‘Red ginseng’ is an herbal medicine prepared by steaming raw ginseng. This process is believed to increase its pharmacological activity. Further conversion through fermentation is thought to increase its intestinal absorption and bioactivity to diminish its toxicity.
Red ginseng (RG) is traditionally used for diabetes. Our own systematic review of 4 RCTs concluded that the evidence for the effectiveness of RG in controlling glucose in type 2 diabetes is not convincing. Few included studies with various treatment regimens prohibit definitive conclusions. More rigorous studies are needed to clarify the effects of RG on this condition.
Now a new RCT has become available. This study was conducted to investigate the effects of daily supplementation with fermented red ginseng (FRG) on blood sugar levels in subjects with impaired fasting glucose or type 2 diabetes. It was a four-week long, randomized, double-blind, placebo-controlled trial. Forty-two subjects with impaired fasting glucose or type 2 diabetes were randomly allocated to two groups assigned to consume either placebo or FRG three times per day for 4 weeks. Fasting and postprandial glucose profiles during meal tolerance tests were assessed before and after the intervention.
Compared to the placebo, FRG supplementation led to a significant reduction in postprandial glucose levels and to an increase in postprandial insulin levels. There also was a significant improvement in the area under the curve (AUC) in the FRG group. However, fasting glucose, insulin, and lipid profiles did not differ from the placebo group.
The authors of this trial concluded that daily supplementation with FRG lowered postprandial glucose levels in subjects with impaired fasting glucose or type 2 diabetes.
What should we make of these findings? Do they indicate that FRG might be an alternative to conventional anti-diabetic drugs? I would caution that we have tons of data for the latter, while we know far too little about FRG to recommend it for routine use.
On the contrary, the findings could suggest that diabetic patients who are well-controlled with diet or anti-diabetic medication should be avoiding ginseng products. If they actually work, they might significantly interfere with their metabolic control which, in turn, could even endanger their lives.
On this blog, I have repeatedly stressed that there is reasonably good evidence to show that some herbal medicines are effective. The one that is probably supported with better evidence than any other is St. John’s wort (SJW). The first systematic review of SJW was published in 1995 and concluded that SJW is an effective symptomatic treatment for various forms of depressions. Meanwhile, many more trials have become available, and the current Cochrane review concludes that the available evidence suggests that the hypericum extracts tested in the included trials a) are superior to placebo in patients with major depression; b) are similarly effective as standard antidepressants; c) and have fewer side effects than standard antidepressants.
This must be good news for many patients; particularly the fact that SJW is much safer than synthetic antidepressants seems attractive. But don’t be fooled – SJW may still cause harm. If taken on its own, it is almost as safe as placebo, but when it is combined with other drugs, it can powerfully interact and significantly lower the plasma level of a wide range of prescription medicines.
Some proponents of alternative medicine have suggested that this caution is alar@BocktheRobber mist, and they insist that, actually, the danger is minimal. Are they correct? We need data, I think, not opinion.
A new article provides new insights.
The objective of this study was to assess how often SJW is prescribed with medications that may interact dangerously with it. The researchers conducted a retrospective analysis of nationally representative data from the National Ambulatory Medical Care Survey. The study setting was U.S. non-federal outpatient physician offices. Patients who were prescribed SJW between 1993 and 2010 were the subjects. The outcome measures were medications co-prescribed with SJW.
Twenty-eight percent of SJW visits involved a drug that has potentially dangerous interaction with SJW. These included selective serotonin reuptake inhibitors, benzodiazepines, warfarin, statins, verapamil, digoxin, and oral contraceptives.
The authors concluded that SJW is frequently used in potentially dangerous combinations. Physicians should be aware of these common interactions and warn patients appropriately.
There is little to add – perhaps just this: the awareness of physicians is undoubtedly desirable, but it is not enough; as SJW and other herbal medicines are usually self-prescribed, consumers’ awareness of the risks associated with herbal medicines is at least as important, I think.
‘THE HINKLEY TIMES’ is not a paper that I read often, I have to admit – but maybe I should! It was there that I found the following remarkable article:
Bosworth MP David Tredinnick has asked questions in the House of Commons about the growing problem of antibiotic resistance within hospitals, suggesting herbal remedies could be answer.
The Tory MP, who has a keen interest in alternative medicine particularly herbal curatives, asked Jeremy Hunt, Secretary of State for Health, whether the problem was being discussed at the very top level.
