MD, PhD, FMedSci, FSB, FRCP, FRCPEd

risk

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THIS POST IS DEDICATED TO HRH, THE PRINCE OF WALES WHO CELEBRATES HIS 66TH BIRTHDAY TODAY AND HAS SUPPORTED HOMEOPATHY ALL HIS LIFE

Like Charles, many people are fond of homeopathy; it is particularly popular in India, Germany, France and parts of South America. With all types of health care, it is important to make therapeutic decisions in the knowledge of the crucial facts. In order to aid evidence-based decision-making, I will summarise a few things you might want to consider before you try homeopathy – either by buying homeopathic remedies over the counter, or by consulting a homeopath.

  1. Homeopathy was invented by Samuel Hahnemann, a charismatic German doctor, about 200 years ago. At the time, our understanding of the laws of nature was woefully incomplete, and therefore Hahnemann’s ideas seemed far less implausible than they actually are. Moreover, the conventional treatments of this period were often more dangerous than the disease they were supposed to cure; consequently homeopathy was repeatedly shown to be better than ‘allopathy’ (a term coined by Hahnemann to insult conventional medicine). Thus Hahnemann’s treatments were an almost instant worldwide success. When, about 100 years later, more and more effective conventional therapies were discovered, homeopathy all but disappeared, only to be re-discovered in developed countries as the baby-boomers started their recent love-affair with alternative medicine.
  2. Many consumers confuse homeopathy with herbal medicine; yet the two are fundamentally different. Herbal medicines are plant extracts with potentially active ingredients. Homeopathic remedies may be based on plants (or any other material as well) but are typically so dilute that they contain absolutely nothing. The most frequently used dilution (homeopaths call them ‘potencies’) is a ‘C30′; a C30-potency has been diluted 30 times at a ratio of 1:100. This means that one drop of the staring material is dissolved in 1 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 drops of diluent – and that equates to one molecule of the original substance per all the molecules of many thousand universes.
  3. Homeopaths know all of this, of course, and they thus claim that their remedies do not work via pharmacological effects but via some ‘energy’ or ‘vital force’. They are convinced that the process of preparing the homeopathic dilutions (they shake the mixtures at each dilution step) transfers some ‘vital energy’ from one to the next dilution. They cite all sorts of fancy theories to explain how this ‘energy transfer’ might come about, however, none of them has ever been accepted by mainstream scientists.
  4. Homeopathic remedies are usually prescribed according to the ‘like cures like’ principle. For instance, if you suffer from runny eyes, a homeopath might prescribe a remedy made of onion, because onion make our eyes water. This and all other basic assumptions of homeopathy contradict the known laws of nature. In other words, we do not just fail to understand how homeopathy works, but we understand that it cannot work unless the known laws of nature are wrong.
  5. The clinical trials of homeopathy are broadly in agreement with these insights from basic science. Today, more than 200 such studies have been published; if we look at the totality of this evidence, we have to conclude that it fails to show that homeopathic remedies are anything other than placebos.
  6. This is, of course, in stark contrast to what many enthusiasts of homeopathy insist upon; they swear by homeopathy and claim that it has helped them (or their pet, aunt, child etc.) repeatedly. Nobody doubts their accounts; in fact, it is indisputable that many patients do get better after taking homeopathic remedies. The best evidence available today clearly shows, however, that this improvement is unrelated to the homeopathic remedy per se. It is the result of an empathetic, compassionate encounter with a homeopath, a placebo-response or other factors which experts often call ‘context effects’.
  7. The wide-spread notion that homeopathy is completely free of risks is not correct. The remedy itself might be harmless (except, of course, for the damage it creates to your finances, and the fact that irrational nonsense about ‘vital energy’ etc. undermines rationality in general) but this does not necessarily apply to the homeopath. Whenever homeopaths advise their patients, as they often do, to forgo effective conventional treatments for a serious condition, they endanger lives. This phenomenon is documented, for instance, in relation to the advice of many homeopaths against immunisations. Any treatment that has no proven benefit, while carrying a finite risk, cannot generate more good than harm.

If you have diabetes, chances are that you need life-long treatment. Before effective anti-diabetic medications became available, diabetes amounted to a death sentence. Fortunately, these times are long gone.

