Many experts have warned us that, when we opt for dietary supplements, we might get more than we bargained for. A recent article reminded us that the increased availability and use of botanical dietary supplements and herbal remedies among consumers has been accompanied by an increased frequency of adulteration of these products with synthetic pharmaceuticals. Unscrupulous producers may add drugs and analogues of various classes, such as phosphodiesterase type 5 (PDE-5) inhibitors, weight loss, hypoglycemic, antihypertensive and anti-inflammatory agents, or anabolic steroids, to develop or intensify biological effects of dietary supplements or herbal remedies. The presence of such adulterated products in the marketplace is a worldwide problem and their consumption poses health risks to consumers.
Other authors recently warned that these products are often ineffective, adulterated, mislabeled, or have unclear dosing recommendations, and consumers have suffered injury and death as a consequence. When Congress passed the Dietary Supplement Health and Education Act, it stripped the Food and Drug Administration of its premarket authority, rendering regulatory controls too weak to adequately protect consumers. State government intervention is thus warranted. This article reviews studies reporting on Americans’ use of dietary supplements marketed for weight loss or muscle building, notes the particular dangers these products pose to the youth, and suggests that states can build on their historical enactment of regulatory controls for products with potential health consequences to protect the public and especially young people from unsafe and mislabeled dietary supplements.
A new study has shown that these problems are not just theoretical but are real and common.
Twenty-four products suspected of containing anabolic steroids and sold in fitness equipment shops in the UK were analyzed for their qualitative and semi-quantitative content using full scan gas chromatography-mass spectrometry (GC-MS), accurate mass liquid chromatography-mass spectrometry (LC-MS), high pressure liquid chromatography with diode array detection (HPLC-DAD), UV-Vis, and nuclear magnetic resonance (NMR) spectroscopy. In addition, X-ray crystallography enabled the identification of one of the compounds, where reference standard was not available.
Of the 24 products tested, 23 contained steroids including known anabolic agents; 16 of these contained steroids that were different to those indicated on the packaging and one product contained no steroid at all. Overall, 13 different steroids were identified; 12 of these are controlled in the UK under the Misuse of Drugs Act 1971. Several of the products contained steroids that may be considered to have considerable pharmacological activity, based on their chemical structures and the amounts present.
The authors concluded that such adulteration could unwittingly expose users to a significant risk to their health, which is of particular concern for naïve users.
The Internet offers thousands of supplements for sale; specifically for bodybuilders there are hundreds of supplements all claiming things that are untrue or untested. The lax regulations that exist in this area seem to be often ignored completely. I think it is important to inform customers that most supplements are a waste of money and some even a waste of health.
As a pharmacy professional, you must:
1. Make patients your first concern
2. Use your professional judgement in the interests of patients and the public
3. Show respect for others
4. Encourage patients and the public to participate in decisions about their care
5. Develop your professional knowledge and competence
6. Be honest and trustworthy
7. Take responsibility for your working practices.
Even though these 7 main principles were laid down by the UK General Pharmaceutical Council, they are pretty much universal and apply to pharmacists the world over.
On this blog, I have repeatedly criticised community pharmacists (here I am only discussing this branch of pharmacists) for selling remedies which are not just of debatable efficacy but which fly in the face of science and have been all but disproven. Recently, I came across this website of a working group of the Austrian Society of Pharmacists. It is in German, so I will translate a few sections for you.
They say that it is their aim to find “explanatory models for the mechanisms of action of homeopathy”. This is a strange aim, in my view, not least because there is no proven efficacy; why then search for a mechanism?
