possible mechanisms of Shanyao in the prevention and treatment of DM in experimental studies. METHODS: We searched nine databases for randomized controlled trials (RCTs) that included Shanyao in the formulae in the treatment of type 2 DM. Furthermore, experimental studies on the prevention and treatment of DM by Shanyao in English- and Chinese-language databases were identified. RESULTS: Fifty-three moderate quality RCTs with herbal formulae containing Shanyao were identified. Results from meta-analysis indicated that Shanyao alone or formulae containing Shanyao in addition to conventional treatments could benefit people with type 2 DM in lowering blood glucose, blood lipids and reducing insulin resistance. Moreover, adverse events were significantly lower in the CHM plus conventional group than those in the conventional group. Shanyao may exert the benefit through various mechanisms including inhibition of α-glucosidase and DPP-IV activity, increase of endogenous GLP-1 and immune regulating activities. CONCLUSION: Evidence from this review suggested that there appeared to be added clinical benefits associated with the use of Shanyao for DM, whether as a food supplement or as a CHM combined with hypoglycemic agents with a good safety profile.

04
CLINICAL STUDY Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan (2012) PMID: 22876444 ↗
The effects of Chinese yam-epimedium mixture on respiratory function and quality of life in patients with chronic obstructive pulmonary disease.
Clinical Trial Synthesis 2012 Clinical Study published in Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan; statistical significance reported at p = 0.05. Key conclusion: CONCLUSION: Chinese yam-epimedium mixture can significantly improve dyspnea, exercise capacity, and the quality of life of patients with stable moderate or severe COPD.
View Original PubMed Abstract ↓

OBJECTIVE: To examine the clinical effects of a mixture of Chinese Yam and epimedium in patients with stable moderate or severe chronic obstructive pulmonary disease (COPD). METHODS: Forty-nine patients with COPD were randomly allocated to a group whose usual treatment was supplemented with oral Chinese yam-epimedium mixture, or a control group given placebo. For each patient, body mass index, airflow obstruction, dyspnea, and exercise capacity were measured and converted into the BODE index before treatment and at one and three months after initiation of treatment. Participants also completed the St. George's respiratory questionnaire (SGRQ) at the same intervals. RESULTS: After one month, improvements were seen in the BODE index and SGRQ of participants taking Chinese yam-epimedium mixture compared to controls. There were statistically significant differences in the SGRQ: three of its components and the total SGRQ scores were significantly decreased (P < 0.05), respiratory symptom scores had improved (P < 0.01), and the dyspnea component of the BODE index had significantly decreased (P < 0.05). Similar improvements were observed after three months of treatment, but exercise tolerance had also improved: the six-minute walking distance had significantly increased (P < 0.05) in the treatment group when compared with controls. CONCLUSION: Chinese yam-epimedium mixture can significantly improve dyspnea, exercise capacity, and the quality of life of patients with stable moderate or severe COPD.

05
CLINICAL STUDY Integrative physiological and behavioral science (1998) PMID: 9594356 ↗
The effects of nutritional supplements on the symptoms of fibromyalgia and chronic fatigue syndrome.
Clinical Trial Synthesis 1998 Clinical Study published in Integrative physiological and behavioral science. Key conclusion: Nutritional supplements resulted in a remarkable reduction in initial symptom severity, with continued improvement in the period between initial assessment and the follow-up.
View Original PubMed Abstract ↓

This article reports the results of a within-subject design. Fifty subjects with a physician diagnosis of fibromyalgia (FM) and/or chronic fatigue syndrome (CFS) were interviewed using a structured interview from. Each subject was interviewed initially, and again nine months later (follow-up). Subjects had, on their own, consumed nutritional supplements including freeze-dried aloe vera gel extract; a combination of freeze-dried aloe vera gel extract and additional plant-derived saccharides; freeze-dried fruits and vegetables in combination with the saccharides; and a formulation of dioscorea complex containing the saccharides and a vitamin/mineral complex. With medical treatments, approximately 25 percent of FM patients improve, but the beneficial effects of medical treatment rarely persist more than a few months. All subjects in this study had received some form of medical treatment prior to taking the nutritional supplements, but none with enduring success. Nutritional supplements resulted in a remarkable reduction in initial symptom severity, with continued improvement in the period between initial assessment and the follow-up. Further research is needed to verify these results, specifically crossover designs in well-defined populations.

