Scientists at Yale School of Medicine design a virus to treat ovarian cancer

Marisa Peryer, Senior Photographer

A new Yale study showed that certain genetically modified viruses can cure ovarian cancer in mice. It may be of use in the treatment of ovarian cancer in humans.

Researchers at the Yale School of Medicine have tested a chimeric virus — containing genes from two different viruses — that can selectively infect and kill ovarian cancer cells in mice. Their findings represent a potential breakthrough in the long-term treatment of ovarian cancer in humans. The study was published in the journal Virology on Nov. 12, two weeks after the death of the paper’s lead author Anthony Van den Pol, former professor of neurosurgery and psychiatry at Yale.

“Every year, around 20,000 women are diagnosed with ovarian cancer, which is a smaller number compared to cancer types such as breast cancer,” said Gil Mor, the scientific director of the C.S. Mott Center for Human Growth and Development at Wayne State University and a co-author of the paper. “However, unfortunately only around 4,000 of those women can survive the disease.”

The main reason behind the lethality of ovarian cancer is the lack of treatments preventing the recurrence of the disease. In 80 percent of cases, patients who respond positively to chemotherapy still experience a return of the disease, according to Mor. He explained that once the cancer comes back and begins to spread, there is little that doctors can do.

The inspiration for the study was born out of a collaboration between Van den Pol and Mor many years ago, when they worked in adjacent labs at the Yale School of Medicine. Van den Pol, a research scientist in the Neurosurgery Department, had concentrated his research on the long-term treatment of brain tumors. Mor, on the other hand, had been working on treatments for ovarian cancer. The two scientists decided to collaborate to find an alternative treatment for ovarian cancer through oncolytic viruses, which selectively infect and kill cancer cells.

In the experiment’s in vitro phase, in which the research takes place in laboratory tubes or petri dishes without a living component, researchers made a virus called Lassa-VSV in the laboratory. Lassa-VSV consists of three parts: the Lassa virus, the vesicular stomatitis virus, or VSV, and a fluorescent label to facilitate tracing, according to Nazli Albayrak, a scientist who was involved in the in vitro phase. During this phase, the team infected different ovarian cancer cell lines, eventually choosing the ones that were infected most frequently to proceed with the research. 

Then, after deciding on the cell line, the team injected tumor cells into the bodies of the mice, the paper explains. As the tumor cells began to replicate, the team then injected the Lassa-VSV virus into the tumor clusters. They observed that the virus infected the tumor cells very effectively yet did not harm the healthy cells

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Ionis announces third investigational antisense medicine to treat nonalcoholic steatohepatitis (NASH) enters development

CARLSBAD, Calif., Nov. 23, 2020 /PRNewswire/ — Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced today that the biopharmaceutical company AstraZeneca has licensed ION455, an investigational antisense medicine being developed as a potential treatment for nonalcoholic steatohepatitis (NASH). ION455 is the second medicine for the treatment of NASH that Ionis has partnered with AstraZeneca. The companies have also partnered on ION839 (AZD2693), which is designed to inhibit the production of patatin-like phospholipase domain-containing 3 (PNPLA3) protein, a major genetic determinant of NASH progression. Separately, Ionis is also developing a wholly owned NASH program. ION224 is designed to reduce the production of DGAT2, or diacylglycerol acyltransferase 2, for treating patients with NASH. ION224 is one of more than 20 medicines in the growing Ionis-owned pipeline that the company is prioritizing and preparing for commercialization.

NASH is the most severe form of nonalcoholic fatty liver disease (NAFLD). It is related to the epidemic of obesity, pre-diabetes and diabetes. Unlike liver disease caused by alcohol consumption, NAFLD is the result of an accumulation of fat in the liver, which can lead to inflammation and cirrhosis, an advanced scarring of the liver that prevents the liver from functioning normally. About 20 percent of NASH patients are reported to develop cirrhosis and 30 to 40 percent of patients with NASH cirrhosis experience liver-related death.i Currently, a liver transplant is the only treatment for advanced cirrhosis and liver failure. Because of the high prevalence of NASH, it has recently become the third most common indication for liver transplantation in the U.S.