Things go from bad to worse when we consider the ‘Notfallapotheke’, the emergency kit which they recommend to consumers who might find themselves in desperate need for emergency care. It includes the following remedies, doses and indications:
Aconitum C 30 2 x 5 Glob, first remedy in cases of fever
Allium cepa C 12 3 x 5 Glob, hayfever or cold
Anamirta cocculusLM 12 : 2 x 5, travel sickness
Apis mellifica C 200 2 x 5 Glob, insect bites
Arnica C 200 1 x 5 Glob, injuries
Acidum arsenicosum C 12 3 – 5 x 5, food poisoning
Atropa belladonna C 30 2 x 5 Glob, high fever
Cephaelis ipecacuahna C 12 2 x 5 Glob, nausea and vomiting
Coffea arabica C 12 2 x 5 Glob, insomnia and restlessness
Euphrasia officinalis C 12 3 x 5 Glob, eye problems
Ferrum phosphoricum C 12 2 x 5 Glob, nose bleed
Lachesis muta C 30 1 x 5 Glob, infected wounds
Lytta vesicatoria C 200 1 – 2 x 5, burns,
Matricaria chamomilla C 30 1 x 3 Glob, toothache
Mercurius LM 12 2 x 5 Glob ear ache, weakness
Pulsatilla LM 12 2 x 5 Glob, ear ache, indigestion
Solanum dulcamara C12 3 x 5 Glob, cystitis
Strychnos nux vomica LM 12 2 x 5 Glob, hangover
Rhus toxicodendron C 200 2 x 5 Glob, rheumatic pain
Veratrum album C12, 3-5 x 3, watery diarrhoea, nausea, vomiting, circulatory problems, collapse.
I can well imagine that, after reading this, some of my readers are in need of some Veratrum album because of near collapse with laughter (or fury?).
We all know that most pharmacists sell such useless remedies; and we might pity them for such behaviour, as they claim they have no choice. But if pharmacists’ professional organisations put themselves so very clearly behind quackery thereby violating all ethical rules in the book, one is truly speechless.
Do I hear someone mutter “what has Austria to do with us?”?
Not a lot, perhaps – but have a look at the range of similar ‘homeopathic emergency kits’ sold outside Austria. Or be stunned by the plethora of homeopathic pharmacies across the globe here and UK-wide here. Or consider the fact that most non-homeopathic pharmacies in the world sell homeopathic remedies. Or let me remind you that a snapshot investigation into UK pharmacies revealed that 13 out of 20 pharmacisits failed to explain that there’s no clinical evidence that homeopathy works. Or be once again reminded that it is “the ethical role of the pharmacist is to give accurate, impartial information regarding the homeopathic therapy, the current scientific proof on their therapeutic effects, including the placebo effect.”
And what is the current scientific proof?
The most reliable verdict that I am aware of comes from the Australian ‘NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL’ (NHMRC) who have assessed the effectiveness of homeopathy. The evaluation concluded that “the evidence from research in humans does not show that homeopathy is effective for treating the range of health conditions considered.”
I rest my case.
Many proponents of alternative medicine seem somewhat suspicious of research; they have obviously understood that it might not produce the positive result they had hoped for; after all, good research tests hypotheses and does not necessarily confirm beliefs. At the same time, they are often tempted to conduct research: this is perceived as being good for the image and, provided the findings are positive, also good for business.
Therefore they seem to be tirelessly looking for a study design that cannot ‘fail’, i.e. one that avoids the risk of negative results but looks respectable enough to be accepted by ‘the establishment’. For these enthusiasts, I have good news: here is the study design that cannot fail.
It is perhaps best outlined as a concrete example; for reasons that will become clear very shortly, I have chosen reflexology as a treatment of diabetic neuropathy, but you can, of course, replace both the treatment and the condition as it suits your needs. Here is the outline:
- recruit a group of patients suffering from diabetic neuropathy – say 58, that will do nicely,
- randomly allocate them to two groups,
- the experimental group receives regular treatments by a motivated reflexologist,
- the controls get no such therapy,
- both groups also receive conventional treatments for their neuropathy,
- the follow-up is 6 months,
- the following outcome measures are used: pain reduction, glycemic control, nerve conductivity, and thermal and vibration sensitivities,
- the results show that the reflexology group experience more improvements in all outcome measures than those of control subjects,
- your conclusion: This study exhibited the efficient utility of reflexology therapy integrated with conventional medicines in managing diabetic neuropathy.
This method is fool-proof, trust me, I have seen it often enough being tested, and never has it generated disappointment. It cannot fail because it follows the notorious A+B versus B design (I know, I have mentioned this several times before on this blog, but it is really important, I think): both patient groups receive the essential mainstream treatment, and the experimental group receives a useless but pleasant alternative treatment in addition. The alternative treatment involves touch, time, compassion, empathy, expectations, etc. All of these elements will inevitably have positive effects, and they can even be used to increase the patients’ compliance with the conventional treatments that is being applied in parallel. Thus all outcome measures will be better in the experimental compared to the control group.
