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  • 06 Oct 2020 12:15 PM | Deleted user

    Complementary Medicines Australia has welcomed the announcement by the Government to modernise the Therapeutic Goods Administration (TGA’s) digital infrastructure.



    CMA welcomes the Government's modernisation of the TGA's digital infrastructure.


    Carl Gibson CEO of CMA said: “CMA has recommended The TGA’s antiquated IT system be refreshed and digitised in our Budget Submissions for some years. We have urged the Government to replace the 1970s legacy system with a more agile integrated system including an upgraded eBusiness support system to deliver a more effective system to industry and consumers.”

    With an investment of $12 million over four years, TGA will be digitised and transformed with modernised business systems and infrastructure. Patients will benefit from improved and faster connection to services and devices.

    The new digital processes will mean more straightforward, faster interactions between industry and Government, earlier approvals of medical products, reduced administrative effort, and timelier decision-making by the TGA.

    “This announcement will result is much less red tape, cutting costs for the medicines and medical devices industry and finally position Australia to faster access emerging and new health technologies in the international market,” said Carl Gibson.

    Streamlined processes will enhance timely decisions on the safety, quality and efficacy of therapeutic goods, their approval for listing on the ARTG as well as greater transparently and bolstered cybersecurity.


  • 02 Oct 2020 10:29 AM | Deleted user

    Complementary Medicines Australia (CMA) has contributed its recommendations to the Department of Health on the development of the National Preventive Health Strategy, 10-year plan. CMA supports the Government in adopting a strategy that recognises that health is more than just the absence of disease, but a holistic state of wellbeing. We underline the importance of an agile health system, one that integrates a range of cost-effective, accessible, evidence-based, preventative health measures and that focuses on equity for all Australians.


    Prevention is better than cure


    A health system focused on prevention, equity, and balance must be at the forefront of any long-term strategy. The initiative comes as the Australian Institute of Health and Welfare (AIHW) released data on the Australian burden of disease, showing chronic diseases dominate in terms of healthy lives lost and that Australians are suffering more burden from living with illness than ever before. 

    “The increasing burden of complex, chronic conditions is unsustainable, and an integrated strategy would empower all Australians to maintain and be supported to have good health. That is why we are calling for greater investment into embedding prevention into the health system, up from the current less than 2% health spend; said Carl Gibson, CEO of Complementary Medicines Australia.

    "Our health system focuses on the treatment of illness and disease, and the burden of chronic disease continues to rise imposing significant costs on the healthcare system. Chronic diseases are the leading cause of illness, disability and death in Australia and they share common, preventable risk factors," explains Carl Gibson.

    Prevention should be based on the best available evidence and build on what has been shown to work. Prevention requires a collective and cohesive effort to be effective and to promote environments that support individuals to lead healthy lives.

    Complementary medicines are an important, culturally acceptable part of healthcare around the world. Increasingly, people are embracing many forms of health and healing, led by skilled healthcare practitioners.

    Carl Gibson says: "Empowering individuals to make the best possible decisions for their health and that of their communities is crucial. Well-targeted programs to build health literacy is vital to help people understand the need for healthier life choices and initiatives; backed by increasing the evidence base on targeted, cost-effective complementary medicine and practitioner approaches as part of routine healthcare.”

    "CMA is pleased to respond to the National Preventive Health Strategy.  A strategy with clear and measurable proposals are needed to help accelerate the health and wellbeing of Australians and create a sustainable, resilient, and efficient approach for the future,” ends Carl Gibson.

    Reference

    http://www.cmaustralia.org.au/resources/Documents/Submissions/Submissions%202020/CMA%20-%20National%20Preventive%20Health%20Submission%2028%20September%202020%20Final.pdf


  • 18 Aug 2020 1:00 PM | Deleted user

    This week is Healthy Bones Action Week - it's a great time to spread the word about the key actions needed to build and maintain healthy bones. 


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Nourishing your dental health

A healthy diet nourishes your whole body, including your teeth and gums. Preventing gum disease and tooth decay can make a significant contribution to your wellbeing and overall health and several nutrients directly impact your oral health.  

