Yesterday, BBC NEWS published the following interesting text about a BBC4 broadcast entitled ‘THE ROYAL ACTIVIST’ aired on the same day:
Prince Charles has been a well-known supporter of complementary medicine. According to a… former Labour cabinet minister, Peter Hain, it was a topic they shared an interest in.
“He had been constantly frustrated at his inability to persuade any health ministers anywhere that that was a good idea, and so he, as he once described it to me, found me unique from this point of view, in being somebody that actually agreed with him on this, and might want to deliver it.”
Mr Hain added: “When I was Secretary of State for Northern Ireland in 2005-7, he was delighted when I told him that since I was running the place I could more or less do what I wanted to do.***
“I was able to introduce a trial for complementary medicine on the NHS, and it had spectacularly good results, that people’s well-being and health was vastly improved.
“And when he learnt about this he was really enthusiastic and tried to persuade the Welsh government to do the same thing and the government in Whitehall to do the same thing for England, but not successfully,” added Mr Hain.
*** obviously there is no homeopathic remedy for megalomania (but that’s a different story)
SPECTACULARLY GOOD RESULTS?
Let’s have a look at the ‘trial’ and its results. An easily accessible report provides the following details about it:
From February 2007 to February 2008, Get Well UK ran the UK’s first government-backed complementary therapy pilot. Sixteen practitioners provided treatments including acupuncture, osteopathy and aromatherapy, to more than 700 patients at two GP practices in Belfast and Derry.
The BBC made an hour long documentary following our trials and tribulations, which was broadcast on BBC1 NI on 5 May 2008.
Aims and Objectives
The aim of the project was to pilot services integrating complementary medicine into existing primary care services in Northern Ireland. Get Well UK provided this pilot project for the Department for Health, Social Services and Public Safety (DHSSPS) during 2007.
The objectives were:
- To measure the health outcomes of the service and monitor health improvements.
- To redress inequalities in access to complementary medicine by providing therapies through the NHS, allowing access regardless of income.
- To contribute to best practise in the field of delivering complementary therapies through primary care.
- To provide work for suitably skilled and qualified practitioners.
- To increase patient satisfaction with quick access to expert care.
- To help patients learn skills to improve and retain their health.
- To free up GP time to work with other patients.
- To deliver the programme for 700 patients.
The results of the pilot were analysed by Social and Market Research, who produced this report.
The findings can be summarised as follows:
Following the pilot, 80% of patients reported an improvement in their symptoms, 64% took less time off work and 55% reduced their use of painkillers.
In the pilot, 713 patients with a range of ages and demographic backgrounds and either physical or mental health conditions were referred to various complementary and alternative medicine (CAM) therapies via nine GP practices in Belfast and Londonderry. Patients assessed their own health and wellbeing pre and post therapy and GPs and CAM practitioners also rated patients’ responses to treatment and the overall effectiveness of the scheme.
• 81% of patients reported an improvement in their physical health
• 79% reported an improvement in their mental health
• 84% of patients linked an improvement in their health and wellbeing directly to their CAM treatment
• In 65% of patient cases, GPs documented a health improvement, correlating closely to patient-reported improvements
• 94% of patients said they would recommend CAM to another patient with their condition
• 87% of patient indicated a desire to continue with their CAM treatment
Painkillers and medication
• Half of GPs reported prescribing less medication and all reported that patients had indicated to them that they needed less
• 62% of patients reported suffering from less pain
• 55% reported using less painkillers following treatment
• Patients using medication reduced from 75% before treatment to 61% after treatment
• 44% of those taking medication before treatment had reduced their use afterwards
Health service and social benefits
• 24% of patients who used health services prior to treatment (i.e. primary and secondary care, accident and emergency) reported using the services less after treatment
• 65% of GPs reported seeing the patient less following the CAM referral
• Half of GPs said the scheme had reduced their workload and 17% reported a financial saving for their practice
• Half of GPs said their patients were using secondary care services less.
Impressed? Well, in case you are, please consider this:
- there was no control group
- therefore it is not possible to attribute any of the outcomes to the alternative therapies offered
- they could have been due to placebo-effects
- or to the natural history of the disease
- or to regression towards the mean
- or to social desirability
- or to many other factors which are unrelated to the alternative treatments provided
- most outcome measures were not objectively verified
- the patients were self-selected
- they would all have had conventional treatments in parallel
- this ‘trial’ was of such poor quality that its findings were never published in a peer-reviewed journal
- this was not a ‘trial’ but a ‘pilot study’
- pilot studies are not normally for measuring outcomes but for testing the feasibility of a proper trial
- the research expertise of the investigators was close to zero
- the scientific community merely had pitiful smiles for this ‘trial’ when it was published
- neither Northern Ireland nor any other region implemented the programme despite its “spectacularly good results”.
So, is the whole ‘trial’ story an utterly irrelevant old hat?
Certainly not! Its true significance does not lie in the fact that a few amateurs are trying to push bogus treatments into the NHS via the flimsiest pseudo-research of the century. The true significance, I think, is that it shows how Prince Charles, once again, oversteps the boundaries of his constitutional role.