06
CLINICAL STUDY Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine (1997) PMID: 10322833 ↗
[Clinical and experimental studies of supplemented sini san in treating chronic brucellosis].
Clinical Trial Synthesis 1997 Clinical Study published in Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine involving n = 76 participants; statistical significance reported at p = 0.01. Key conclusion: CONCLUSION: SSNS was effective in treating CB, including the long-term follow-up result.
View Original PubMed Abstract ↓

OBJECTIVE: To observe the effect of supplemented Sini San (SSNS) in treating chronic Brucellosis (CB). METHODS: One hundred and twenty-seven patients were randomly divided into two groups, 76 cases in the treatment group were treated with SSNS and 51 cases in the control group treated with Dioscorea Nipponica Power. The effect of SSNS on mice model of CB was also observed simultaneously. RESULTS: The short-term effects were that the total effective rate and markedly effective rate of the treatment were 98.7% and 92.1%, which were better than those of the control group (82.4% and 41.2%) respectively, P < 0.01. The long-term follow-up result of the treatment group also showed its superiority to the control group, the total effective rates of the two groups were 98.7% and 51.0%, and the markedly effective rates were 90.8% and 21.6% respectively (P < 0.01). Animal experiments indicated SSNS has obvious effect of antibiotics and immunomodulation. CONCLUSION: SSNS was effective in treating CB, including the long-term follow-up result.

07
META-ANALYSIS Frontiers in plant science (2025) PMID: 40007964 ↗
Saponin content in medicinal plants in response to application of organic and inorganic fertilizers: a meta-analysis.
Clinical Trial Synthesis 2025 Meta-Analysis published in Frontiers in plant science. Key conclusion: On the other hand, organic fertilizers improve the soil environment and stimulate saponin accumulation, they do not supply all the nutrients required for the sustained growth of these plants.
View Original PubMed Abstract ↓

The application of fertilizers is a key agronomic practice in the artificial cultivation of medicinal plants, aiming to boost yields and enhance the levels of their bioactive constituents. However, systematic investigations on the influence of various fertilizers on the concentration of active compounds in saponin-containing medicinal plants remain insufficient. In this study, 966 experimental outcomes from 29 papers were analyzed via meta-analysis to examine the effects of organic fertilizers, inorganic fertilizers, and their combined application on the levels of different saponin monomers in medicinal plants. The findings from the meta-analysis revealed that inorganic fertilizers contribute positively to the accumulation of saponins such as Rg1 in ginseng, Rb1, Rc, Rd, Re, and Rg1, in addition to the saponins from Paris polyphylla, Dioscorea, Panax quinquefolius, and Platycodon grandiflorus. Moreover, the application of organic fertilizers was found to markedly elevate the concentrations of Notoginsenoside R1, Ginsenoside Rb1, Ginsenoside Rb2, Re, and Rg1, along with Lancemasid saponins and Quinoa saponins. The combined use of both organic and inorganic fertilizers was shown to effectively increase the levels of Notoginsenoside R1 and Panax ginsenosides, encompassing Rb1, Rb2, Rc, Rd, Re, and Rg1. Overall, the results suggest that both individual and combined applications of organic and inorganic fertilizers have a positive impact on the enhancement of saponin monomers in medicinal plants. However, inorganic fertilizers promote the increase of saponin content, their prolonged use may lead to soil compaction and acidification, which could compromise the yield and quality of medicinal plants. On the other hand, organic fertilizers improve the soil environment and stimulate saponin accumulation, they do not supply all the nutrients required for the sustained growth of these plants. Therefore, a balanced fertilization strategy combining both organic and inorganic fertilizers is recommended as the optimal approach for cultivating saponin-rich medicinal plants.

08
META-ANALYSIS Alternative therapies in health and medicine (2023) PMID: 37856796 ↗
Meta-analysis of Huangqi (Astragalus membranaceus) and Chinese Yam (Rhizoma Dioscoreae) for Diabetic Nephropathy.
Clinical Trial Synthesis 2023 Meta-Analysis published in Alternative therapies in health and medicine; statistical significance reported at p = 0.01. Key conclusion: RESULTS: In all studies, all heterogeneous (P < .01, I2 = 94%, the intervention groups had a significantly greater reduction in 24-h UP than the control groups did (P < .05).
View Original PubMed Abstract ↓

