evidence
Deep venous thrombosis (DVT) is usually a blood clot in a deep vein of a leg. It is a potentially life-threatening condition, because the clot can detach itself and end up in the lungs thus causing a pulmonary embolism which can be fatal. A DVT therefore is a medical emergency which is typically managed by immobilising the patient and putting him/her on anticoagulants.
Yet, homeopaths seem to have discovered another approach. Indian homeopaths just published a case report of a DVT in an old patient totally cured exclusively by the non-invasive method of treatment with micro doses of potentized homeopathic drugs selected on the basis of the totality of symptoms and individualization of the case. The authors concluded that, since this report is based on a single case of recovery, results of more such cases are warranted to strengthen the outcome of the present study. 
The patient was advised by his doctor to have surgery which he refused. Instead, he consulted a homeopath who treated him homoeopathically. No conventional treatments were given. The patient recovered, yet his recovery is almost certainly unrelated to the homeopathics he received. Spontaneous recovery after DVT is not uncommon, and it is almost certain that it is this what the case report describes.
It is simply not plausible, nor is there evidence that homeopathy can alter the natural history of a DVT. This means that what the Indian homeopaths have described in their paper is nothing less than a case of gross negligence. Had the patient died of a pulmonary embolism due to an untreated DVT, it could have put them behind bars.
While it is, of course, most laudable that homeopaths have taken to publishing even their most serious errors, it would be more reassuring, if they developed some sort of insight into their mistakes. Instead, they seem naively confident and stupidly ignorant of the danger they pose to the public: homeopathy can play significant therapeutic roles in very serious diseases like DVT, provided the drugs are needs to be carefully selected on the basis of i) individualization of cases, ii) the totality of symptoms and personalized data, and iii) taking into consideration the pathogenicity level and proper diagnosis of the disease. Further, homeopathy may also be safely used in patients with conventional drug allergy (antibiotics) or other physical conditions preventing intake of conventional medicines.
My conclusion and recommendation: stay away from homeopaths, folks!
Hard to believe but true: a German court recently decided that a homeopathic product called ‘HCG C30 Globuli’ is legal. HCG, of course, stands for ‘Human Chorionic Gonadotropin’, the hormone that supports the normal development of an egg in a woman’s ovary, and stimulates the release of the egg during ovulation.
The plaintiff had argued that a C30 potency contains no HCG at all, and that therefore consumers are misled by the name. To be precise, a C30 is a dilution of 1:1000000000000000000000000000000000000000000000000000000000000! This corresponds to something like one molecule of HCG per universe. The manufacturer, on the other hand, argued that their product complies with the rules of manufacturing homeopathics.
The court ruled as follows: ‘The fact that, due to the extreme dilution, the materiel cannot be identified any longer using current methodologies, does not mean that one can assume that the material is not, in fact, contained in the homeopathic drug’. As consumers who buy homeopathics are open to its tenets, they are not being misled by this product. Critics of homeopathy may see this differently; however, this group of people are unlikely to use such products. Therefore, there is no case to answer.
The judge also mentioned that, if the ruling had come out in favour of the defendant, it would have affected no end of further homeopathic products. And this, the court argued, would not be in the interest of the consumer.
For those who read German, here is the article reporting the case:
Beim Thema Homöopathie scheiden sich die Geister. Viele Wissenschaftler halten die Zuckerkügelchen bestenfalls für Placebos, andere hingegen schwören auf die heilende Wirkung. Ein Hersteller von Homöopathischen Arzneimitteln konnte nun vor Gericht einen Erfolg für sich verbuchen: Das Landgericht (LG) Darmstadt hat die Unterlassungsklage eines Vereins abgewiesen, der beantragt hatte, dem Hersteller zu verbieten, das Produkt “HCG C30 Globuli” unter dieser Bezeichnung zu bewerben oder in den Verkehr zu bringen (Urt. v. 30.01.2020, Az. 15 O 25/19).
Der Verein, dem laut Urteil beinahe alle Industrie- und Handelskammern sowie zahlreiche Apothekerkammern und Pharmaunternehmen angehören, hatte argumentiert, dass sich das Schwangerschaftshormon HCG gar nicht in den Produkten des Herstellers befinde und somit Verbraucher in die Irre führe. Die Präparate bestünden ausschließlich aus Zucker. Der Hersteller entgegnete dem, dass das Präparat HCG in der Dosierung C30 enthalte und gemäß dem Homöopathischen Arzneimittelhandbuch hergestellt worden sei.
Bei der Dosierung C30 wird der Ausgangsstoff 30 mal im Verhältnis 1:100 verdünnt. Am Ende beträgt das Verdünnungsverhältnis 1:10 hoch 60.
Dass der Ausgangsstoff bei dieser Dosierung “aufgrund der extremen Verdünnung mit den bisher bekannten wissenschaftlichen Methoden nicht mehr nachweisbar ist, führt nicht dazu, dass angenommen werden kann, dass der Stoff tatsächlich nicht in dem homöopathischen Medikament enthalten ist”, entschied das LG jedoch.