He said: “Does my right honourable friend agree that a critical problem that A and E units will face in the future is antibiotic resistance? Is he aware that the science and technology committee, of which I am a member, has been looking at this issue and it also interests the health committee, of which I am also a member? Can he assure me that he is talking to the Prime Minister about how to stimulate new antibiotic research, and will he also remember that nature has its own remedies, such as tea tree oil?”
In reply Mr Hunt said: “My honourable friend is right about the seriousness of the issue of antimicrobial resistance. Some 25,000 people die in Europe every year as a result of the failure of antibiotics – more than die in road traffic accidents. I raised the issue at the World Health Assembly and I have discussed it closely with the Prime Minister.”
David Tredinnick is no stranger to strange ideas. Wikipedia (yes I know, many people do not like it as a source) sums it up quite succinctly:
He is a supporter of complementary and alternative medicine (CAM). He has made supportive comments in Parliament on homeopathy, despite continued lack of evidence of its effectiveness. He has supported chiropractic and mentioned the influence of the Moon on blood clotting. In this same debate he characterised scientists as “racially prejudiced”. He has tabled several early day motions in support of homeopathy’s continued funding on the National Health Service.Tredinnick’s views continue to cause amused disbelief in some quarters and a spokesman for the Royal College of Surgeons of England said they would “laugh their heads off” at the suggestion they could not operate at the full moon.
At the 2010 general election, in addition to candidates from the two main parties, Tredinnick was opposed by New Scientist journalist Dr. Michael Brooks who objected to “Tredinnick’s outspoken promotion of complementary and alternative medicine.”During a hustings debate called by Brooks to “highlight the scientific literacy of the UK’s elected representatives” Brooks claimed that Tredinnick regarded homeopathy as a suitable treatment for Malaria and HIV, which Tredinnick did not deny. Tredinnick in turn argued that “alternative treatments are incredibly good value for money” and stated his belief that randomised controlled trials are not effective at evaluating very dilute preparations.
In March 2013 Tredinnick was ridiculed as “nonsensical” by the government’s outgoing chief scientist, Sir John Beddington, who said the MP had fallen for the “Galileo fallacy” (Galileo was laughed at but was right, therefore since I am laughed at I must be right).
In July 2013 Tredinnick sponsored an EDM congratulating a farmer on his decision to use homeopathy with what were claimed to be positive results.The motion was supported by one other MP but the British veterinary association says there is no evidence of any benefit.
Tredinnick is a supporter of astrology especially the use of it in medical practice.In November 2009, he spoke at a meeting organised by the Astrological Association of Great Britain, where he related his personal experience of astrology and illness, advocating that astrology be integrated into the NHS.
Tredinnick’s appointment to the Health committee in June 2010 was criticised in two science reports in the Guardian. Martin Robbins said his appointment was “an extremely disturbing development” even though “Tredinnick is a figure unlikely to be taken seriously by policymakers” whilst Nature‘s Adam Rutherford described Tredinnick as “misinformed about a great many things” and said that “giving [him] influence on medical policy ..is a bad move.”The Telegraph writer Ian Douglas also described it as “a problem.”
His appointment to the Science and technology committee also drew criticism. Andy McSmith in the Independent, cited his views that homeopathy could cure HIV, TB, malaria, urinary infections, diarrhoea, skin eruptions, diabetes, epilepsy, eye infections, intestinal parasites, cancer, and gangrene amongst others and quoted Imran Khan, head of the Campaign for Science and Engineering, as saying that “someone with such incredibly odd views is not helpful”. Tom Whipple in the Times said his appointment caused despair,whilst Elizabeth Gibney in the Times Higher Education quoted the Skeptical Voter website as saying that Tredinnick is “perhaps the worst example of scientific illiteracy in government”…
In 2009 Tredinnick attempted to claim the £125 cost of attending a course on “intimate relationships” through his Parliamentary expenses. He was also found to have used expenses to purchase astrology software, claiming it was for a debate on alternative medicine.
Compared to some of theses bizarre activities, the notion that herbal remedies might provide the solution for antibiotic resistance seems almost reasonable and clever.