Auricular acupuncture (AA), according to the ‘COLLEGE OF AURICULAR ACUPUNCTURE’, has its origins in Modern Europe. In 1957 Dr. Paul Nogier, a neurologist from Lyons in France, observed a locum doctor treating sciatica by cauterizing an area of the ear. This prompted extensive research culminating in the development of the somatopic correspondence of specific parts of the body to the ear based upon the concept of an inverted foetus. Dr. Nogier believed that pain and other symptoms in the body could be alleviated by needling, massaging or electronically stimulating the corresponding region of the ear. Auricular Acupuncture is a specialized complementary therapy where acupuncture points on the outer ear are treated, using either needles or acupunctoscopes (electrical location and stimulation machines) to help relieve many chronic complaints. There are over 200 acupuncture points on the ear, each point named after an area of our anatomy. The outer ear acts like a switchboard to the brain. Each acupuncture point being treated, triggers electrical impulses from the ear via the brain, to the specific part of the body being treated.
Sounds odd? Well, that’s because it is odd!
But just because something is odd does not mean it is ineffective – so, what does the reliable evidence tell us? Here are some conclusions from systematic reviews:
All of these analyses point out that the quality of the studies is usually very poor, and stress that more and better research is required. It is therefore interesting to note that a new study has just been published. Perhaps it could settle the question about the effectiveness of AA?
The aim of this study was 1) to evaluate whether auricular acupuncture effective for reducing health care provider stress and anxiety and 2) to determine, if auricular acupuncture impacts provider capacity for developing caring relationships with patients. Pre-intervention and post-intervention surveys were evaluated to see, if auricular acupuncture was associated with changes in State-Trait Anxiety Inventory (STAI), Professional Quality of Life, and Caring Ability Inventory scores. The results indicate that, compared with baseline, participants had a significant reduction in state anxiety (STAI), trait anxiety (STAI), burnout, and secondary traumatic stress scores (Professional Quality of Life). Significant increases were noted in courage and patience, two dimensions of the Caring Ability Inventory.
From these findings, the authors conclude that auricular acupuncture is an effective intervention for the relief of stress/anxiety in providers and supports heightened capacity for caring.
Sounds odd again? Yes, because it is odd!
I would argue that a study of any controversial therapy that has already been tested repeatedly in poor quality trials must have sufficient scientific rigor to advance the field of inquiry. If it does not fulfil this criterion, it is quite simply not ethical. The new study does not even have a control group; we can therefore not begin to tell whether the observed outcomes were due to non-specific effects, the natural history of the condition or regression towards the mean (to mention but a few of the possible sources of bias). To conclude that AA is ‘an effective intervention’ is therefore utterly barmy.
All of this could be entirely trivial and inconsequential. I am afraid, however, that it is not. Alternative medicine is littered with such unethically flawed research conducted by naïve and clueless pseudo-scientists who arrive at outrageous conclusions. This relentless flow of false-positive findings misleads consumers, health care professionals, decision makers and everyone else to draw the wrong conclusions about bogus therapies. And, in the end, this sort of thing even does a grave disfavour to any branch of alternative medicine that might have some degree of respectability.
IT IS HIGH TIME THAT THIS NONSENSE STOPS! IT BORDERS ON SCIENTIFIC MISCONDUCT.
Boiron is the world’s biggest producer of homeopathic remedies. It also is a firm that is relatively active in research into homeopathy. Here is one of their investigations which I find most remarkable.
This study was designed to describe the sociodemographic and clinical characteristics of patients recommended allopathic and/or homeopathic medicines for influenza-like illness (ILI) or ear nose and throat ENT disorders by pharmacists in France and to investigate the effectiveness of these treatments.
The introduction of the article includes interesting information; it informs us that, although homeopathy is more popular in Europe than in the Unites States, sales of homeopathic medicines in the United States grew by more than 1,000% in the late 1970s and early 1980s and continue to grow. In parallel, the number of physicians specializing in homeopathy doubled between 1980 and 1982. In 2003, sales of homeopathic medicines in the United States were estimated to be between $300 and $450 million, with an average growth rate of approximately 8% per year. Homeopathic drugs are among the top 10 nonprescription products sold in the category of analgesics to treat coughs, colds, and flu. The sale of homeopathic medicines in the United States is controlled by the Food, Drug, and Cosmetic Act and regulations issued by the U.S Food and Drug Administration (FDA). Homeopathic medicines in the United States are subject to well-controlled regulatory processes that closely resemble those used for allopathic medicines. FDA regulations for the sale of homeopathic medicines in the United States state that they can only be sold without prescription if they are for self-limiting conditions such as the common cold…
Am I mistaken, or does that paragraph read a bit like a text written by the marketing team of Boiron wanting to establish their products in the US?