Eine Irreführung der angesprochenen Verbraucherkreise könne nicht angenommen werden, so das LG weiter. Laut Urteil müsse grundsätzlich davon ausgegangen werden, “dass es sich bei dem angesprochenen Verkehrskreis um Personen handelt, die grundsätzlich der Homöopathie offen gegenüberstehen und denen bekannt ist, dass die Wirkstoffe bei homöopathischen Arzneimitteln geringer dosiert sind, als bei klassischen schulmedizinischen Produkten.”
Anhänger der klassischen Schulmedizin würden laut Gericht hingegen davon ausgehen, dass Homöopathie wirkungslos sei und Behandlungserfolge ausschließlich auf den Placeboeffekt zurückzuführen seien. “Dieser Personenkreis wird von der Werbung der Beklagten nicht angesprochen, da klar erkennbar ist, dass ein homöopathisches Arzneimittel vertrieben wird”, entschieden die Darmstädter Richter.
Würde man der Auffassung des klagenden Vereins folgen und unterstellen, dass der Inhaltsstoff bei einer Verdünnung “C30” nicht enthalten ist, würde dies laut Gericht dazu führen, dass eine Vielzahl homöopathischer Arzneien nicht mehr vertrieben werden dürfte. “Ein solches faktisches Verbot dürfte sicherlich nicht im Sinne der Verbraucher sein, die – aus welchen Gründen auch immer – von einer gewissen Möglichkeit der Wirksamkeit homöopathischer Arzneimittel, auch in der Verdünnung C30 ausgehen”, hieß es im Urteil.
Auch die von dem Verein vorgeschlagene Verwendung von Phantasiebezeichnungen für die fraglichen Produkte lehnte das Gericht ab. Da Angaben zu Anwendungsgebieten bzw. Beschwerden bereits aufgrund gesetzlicher Vorgaben “zum Nachteil des Verbrauchers” verboten worden seien, würden Phantasiebezeichnungen eine Anwendung nach der klassischen Homöopathie erheblich erschweren, “wenn nicht gar unmöglich machen.”
[see also here]
Apart from the fact that homeopathic HCG makes no sense (for which condition should it be effective?), what has happened here, it seems to me is nothing less that the German judiciary defending the madness of homeopathy.
An article in the ‘Long Island Press’ caught my attention. Here are some excerpts:
A simple painless spinal adjustment by a chiropractor could be the latest breakthrough in the treatment of drug and alcohol addiction… Bridge Back to Life, an outpatient addiction treatment program, has teamed up with New York Chiropractic College (NYCC) … to offer the latest breakthrough therapy for substance use disorder. The first-of-a kind partnership, the brainchild of Bridge Back to Life’s medical director Dr. Russell Surasky, brings doctors from NYCC to evaluate and treat the center’s patients undergoing addiction therapy. Several diagnostic tests are performed at the base of the brainstem to determine if a misalignment exists. If present, the practitioners are taught to incorporate gentle painless, corrective spinal adjustments into the patient’s care plan. This treatment reduces stress on the spinal column and limbic system of the brain…
“Safe, painless adjustments to the upper cervical spinal bones can help normalize the brain’s limbic system by helping with the overall circulation of cerebrospinal fluid of the brain… I truly believe that this agreement with the college will serve as a national model for drug rehabilitation centers throughout the country,” says Surasky, who is triple board certified in neurology, addiction medicine, and preventive medicine. “Not only can spinal adjustments reduce the chronic pain issues that may have led patients into drug addiction in the first place, but now we also have evidence that spinal adjustments actually accelerate the healing of the brain from addiction.”
Surasky points to a study done in 2001 in the journal Nature: Molecular Psychiatry, which looked at the impact of spinal manipulations at an inpatient addiction treatment facility in Miami. The study found that chemically dependent patients who received specific spinal adjustments as part of their treatment reported fewer drug cravings and mental health symptoms. Moreover, 100 percent of the study patients who received chiropractic care completed the inpatient program, while about half of those not receiving treatments dropped out prior to completion. Yet no further studies were performed, and the information languished. Surasky began treating patients with the spinal adjustments at his private practice in Great Neck before bringing the treatment to Bridge Back to Life.
Mary W. came to Surasky’s Great Neck office for help with alcohol addiction nearly one year ago. She received monthly Vivitrol shots and had marked success in curbing her cravings and drastically reducing her drinking. But Mary still had one-day “slips” from time to time. She also complained of insomnia and migraine headaches. She recalled an accident in the past, where she hit her head. Dr. Surasky took X-rays of her upper neck and performed a Tytron scan. He said the digital images showed she had misalignments at the C1 vertebral level, likely putting pressure on the lower brainstem area. In addition to Vivitrol shots, Mary started receiving upper cervical adjustments and has remained sober since. Her migraines have dropped from five per month to one or none and she is sleeping better.
Where to start?
There is much to be concerned about in this short article. Let me mention just a few obvious points:
- A treatment that is not backed by solid evidence is hardly a ‘breakthrough’.
- The ‘misalignments’ they are looking for do not exist.
- Spinal manipulation is not as safe as presented here.
- The assumption that it reduces stress on the limbic system is far-fetched.
- To suggest this approach as a ‘national model’, is simply ridiculous.