Always brush gently but carefully twice daily, floss regularly, and see your dentist twice a year or as requested and use a fluoride-containing toothpaste. Fluoride hardens tooth enamel and is added to water supplies across Australia.




Here are seven essential nutrients for teeth and gum health.

1. Calcium

Calcium compounds give enamel and teeth their strength. Although it is the hardest substance in the human body, there is only a thin layer of enamel of your teeth. Over time, enamel and calcium can be stripped from the teeth by acids from foods and drinks. Calcium in the diet helps to form and maintain healthy teeth and strengthen your jawbone.

Over half of all Australians aged two years and over do not consume enough calcium from foods.

Find calcium in dairy and plant-based milk products, canned salmon and sardines, tofu, seaweed, leafy vegetables, nuts, and fortified foods. If you do not get enough calcium in your diet, you may be deficient, talk to your healthcare professional.


2. Magnesium

Magnesium and other nutrients are needed for optimum bone and tooth health. Magnesium is responsible for over 700 functions in your body, including maintaining strong tooth enamel. More than six in 10 men and seven in 10 women do not get enough magnesium daily.

People who are especially at risk of not getting enough magnesium are those with diseases such as Crohn's disease and coeliac disease, people with type 2 diabetes, older people and people who have alcoholism.

Find magnesium in dark green leafy vegetables, fish, nuts, seeds, avocados, bananas, dried fruit and dark chocolate cereals and coffee.


3. Vitamin A

This fat-soluble vitamin helps to keep mucous membranes healthy so getting enough vitamin A is vital for healthy gums and to prevent dry mouth. Vitamin A is also essential for wound healing.

Vitamin A deficiency is rare in Australia, but it can result from inadequate intake, fat malabsorption, or liver disorders. Deficiency in vitamin A lack leads in weak enamel, enamel with pits or enamel that is less dense. Consuming too much vitamin A can be harmful; always consult a healthcare professional before taking a vitamin A supplement.

Vitamin A is derived from animal sources such as liver, organ meats, salmon and dairy foods. Orange-coloured veggies and fruits contain beta carotene, which is converted into vitamin A in the body. Find beta-carotene in carrots, pumpkin, cantaloupe, apricots, mangos and more.


4. Vitamin C

This water-soluble vitamin is vital for the formation of blood vessels and other key tissues that support your teeth; vitamin C is also crucial for wound healing. Keeping your skin and connective tissue healthy, aiding wound healing, and preventing infections. Vitamin C can protect against gingivitis, the early stage of gum disease, and can prevent your teeth from loosening. Severe vitamin C deficiency can trigger bleeding gums.

Vitamin C deficiency may occur including those who don't consume enough veggies and fruit, including older adults, low-income households, people with an eating or digestive disorder such as coeliac disease, ulcerative colitis or Crohn's disease. It may also occur in heavy smokers and those who are dependent on alcohol or drugs.

Vegetables and fruits contain vitamin C. Brussels sprouts, spinach, citrus fruit, and berries are exceptionally rich, so eat raw or just cooked in a small amount of water to retain this delicate water-soluble vitamin.


5. Vitamin D

Vitamin D signals your intestines to absorb calcium, giving enamel and teeth their strength. Without enough vitamin D, calcium will leach out of your bones.

The Australian Bureau of Statistics (ABS) found 23% or one in four Australian adults has some form of Vitamin D deficiency.

The most significant source of vitamin D is the action of sunlight on a cholesterol-like substance in the skin. Food sources include Vitamin D fortified foods such as milk, orange juice and cereal plus fatty fish and egg, canned tuna, and UV-exposed mushrooms.


6. Probiotics

Many different types of bacteria live in your mouth. One of these is Streptococcus mutans. S. mutans turns sugar into lactic acid, and this acidic environment leads to cavities and plaque. One study showed that another type of bacteria which is a part of saliva, Lactobacillus Salivarius can help fight cavity-causing bacteria. L. salivarius metabolises carbohydrates producing organic acids such as lactic acid and acetic acid, which help to inhibit the growth of pathogens and other microorganisms that can cause infection and disease.  