7. Altern Ther Health Med. 2023 Nov;29(8):840-845. Meta-analysis of Huangqi (Astragalus membranaceus) and Chinese Yam (Rhizoma Dioscoreae) for Diabetic Nephropathy. Wang C, Li S, Meng J, Xia M, Bo Q, Ying W. CONTEXT: Diabetic nephropathy (DN), also known as diabetic kidney disease (DKD), has caused enormous economic pressure and serious health problems worldwide. TCM practitioners commonly use a combination of Astragalus membranaceus (A. membranaceus) and Rhizoma Dioscoreae (R. Dioscoreae) in the treatment of DN. Research is still lacking on the therapeutic effects of TCM for DN. OBJECTIVE: The systematic review and meta-analysis intended to evaluate whether the combination of A. membranaceus and R. Dioscoreae together with Western medicine can provide better efficacy against DN than treatment with traditional Western medicine alone, to provide a clinical medical basis for the use of the TCM combination. DESIGN: The research team performed a performed a systematic narrative review by searching the Web of Science, Science Direct, Pubmed, China National Knowledge Infrastructure (CNKI), VIP, Wanfang, Chinese Science and Technology Journal Database, and Biomedical Literature Chinese Database from databases' inceptions to May 2023. The team used the keywords astragalus and yam, diabetic nephropathy, antidiabetic, and 24-h urinary protein. SETTING: The review and meta-analysis occurred at Jiangxi Hospital of Integrated Traditional China and Western Medicine in Nanchang, Jiangxi, China. INTERVENTION: To perform a subgroup analysis, the research team divided the studies into two groups based on the TCM treatment course, with one subgroup receiving treatment for ≤4 weeks and the second receiving treatment for >4 weeks, to judge whether a time-dependence existed for the effects of the TCM combination on UP. OUTCOME MEASURE: All studies used 24-h urinary protein (UP) as the outcome measure. RESULTS: In all studies, all heterogeneous (P < .01, I2 = 94%, the intervention groups had a significantly greater reduction in 24-h UP than the control groups did (P < .05). The heterogeneity for a treatment course of ≤4 weeks was P < .01, I2 = 97%, and for a course of >4 weeks was

09
RANDOMIZED TRIAL (RCT) Journal of ethnopharmacology (2026) PMID: 41763617 ↗
Efficacy and safety of medicine-food homology Shenqi paste in older adults with diabetic sarcopenia: A randomized, double-blind, placebo-controlled trial.
Clinical Trial Synthesis 2026 Randomized Controlled Trial (RCT) published in Journal of ethnopharmacology involving n = 74 participants; statistical significance reported at p = 0.001. Key conclusion: 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
View Original PubMed Abstract ↓

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

10
CLINICAL STUDY Journal of the American College of Cardiology (2024) PMID: 38599715 ↗
Water Conservation Overrides Osmotic Diuresis During SGLT2 Inhibition in Patients With Heart Failure.
Clinical Trial Synthesis 2024 Randomized Controlled Trial (RCT) published in Journal of the American College of Cardiology involving n = 14 participants; statistical significance reported at p = 0.0001. Key conclusion: CONCLUSIONS: Physiological-adaptive water conservation eliminated the expected osmotic diuretic potential of dapagliflozin and thereby prevented a glucose-driv
View Original PubMed Abstract ↓

BACKGROUND: Sodium-glucose cotransporter 2 inhibitors are believed to improve cardiac outcomes due to their osmotic diuretic potential. OBJECTIVES: The goal of this study was to test the hypothesis that vasopressin-driven urine concentration overrides the osmotic diuretic effect of glucosuria induced by dapagliflozin treatment. METHODS: DAPA-Shuttle1 (Hepato-renal Regulation of Water Conservation in Heart Failure Patients With SGLT-2 Inhibitor Treatment) was a single-center, double-blind, randomized, placebo-controlled trial, in which patients with chronic heart failure NYHA functional classes I/II and reduced ejection fraction were randomly assigned to receive dapagliflozin 10 mg daily or placebo (1:1) for 4 weeks. The primary endpoint was change from baseline in urine osmolyte concentration. Secondary endpoints included changes in copeptin levels and solute free water clearance. RESULTS: Thirty-three randomized, sodium-glucose cotransporter 2 inhibitor-naïve participants completed the study, 29 of whom (placebo: n = 14; dapagliflozin: n = 15) provided accurate 24-hour urine collections (mean age 59 ± 14 years; left ventricular ejection fraction 31% ± 9%). Dapagliflozin treatment led to an isolated increase in urine glucose excretion by 3.3 mmol/kg/d (95% CI: 2.51-4.04; P < 0.0001) within 48 hours (early) which persisted after 4 weeks (late; 2.7 mmol/kg/d [95% CI: 1.98-3.51]; P < 0.0001). Dapagliflozin treatment increased serum copeptin early (5.5 pmol/L [95% CI: 0.45-10.5]; P < 0.05) and late (7.8 pmol/L [95% CI: 2.77-12.81]; P < 0.01), leading to proportional reductions in free water clearance (early: -9.1 mL/kg/d [95% CI: -14 to -4.12; P < 0.001]; late: -11.0 mL/kg/d [95% CI: -15.94 to -6.07; P < 0.0001]) and elevated urine concentrations (late: 134 mmol/L [95% CI: 39.28-229.12]; P < 0.01). Therefore, urine volume did not significantly increase with dapagliflozin (mean difference early: 2.8 mL/kg/d [95% CI: -1.97 to 7.48; P = 0.25]; mean difference late: 0.9 mL/kg/d [95% CI: -3.83 to 5.62]; P = 0.70). CONCLUSIONS: Physiological-adaptive water conservation eliminated the expected osmotic diuretic potential of dapagliflozin and thereby prevented a glucose-driv

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