Interesting and Useful News about Herbal Medicines
News clip about Po Chai Pills recall is outdated: Health Sciences Authority
SINGAPORE – If you have seen a news clip about Po Chai Pills being recalled in Hong Kong, do not worry – it is an old clip from 2010, the Health Sciences Authority (HSA) has clarified.
In the clip that has recently resurfaced online, a newscaster says the popular indigestion and diarrhoea remedy has been recalled because of two chemical substances.
These are phenolpthalein, a laxative, and sibutramine, a banned western medicinal ingredient for slimming. The clip claims the substances were detected after testing by Singapore authorities.
HSA said in a clarification on Monday (Oct 16) that the incident occurred in 2010.
Po Chai Pills are still sold in bottle form in Singapore, and HSA assured the public that it continues to monitor the product under its product quality surveillance programme.
The latest laboratory test in June last year found the product to be compliant with quality standards, and did not contain phenolphthalein, sibutramine or any other western potent medicinal ingredients or contaminants.
The compound medicine company also put up a notice on its website pochaipills.com clarifying that the news clip is outdated and “carries inaccurate representations and also confuses the public”.
The pills, which are made in Hong Kong with more than 10 Chinese medicinal ingredients, are used for a variety of gastrointestinal ills.
The 2010 recall occurred after HSA detected the substances in the capsule form of the pills during routine surveillance checks.
Po Chai products were previously available in two forms – bottles and capsules.
The manufacturer stopped producing the pills in capsule form and stopped marketing it in Singapore since May 2010, after HSA recalled the specific batch of the product.
Acupuncture Plus Herbs Beats Acid Reflux Drug
Acupuncture plus herbal medicine outperforms omeprazole (Prilosec, Zegerid) for the treatment of acid reflux. Often referred to as gastroesophageal reflux disease, GERD, or reflux esophagitis, acid reflux occurs when stomach acid reverses direction and enters the esophagus, causing inflammation, heartburn (burning pain), regurgitation of acid into the throat or mouth, nausea, or bloating. Acupuncture plus herbs was more effective than drug therapy in both the short and long-term. In addition, acupuncture plus herbal medicine had a lower relapse rate.
Chinese Medicine Theory
- PC6 (Neiguan)
- ST36 (Zusanli)
- CV12 (Zhongwan)
- BL18 (Ganshu)
- BL19 (Danshu)
- LV3 (Taichong)
- Shi Chang Pu 15 grams
- Zi Dou Kou 6 g
- Huo Xiang 12 g
- Sha Ren 9 g
- Pu Gong Ying 15 g
- Lian Qiao 20 g
- Dong Ling Cao 15 g
- Huang Qin 9 g
- Huang Lian 9 g
- Sheng Mu Li 30 g
- Qing Ban Xia 9 g
- Mu Xiang 6 g
- Chai Hu 12 g
- Zhi Shi 15 g
- Hou Pu 12 g
- Fu Ling 20 g
- Recovery: Absence of symptoms.
- Significantly effective: Significant absence of symptoms.
- Effective: Symptoms showed improvement.
- Not effective: Symptoms showed no visible improvement.
What Is Horny Goat Weed & Does It Actually Work?
Using Herbs as Medicine
As a practitioner of Chinese Medicine – both Acupuncture and Chinese Herbal Medicine – I am invested in herbal medicine and its use and application. As such, I am going to write a series of articles on the subject of herbal medicine, which is truly the oldest form of medicine on the planet.
Having good health and wellness practices in your life are so basic to living a vital life full of energy, zest, purpose and fulfillment.
And good health and wellness practices are basic to living a Low Density Lifestyle – the better you feel, the more you feel less dense and in the flow.
And achieving good health and healthy living are not that complicated to do, although it seems to be something out of the reach of most people.
A whole foods-oriented diet, movement, attitude, stress management, energy practices – such as acupuncture, reiki, yoga and tai chi – and feeling a sense of fulfillment are key ingredients to healthy living and living a Low Density Lifestyle.
Drug therapy has only been around in recent times. On the contrary, Herbal Medicine, which is nature’s medicine cabinet, is the oldest form of medicine.
Many drugs are made from herbs. For instance, inulin comes from the roots of dahlias, quinine from the cinchona, morphine and codeine from the poppy, digoxin from the foxglove, and aspirin from meadowsweet (aspirin also owes a big thanks to willow bark, which contains salicin, which is converted in the body into salicylic acid).
The word aspirin comes from an abbreviation of meadowsweet’s Latin genus Spiraea, with an additional “A” at the beginning to acknowledge acetylation, and “in” was added at the end for easier pronunciation.
The word drug itself comes from the Dutch word “druug” (via the French word Drogue), which means “dried plant.”
The use of herbs as medicine has been around as long as humans have walked the earth, but for many people, they have lost track of their roots (no pun intended). Herbal Medicine has been used by most cultures in every continent on earth as part of their traditional healing practices.
From the Sumerians and Traditional Egyptian Medicine, to Ayurvedic and Chinese Medicine, to the ancient Greeks and Romans, to Hippocrates and European Medicine, and to indigenous people all over the world, herbs have always been seen as an essential aid in helping a person heal.
The World Health Organization (WHO) estimates that 80 percent of the world’s population presently uses herbal medicine for some aspect of primary health care.
To this day, herbal remedies are very common in Europe. In Germany, herbal medications are dispensed by apothecaries. Prescription drugs are sold alongside essential oils, herbal extracts, or herbal teas.
In the United Kingdom, the training of medical herbalists is done by state funded Universities. For example, Bachelor of Science degrees in herbal medicine are offered at Universities such as University of East London, Middlesex University, University of Central Lancashire, University of Westminster, University of Lincoln and Napier University in Edinburgh.
So what has happened? Why are herbs the forgotten orphan of medicine and healing?
Because we have come to deify the modern medical approach of drugs and surgery for all health issues, whereas in actuality modern medicine is at its best in emergency situations – that’s when the use of a drug makes more sense than the use of an herb.
But for chronic health problems, a different approach is needed. One that stresses natural remedies.
And when natural remedies are used, herbal medicine must always be part of the approach.
Traditional Chinese medicine may benefit some heart disease patients
Traditional Chinese medicine might be effective as a complement or alternative to traditional Western medicine for primary and secondary prevention of heart disease, according to a state of the art review paper published today in the Journal of the American College of Cardiology.
Heart disease is the number one cause of death worldwide, and despite advances in Western medicine for treating and preventing heart disease, unmet needs remain. As a result, traditional Chinese medicine is being increasingly looked at as a supplement to Western medicine, but to date randomized controlled trials are overall of poor quality and flawed.
Western scientists often reject Chinese medicine for specific reasons: the formula consists of dozens of ingredients with many chemical molecules, making it hard to clarify the therapeutic mechanism; the medications available in China do not undergo the same rigorous approval process as Western drugs to guarantee efficacy and safety; and most trials were conducted in China by traditional Chinese medicine physicians with medications largely unavailable in the United States.
Researchers in this review looked at studies published over the past 10 years on randomized controlled trials of traditional Chinese medicine used for patients with hypertension, dyslipidemia, diabetes/pre-diabetes, atherosclerotic cardiovascular disease and chronic heart failure to assess the efficacy and safety of traditional Chinese medicine.
In all, certain Chinese medications showed suggested benefits for each of the cardiovascular health conditions studied. For example, researchers looked at eight randomized controlled trials on traditional Chinese medicine and hypertension. The evidence indicated that Tiankuijiangya, Zhongfujiangya, Qiqilian, Jiangya and Jiangyabao have antihypertensive effects and a good safety profile, making them a potential good alternative for patient intolerant of or who cannot afford Western medications.
However, whether those benefits transferred into long-term positive cardiovascular outcomes would have to be determined by long-term trials.
“Of note, one should bear in mind that traditional Chinese medicine medications are usually prescribed as complex formulae, which are often further manipulated by the practitioner on a personalized basis,” said Yuxia Zhao, senior author of the review and a physician in the Department of Traditional Chinese Medicine at Shandong University Qilu Hospital in Jinan, Shandong, China. “The pharmacological effects and the underlying mechanisms of some active ingredients of traditional Chinese medications have been elucidated. Thus, some medications might be used as a complementary and alternative approach for primary and secondary prevention of cardiovascular disease.”
Which is deadlier – herbal remedies or conventional medicines?
Two people in San Francisco ended up in intensive care after taking a herbal remedy, it was reported last week. The incident is likely to raise questions about the safety of herbal medicines. But are they any more dangerous than the drugs dispensed by your doctor or those sold over the counter without a prescription?