“Today, there are no FDA-approved medicines to specifically treat nonalcoholic steatohepatitis. However, due in large part to the progress made by our cardio-metabolic franchise, three Ionis-discovered novel medicines are now in development. These are encouraging advances that we hope will one day bring therapeutic benefit to patients who have limited treatment options,” said Brett P. Monia, Ph.D., Ionis’ chief executive officer. 

ION455 is the fourth medicine to reach development in partnership with AstraZeneca. Ionis earned $30 million from AstraZeneca for licensing ION455 and is eligible to earn up to $300 million in milestone payments plus royalties on net sales. AstraZeneca will have responsibility for further development of ION455, including regulatory filings, and commercialization.

In addition to NASH, Ionis and AstraZeneca are collaborating on potential treatments for kidney disease, cardiovascular disease and cancer.

Ionis’ Forward-looking Statement

This press release includes forward-looking statements regarding Ionis’ business and the therapeutic and commercial potential of ION455, ION839 (AZD2693), ION224 and Ionis’ technologies and products in development. Any statement describing Ionis’ goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, including those related to the impact COVID-19 could have on our business, and including but not limited to those related to our commercial products and the medicines in our pipeline, and particularly those inherent in the process of discovering, developing and commercializing medicines that are safe and effective for

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Positive Coronavirus Case At Clark’s Trunk Or Treat

CLARK, NJ — A person who attended Clark’s Trunk or Treat event has tested positive for the coronavirus, the Clark Health Department stated.

The event was held on Saturday at the Clark Municipal Building.

The Clark Health Department is warning anyone who went to the event to monitor for COVID-19 symptoms, fever, chills, muscle aches/pains, cough, sore throat, shortness of breath or difficulty breathing, wheezing, abdominal pain, and diarrhea to name a few.

Anyone with questions or concerns should speak with their primary care physician or pediatrician.

“If you are feeling ill, stay home from school, work and limit exposure with other people,” Clark Health Officer Nancy Raymond said. “Continue to practice social distancing, good hand hygiene, sanitize high hand contact surfaces and wear face coverings that cover your nose, mouth and chin.”

Those who are being tested for the COVID-19 virus, must stay home until they receive their result.
Those who may test positive will be contacted by the Clark Health Department for further guidance and contact tracing.

As of Friday, the Clark Health Department reports a total of 337 COVID-19 cases in Clark with 333 closed and 4 cases pending.

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This article originally appeared on the Clark-Garwood Patch

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Taysha Gene Therapies Receives Rare Pediatric Disease Designation and Orphan Drug Designation for TSHA-104 to Treat SURF1-Associated Leigh Syndrome

Taysha anticipated to submit Investigational New Drug Application for TSHA-104 to FDA in 2021

Rare pediatric disease and orphan drug designations now obtained in multiple pipeline programs, including TSHA-101 for GM2 gangliosidosis, TSHA-102 for Rett syndrome and TSHA-118 for CLN1

Taysha Gene Therapies Inc. (Nasdaq: TSHA), a patient-centric gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system in both rare and large patient populations, today announced that it has received rare pediatric disease designation and orphan drug designation from the U.S. Food and Drug Administration (FDA) for TSHA-104, an AAV9-based gene therapy in development for SURF1-associated Leigh syndrome. Taysha anticipates it will submit an Investigational New Drug (IND) application to the FDA for TSHA-104 in 2021.

“We have now obtained rare pediatric disease and orphan drug designations in multiple gene therapy programs, which we believe will allow us to work more effectively with the FDA as we advance our broad portfolio,” said RA Session II, President, CEO and Founder of Taysha. “The receipt of these designations highlights the dedication that our team has to advancing our gene therapy pipeline as efficiently and rapidly as possible.”

Leigh syndrome is a severe neurological disorder that usually presents in the first year of life. It is characterized by progressive loss of mental and movement abilities that can result in death within two to three years. Approximately 10-15% of people with Leigh syndrome have a SURF1 mutation.

“Being diagnosed with a mutation in the SURF1 gene is a truly devastating event for families,” said Kasey Woleben, Founder of Cure SURF1 Foundation. “Taysha’s commitment to developing a gene therapy for SURF1 deficiency is greatly welcomed by the patient community and has the potential to save the lives of children afflicted with this progressive disorder.”