Anyway, the methodology and results of the study are described in the abstract as follows:
A prospective, observational, multicenter study was carried out in randomly selected pharmacies across the 8 IDREM medical regions of France. Pharmacies that agreed to participate recruited male or female patients who responded to the following inclusion criteria: age ≥ 12 years presenting with the first symptoms of an ILI or ENT disorder that were present for less than 36 hours prior to the pharmacy visit. All medicines recorded in the study were recommended by the pharmacists. The following data were recorded at inclusion and after 3 days of treatment: the intensity of 13 symptoms, global symptom score, and disease impact on daily activities and sleep. Two groups of patients were compared: those recommended allopathic medicine only (AT group) and those recommended homeopathic medicine with or without allopathic medicine (HAT group). The number and severity of symptoms, change in global symptom score, and disease impact on daily activities and sleep were compared in the 2 treatment groups after 3 days of treatment. Independent predictors of recommendations for homeopathic medicine were identified by multi- factorial logistic regression analysis.
A total of 242 pharmacies out of 4,809 (5.0%) contacted agreed to participate in the study, and 133 (2.8%) included at least 1 patient; 573 patients were analyzed (mean age: 42.5 ± 16.2 years; 61.9% female). Of these, 428 received allopathic medicines only (74.7%; AT group), and 145 (25.3%) received homeopathic medicines (HAT group) alone (9/145, 1.6%) or associated with allopathy (136/145, 23.7%). At inclusion, HAT patients were significantly younger (39.6 ± 14.8 vs. 43.4 ± 16.1 years; P less than 0.05), had a higher mean number of symptoms (5.2 ± 2.5 vs. 4.4 ± 2.5; P less than 0.01), and more severe symptoms (mean global symptom score: 24.3 ± 5.5 vs. 22.3 ± 5.8; P = 0.0019) than AT patients. After 3 days, the improvement in symptoms and disease impact on daily activities and sleep was comparable in both groups of patients.
From these findings, the authors draw the following conclusions: Patients recommended homeopathic medicine by pharmacists were younger and had more severe symptoms than those recommended allopathic medicine. After 3 days of treatment, clinical improvement was comparable in both treatment groups. Pharmacists have an important role to play in the effective management of ILI and ENT disorders.
And, to make perfectly clear what all this is about, the first sentence of the ‘discussion’ puts it to the point by stating that homeopathic medicine, with or without allopathic medicine, appears to be effective at alleviating the symptoms of ILI or ENT disorders.
As I have heard it said that Boiron seems to have the nasty habit of threatening their critics with legal action, I ought to be quite cautious in my assessment of this ‘masterpiece of promotion’. Yet a few comments must surely be permitted.
‘To describe the sociodemographic and clinical characteristics of patients recommended allopathic and/or homeopathic medicines’ is not what I personally find an interesting subject of research, nor is it anything that will affect health care meaningfully, I think. Yet ‘to investigate the effectiveness of these treatments’ is certainly interesting and important. I will therefore focus on this second aim of the study.
Hold on, was this really a ‘study’? On closer inspection, it seemed much more like a survey. People who felt that they were suffering from ILI and ENT disorders and thus went to a pharmacy to buy something for their problem were offered either homeopathic or conventional medicines. Those who accepted either of the recommendations were asked to fill out some self-assessment forms and received a phone call three days later to check their symptoms. 94% of all patients in the homeopathy group took homeopathic medicine in combination with ‘allopathic’ medicine (it is interesting, perhaps even telling, that this term used by the authors was invented by Hahnemann as an insult to conventional medicine!). There was no examination by a doctor to verify what condition the survey-participants were truly suffering from, and there was no verification that the information provided during the follow-up telephone call was in any way real. The most frequently recommended homeopathic medicine was Anas barbariae 200C (Oscillococcinum) which is Boiron’s famous homeopathically diluted (about one molecule per universe, I guess) duck-liver heavily promoted in France against colds and similar conditions.
As it turns out, those survey-participants who accepted the homeopathic recommendation were significantly younger than those who accepted the recommendation for a conventional treatment (many surveys confirm that younger people are more prone to trying alternative medicine than older ones). It stands to reason, that the younger (and therefore fitter) patients were in better general health and therefore might recover quicker than the older ones. But, in fact, they did not!
Could this be due to the homeopathic remedies actually delaying recovery? Of course not! Who would be silly enough to claim that homeopathy could have this (or any other) effect? According to the authors, it is due to the fact that this group ‘had more severe symptoms than those recommended allopathic medicine’. But, as I said, we have to take their word for it; there is no independent verification of this. It would, of course, be quite ridiculous to postulate that those survey-participants accepting homeopathy were also a little more introspective or concerned about their own health (perhaps even more gullible) and thus claimed more severe symptoms!
And what about the authors’ conclusion that clinical improvement was comparable in both treatment groups? Well, this is more than a little problematic, in my view: first, we have no independent verification of the ‘improvement’ in either group. Second, we don’t know that the conventional treatments actually worked, and it could well be that both approaches were similarly ineffective, and that the observed outcomes are merely a reflection of the natural history of the condition. And third, one might expect the homeopathic (younger) group to do not similarly well but slightly better, simply because the natural history of the illness would tend to be more benign in younger people.
