For those who dont know, integrative medicine is the blending of conventional medicine with complementary or alternative medicine.

Essentially, an integrative treatment is one that utilizes traditional drugs and surgery in combination with other holistic therapies such as Ayurveda, homeopathy, acupuncture, yoga, meditation and massages.

This medical practice doesnt just remedy a patients disease or pain. It also dives deeply into the patients physical, emotional, spiritual and pathophysiological wellness.

Integrative medicine is preventative and curative, just like conventional medicine, but it also brings forth a dimension of healing that conventional medicine and alternative medicine simply cant reach on their own.

It is understandable why people tend to be skeptical about alternative medicine. After all, the scientific evidence proving the legitimacy of alternative treatments is just beginning to roll out.

Additionally, alternative medical treatments are known to take much longer to work than conventional treatments. This is because every health issue is dealt with at its root by promoting lifestyle changes, emotional/spiritual wellness therapies and natural (non-lab-made) medication. Therefore, alternative medicine is not the best option in emergency situations.

On the other side, alternative medicine patients do receive personal attention and tailored treatment plans to heal not only their ailments but also their body and mind.

Patients often feel long-term betterment due to the fact that they are given the lifestyle tools to promote further healing. Alternative medicine patients also tend to suffer less from the side effects of their medication.

Last but not least, alternative medicine is much more affordable than conventional medicine.

On the other hand, conventional medicine is widely accepted throughout the world, especially in western societies. There is a lot of scientific evidence proving the effectiveness of conventional medicine.

It is especially great in emergency situations and can be helpful if a patient wants to treat an illness and its symptoms quickly.

Unfortunately, conventional medicine does fall short since treatment is often localized to where the disease or pain is rather than treating a patient on the whole.

In these ways, conventional medicine might not be the best in cases of chronic pain and illness.

Alternative medicine and conventional medicine both have drawbacks and benefits, but together they make an incredible treatment plan.

Where one falls short the other pulls through and vice versa. The best example is a cancer patient.

Telling a cancer patient to only take natural medication and to practice yoga to rid themselves of the cancer is impractical.

Telling a cancer patient to go through chemotherapy without accounting for other facets of their wellness is also impractical.

A patient should go through chemo while also focusing on alternative medicine treatments such as inflammatory food avoidance.

As time passes, studies increasingly show that there is a strong connection between mind and body when it comes to illness.

For example, studies have demonstrated that depression is a risk factor for heart disease.

The mind and body affect one another, so a successful, sustainable treatment would address mind-body related health issues along with physical issues.

For example, studies show that Cognitive Behavioral Therapy in combination with highly active antiretroviral therapy is a great combination to treat HIV-positive men.

In this treatment, both mind and body are looked after to foster the long-term healing of HIV-positive men.

While alternative medicine works best for some people, and conventional medicine works better for others, it is the gap that integrative medicine bridges that truly promotes sustainable and successful health and wellness.

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Choose integrative medicine for health and wellness - Technique

'The Douglass Update on Integrative Medicine - Integrating the Best from All Medical Disciplines'

NEW SMYRNA BEACH, Fla., Sept. 20, 2022 /PRNewswire/ -- Gathering evidence-based information from the full spectrum of medical sciences, The Douglass Update (TDU) - http://www.douglassupdate.com - is a new podcast and website devoted to exploring facts from a wide health field. Hosted by Dr. W. Campbell Douglass III, TDU will explore breaking health news along with best-practice medicine, offering concise narratives on specific health-related subjects along with interviews on relevant topics conducted with leading experts. The podcast is released weekly with complete access to archived material via TDU's website.

Following a long family tradition of medicine that speaks truth to medical power, Dr. Douglass is a board-certified physician with over three decades of experience in integrative medicine, primary care, and emergency medicine.

"I think we're at a critically important crossroads in the history of medicine," said Dr. Douglass. "The freedom to incorporate the best from all medical disciplines has never been so important as it is now in the era of COVID-19, as the medical-industrial complex determines mainstream media programming and lashes out against those who do not follow in lockstep. Speaking out against this medical fascism that's unfolding can be scary, but the time has come to call out the blatant authoritarian overreach by healthcare corporations and government agencies. TDU will cover this, and many other medical topics deemed too dangerous for industry-friendly doctors to speak about."

TDU: A Mission of Medical Integration and Integrity

Seeking to update listeners on how best to combine the most crucial and salient facts from all medical disciplines while stressing the importance of guarding and keeping freedoms, the TDU podcasts are packaged into 15-20 minutes of intriguing and entertaining health information and news. The target audience for TDU is intelligent adults who are interested in health but who do not necessarily have backgrounds in science or healthcare.

"It's for people who are looking for the truths about health and healing in a country overrun by industry and media corporatism ('medical fascism'). And it's time to test the virtue of telling the truth by heaving the societal gag rule that's been imposed on us doctors," said Dr. Douglass. "It's time to declare that the emperor has no clothes; it's time to call some folks to the carpet; it's time to point to the elephant-in-the-room and the blatant encroachments on our healthcare freedoms."

Learn more about upcoming shows by subscribing to The Douglass Updatenewsletter and following TDU on social media: Twitter, LinkedIn, Instagram, Facebook, YouTube, and SoundCloud.

About The Douglass Update (TDU)

Founded and hosted by Dr. W. Campbell Douglass ("Camp"), M.D., M.S., The Douglass Update is a comprehensive health education platform including a weekly podcast, dedicated website, newsletter, blog and bookstore, along with integrative medicine products and services. Dr. Camp Douglass holds Bachelor's and Master's degrees in Nutrition from the University of Florida and Purdue University respectively, and his M.D. degree from Loma Linda University School of Medicine. He is board-certified in Family Practice and has practiced medicine for over 30 years. Learn more about his work at: http://www.DouglassUpdate.com.