Taysha has secured rare pediatric disease designation and orphan drug designation for multiple of its programs, including GM2 gangliosidosis, CLN1, Rett syndrome and now SURF1. In addition to these designations, the company also has fast track status for the CLN1 program.

“SURF1 deficiency is a monogenic mitochondrial disorder and is the most common cause of cytochrome c oxidase deficient Leigh syndrome,” said Steven Gray, Ph.D., Chief Scientific Advisor of Taysha and Associate Professor in the Department of Pediatrics at UT Southwestern. “Obtaining these key designations highlights our commitment to developing a gene therapy for the treatment of SURF1 deficiency.”

The FDA defines a rare pediatric disease as a serious or life-threatening disease in which the disease manifestations primarily affect individuals aged from birth to 18 years. Pediatric diseases recognized as “rare” affect under 200,000 people in the U.S. The Rare Pediatric Disease Priority Review Voucher Program is intended to address the challenges that drug companies face when developing treatments for these unique patient populations. Under this program, companies are eligible to receive a priority review voucher following approval of a product with rare pediatric disease designation if the marketing application submitted for the product satisfies certain

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Older males recovering from COVID-19 may have best plasma to treat it

A new study has found higher numbers of anti-SARS-CoV-2 antibodies in older males who required hospitalization for COVID-19.

Scientists have found that being hospitalized with COVID-19, as well as being male and of older age, increases the chances of a person having high plasma levels of antibodies that can protect against the disease.

This plasma, which is a component of blood, may help treat the disease in others.

The research, which features in the Journal of Clinical Investigation, is the first step toward confirming whether blood plasma therapy is effective in treating COVID-19.

As scientists continue to search for an effective vaccine for SARS-CoV-2, the virus that causes COVID-19, treatments that can reduce the risk of death are crucial for lowering the mortality rate associated with the disease.

However, to date, research has shown few treatments to be effective.

Furthermore, a major study by the World Health Organization (WHO) — currently available as a preprint — found that remdesivir, the most promising treatment for COVID-19, appears to make no significant difference to the mortality rate.

One possible treatment that may be effective is antibody therapy through convalescent plasma infusion.

Antibody therapies work by infusing a person who has an infection with the plasma of a person who has overcome that infection. The plasma of the person who has recovered may contain antibodies that their body created in response to the initial infection.

Research has suggested that this may be effective in treating people with COVID-19, and observational studies have, so far, produced promising results. However, further research is necessary to confirm these initial findings.

For this research to proceed, however, scientists need a greater knowledge of the makeup of the blood plasma that the process uses so that they can develop a standardized approach to the treatment.

To contribute to this goal, the scientists behind the present article conducted a study to determine what effect age, sex, and the severity of the disease had on the size and overall quality of a person’s antibody response to SARS-CoV-2.

This is important as the antibody response that COVID-19 induces can vary significantly. The scientists behind the present study suggest that this may be because antibodies are typically linked to disease severity, and COVID-19 symptoms can range from undetectable to life threatening.

Determining what factors lead to blood plasma containing antibodies of good quantity and quality may make it easier to standardize and optimize the treatment.

The study involved 126 adults who had recovered from a COVID-19 infection. The researchers took blood from the participants, as well as information regarding their age, sex, and whether they required hospitalization for the disease.

The scientists analyzed the plasma’s ability to neutralize the cells of SARS-CoV-2 in cell cultures. They also used commercially available tests to determine the level of antibodies.

They found that a strong antibody response was associated with hospitalization for

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FDA approves remdesivir to treat COVID-19

The Food and Drug Administration said Thursday in a letter that it has approved remdesivir as a treatment for coronavirus patients.

It had been authorized for use on an emergency basis since spring and now has become the first drug to win full U.S. approval for treating COVID-19.

“The approval … marks an important milestone in efforts to help address the pandemic by offering an effective treatment that helps patients recover faster,” Dr. Barry Zingman said in a news release provided by Gilead Sciences, which said the use of the drug is for patients hospitalized with COVID-19.