Before I finish,I should make a brief comment about the authors’ courageous statement that homeopathic medicine, with or without allopathic medicine, appears to be effective at alleviating the symptoms of ILI or ENT disorders. I think, for the reasons I already provided, this is extremely doubtful. In my view, more critical scientists would have phrased the conclusions differently:
THIS SURVEY SHOWS THAT EVALUATING THE EFFECTIVENESS OF MEDICAL INTERVENTIONS REQUIRES A MORE RIGOROUS METHODOLOGY THAN THAT OF A SURVEY.
But perhaps this would be asking a little too much of the authors; after all, at the end of the article, we find this telling footnote: Laboratoires Boiron provided financial support for the study. Cognet-Dementhon, Thevenard, Duru, and Allaert received consulting fees from Laboratoires Boiron for this study. Danno and Bordet are employees of Laboratoires Boiron.
Guest post by Michelle Dunbar
According to the CDC, more than 30,000 people died as a result of a drug overdose in 2010. Of those deaths none were attributed to marijuana. Instead the vast majority were linked to drugs that are legally prescribed such as opiates, anti-depressants, anti-psychotics, tranquilizers and benzodiazepines. As misuse and abuse of prescription medications continues to rise, the marijuana legalization debate is also heating up.
Nearly 100 years of propaganda, fear mongering and blatant misinformation regarding marijuana has taken its toll on our society. As the veil of lies surrounding marijuana is being lifted, more and more people are pushing for legalization. Marijuana is now legal for both medicinal and recreational use in two states and other states are introducing legislation of their own. Marijuana is approved for medicinal use with a prescription in 21 states and also Washington, D.C. with most other states expected to introduce legislation to approve use for medicinal purposes in the next few years.
Last year Dr. Sanjay Gupta, the medical correspondent for CNN, aired a controversial documentary, “Weed”, where he showed various promising medicinal uses for marijuana. He admits that he was wrong for many years about marijuana legalization, and after doing his own extensive research he is encouraged by the many real life cases he has seen where people with chronic, serious medical issues have been and continue to be helped by marijuana. He noted that marijuana does not have the dangerous side effects that many prescription medications do and that it is actually safer than many drugs being prescribed today. Dr. Gupta said in the program that there is not one documented case where death was due to marijuana overdose and he is right.
But as with any systematic paradigm shift, there will always be those whose minds are closed to change. So as the march toward legalization continues, there is new anti-legalization propaganda being written and spread through mainstream and social media. There have been multiple reports out of Colorado that there are now deaths attributed to marijuana overdose. Some say children were involved which automatically evokes feelings of fear in parents across the country. But when I tried to find more reliable sources to verify these articles, none existed. The AP reported on April 2 that a Wyoming college student jumped to his death in Colorado after eating a marijuana cookie while on Spring Break in Colorado. The autopsy listed marijuana intoxication as a “significant contributing factor” in the teen’s death. (Gurman)
Like alcohol, Colorado bans the sale of marijuana and marijuana edibles to people under the age of 21. But much like alcohol, teens that want to get it will always find a way. This young man was just 19, and his death has been ruled accidental. While it is true his death is tragic, is it a reason to reverse the course with marijuana? If you believe this is the case then you must consider the real dangers posed by alcohol. Many people who would like to see marijuana legalized say that it is much safer than the legal drug alcohol. Based solely on the numbers of hospitalizations and deaths, especially with young people, they would be right.
According to an article posted on Forbes.com in March of this year, “1,825 college students between the ages of 18 and 24 die each school year from alcohol-related unintentional injuries.” The author, Dr. Robert Glatter, MD attributes these deaths to one of the leading health risks facing our young people, and that is binge drinking. This number is quite small in comparison to emergency room visits and hospitalizations of young people that are a direct result of alcohol use.
Taking the most heat are the marijuana edibles that are now for sale in states where marijuana has become legal. The concern is that children are eating marijuana laced candy and baked goods and becoming ill. This would seem to be confirmed by an article in USA Today that reported that calls to the Rocky Mountain Poison Control is Colorado regarding marijuana ingestion in children had risen to 70 cases last year. While they admitted that this number was low, it was the rapid rise from years previous that caused concern. To put this in perspective, there are approximately 1.4 million pediatric poisonings each year involving prescription medications not including marijuana. (Henry, et.al) That is an average of approximately 28,000 calls per state. Tragically several hundreds of these cases result in deaths of these children, with the highest rates of death involving narcotics, sedatives and anti-depressants. (Henry, et.al.)
Of those 70 cases reported in Colorado involving marijuana, none resulted in death. The results are quite clear marijuana is as safe as prescription drugs are dangerous. For those who want to weigh in on the marijuana legalization debate, it is important to do your research, look at the big picture and put everything in perspective. Alcohol is legal and heavily regulated, yet its use is linked to thousands of deaths each year. Prescription drugs are legal and heavily regulated, yet they too are linked to thousands of deaths each year. Marijuana, on the other hand, is not legal and not available in much of the country, and thus far has not caused one death from overdose ever.
Additionally, research is showing marijuana has promise in treating many diseases more effectively and safely than dangerous prescription medications being used today. From cancer to epilepsy to depression and anxiety, to chronic autoimmune diseases, scientists are just scratching the surface when it comes to the potential life-changing and perhaps even, life-saving uses for marijuana.