Media Contact:Kathy Jo KingPhone: (407) 900-8556Email: [emailprotected]Sponsorship page: http://www.douglassupdate.com/?page_id=419Physical address: 405-C Flagler Ave, #2573; New Smyrna Beach FL; 32169

SOURCE The Douglass Update

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Integrating the Best from All Medical Disciplines and Fighting Medical Fascism - The Douglass Update Launches Fully Integrated Med-Sciences Education...

Magnesium is a mineral involved in over 300 different biochemical pathways in the body, and that includes ones that promote relaxation. "When we're stressed, we use up our body's store of magnesium. This is one reason why I've been experimenting with taking magnesium for better, more restful sleep for years,"* Moday writes in her review of mbg's sleep support+ supplement.

The integrative medicine specialist explains that magnesium supports muscle relaxation and eases the release of stress hormones like adrenaline, helping to maintain a healthy cortisol response. "It's also crucial in maintaining healthy serotonin and dopamine levels in the brain, which are both needed for mood and a clear mind during the day," she adds.

And in her quest to find the best magnesium supplement available, Moday discovered mbg's pioneering sleep support+ formula.After taking it for a few months, her deep sleep increased in duration, she fell asleep faster, and she woke up feeling more refreshed, Moday writes in her review.*

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I'm An M.D. & This Is The Supplement I Trust For Consistently Deep Sleep - mindbodygreen

Every medical college in the country must have a Department of Integrative Medicine Research

Every medical college in the country must have a Department of Integrative Medicine Research

The National Medical Commission (NMC) has made it compulsory for every medical college to have a Department of Integrative Medicine Research to promote integration of modern medicine with homoeopathy and Indian systems of medicine such as Ayurveda.

Suresh Chandra Sharma, Chairman, NMC, said this at his first joint meeting with the functionaries of the National Commission for Homoeopathy (NCH) and the National Commission for Indian Systems of Medicine (NCISM). The meeting was held on June 29 as per Section 50(1) of the NMC Act, 2019. Its details were made available through a query under the Right to Information (RTI) Act by K.V. Babu, Kannur-based ophthalmologist and RTI activist.

Dr. Sharma said at the meeting that the best methods for integration should be found out and implemented in a scientific manner for the development of all three sectors. This should eventually serve the purpose of helping the mankind in disease prevention, cure and control, he said.

Aruna V. Vanikar, president, Under Graduate Medical Education Board, NMC, said that steps were being taken to change the MBBS course curriculum. Yoga would be included as mandatory practice for 10 days for students as well as the faculty. It would start on June 10 every year and conclude on the International Day for Yoga. A module prepared by the Morarji Desai Institute of Yoga, New Delhi, had been included in the curriculum. There would be male and female instructors. Yoga might be included in theory part as well subject to its acceptability.

Anil Khurana, chairperson, NCH, said MBBS students can do a one-week internship in Ayush systems in homoeopathy colleges so that they gain awareness and respect for other system of medicine. He also expressed the need to have the right perception about homoeopathy in society. Dr. Khurana urged caution at the time of preparing regulations to avoid disrespect about other systems of medicines. He pointed out that it was a wrong perception that the quality of Ayush research was not up to the mark. Research had shown that the death rate in Japanese encephalitis cases had come down by 15% using homoeopathy treatment, he added.

Vaidya Jayant Deopujari, Chairman, NCISM, spoke about the different definitions of integration and sought a consensus. In the postgraduate system of medicine, while there was clarity with respect to nomenclature in modern medicine, Ayurveda did not have it and it was leading to confusion, he said.

From the above documents, it is clear that the dissolution of the Medical Council of India and its replacement with the NMC was for promoting unscientific mixopathy calling it integration. It will be a disaster if this trend continues, Dr. Babu told The Hindu on Wednesday.

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NMC bats for integration of modern medicine with Ayush - The Hindu

The Fundacin Cientfica Litoral will hold the third meeting of Traditional and Complementary Medicine today, with the main aim of stirring up a debate concerning what is called integrated medicine. Its main purpose is to stir up debate about what is called integrative medicine. That is, not only to make complementary medicine visible, but to think about how they can help improve the formal health system, he told AIM Biochemist. Told Pablo Basso, member of the organization. Activity is from 9 a.m. to 5 p.m. at the La Vieja Usina Cultural and Convention Center.

Complementary therapies in health currently have a wide range of options and are in increasing demand, although the health system lacks the ability to envision them due to discrepancies in self and others, as well as health-seeking problems. Traditional. Basso explained to the agency that countless experiences around the world have demonstrated that the use of alternative therapies to conventional therapies has significantly improved the variables that have been measured. For example, hospitalizations. It has become possible to reduce the average days. In post-treatment procedures, therapy also reduces the degree of anxiety at pre-consultation, or improves conditions in the cohort of terminal patients. But he pointed out that perhaps the most important contributions are in areas where Western medicine has failed, such as the pursuit of individual and community balance that is not served by a system that has based its progress on medicalization.

le provincial He also noted that the debate we intend to inaugurate this day is precisely what holds the possibilities and benefits of integrating therapies into a logical balance. It is also important that we define the regulatory framework. What this will be and the scope and importance of these complementary treatments within action protocols against certain diseases, as well as the limitations regarding themselves and those who do them. It is clear that the formal health system can only provide new care through precise regulations tendencies, hence the importance of thinking of a provincial law.

learn more For Basso, it is interesting to learn more about the demand for alternative therapies by society as a whole, as well as their prospects for inclusion in the formal health system. Personally, I believe that we cannot ignore the demand and preference that people are showing. In a survey conducted by the Foundation, we realized that almost 70 percent of those surveyed found alternative therapies. users of.What happenedThe formal health system, with its traditional methods, nor the efficiency of alternative treatments in itself, cannot at all identify the biological functions involved.