Earlier this month, a World Health Organization-sponsored global study found remdesivir did not help patients survive or even recover faster, but a U.S. study found the infused drug shortened recovery time for some patients by about a third.

In a large study led by the U.S. National Institutes of Health, the drug cut the time to recovery by five days — from 15 days to 10 on average. President Donald Trump received it when he was sickened earlier this month.


Fauci talks about early results in remdesivir study

The drug is for adults and certain children ages 12 and older, depending on their weight. For patients younger than 12, the FDA will still allow the drug’s use in certain cases under its previous emergency authorization.

It works by inhibiting a substance the virus uses to make copies of itself. Certain kidney and liver tests are required before starting patients on it to ensure it’s safe for them and to monitor for any possible side effects. And the label warns against using it with the malaria drug hydroxychloroquine, because that can curb its effectiveness.

Gilead charges $2,340 for a typical treatment course for people covered by government health programs in the United States and other developed countries, and $3,120 for patients with private insurance. The amount that patients pay out of pocket depends on insurance, income and other factors.

So far, only steroids such as dexamethasone have been shown to cut the risk of dying of COVID-19. The FDA also has given emergency authorization to using the blood of survivors, and two companies are currently seeking similar authorization for experimental antibody drugs.

CNN contributed to this report.

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Ionis’ third novel antisense medicine for ALS, its first designed to treat a broad ALS population, begins clinical trial

CARLSBAD, Calif., Oct. 22, 2020 /PRNewswire/ — Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), the leader in antisense therapeutics, today announced that the first patients have been dosed with ION541 (also known as BIIB105), an investigational antisense medicine being developed as a potential therapy to treat most forms of amyotrophic lateral sclerosis (ALS) regardless of family history. This is another milestone in the continuing progress of Ionis’ ambitious program to develop novel treatments for ALS. Almost all cases of ALS share the pathological hallmark of TDP-43 protein aggregation in motor neurons. ION541 targets ataxin-2 RNA (ATXN2), which has been shown to prevent or reverse TDP-43 toxicity in preclinical models of ALS.

(PRNewsfoto/Ionis Pharmaceuticals, Inc.)

ALS is a rare, progressive and fatal neurodegenerative disorder that affects approximately 55,000 people globally.i  About 90 percent of ALS cases occur in people who have no apparent family history of the disease. People with ALS experience muscle weakness, loss of movement, and difficulty breathing and swallowing, resulting in a severely declining quality of life and potentially death.

“As our third medicine designed to treat different forms of ALS to enter clinical trials, ION541 represents yet another example of the power of Ionis’ antisense technology to potentially target root causes of devastating neurodegenerative diseases,” said Frank Bennett, Ph.D., Ionis’ chief scientific officer and franchise leader for neurological programs. “Initiation of this clinical trial for ION541 marks an important milestone in Ionis’ ALS program and reaffirms our commitment to the ALS community.”

Ionis received a payment of $10 million from Biogen for initiation of this Phase 1/2 clinical trial of ION541. Biogen is developing ION541 as part of a broad strategic collaboration with Ionis to advance novel antisense therapies for the treatment of neurological disorders.

Learn more about the Phase 1/2 trial of ION541 at: https://clinicaltrials.gov/ct2/show/NCT04494256?term=biib105&draw=2&rank=1

Ionis’ other leading investigational medicines to treat ALS are tofersen (BIIB067) and IONIS-C9Rx (BIIB078), both partnered with Biogen. Tofersen is designed to reduce the production of superoxide dismutase 1 (SOD1), the cause of a genetic form of ALS, referred to as SOD1-ALS, that results from mutations in the SOD1 gene. SOD1-ALS is the second most common genetic form of ALS, accounting for up to 20 percent of genetic ALS. Tofersen is currently in a Phase 3 clinical trial in SOD1-ALS patients with data expected in 2021. IONIS-C9Rx is designed to selectively reduce the mutant C9ORF72 RNA and associated neurotoxicity. Mutations in the C9orf72 gene account for greater than 30 percent of genetic ALS cases and five to 10 percent of all patients with ALS. It is the most common genetic form of ALS worldwide. IONIS-C9Rx is the first drug to enter clinical development that specifically targets the mutant C9ORF72 RNA and is a potentially first-in-class therapy for patients with C9orf72-ALS, referred to as C9-ALS. IONIS-C9Rx, which earlier this year received Fast Track designation from the U.S. Food and Drug Administration, is currently in a Phase 1/2 trial in C9-ALS patients.