- The notion that adjustments increase the circulation of the cerebrospinal fluid is not evidence-based.
- What are ‘chronic pain tissues’?
- The claim that spinal manipulation accelerates healing of the brain is not evidence-based.
- The study in Nature Molecular Psychiatry does not seem to exist (I could not find it, if anyone can, please let me know).
- X-ray diagnostics cannot diagnose ‘misalignments’.
- Tytron scans are used mostly by chiropractors are not a reliable diagnostic method.
- Anecdotes are not evidence.
In short: this article reads like an advertisement for chiropractic as a treatment of addictions. As there is no evidence that chiropractic spinal manipulations are effective for this indication, it is hard to think of anything more irresponsible than that.
And here is the question that I often ask myself:
Are there any bogus, profitable, unethical claims that chiropractors would shy away from?
The website of this organisation is always good for a surprise. A recent announcement relates to a course of Thought Field Therapy (TFT):
As part of our ongoing programme to explore prospects for improved healthcare, the College is pleased to announce a course on TFT – a “Tapping” therapy – independently provided by Janet Thomson MSc.
In healthcare we may find ourselves exhausting the evidence-based options and still looking for ways to help our patients. So when trusted practitioners suggest simple and safe approaches that appear to have benefit we are interested.
TFT is a simple non-invasive, technique that anyone can learn, for themselves or to pass on to their patients, to help cope with negative thoughts and emotions. It was developed by Roger Callahan who discovered that tapping on certain meridian points could help counter negative emotions. Janet trained with Roger and has become an accomplished exponent of the technique.
Janet has contracted her usual two-day course into one: to get the most from this will require access to her Tapping For Life book and there will be pre-course videos demonstrating some of the key techniques. The second consecutive day is available for advanced TFT training, to help in dealing with difficult cases, as well as how to integrate TFT with other modalities.
How much does it cost (excluding booking fee)? Day One only – £195; Day Two only – £195 (only available if you have previously completed day one); Both Days – £375.
When is it? Saturday & Sunday 7th-8th March – 09:30-17:30
What, you don’t know what TFT is? Let me fill you in.
According to Wiki, TFT is a fringe psychological treatment developed by an American psychologist, Roger Callahan.[2] Its proponents say that it can heal a variety of mental and physical ailments through specialized “tapping” with the fingers at meridian points on the upper body and hands. The theory behind TFT is a mixture of concepts “derived from a variety of sources. Foremost among these is the ancient Chinese philosophy of chi, which is thought to be the ‘life force’ that flows throughout the body”. Callahan also bases his theory upon applied kinesiology and physics.[3] There is no scientific evidence that TFT is effective, and the American Psychological Association has stated that it “lacks a scientific basis” and consists of pseudoscience.[2]
Other assessments are even less complimentary: Thought field therapy (TFT) is a New Age psychotherapy dressed up in the garb of traditional Chinese medicine. It was developed in 1981 by Dr. Roger Callahan, a cognitive psychologist. While treating a patient for water phobia:
He asked her to think about water, tap with two fingers on the point that connected with the stomach meridian and much to his surprise, her fear of water completely disappeared.*
Callahan attributes the cure to the tapping, which he thinks unblocked “energy” in her stomach meridian. I don’t know how Callahan got the idea that tapping on a particular point would have anything to do with relieving a phobia, but he claims he has developed taps for just about anything that ails you, including a set of taps that can cure malaria (NPR interview).
TFT allegedly “gives immediate relief for post traumatic stress disorder (PTSD ), addictions, phobias, fears, and anxieties by directly treating the blockage in the energy flow created by a disturbing thought pattern. It virtually eliminates any negative feeling previously associated with a thought.”*
The theory behind TFT is that negative emotions cause energy blockage and if the energy is unblocked then the fears will disappear. Tapping acupressure points is thought to be the means of unblocking the energy. Allegedly, it only takes five to six minutes to elicit a cure. Dr. Callahan claims an 85% success rate. He even does cures over the phone using “Voice Technology” on infants and animals; by analyzing the voice he claims he can determine what points on the body the patient should tap for treatment.
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Yes, TFT seems utterly implausible – but what about the clinical evidence?
There are quite a few positive controlled clinical trials of TFT. They all have one thing in common: they smell fishy to me! I know, that’s not a very scientific judgement. Let me rephrase it: I am not aware of a single trial that proves TFT to have effects beyond placebo (if you know one, please post the link).
And Janet Thomson, MSc (the therapist who runs the course), who is she? Her website is revealing; have a look if you are interested. If not, it might suffice to say that she modestly claims that she is an outstanding Life Coach, Therapist & Trainer.
So, considering that TFT is so very implausible and unproven, why does the ‘College of Medicine and Integrated Healthcare’ promote it in such strong terms?
I have to admit, I do not know the answer – perhaps they want at all costs to become known as the ‘College of Quack Medicine’?