In its irreversible hospital-centered tendencies and its dominant medical practice, it is impossible for a formal system to imagine treatments that are not controlled from the systems nerve center. The health patriarchy identified in the phrase the right to receive the best care available establishes responsibilities that the current health system cannot ignore and that includes the preservation of medicine to include other medicinal options except in the name of adjuvant. prevents from traditional (the concept complementary may be a debated choice)

Medicalization is becoming an essential condiment to traditional treatments and has brought logical consequences of the pharmaceutical industrys reliance, both individual and systemic, under market logic rather than health logic. Naturalist alternatives are gaining supporters to the same extent that abuse of medicalization generates mistrust.

Health demands are changing and there is a possibility that not only cures are needed but wellness states may also be needed. The concept of physical and emotional balance cannot be solved by the traditional health system.

Traditional medicine has a passive role of the patient that puts the onus on the influencers. This condition excludes the will of the patient from the therapeutic process. Perhaps the discovery of the patients leading role during the therapeutic process determines the choice of other possibilities for individual health needs.

Because of its expansion, it is interesting to learn more about the demand for alternative therapies by society as a whole, as well as their potential for inclusion in the formal health system.

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They Hold The Third Meeting Of Traditional And Complementary Medicine - World Nation News

LOS ANGELES, Sept. 21, 2022 /PRNewswire/ -- Deepak Chopra and SEVA.LOVE, a first-of-its-kind platform that is empowering a culture of wellbeing in the metaverse, today announced "ChopraVerse," the metaverse for wellbeing in collaboration with Utopia. Utopia is a Web3 ecosystem brought together by Alejandro Saez, Maria Bravo, Eva Longoria, and Javier Garcia. The ChopraVerse initiative is part of Seva.Love's ongoing mission to create a more conscious Web3 community for a peaceful, just, sustainable, healthier and joyful world. The House of Enlightenment, designed by Vera Iconica Architecture, is Deepak Chopra's personal home in the metaverse that was initially designed for the physical world incorporating eastern wisdom design principles and the latest in wellness architecture.

The Metaverse today is mostly about gaming. The ChopraVerse is about creating a world which enhances our wellbeing. A world that will be photorealistic and inhabited by human avatars and AI beings. A world where no one will feel alone one that offers infinite experiences and possibilities. As part of the initial launch, The ChopraVerse will make the "Deepak Chopra - House of Enlightenment" available for everyone to experience in the metaverse and also enable downloadable blueprints for build in the physical world via NFTs.

"ChopraVerse is creating homes for multidimensional living, nourishing the body, mind, spirit and environment as a unified experience in awareness. It will give everyone an opportunity to generate their own abode for the return to wholeness and healing," says Deepak Chopra, world-renowned pioneer in integrative medicine, NY Times best selling author and co-founder of Seva.Love.

Utopia, which recently acquired Virtual Voyagers, has carried out more than 230 projects related to the metaverse for major brands such as META and Vodafone, winning more than 20 awards for innovation and creativity. "The opportunity Web3 technology currently presents to creators, developers and businesses is exciting on many levels. Utopia is born from the dream, duty, and vision of achieving a connection between the tangible and virtual world - in which we will live in an ethical, inclusive, and responsible way," says Nino Saez, co-founder and CEO of Utopia.

"The ChopraVerse will transform how we interact and experience wellbeing in the digital and physical world. Our collaboration with Utopia will enable us to experience interoperable metaverse experiences in real-time, 3D virtual worlds that can be experienced synchronously, maintain presence and have a collaborative experience," says Poonacha Machaiah, co-founder and CEO of SEVA.LOVE. "While the NFT world is incredible, it is still evolving, and we saw a gap in the market to build a wellbeing community and make real social impact via the metaverse."

"The Utopia and ChopraVerse collaboration will enable an ecosystem in the digital world for impactful collaborations within the metaverse, where we aim to bring global action to educate the world, connecting philanthropists, embracing brands and businesses using the power of the blockchain to raise awareness on building a more ethical and transparent world, a community of philanthropreneur's, spreading kindness fast to where it's needed," says Maria Bravo, co-founder Utopia and Global Gift Foundation.

The ChopraVerse roadmap has planned NFT drops which will serve as access tokens to the ChopraVerse in Utopia. Additionally, there will also be a limited number of NFTs that will integrate blueprints and wellbeing design principles, by licensure through the Architect, Vera Iconica Architecture, that can be leveraged to build homes in the physical world. "The House of Enlightenment was designed both to be built in the physical world and to be experienced by many in the digital world as a home that optimizes health and wellbeing in harmony with nature. It is an education and awareness tool that anyone can go into to learn meditation or how your surroundings are impacting your health and behavior and what you can do to elevate your state of being," says Veronica Schreibeis Smith, CEO & Founding Principal, Vera Iconica Architecture.

The ChopraVerse platform has built on its partnership with Deepak Chopra and is collaborating with other global wellbeing experts, products and services within its own metaverse while also integrating with brands and experiences in the Utopia metaverse.

For more information please visit: http://www.chopraverse.io

About Seva.Love

Seva.Love is the metaverse for wellbeing initiative that has been founded by serial technology entrepreneur Pooancha Machaiah and world-renowned pioneer in integrative medicine, personal transformation and NY Times bestselling author Deepak Chopra, MD.

Seva.Love is championing wellbeing and social impact in Web3 by curating leading artists, influencers, wellbeing experts and creating conscious communities. Seva.Love has exclusive access to Deepak Chopra web3 content and the ChopraVerse will enable transmedia storytelling and engage communities in the metaverse and IRL. Access to the Seva ecosystem will be via NFTs and the Seva token. For more information please visit https://www.seva.love/ and follow us at twitter: @sevaislove instagram: @sevaislove discord: https://discord.seva.love/

About Utopia

Utopia Group is a Web3 ecosystem brought together by four founders, Alejandro Saez, Maria Bravo, Eva Longoria, and Javier Garcia - with the mission of disrupting how businesses operate and innovate using the power of blockchain technology.