Ionis’ Forward-looking Statement

This press release includes forward-looking

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Keck Medicine of USC enrolling individuals in phase 3 clinical trial to treat mild Alzheimer’s disease using deep brain stimulation

IMAGE

IMAGE: Darrin Lee, MD, PhD, a neurosurgeon with Keck Medicine of USC and the principal investigator of the site’s clinical trial
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Credit: Image courtesy of Ricardo Carrasco III of Keck Medicine of USC

LOS ANGELES — An estimated 5.5 million people in the United States live with Alzheimer’s disease, which is the most common form of dementia.

Keck Medicine of USC is enrolling individuals in an international phase 3 clinical trial to examine the safety and effectiveness of deep brain stimulation to treat Alzheimer’s. The study uses electrical impulses to stimulate the region of the brain known as the fornix, which is associated with memory and learning.

“Deep brain stimulation has successfully treated conditions such as Parkinson’s disease by improving motor skills, and we are now investigating if this therapy can stabilize or improve cognitive function,” says Darrin Lee, MD, PhD, a neurosurgeon with Keck Medicine of USC and the site’s principal investigator of the study. “Based on the results of earlier phases of this clinical trial, the treatment offers a potential benefit for patients with mild Alzheimer’s.”

This randomized, double-blind study will last four years. Subjects will first take a standardized assessment test for Alzheimer’s to be used as a baseline measure of cognitive ability throughout the study.

Next, researchers will implant electrodes into subjects’ brains that connect to a battery pack, similar to a heart pacemaker, placed underneath the collarbone.

For the first year of the study, subjects will be given either low-frequency stimulation to the brain, high-frequency stimulation or a placebo — no stimulation.

“For those with Alzheimer’s disease, certain parts of the brain become atrophied,” Lee says. “We are testing to see if stimulating the brain’s fornix can reawaken brain activity in this area and stop the progression of the disease.”

During the first year, subjects will be given subsequent cognitive tests to check if their memory or learning skills have held steady or improved. At the end of the year, study researchers will examine data to determine which level of stimulation had the most impact on these skills.

For the next three years of the trial, all subjects in the study will receive what researchers have determined is the optimal frequency of deep brain stimulation, even those originally receiving the placebo. Patients will continue to be given cognitive assessments throughout the four-year period.

To qualify for the trial, patients must be 65 or older, have been diagnosed with mild Alzheimer’s and take Alzheimer’s medication, and have a caregiver or family member who can accompany them to doctor visits.

The clinical trial involves approximately 200 patients at some 20 sites in the United States, Canada and Germany. Keck Medicine plans to enroll 8-15 patients.

The trial is sponsored by Functional Neuromodulation, Inc.

Those interested in enrolling in the clinical trial with Keck Medicine can contact Amanda Romano at [email protected] or 213-393-5640.

###

Keck Medicine co-investigators of the trial include psychiatrist Carlos Manuel Figueroa, MD, and neurologist Elizabeth Joe, MD.

Deep brain stimulation has been

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How Holistic Medicine Is Used to Treat Cancer

Holistic Cancer Treatments

The best way to fight cancer is to not get cancer in the first place. "Easier said than done," you say. "My family has a history of cancer," you say. "Three of my friends just got cancer," you say.

This is a story I have heard many times, as, probably, have you. So how do you deal with this?

Let's take the first scenario: "My family has a history of cancer." Well, your family's history of cancer just means you need to educate yourself on the causes of cancer. Is cancer hereditary? No, it is not. Isn't there a certain gene that makes me susceptible to cancer? That has not been proven to date. What about what doctors are telling me? Unless they are cancer specialists, I would get more than one opinion.

There are many Holistic Cancer Treatments out there for you to investigate. These I have found to work for my clients.