It is a common belief that herbal medicines are safe and research suggests that they are used by at least a third of people in some countries, such as the UK.
To better understand the relative risks involved, it is helpful to put herbal medicines and pharmaceutical drugs into context. It is generally accepted that pharmaceuticals cause side effects. But, as part of licensing requirements, a risk-benefit analysis is undertaken to determine whether the benefits outweigh the potential harms. In other words, is the possible harm caused by the drug acceptable? If it is, the drug may be granted a marketing authorisation (product licence) by a regulatory authority, such as the Food and Drug Administration in the US or the European Medicines Agency in Europe.
Undeniably, pharmaceutical drugs kill people. In the US, it is estimated that pharmaceuticals kill around 100,000 people every year. For certain conditions, however, there may be no alternative to drug therapy and certain medicines can prolong life, such as drugs used to treat diabetes, heart disease and cancer.
By contrast, herbal medicines are considered by many to be a safer alternative and are preferred by a sizeable section of the public for treating non-life-threatening conditions. And there is some evidence to support the idea that herbal medicines are safer for minor ailments. For example, drugs to treat mild to moderate pain, such as paracetamol and aspirin, are known to cause side effects, including some that – although rare – can be serious, such as gastric bleeds. Whereas with herbal equivalents, such as devil’s claw, the risks of side effects are reportedly lower.
A tricky comparison
Adverse events associated with herbal remedies are reported far less often than those associated with pharmaceuticals. For example, in the UK, between 2006 and 2008, there were only 284 such reports for herbal medicines compared with 26,129 for pharmaceuticals in a similar two-year period.
The reasons for this vast difference are complex, and it has been suggested that adverse events of herbal medicines are unrecognised or underreported. Also, there are many more drugs consumed than herbal remedies so it is to be expected that the figures for pharmaceuticals are higher. However, the enormous difference does suggest that adverse events are far more common with pharmaceuticals than herbal remedies.
When serious side effects are triggered by herbal remedies it is often due to poor quality products, products containing newly discovered plant ingredients, or products that have been adulterated – including with pharmaceutical drugs.
For the public, buying herbal products that are regulated offers some assurance that the medicines are both safe and of acceptable quality. For instance, in the UK, traditional herbal remedies are manufactured to a high standard and include a patient information leaflet, which lists known side effects and, importantly, warns of possible interactions with pharmaceuticals, another cause of adverse reactions.
For example, St John’s wort – a herbal remedy used to treat mild depression – is known to have side effects when taken alongside fluoxetine (Prozac). The makers of these products also have a legal obligation to monitor any adverse reactions and report them to the regulators.
Another way to help avoid adverse reactions, especially when dealing with conditions that are not always suitable for self-treatment with over-the-counter drugs, is to visit a qualified herbalist. The training and regulation of herbalists varies widely from country to country and without government regulation of these practitioners, it is difficult for the public to assess who is legitimate.
However, voluntary regulation by professional associations does exist and is effective in many countries, including the US, Canada, the UK and Australia. This regulation helps to ensure that practitioners are appropriately educated and safe.
Herbal medicines are relatively safe compared with pharmaceuticals provided that they are regulated products or that they are prescribed by herbal practitioners who are registered with an appropriate governing body. But consumers need to be better informed about the dangers of obtaining herbs from unregulated sources if further cases of serious side effects are to be avoided.
How traditional Chinese medicine drove the discovery of a Nobel-winning anti-malarial drug
Tu Youyou was tasked with finding a cure for malaria by Mao Zedong in 1969. More than four decades later, her discoveries help save more than 100,000 lives every year in Africa alone, and she has been rewarded with the highest honour in medicine, the Nobel Prize, shared with fellow parasite-battling scientists William C Campbell and Satoshi Ōmura.
What might seem unusual about her scientific work is that Tu began by looking to the plants used in traditional Chinese medicine. But it is far from the only time a modern cure has been found from traditional Chinese medicine and it is unlikely to be the last.
Tu and her colleagues searched ancient Chinese medical texts for references to herbs and recipes that might have been used to fight malaria-type symptoms such as fever, rigors and headache. They systematically screened the well-documented texts and sifted through more than 2,000 herb preparations of traditional Chinese herbs and from these identified 380 herb extracts and tested them on mice being infected by malaria parasites.
One of these, the common Chinese plant sweet wormwood (Artemesia annua) was prescribed in a 4th century Jin dynasty text, for treating fevers – a key malaria symptom. When tested, it was found to reduce the number of malaria parasites in the blood.
Turning the plant into a drug
Tu’s team then started to use different solvents to isolate different chemicals from sweet wormwood. They tested these chemicals one by one against mice infected by malaria parasites until they identified a compound that at a very low dose can kill the parasites faster than other anti-malarial drugs. This compound, artemisinin, can uniquely produce chemically reactive molecules in the parasite that kills them.
Isolating different classes of chemicals in plants requires strategy and patience. And producing a pure single compound such as artemisinin in a reasonable quantity from a plant with a higher potency than a synthetic drug is a major achievement. This is often done using a solvent to dissolve certain chemicals from plant material and then slowly evaporating the resulting solution to isolate the compounds. By repeating the process using different solvents it is possible to separate different chemicals.
But as well as following scientific methods to isolate the artemisinin, Tu again drew from Chinese medicine, a key element of which involves preparing plants in certain ways to affect their chemical properties. In line with this, Tu discovered that isolating the artemisinin from the plant was best performed at low temperatures.
Impact on malaria
The discovery of artemisinin has made a huge difference in the management of malaria treatment in the world. In 2013, 392 million treatment courses using the drug were procured by countries where the disease in endemic. If the malaria parasite were to become resistant to the drug it would severely hamper the goal of malaria eradication and also result in large increases in African childhood mortality.
To prevent this from happening, doctors have tried to limit the use of artemisinin-based compounds by combining them with other drugs that kill the parasites in a different way. Such artemisinin based combination therapy is recommended for treatment of uncomplicated malaria (which doesn’t severely affect the internal organs) caused by the parasite Plasmodium falciparum. Only severe malaria cases are given full doses of artemisinin derivatives (artesunate or artemether)
Despite the efforts to quickly diagnose and carefully treat malaria, there have been reports of resistance to artemisinin derivatives on the Thai-Cambodian border. In view of the potential resistance to artemisinin derivatives, perhaps a traditional Chinese approach of holistic treatment featuring a prescription of a combination of plants should be re-visited.
Mulberry leaf extract could reduce the risk of type 2 diabetes
Consuming refined carbohydrates is linked to a heightened risk of developing type 2 diabetes, not to mention heart disease. But what if a supplement could decrease the breakdown of carbohydrates into simple sugars? That might reduce a person’s risk of developing type 2 diabetes. Our latest study, published in PLOS ONE, shows that an extract made from mulberry leaves might do just that.
Previous research shows that herbal medicines could be effective in regulating blood glucose levels. Indeed, the history of the commonly used diabetic drug metformin can be traced back to the use of a herbal medicine, Galega officinalis (goat’s rue or French lilac) in medieval Europe. G. officinalis was found to be rich in guanidine, a substance with blood glucose-lowering activity that formed the chemical basis of metformin (biguanide). This insulin sensitising drug was introduced in 1957.
Mulberry leaves have been used in traditional Chinese medicine for several millennia and its use was first recorded in around 500AD. In the Grand Materia Medica, it states that “if the juice (of the herb) is decocted and used as a tea substitute it can stop wasting and thirsting disorder”. Wasting (weight loss) and excessive thirst along with increased urination and tiredness are symptoms associated with diabetes. We aimed to investigate the effects of mulberry extract on blood glucose and insulin responses in healthy volunteers with a randomised, double-blind, placebo-controlled clinical trial – the gold standard for a clinical trial.
We took blood samples from 37 healthy volunteers after they had consumed a carbohydrate rich drink (containing maltodextrin, a dietary starch with a high glycaemic index that is commonly added to many foods and beverages). Each participant took either a placebo or one of three doses of the extract along with the drink on four separate days. We measured each person’s glucose and insulin levels over the following two hours.
Our analysis showed that the standard strength mulberry extract (250mg) reduced the total glucose and insulin rises by 22% and 24% respectively compared to a placebo. These results were both statistically significant (unlikely to be due to chance) and clinically significant, and thus could have meaningful health benefits. The extract effectively reduced the total amount of sugar being absorbed into the bloodstream by over 20%.
The extract didn’t cause any side effects in the volunteers, such as nausea and flatulence – side effects which are common with many diabetic medications. An active component in the extract, 1-deoxynojirimycin (DNJ), blocks the breakdown of carbohydrates into simple sugars, preventing the absorption of sugar, lowering blood-glucose rises. Although mulberry leaves can be used to make tea, the particular extract we used had undergone strict quality control processes in order to guarantee consistency of its DNJ content.