I missed this article by Canadian vascular surgeons when it came out in 2018. It is well-argued, and I think you should read it in full, if you can get access (it’s behind a pay wall). It contains interesting details about the anti-vax attitude of doctors of integrative medicine (something we discussed before), as well as the most dubious things that go on in the ‘Cleveland Clinic’. Here is at least the abstract of the article:
Evidence-based medicine, first described in 1992, offers a clear, systematic, and scientific approach to the practice of medicine. Recently, the non-evidence-based practice of complementary and alternative medicine (CAM) has been increasing in the United States and around the world, particularly at medical institutions known for providing rigorous evidence-based care. The use of CAM may cause harm to patients through interactions with evidence-based medications or if patients choose to forego evidence-based care. CAM may also put financial strain on patients as most CAM expenditures are paid out-of-pocket. Despite these drawbacks, patients continue to use CAM due to media promotion of CAM therapies, dissatisfaction with conventional healthcare, and a desire for more holistic care. Given the increasing demand for CAM, many medical institutions now offer CAM services. Recently, there has been controversy surrounding the leaders of several CAM centres based at a highly respected academic medical institution, as they publicly expressed anti-vaccination views. These controversies demonstrate the non-evidence-based philosophies that run deep within CAM that are contrary to the evidence-based care that academic medical institutions should provide. Although there are financial incentives for institutions to provide CAM, it is important to recognize that this legitimizes CAM and may cause harm to patients. The poor regulation of CAM allows for the continued distribution of products and services that have not been rigorously tested for safety and efficacy. Governments in Australia and England have successfully improved regulation of CAM and can serve as a model to other countries.
Those who have been following this blog a little know how much I agree with these authors. In fact, in the peer-reviewed literature, I have been publishing similar arguments for almost 20 years, e.g:
- Integrative medicine: not a carte blanche for untested nonsense. Ernst E. Arch Intern Med 2002. PMID 12153386
- Disentangling integrative medicine Ernst E. Mayo Clin Proc 2004 – Review. PMID 15065622
- Integrated medicine. Ernst E. J Intern Med 2012. PMID 21682782 Free article.
- Integrative medicine: more than the promotion of unproven treatments? Ernst E. Med J Aust 2016. PMID 26985838
The ‘neurocalometer’ (NCM) is a device promoted from 1924 by BJ Palmer (the son of DD Palmer, the founder of chiropractic) which he claimed could locate subluxations. Even though it was useless for diagnosing anything, thousands of chiropractors swore by it and some use it to the present day. This enthusiast, for instance, justifies it by claiming that abnormal signals generated by spinal misalignments travel into the spinal cord along nerve fibers which connect directly to the part of the nervous system that controls blood flow in the skin. These abnormal signals disrupt the ability of the nervous system to keep the skin temperature even and balanced. The resulting temperature imbalance can be detected using the Neurocalometer or a similar device.
The history of the NCM is most revealing. BJ Palmer more or less forced his followers into a leasing agreement with the Palmer School of Chiropractic (PSC). The lease duration was 10 years, roughly the same amount of time as the patent rights on the device would last. “Leasees were required to charge patients ten dollars per NCM reading (a sum that is equivalent to charging >60 US$ for that service today). BJ’s historic speech at lyceum (August 24, 1924), “The Hour Has Struck”, provided the opportunity to announce: The price until midnight September 14th remains the same. Beginning tomorrow morning at eight o’clock $100 cash and 13 payments of $50 each, each month, and when $500 has been paid you will be entitled to your technique and your Neurocalometer .. . Those who pay the full cash of $500 in advance now get preferential position and delivery overall-time-payment contracts. The price after midnight of September 14th will raise to $2,200, or an increase of $700. The terms will then be $200 cash and $100 a month until $1,000 has been paid, at which time you will be entitled to your technique and your Neurocalometer … this same easy plan has gone out to the entire field …
This sales ploy was so successful that Western Union’s local cash reserves were apparently unable to keep pace with the hundreds of incoming contracts on September 14. The next day, BJ penned an article for the Fountain Head News (FHN) announcing a further increase, from $2,200 to $3,000 for the 10 year lease, and tentatively set to take effect on January 1, 1925. The NCM, he explained, has established itself, its earning values have been printed for your information, letters from users have been printed and distributed to you – it is no longer an unknown quantity. It has established itself . The price for the NCM eventually reached an initial fee of $3,500 and a monthly rental fee of $5. By comparison, an expensive car then costs $1,000, and a home could be purchased for $3,500.
BJ viewed the introduction of the NCM as a means of producing fundamental change throughout the chiropractic profession. From his perspective he was not merely marketing a device, but was organizing a straight chiropractic renaissance. BJ spoke frequently of his “BACK-TO-CHIROPRACTIC-NEUROCALOMETER MOVEMENT” He likened chiropractic to a cow, and asked: Whose cow is Chiropractic anyway? It is more my cow or your cow? Must I always stand at the feeding end? Can’t I get a glass of milk once in a while? Who is that man that speaks to me about the rights of the sick to get well? Who is that man that dares say I am the downfall of this profession? Do you know of any chiropractor adjusting for fifty cents when he could collect five dollars, just for the love of the rights of the sick to get well? Do you know of any reducing their price on the theory of their love for the rights of the sick to get well if he could get it?
BJ claimed that the NCM is a very delicate, sensitive instrument which, when placed upon the spine:
- Verifies the proper places for adjustments.
- It measures the specific degree of vertebral pressures upon nerves.