Drug Overdose in the United States: Fact Sheet. (2014, February 10). Centers for Disease Control and Prevention. Retrieved May 4, 2014, from http://www.cdc.gov/homeandrecreationalsafety/overdose/facts.html
Glatter, R. (2014, March 11). Spring Break’s Greatest Danger. Forbes. Retrieved May 5, 2014, from http://www.forbes.com/sites/robertglatter/2014/03/11/spring-breaks-greatest-danger/
Gurman, S. (2014, April 2). Young man leaps to death after eating pot-laced cookie. USA Today. Retrieved May 5, 2014, from http://www.usatoday.com/story/news/nation/2014/04/02/marijuana-pot-edible-death-colorado-denver/7220685/
Henry, K., & Harris, C. R. (2006). Deadly Ingestions. Pediatric Clinics of North America, 53(2), 293-315.
Hughes, T. (2014, April 2). Colo. Kids getting into parents’ pot-laced goodies. USA Today. Retrieved May 5, 2014 from http://www.usatoday.com/story/news/nation/2014/04/02/marijuana-pot-edibles-colorado/7154651/
I am constantly on the look-out for good studies of alternative medicine, particularly those that yield positive findings. The trouble is that there aren’t many of those; studies tend to be either good or positive. Could this one be an exception?
The aim of this brand-new trial was to determine, if dietary supplements of glucosamine and/or chondroitin, result in reduced joint space narrowing (JSN) and pain in patients with knee osteoarthritis. It was designed as a double-blind randomised placebo-controlled clinical trial with 2-year follow-up. 605 participants, aged 45–75 years, reporting chronic knee pain and with evidence of medial tibio-femoral compartment narrowing (but retaining >2 mm medial joint space width) were randomised to once daily: glucosamine sulfate 1500 mg (n=152), chondroitin sulfate 800 mg (n=151), both of these dietary supplements (n=151) or placebo capsules (n=151). JSN (mm) over 2 years was measured from digitised knee radiographs. Maximum knee pain (0–10) was self-reported in a participant diary for 7 days every 2 months over 1 year.
The results indicate that, after adjusting for factors associated with structural disease progression (gender, body mass index (BMI), baseline structural disease severity and Heberden’s nodes), allocation to the dietary supplement combination (glucosamine–chondroitin) resulted in a statistically significant (p=0.046) reduction of 2-year JSN compared to placebo: mean difference 0.10 mm (95% CI 0.002 mm 0.20 mm); no significant structural effect for the single treatment allocations was detected. All 4 groups demonstrated reduced knee pain over the first year, but no significant between-group differences (p=0.93) were detected. 34 (6%) participants reported possibly-related adverse medical events over the 2-year follow-up period.
The authors drew the following conclusions: allocation to the glucosamine–chondroitin combination resulted in a statistically significant reduction in JSN at 2 years. While all allocation groups demonstrated reduced knee pain over the study period, none of the treatment allocation groups demonstrated significant symptomatic benefit above placebo.
This study has many strengths: it addresses a relevant research question, has a sufficiently large sample size, includes a long follow-up, and is well reported. So, it is a good study of an alternative therapy that is used by many patients. But did it really produce a positive result, i.e. findings which suggest that the tested treatments are effective? The answer seems ‘yes and no’. The combined, regular intake of both supplements caused less joint space narrowing which is a good objective sign of reduced disease activity. However, this was not paralleled by a reduction in pain that was better than that on placebo.
So, if you are a fan of glucosamine/chondroitin supplements, you will be pleased with this study, but if you are not in favour of such medications or do not have the spare cash to afford the considerable costs, you might say: I told you, they are pretty useless!
Cancer patients are understandably desperate and leave no stone unturned to improve their prognosis. Thus they become easy prey of charlatans who claim that this or that alternative therapy will cure them or improve their outlook. One of the most popular alternative cancer therapies is mistletoe, a treatment dreamt up by Rudolf Steiner on the basis of the ‘like cures like’ principle: the mistletoe plant grows on a host tree like a cancer in the human body. One of many websites on this subject, for instance, states:
- integrates with conventional cancer treatments
- can be used for a wide range of cancers
- may be started at any stage of the illness….
- Improved quality of life
- generally feeling better
- increased appetite and weight
- less tired/more energy
- reduced pain
- better sleep pattern
- felling more hopeful and motivated
- reduced adverse effects from chemo and radiotherapy
- reduced risk of cancer spread and recurrence
- increased life expectancy.
Mistletoe extracts have been shown in studies to:
- stimulate the immune system
- cause cancer cell death
- protect healthy cells against harmful effects of radiation and chemotherapy.
In fact, the debate about the efficacy of mistletoe either as a cancer cure, a supportive therapy, or a palliative measure is often less than rational and seems never-ending.
The latest contribution to this saga comes from US oncologists who published a phase I study of gemcitabine (GEM) and mistletoe in advanced solid cancers (ASC). The trial was aimed at evaluating: (1) safety, toxicity, and maximum tolerated dose (MTD), (2) absolute neutrophil count (ANC) recovery, (3) formation of mistletoe lectin antibodies (ML ab), (4) cytokine plasma concentrations, (5) clinical response, and (6) pharmacokinetics of GEM.