Tredinnick does not seem to know that:
- many antibiotics originate from plants or other natural substances,
- several large pharmaceutical companies are feverishly looking for more such substances from plants,
- most plants do actually contain substances which have antibiotic activity,
- however, most cannot be used as medicines, for instance, because they are far too toxic (tea tree oil is a good example for this),
- once a pure compound has been isolated from a plant and is used therapeutically, it ceases to be herbal medicine (which is defined as the use of full plant extracts),
- it is thus unlikely that full plant extracts, i. e. herbal medicine, will ever provide a solution to antibiotic resistance.
I have little doubt that Tredinnick will continue to mislead parliament and the public with his nonsensical views about alternative medicine. And even if it might have no effect whatsoever, I will continue to point out just how nonsensical they are.
Guest post by Michelle Dunbar
According to the CDC, more than 30,000 people died as a result of a drug overdose in 2010. Of those deaths none were attributed to marijuana. Instead the vast majority were linked to drugs that are legally prescribed such as opiates, anti-depressants, anti-psychotics, tranquilizers and benzodiazepines. As misuse and abuse of prescription medications continues to rise, the marijuana legalization debate is also heating up.
Nearly 100 years of propaganda, fear mongering and blatant misinformation regarding marijuana has taken its toll on our society. As the veil of lies surrounding marijuana is being lifted, more and more people are pushing for legalization. Marijuana is now legal for both medicinal and recreational use in two states and other states are introducing legislation of their own. Marijuana is approved for medicinal use with a prescription in 21 states and also Washington, D.C. with most other states expected to introduce legislation to approve use for medicinal purposes in the next few years.
Last year Dr. Sanjay Gupta, the medical correspondent for CNN, aired a controversial documentary, “Weed”, where he showed various promising medicinal uses for marijuana. He admits that he was wrong for many years about marijuana legalization, and after doing his own extensive research he is encouraged by the many real life cases he has seen where people with chronic, serious medical issues have been and continue to be helped by marijuana. He noted that marijuana does not have the dangerous side effects that many prescription medications do and that it is actually safer than many drugs being prescribed today. Dr. Gupta said in the program that there is not one documented case where death was due to marijuana overdose and he is right.
But as with any systematic paradigm shift, there will always be those whose minds are closed to change. So as the march toward legalization continues, there is new anti-legalization propaganda being written and spread through mainstream and social media. There have been multiple reports out of Colorado that there are now deaths attributed to marijuana overdose. Some say children were involved which automatically evokes feelings of fear in parents across the country. But when I tried to find more reliable sources to verify these articles, none existed. The AP reported on April 2 that a Wyoming college student jumped to his death in Colorado after eating a marijuana cookie while on Spring Break in Colorado. The autopsy listed marijuana intoxication as a “significant contributing factor” in the teen’s death. (Gurman)
Like alcohol, Colorado bans the sale of marijuana and marijuana edibles to people under the age of 21. But much like alcohol, teens that want to get it will always find a way. This young man was just 19, and his death has been ruled accidental. While it is true his death is tragic, is it a reason to reverse the course with marijuana? If you believe this is the case then you must consider the real dangers posed by alcohol. Many people who would like to see marijuana legalized say that it is much safer than the legal drug alcohol. Based solely on the numbers of hospitalizations and deaths, especially with young people, they would be right.
According to an article posted on Forbes.com in March of this year, “1,825 college students between the ages of 18 and 24 die each school year from alcohol-related unintentional injuries.” The author, Dr. Robert Glatter, MD attributes these deaths to one of the leading health risks facing our young people, and that is binge drinking. This number is quite small in comparison to emergency room visits and hospitalizations of young people that are a direct result of alcohol use.
Taking the most heat are the marijuana edibles that are now for sale in states where marijuana has become legal. The concern is that children are eating marijuana laced candy and baked goods and becoming ill. This would seem to be confirmed by an article in USA Today that reported that calls to the Rocky Mountain Poison Control is Colorado regarding marijuana ingestion in children had risen to 70 cases last year. While they admitted that this number was low, it was the rapid rise from years previous that caused concern. To put this in perspective, there are approximately 1.4 million pediatric poisonings each year involving prescription medications not including marijuana. (Henry, et.al) That is an average of approximately 28,000 calls per state. Tragically several hundreds of these cases result in deaths of these children, with the highest rates of death involving narcotics, sedatives and anti-depressants. (Henry, et.al.)