To treat bad breath and other oral problems, you might use an antimicrobial mouthwash. But good bacteria are necessary for a healthy oral microbiome. Using an antimicrobial mouthwash will kill the cavity-causing bacteria as well as the beneficial ones.

L. salivarius has also been shown to reduce the level of plaque-forming bacteria in the mouth while freshening breath and reducing gum sensitivity.  

Dairy products such as yogurt and kefir naturally contain L. salivarius. But due to modern pasteurisation and manufacturing, the beneficial bacterial cultures do not always survive. Fermented vegetables are a source of L. salivarius, particularly if they are made using a brine base (water and a higher concentration of salt). Other sources include tomatoes, bananas, chicory root, artichokes, garlic, and asparagus.


7. CoQ10

Antioxidant CoQ10 battles free radical damage to your cells and synthesise energy at the cell level, making it vital for all tissues and organs, including the gingiva (gums). The effects of taking additional CoQ10 isn't yet known, biopsies have shown subnormal levels of CoQ10 in 60% – 96% of the muscles in patients with periodontal disease. Natural CoQ10 production reaches a peak in your early 20s after which time, the natural capacity to synthesise this coenzyme from foods is reduced. 

Find CoQ10 in organ meats, poultry mackerel and sardines, soy and canola oils, nuts, fruits, vegetables, eggs, and dairy products.


What about supplements?

Certain supplements may be suggested by a healthcare professional – such as vitamin D if you do not get adequate safe sun exposure or calcium and vitamin D supplements if you do not consume enough calcium in your diet.

Remember, before changing your diet or taking supplements or medicines, talk to your healthcare professional. And as always, follow the directions and dosage on the label.


References

https://www.abs.gov.au/ausstats/abs@.nsf/Lookup/by%20Subject/4364.0.55.008~2011-12~Main%20Features~Calcium~401

https://www.healthdirect.gov.au/foods-high-in-magnesium#:~:text=Most%20young%20children%20in%20Australia%20get%20enough%20magnesium%2C,diabetes%2C%20older%20people%20and%20people%20who%20have%20alcoholism

https://www.abs.gov.au/ausstats/abs@.nsf/Lookup/4364.0.55.006Chapter2002011-12

https://aem.asm.org/content/82/7/2187.full



For consumers considering buying complementary medicines overseas, four reasons why buyers should beware

Where it comes to quality standards, Australian complementary medicines lead the way. Consumers can be sure that Australian products meet the high standard of good manufacturing practice, but that can’t be said for products manufactured overseas. And, when complementary medicines are purchased online from unknown overseas websites that aren’t subject to the same regulations as those enforced in Australia, buyers should beware.


Consumers around the world can buy Australian complementary medicines with confidence.


The Therapeutic Goods Administration (TGA) receives many reports about overseas-based websites offering 'herbal' or 'drug free' weight-loss products. Far from being 'natural,' though, many products contain ingredients that may be harmful and may not be disclosed on the product label.

Here are four reasons to buy Australian:  

1. Australian complementary medicine products are made according to Good Manufacturing Practice

Australian complementary medicines are included on the TGA’s Australian Register of Therapeutic Goods (ARTG) and can readily be identified with an AUSTL (listed) or AUSTR (registered) number on the label. Products not listed on the ARTG may not have been made under Good Manufacturing Practice (GMP) principles and may not meet the quality and safety standards expected by consumers. In Australia, there are 92[i] TGA licensed medicine manufacturing sites across the country, all of which operate to GMP standards for therapeutic goods. Consumers of Australian made complementary medicines can be confident that products contain what they say they do. Again, this may not be the case for products purchased from unknown overseas websites.


2. Traceability of ingredients

Outside Australia, independently authenticated reference materials for the testing of medicinal herbs is not guaranteed. Thus, there may be instances where there are lower levels of stated herbal active ingredients, the wrong herb entirely, or adulteration with other unknown ingredients. In comparison, Australian made complementary medicines are verified and screened for the absence of both elemental impurities and microbial contaminants.