The overall effect is pure magic: even an utterly ineffective treatment will appear as being effective – the perfect method for producing false-positive results.
And now we hopefully all understand why this study design is so very popular in alternative medicine. It looks solid – after all, it’s an RCT!!! – and it thus convinces even mildly critical experts of the notion that the useless treatment is something worth while. Consequently the useless treatment will become accepted as ‘evidence-based’, will be used more widely and perhaps even reimbursed from the public purse. Business will be thriving!
And why did I employ reflexology for diabetic neuropathy? Is that example not a far-fetched? Not a bit! I used it because it describes precisely a study that has just been published. Of course, I could also have taken the chiropractic trial from my last post, or dozens of other studies following the A+B versus B design – it is so brilliantly suited for misleading us all.
A recent article by Frank King (DC, ND) caught my eye. In it, he praises homeopathy in glowing terms. First I was not sure whether he is pulling my leg; then I decided he was entirely serious. Am I mistaken?
Here is the crucial passage for you to decide:
Even though the founder of homeopathy lived more than 200 years ago, he wrote about genetics. Samuel Hahnemann, MD, not only emphasized the importance of natural healing methods, he also recognized the influence of genetics in some types of illnesses.
Hahnemann used the term miasm to refer to the source of chronic diseases. He recognized several miasms, such as psora (meaning “itch”), syphilis, tuberculosis, gonorrhea, and cancer. In addition to recognizing and naming these miasms, he developed homeopathic remedies to address and correct them.
When your patient treatment protocols reach a plateau with chiropractic and nutritional support, consider turning to the constitutional homeopathic remedies, miasms, and detoxification formulas. Toxins inhibit the body’s ability to heal by interfering with the normal nerve pathways.
For example: Due to the steady growth in heavy-metal exposure modern civilization has experienced since the Industrial Revolution, mercury could be considered a modern miasm. Animal studies indicate that mercury’s negative effects can carry through to future generations, just as some of the other miasms do.
Mercurius is homeopathically prepared mercury to help address the symptoms of mercury toxicity, which can manifest as slow thought processes, chilliness, weak digestion, sore throat, and night sweats.
This is just one of the more than 1,300 Homeopathic Pharmacopoeia of the United States ingredients recognized by the FDA.
Homeopathy can be the perfect complement to chiropractic care. It can correct the energetics (including the genetics) of the deepest areas of the body, mind, and emotions, where the hands of the chiropractor can’t reach.
In case you don’t know much about homeopathy, it is true that Hahnemann believed in ‘miasms’, i.e. noxious vapours as the cause of a disposition to certain diseases. Even by Hahnemann’s standards, it turned out to be one of his more crazy ideas. To claim that, by believing in miasms, he foresaw the science of genetics is more than a little far-fetched.
In case you are not sure what toxins do in our body, rest assured that only chiropractors believe they inhibit the body’s ability to heal by interfering with the normal nerve pathways.
And in case you think you suffer from slow thought processes, chilliness, weak digestion, sore throat, and night sweats and thus feel like rushing to the next pharmacy to buy some Mercurius, don’t! This would not eliminate any mercury from your body, it would just eliminate cash from your pocket (in that sense, homeopathy might indeed occasionally reach where the hands of the chiropractor can’t reach).
One can say a lot about alternative medicine, I think, but nobody can deny that it regularly provides us with perfect (unintentional) comedy.
Kinesiology tape is all the rage. Its proponents claim that it increases cutaneous stimulation, which facilitates motor unit firing, and consequently improves functional performance. But is this just clever marketing, wishful thinking or is it true? To find out, we need reliable data.
The current trial results are sparse, confusing and contradictory. A recent systematic review indicated that kinesiology tape may have limited potential to reduce pain in individuals with musculoskeletal injury; however, depending on the conditions, the reduction in pain may not be clinically meaningful. Kinesiology tape application did not reduce specific pain measures related to musculoskeletal injury above and beyond other modalities compared in the context of included articles.
The authors concluded that kinesiology tape may be used in conjunction with or in place of more traditional therapies, and further research that employs controlled measures compared with kinesiology tape is needed to evaluate efficacy.