Of those 70 cases reported in Colorado involving marijuana, none resulted in death. The results are quite clear marijuana is as safe as prescription drugs are dangerous. For those who want to weigh in on the marijuana legalization debate, it is important to do your research, look at the big picture and put everything in perspective. Alcohol is legal and heavily regulated, yet its use is linked to thousands of deaths each year. Prescription drugs are legal and heavily regulated, yet they too are linked to thousands of deaths each year. Marijuana, on the other hand, is not legal and not available in much of the country, and thus far has not caused one death from overdose ever.
Additionally, research is showing marijuana has promise in treating many diseases more effectively and safely than dangerous prescription medications being used today. From cancer to epilepsy to depression and anxiety, to chronic autoimmune diseases, scientists are just scratching the surface when it comes to the potential life-changing and perhaps even, life-saving uses for marijuana.
Drug Overdose in the United States: Fact Sheet. (2014, February 10). Centers for Disease Control and Prevention. Retrieved May 4, 2014, from http://www.cdc.gov/homeandrecreationalsafety/overdose/facts.html
Glatter, R. (2014, March 11). Spring Break’s Greatest Danger. Forbes. Retrieved May 5, 2014, from http://www.forbes.com/sites/robertglatter/2014/03/11/spring-breaks-greatest-danger/
Gurman, S. (2014, April 2). Young man leaps to death after eating pot-laced cookie. USA Today. Retrieved May 5, 2014, from http://www.usatoday.com/story/news/nation/2014/04/02/marijuana-pot-edible-death-colorado-denver/7220685/
Henry, K., & Harris, C. R. (2006). Deadly Ingestions. Pediatric Clinics of North America, 53(2), 293-315.
Hughes, T. (2014, April 2). Colo. Kids getting into parents’ pot-laced goodies. USA Today. Retrieved May 5, 2014 from http://www.usatoday.com/story/news/nation/2014/04/02/marijuana-pot-edibles-colorado/7154651/
The news that the use of Traditional Chinese Medicine (TCM) positively affects cancer survival might come as a surprise to many readers of this blog; but this is exactly what recent research has suggested. As it was published in one of the leading cancer journals, we should be able to trust the findings – or shouldn’t we?
The authors of this new study used the Taiwan National Health Insurance Research Database to conduct a retrospective population-based cohort study of patients with advanced breast cancer between 2001 and 2010. The patients were separated into TCM users and non-users, and the association between the use of TCM and patient survival was determined.
A total of 729 patients with advanced breast cancer receiving taxanes were included. Their mean age was 52.0 years; 115 patients were TCM users (15.8%) and 614 patients were TCM non-users. The mean follow-up was 2.8 years, with 277 deaths reported to occur during the 10-year period. Multivariate analysis demonstrated that, compared with non-users, the use of TCM was associated with a significantly decreased risk of all-cause mortality (adjusted hazards ratio [HR], 0.55 [95% confidence interval, 0.33-0.90] for TCM use of 30-180 days; adjusted HR, 0.46 [95% confidence interval, 0.27-0.78] for TCM use of > 180 days). Among the frequently used TCMs, those found to be most effective (lowest HRs) in reducing mortality were Bai Hua She She Cao, Ban Zhi Lian, and Huang Qi.
The authors of this paper are initially quite cautious and use adequate terminology when they write that TCM-use was associated with increased survival. But then they seem to get carried away by their enthusiasm and even name the TCM drugs which they thought were most effective in prolonging cancer survival. It is obvious that such causal extrapolations are well out of line with the evidence they produced (oh, how I wished that journal editors would finally wake up to such misleading language!) .
Of course, it is possible that some TCM drugs are effective cancer cures – but the data presented here certainly do NOT demonstrate anything like such an effect. And before such a far-reaching claim is being made, much more and much better research would be necessary.
The thing is, there are many alternative and plausible explanations for the observed phenomenon. For instance, it is conceivable that users and non-users of TCM in this study differed in many ways other than their medication, e.g. severity of cancer, adherence to conventional therapies, life-style, etc. And even if the researchers have used clever statistical methods to control for some of these variables, residual confounding can never be ruled out in such case-control studies.
Correlation is not causation, they say. Neglect of this elementary axiom makes for very poor science – in fact, it produces dangerous pseudoscience which could, like in the present case, lead a cancer patient straight up the garden path towards a premature death.
The aim of this survey was to investigate the use of alternative medicines (AMs) by Scottish healthcare professionals involved in the care of pregnant women, and to identify predictors of usage.