The complementary medicine manufacturing industry in Australia must demonstrate traceability back to authenticated reference materials for all botanicals used. Identification tests are specific for the herbal material and are usually a combination of three or more of:

Macroscopic characters

Microscopic characters

Chromatographic procedures

Chemical reactions.

In short, consumers who choose Australian-made complementary medicine products can be assured of high standards.


3. Australia has a worldwide reputation for quality

Manufacturers of natural healthcare products in Australia have a respected reputation for quality and purity. Carl Gibson, CMA CEO says: “Globally, discerning consumers are choosing Australian products as their number one choice for health and wellbeing with demand for Australian complementary medicines continuing to grow. Australian complementary medicines are a true Australian success story."



4. Buying Australian supports local jobs, manufacturing and exports

Nearly 30,000 Australian jobs are supported by Australia’s complementary medicines industry which is growing annually at a rate of 6.0%. This $5.2 billion industry employs more than 2600[ii] Australians in manufacturing alone.

Regarding exports, Australia’s complementary medicines industry is a $1.1 billion[iii] success story. “With international and local demand continuing to grow, and local manufacturing holding its own, exports have risen 15% in the last year alone.

“As an industry, we can be proud of our world-class quality leading to healthy growth story right here in Australia,” says Carl.


Finding a trusted Australian website

Websites that use the term "au" may lead the consumer to believe they are buying from an Australian website or products that are allowed in Australia, but this may not be the case.

To be sure, it is important to look for products that are marked 'Registered Aust R' or 'Listed Aust R'. This  means the product was manufactured in a laboratory licensed by the TGA which ensures medicines available in Australia are of an acceptable standard.

Ends

Regulated in Australia as medicines under the Therapeutic Goods Act 1989, complementary medicines include vitamins, mineral and nutritional supplements, homeopathic, products and herbal medicines. The term ‘complementary medicines’ also comprises traditional medicines, which includes traditional Chinese medicines, Ayurvedic, Australian Indigenous and Western herbal medicines.

For more information, access to further case studies, or to interview the CEO of Complementary Medicines Australia, Carl Gibson, contact Ravinder Lilly on: Ravinder.Lilly@cmaustralia.org.au or 0418 928 756.


References
[i] Therapeutic Goods Administration, 2020. TGA Complementary Medicines manufacturing licence registry, Canberra: Australian Government Department of Health.

[ii] IbisWorld, 2020. Vitamin and Supplement Manufacturing in Australia: Market Research Report., Sydney.

[iii] Austrade, 2020. Australian Complementary Medicines Export Statistics 2016-2019, Canberra.


Diabetes and the emotional health of Aboriginal and Torres Strait Islanders people

This week,13-17 July, is Diabetes Australia’s National Diabetes Week. The focus this year is on the mental and emotional health issues faced by people with diabetes. 

 

More research into evidence about diabetes-specific emotional and mental health problems in ATSI people is needed.

 



Greater risk

Type 2 diabetes is the fastest growing chronic disease in Australia, and people of Aboriginal and Torres Strait Islander (ATSI) origin are at even greater risk. ATSI people are almost four times more likely than non-Indigenous Australians to have diabetes or pre-diabetes. Because of this, the risk of developing complications from diabetes (including kidney and eye diseases, heart attack and stroke) also occur at a younger age. The successful prevention and management of diabetes in these communities encompasses a broader picture involving economic and social factors plus political intervention.

 

Mental and emotional health issues

As well as the physical challenges of diabetes, mental challenges exist. Almost 500,000 people with diabetes will experience mental or emotional health issues this year[i]. The prevalence of mental health problems, particularly depression and anxiety, appears to be more common in people with diabetes compared to the general population, including ATSI communities. But more research is vital since evidence about diabetes-specific emotional and mental health problems in ATSI people is scant.

 

Evaluation methods

Among the type of evaluation methods regarding anxiety and depression available, a clinical interview is preferred. But language or cultural barriers may provide a challenge. Cultural sensitivities also play a part. For example, the appropriateness of written ‘pen and paper’ questionnaires or a ‘one-on-one’ questioning style may not be acceptable, especially if the health professional is a stranger to the Indigenous person.