In order to draw definitive conclusions about the long-term health benefits of mulberry leaf extract, longer, more pragmatic trials reflecting real-life dietary habits are needed to show if this herbal supplement could prevent the development of type 2 diabetes. The initial results are certainly promising.
Natural protein could beat insulin resistance and provide a new treatment for diabetes
Insulin is a hormone that helps control glucose (blood sugar) levels in the blood, which tend to increase after meals. People suffering from type-2 diabetes are resistant to the glucose-lowering effects of insulin. Few medicines can safely reduce this insulin resistance. But new research on mice, just published in the journal Nature, has found a target that might help develop a more effective treatment.
High on sugar
Our brains run on glucose. To keep glucose constantly available in the blood requires an elaborate system of checks and balances. Insulin tells the cells of the liver, muscles and fat to take glucose away from the blood. The liver also makes and releases glucose, so when we have a meal, insulin also tells it to stop production.
Insulin production is determined not only by the size and composition of a meal but also the sensitivity of the body to insulin’s actions. This means the right amount of insulin is made and released, ensuring that glucose levels fluctuate only slightly, no matter the meal. But when diabetes occurs there is not enough insulin, or not enough insulin-function, to keep glucose levels under control. This can cause glucose levels to end up too high or too low.
Many different factors can contribute to the decline and loss of insulin’s functions. In type-1 diabetes, a person’s immune system inadvertently destroys the insulin-producing beta-cells of the pancreas so they have to have insulin injections.
In type-2 diabetes – the kind that most diabetes patients have – the capacity for producing enough insulin to adequately control glucose levels is eroded over many years. At the same time, the body becomes less sensitive to the glucose-lowering effects of insulin. To compensate for this insulin resistance, more and more insulin must be made and released by the pancreas to keep glucose under control. As they do until eventually this system fails.
Type-2 diabetes is treated with diet, increased physical activity and medications to not only maintain good glucose levels but also optimal blood pressure, weight and lipid (fatty compounds) levels. However, even with best practice, “normal” glucose levels (similar to those in individuals without diabetes) are seldom achieved. This is partly because the delicate control of insulin production by the pancreas is almost impossible to match with insulin injections or oral medications that stimulate insulin production.
However, if all resistance to insulin’s effects could be safely removed, even a damaged pancreas could have enough capacity to bring glucose levels back under control or even back to “normal”.
Taking the resistance head-on
The new study, by Ronald Evans from the Salk Institute for Biological Studies and his colleagues, describes a new regulator of the body’s sensitivity to insulin, and identifies a potential target for the treatment of type-2 diabetes. The team studied a protein called Fibroblast Growth Factor 1 (FGF-1 or acidic FGF), which is involved in the regulation of many physiological processes, including wound healing, blood-vessel growth, nerve regeneration and fat cell development. Their work shows that FGF-1 may also play a significant role in reducing insulin resistance.
They found in earlier experiments that mice which were genetically deficient of FGF-1 developed severe insulin resistance. But in the new study, elevated glucose levels came down when FGF-1 was injected into mice with genetic or diet-induced forms of type-2 diabetes.
Importantly, this glucose-lowering effect was not seen in mice without diabetes, presumably because there was already enough insulin being made to maintain glucose control (and improvements in insulin sensitivity are normally easily offset by reduced insulin production). Also, FGF-1 did not work in mice that did not produce insulin at all (as in untreated type 1 diabetes), which suggests that FGF-1 specifically works with and through insulin to lower glucose levels in diabetes.
However, the key problem with growth factors like FGF-1 is that, among many other functions, they help things to grow, including some cancers. It is known, for example, that some cancers express high levels of FGF-1 and many grow faster and more aggressively in response to FGF-1.
What is most interesting is that when the growth-enhancing part of FGF-1 was removed it still improved glucose levels in diabetic mice. This suggests that FGF-1’s growth effects are independent to its actions on insulin sensitivity. This also raises the possibility of selective therapeutics without the alarming risk of enhancing cancer.
Of course, translation from mice to clinical practice is a challenging task. But this is a promising a start. Clinical trials are already underway to see if FGF-1 can be used to treat conditions ranging from heart disease to spinal damage. Thanks to this work, it looks like diabetes will be next.
Next, read this: Insulin pill may soon be a reality
Herbal Medicines Adulterated, Contaminated or just plain Missing. It’s an International Scandal
In the wake of the ABC statin story there have been a lot of comments on the Conversation about the evils of Big Pharma. Less attention has been given to Big Supplement, the multimillion dollar herbal supplement industry. Despite the known lack of efficacy of many herbal medicines, and the potential for harm, or contamination, the herbal medicine industry seems to get a free pass.
In the latest revelations, it appears that many herbal medicines have little, if any, of the ingredients on their labels. And what is there instead may be toxic.
The scope of the problem
Regulating herbal medicines can be quite difficult, if you want to ensure a herbal medicine has the mixture of herbs that the label states. In many cases the active ingredients are not known, so you cannot measure the active ingredients to make sure you are getting what you paid for. And most herbal medicines are presented as highly processed powders or teas. One pile of slightly greenish dust looks like another.
Worse still, even if you had access to the original plant, for many plants it takes an expert to tell them from other species that have no medicinal value, or one that may be even toxic.
Currently we largely rely on herbal companies to be honest about what goes into their products. But independent verification of the identity that what people are ingesting for their health is in fact the real deal is highly desirable.
So how do you tell if the pile of finely ground plant material is the herb (or herbs) in question. Enter DNA Barcoding.
DNA Barcoding to identfy herbs in Herbal Medicine
DNA Barcoding is an approach to identifying species by looking at particular variable regions in a species DNA. All species are evolutionarily related, so the DNA of species that are very closely related is more similar to each other than species that are more distantly related. So in theory by sequencing the genes of enough species, we can identify which species otherwise unidentifiable tissue belongs to by comparing DNA from the said tissue to a bank of DNA from known species.
The principle is similar to that used in paternity testing and identifying disaster victims.
Simple in theory, complicated in practice, if you choose DNA sequences that don’t vary much, like housekeeping genes, then you can’t tell closely related species apart. If you chose highly variable genes, like the chunks of broken viruses that litter our genome, then more distant relatives will be lost in the noise.
For this research report, Canadian researchers created a DNA sequence bank from known herbs used in herbal medicine. They used sequences from two separate gene regions to improve selectivity and reduce false positives and false negatives. After doing blind testing of known herbal samples to ensure that the tests were selective and sensitive (i.e. when the test said herb x was present it really was present), they then examined 44 herbal products on sale in North America, sourced from Canada and the US.
What’s on the label is not what’s in the bottle
What did they find? Well, the primary finding was that nearly one in ten herbal medicines had no herbs in them, just filler.
I’ll repeat that. Nearly one in ten herbal medicines had no herbs in them.
This is an astonishing result. Imagine the outrage if pharmaceutical companies were selling drugs with no active ingredient in them.
The rest of the news was no better, around a third of the herbal medicines had substitutions, where a different species was used instead of the one listed on the bottle. Around a third also had contaminants or fillers that were not listed on the labels.
Overall, less than half of the herbal medicines actually had what was listed on the label.
Seriously, they replaced an anti-depressive with a laxative. I just spent a good part of Saturday boiling up Senna pods (a story for another day), and I cannot even conceive of how you could get the two confused, even when chopped up. If the substitution was accidental, this is a fundamental failure of quality control and governance. If deliberate, words fail me.
Not only will Senna not relieve depression but Senna can have serious side effects including liver damage if used for some time (as you would with anti-depressants). And this was not the only case where a potentially toxic herb was substituted.
In other cases the contaminants were a serious worry. Many herbs were contaminated with Walnut, possibly leaves that got caught up in harvesting the authentic plant. These have the toxic chemical juglone in them.
Even the relatively harmless fillers can be an issue if they do not appear on the label. Wheat as a filler can be an issue to someone with gluten allergy.
This is not the first study to show contamination and substitution in herbal medicines, but it is the largest and most comprehensive in a developed country.
Australia is not immune
You might wish to take some comfort in the knowledge that Australia’s Therpaeutic Goods Administration treats herbal medicines as medicines. Unlike the United States, where they are treated as food supplements and monitored with less stringent rules than ours. But herbs for the Canadian study sourced in Canada, which has approaches to herbal medicines not dissimilar to ours, were found to have substantial contamination and substitution issues.
