This podcast episode is a long time coming and I am glad to present it to you now. Berberine is one of my favorite herbs/supplements, which I have been using and recommending for years to address blood sugar imbalances, bacterial infections and even influence gene expression. I hope you find it informative and feel free to send any questions my way.

As always, sharing is caring and if you have not subscribed to my podcast already, please do!

#214 The benefits of Berberine

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Last week, roughly 5,000 liver community stakeholders gathered in London for the 2022 International Liver Congress (#ILC2022,) the first major hepatology Congress to be held in person since the start of the pandemic (smaller, but very valuable, meetings like NASH-TAG, LiverCONNECT and Paris NASH have taken place with an in-person component, but the International Liver Congress and The Liver Meeting have not). On the last full day of the program, several vitally important drug development studies were presented during the late-breaker and dedicated sessions. The conversations in this episode will review some of the most important findings. This particular conversation discusses two presentations on resmetirom, the late-breaker safety results (and some preliminary, secondary efficacy markets) from the Phase 3 MAESTRO NAFLD-1 trial, and a separate study looking at 180 cirrhotic patients in the open-label cohort of MAESTRO.

MAESTRO NAFLD-1 was a double-blind, randomized, placebo-controlled trial of 80 or 100 milligrams of resmetirom versus placebo, with close to 1,200 patients in these three cohorts. There was a fourth 100mg open-label cohort as well, with 180 cirrhotic patients among the trial population. For MAESTRO NAFLD-1, the primary endpoint was safety. In addition, there were several key secondary endpoints, including pathogenic lipids, and certain MRI characteristics, along with FibroScan (both KAP and KPA). To primary author Harrison, the "take-home point" from this study was "there was no bad news from MAESTRO NAFLD-1, and it did meet its primary endpoint with all the key secondary endpoints under hierarchical control having statistical significance as well. 

One more interesting point from this presentation. Because the study was fielded during the COVID-19 pandemic, patients in the three closed-label arms missed an average of two months of doses due to pandemic-related logistical challenges. Despite this, the secondary endpoints demonstrated efficacy, although some demonstrated reduced efficacy compared to what we would expect from a full course of therapy.

Stephen then shares significant data from the first 105 patients in the open-label cirrhosis group. Without going into detail, the "take-home point" here is that "in addition to the safety and tolerability... we were moving noninvasive tests in a way that made us feel like something positive was happening relative to maybe some early portal hypotensive changes." Stephen notes the caveat that the researchers performed neither endoscopy nor HPG measurements in this population.

S3-E34.1 - #ILC2022 Looking Back: Resmetirom Late-Breaker and Cirrhosis Study

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Our week of "Greatest Hits" episodes from the vault continues with this conversation from the episode announcing the launch of the NAIL-NIT consortium. Stephen Harrison and Mazen Noureddin discuss the thinking behind their new consortium and its targets. In this conversation, they discuss challenges with the NAS score.

The early part of 2022 had several episodes discussing the increasing need to move beyond biopsy (yes, semi-quantitative, but even AI-assisted at some levels) to a future shaped by NITs. One pivotal issue that emerged regarded ballooned hepatocyte evaluation and its impact on NAS scores. 

As I wrote: The first section focuses mostly on what we can and cannot learn from a NAS score, and implications of its shortcomings on the drug development process. After this, Stephen Harrison notes the complex role the liver plays in energy transfer throughout the entire metabolic process. This suggests that the effects of Fatty Liver disease vary among individual patients and, as a result, drug development and patient diagnosis and treatment should provide sufficient insight to optimize each patient’s therapy. As the conversation closes, Mazen Noureddin is responding to a question from Louise Campbell about what we will learn about optimal testing strategy. Mazen suggests there is unlikely to be a single "winning" test but, instead, a combination of NITs probably will be necessary to answer all the questions necessary to optimize therapy.

S3-E38.5 - From the Vault: NAIL-NIT tackles NAS Score Challenges

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One serious challenge in the overall management of Fatty Liver disease involves creating cost-effective methods for "early" diagnosis. The term "early" is relative because, as Ian Rowe puts it, a "substantial proportion" of people admitted to hospital with various symptoms of decompensating cirrhosis or hepatic encephalopathy never received a diagnosis of advanced liver disease before they presented. Simply diagnosing these patients during advanced fibrosis (F2 or F3) can save lives, improve longevity and quality of life for these patients and save money for healthcare systems, all at the same time. 

Ian spends the first ten minutes of this episode describing a model he and Richard Parker developed to evaluate five diagnostic strategies:

• Targeted -- simple non-invasive liver screening 
• Targeted + risk stratification -- targeted assessment plus FIB-4 or VCTE (FibroScan) for patients believed to be at high risk
• iLFT -- automated assessment of abnormal LFTs analyzed with other systemic measures in a medical record system 
• "Comprehensive" -- a "kitchen sink" approach that runs iLFT analysis and conducts FIB-4 +/- VCTE on every patient
• "Fibrosis first" -- an approach that deploys viroserological and iron testing plus FIB-4 +/- VCTE for every patient 

"Fibrosis first" scored best in cost effectiveness (cost per correct diagnosis of treatable liver disease) and "decision curve analysis", which looks at true positive outcomes and false positive outcomes, correctly identifying 85% of treatable liver disease patients (vs. 90% for the comprehensive approach and less than 15% for the current targeted approach.)  Fibrosis first has the added benefit of not progressing treatment for people who may have steatosis without fibrosis. 