…unless, of course, you decide to listen to the promises of alternative practitioners many of whom offer a cure for diabetes. Here is just one website of hundreds that does just that. The following is an abbreviated quote where I have changed nothing, not even the numerous spelling mistakes:

Modern medicine has no  permanent cure for diabetes but alternative medicines like yoga ,mudra,ayurveda is very useful to control and even cure diabetes.Ayurveda is an alternative medicine to cure diabetes.

Alternative medicine like ayurveda is a best to cure diabetes naturally.
A serious disorder of the glands,of pancreas to be exact,is diabetes,or madhumeha as described in ayurveda.It is one of the most insidious disorders of the metabolism and,if left undiagnosed or untreated,it may lead to rapid emaciation and ultimately death…
Ayurveda medicines to cure diabetes
In ayurveda the following medicines have been recommended for this disease
Shiljita ————————–240 mg
Nyagrodadhi churna ———3 gm
These should be given twice after meals with decoction of arni.
Vasantakusumakara rasa —120 mg
Shudha Shilajit ————–240 mg
Nag Bhasma —————–120 mg
Haldi ————————–500 mg
Amlaki Churna ————-500 mg
Twice daily with powder of rose-apple stones.Twice daily with honey.
Chadraprabha  Vati ——– 500 mg
Mudra the alternative treatment to cure diabetes naturally
Mudra is a non medical and no cost treatment to cure diabetes.You can perform mudras at any time or any position.It is an effective way of treatment you can get better result if you practice it regularly .

It goes without saying that none of these treatments would cure diabetes. A Cochrane review concluded that there is insufficient evidence at present to recommend the use of these interventions in routine clinical practice. It also goes without saying that not many patients would fall for the nonsense proclaimed on this or so many other websites. But even just one single patient dying because of some charlatan promising a cure for life-threatening diseases is one patient too many.

Here and elsewhere, I have repeatedly written about the many things that can go wrong with acupuncture. This invariably annoys acupuncture fans who usually counter by accusing me of being alarmist. Despite their opposition, I continue to think it is important to regularly point out that acupuncture – contrary to what many acupuncturists would tell us – can result in serious injury. I will therefore carry on reporting new evidence about the harm caused by acupuncture. Here is a very brief review of new (2014) articles on this important topic.

A recent study found that the incidence of any adverse events per patient was 42.4% with traditional acupuncture, 40.7% with minimal acupuncture and 16.7% with non-invasive sham acupuncture. These figures are much higher than those around 10% previously reported.

Other authors described the case of a broken off acupuncture needle in a patient’s abdomen. A very long needle was used which happily is unusual in routine practice.

Pneumothorax has been often noted as a complication of acupuncture – it is by far the most frequently reported serious complication caused by acupuncture; well over 100 instances have been described in the medical literature which, of course, reflects only the tip of an iceberg – new cases are being reported almost on a monthly basis.

Cardiac tamponade is even more dangerous but fortunately also much rarer. A case of life-threatening cardiac tamponade due to penetration of an acupuncture needle directly into the right ventricle was recently published. Cardiac tamponade can happen when the patient is unfortunate enough to have a sternal foramen, an congenital abnormality that is not normally detected by simple inspection or palpation. An investigation found that the frequency of a sternal foramen is approximately 10.5%. The authors concluded that sternal acupuncture should be planned in the region of corpus-previous CT should be done to rule out this variation. Furthermore, we strongly recommend the acupuncture technique which prescribes a safe superficial-oblique approach to the sternum.

A review from Egypt noted that acupuncture presented a significant risks for acquiring hepatitis C infections.

Other types of infections can also be transmitted by acupuncture needles, if the therapist fails to adhere to proper procedures of sterility. One report described the diagnosis, treatment and >1 year follow-up of 30 patients presenting with acupuncture-induced primary inoculation tuberculosis.

Similarly, Chinese authors reported the case of a 54-year-old woman who presented with progressive low back pain and fever. She underwent surgical decompression, with an immediate improvement of her pain. A culture of the epidural abscess grew Serratia marcescens. One year postoperatively, magnetic resonance imaging revealed the almost complete eradication of the abscess. This case is the first case of Serratia marcescens-associated spinal epidural abscess formation secondary to acupuncture.