135 professionals (midwives, obstetricians, anaesthetists) involved in the care of pregnant women filled a questionnaire. A response rate of 87% was achieved. A third of respondents (32.5%) had recommended (prescribed, referred, or advised) the use of AMs to pregnant women. The most frequently recommended AMs modalities were: vitamins and minerals (excluding folic acid) (55%); massage (53%); homeopathy (50%); acupuncture (32%); yoga (32%); reflexology (26%); aromatherapy (24%); and herbal medicine (21%). Univariate analysis identified that those who recommended AMs were significantly more likely to be midwives who had been in post for more than 5 years, had received training in AMs, were interested in AMs, and were themselves users of AMs. However, the only variable retained in bivariate logistic regression was ‘personal use of AM’ (odds ratio of 8.2).
The authors draw the following conclusion: Despite the lack of safety or efficacy data, a wide variety of AM therapies are recommended to pregnant women by approximately a third of healthcare professionals, with those recommending the use of AMs being eight times more likely to be personal AM users.
There are virtually thousands of websites which recommend unproven treatments to pregnant women. This one may stand for the rest:
Chamomile, lemon balm, peppermint, and raspberry leaf are also effective in treating morning sickness. Other helpful herbs for pregnancy discomforts include:
- dandelion leaf for water retention
- lavender, mint, and slippery elm for heartburn
- butcher’s broom, hawthorn, and yarrow, applied externally to varicose veins
- garlic for high blood pressure
- witch hazel, applied externally to haemorrhoids.
Our research has shown that midwives are particularly keen to recommend and often sell AMs to their patients. In fact, it would be difficult to find a midwife in the UK or elsewhere who is not involved in this sort of thing. Similarly, we have demonstrated that the advice given by herbalists is frequently not based on evidence and prone to harm the unborn child, the mother or both. Finally, we have pointed out that many of the AMs in question are by no means free of risks.
The most serious risk, I think, is that advice to use AM for health problems during pregnancy might delay adequate care for potentially serious conditions. For instance, the site quoted above advocates garlic for a pregnant women who develops high blood pressure during pregnancy and dandelion for water retention. These two abnormalities happen to be early signs that a pregnant women might be starting to develop eclampsia. Treating such serious conditions with a few unproven herbal remedies is dangerous and recommendations to do so are irresponsible.
I think the new survey discussed above suggests a worrying degree of sympathy amongst conventional healthcare professionals for unproven treatments. This is likely to render healthcare less effective and less safe and is not in the interest of patients.
Cancer patients are bombarded with information about supplements which allegedly are effective for their condition. I estimate that 99.99% of this information is unreliable and much of it is outright dangerous. So, there is an urgent need for trustworthy, objective information. But which source can we trust?
The authors of a recent article in ‘INTEGRATIVE CANCER THARAPIES’ (the first journal to spearhead and focus on a new and growing movement in cancer treatment. The journal emphasizes scientific understanding of alternative medicine and traditional medicine therapies, and their responsible integration with conventional health care. Integrative care includes therapeutic interventions in diet, lifestyle, exercise, stress care, and nutritional supplements, as well as experimental vaccines, chrono-chemotherapy, and other advanced treatments) review the issue of dietary supplements in the treatment of cancer patients. They claim that the optimal approach is to discuss both the facts and the uncertainty with the patient, in order to reach a mutually informed decision. This sounds promising, and we might thus trust them to deliver something reliable.
In order to enable doctors and other health care professionals to have such discussion, the authors then report on the work of the ‘Clinical Practice Committee’ of ‘The Society of Integrative Oncology’. This panel undertook the challenge of providing basic information to physicians who wish to discuss these issues with their patients. A list of supplements that have the best suggestions of benefit was constructed by “leading researchers and clinicians“ who have experience in using these supplements:
- vitamin D,
- maitake mushrooms,
- fish oil,
- green tea,
- milk thistle,
The authors claim that their review includes basic information on each supplement, such as evidence on effectiveness and clinical trials, adverse effects, and interactions with medications. The information was constructed to provide an up-to-date base of knowledge, so that physicians and other health care providers would be aware of the supplements and be able to discuss realistic expectations and potential benefits and risks (my emphasis).
At first glance, this task looks ambitious but laudable; however, after studying the paper in some detail, I must admit that I have considerable problems taking it seriously – and here is why.