A total of 44 study participants were enrolled; 20 were treated in stage I (mistletoe dose escalation phase) and 24 in stage II (gemcitabine dose escalation phase). All patients had stage IV disease; the majority had received previous chemo-, hormonal, immunological, or radiation therapy, and 23% were chemotherapy-naïve.
Patients were treated with increasing doses of a mistletoe-extract (HELIXOR Apis (A), growing on fir trees) plus a fixed GEM dose in stage I, and with increasing doses of GEM plus a fixed dose of mistletoe in stage II. Response in stage IV ASC was assessed with descriptive statistics. Statistical analyses examined clinical response/survival and ANC recovery.
The results show that dose-limiting toxicities were neutropenia, thrombocytopenia, acute renal failure, and cellulitis, attributed to mistletoe. GEM 1380 mg/m2 and mistletoe 250 mg combined were the MTD. Of the 44 patients, 24 developed non-neutropenic fever and flu-like syndrome. GEM pharmacokinetics were unaffected by mistletoe. All patients developed ML3 IgG antibodies. ANC showed a trend to increase between baseline and cycle 2 in stage I dose escalation.
6% of patients showed a partial response, and 42% had stable disease. Of the 44 study participants, three died during the study, 10 participants requested to terminate the study, 23 participants progressed while on study, one terminated the study due to a dose limiting toxicity, 6 left due to complicating disease issues which may be tied to progression, and one voluntarily withdrew.
An attempt was made to follow study subjects once they terminated study treatment until death. At the last attempt to contact former participants, three were still alive and five others were lost to follow-up. The median time to death of any cause was approximately 200 days. Compliance with mistletoe injections was high.
The authors explain that a partial response rate of 6% is comparable to what would be expected from single agent gemcitabine in this population of patients with advanced, mostly heavily pretreated carcinomas. The median survival from study enrollment of about 200 days is within the range of what would be expected from single agent gemcitabine.
The authors concluded that GEM plus mistletoe is well tolerated. No botanical/drug interactions were observed. Clinical response is similar to GEM alone.
These results are hardly encouraging but they originate from just one (not particularly rigorous) study and might thus not be reliable. So, what does the totality of the reliable evidence tell us? Our 2003 systematic review of 10 RCTs found that none of the methodologically stronger trials exhibited efficacy in terms of quality of life, survival or other outcome measures. Rigorous trials of mistletoe extracts fail to demonstrate efficacy of this therapy.
Will this stop the highly lucrative trade in mistletoe extracts? will it prevent desperate cancer patients being misled about the value of mistletoe treatment? I fear not.
THERE WILL NEVER BE AN ALTERNATIVE CANCER CURE
This statement contradicts all those thousands of messages on the Internet that pretend otherwise. Far too many ‘entrepreneurs’ are trying to exploit desperate cancer patients by making claims about alternative cancer ‘cures’ ranging from shark oil to laetrile and from Essiac to mistletoe. The truth is that none of them are anything other than bogus.
Why? Let me explain.
If ever a curative cancer treatment emerged from the realm of alternative medicine that showed any promise at all, it would be very quickly researched by scientists and, if the results were positive, instantly adopted by mainstream oncology. The notion of an alternative cancer cure is therefore a contradiction in terms. It implies that oncologists are mean bastards who would, in the face of immense suffering, reject a promising cure simply because it did not originate from their own ranks.
BUT THAT DOES NOT NECESSARILY MEAN THAT ALTERNATIVE CANCER TREATMENTS ARE USELESS
So, let’s forget about alternative cancer ‘cures’ and let’s once and for all declare the people who sell or promote them as charlatans of the worst type. But some alternative therapies might nevertheless have a role in oncology – not as curative treatments but as supportive or palliative therapies.
The aim of supportive or palliative cancer care is not to cure the disease but to ease the suffering of cancer patients. According to my own research, promising evidence exists in this context, for instance, for massage, guided imagery, Co-enzyme Q10, acupuncture for nausea, and relaxation therapies. For other alternative therapies, the evidence is not supportive, e.g. reflexology, tai chi, homeopathy, spiritual healing, acupuncture for pain-relief, and aromatherapy.
So, in the realm of supportive and palliative care there is both encouraging as well as disappointing evidence. But what amazes me over and over again is the fact that the majority of cancer centres employing alternative therapies seem to bother very little about the evidence; they tend to use a weird mix of treatments regardless of whether they are backed by evidence or not. If patients like them, all is fine, they seem to think. I find this argument worrying.
Of course, every measure that increases the well-being of cancer patients must be welcome. But this should not mean that we disregard priorities or adopt any quackery that is on offer. In the interest of patients, we need to spend the available resources in the most effective ways. Those who argue that a bit of Reiki or reflexology, for example, is useful – if only via a non-specific (placebo) effects – seem to forget that we do not require quackery for patients to benefit from a placebo-response. An evidence-based treatment that is administered with kindness and compassion also generates specific non-specific effects. In addition, such treatments also generate specific effects. Therefore it would be a disservice to patients to merely rely on the non-specific effects of bogus treatments, even if the patients do experience some benefit from them.