The Utopia Group's vision is to focus on bridging the gap between the physical and digital worlds. Through Utopia's acquisition of Virtual Voyageurs, the group will offer strategic consulting services, particularly developing metaverse applications and experiences, as well as educational programs and initiatives in the world of Web3.

About Vera Iconica Architecture

Founded in 2010 in Jackson by Wyoming native and Wellness Architecture pioneer, Veronica Schreibeis Smith, Vera Iconica specializes in Architecture, Interior Design, and Real Estate Development and is known globally for its Wellness Kitchen. Based in the Mountain West with offices in Jackson and Denver, Vera Iconica's highly flexible, international team of experts merges cultural, spiritual, and qualitative elements with hard science to create highly customized solutions that elevate healthy, conscious living. For more information please visit https://veraiconica.com/ and follow at instagram: @veraiconicaarchitecture

SOURCE SEVA.LOVE

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Deepak Chopra & Seva.Love Announce "ChopraVerse: House of Enlightenment," the Metaverse for Wellbeing in Collaboration with Utopia - PR...

Based on a systematic review of 17 medical studies, a recently published paper has raised questions and sparked debate about the chemical imbalance theory of depression. Although the study did not perform additional research, after synthesizing and evaluating evidence in the principal relevant areas, the authors conclude the longstanding theory is unproven.

Serotonin is a monoamine neurotransmitter, a chemical that regulates mood, sleep, appetite, and sexual desire. The chemical imbalancetheory suggests that depression is caused by lowered serotonin levels in the brain.

The paper, published July 20 in the journal Molecular Psychiatryby a multi-national team of researchers, is entitled The serotonin theory of depression: a systematic umbrella review of the evidence. The paper questions the chemical imbalance theory that began in the 1960s, based on the premise that reduced serotonin activity causes depression. This hypothesis was derived from the fact that the first two specifically antidepressant drugs, discovered in the 1950s, were both shown to increase brain levels of serotonin. Therefore, early experiments assumed a causal relationship between serotonin and depression.

Subsequently, a variety of antidepressants often referred to as happy pills were developed, promoted around, and reinforced this theory.

Although many professionals and the public still accept the serotonin theory of depression, the authors of the paper said they found no conclusive evidence that depression is associated with, or caused by, reduced serotonin concentration or activity in the brain. The study also calls into question whether raising serotonin levels via antidepressants is a reliable treatment for depression.

Although clinical experts have determined that antidepressants help in the treatment of severe depression, their mechanism is not entirely understood.

Expert reaction to the study was immediate and vigorous. The day the paper was published, BritainsScience Media Centre published a round-up of various experts and their responses.

Among them was Michael Bloomfield, Ph.D., psychiatrist and researcher at University College, London. While Bloomfield said that the hypothesis that depression was caused by a chemical imbalance in serotonin was a really important step forward in the middle of the 20thcentury, he called the review unsurprising. He noted, I dont think Ive met any serious scientists or psychiatrists who think that all causes of depression are caused by a simple chemical imbalance in serotonin.

Phil Cowen, a professor of psychopharmacology at Oxford University, has studied the effects of serotonin on depressed patients for 30 years. He believes no mental health professional today would support the view that a complex disorder like depression stems from a deficiency in a single neurotransmitter.

Professor Gitte Moos Knudsen, head of the Department of Neurology and Neurobiology Research Unit at Denmarks University Hospital of Copenhagen, said the study is based on a misconception, namely that depression is a single disease with a single biochemical deficit. Today, Knudsen notes, it is largely accepted that depression is a heterogeneous disorder with potentially multiple underlying causes.

Although the July 20 paper did not focus on the pros and cons of using antidepressants, their mechanism of action in treating depression has become the focus of discussion. This is because most of the antidepressants used today have roots in the questionable chemical imbalance theory.

In response to the study, Frederick Sundram, deputy head of psychological medicine at the University of Auckland, New Zealand, wrotethat the mechanism of action for antidepressants is not yet fully understood. He believes there may be other mechanisms at work, such as neuroplasticity. In addition, he wrote, 30 to 40 percent of the efficacy of antidepressants is due to a placebo effect.

Sundram claimed the brain chemical imbalance theory takes a simplified approach to a very complex human condition, an approach that is not shared by most psychiatrists. For example, he said, if someone has a history of personal trauma and lives under the constant stress of social isolation, unemployment, economic problems, leading to depression, antidepressants are unlikely to solve the problem.

In March, the World Health Organization (WHO) published a report that mirrors Sundrams view. The report noted that the global prevalence of anxiety and depression rose 25 percent in 2020, during the COVID-19 pandemic. The WHO said that peoples anxiety and depression were exacerbated by feelings of isolation under lockdowns, financial worries, and fear of illness or death for themselves and their loved ones. All of these are issues for which an antidepressant alone may be insufficient.

The Royal College of Psychiatrists, a British mental health authority, responded to the study by citing its position paper on antidepressants (pdf), which states that although the idea of using antidepressants to correct a chemical imbalance in the brain is too simplistic, they do have early physiological and psychological effects.

The Royal College suggests that antidepressants treat the symptoms of depression but do not directly address any underlying psychosocial causes, so medication is often combined with psychotherapy that can improve the patients ability to cope with difficult life situations.

Dr. Jing-Duan Yang is a psychiatrist and founder of the Yang Institute of Integrative Medicine. In a video presentation on Aug. 20, Yang explained why the chemical imbalance theory has become so prevalent. Yang said that once a theory developed by science becomes tied to a product, its promotion and subsequent researchers tend to exaggerate or embellish the original scientific evidence.

Drawing from his 20 years of clinical experience, Dr. Jing-Duan Yang believes antidepressants do work for some patients. However, it remains to be seen if [they work] in the way that was originally hypothesized, he said.