- It measures the specific degree of interference to transmission of mental impulses as a result of vertebral pressure.
- It proves the exact intervertebral foramina that contains bone pressure upon nerves.
- It proves when the pressure has been released upon nerves at a specific place.
- It proves how much pressure was released, if any.
- It verifies the differences between cord pressure or spinal nerve pressure cases.
- It establishes which cases we can take and which we should leave alone.
- It proves by an established record which you can see thereby eliminating all guesswork on diagnoses.
- It establishes, from week to week, whether you are getting well or not.
- It makes possible a material reduction in time necessary to get well, thus making health cheaper….
The NCM was not invented by BJ but by Dossa Dixon Evins, one of the lesser-known figures in chiropractic history. Evins was a vaudeville entertainer with his wife Billie, an inventor, electrical engineer, and a radio operator for the Secret Service during World War I. Yet, it was BJ who took the glory and the money: Along comes the Neurocalometer. You hear me tell much good about it. You hear me say that it is “THE MOST VALUABLE INVENTION OF THE AGE BECAUSE IT PICKS, PROVES AND LOCATES THE CAUSE OF ALL DIS-EASES OF THE HUMAN RACE.
Of course, BJ insisted that his claims were based on extensive scientific research: Experimental work on approximately a thousand cases had proven there are many subluxations in the spine which the X-Ray does not locate, causing pressure upon nerves. This instrument locates them. Experimental work also shows that by using the instrument as a check, results can be obtained in from one-fourth to one-half the time now necessary under the present method. In other words, should it take 100 adjustments to get a case well now, it would take only 25 to 50 to get the same case well using the new NEUROCALOMETER. So superior was the device that even BJ himself could not find subluxations as accurately as the NCM:. . . Eighteen months of education when focalized down to a pin point means where to pick majors and why . . . in 30 minutes the Neurocalometer can do more in picking correct majors than anybody attending school for 17 months, or more than I can do after 28 years.
However, not everyone was impressed and some chiropractors even objected openly to BJ and his machinations. The result was that the chiropractic profession split into:
- those who followed BJ’s instructions (the ‘straights’)
- and those who either could not afford to or were not convinced by BJ (the ‘mixers’).
Dissatisfaction with Palmer and with the “intimidation” policies of the Universal Chiropractors’ Association (UCA) had already been growing. Now it reached into the UCA to such an extent that BJ resigned to form (in 1926) the Chiropractic Health Bureau (today’s International Chiropractors’ Association). By 1930, the UCA and other organizations had merged to form the National Chiropractic Association, immediate predecessor of today’s American Chiropractic Association.
The years immediately following the NCM’s introduction were a a period of extraordinary prosperity for BJ and his PSC. Classes filled, debts were paid and plans for additional buildings were drawn; the prosperity would continue until the stock market crash of 1929, in which the Palmer family suffered substantial financial loss. As many as a thousand NCMs may have been leased in the first year; this suggests at least several millions of dollars in revenues, a fabulous sum in the 1920s. The chiropractic historian Keating stated that the NCM’s introduction provides a model of unethical promotions in health care.
The PSC eventually revived with the influx of veterans after World War 2. Rentals of the NCM (and derivative instruments) continued, and a firm core of true believers in BJ remained loyal. Today, the PSC continues to provide repair services for the NCM, although new contracts for the device ceased to be issued in 1990. Similar thermocouple devices remain popular among subluxation-based chiropractors and several models are still marketed.
A widely used chiropractic paediatrics textbook (Pediatric Chiropractic. Baltimore: Williams & Wilkins, 1998, pp 323-423) even advises that such devices are useful for examining new-borns: The purpose of skin temperature analysis (e.g. Temp-o-scope, Nervoscope) is to obtain objective neurological evidence of a vertebral subluxation complex [VSC]. . . .
Today is Valentine’s Day, a good moment to take a critical look at some of the libido-boosters so-called alternative medicine (SCAM) has to offer. The Internet offers plenty; this website, for instance, advertises over 20 different natural (mostly botanical) products. But such sites are typically thin on evidence.
A quick Medline search locates plenty of research. Much of it seems to be on rats which is not so relevant – unless, of course, your husband is a rat. In terms of clinical trials, Medline too is not all that informative. Here are some of the studies I found:
Eurycoma longifolia is reputed as an aphrodisiac and remedy for decreased male libido. A randomized, double-blind, placebo controlled, parallel group study was carried out to investigate the clinical evidence of E. longifolia in men. The 12-week study in 109 men between 30 and 55 years of age consisted of either treatment of 300 mg of water extract of E. longifolia (Physta) or placebo. Primary endpoints were the Quality of Life investigated by SF-36 questionnaire and Sexual Well-Being investigated by International Index of Erectile Function (IIEF) and Sexual Health Questionnaires (SHQ); Seminal Fluid Analysis (SFA), fat mass and safety profiles. Repeated measures ANOVA analysis was used to compare changes in the endpoints. The E. longifolia (EL) group significantly improved in the domain Physical Functioning of SF-36, from baseline to week 12 compared to placebo (P = 0.006) and in between group at week 12 (P = 0.028). The EL group showed higher scores in the overall Erectile Function domain in IIEF (P < 0.001), sexual libido (14% by week 12), SFA- with sperm motility at 44.4%, and semen volume at 18.2% at the end of treatment. Subjects with BMI ≥ 25 kg/m(2) significantly improved in fat mass lost (P = 0.008). All safety parameters were comparable to placebo.