Other authors reported a rare case of isolated unilateral hypoglossal nerve injury following ipsilateral acupuncture for migraines in a 53-year-old lady.

Finally, Greek authors published a case of severe rhabdomyolysis and acute kidney injury after acupuncture sessions. Rhabdomyolysis is a rare condition that can be caused by muscle injury and presents with muscle weakness and pain. It is characterized by myoglobinuria which, in turn, may cause acute kidney injury.

I can hear the world of acupuncture arguing that all of these events are extreme rarities and that conventional treatments are much more dangerous. This may well be true but it also ignores the following facts:

  • The frequency of such events is essentially unknown. Contrary to conventional medicine, alternative medicine has no functioning systems to monitor adverse events. Therefore the true incidence figures of acupuncture-related complications are anyone’s guess.
  • Most conventional treatments in common use are backed up by good evidence for efficacy and therefore demonstrably do more good than harm, even if they regularly cause adverse effects. This is not the case for acupuncture. In the absence of solid evidence for efficacy, even relatively rare or minor adverse effects would mean that the risk/benefit profile of acupuncture is not positive.

For these reasons, it is an ethical imperative, I think, to keep a keen eye on the harm caused by acupuncture and to inform the public about the fact that it is undeniably not free of risks.

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.

Cardiovascular (and most other types of) patients frequently use herbal remedies in addition to their prescribed medicines. Can this behaviour create problems? Many experts think so.

The aim of a new study was to investigate the effect of herbal medicine use on medication adherence of cardiology patients. All patients admitted to the outpatient cardiology clinics, who had been prescribed at least one cardiovascular drug before, were asked to complete a questionnaire. Participants were asked if they have used any herbals during the past 12 months with an expectation of beneficial effect on health. Medication adherence was measured by using the Morisky Scale. High adherence was defined as a Morisky score lower than 2 and a score of 2 or more was seen as low adherence.

A total of 390 patients participated in this study; 29.7% of them had consumed herbals in the past 12 months. The median Morisky score was significantly higher in herbal users than non-users. The number of herbals used was moderately correlated with the Morisky score. In stepwise, multivariate logistic regression analysis, herbal use was significantly associated with low medication adherence.

From these findings, the authors conclude that herbal use was found to be independently associated with low medication adherence in our study population.

So far, the main known risk of herbal medicine use was the possibility that there might be herb-drug interactions. To the best of my knowledge, nobody has yet studied the possibility that herbal medicine users might neglect to take their prescribed drugs. The results of this investigation are somewhat worrying but they do make sense. Some patients who buy and take herbal remedies might think that they do not need to regularly take their prescribed medications because they already take herbal medicine which takes care of their health problem. They might even have been told by their herbalist that the herbal remedies suffice.

If that is so, and if the phenomenon can be confirmed in further investigations, it should be relevant not just in cardiology but in all fields of medicine. And if that is true for herbal remedies, it might also be the case for other types of alternative medicine. In other words, alternative medicine use might be a marker for poor adherence to prescribed medication. I feel that this hypothesis merits further study.

It goes without saying that poor adherence to prescribed drugs can be a very dangerous habit. Clinicians should therefore warn their patients and tell them that herbal remedies are no replacement of prescription drugs.

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:

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.
  • 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.

An article with this title was published recently by a team from Israel; essentially, it reports two interesting case histories:

Case 1

A 59-year-old male underwent a course of acupuncture for chronic low back pain, by a acupuncturist. During the therapy, the patient noted swelling at the point of puncture, but his therapist dismissed the claim. The region continued to swell, and three days later his family doctor diagnosed cellulitis and prescribed oral amoxicillin with clavulanic acid. The following day the patient’s condition worsened—he started to suffer from chills and more intense pain, so he went to the emergency room. At that stage, the patient had a fever of 37.9°C, a pulse of 119, and a blood pressure of 199/87. Edema was noted over the patient’s entire right flank (Figure 1A). Laboratory results were notable for a level of glucose of 298 mg/dL, sodium of 128 mmol/L, and white blood count (WBC) of 26,500 cells/μL with left shift. An emergency CT revealed an abscess of the abdominal wall involving the muscles, but no intra-abdominal pathology (Figure 1B).