This need for further research has just been met by Korean investigators who conducted a study testing the true effects of KinTape by a deceptive, randomized, clinical trial.
Thirty healthy participants performed isokinetic testing of three taping conditions: true facilitative KinTape, sham KinTape, and no KinTape. The participants were blindfolded during the evaluation. Under the pretense of applying adhesive muscle sensors, KinTape was applied to their quadriceps in the first two conditions. Normalized peak torque, normalized total work, and time to peak torque were measured at two angular speeds (60°/s and 180°/s) and analyzed with one-way repeated measures ANOVA.
Participants were successfully deceived and they were ignorant about KinTape. No significant differences were found between normalized peak torque, normalized total work, and time to peak torque at 60°/s or 180°/s (p = 0.31-0.99) between three taping conditions. The results showed that KinTape did not facilitate muscle performance in generating higher peak torque, yielding a greater total work, or inducing an earlier onset of peak torque.
The authors concluded that previously reported muscle facilitatory effects using KinTape may be attributed to placebo effects.
The claims that are being made for kinesiology taping are truly extraordinary; just consider what this website is trying to tell us:
Kinesiology tape is a breakthrough new method for treating athletic sprains, strains and sports injuries. You may have seen Olympic and celebrity athletes wearing multicolored tape on their arms, legs, shoulders and back. This type of athletic tape is a revolutionary therapeutic elastic style of support that works in multiple ways to improve health and circulation in ways that traditional athletic tapes can’t compare. Not only does this new type of athletic tape help support and heal muscles, but it also provides faster, more thorough healing by aiding with blood circulation throughout the body.
Many athletes who have switched to using this new type of athletic tape report a wide variety of benefits including improved neuromuscular movement and circulation, pain relief and more. In addition to its many medical uses, Kinesiology tape is also used to help prevent injuries and manage pain and swelling, such as from edema. Unlike regular athletic taping, using elastic tape allows you the freedom of motion without restricting muscles or blood flow. By allowing the muscles a larger degree of movement, the body is able to heal itself more quickly and fully than before.
Whenever I read such over-enthusiastic promotion that is not based on evidence but on keen salesmanship, my alarm-bells start ringing and I see parallels to the worst type of alternative medicine hype. In fact, kinesiology tapes have all the hallmarks of alternative medicine and its promoters have, as far as I can see, all the characteristics of quacks. The motto seems to be: LET’S EARN SOME MONEY FAST AND IGNORE THE SCIENCE WHILE WE CAN.
It has been estimated that 40 – 70% of all cancer patients use some form of alternative medicine; may do so in the hope this might cure their condition. A recent article by Turkish researchers – yet again – highlights how dangerous such behaviour can turn out to be.
The authors report the cases of two middle-aged women suffering from malignant breast masses. The patients experienced serious complications in response to self-prescribed use of alternative medicine practices to treat their condition in lieu of evidence-based medical treatments. In both cases, the use and/or inappropriate application of alternative medical approaches promoted the progression of malignant fungating lesions in the breast. The first patient sought medical assistance upon development of a fungating lesion, 7∼8 cm in diameter and involving 1/3 of the breast, with a palpable mass of 5×6 cm immediately beneath the wound. The second patient sought medical assistance after developing of a wide, bleeding, ulcerous area with patchy necrotic tissue that comprised 2/3 of the breast and had a 10×6 cm palpable mass under the affected area.
The authors argue that the use of some non-evidence-based medical treatments as complementary to evidence-based medical treatments may benefit the patient on an emotional level; however, this strategy should be used with caution, as the non-evidence-based therapies may cause physical harm or even counteract the evidence-based treatment.
Their conclusions: a malignant, fungating wound is a serious complication of advanced breast cancer. It is critical that the public is informed about the potential problems of self-treating wounds such as breast ulcers and masses. Additionally, campaigns are needed to increase awareness of the risks and life-threatening potential of using non-evidence-based medical therapies exclusively.
I have little to add to this; perhaps just a further reminder that the risk extends, of course, to all serious conditions: even a seemingly harmless but ineffective therapy can become positively life-threatening, if it is used as an alternative to an effective treatment. I am sure that some ‘alternativists’ will claim that I am alarmist; but I am also convinced that they are wrong.