Yoga is a popular form of complementary and alternative treatment. It is practiced both in developing and developed countries. Use of yoga for various bodily ailments is recommended in ancient ayvurvedic (ayus = life, veda = knowledge) texts and is being increasingly investigated scientifically. Many patients and yoga protagonists claim that it is useful in sexual disorders. We are interested in knowing if it works for patients with premature ejaculation (PE) and in comparing its efficacy with fluoxetine, a known treatment option for PE. Aim: To know if yoga could be tried as a treatment option in PE and to compare it with fluoxetine. Methods: A total of 68 patients (38 yoga group; 30 fluoxetine group) attending the outpatient department of psychiatry of a tertiary care hospital were enrolled in the present study. Both subjective and objective assessment tools were administered to evaluate the efficacy of the yoga and fluoxetine in PE. Three patients dropped out of the study citing their inability to cope up with the yoga schedule as the reason. Main outcome measure: Intravaginal ejaculatory latencies in yoga group and fluoxetine control groups. Results: We found that all 38 patients (25-65.7% = good, 13-34.2% = fair) belonging to yoga and 25 out of 30 of the fluoxetine group (82.3%) had statistically significant improvement in PE. Conclusions: Yoga appears to be a feasible, safe, effective and acceptable nonpharmacological option for PE. More studies involving larger patients could be carried out to establish its utility in this condition.
Antidepressants including selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenaline reuptake inhibitors (SNRIs) are known to cause secondary sexual dysfunction with prevalence rates as high as 50%-90%. Emerging research is establishing that acupuncture may be an effective treatment modality for sexual dysfunction including impotence, loss of libido, and an inability to orgasm. Objectives: The purpose of this study was to examine the potential benefits of acupuncture in the management of sexual dysfunction secondary to SSRIs and SNRIs. Subjects: Practitioners at the START Clinic referred participants experiencing adverse sexual events from their antidepressant medication for acupuncture treatment at the Mood and Anxiety Disorders, a tertiary care mood and anxiety disorder clinic in Toronto. Design: Participants received a Traditional Chinese Medicine assessment and followed an acupuncture protocol for 12 consecutive weeks. The acupuncture points used were Kidney 3, Governing Vessel 4, Urinary Bladder 23, with Heart 7 and Pericardium 6. Participants also completed a questionnaire package on a weekly basis. Outcomes measured: The questionnaire package consisted of self-report measures assessing symptoms of depression, anxiety, and various aspects of sexual function. Results: Significant improvement among male participants was noted in all areas of sexual functioning, as well as in both anxiety and depressive symptoms. Female participants reported a significant improvement in libido and lubrication and a nonsignificant trend toward improvement in several other areas of function. Conclusions: This study suggests a potential role for acupuncture in the treatment of the sexual side-effects of SSRIs and SNRIs as well for a potential benefit of integrating medical and complementary and alternative practitioners.
The primary objectives were to compare the efficacy of extracts of the plant Tribulus terrestris (TT; marketed as Tribestan), in comparison with placebo, for the treatment of men with erectile dysfunction (ED) and with or without hypoactive sexual desire disorder (HSDD), as well as to monitor the safety profile of the drug. The secondary objective was to evaluate the level of lipids in blood during treatment. Participants and design: Phase IV, prospective, randomized, double-blind, placebo-controlled clinical trial in parallel groups. This study included 180 males aged between 18 and 65 years with mild or moderate ED and with or without HSDD: 90 were randomized to TT and 90 to placebo. Patients with ED and hypertension, diabetes mellitus, and metabolic syndrome were included in the study. In the trial, an herbal medicine intervention of Bulgarian origin was used (Tribestan®, Sopharma AD). Each Tribestan film-coated tablet contains the active substance Tribulus terrestris, herba extractum siccum (35-45:1) 250mg which is standardized to furostanol saponins (not less than 112.5mg). Each patient received orally 3×2 film-coated tablets daily after meals, during the 12-week treatment period. At the end of each month, participants’ sexual function, including ED, was assessed by International Index of Erectile Function (IIEF) Questionnaire and Global Efficacy Question (GEQ). Several biochemical parameters were also determined. The primary outcome measure was the change in IIEF score after 12 weeks of treatment. Complete randomization (random sorting using maximum allowable% deviation) with an equal number of patients in each sequence was used. This randomization algorithm has the restriction that unequal treatment allocation is not allowed; that is, all groups must have the same target sample size. Patients, investigational staff, and data collectors were blinded to treatment. All outcome assessors were also blinded to group allocation. Results: 86 patients in each group completed the study. The IIEF score improved significantly in the TT group compared with the placebo group (Р<0.0001). For intention-to-treat (ITT) there was a statistically significant difference in change from baseline of IIEF scores. The difference between TT and placebo was 2.70 (95% CI 1.40, 4.01) for the ITT population. A statistically significant difference between TT and placebo was found for Intercourse Satisfaction (p=0.0005), Orgasmic Function (p=0.0325), Sexual Desire (p=0.0038), Overall Satisfaction (p=0.0028) as well as in GEQ responses (p<0.0001), in favour of TT. There were no differences in the incidence of adverse events (AEs) between the two groups and the therapy was well tolerated. There were no drug-related serious AEs. Following the 12-week treatment period, significant improvement in sexual function was observed with TT compared with placebo in men with mild to moderate ED. TT was generally well tolerated for the treatment of ED.