ALTERNATIVE ‘PAMPERING’ AS A COMPENSATION FOR INADEQUACIES IN THE SYSTEM?
So, why are unproven or disproven treatments like Reiki or reflexology so popular for cancer palliation? This question has puzzled me for years, and I sometimes wonder whether some oncologists’ tolerance of quackery is not an attempt to compensate for any inadequacies within the routine service they deliver to their patients. Sub-standard care, unappetising food, insufficient pain-control, lack of time and compassion as well as other problems undoubtedly exist in some cancer units. It might be tempting to assume that such deficiencies can be compensated by a little pampering from a reflexologist or Reiki master. And it might be easier to hire a few alternative therapists for treating patients with agreeable yet ineffective interventions than to remedy the deficits that may exist in basic conventional care.
But this strategy would be wrong, unethical and counter-productive. Empathy, sympathy and compassion are core features of conventional care and must not be delegated to quacks.
Guest post by Dr. Richard Rawlins MB BS MBA FRCS, Consultant Orthopaedic and Trauma Surgeon
On 14th November 2013 the Daily Telegraph advised that ‘Meditation could help troops overcome the trauma of war: Troops suffering post traumatic stress should take up yoga and acupuncture to get over the horrors of war. The Royal Navy and Royal Marines Children’s Fund is urging troops to try alternative therapies to get over psychological disorders when they return from conflict zones. After receiving a Whitehall grant, the charity has written a book aimed at helping families understand and cope with the impact and stresses suffered by troops before, during and after warfare. It suggests servicemen try treatments such as massage, reflexology, reiki and meditation.’
As a former Surgeon Lieutenant Commander in the Royal Naval Reserve I treated servicemen on their return from the Falklands. As a father of a platoon commander who served with the Grenadier Guards in Helmand I support Combat Stress. As a member of the Magic Circle I am well acquainted with methods of deceit, deception and delusion. As a doctor I care and hope to see all patients treated appropriately, but alternative therapies must be considered critically.
To assist management of Post Traumatic Stress Disorder the Children’s Fund book provides details of relevant therapies, institutions providing them and knitting patterns for making dolls representing the service personnel and their families. The title Knit the Family is both a suggestion for practical help by making dolls and a metaphor for knitting families back together after deployment. All of which is highly laudable and deserving of substantial support. But…
I do not doubt yoga, meditation, relaxation and doll making can provide valuable emotional support for one of the most pernicious outcomes of combat. I do not doubt that support from an empathic caring practitioner or a conscientious counsellor is of benefit. But what is the added value of pressing on ‘zones’ in the feet? Of positioning hands around a patient and providing them with charms? Of feeling for and adjusting ‘subtle rhythms in cerebro-spinal fluid’? Of inserting needles in the skin? Unless there is evidence that such manoeuvres and modalities actually do provide benefit greater than any other method for producing placebo effects – why spend any valuable funds on such practices? Would not the charitable funds be better spent on psychotherapy, counselling, yoga and meditation? There is no need for CAM therapy. The RN & RM Children’s Fund suggests that complementary and alternative medicine can help PTSD. I know of no evidence alternatives such as reiki, reflexology, CST, acupuncture, Emotional Freedom Techniques (utilising ‘finger tapping’), Thought Field Therapy and Somatic Experiencing all of which are set out in the charity’s book, can provide any benefit. Indeed, the book admits there is no scientific evidence of such benefit. Spending time in a therapeutic relationship helps, but there is no evidence the therapies have any effect on their own account – and there is plenty of evidence they almost certainly do not. That is why they are referred to as being implausible and are termed ‘alternative medicine’.
In order service personnel and their families can give fully informed consent to any proposed treatment they will need to consider the probability that they are wasting time and scarce funds on implausible treatments. And members of the public who might wish to support the charity will need to carefully consider the use to which their funds might be put.
The National Institute for Clinical Excellence (NICE) has Guidelines for the management of Post Traumatic Stress Disorder and emphasises ‘Families and carers have a central role in supporting people with PTSD and many families may also need support for themselves …Healthcare professionals should identify the need for appropriate information about the range of emotional responses that may develop and provide practical advice on how to access appropriate services for these problems.’
Note that the NICE guidelines, quoted in Knit the Family, require that PTSD support services should be ‘appropriate’. So presumably the Fund has decided that implausible non-evidenced based modalities of treatment are appropriate. But just how did it come to such a decision? I have asked questions on this and a number of other points and await an answer.
And there is more to this matter. Knit the Family acknowledges the support it has received from Whitehall’s Army Covenant Libor Fund and also from the Barcarpel Foundation. Barcarpel’s website tells us it ‘is a particularly enthusiastic supporter of Complementary Medicine’ and ‘has made substantial donations to the Homeopathic Trust for Research & Education as well as establishing the Nelson Barcapel Teaching Fellowship at Exeter, specifically to enable medical practitioners to take the Integrated Healthcare programme.’ ‘Nelson’ not for the Admiral but for the firm which manufactures homeopathic remedies, sponsored the inaugural meeting of the ‘College of Medicine’, and whose Chairman Robert Wilson is also Chairman of Barcarpel. And ‘integrated medicine’ means the incorporation of non-evidenced based therapies with orthodox care. Which might be reasonable if there was evidence CAMs had an effect on PTSD – but there is no such evidence.