And the TGA’s rules will not necessarily help. The TGA relies on honesty from sponsors of herbal medicines when they are registered, with post marketing follow-up. This follow-up consists of random surveys and targeted surveys from concerns raised by consumers.
Given that there are over 10,000 licensed herbal medicines in Australia, and nearly 2000 new herbal medicines being registered each year, the number that can be checked by this method is rather small. In a TGA survey in 2009-2010, 110 complementary medicines were tested. An astonishing 90% of complimentary medicines surveyed were non-compliant with their licence conditions.
The license conditions cover everything from advertising and unsupported therapeutic claims to composition. Forty one (37%) of these non-compliance’s resulted in the sponsor withdrawing the medicine or the TGA revoking the licence. In the same time frame no prescription or over the counter medicine had their licences revoked.
We don’t exactly know what proportion of these revoked licences are due to herbal medicines having the wrong ingredients or being contaminated, but recent cancellation notices suggest that 11% of all cancellations are due to problems with component concentrations or contents. This sampling result indicates that Australia, like the rest of the developed world, has a significant problem.
The Herbal Medicine Industry is an international industry, with products travelling all over the world. The widespread substitution and contamination of herbal medicines is an international scandal. Despite the vigilance of the TGA, Australia is almost certainly not immune from this scandal.
Disclaimer: I’m one of a group of researchers who have just won an NHMRC grant to determine the extent of contamination and substitution of herbal medicines in Australia.
What’s in your herbal medicines?
by Ian Musgrave and Michael Bunce
Many people take herbal medicines, including traditional Chinese medicine (TCM) thinking they are doing something positive for their health. Ironically, in many cases they may be doing just the opposite.
Have you ever wondered what is actually in the herbal medicine products you buy? Has the herb on the label been replaced with another herb? Have pharmaceuticals been snuck in?
Making sure that a tablet claiming to have 500 milligrams of paracetamol really does contain 500 milligrams of paracetamol is relatively easy, there are established assays to measure paracetamol routinely. But how do you test for herbs?
Most herbal medicines are pills or powders that have removed all trace of structure we would normally use to identify plants, and many plants have no chemical signature that is able to definitively identify them. And what about all the other possible contaminants and adulterants that could hide in the complex brew of chemicals from herbal medicines?
For the first time, our group of researchers from Curtin University, Murdoch University and the University of Adelaide have combined some of the most cutting-edge and sensitive analytical techniques to screen a set of traditional Chinese medicines available in Australia.
We used a three-pronged approach, combining DNA sequencing, toxicology and heavy metal testing to elucidate the true composition of 26 TCMs purchased at random from the Adelaide Markets; most were either for colds and flu’s or for general wellness.
What did we find?
Coglan et al.,Sci Reports 2015
Nearly nine in ten of these medicines had some form of undeclared substance in them as either adulteration or contamination. Sixteen of TCM’s had more than one contaminant or adulterant.
While around half of these medicines were not listed with the Therapeutic Goods Administration (TGA), and should not have been available for purchase, contaminants were found in both TGA-listed and non-listed medicines. These adulterants/contaminants included pharmaceuticals and toxic heavy metals.
Plant and/or animal DNA from species not listed on the labels were also found. The most concerning finding was snow leopard DNA (snow leopards are an endangered species), which was detected in one medicine. DNA from pit viper, frog, rat, cat and dog was also detected in several medicines.
Among the pharmaceuticals found were paracetamol, antihistamines, anti-inflammatories and antibiotics, and stimulants such as pseudoephedrine. Of particular concern were drugs such as warfarin, which have significant potential for harm if not taken under medical supervision, and ephedrine, which is banned in Australia.
Significant levels of toxic heavy metals such as arsenic, cadmium and lead were found in over half the medicines. In at least four of these medicines following the directions on the label would expose you to over ten times the TGA’s regulatory limit for heavy metals in medicines.
What does this mean?
Are the levels of undeclared materials in these products adulteration or contamination? In adulteration, the material is added deliberately. In contamination, the material is added inadvertently, for example, through unclean workplaces or herbs grown on contaminated soil.
Whether a compound is a result of deliberate adulteration or contamination has different regulatory implications. It can mean the difference between banning a substance or cleaning up the workplace.
It can be tricky to decide which is which. In TCM materials, for instance, heavy metals or toad venom may be added as part of the treatment. However, by looking at the patterns of materials we found, we can get some hints.
One TCM claiming to enhance weight gain with appetite stimulation contained pharmaceutically relevant levels of the drug cyproheptadine, a known appetite enhancer.
Intriguingly, high levels of arsenic were often found with similar levels of lead. Lead arsenate has been used as a pesticide, and the high levels may come from persistently contaminated soils.
What this means is that you should be very careful about choosing and purchasing TCMs. Definitely avoid any medicine that does not have an ARTG listing (it should have a number like AUST L 123456 on the front of the bottle). But even medicines with these AUST L labels are no guarantee of safety.
This also highlights the importance of informing your health practitioner if you are taking TCMs as adulterants might interact with conventional medication to cause adverse effects.
What are the regulatory implications?
Unlike countries such as the United States, where many herbal medicines are regulated as dietary supplements, in Australia, herbal medicines are regulated through the TGA as medicines.
TGA-regulated medicines can be approved as either “registered” or “listed”. Most herbal medicines are classified as “listed”. Unlike registered medicines such as paracetamol and warfarin, the evidence required for approval is much less stringent.
In many ways it is an honour system, where the herbal medicines sponsor says there’s no evidence of harm, and they hold documentation that shows this. Mostly, the evidence is historical, claiming that people have been using it for generations without evidence of harm. As well, if the compounds are on the TGA’s list of “generally recognised are safe” materials extensive safety testing is not required.
The TGA uses post marketing follow-up to check for compliance with the “listed” medicine regulations. This follow-up consists of random surveys as well as targeted surveys from concerns raised by consumers.
In Australia, nearly 2,000 new herbal medicines are registered each year.
In a TGA survey in 2012-2013, 145 complementary medicines were tested. Around 83% of complimentary medicines surveyed were deemed to be non-compliant, with 6% failing due to product composition, formulation or manufacturing.
Using a combination of new molecular approaches, our survey found a much higher level of adulteration and contamination in TCMs than found in the TGA’s surveys. Adding DNA ingredient screening to the TGA’s armoury of analytical methods would help ensure that undeclared ingredients are not included in the herbal medicines we consume.
The herbal medicine industry is a billion dollar international industry, with products travelling all over the world.
Globally, we need a better auditing “toolkit” to ensure consumers of herbal medicines, as well as people testing their efficacy, are not being misled.
This research, we think, provides a roadmap to more effective regulation of the herbal medicine sector.
* The results of our screening have been passed on to the TGA, which is following this up.
Western herbal medicine – panacea or placebo?
PANACEA OR PLACEBO – A weekly series assessing the evidence behind complementary and alternative medicines.
Herbs have been used for therapeutic purposes in most cultures for hundreds and even thousands of years. The father of Western medicine, Hippocrates (460 BC – 377 BC) is known to have used many plants and herbs for medicinal purposes. Hippocrates’ use of up to 400 plants are well documented in a collection called the Corpus Hippocraticum.
Western herbal medicines have traditionally been used to help prevent and treat diseases. Many useful pharmaceuticals have been derived from such herbs, including:
- salicylic acid to make aspirin from the bark of the white willow tree (Salix alba);
- morphine from the poppy plant (Papaver somniferum);
- digitalin, digitoxin and digoxin from the plant foxglove (Digitalis purpurea);
- atropine from the belladonna plant (Atropa belladonna) and;
- quinine from the bark of the quinine tree (Cinchona ledgeriana).
In herbal medicine, the whole plant or parts of the plant (flowers, leaves, bark, fruit, seeds, stems and roots) are used for their potential therapeutic properties.
Herbal medicines differ from pharmaceuticals as they contain complex multi-component substances, and like pharmaceuticals can exert biochemical and physiological effects on the body. There are natural variations of the active components in herbs, which is why there are differences in the profiles of batches of the same herbal ingredient.
This variation creates difficulties for research and analysis of systematic reviews of trials. Standardisation of extracts of herbs has improved over the years but remains an ongoing issue for both research and clinical use.
Safety is also an issue for herbs. As they contain active substances, herbs can cause adverse reactions as a result of interacting with pharmaceutical drugs. A good example is St John’s wort, which is used for treating mild depression. The hyperforin levels found in this plant can result in reduced efficacy for drugs such as digoxin, the oral contraceptive pill and warfarin.