What makes me suspicious about these trials is that:
- they are mostly on the flimsy side,
- there are as good as no independent replications,
- they all report positive outcomes. I was unable to find a single study where the authors concluded: SORRY, BUT THIS STUFF IS USELESS!
Disappointed with the quality and the content of the existing trials, I am now off to buy some oysters!
The University College London Hospitals (UCLH) include the ‘Royal London Hospital for Integrated Medicine’ (RLHIM). The RLHIM offers a range of so-called alternative medicines (SCAMs), including acupuncture.
This is how they advertise traditional acupuncture to the unsuspecting public:
Acupuncture is a part of Traditional Chinese Medicine (TCM). This is a system of healing which has been practised in China and other Eastern countries for thousands of years.
Although often used as a means of pain relief, it can treat people with other illnesses. The focus is on improving the overall well-being of the patient, rather than the isolated treatment of specific symptoms.
You will be seen individually and assessed by an acupuncturist trained in TCM. They will use traditional Chinese techniques including pulse, tongue and abdominal diagnosis. They will also ask you about your medical history and lifestyle.
The TCM trained acupuncturist can stimulate the body’s own healing response and help to restore its natural balance.
The principal aim of acupuncture in treating the whole person is to create balance between your physical, emotional and spiritual needs. It can help to relax, improve mood and sleep, relieve tension and improve your sense of well-being, as well as improving symptoms.
We will assess your individual needs and discuss a treatment plan with you during your initial consultation.
The treatment may include the use of the following:
- The use of fine acupuncture needles
- Moxibustion (burning of the herb mugwort close to the surface of the skin)
- Cupping therapy (to create local suction on the skin)
- Acupressure (pressure applied to acu-points to stimulate energy flow)
- Electro-acupuncture (a low voltage current is passed between 2 needles)
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How reliable is this information? I will try to answer this question by discussing the 6 statements that, in my view, are most questionable.
Although often used as a means of pain relief, it can treat people with other illnesses
Whether acupuncture is effective for pain relief is debatable. A recent analysis cast considerable doubt on the assumption. The notion that acupuncture ‘can treat people with other illnesses’ seems like a ‘carte blanche’ for treating virtually any condition regardless of evidence.
Improving the overall well-being of the patient
I am not aware of sound evidence that acupuncture is an effective treatment for improving overall well-being.
Traditional Chinese techniques including pulse, tongue and abdominal diagnosis
These diagnostic techniques have not been adequately validated and have no place in evidence-based healthcare.
The TCM trained acupuncturist can stimulate the body’s own healing response and help to restore its natural balance
I am not aware of sound evidence to show that acupuncture stimulates healing. The statement seems like another ‘carte blanche’ for treating anything the therapist feels like, regardless of evidence.
The principal aim of acupuncture in treating the whole person is to create balance between your physical, emotional and spiritual needs
The claim that acupuncture is a holistic treatment is based on little more than wishful thinking by acupuncturists.
It can help to relax, improve mood and sleep, relieve tension and improve your sense of well-being, as well as improving symptoms
I am not aware of sound evidence that acupuncture is effective in treating any of the named conditions. The end of the sentence (‘as well as improving symptoms’) is another ‘carte blanche’ for doing anything the acupuncturists feels like.
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The UCLH are firmly committed to EBM. The RLHIM claims to be ‘a centre for evidence-based practice’. This claim is not supported by the above advertisement of acupuncture which is clearly not based on good evidence. Moreover, it has the potential to mislead vulnerable patients and thus cause considerable harm. In my view, it is high time that the UCLH address this problem.
The Indian AYUSH quacks are rarely out of the headlines these days. After recently promoting homeopathy for the coronavirus epidemic, they are at it yet again. This time they seem to want us to believe that homeopathy is an effective cancer therapy. And guess who is helping them promote this dangerous claim? Yes, it’s the “Pyromaniac In a Field of (Integrative) Straw Men”, Michael Dixon!
“Time for integration has come and it is not because allopathic medicines fail in treatment but rather it is the demand of the people and patients worldwide,” said Dr Michael Dixon, Chair-College of Medicine and Integrated Health, UK, and Visiting Professor, University of Westminster and University College London, while inaugurating the two-day ‘International Conference on Integrative Oncology 2020. The ICIO 2020 is held in Indai in association with Central Health & FW Ministry, AYUSH/TCAM Ministry, all AYUSH/TCAM research councils and the governments of Kerala and Maharashtra, and National AYUSH Mission and organised by the Global Homeopathy Foundation (GHF).