The first question I ask myself when reading the abstract is: Who are these “leading researchers and clinicians”? Surely such a consensus exercise crucially depends on who is being consulted. The article itself does not reveal who these experts are, merely that they are all members of the ‘Society of Integrative Oncology’. A little research reveals this organisation to be devoted to integrating all sorts of alternative therapies into cancer care. If we assume that the experts are identical with the authors of the review; one should point out that most of them are proponents of alternative medicine. This lack of critical input seems more than a little disconcerting.
My next questions are: How did they identify the 10 supplements and how did they evaluate the evidence for or against them? The article informs us that a 5-step procedure was employed:
1. Each clinician in this project was requested to construct a list of supplements that they tend to use frequently in their practice.
2. An initial list of close to 25 supplements was constructed. This list included supplements that have suggestions of some possible benefit and likely to carry minimal risk in cancer care.
3. From that long list, the group agreed on the 10 leading supplements that have the best suggestions of benefit.
4. Each participant selected 1 to 2 supplements that they have interest and experience in their use and wrote a manuscript related to the selected supplement in a uniformed and agreed format. The agreed format was constructed to provide a base of knowledge, so physicians and other health care providers would be able to discuss realistic expectations and potential benefits and risks with patients and families that seek that kind of information.
5. The revised document was circulated among participants for revisions and comments.
This method might look fine to proponents of alternative medicine, but from a scientific point of view, it is seriously wanting. Essentially, they asked those experts who are in favour of a given supplement to write a report to justify his/her preference. This method is not just open bias, it formally invites bias.
Predictably then, the reviews of the 10 chosen supplements are woefully inadequate. These is no evidence of a systematic approach; the cited evidence is demonstrably cherry-picked; there is a complete lack of critical analysis; for several supplements, clinical data are virtually absent without the authors finding this embarrassing void a reason for concern; dosage recommendations are often vague and naïve, to say the least (for instance, for milk thistle: 200 to 400 mg per day – without indication of what the named weight range refers to, the fresh plant, dried powder, extract…?); safety data are incomplete and nobody seems to mind that supplements are not subject to systematic post-marketing surveillance; the text is full of naïve thinking and contradictions (e.g.”There are no reported side effects of the mushroom extracts or the Maitake D-fraction. As Maitake may lower blood sugar, it should be used with caution in patients with diabetes“); evidence suggesting that a given supplement might reduce the risk of cancer is presented as though this means it is an effective treatment for an existing cancer; cancer is usually treated as though it is one disease entity without any differentiation of different cancer types.
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. But I do wonder, isn’t being in favour of integrating half-baked nonsense into cancer care and being selected for one’s favourable attitude towards certain supplements already a conflict of interest?
In any case, the review is in my view not of sufficient rigor to form the basis for well-informed discussions with patients. The authors of the review cite a guideline by the ‘Society of Integrative Oncology’ for the use of supplements in cancer care which states: For cancer patients who wish to use nutritional supplements, including botanicals for purported antitumor effects, it is recommended that they consult a trained professional. During the consultation, the professional should provide support, discuss realistic expectations, and explore potential benefits and risks. It is recommended that use of those agents occur only in the context of clinical trials, recognized nutritional guidelines, clinical evaluation of the risk/benefit ratio based on available evidence, and close monitoring of adverse effects. It seems to me that, with this review, the authors have not adhered to their own guideline.
Criticising the work of others is perhaps not very difficult, however, doing a better job usually is. So, can I offer anything that is better than the above criticised review? The answer is YES. Our initiative ‘CAM cancer’ provides up-to-date, concise and evidence-based systematic reviews of many supplements and other alternative treatments that cancer patients are likely to hear about. Their conclusions are not nearly as uncritically positive as those of the article in ‘INTEGRATIVE CANCER THERAPIES’.
I happen to believe that it is important for cancer patients to have access to reliable information and that it is unethical to mislead them with biased accounts about the value of any treatment.
Times of celebration are often also times of over-indulgence and subsequent suffering. Who would not know, for instance, how a hangover can spoil one’s pleasure at the start of a new year? But where is the research that addresses this problem? Scientists seem to be cynically devoid of sympathy for the hangover-victim – well, not all scientists.