Western herbal medicines used by Hippocrates and still commonly used today include fennel, cinnamon, clove, chaste-berry, anise or licorice, coriander, garlic, St John’s wort, white willow bark, valerian, linseed, peppermint, chamomile, celery, clove (oil), Viscum album, elder-wood, sage and nettle.
The evidence base
Most of the evidence for herbal medicine stems from traditional use accumulated over hundreds of years and is documented in key monographs. Randomised control trials have also been conducted for some herbs but the majority vary in quality, lack methodological rigour, are often of short duration and have small numbers of participants.
Still, there are some Cochrane reviews and research worthy of mention that demonstrate the potential effectiveness of some herbs. Cranberry tablets (not the juice) for the prevention of recurrent urinary tract infections in young women, for instance, or St John’s wort for mild, moderate and major depression, various herbs (STW 5 and STW 5-II) for irritable bowel syndrome, and rosehip and avocado-soybean unsaponifiables for osteoarthritis.
As the trials included in the systematic reviews are quite diverse, it’s difficult in some cases to know the type of extract, dosage or form of herbs that are most active and clinically effective.
Larger rigorous and high-quality trials are needed to help identify which herbs or standardised extracts of herbs are clinically useful. This would also help identify the safety profile of Western herbal medicines, especially with prolonged use.
This is the sixth article in our series Panacea or Placebo. Click on the links below to read the other instalments:
Why Mexican immigrants are healthier than their US-born peers
Supporters of Donald Trump’s wall might have us believe that Mexicans who enter the US illegally carry disease and take advantage of America’s healthcare system. But several large public health surveys suggest that most Mexican immigrants are healthier than the average American citizen. So what can Americans learn about health from their Mexican neighbours?
The “Hispanic health paradox” was first identified in 1980, in the Hispanic health and nutrition examination survey. Results of the survey were compared with a second part of the survey, which looks at all Americans. Of all Hispanic groups, people from Mexico have some of the best health compared with the rest of Americans. For example, Mexicans have lower rates of high blood pressure, cardiovascular disease and most cancers than the general US population.
But, by the second or third generation, people of Mexican descent do not seem to have any health advantage over other Americans. This suggests that the paradox depends on cultural factors, such as physical activity, eating habits and family support.
I conducted research for my PhD thesis in “Los Duplex,” one of the first Mexican immigrant neighbourhoods in the city of Athens, in Georgia. I wanted to know if traditional medical practices migrated with people from Mexico to the US.
The World Health Organisation (WHO) defines traditional medicine as “the sum total of the knowledge, skills, and practices based on the theories, beliefs, and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness”. Traditional medicine is recognised and promoted by the WHO as an important healthcare resource.
At the time of my study, about 75% of the 131 homes in Los Duplex were occupied by Mexican tenants. Most were recent immigrants who worked in a nearby poultry processing plant. As part of my research, I collected family health histories and self-assessments of health, which were generally positive. I also found that Mexicans in Los Duplex approached health and healing by drawing on both traditional and mainstream medicine.
Living well in Los Duplex
Mexican immigrants in Los Duplex cared for and supported each other physically, emotionally and financially. Strong social networks help migrants cross the border and find jobs in the US. They also help spread knowledge of medical resources and traditional practices, which together form a holistic system of healthcare.
The Mexican families in my study had a relatively easy time accessing the mainstream medical system of Athens. But mainstream medicine was seen as a last resort. Immigrants reported that traditional Mexican health practices can often prevent or resolve problems before they require medical attention. Such practices promoted keeping calm, staying active and maintaining a positive attitude, to consuming traditional foods and herbal remedies.
Most Mexican women routinely cooked meals for their families made with beans and corn tortillas (the traditional Mexican staple foods), as well as meat and vegetables. Food was prepared fresh with a variety of seasonings, like onion, garlic, mint, chillies, cumin, and oregano. These add micronutrients and antioxidants, as well as flavour. Although children consumed sweets and fizzy drinks, which could be bought in the neighbourhood, meals were usually served with homemade drinks made from fresh fruit.
Mexican migrants in Los Duplex also used a variety of medicinal plants, as well as other home remedies. They generally used these medicines for the health problems they experienced most frequently in Georgia: respiratory tract infections and digestive disorders. And there is some evidence for these traditional remedies. For example, the herb gordolobo (Gnaphalium spp.), which is used in Los Duplex for coughs and chest congestion, has been shown to have anti-inflammatory and antimicrobial properties that are useful in preventing and treating respiratory disease. And manzanilla (Matricaria recutita), which is used to relieve stomachache and menstrual cramps, has antimicrobial and antispasmodic properties.
Mexican women described herbal remedies as inexpensive, natural and safe. But they were wary of most pharmaceuticals, even though they sometimes used them. Reasons for mistrusting pharmaceuticals related to their side effects. Drugs to counteract the side effects of other drugs were seen as especially problematic.
Too much, too little, just right
I asked people in Los Duplex why they thought Mexican immigrants were healthier than Americans. They attributed this to Americans’ overconsumption of fast foods, as well as the consumption of too many “pastillas” (pills). Most Americans do indeed rely heavily on pharmaceutical drugs, even for relatively minor conditions. Overmedication may in fact be undermining the health of many Americans.
Of course, under-medication is also a problem for uninsured Americans and other groups with limited access to medical care, including some Mexican migrants. For example, undocumented Mexican farm workers earn so little they can lack the means to see a doctor or pay for medicine. This is particularly problematic as these migrants often live in makeshift housing, with limited facilities for cooking or making herbal remedies. For these and other reasons (such as pesticide exposure), Mexican migrant farm workers have worse health than Americans.
My research on Mexican immigrants suggests that both too much and too little mainstream medicine is a potential threat to health. Because of their traditional medical knowledge, the Mexicans of Los Duplex were able to achieve the right balance between complementary and mainstream medicine. Their holistic approach to health and healing provides a valuable lesson for American citizens.
Science or Snake Oil: can a detox actually cleanse your liver?
This is the first article in our new ongoing series Science or Snake Oil. Articles will look at the claims for a product and decide whether they are supported by science or lacking in evidence.
The human adult liver weighs about one-and-a-half kilograms, making it one of the largest organs in the body. It is responsible for a range of functions. It helps break down fats, carbohydrates and proteins into substances the body can utilise.
The liver acts as a storage unit for these substances (including vitamins and minerals) and supplies the body with them when they need it. For example, when your blood sugar level drops, the liver will release stored carbohydrate (glycogen) to rectify the problem.
It also acts by metabolising toxins into harmless substances or by eliminating toxic substances from the body. Clever marketing has led us to believe it is the food that contains toxins and, hence, following a diet that eliminates certain foods and taking over-the-counter products that “cleanse” your liver of “toxins” will detoxify the liver.
Can the liver be ‘cleansed’?
We have a misconception we can “cleanse” the body by following a “detox” diet.
This is a complete fallacy. To explain this process one must first understand exactly what a toxin is. A toxin is a harmful substance that enters your body from the environment. Examples include carbon monoxide from motor vehicles, bisphenol A (BPA) from consumer plastics, and heavy metals such as lead and mercury. Toxins can also include drugs and poisons.
However, substances are only toxic based on the quantities in which we ingest them. The situation in which “detoxification” is required is when someone is being treated in a hospital for a dangerous level of a substance that is life-threatening.
The liver is otherwise working to eliminate unwanted substances in the body through our faeces and urine. These are the toxic byproducts from the metabolization of foods. For example, excessive amounts of protein can be dangerous to the liver.
Many over-the-counter products claim to “clean” your liver of “toxins”. But does the liver really respond to an over-the-counter product that claims to “detoxify” or “heal” its function?
Most of these products contain the active ingredients from Silybum marianum (known as milk thistle) and Taraxacum officinale (known as dandelion). Many of the formulations also contain other ingredients such as selenium, phosphatidylcholine, amino acids, artichoke leaf, green tea leaf and turmeric root, to name a few.
Several companies produce a range of liver detox or liver cleanse products with varying quantities and ingredient compositions. But how strong is the evidence to show these active ingredients actually help with liver repair?
Milk thistle extract (standardised to 80% silymarin) is the most commonly marketed herb claimed to “detoxify” the liver. Silymarin is the active ingredient in milk thistle. The use of milk thistle for treatment of various diseases dates back to Dioscorides, the first-century Greek physician.
There is some evidence to suggest milk thistle (usually accompanied by other substances) is beneficial for improving blood cholesterol, insulin resistance and inflammatory markers in the body. There is no evidence, however, to suggest milk thistle “detoxifies” the liver – which many of these products claim.
Dandelion’s therapeutic use dates back to the tenth century for liver and spleen disorders.