In 2004, I published an article rather boldly entitled ‘Ear candles: a triumph of ignorance over science’. Here is its summary:
Ear candles are hollow tubes coated in wax which are inserted into patients’ ears and then lit at the far end. The procedure is used as a complementary therapy for a wide range of conditions. A critical assessment of the evidence shows that its mode of action is implausible and demonstrably wrong. There are no data to suggest that it is effective for any condition. Furthermore, ear candles have been associated with ear injuries. The inescapable conclusion is that ear candles do more harm than good. Their use should be discouraged.
Sadly, since the publication of this paper, ear candles have not become less but more popular. There are about 3 000 000 websites on the subject; most are trying to sell products and make claims which are almost comically misguided; three examples have to suffice:
- The candles work on a chimney principle, drawing any impurities to the surface where they can be gently removed. They equalise the pressure in the head and ears, making them suitable for most conditions.
- These candles are cleansing, soothing and relaxing which helps with chills / colds, feeling of pressure in the ear, tinnitus and everyday noise / sensory overload.
- As it burns, the cone’s ingredients turn to vapour and the airflow creates a vibrational effect. Warmth, vibration and vapour massage the ear canal breaking down any blockages. Wax, toxins and impurities are then drawn out by suction from the heat and vacuum effect of the burning cone. Ear Candling also stimulates the ear’s circulatory system and upper lymph system aiding the body’s natural healing responses.
I said ALMOST comical because such nonsense has, of course a downside. Not only are consumers separated from their cash for no benefit whatsoever, but they are also exposed to danger; again, three examples from the medical literature might explain:
- Otolaryngologists from London described a case of ear candling presenting as hearing loss, and they concluded that this useless therapy can actually cause damage to the ears.
- A 50-year-old woman presented to her GP following an episode of ear candling. After 15 minutes, the person performing the candling burned herself while attempting to remove the candle and spilled candle wax into the patient’s right ear canal. On examination, a piece of candle wax was found in the patient’s ear, and she was referred to the local ear, nose, and throat department. Under general aesthetic, a large mass of solidified yellow candle wax was removed from the deep meatus of the ear. The patient had a small perforation in her right tympanic membrane. Results of a pure tone audiogram showed a mild conductive hearing loss on the right side. At a follow-up appointment 1 month later, the perforation was still there, and the patient’s hearing had not improved.
- A case report of a 4-year-old girl from New Zealand was published. The patient was diagnosed to suffer from otitis media. During the course of the ear examination white deposits were noticed on her eardrum; this was confirmed as being caused by ear candling.
I should stress that we do not know how often such events happen; there is no monitoring system, and one might expect that the vast majority of cases do not get published. Most consumers who experience such problems, I would guess, are far to embarrassed to admit that they have been taken in by this sort of quackery.
It was true 10 yeas ago and it is true today: ear candles are a triumph of ignorance over science. But also they are a victory of gullibility over common sense and the unethical exploitation of naive hope by greedy frauds.
If you believe herbalists, the Daily Mail or similarly reliable sources, you come to the conclusion that herbal medicines are entirely safe – after all they are natural, and everything that is natural must be safe. However, there is plenty of evidence that these assumptions are not necessarily correct. In fact, herbal medicines can cause harm in diverse ways, e. g. because:
- one or more ingredients of a plant are toxic,
- they interact with prescribed drugs,
- they are contaminated, for instance, with heavy metals,
- they are adulterated with prescription drugs.
There is no shortage of evidence for any of these 4 scenarios. Here are some very recent and relevant publications:
German authors reviewed recent case reports and case series that provided evidence for herbal hepatotoxicity caused by Chinese herbal mixtures. The implicated remedies were the TCM products Ban Tu Wan, Chai Hu, Du Huo, Huang Qin, Jia Wei Xia Yao San, Jiguja, Kamishoyosan, Long Dan Xie Gan Tang, Lu Cha, Polygonum multiflorum products, Shan Chi, ‘White flood’ containing the herbal TCM Wu Zhu Yu and Qian Ceng Ta, and Xiao Chai Hu Tang. the authors concluded that stringent evaluation of the risk/benefit ratio is essential to protect traditional Chinese medicines users from health hazards including liver injury.