Dr. Yang believes antidepressant drugs have helped to reduce inflammation in the brain, and some studies suggest depression is related to the inflammatory response in the brain. Therefore these drugs may improve serotonin function but by some other mechanism.

Yang said although antidepressants are clinically proven and effective for many people, most have a variety of side effects, so patients should be cautious when using them.

Yang gave the example of a patient he treated for nearly twenty years. The patient used the common drug Cymbalta for about ten years to improve her serotonin and norepinephrine function against anxiety and depression. The patient reported side effects such as weight gain and increased blood pressure.

After switching the patient to Lexapro, a drug that simply improves serotonin function, her anxiety and depression improved once again. But it wasnt long before she started gaining weight again. She began having other disturbing side effects such as decreased libido, blurred vision, and a feeling that ants and bugs were crawling over her body.

Yang said the most serious concern about this and other common antidepressants is their black box warning, which warns that teens and young adults are prone to more suicidal thoughts and tendencies in the first few weeks of taking the drug. In addition, for some people, anti-depressants increase symptoms of depression.

Dr. Dong Shidao, a traditional Chinese medicine (TCM) doctor living in New Zealand, told The Epoch Times that TCM believes depression is strongly linked to the liver and its response to human emotions.

Chinese medicine believes the liver plays a key role in controlling the flow of qiusually translated as vital energy through the body. When the liver is free of emotional turmoil, qi flows smoothly, and depression is avoided. Depression occurs when negative emotions disrupt the livers functioning, and the flow of qi becomes stagnant or blocked.

Dong believes people become prone to liver qi stagnation when they allow worries and anxiety to remain unchecked. Instead of learning to care for themselves by developing support systems and good relationships, people today spend too much time on their cell phones and computers, says Dong. They dont know how to calm their worries in a healthy way, in order to avoid liver-related depression.

Dong believes the stress of modern society only makes depression worse. To make his point, he uses a famous Chinese saying: If the righteousness exists within, the evil will not enter. He predicts that the more society devolves, the more vulnerable people will be to depression.

Chinese medicine also has medication to treat liver qi stagnation, said Dong. But medication and acupuncture focus on unblocking and adjusting the whole body. TCM frequently uses a botanical formulation called Xiao Chi Hu Tang. The seven-herb formula was developed 1,800 years ago in China by Dr. Zhang Zhongjing and is still relied upon today to treat liver and gastrointestinal disorders.

Read more:
Study Reignites Debate on the Chemical Imbalance Theory of Depression - The Epoch Times

Introduction

Lumbar spinal stenosis (LSS) is a disease that involves narrowing of the spinal cavity due to hyperplasia of the spine and adjacent tissues. LSS is primarily an acquired degenerative stenosis associated with diminished space in the lumbar spinal canal or neural foramen causing neural or vascular compression. It affects over 100 million patients.1,2 Degenerative LSS can cause neurogenic claudication and other neurological symptoms, with or without pain, in the lower back and lower extremities.3 The symptoms of LSS are posture-dependent, exacerbated by walking, and are relieved by rest.

Although the underlying mechanism of LSS remains unclear, the main symptoms affecting the lower extremities include neurogenic claudication, radiating pain, paresthesia, and hypotonia.4 This chronic degenerative illness is newly diagnosed in five out of 100,000 people each year, and its prevalence increases with age.5 The anatomical deterioration of LSS and the symptoms experienced by patients are often inconsistent.6,7 Although its clinical symptoms improve through conservative care, the difference in efficacy in terms of symptom improvement between surgical and non-surgical treatments is not evident.8 In addition, considering the economic utility of surgical intervention and the risk of adverse reactions, conservative care is recommended first for the treatment of LSS, and surgery is only conducted if pain persists or neurogenic claudication occurs after conservative care.9 Despite this, LSS remains one of the most common indications for spinal surgery.10

The major treatment goals of non-surgical care of LSS include pain improvement, increased walking distance, and alleviated LSS-specific symptoms, such as neurological symptoms. Rehabilitation, including physiotherapy and kinesiotherapy, is currently considered as the most effective intervention.11 Various other interventions often focus on pharmacotherapy, including massage, exercise, thermotherapy, and acupuncture.12 Although effective non-surgical conservative care is recommended for the clinical improvement of LSS, no particular treatment has been established as a superior intervention.

Pharmacopuncture is a traditional integrative intervention used in East Asian countries, including the Republic of Korea and China. Pharmacopuncture aims to maximize treatment effects by injecting pharmacopuncture solutions extracted, purified, diluted or mixed from herbal medicines at various acupuncture points, including Ah-shi points and cutaneous and muscle meridians using a solution injection syringe. The most representative pharmacopuncture solutions are bee-venom, placenta, and plant extract. In a previous study conducted among Korean medicine clinics, 98.6% of 33,145 inpatients and 77.6% of 373,755 outpatients received pharmacopuncture over a 4-year period, thus indicating that it is a commonly used medical procedure.13 It is recommended by the Korean Medicine Clinical Practice Guidelines for alleviating pain and promoting functional recovery in patients with lumbar herniated intervertebral discs.

Several clinical studies have reported on the active use of various pharmacopuncture treatments for medical ailments and paralytic diseases. Major diseases treated with pharmacopuncture include musculoskeletal pain disorders, such as neck pain, degenerative knee arthritis, and lumbar pain. According to a survey conducted with the aim of clinical practice guideline development, 94.3% of Korean medicine doctors reportedly use pharmacopuncture to manage LSS.14 Pharmacopuncture is a safe intervention that rarely produces adverse reactions, which are at most mildly severe and do not develop sequelae or require rescue interventions.15 Therefore, we plan to conduct a clinical study to compare the efficacy of pharmacopuncture and conventional non-surgical treatment for lumbar spinal pain.