Of greater relevance is that the majority of research investigating the efficacy of this flower extract has been tested only in animals. Similar to milk thistle extract, there is no evidence to suggest it helps to eliminate toxins or detoxify the liver, and hence serves no benefit for such a proposed indication.
A healthy liver
To have a well-functioning liver you simply have to eat healthy foods and limit your consumption of substances, such as alcohol, that cause it to work harder. Excessive consumption of any one particular food may contribute to an increased load on the liver.
Therefore, a healthy, well-balanced diet based on national guidelines is the best liver “cleanse” available, rather than spending disposable income on over-the-counter products that are not backed by scientific literature supporting such claims.
Complementary medicines are one of the largest growing markets in the world. Governing bodies must continue to incentivise companies to conduct innovative research to support the specific claims accompanying their products. It’s imperative companies are transparent in their advertising claims so consumers know what they are spending their money on from both an efficacy and safety point of view.
Evidence for approved ingredients should not be generalised from product to product. This is because the evidence supporting one such product is made up of a unique combination of ingredients and dosages. The most recent review of the regulatory framework for complementary medicines is available on the Department of Health website.
Ginseng could be an effective way to prevent the flu
Ginseng, the root of the plant Panax ginseng, is one of the most commonly used herbal medicines and is often sold as an over-the-counter remedy for fatigue. Although it has been used by humans for thousands of years, more recent research has begun to investigate therapeutic and pharmacological uses including anti-allergy and anti-inflammatory properties. It is also known to act on the immune system and to affect viral replication. And it may also be a very effective way of preventing the flu.
The findings of a recent study we carried out suggest that normal consumption of Korean red ginseng extract by healthy individuals could prevent infections by different flu virus strains. And studies in mice suggest that long-term ginseng intake could confer and prepare immune systems with better resistance to fight future pathogens.
The effect that ginseng has on flu virus infections regardless of strain makes it different from the strain-specific protection from annual vaccinations (often given to those most at risk such as the elderly and pregnant women, and determined by the strains in most circulation in a given year) and prescribed antiviral drugs such as Tamiflu – which recently came under fire over its effectiveness as a treatment against severe flu.
Korean red ginseng extracts are produced by steaming and drying the fresh roots of six-year-old Panax ginseng plants. These are then boiled in water and the supernatants – or liquids above the settled material – are concentrated. It is this preparation that can be designated as “red ginseng extract.” Because of its prominent biological effects, extracts from this particular plant have been used in animal studies. Despite known beneficial effects on human health and its action on viral infection, the mechanism for how it does this remains largely unknown.
In previous studies, we investigated the effects of ginseng given orally in mice – the most common way that healthy people take ginseng as a supplement. We found that this gave the mice a moderate but significant resistance to infection with the 2009 pandemic flu virus strain – on the whole it didn’t prevent illness, which was shown by them losing weight, but it did result in better survival.
Protection from ginseng given before infection wasn’t strong because the mice still became ill but we also found that treating them with ginseng after infection gave even less protection.
However most human adults who consume ginseng already have some immunity to the flu, either through previous contact with the virus or vaccination. So we tried giving ginseng instead to vaccinated mice instead through oral doses and found that it significantly improved how well the mice were able to fight different strains of flu viruses through cross-protection.
Infection of mice with a mixture of influenza virus and ginseng extract resulted in better clearance of lung viral levels and lower levels of inflammatory cytokines, the small proteins that are important in helping cells to send signals. But it also led to higher levels of antiviral cytokines. From these lab tests we know that Korean red ginseng extract may inhibit the flu virus growing. The extract appears to have multiple mechanisms against fighting infectious diseases, which might be beneficial if taken in healthy mice with previous exposure and prior to infections.
Our more recent study, published in Nutrients found that ginseng improved the survival of human lung epithelial cells (tissue cells that line cavities in the lung) when someone is infected with the flu virus. Also, ginseng treatment reduced the expression of pro-inflammatory genes, probably in part by interfering with chemically reactive molecules that contain oxygen and which are formed by the flu virus.
Taking ginseng for a longer term (around 60 days) showed multiple effects on the immune system of mice such as stimulating anti-viral protein production after flu virus infection. Ginseng also inhibited the infiltration of inflammatory cells into the lungs in mice. So ginseng might have potential beneficial effects in preventing flu virus infections by acting on the immune system in multiple ways.
Small doses of ginseng has been taken in humans for many years with no major side effects. But while ginseng looks like a promising way to help prevent flu, results only relate to healthy individuals taking normal doses. Based on animal studies it also has shown no or only minimal protective beneficial effects if treated after the onset of symptoms.
Does traditional Chinese medicine have a place in the health system?
Most of traditional healing practices are based on intuitive principles of diseases involving the imbalance of elemental qualities.
For the ancient Greeks and Romans, whose systems of traditional healing were accepted in Europe until the scientific revolution, these elements were the four bodily fluids or humours. Each corresponded to the four fundamental elements of the world – earth, water, air and fire.
In traditional Chinese medicine, the elements are wood, fire, earth, metal and water; for the ancient Unani medicine in India, the four humors (akhlaat) are air, earth, fire and water; for Indian Ayurveda medicine, health is the balance of three elemental energies in the universe: air, water and fire.
None of the ideas have any scientific basis.
With the advent of modern medicine, traditional European practices were relegated to a handful of surviving herbal remedies. Similarly in China, despite recent attempts to retain traditional healing practices, modern medicine is supplanting traditional medicine.
Paradoxically, in Australia and other developed countries there’s increased interest in complementary and alternative medicines, reverting to irrational approaches to health practice, despite people from such countries benefiting most from medicine’s advances.
The resurgence of interest in traditional Chinese healing in Australia, along with other alternative medicines, is due to rising discontent with conventional medicine; a preference for natural (or gentler) alternatives to pharmaceutical drugs or surgery; desire for greater control over personal health care and the relatively low success rate of conventional medicine in treating conditions, such as chronic pain, for some individuals.
This has led to the recent contentious decision to permit traditional Chinese medicine practitioners to be registered with the new national Chinese Medicine Board of Australia from July this year. The board will be a new member of the Australian Health Practitioner Regulation Agency.
The decision follows Victoria’s move (in 2000) to register traditional Chinese medicine practitioners, which has had a positive impact on tightening standards and dealing with complaints.
Among traditional Chinese medicine practitioners to be registered are those who provide Chinese medical diagnosis, dispense Chinese herbs and perform acupuncture. All three components of this practice have serious flaws, being based on non-existent energies (Yin and Yang), non-existent bodily structures (meridiens) and on principles of disease diagnosis based on the imbalance of five non-existent elements. It is therefore doubtful whether such practitioners are able to make correct and safe diagnoses.
Proponents of traditional medical practices often point out that extracts from animals and plants have been the source of effective remedies in modern medicine. And while pharmacology and medicinal chemistry have enabled this revolution since mid-1800s, only a handful of the extracts used in traditional healing have been proven to contain active principles beneficial for fighting disease. These include about 120 chemical substances out of the thousands of herbal remedies used in traditional medicines.
Take, for instance, qing hao su, a herb used in China for treating fever for over 2,000 years. About 40 years ago, scientific research found that it had specific anti-malarial activity and its active compound, artemesin, was isolated.
In fact, it’s fortunate that most herbal remedies have little acute toxicity. This is due to empirical experience, which over time has selected out those proven to be overtly toxic. But the more subtle, chronic toxicity of herbal remedies remains a serious concern.
Only 6% of plants species have been screened chemically and pharmacologically to identify their active principles. This process, started by modern medicine just over 150 years ago, is continuing with investigations of potential benefits of new therapies often based on a long history of empirical evidence.
This is why research on active chemical principles in herbal remedies showing some potential beneficial effect is fully supported by the Friends of Science in Medicine (FSM), of which I am a founding member.
FSM represents a growing number of medical researchers, clinicians and members of the public concerned by the “current trend which sees government-funded tertiary institutions offering courses in the health care sciences that are not underpinned by sound scientific evidence”. We are worried that this gives unwarranted credibility given to their practitioners and practices, including traditional Chinese medicine.
Even though it falls within traditional Chinese medicine, acupuncture requires separate consideration because, despite being based on a flawed theory of non-existent “meridiens”, it has shown promising effectiveness in some ailments.
But it’s important to remember that despite its popularity, acupuncture has only proven beneficial in alleviating some symptoms of pain and nausea. And the mechanisms by which it appears to work are similar to the physiological processes in the nervous system underlying the placebo effects on pain. Ultimately, research on acupuncture has enabled it to become incorporated in medicine in the few conditions for which it has proven to be effective.