During the course of my research-career, I must have conducted well over 60 clinical trials, but none was remotely as entertaining as the one my Exeter-team did several years ago to test whether an artichoke extract is effective in preventing the signs and symptoms of alcohol-induced hangover.
We recruited healthy adult volunteers from our own ranks to participate in a randomized double-blind crossover trial. Participants received either 3 capsules of commercially available standardized artichoke extract or indistinguishable, inert placebo capsules immediately before and after alcohol exposure. After a 1-week washout period the volunteers received the opposite treatment. Each participant predefined the type and amount of alcoholic beverage that would give him/her a hangover and ate the same meal before commencing alcohol consumption on the two study days. The primary outcome measure was the difference in hangover severity scores between the artichoke extract and placebo interventions. Secondary outcome measures were differences between the interventions in scores using a mood profile questionnaire and cognitive performance tests administered 1 hour before and 10 hours after alcohol exposure.
The mean number of alcohol units consumed per person during treatment with artichoke extract and placebo were 10.7 and 10.5 respectively, equivalent to 1.2 g of alcohol per kilogram body weight. The volume of non-alcoholic drink consumed and the duration of sleep after the binge were similar during the artichoke extract and placebo interventions. The hangovers we experienced the mornings after our alcohol exposure were monumental but unaffected by the treatments. None of the outcome measures differed significantly between interventions. Adverse events of the treatment were rare and were mild and transient. Our results therefore suggested that artichoke extract is not effective in preventing the signs and symptoms of alcohol-induced hangover.
While it was great fun to obtain ethic’s approval and run this trial, the results of our two binges in the name of science were, of course, a disappointment. As diligent researchers we felt we had to do a little more for the poor victims of over-indulgence.
We thus decided to conduct a systematic review aimed at assessing the clinical evidence on the effectiveness of any medical intervention for preventing or treating alcohol hangover. We conducted systematic searches to identify all RCTs of any medical intervention for preventing or treating alcohol hangover. Fifteen potentially relevant trials were found. Seven publications failed to meet all inclusion criteria. Eight RCTs assessing 8 different interventions were reviewed. The agents tested were propranolol, tropisetron, tolfenamic acid, fructose or glucose as well as the dietary supplements Borago officinalis (borage), Cynara scolymus (artichoke), Opuntia ficus-indica (prickly pear), and a yeast based preparation. All studies were double blind. Significant intergroup differences for overall symptom scores and individual symptoms were reported only for tolfenamic acid, gamma linolenic acid from borage, and a yeast based preparation.
We concluded that the most effective way to avoid the symptoms of alcohol induced hangover is to practise abstinence or moderation.
WISE WORDS PERHAPS, BUT EASIER SAID THAN DONE, I’M SURE.
Web-sites have become a leading source of information on health matters. This is particularly true in the realm of alternative medicine. Conventional health care professionals often know too little about this subject to advise their patients, and alternative practitioners are usually too biased to be trusted. So many consumers turn to the Internet and hope that it offers information which is reliable. But is it?
American pharmacists published a study evaluating the quality of on-line information on herbal supplements. They conducted a search of 13 common herbals – including black cohosh, echinacea, garlic, ginkgo, ginseng, green tea, kava, saw palmetto, and St John’s wort - and reviewed the top 50 Web sites for each using a Google search. Subsequently, they analysed clinical claims, warnings, and other safety information.
A total of 1179 Web sites were examined in this way. Less than 8% of retail sites provided information regarding potential adverse effects, drug interactions, and other safety information; only 10.5% recommended consultation with a healthcare professional. Less than 3% cited scientific literature to support their claims.
The authors’ conclusions were worrying: Key safety information is still lacking from many online sources of herbal information. Certain nonretail site types may be more reliable, but physicians and other healthcare professionals should be aware of the variable quality of these sites to help patients make more informed decisions.
Having conducted my fair share of similar research (e.g. here or here or here or here), I can only concur with these conclusions. When it comes to health care, the Internet is a scary place! In the realm of alternative medicine, it is dominated by people who seem not to care much about anything other than their profits.
But what can be done to change this situation? How can we protect the public from Internet-charlatans? How can one control the Internet? I wish I knew! But there are nevertheless means of directing consumers to those sites which do offer reliable information. Kite-marking high quality sites might be one way of achieving this. This task would, of course, be huge and difficult, but in the interest of public safety, governments and other official institutions should consider tackling it.