Figure 1.
Figure 1.The patient received broad-spectrum antibiotics and was taken to the operating room for debridement. Upon incision there was subcutaneous edema with no puss, gangrene of the entire external oblique muscle, and an abscess between the external and internal oblique muscles. The muscles were debrided back to healthy, bleeding tissue and the wound copiously irrigated with saline. The wound was left open, with gauze and iodine as a cover. Gram stains and cultures returned group B streptococcus (GBS) sensitive to penicillin, and antibiotic coverage was adjusted accordingly. The patient returned to the operating room for serial debridement until the wound developed healthy granulation tissue. The patient received four units of blood and required 13 days of hospitalization. To date, he suffers from a disfiguring wound of his abdominal wall.

Considering the fact that group B streptococci live primarily in the female vagina, and that the acupuncturist was a young female, it is possible to assume that the cause for this grave illness was due to improper hygiene while treating our patient with acupuncture. Although rare, this tragic consequence of acupuncture has been seen previously by other researchers.

Case 2

A 27-year-old male with chronic cervical and back pain without any previous medical treatment or imaging was referred to a tertiary medical facility. To manage his pain, the patient used the services of a chiropractor who used cervical manipulation. Immediately after such a manipulation, the patient felt a severe cervical pain; 30 minutes after manipulation the patient started feeling paresthesia in his hands and legs. The patient was admitted to an emergency room with symptoms of progressive weakness in all four extremities and weakness. No additional symptoms were seen. Immediate MRI demonstrated an epidural hematoma at the C3-4 level (Figure 2).

Figure 2.
Figure 2.

The patient underwent immediate surgery to evacuate the hematoma via an anterior approach and C3-4 cage placement. The day after surgery the patient showed a remission of symptoms. At 6 months follow-up his remission was complete.

The literature includes several reports of SSPE immediately following a chiropractic manipulation that was considered the cause of this event. The authors of this case report concluded that chiropractic procedures can be dangerous when performed by practitioners who might be only partially trained, who might tend to perform an insufficient patient examination before the procedure, and thus endanger their patients.

On this blog, I have repeatedly warned that not all alternative treatments are free of risks. These two cases are impressive reminders of this undeniable fact.

I am sure that most proponents of alternative medicine will try to claim that

  • such complications are true rarities,
  • I am alarmist to keep alerting my readers to such events,
  • conventional medicine is dimensions more harmful,
  • the above cases are caused by poor practice.

However, I feel compelled to stress that there are no adequate post-marketing surveillance systems in alternative medicine and that the true frequencies of such events are therefore unknown. It seems therefore imperative (and not alarmist) to publicize such risks as widely as possible – in the hope that alternative practitioners, one day, might do the ethically and morally correct thing and implement proper surveillance of their practices.

Some time ago, the NYT carried an article entitled HOW YOGA CAN WRECK YOUR BODY. While this might be just a trifle alarmist, it seems clear that injuries can occur and do occur more and more – not least because yoga has become so very popular. It seems relevant therefore to ask what the risks truly are. A recent article might be useful in this respect.

The aim of this study was to examine whether a national sample of yoga practitioners would report discontinued use of yoga due to injury from the practice, assess what injuries resulted in discontinued use, determine what injuries were most common and identify injuries requiring medical attention. The authors used a secondary data analysis of a nationally representative sample of 23,393 adults from the United States.

The results indicate that less than 1% of individuals who had ever practiced yoga (n = 2230) reported an injury from yoga that led to discontinued use. Of those reporting injury, less than one-third (n = 4) reported seeking medical attention. The most commonly reported side-effect of yoga was back pain. Approximately, half of those reporting back pain sought medical attention.

The authors concluded that injury due to yoga is an infrequent barrier to continued practice and severe injury due to yoga is rare.

So, yoga is fairly safe but, in rare cases, injuries can occur. If you are interested in preventing such harm, there are some precautions you can take to make sure you do not sustain injuries.

And one last thing: in my experience,  many yoga make quite absurd claims – so, if it sounds to be too good to be true, it probably is.

Niacin – also known as vitamin B3 or nicotinic acid - is a natural compound (formula C
6
H
5
NO
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.

‘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.

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