My view, shared by many, is that there’s only one medicine and adjectives such as traditional and “Western” are irrelevant. Rather, medicine is about efficacy and safety, proven through scientific research.
Living in a modern society requires that in matters of health, we unapologetically only accept practices that have undergone the scrutiny of science. And once that criteria is fulfilled, we can accept it as effective medical treatment and teach it in our universities.
Sadly, this is not the case for most traditional Chinese medical practices and practitioners.
Quality research of herbal medicines is possible
TESTING ALTERNATIVE THERAPIES – La Trobe University’s decision to accept funding from Swisse for a new centre to research alternative medicines has sparked controversy. This series looks at how the evidence behind alternative medicines can be assessed, and the ethics of such links between industry and research institutions.
Many complementary medicines, such as simple vitamins and mineral supplements, lend themselves readily to research. But others present challenges for rigorous scientific tests reflecting, for example, the complexity of herbal mixtures.
Still, even this research is feasible and can inform effective and safe treatment. And these treatments can provide additional options for the long-term treatment of multi-symptom, chronic diseases at comparatively low cost to the health-care system.
Testing herbal medicines
New drugs are rigorously tested prior to market for both their curative potential and their capacity to cause serious harm or side effects.
It takes some 10 to 15 years, and many millions of dollars to take a modern pharmaceutical on the long journey from bench to bedside – even though most drugs have a single “active” chemical compound, able to be isolated and used at concentrations that are relatively easily traced within the body.
Herbal mixtures, on the other hand, are comprised of many potentially active chemical compounds at relatively low concentrations. These complex formulations are enormously difficult to identify and understand in terms of minimum quality control requirements, dosage strength and form, and their complex mechanisms of action.
To test whether a complementary medicine actually has medicinal benefit, you need to know two things – what’s in it (chemical composition, stability, and consistency across manufacturing batches) and how well it works in the human body (efficacy and safety in addressing a particular disease, as well as mechanisms of action).
Detailed chemical analysis of herbal medicines is now possible with mass spectrometry and nuclear magnetic resonance techniques. Complex chemical mixtures can be fully profiled, compounds identified and accurately quantified, and tracked over time to ensure chemical stability of the product.
Mechanisms of the actions of herbal medicines are readily determined through conventional scientific laboratory approaches including lab tests and small animal studies.
How well their components are absorbed and metabolised by the body is also studied and the results contribute to dosage, safety and herb-drug interaction data. This sort of research data are used similarly for conventional drug development.
Appropriate clinical trials
The other challenge for testing herbal medicine lies in designing effective clinical trials.
Herbal medicine practitioners often differentiate between individual patients with the same medical diagnosis to the extent of prescribing different treatments, so interventions are as personalised and targeted to the patient as possible.
But clinical trials offer little flexibility in tailoring treatments or indeed modifying treatment over time to suit a patient’s changing presentation.
Everyone in conventional clinical trials usually receives the same treatment and are then more easily compared with a standard or placebo (dummy) treatment. But a trial that aims to test the theoretical capability of a herbal medicine to distinguish between people with the same disease needs to incorporate these differences in its design.
While many clinical trials of complementary medicines have standardised treatment throughout the study, others have ventured to test individualised therapies.
We now know that it’s possible to accommodate tailored treatment while ensuring patients and practitioners don’t know whether they’re receiving or giving the real medicine or a placebo.
This is not a new problem.
Designing rigorous clinical trials that test treatments tailored to individual patients presents similar challenges in physiotherapy, nursing and other disciplines that involve a high degree of interaction between clinician and patient. And it’s just as difficult to design a believable placebo treatment to be used for patients receiving personalised physiotherapy!
Despite the significant challenges presented by herbal medicine research, we must continue doing rigorous scientific studies in recognition of high levels of their use, the need for better guidance, and the opportunity to impact the growing chronic disease burden.
Read the opposite viewpoint:
This is the third article in our series about complementary and alternative therapies. Click on the links below to read the others:
- Here’s why we should research alternative therapies
- Herbal medicines – toxic side effects and drug interactions
Why you shouldn’t be popping herbal medicines before you go for surgery
Herbal therapies, taken for medicinal and health reasons, are becoming increasingly popular and are often regarded as innately safe. But their interaction with other medicines is less well known – and could be dangerous.
One fifth of patients on prescription medication also use herbal remedies, high dose dietary supplements or both, according to the South African Journal of Anaesthesia and Analgesia. When herbal medicines sold by traditional healers are included, that figure shoots up to 80%.
Herbal therapies are plant-derived products. They have been part of human existence since the beginning of time and span the spectrum from home-brewed teas prepared from collected leaves and herbs to products with official approved status granted by drug-regulating authorities.
The danger of herbal medicines lies in the widespread perception that because they are “natural”, they are safe. This perception is ill informed. The manufacture of herbal medicine is poorly regulated in South Africa. This means the true content of different preparations vary greatly between manufacturers. Some tend to under-report or omit the side effects of their therapies and overemphasise the positive effects.
How it can be bad for you
How herbal medicines and conventional drugs interact is not fully understood. For patients who fail to disclose using herbal medicines before they go into surgery, the side effects can be dire. Among the most dangerous adverse effects are increased bleeding and resultant blood loss throughout the surgery.
Research from the New England Journal of Medicine shows that 70% of patients don’t tell the doctors and physicians treating them that they are using any of these drugs.
A survey looking at the increased surgical risk from herbal products found up to 51% of surgical patients used herbal medicine in the two weeks before a procedure. Of the drugs patients used, 27% altered clotting, 30% had a direct influence on heart rhythm, rate and blood pressure and 20% increased sedation.
These are the three most high risk problems during operations and could result in complications – or even death.
Numerous research publications have shown that these could have serious implications if they are used with other medication.
For instance, when used in clinically effective doses, garlic’s interaction with oral contraceptives may result in contraceptive failure. Ginger can cause decreased blood pressure, exaggerating the effects of blood pressure medication and interfering with blood pressure therapy.
And although wounds are often treated with kava, its side effects include anxiety, insomnia, restlessness, muscle pain and headaches, drowsiness and depression of motor reflexes. This may be the result of kava interacting with the central nervous system depressants such as sedatives and tranquilisers or alcohol.
When evening primrose oil interacts with anaesthetics, it could increase the risk of seizures during or after an operation. And when ginger, evening primrose oil or gingko interact with medicine to prevent the blood from clotting these interactions could increase the risk of bleeding.
At the South African Society of Anaesthesiologists, we have anecdotal evidence of patients not disclosing their use of herbal medicines such as omega oils, arnica tablets, evening primrose oil and St. John’s wort. In most instances it meant the physicians had to return to theatre because their patients’ excessive bleeding.
The science behind it
Some physicians may not be familiar with all the clinical effects of the herbal medication or the action of a specific herb and would therefore underestimate the risk it poses to their patient.
The bioactive components contained in a single herb may contribute, in varying degrees, to the observed effect and interaction, leading to difficulties in predicting and explaining herb-drug interactions.
Other herbal medicines compete for the same cytochrome pathway as anaesthetic agents commonly used, which may slow down the clearance of the anaesthetic drug administered, predisposing patients to toxic effect as a result of higher plasma concentration. The net effect of such interactions is pharmacological chaos and unexpected drug toxicity.
Most medical authorities agree that the use of herbal supplements and medicines should be stopped at least two weeks before surgery.
Perhaps you, like many others, take herbal medicines because you believe it’s the smart thing to do. In some cases it may well be so. But to tell your healthcare practitioner that you use such therapies, especially in run-up to and after a surgical procedure, may be one of the smartest things you ever do.
Herbal medicine shows potential to treat cancer
Image caption and credit: PhD student Dina Hajjar has been examining anticancer properties of plants used in traditional medicine in Saudi Arabia. Credit: KAUST
Researchers from KAUST have been searching locally for plants that have potential for use to combat cancer. Now, three plants used for traditional medicine in Saudi Arabia are shown to be worthy of further investigation for anticancer properties.
Cancer is a leading cause of illness and death worldwide. In 2015, the World Health Organization (WHO) recorded 8.8 million cancer-related deaths, but almost twice as many cases are diagnosed each year. And the WHO predict that the number of cancer diagnoses is likely to continue to increase by about 70% for at least the next two decades due to growing longevity.
Seeking to expand the armory of cancer treatments—especially ones that are simple and inexpensive to manufacture—a team led by Timothy Ravasi and Christian Voolstra from KAUST has investigated the biological potential (bioactivity) of a range of plants used locally in traditional medicine.
Use of herbal medicines is common in Saudi Arabia, explains Ravasi’s PhD student, Dina Hajjar. “However, there are almost no scientific studies,” says Hajjar. “Saudi people tend to use information inherited from their families to decide about these plants without validated knowledge of their biological or chemical activity.”