Hypercholesterolemia is an important, independent risk factor for cardiovascular disease, according to a generally accepted wisdom. Measures to normalise elevated blood lipids include diet, exercise and drugs, of which statins are the most widely prescribed. But many people have become somewhat sceptical about the wide-spread use of statins: Traditionally, doctors have viewed statin drugs as the most effective way to lower high LDL cholesterol. But today researchers are starting to believe that statins may not be the magic bullet they’ve always been made out to be. Statins can cause severe adverse effects and some experts have questioned whether they generate more benefit than harm and suggested that ‘BIG PHARMA’ are pushing statins not for the benefit of public health but for maximising profit.
This begs the question: is there an alternative?
This RCT tested the efficacy of a dietary supplement providing 1.8 g/day esterified plant sterols and stanols to improve the fasting lipid profile of men and women with primary hypercholesterolemia. Repeated measures analysis of covariance was used to compare outcomes for sterol/stanol and placebo treatment conditions using the baseline value as a covariate. Thirty subjects were randomized and all of them completed the trial.
Baseline (mean±standard error of the mean) plasma lipid concentrations were: total cholesterol 236.6±4.2 mg/dL (6.11±0.11 mmol/L), high-density lipoprotein (HDL) cholesterol 56.8±3.0 mg/dL (1.47±0.08 mmol/L), LDL cholesterol 151.6±3.3 mg/dL (3.92±0.09 mmol/L), non-HDL cholesterol 179.7±4.6 mg/dL (4.64±0.12 mmol/L), and triglycerides 144.5±14.3 mg/dL (1.63±0.16 mmol/L). Mean placebo-adjusted reductions in plasma lipid levels were significant (P<0.01) for LDL cholesterol (-4.3%), non-HDL cholesterol (-4.1%), and total cholesterol (-3.5%), but not for triglycerides or HDL cholesterol.
The authors conclude that these results support the efficacy of 1.8 g/day esterified plant sterols/stanols in softgel capsules, administered as an adjunct to the National Cholesterol Education Program Therapeutic Lifestyle Changes diet, to augment reductions in atherogenic lipid levels in individuals with hypercholesterolemia.
These findings are encouraging but certainly not rock solid. The study was too small, and the effect sizes were less than impressive. A brand-new systematic review, however, provides much more convincing data.
Its aim was to quantify the LDL-cholesterol-lowering effect of plant sterols/stanols as supplements. Eight eligible clinical trials were identified. Among the trials with a duration between 4 and 6 weeks, plant sterol/stanol dose ranged from 1.0 to 3.0 g/day administrated mainly with the main meals (2 or 3 times/day). Intake of plant sterol/stanol supplements decreased LDL-cholesterol concentrations by 12 mg/dL (0.31 mmol/L) compared with placebo. Further analysis showed no significant difference between the LDL-cholesterol-lowering action of plant sterols/stanols supplements vs foods enriched with plant sterols/stanols. The authors concluded that plant sterol/stanol supplements as part of a healthy diet represent an effective means of delivering LDL-cholesterol-lowering similar to plant sterols/stanols delivered in various food formats.
Crucially, this positive verdict does not stand alone. Another recent review included 5 trials and concluded that a dose-effect relationship of plant stanols in higher doses than currently recommended has been demonstrated by recent clinical studies and a meta-analysis.
Plant sterols seem to be not just effective but also safe: none of the trials published to date reported significant adverse effects. The only concern is the potential decrease in the concentrations of lipid-soluble antioxidants and vitamins, including β-carotene, α-tocopherol, lutein, and α-carotene. It is currently not clear whether these effects are clinically relevant.
The relative merits of phytosterols versus statins are not easy to evaluate. We have hundreds of studies of statins but just a few of sterols. This means our knowledge in this area is incomplete. Statins can cause serious adverse effects but their effects on blood lipids is about one order of magnitude larger that those of sterols. There is plenty of evidence to show that statins lower the risk of cardiovascular disease, while such data are missing for phytosterols.
The choice between statins and plant sterols is thus not easy, particularly considering the often emotional arguments and hype used in the ‘cholesterol-debate’. Phytosterols offer one more alternative therapy for lowering LDL-cholesterol levels. They seem safe and have the added attraction of being ‘natural’ – but the lipid-effects are relatively small, the impact on cardiovascular morbidity and mortality is uncertain, and fairly high doses are required to see any lipid-lowering at all.