A recent review of Nigerian anti-diabetic herbal remedies suggested hypoglycemic effect of over 100 plants. One-third of them have been studied for their mechanism of action, while isolation of the bioactive constituent(s) has been accomplished for 23 plants. Several plants showed specific organ toxicity, mostly nephrotoxic or hepatotoxic, with direct effects on the levels of some liver function enzymes. Twenty-eight plants have been identified as in vitro modulators of P-glycoprotein and/or one or more of the cytochrome P450 enzymes, while eleven plants altered the levels of phase 2 metabolic enzymes, chiefly glutathione, with the potential to alter the pharmacokinetics of co-administered drugs
US authors published a case of a 44-year-old female who developed subacute liver injury demonstrated on a CT scan and liver biopsy within a month of using black cohosh to resolve her hot flashes. Since the patient was not taking any other drugs, they concluded that the acute liver injury was caused by the use of black cohosh. The authors concluded: we agree with the United States Pharmacopeia recommendations that a cautionary warning about hepatotoxicity should be labeled on the drug package.
Hong Kong toxicologists recently reported five cases of poisoning occurring as a result of inappropriate use of herbs in recipes or general herbal formulae acquired from books. Aconite poisoning due to overdose or inadequate processing accounted for three cases. The other two cases involved the use of herbs containing Strychnos alkaloids and Sophora alkaloids. These cases demonstrated that inappropriate use of Chinese medicine can result in major morbidity, and herbal formulae and recipes containing herbs available in general publications are not always safe.
Finally, Australian emergency doctors just published this case-report: A woman aged 34 years presented to hospital with a history of progressive shortness of breath, palpitations, decreased exercise tolerance and generalised arthralgia over the previous month. A full blood count revealed normochromic normocytic anaemia and a haemoglobin level of 66 g/L. The blood film showed basophilic stippling, prompting measurement of lead levels. Her blood lead level (BLL) was 105 µg/dL. Mercury and arsenic levels were also detected at very low levels. On further questioning, the patient reported that in the past 6 months she had ingested multiple herbal preparations supplied by an overseas Ayurvedic practitioner for enhancement of fertility. She was taking up to 12 different tablets and various pastes and powders daily. Her case was reported to public health authorities and the herbal preparations were sent for analytical testing. Analysis confirmed high levels of lead (4% w/w), mercury (12% w/w), arsenic and chromium. The lead levels were 4000 times the maximum allowable lead level in medications sold or produced in Australia. Following cessation of the herbal preparations, the patient was commenced on oral chelation therapy, iron supplementation and contraception. A 3-week course of oral DMSA (2,3-dimercaptosuccinic acid) was well tolerated; BLL was reduced to 13 µg/dL and haemoglobin increased to 99 g/L. Her symptoms improved over the subsequent 3 months and she remains hopeful about becoming pregnant.
So, how safe are herbal medicines? Unfortunately, the question is unanswerable. Some herbal medicines are quite safe, others are not. But always remember: whenever you administer a treatment you should ask yourself one absolutely crucial question: do the documented benefits outweigh the risks? There are several thousand different herbal medicines, and for less than a dozen of them can the honest answer to this question be YES.
Niacin – also known as vitamin B3 or nicotinic acid – is a natural compound (formula C
2 ) and an essential nutrient for humans. It is water-soluble, which means it is not stored in the body. Excess amounts of the vitamin leave the body through the urine. That means we need a continuous supply of niacin in your diet.
Niacin is found in variety of foods, including liver, chicken, beef, fish, cereal, peanuts and legumes. It can also be synthesized from tryptophan, an essential amino acid found in protein. Niacin has long been an accepted treatment for high cholesterol. It is well-documented to increase the levels of high-density cholesterol (HDL or “good cholesterol”) and to decrease the levels of low-density cholesterol (LDL or “bad cholesterol”).
But what do these effects really mean? Do they translate into true health benefits? A brand-new study casts doubt on the value of niacin therapy:
After a pre-randomization run-in phase to standardize the background statin-based LDL cholesterol-lowering therapy and to establish participants’ ability to take extended-release niacin without clinically significant adverse effects, the researchers randomly assigned 25,673 adults with vascular disease to receive 2 g of extended-release niacin and 40 mg of laropiprant or a matching placebo daily. The primary outcome was the first major vascular event (non-fatal myocardial infarction, death from coronary causes, stroke, or arterial revascularization).