This study is a multi-centered, pragmatic, randomized, controlled clinical trial involving seven hospitals (Jaseng Hospital of Korean Medicine, Daejeon Jaseng Hospital of Korean Medicine, Bucheon Jaseng Hospital of Korean Medicine, Haeundae Jaseng Hospital of Korean Medicine, Kyung Hee University Korean Medicine Hospital at Gangdong, Kyung Hee University Korean Medicine Hospital, and Dongguk University Bundang Oriental Hospital) distributed across the Republic of Korea. Pragmaticity was determined prior to study initiation, according to the Pragmatic Explanatory Continuum Indicator Summary tool, version 2 (PRECIS-2).16 Eligibility and recruitment are explanatory, but settings, delivery of intervention, and adherence are more pragmatic. Ninety-eight patients with LSS who voluntarily consent to participate will be randomly assigned to the pharmacopuncture group or the conservative care group, in a 1:1 ratio.

This study is an investigator-initiated clinical trial and has been approved by the institutional review board of each site (JASENG 2021-12-019, JASENG 2021-12-008, JASENG 2021-12-003, JASENG 2021-12-017, KHNMCOH 2022-01-001, KOMCIRB 2021-12-002, DOBUH 2022-001) prior to patient enrollment. All study procedures will be carried out by the investigators according to the Declaration of Helsinki and the Korean Good Clinical Practice Guidelines. Version 2.0 of the study protocol has been registered and will be updated at Clinicaltrials.gov (NCT05242497) and the Clinical Research Information Service, the South Korean registration service for clinical trials (KCT0007145). The study protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines and checklist and partially follows the Consolidated Standards of Reporting Trials (CONSORT) extension for pragmatic clinical trials. While the assessor will be blinded to group allocation and patient information throughout the study period, researchers and patients will not be blinded.

Inclusion criteria comprise the following: 1) diagnosis of LSS (L1-S1) using radiology (computed tomography or magnetic resonance imaging) by radiologist, 2) neurogenic claudication, 3) symptoms (lumbar back pain or radiating pain) with severity of the dominant pain rated at 5 or more on the numeric rating scale (NRS), and 4) age 1969 years. Every participant will have to understand and agree to the study protocol. Written informed consent will be obtained; no alternative consent process will be allowed.

Patients with the following conditions or situations will be ineligible: vascular claudication; pathologies of non-spinal origin; soft tissue pathologies or other systemic illnesses that may cause lumbar back pain or radiating leg pain, such as spinal tumors and fractures; any other chronic comorbidity that may interfere with interpretation of the results, such as dementia or stroke; prescribed medicine that may interfere with interpretation of the results, such as corticosteroids, immunosuppressants, or psychotropic drugs; treatment in the past 7 days involving any medication that may influence pain, such as non-steroidal anti-inflammatory drugs (NSAIDs), pharmacopuncture, or physical therapy; pregnant or planning to become pregnant during the study period; spinal surgery within the past 3 months; previous participation in other clinical trials within 1 month of enrollment; plans to participate in other clinical trials during the study; inability to fill out the informed consent form; and being deemed unsuitable for participation as assessed by the researchers.

Eligible participants who have signed the informed consent form will be randomly assigned to the pharmacopuncture group or the conservative care group in a 1:1 ratio. A random sequence has been generated by an independent statistician prior to the first enrollment. Random sequence generation was based on permuted block randomization with a random number table, which was generated using R 4.1.1 software (the R Foundation for Statistical Computing, Vienna, Austria). Block sizes of 2, 4, and 6 were randomly selected. The generated random sequence has been sealed in an opaque envelope and stored in a double-locked locker. Only the statistician is aware of the full randomization sequence. The delegated research coordinator in each institution will open a randomization envelope for each patient and assign the patient to the appropriate group.

Both the pharmacopuncture and control interventions will be performed biweekly for 12 weeks to account for the chronic nature of LSS. The roles of the physician and the researcher are distinct. The researcher did not act as a physician and did not get involved in the treatment process. In the pharmacopuncture group, the Korean medicine doctor served as a physician, whereas in the conservative treatment group, the conservative medicine doctor served as a physician in order to provide the most effective treatment. The physicians will decide on the prescribed medication, treatment, and perform the procedure according to the medical strategy for each intervention group. The researchers will record treatment details on the electronic case report form in a timely manner. In the pharmacopuncture group, the physicians will decide on the details related to the depth, location, and the inserted pharmacopuncture content according to their medical decisions. In the conservative care group, the physicians will decide on the details of conservative care, including physiotherapy, and will prescribe medications according to their medical decisions. Any medications or physiotherapy procedures that relieve symptoms in the lower back and lower extremities, or that improve LSS, will be recorded in the electronic case report form in a timely manner. Follow-up surveys and assessments will be performed at weeks 25 and 53, respectively.

Patients will be allowed to receive rescue medicine (including analgesics) for reasonable conditions, based on medical decisions by the physicians. The adherence rate will be calculated after excluding those who meet the dropout criteria. We set our benchmark rate at 70% to encourage participation; however, patients who fail to meet an adherence rate of 70% will not be excluded from the study. Specific details on the use of rescue medicine and the adherence rate of each patient will be recorded in an electronic case report form in a timely fashion.

Patients will be excluded from the study due to the following: (1) a significant disease develops during the study period that may interfere with the interpretation of the results; (2) request for discontinuation or withdrawal of consent; (3) pregnancy occurs during the study period; (4) performance status is too poor to allow administration of an intervention; and (5) any other reason for which discontinuation is deemed to be better for the patient based on medical decisions.

Both the NRS and visual analog scale (VAS) will be used to assess the severity of lower back pain and radiating pain in the lower extremities. The NRS is a pain scale on which the patients express their subjective perception of pain as a whole number from 0 to 10, where 0 denotes no pain or discomfort and 10 indicates the most severe pain and discomfort imaginable. The VAS score, in terms of lower back pain and radiating leg pain, will be reported. In the VAS, the patient indicates the pain severity on a line, ranging from a minimum of 0 mm to a maximum of 100 mm, where a higher score suggests worse severity.