 

Where possible, and with permission, health professionals are working with Indigenous health workers to help distinguish the cultural elements of the person’s clinical presentation. Identifying various aspects that may indicate a mental health problem all the while bearing in mind language barriers and culturally appropriate practice.


Mental health screening

The development of culturally appropriate mental health screening for ATSI people is an important and growing area of work. A number of guidelines currently exist regarding mental health assessment in ATSI communities exist[ii]. Plus, culturally targeted information is being disseminated via audio-visual touchscreens around Australia including to some of Australia’s most remote communities. These provide vital health information and may be a way to determine emotional health. There were over 50 hubs in 2016[iii]These and more vital services are set to grow as improving the lives of people affected by all types of diabetes and those at risk among ATSI communities is a priority for Diabetes Australia[iv].

 

Support

Mental health support for people with diabetes and their families is vital for all. Anyone experiencing distress can seek immediate advice and support through Beyond Blue (1300 224 636), Lifeline (13 11 14) or Kids Helpline (1800 55 1800).

For more information about the Heads Up on Diabetes campaign, please visit www.diabetesaustralia.com.au/national-diabetes-week. 


References

[i] https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/national-diabetes-week-2020-heads-up-on-diabetes 

[ii] https://www.telethonkids.org.au/globalassets/media/documents/aboriginal-health/working-together-second-edition/working-together-aboriginal-and-wellbeing-2014.pdf

[iii] https://www.naccho.org.au/wp-content/uploads/Diabetes-Story-presentation.pdf 

[iv] https://www.diabetesaustralia.com.au/aboriginal-and-torres-strait-islanders


Australian Complementary Medicines: the highest standards in the world  


Because consumers want to take control of their health, interest in natural and complementary medicines continues to grow. Consumers of Australian complementary medicines can be confident that they are manufactured according to the highest standards in the world. Operated under the auspices of the government’s Therapeutic Goods Administration, medicinal requirements establish and maintain the highest quality, safety and efficacy standards. 


 

The herb Andrographis has been used traditionally for thousands of years in Ayurvedic medicine, western herbal medicine, and traditional Chinese medicine for its anti-inflammatory properties.


Recently, there has been some media coverage of reported increases in the side effects relating to the use of one of Australia’s most popular immune health herbs - Andrographis. These side effects may include some loss of taste and appetite, which are similar to some of the symptoms of infection with COVID 19. The increase in Australians taking immune-supporting supplements during the COVID-19 pandemic may be behind the small rise in reports of taste sensation side effects.


Andrographis explained

Used traditionally in Ayurvedic medicine, western herbal medicine, and traditional Chinese medicine for its anti-inflammatory properties, Andrographis paniculatacontains andrographolide, a terpenoid compound shown to have antiviral effects, including against viruses that cause respiratory infections. When taken at the first sign of cold symptoms – i.e. used acutely rather than long-term – Andrographis may help to prevent a cold from developing with full force and may help to ease the symptoms of mild upper respiratory tract infections (URTIs). Andrographis can be used to relieve symptoms of mild fever, the common cold and sore throat. It is strongly recommended that consumers always follow the directions on the label and for a pharmacy-only product, follow the advice of a healthcare professional. 


Andrographis is indicated for the relief of symptoms of mild URTIs: May reduce the severity of symptoms associated with uncomplicated URTIs e.g. cough, expectoration, nasal discharge, headache, fever, sore throat, earache, fatigue and sleep disturbance.


Potential causes of taste disturbance 

Many factors can affect the sense of taste (and smell, which are very closely related). These include the ageing process, particularly after the age of 60. 
Some other factors that may contribute include: 

- Nasal and sinus problems, such as allergies, sinusitis or nasal polyps

- Certain medications, including beta-blockers and angiotensin-converting enzyme (ACE) inhibitors

- Dental problems

- Cigarette smoking

- Head or facial injury

- Alzheimer's disease

- Parkinson's disease.