The rest of the conversation entails Ian, Louise Campbell and Roger Green sharing questions and observations. Highlights:

• Louise agrees that the current targeted pathway approaches do not work and  identifies lack of access to advanced testing in primary care as a central issue. She asks how many additional patients with Type 2 Diabetes, other metabolic diseases or CVD could be identified through this approach. Ian cannot answer because the question is outside the scope of the research. He points out that to assess different approaches accurately, researchers and policymakers need to settle on whether the goal is to identify steatohepatitis or something broader. 
• Louise asks about the frequency and nature of referrals. Ian notes that one issue with iLFT is a high level of referrals for conditions that might not require treatment, the most common of which is "abnormal LFT without fibrosis."
• Roger notes that iLFT might help patients who complain they never heard about their NASH earlier. He also recalls Quentin Anstee and Stephen Harrison discussing recently that FIB-4 can serve as a prognostic measure not only for liver-related deaths, but also CV deaths and all-cause mortality. 
• Louise suggests that patients will do better if they adopt a  behavior belief model instead of a sick patient approach and that the earlier in disease we intervene, the more success we will have. Roger and Ian note that Louise’s focus is broader in scope than his model. Ian further notes that we do not know when non-fibrotic patients should be tested again, although he has some thoughts about this. 
• Louise notes that one element that might make iLFT costly is that only 45% of patients picked up on iLFT are referred into the model. Ian notes that this insight might require changes in the model.

As the conversation winds down, it shifts toward policy issues: should we focus testing on the workforce (Louise) and it the best point of intervention to limit advertising of unhealthy foods (Ian).

S3-E39 - Reviewing a Decision Model for Early NASH Diagnosis

Molecular hydrogen is my number 1 supplement or product to use for my health. I've been using it for about 4 years now and recommended many people try it, but what exactly is "molecular hydrogen" and what does the research say about it? Does it really benefit the body? You might be blown away by what has been uncovered with molecular hydrogens abilities!

I hope you enjoy this educational episode and please like, share and subscribe if you haven't already. :)

Studies;
https://molecularhydrogeninstitute.org/brain/
https://symbiosisonlinepublishing.com/microbiology-infectiousdiseases/microbiology-infectiousdiseases70.php
https://journals.lww.com/nsca-jscr/Abstract/2022/10000/Hydrogen_Rich_Water_Consumption_Positively_Affects.15.aspx
https://www.lenntech.com/periodic/elements/h.htm#ixzz71U7CbePk
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5731988/

#265 What is Molecular Hydrogen?

Ray talks about NASH aka fatty liver and the benefits of Mitoblast.

Ray's Healthy Tidbit About Mitoblast And Fatty Liver Episode 111

Gout is so common, and can effect anyone! There are many driving factors behind gout and what can bring on a flare. So in this weeks podcast we look at gout more in depth, what it is, symptoms, testing and treatment. 

Please do share with anyone you feel may benefit to help us spread the word of good health and have a very Merry Christmas xo

#142 Understanding Gout

Digital Journal Club 1: Posted 2/13/20. "THE QUALITY AND OUTCOMES OF CARE PROVIDED TO PATIENTS WITH CIRRHOSIS BY ADVANCED PRACTICE PROVIDERS" Hepatology January 2020.

Journal Club #1: Role of Advanced Practice Providers in the Care of Patients with Cirrhosis

Dr Marno Ryan is a Gastroenterologist and Hepatologist with a special interest in fatty liver disease which is fast becoming a serious health issue not only in Australia but throughout the world.

She says that despite 30% of the population in Australia having the disease, not everyone will go on to develop more serious liver issues such as non-alcoholic steato-hepatitis (NASH).

But for those who do develop NASH, losing between 5-10% of body weight can make a really positive difference she says.

Listen to find out the best diet and drinks for liver health.

Dr Marno Ryan on how 5-10% weight loss can make all the difference

Patient advocates discuss how doctors and other providers can serve patient needs better

https://bit.ly/Ep18-Patient-Wants

Guest surfer Anthony Villiotti, President of NASH kNOWledge, Inc. joins the Surfers. Tony and Surfer Donna Cryer, President & CEO of Global Liver Institute, discuss the way that better delivery of disease information and care can keep patients healthier longer and make them more knowledgeable about their disease. Too often patients are told not to worry about a fatty liver until the day they learn they need a transplant -- this has to stop! Learn how we developed our word of the week ("indoctrinologist"), why the "What? So what? Now what?" approach would be valuable, and how timely information and coordinated care will lead to better patient outcomes.

What NASH Patients Want From the Healthcare System - Ep 18

Healthy Choices is hosted by Ray Solano, Pharmacist,  Certified Clinical Nutritionist and owner of PD Labs, a specialty compounding pharmacy.  Each week, Ray talks about hot topics in the healthcare industry as well as interviews top practitioners in the industry.  Ray's topics also include tips on diet, exercise, supplements and overall health. You won't want to miss this podcast!

This podcast aims to teach you how to understand your body, take care of yourself and learn how to constantly stack conditions in your favor. Integrative Health practitioner, Nutritional Therapist, Biohacker, Certified Iridologist, Personal trainer and Pilates instructor. I specialize in orthomolecular nutrition, long term sustainable weight loss, female hormones, metabolic health, sleep quality, brain health and more. Commit to learning how your body really works and achieve sustainable results.

The information in these podcast episodes is for informational purposes only and should not be taken as medical advice. All guest opinions are their own and do not reflect my own.

Drug developers, investors, researchers, and corporate executives wrestle weekly to understand what is happening in commercial development of NASH medications. Hepatology researcher and Key Opinion Leader Stephen Harrison, M.D., C-suite veteran Peter Traber, M.D., and Forecasting and pricing guru Roger Green, M.B.A. discuss the issues affecting the evolving NASH market from their own unique perspectives on the Surfing the NASH Tsunami podcast.

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