The claudication-free walking distance and maximal walking distance will be assessed to evaluate functional impairment. The Zurich Claudication Questionnaire (ZCQ), an LSS-specific questionnaire, will also be used to evaluate patient-centered improvements. The ZCQ is a patient-reported outcome measure that evaluates disease severity, function, and satisfaction with treatment in patients with LSS. The ZCQ was translated into Korean and validated in 2018.17 The Oswestry Disability Index is a validated, functional disability questionnaire for assessing lower back pain.18 The possible range of each item score is 0 to 5. The total score range is 0 (a better outcome) to 100 (a worse outcome). Short-Form 12 for Health-Related Quality of Life (SF-12 v2) consists of 12 questions across 8 domains, with higher scores indicating better health-related quality of life.19 Cost analysis will be performed using a structured questionnaire covering the following areas: official/unofficial medical costs, non-medical expenses, and time and productivity loss.

The Patient Global Impression of Change will be used to assess a patients impression of their improvements. Patients will rate improvement after treatment on a 7-point Likert scale, ranging from very much improved to very much worse. The EuroQoL 5 Dimensions 5 Levels will be used to assess effects on patients quality of life. The questionnaire consists of questions in five areas (mobility, self-care, usual activities, pain, and anxiety/depression) that ask about the patients current state of health. Answers are provided on a 5-point Likert scale.

Any adverse events will be recorded using the Medical Dictionary for Regulatory Activities. Causality will be evaluated using the World Health OrganizationUppsala Monitoring Center causality assessment system. Treatment-related adverse events will be recorded independently. The severity of adverse events will be assessed using the Spilker method.

Patients will be recruited nationwide through social media and flyers that will be handed out locally. Broadcast notifications will also be posted on hospital boards and electronic posts on the online webpage. Recruitment began in May 2022.

The researchers designed a data dictionary according to the protocol prior to establishing the database for the study. Data will be recorded in a web-based electronic database (MyTrials, Bethesda software, Seoul, Republic of Korea). The authorized clinical research coordinator will record data, and the data safety monitoring committee will be able to access the database to monitor, audit, and lock or release data. Automatic queries are generated in a timely manner in response to recorded data according to predefined algorithms. Initial and interim meetings will be held periodically to monitor integrity and consistency, to coordinate data collection and address concerns, and to determine whether the study should be continued or halted. Independent data monitoring will occur at a minimum of three timepoints: prior to enrollment of the first patient, after a third of the planned dataset is collected, and after every piece of data is recorded and determined to be locked. Although the interim monitoring interval is planned to occur bimonthly, it can be changed according to the risk of each study site.

The total planned sample size is 98 patients. This sample size was determined to provide 80% power, assuming a significance rate of 0.05, an optimal difference between the two groups of 1.75, with a mean standard deviation of 2.75.20,21 Based on this equation, there were 38.8 participants in each group, and the sample size was calculated to be 98 people, since the study was done in seven hospitals and 20% of the participants dropped out.

The primary analysis will be intention-to-treat analysis. A per-protocol analysis will also be performed for patients who adhere to more than 70% of the intended treatment schedule. Missing values will be analyzed with a mixed model for repeated measures. Sensitivity analysis will be carried out based on multiple imputations and the last-observation-carried-forward method. For survival analysis, patients who dropped out during the treatment period will be right-censored, and if intermittent censoring occurs, the event will not occur within the intermittent censored period. Sociodemographic characteristics and treatment expectancy will be described per group using descriptive statistics. Each continuous variable will be presented as a mean and standard deviation, or a median and interquartile range. The differences between the two groups will be assessed using Students t-test or Wilcoxons rank-sum test, according to their distribution. Categorical variables will be presented as the frequency and percentile (%) and will be assessed using the chi-square test or Fishers exact test.

The primary outcome will be the change in the severity of the dominant lower back pain and radiating pain in the lower extremities at the end of treatment. This severity will be compared with that at baseline. A linear mixed model will be used, mainly the random intercept model. The random effects of the patients will be included in the random intercept model, and the baseline outcomes and covariant factors will be addressed using covariates as fixed effects. Changes over time between groups will be analyzed using this method by including time, group, and the interaction in the model. Sensitivity analysis will be assessed through analysis of covariance (ANCOVA), considering the group as a fixed factor.

The area under the curve (AUC) will also be analyzed to determine cumulative effectiveness. The AUC will be cumulatively evaluated using ANCOVA with multiple imputations. The minimal clinically important difference (MCID) achieved will be determined according to the NRS score for severity of lower back pain. MCID achievement will be estimated using KaplanMeier survival analysis, and statistical significance will be assessed using the log rank test. Hazard ratios will be assessed using Cox proportional hazard ratio models.

All analyses will be performed using SAS v.9.4 (SAS Institute, Inc., Cary, NC, USA) or R v.4.1.1 (the R Foundation for Statistical Computing, Vienna, Austria). Differences will be considered statistically significant at a p-value < 0.05.

If we fail to achieve a statistical difference of superiority regarding the hypothesis of intervention, non-inferiority analysis will be conducted as an alternative. A pre-specified, non-inferiority margin will be set at 50% of the MCID for lower back pain (0.9). If the difference in the change in pain severity between the two groups does not exceed the lower limit of the 95% confidence interval, pharmacopuncture will be considered non-inferior to conventional care, including physiotherapy and medication.