Maintaining a proper balance in the body's pH can have a positive effect on all major body systems, including your digestive, circulatory, respiratory and immune systems. This balance promotes more oxygen affinity in the blood, thus allowing the body to function properly.

So what can we do to start to eat and live healthy? I'm going mention smoking smoking here, but that's all. You know who you are – stop smoking! The next biggest cancer threat in my opinion is soda. It is about the most acidic drink you can get. You all know that I am an alkaline water advocate. I drink between 50 and 90 ounces of alkaline water a day, but not as much as recommended by doctors who advocate alkaline water. However, if I drink one 12-ounce can of soda – diet or otherwise does not make a difference – I have to drink 400 ounces of alkaline water just to get my body back to the pH it was before drinking that one soda.

Having an acidic body greatly lowers your immune system, making you susceptible to disease and of course cancer, depending upon your other eating and drinking habits.

Back in 2011 My Ex-Wife Judy was diagnosed with Colon Cancer. I got a call from my Son Kris in California who let me know. Judy had Breast Cancer in 2002 and had a mastectomy and Chemo and Radiation Treatments. I met with Judy and her Husband Doug and let them know of the health benefits of Alkaline Water. Judy started drinking 2.5 gallons of 9.5 ph. alkaline water a week. She did this for over one year. She had the tumor removed on her colon but refused chemo and radiation as it was hard on her body and immune system the last time around. Judy is Cancer free today.

Here are some foods to make your body more alkaline: lemons, watermelon, limes, grapefruit, mangos and papayas. Frozen lemons grated over salads or hot cereals are great and very alkaline. Use the whole lemon when freezing. This is …

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Traditional Chinese Medicine to Treat and Heal Tinnitus

Chinese Medicine believes that there are several types of tinnitus. These are related to different energetic issues associated with the energy flow and proper function of several organs including the kidney, liver, and gallbladder. There are always several ways that Traditional Chinese Medicine can repair a symptom or disease. The ancient art of Tuina can be used to relieve hearing loss and tinnitus. Tuina is oriental body work that may seem similar to massage with hard pressure hand movements on muscles or tendons combined with acupressure. Medical Qi Gong may also heal tinnitus for some people. Auricular acupuncture and scalp acupuncture are other options for treat tinnitus in Traditional Chinese Medicine. Moxa may be added as part of an overall treatment plan.

It is important to look at other factors which can cause or contribute to hearing loss and tinnitus. Heavy metal toxins can be a very big factor. These should have diagnostic testing and be treated with oral chelation or IV chelation in very severe cases. Oral chelation requires a longer period of time and is more gentle on the body. IV chelation requires electrolyte supplementation. It is important to have vitamin and antioxidants to support the body when undergoing any type of chelation. Carbonated beverages or beer may be connected with higher levels of aluminum in your body. Cigarettes may also contribute to ear ringing. Chelation may require four to nine months for the detoxification of heavy metals and toxins from your body. The use of far infrared sauna during this time can speed your detoxification process. Do not do more than two per week when taking chelation therapy. It is also important to drink pure water and flush your kidneys during this time.

Chinese Patent formulas that are useful in treating this disease include:

• Wai Gan Fen Re Xing (respiratory infection),

• Er Long Zuo Ci Wan (for aging of kidney and liver)

• Shen Jing Shai Ruo Wan (for insomnia, fatigue, insomnia, and tinnitus)

• Jiang Ya Wan (for dizziness, hypertension, and tinnitus)

• Da Bu Yin Wan (for nights sweats, hyperthyroidism, and tinnitus)

• An Shen Bu Xin Wan (for insomnia, memory, palpitations, and tinnitus)

• Shen jing Kui Xu Xing (kidney dysfunction)

• Pi Qi Xu Ruo Xing (abnormal spleen function)

The Japanese herbal formula Yoku-kan-san may be useful in treating tinnitus.

The addition of scalp acupuncture is great and may speed the healing process if the tinnitus is due to a deficiency condition. If the problem is an excess condition, body acupuncture and asian bodywork may be more effective. Try medical qi gong and qi gong for healing tinnitus, hearing loss, and eye problems.

© Dr R Stone, MD-India

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