Colds and flu can cause temporary loss of smell and taste, which usually comes back within a week or two. However, the return of these senses can be unpredictable and, in some cases, can be permanent. 


Zinc deficiency

Zinc is an essential trace element for all forms of life. Situations of stress, acute trauma and infection can lead to lower zinc levels. Mild deficiency in zinc may also lead to impaired taste sensation. A 2011-2012 ABS survey found more than one in three males (37%) and one in ten females (9%) had inadequate usual zinc intakes.


The importance of healthcare professional advice

Andrographis is available widely including in practitioner-only products dispensed by a healthcare professional.   Consumers should always follow the directions on the label. 


If any adverse symptoms develop, it is important to stop taking the product as soon as possible and seek medical advice.

 

Anyone who suspects they have COVID-19 should be tested. Furthermore, in discussing their health with a GP, it is important to talk about all the medicines being taken, including supplements. 


Well researched, responsibly formulated, evidence-based, high-quality products

Consumers can be assured that Australian complementary medicines companies regularly monitor product use and report trends; this is standard pharmacovigilance procedure in Australia. As such, pharmacies and the government’s Therapeutic Goods Administration have already been contacted to inform them of increased trends.


Australian complementary medicines are tested regularly and comprehensively to ensure that the ingredients on the label are those in the bottle and the many strict processes put in place ensure that consumers have access to well researched, responsibly formulated, evidence-based, high-quality products.


References

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4002847 

2. https://www.ncbi.nlm.nih.gov/books/NBK71143/

3. Bensky D. Chinese herbal medicine materia medica. 3rd Ed. 2015

4. Saxena RC, Singh R, Kumar P, et al. A randomized double blind placebo controlled clinical evaluation of extract of Andrographis paniculate (KalmCold) in patients with uncomplicated upper respiratory tract infection. Phytomedicine: international journal of phytotherapy and phytopharmacology 2010;17(3-4):178-85.

5. Mayo Clinic https://www.mayoclinic.org/healthy-lifestyle/healthy-aging/expert-answers/loss-of-taste-and-smell/faq-20058455#:~:text=However%2C%20other%20factors%20can%20contribute,%2Dconverting%20enzyme%20(ACE)%20inhibitorsaccessed 07/07/2020

6. Healthdirect. Anosmia.https://www.healthdirect.gov.au/anosmia-loss-of-smellaccessed 07/07/2020

7. Linus Pauling Institute, Oregon State University.https://lpi.oregonstate.edu/mic/minerals/zinc

8. ABS Australian Health Survey: usual nutrient intakes 201112

https://www.abs.gov.au/ausstats/abs@.nsf/Lookup/by%20Subject/4364.0.55.008~2011-12~Main%20Features~Zinc~408accessed 07/07/2020


Probiotics: the evidence and the standards you can expect from Australian  supplements

Probiotics are living microorganisms that boost health when consumed in adequate amounts. There are many different types, and they can be obtained from foods and supplements.



Mounting evidence supports the role of specific probiotic strains in several conditions.


There are ten times more microbial cells living in and on the body1 than body cells. Hundreds of different types of microorganisms and strains interact differently with the gastrointestinal tract and the immune system. More and more research is examining the complex functioning of the human gut flora or microbiome and its effects on mind and body. In fact, the metabolic activities of the gut microbiome are so complex that they have been likened to an organ and some scientists refer to the microbiome as the forgotten organ2.


Widely researched

Probiotics are widely researched for their effects on digestive health and mounting evidence supports the role of specific probiotic strains in several conditions.  These include3:

  • Antibiotic-associated diarrhoea (AAD)

The International Scientific Association for Probiotics and Prebiotics (ISAPP) Board of Directors state: “All hospital formularies should stock at least one appropriately tested probiotic. Further, all physicians should consider recommending appropriately tested probiotics for their patients for whom they prescribe antibiotics”4.

  • Irritable bowel syndrome (IBS)

Many studies show probiotics may help to ease symptoms such as occasional diarrhoea, gas, bloating or distension. The benefits can be meaningful and very helpful to people with such symptoms that severely impact the quality of life5 6.