Although surgery is considered the gold standard for LSS patients, non-surgical interventions are recommended as the first line of treatment.22 Surgical intervention, including laminectomy for patients with symptomatic and progressive LSS, spinal instability, and other conditions can lead to re-operation within the first year.23 Since LSS is a degenerative disorder and aging patients tend to have more comorbidities, the risk of major complications associated with surgery is also considerable.24 Known major complications within a month after surgery include a 0.4% mortality rate, which increases with age. The rate of adverse events, including perioperative and post-operative complications, is 10%24%.25,26

Non-surgical interventions are non-inferior to surgical interventions, are patient-centered, and lead to fewer complications. The Spine Patient Outcome Research Trial (SPORT) has compared surgical and non-surgical interventions pragmatically, and sheds light on their effectiveness and cost-effectiveness based on real-world data.27,28 The SPORT did not identify specific non-surgical interventions, but rather non-operative interventions as per usual recommended care, including physiotherapy, education, and instructions regarding home exercise and use of NSAIDs.

Conservative treatment methods for LSS are not yet standardized.22 Several options have been suggested, including pharmacotherapy (both oral medication and injection) and physiotherapy. The Finnish lumbar spinal research group used non-operative interventions, including assessment for individual treatment, prescribed analgesics, individualized physiotherapy, and active back exercises. It also provided education with a paper brochure that included the principles of activation and physical training, maintaining pain-relieving body postures, and basic ergonomics.29,30 Another study described conservative treatment as involving an orthosis and a rehabilitation department program that included daily physiotherapy; however, regular physiotherapy was not provided.31

Comprehensive conservative care for LSS typically includes physiotherapy and analgesics.20,22,27 Specific methods are yet to be identified, but physiotherapy includes physical exercises and manual therapy.32 Pharmacotherapy is recommended only to a limited extent. Acetaminophen and NSAIDs are effective, but neither are significantly more effective than the other.7 Analgesics, including opioids and muscle relaxants, are not more effective than acetaminophen or NSAIDs.33 Prostaglandins, pregabalin, and other medications have shown positive outcomes, with or without statistical significance, but none have been predominantly recommended.3437 Since no specific intervention is currently recommended as the first-line treatment, conservative approaches should be multi-modal and patient-centered on an individual basis, and specific decisions should be made by physicians.

Pharmacopuncture is officially accepted and practiced in South Korea and is commonly used in patients with LSS.10,11 Pharmacopuncture for stenosis tends to be combined with acupuncture and Chuna manual therapy. In one study, when integrated Korean medical treatment was administered to patients with LSS, 93.6% of patients admitted to the clinic received pharmacopuncture and 14.0% received bee venom acupuncture,38 illustrating the active practice of pharmacopuncture for stenosis. Another retrospective chart review with a follow-up survey also reported the efficacy of multimodal Korean medicine therapy, including Hwangryunhaedoktang pharmacopuncture in patients with LSS.39 However, specific forms of pharmacopuncture cannot be prioritized for patients with LSS, since the effect of acupuncture cannot be understood solely based on the ingredients of the subcutaneously injected drug. Pharmacopuncture is a far-reaching treatment when considering the local effect of acupuncture; the distant effect of stimulating acupoints and the composition of herbal medicine are comprehensively understood.

Thus, to collect real-world data for investigating optimal non-surgical interventions for stenosis, we have designed this clinical study to compare the effectiveness of pharmacopuncture with optimal conservative care, including physiotherapy and pharmacotherapy (the control group), as determined by physicians. Due to the pragmatic nature of the research design, it may not be sufficient to validate the experimental efficacy of the pharmacopuncture. However, in clinical settings, the efficacy identified in a fully controlled experimental design does not always appear. By structuring the study to resemble a clinical setting, we were able to compare the effectiveness of the use of pharmacopuncture with that of conservative treatment approaches and demonstrate the effectiveness in real world. In assessing the domains of the PRECIS-2, our clinical study will adopt an approach that allows pragmaticity for delivery, while taking a somewhat conservative explanatory approach to collection, to evaluate the overall effectiveness in a real-world setting. We will allow for combinatory interventions with a pragmatic perspective and will analyze the therapeutic interventions and strategies used for stenosis in the actual clinical environment with immediacy.

However, our study is limited by the fact that neither the physician nor the patient could be blinded. To compensate for these limitations, however, we employed a blinded assessor when evaluating the outcome.

Our study outcomes reflect the treatment goals for patients with stenosis, which include alleviating symptom intensity, decreasing claudication, increasing walking distance, temporarily delaying the onset of neurological defects, reducing the need for surgery, and ensuring post-operative treatment satisfaction. The primary outcome is the change in the severity of the dominant pain, between lower back pain or pain in the lower extremities. The blinded assessor evaluated walking distance and physical examination as outcomes. Patient-reported outcomes include the ZCQ, SF-12 v2, and other questionnaire scores.

This pragmatic, randomized, controlled, parallel-group clinical study will compare the effectiveness of pharmacopuncture to that of conservative care, including physiotherapy and pharmacotherapy. The study results will inform treatment planning and the selection of appropriate non-surgical treatment for individual patients with LSS.

ANCOVA, analysis of covariance; AUC, area under the curve; CONSORT, Consolidated Standards of Reporting Trials; LSS, lumbar spinal stenosis; MCID, minimal clinically important difference; NRS, numeric rating scale; NSAIDs, non-steroidal anti-inflammatory drugs; PRECIS-2, Pragmatic Explanatory Continuum Indicator Summary tool, version 2; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials; SF-12 v2, Short-Form 12 for Health-Related Quality of Life; SPORT, Spine Patient Outcome Research Trial; VAS, visual analog scale; ZCQ, Zurich Claudication Questionnaire.

Availability of data and materials: The datasets used or analyzed during the current study are available from the corresponding author on reasonable request.

This study was approved by the institutional review board of each site (JASENG 2021-12-019, JASENG 2021-12-008, JASENG 2021-12-003, JASENG 2021-12-017, KHNMCOH 2022-01-001, KOMCIRB 2021-12-002, DOBUH 2022-001) prior to patient enrollment. All patients will provide written informed consent.

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

This research was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number: HF21C0099).

The authors report no conflicts of interest in this work.

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