During a median follow-up period of 3.9 years, participants who were assigned to extended-release niacin-laropiprant had an LDL cholesterol level that was 10 mg per deciliter (0.25 mmol/l) lower and an HDL cholesterol level that was 6 mg per deciliter (0.16 mmol/l) higher than the levels in those assigned to placebo. Thus the lipid-effects of previous studies were confirmed.
However, assignment to niacin-laropiprant, as compared with assignment to placebo, had no significant effect on the incidence of major vascular events Niacin-laropiprant was associated with an increased incidence of disturbances in diabetes control that were considered to be serious and with an increased incidence of diabetes diagnoses as well as increases in serious adverse events associated with the gastrointestinal system, the musculoskeletal system, the skin and infections and bleeding.
Based of these data, the authors arrived at the following conclusion: among participants with atherosclerotic vascular disease, the addition of extended-release niacin-laropiprant to statin-based LDL cholesterol-lowering therapy did not significantly reduce the risk of major vascular events but did increase the risk of serious adverse events.
This extremely well-done trial is a poignant reminder of the fact that, in health care, we must never take our assumptions for granted. Here the underlying assumption was that the Niacin-induced lipid changes lead to a reduction of cardiovascular risks. Not only it proved to be erroneous but, through serious adverse effects, Niacin actually decreased patients’ health status.
The lessons from all this are straight forward, I think:
- ‘Natural’ does not necessarily mean safe.
- Long-established does not necessarily mean efficacious.
- Assumptions are merely assumptions, nothing more; if we want to make sure that they hold, we need to test them.
- When we finally do test assumptions, we better do it rigorously.
Have you noticed?
Homeopaths, acupuncturists, herbalists, reflexologists, aroma therapists, colonic irrigationists, naturopaths, TCM-practitioners, etc. – they always smile!
I think I might know the answer. Here is my theory:
Alternative practitioners have in common with conventional clinicians that they treat patients – lots of patients, day in day out. This wears them down, of course. And sometimes, conventional clinicians find it hard to smile. Come to think of it, alternative practitioners seem to have it much better. Let me explain.
Whenever a practitioner (of any type) treats a patient, one of three outcomes is bound to happen:
- the patient gets better,
- the patients roughly remains how she was and experiences no improvement,
- the patient gets worse.
In scenario one, everybody is happy. Both alternative and conventional practitioners will claim with a big smile that their treatment was the cause of the improvement. There is a difference though: the conventional practitioner who adheres to the principles of evidence-based medicine will know that the assumption is likely to be true, while the alternative practitioner is probably just guessing. In any case, as long as the patient gets better, all is well.
In scenario two, most conventional clinicians will get somewhat concerned and find little reason to smile. Not so the alternative practitioner! He will have one of several explanations why his therapy has not produced the expected result all of which allow him to carry on smiling smugly. He might, for instance, explain to his patient:
- You have to give it more time; another 10-20 treatment sessions and you will be as right as rain (unfortunately, further sessions will come at a price).
- This must be because of all those nasty chemical drugs that you took for so long – they block up your system, you know; we will have to do some serious detox to get rid of all this poison (of course, at a cost).
- You must realize that, had we not started my treatment when we did, you would be much worse by now, perhaps even dead.
In scenario three, any conventional clinician would have stopped smiling and begun to ask serious, self-critical questions about his diagnosis and treatment. Not so the alternative practitioner. He will point out with a big smile that the deterioration of the symptoms only appears to be a bad sign. In reality it is a very encouraging signal indicating that the optimal treatment for the patient’s condition has finally been found and is beginning to work. The acute worsening of the complaints is merely an ‘aggravation’ or’ healing crisis’. Such a course of events had to be expected when true healing of the root cause of the condition is to be achieved. The thing to do now is to continue with several more treatments (at a cost, of course) until deep healing from within sets in.
Many of us want the cake and eat it – but alternative practitioners, it seems to me, have actually achieved this goal. No wonder they smile!