Dr Dixon called upon integration of various medical streams while combating diseases. He pointed out that anti-microbial resistance, over-prescription of opiates and over-prescription of conventional medicines have compounded the situation. “Enormous issues persist back in United Kingdom (UK), National Health Services (NHS) England banned herbal and homoeopathic medicines while Royal College of General Practitioners asked general practitioners not to offer Homoeopathy and National Institute for Clinical Excellence changed guidelines on palliative care and back pain,” said Dr Dixon.
However, he said the good news is that at last AYUSH has arrived in UK with the College of Medicine and Integrated Health taking the lead. “Integration of medical systems is of paramount importance in oncology for prevention, treatment, treating side-effects of conventional medicine and preventing recurrence.”
Those who address the inaugural function include:
- Dr Jayesh Sanghavi, vice- chairman GHF,
- Dr T K Harindranath, president, Indian Homoeopathic Medical Association,
- Dr Piyush Joshi, secretary general, Homoeopathic Medical Association of India,
- Dr Eswaradas, chairman, GHF, Dr Issac Mathai, Soukya Holistic Clinic,
- Dr Velavan, Radiation Oncologist, Erode Cancer Centre,
- Dr Sandeep Roy, chairman, organising committee ICIO 2020,
- Dr Madhavan Nambiar IAS (retd), Patron GHF
- Dr Sreevals G Menon, Managing Trustee, GHF
Around 25 papers are being presented at the summit. Two of them stand out, in my view:
- Dr Vinu Krishnan, member, sub-committee on cancer, Central Council for Research in Homoeopathy, New Delhi, Analysis and observations of stage 3 and 4 lung cancers using homoeopathic interventions
- Dr Ravi, associate professor with Virar Homoeopathic Medical College, Mumbai, Clinical assessment of homeopathy and its role in survival in 3rd and 4th stage cancers
I find it imperative to point out that, according to the best evidence available to date, there is no reason to believe that:
- Homeopathy is effective in stage 3 and 4 lung cancers
- Homeopathy has positive effects on cancer survival
In my view, anyone who makes desperate cancer patients believe otherwise or supports conferences where such notions are being promoted is a dangerous charlatan.
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PS
In case you are new to this blog and have not heard of Dr Dixon, allow me to alert you to 4 previous posts:
Johrei healing and the amazing Dr Dixon (presidential candidate for the RCGP)
Dr Dixon’s safe herbal medicine
Prince Charles becomes patron of the ‘College of Medicine and Integrated Health’
What is pseudoscience and how can it be differentiated from science? This ‘demarcation problem’ has occupied many of our best minds and which nevertheless is largely unresolved. Two brave academics have recently published a paper aimed at providing organisations within the justice system with an overview of:
a) what science is and is not;
b) what constitutes an empirically driven, theoretically founded, peer-reviewed approach;
c) how to distinguish science from pseudoscience.
In it, they demonstrate that not all information which is presented as comprehensively evaluated is methodologically reliable for use in the justice system. Even though it does not really solve the old demarcation problem, I found their article important and informative and therefore take the liberty of quoting a brief excerpt here:
Organisations within the justice system do use empirically and theoretically supported approaches. However, some implemented approaches lack empirical evidence. In more perturbing cases, police officers, lawyers and judges may resort to pseudoscience – that is, bodies of information that may appear to be scientific but, in reality, lack the characteristics of scientific knowledge. … if members of the justice community are not advised about the publishing process then pseudoscientists can be fairly proficient at providing counterarguments. In addition, pseudoscientists can use several other fallacious arguments to achieve maximum support for their approaches.
For example, pseudoscientists might argue that their approaches are supported by a select number of articles, theses or books, and that they are reliable due to their acceptance by important organisations. However, if upon reading such literature it becomes apparent that there is no empirical or theoretical support, or that the steps leading to the conclusions are not thoroughly justified (be this methodologically or through evaluation), the implementation of their approaches remains merely destitute of vision. In addition, such reference to important organisations – often known as ‘name-dropping’–is detrimental by nature; doing so lends support to the notion that one might be unable to distinguish pseudoscience from science and may not understand the role that science plays in developing better professional practice.
Fallacious arguments from pseudoscientists can also address negative comments in a way that attempts to discourage further criticism from members of the scientific community. They can engage in legal threats and ad hominem attacks – that is, opposition to an argument ‘by questioning the personal circumstances or personal trustworthiness of the arguer who advanced it’. For example, if academics raise concerns regarding a particular pseudoscience without having attended its associated seminars, pseudoscientists might assert that the academics do not have the required understanding and that, as such, their criticism is of no value. If the academics had indeed attended the seminars, the pseudoscientists might instead suggest that their concerns are raised out of obscure or malicious reasons. Pseudoscientists might even state that they are criticised due to their revolutionary approach and refer to a quote dubiously attributed to the German philosopher Arthur Schopenhauer: ‘All truth passes through three stages. First, it is ridiculed. Second, it is violently opposed. Third, it is accepted as self-evident’. However, as Sagan rightly points out,
the fact that some geniuses were laughed at does not imply that all who are laughed at are geniuses. They laughed at Columbus, they laughed at Fulton, they laughed at the Wright brothers. But they also laughed at Bozo the Clown.