  • Allergy

The World Allergy Organisation recommends probiotic use for the primary prevention of eczema7.

  • Infant health

Potential benefits of probiotics have been seen for infants with pre-term infant NEC, colic, diarrhoea, and the reduction of antibiotic use8. Of these probiotics, Lactobacillus rhamnosus LGG is one of the most well studied and effective probiotics in children9.


Individual variation

As with any supplement or medicine, diet, lifestyle, health status, genetics and microbiome differences contribute to variations in an individual’s response. Peer-reviewed literature used by reputable academic boards such as ISAPP, and placebo-controlled trials demonstrate clear, clinical benefits for the use of probiotics.

Understanding how the microbiome influences the response to any therapy and how to personalise treatment are exciting areas of research. But this kind of precision medicine does not negate the value of therapies based on randomised, placebo-controlled trials that can show the overall benefit for the group of individuals studied.


Antibiotics and probiotics

There is a significant body of research demonstrating that certain strains of probiotics can assist with the prevention and treatment of antibiotic associated gastrointestinal symptoms, as well as microbiome-related outcomes. However one 2018 study caused some confusion10.

Israel’s Dr Eran Segal found that one probiotic might delay the restoration of gut bacteria in individuals taking antibiotics compared to individuals who took antibiotics alone. Yet a number of challenges may have been identified including that the probiotic was not administered until seven days after treatment, after the damage by the antibiotics had been done.

The study did not track clinical outcomes, and there were potential methodological issues with the microbiome data leading the researchers to these conclusions. Further, the particular probiotic used in the study has no clinical evidence that it assists with antibiotic-associated gastrointestinal symptoms. However, several probiotic strains have been well-studied for clinical benefits alongside antibiotic use11.  

Dozens of human studies with specific probiotics have documented that probiotics help against AAD or C. difficile infection. And in most clinical trials, the probiotic is administered together with the antibiotics.


Safety of probiotics

There are no recognised long term consequences of taking probiotics but it is important to be cautious regarding probiotic use in immunocompromised individuals; it is important to seek the advice of a healthcare practitioner.


Australian standards differentiate Australian products

In Australia, probiotics are regulated as medicines. Claims must comply with the TGA Levels of Evidence Guidelines, evidence likely to be based on strains. The identification and enumeration of the probiotics as per the clinical trial/s is stated.

These pharmaceutical standards differentiate Probiotics in the Australian market versus those in the US Dietary Supplements market for example.

The TGA classifies probiotics as therapeutic goods and Commonwealth legislation applies to all states and territories. The legislation stipulates various Regulations, Therapeutic Goods Orders and Guidelines which companies and manufacturers are obliged to conform to. Probiotics in Australia are produced under the Pharmaceutical model which follows the Pharmaceutical Inspection Conventions Scheme (PICs), an international-based pharmaceutical code of GMP. Dietary Supplements in the USA need to conform to a code of Good Manufacturing Practice (GMP) considered the highest standard of GMP.

References

1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1500832

2 https://www.sciencealert.com/how-many-bacteria-cells-outnumber-human-cells-microbiome-science

3 https://pubmed.ncbi.nlm.nih.gov/32289131/

4 https://isappscience.org/isapp-take-home-points-from-american-gastroenterological-association-guidelines-on-probiotic-use-for-gastrointestinal-disorders/

5 https://pubmed.ncbi.nlm.nih.gov/19622191/

6 https://pubmed.ncbi.nlm.nih.gov/19236549/

7 https://pubmed.ncbi.nlm.nih.gov/25628773/

8 https://academic.oup.com/eurpub/article/29/3/494/5094938).

9 https://onlinelibrary.wiley.com/doi/abs/10.1111/apt.15267

10 https://www.cell.com/cell/pdf/S0092-8674(18)31108-5.pdf

11 https://isappscience.org/clinical-evidence-not-microbiota-outcomes-drive-value-probiotics/


Media

As the voice of the complementary medicines products industry, we keep our members, government, media and the community up to date with the latest industry wide news.

Media Enquiries:
media@cmaustralia.org.au
ph: 02 6260 4022


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