The team initially investigated 52 plants before they homed in on three plants that showed promise—Juniperus phoenicea (known in herbal medicine as Arar or Phoenican juniper), Anastatica hierochuntica (known as Kaff Maryam or the Jericho rose) and Citrullus colocynthis (known as Hanzal or bitter cucumber).
The team used cell-based phenotypic profiling via imaging-based high-content screening to assess anticancer activity. This approach followed a technique developed in 2016 by Stephan Kremb and Christian Voolstra that uses a comprehensive marker panel with standardized settings—an efficient process that could potentially be easily adopted by other laboratories. This meant the team compared the cytological profiles of fractions taken from the plants with a set of reference compounds with established mechanisms of action.
This enabled the team to show, for the first time, that these three plants contain potent anticancer substances—topoisomerase inhibitors, which are compounds that can block the topoisomerase enzymes that control changes in DNA—that could be used to develop novel anticancer inhibitors.
There are many steps, however, before these compounds are properly tested and available for clinical treatments for cancer. “The active compounds identified in the study will need to be evaluated and better characterized,” says Hajjer. “Also, active compounds need to be synthesized and tested in vivo.”
This study proves the power of using imaging-based high-content screening in revealing information about the bioactivity of unknown natural resources. Hajjar adds that it also highlights the opportunity for more exciting discoveries amongst the natural resources of Saudi Arabia.
Made in Hong Kong: the story of Po Chai Pills, ‘cure all’ medicine Chinese families have relied on for over 60 years
The tiny pills that reputedly remedy everything from stomach pains to menstrual cramps have long been a staple of local medicine cabinets. Now the company is looking to attract younger consumers to keep the legacy going
When Derek Sum Kwong-yip was a child, his family always had Po Chai Pills on hand. “Every time I complained about tummy pain, my mother would hand me a bottle,” he says.
Curing more than just stomach pains, the pills were reputed to relieve menstrual cramps and even cold symptoms, living up to the meaning of their name: “cure-all pills”.
Little did Sum know that, decades later, he would end up owning the company that makes the venerable Chinese medicine.
Sum is a pharmacist, trained in the Welsh city of Cardiff, and also the CEO of Jacobson Pharma, a company that makes dozens of generic drugs for Hong Kong hospitals. In 2010, Jacobson bought Li Chung Shing Tong, the manufacturer of Po Chai Pills and other herbal remedies.
Even if you have never popped a bottle of the tiny, buckshot-shaped herbal pills, you have almost certainly seen their colourful vintage packages on chemists’ shelves. The pills were developed in 1896 by entrepreneur Li Shiu-kei in the city of Foshan in Guangdong province and were manufactured there until 1949, when the Li family fled to Hong Kong following the communist revolution.
The Foshan factory was subsequently nationalised, so the family opened a new facility in North Point. By then, Po Chai Pills were already a household name in Hong Kong – and their popularity only grew with a series of animated television commercials in the 1970s and ’80s.
By the time Jacobson acquired Po Chai Pills from the Li family, a survey showed that 97 per cent of consumers in Hong Kong were familiar with the brand, along with 96 per cent of consumers in Singapore and 89 per cent in Macau.
“It has become a household name that passes from one generation to the next,” Sum says. “It comes with a high level of trust and confidence among end users. There is a lot of value in this brand waiting to be unlocked.”
Despite their enviable position in the market, Po Chai Pills have had their ups and downs. In 2010, internal company tests revealed some pills were contaminated with chemicals that can raise blood pressure and cause cancer. The products were recalled, but Li Chung Shing Tong failed to tell the Department of Health, which led to sales of the pills being temporarily banned.
The episode made it clear that the company needed to be more stringent. “We have upgraded the standard of manufacturing as well as the stringency of quality control,” Sum says. “We needed to put in quite a lot of resources to make it happen.”
In 2015, the company shifted production to a new factory in Tai Po. Most of its 70 workers live near the old factory in North Point, so a shuttle service runs between the two neighbourhoods. “Every single box of Po Chai Pills all over the world comes from this factory,” says Kevin Chu, the general manager of Li Chung Shing Tong. The production line operates eight hours a day, five days a week, producing 10 million boxes of pills a year.
Like Sum, Chu is a pharmacist, and his family usually had a box of Po Chai Pills on hand for stomach troubles. After graduating from the Chinese University of Hong Kong pharmacy programme in the 1990s, he began working in local hospitals, but became unsatisfied with the approach to health issues. “I knew how Western medicine works and I knew its limitations,” he says. “It doesn’t offer a cure for diseases, it offers alleviation. I thought, ‘What should medicine do?’”
Chu decided to return to school, this time to study traditional Chinese medicine (TCM), which is known for a more holistic approach to health problems. “It was a strange move at the time,” he says. Though it has been practised for thousands of years, TCM has only recently received interest from the global scientific community. “One of my aspirations was to modernise it,” Chu says. “Western medicine has to go through rigorous research and control measures, and that was lacking in Chinese medicine at the time.”
After years of research, Chu developed a drug, Oncozac, from Chinese medicinal mushrooms that strengthens the immune system and can relieve side effects caused by cancer treatment. That caught the attention of Sum, who hired Chu to revamp Po Chai Pills’ manufacturing process.
It was not easy at first. “The production staff here are so proud of what they are doing,” Chu says. “But they were so proud they didn’t want to change.”
The sleek new factory helped convince them. It includes a laboratory where each of the pills’ 14 herbal ingredients are tested to quantify their active ingredients. It is a lot to squeeze into the pills’ small size, each measuring just four millimeters in diameter. “They dissolve in your stomach in less than 15 minutes,” Chu says. “Chinese medicine normally works slowly, but Po Chai Pills work very quickly.”
The manufacturing area looks as clean as you would expect from any pharmaceutical company. In a changing room, Chu covers his shoes in sterile bootees, dons a hairnet and fits a surgical mask around his face. He then walks into a room where a stainless steel machine is grinding herbs into a fine powder.
Chu cannot reveal exactly which herbs make their way into Po Chai Pills. He does say, though, that the company has been working with the same farmers on the mainland for 20 years, and none of the ingredients are particularly rare, which makes the pills affordable. Old packages of Po Chai Pills from the 1970s list a variety of ingredients common in Chinese medicine, including angelica, chrysanthemum and rose.
After the herbs are ground together, the mixture is soaked with water, which acts as a binding agent, and passed through a machine that looks like a meat grinder. Then it is extruded into long thin strands. “It’s just like making spaghetti,” Chu jokes. The strands are chopped into pills, put into a tumbler to round off rough edges, and then dried in ovens that are hot enough to kill bacteria but not so hot that it affects the active ingredients.
Next, the pills are coated in red food colouring to give them their distinctive ruddy sheen. This is one of the few ingredients that have been altered over the years, because the pills were previously coloured with cinnabar, which contains mercury. Today, each batch of Po Chai Pills is tested for microbial contamination, heavy metals and plasticised residue. “We test everything and we test all the time,” Chu says.
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Traditional ingredients, modern process – that sums up how Po Chai Pills are now made. It also reflects the way they are marketed. Though they are packaged with custom-made machines from Germany and Italy, each box of pills looks the same as it has for decades, with an intricate crest bearing the portrait of Li Shiu-kei and a 1960s-era photo of Hong Kong. “The heritage and credibility are so important,” Chu says. “What changes is how we interact with the public.”
In recent years, the company has worked with pop starlet Angela Yuen Lai-lam – whose surname is a homonym for “pill” – to produce a series of Facebook ads targeting consumers in their 20s. In one video, Yuen spends the night singing karaoke before stumbling into bed drunk, at which point she is offered a glass of water and a bottle of Po Chai Pills, which are reputed to ease the pain of the morning after.
The new ad campaign is just part of a bigger strategy to expand the pills’ reach. Although they have long been popular among the Chinese diaspora (“People say if there are Chinese people, there are Po Chai Pills,” Chu says), the product is less well known in mainland China,where a similar brand made by the Li family’s nationalised factory dominates the market.
The product line will also be expanded, with a new range of Po Chai Pills spin-offs – all related to gastrointestinal problems – planned for release next year.
So far, Jacobson’s strategy for Po Chai Pills seems to be working. Local sales of the product increased 22 per cent in the 2016-17 financial year, with HK$74 million of the pills were sold.
Chu says the company will continue making its products in Hong Kong. “When I joined in 2010, I felt the culture here – there’s a special bond between the public and this brand,” he says. “I think Hong Kong-made products give people a sense of belonging.