‘Special thanks are given to Jonathan Poston, Chair of the Craniosacral Therapy Association, for assistance with setting up the project; Liz Kalinowska, Fellow of the Craniosacral Therapy Association, for wise advice; Michael Kern, Founder/Principal of Craniosacral Therapy Educational Trust; Cathy Cremer, whose experience with the UK Forces Project has contributed to an understanding of how best to explain the benefits of CST for those suffering from PTSD; Silvana Calzavara whose experience working at Headway East London (acquired brain injury) proved invaluable at the Portsmouth CST clinic; Monica Tomkins, Eva Kretchmar, Sally Christian, Talita Harrison, Cathy Brooks and Simon Copp for their contribution in carrying the CST project forward.’
So we see that a group of enthusiasts for CST have inveigled their way into the Children’s Fund and are set on promoting the use of this implausible therapy for some of our most vulnerable patients. An insurgency if ever there was one. They have not been able to offer any evidence that ‘subtle rhythms’ can be felt in the cerebro-spinal fluid, let alone manipulative methods can influence the flow of cerebro-spinal fluid. And if they are not doing that, they are not doing CST. The care and attention provided by these practitioners can be applauded, but not the methods they purport to use. In which case, why use them? Would the Children’s Fund not do better to spend its funds on plausible evidence based therapies? How has the Fund assessed whether or not the promoters of CST and other CAMs are quacks? Or whether or not they are frauds? The public who are considering donations need to be reassured. The service personnel who so deservedly need support should be treated with honestly, integrity and probity – not metaphysics.
Has it ever occurred to you that much of the discussion about cause and effect in alternative medicine goes in circles without ever making progress? I have come to the conclusion that it does. Here I try to illustrate this point using the example of acupuncture, more precisely the endless discussion about how to best test acupuncture for efficacy. For those readers who like to misunderstand me I should explain that the sceptics’ view is in capital letters.
At the beginning there was the experience. Unaware of anatomy, physiology, pathology etc., people started sticking needles in other people’s skin, some 2000 years ago, and observed that they experienced relief of all sorts of symptoms.When an American journalist reported about this phenomenon in the 1970s, acupuncture became all the rage in the West. Acupuncture-fans then claimed that a 2000-year history is ample proof that acupuncture does work.
BUT ANECDOTES ARE NOTORIOUSLY UNRELIABLE!
Even the most enthusiastic advocates conceded that this is probably true. So they documented detailed case-series of lots of patients, calculated the average difference between the pre- and post-treatment severity of symptoms, submitted it to statistical tests, and published the notion that the effects of acupuncture are not just anecdotal; in fact, they are statistically significant, they said.
BUT THIS EFFECT COULD BE DUE TO THE NATURAL HISTORY OF THE CONDITION!
“True enough”, grumbled the acupuncture-fans and conducted the very first controlled clinical trials. Essentially they treated one group of patients with acupuncture while another group received conventional treatments as usual. When they analysed the results, they found that the acupuncture group had improved significantly more. “Now do you believe us?”, they asked triumphantly, “acupuncture is clearly effective”.
NO! THIS OUTCOME MIGHT BE DUE TO SELECTION BIAS. SUCH A STUDY-DESIGN CANNOT ESTABLISH CAUSE AND EFFECT.
The acupuncturists felt slightly embarrassed because they had not thought of that. They had allocated their patients to the treatment according to patients’ choice. Thus the expectation of the patients (or the clinician) to get relief from acupuncture might have been the reason for the difference in outcome. So they consulted an expert in trial-design and were advised to allocate not by choice but by chance. In other words, they repeated the previous study but randomised patients to the two groups. Amazingly, their RCT still found a significant difference favouring acupuncture over treatment as usual.
BUT THIS DIFFERENCE COULD BE CAUSED BY A PLACEBO-EFFECT!
Now the acupuncturists were in a bit of a pickle; as far as they could see, there was no good placebo for acupuncture! Eventually some methodologist-chap came up with the idea that, in order to mimic a placebo, they could simply stick needles into non-acupuncture points. When the acupuncturists tried that method, they found that there were improvements in both groups but the difference between real acupuncture and placebo was tiny and usually neither statistically significant nor clinically relevant.
NOW DO YOU CONCEDE THAT ACUPUNCTURE IS NOT AN EFFECTIVE TREATMENT?
Absolutely not! The results merely show that needling non-acupuncture points is not an adequate placebo. Obviously this intervention also sends a powerful signal to the brain which clearly makes it an effective intervention. What do you expect when you compare two effective treatments?
IF YOU REALLY THINK SO, YOU NEED TO PROVE IT AND DESIGN A PLACEBO THAT IS INERT.
At that stage, the acupuncturists came up with a placebo-needle that did not actually penetrate the skin; it worked like a mini stage dagger that telescopes into itself while giving the impression that it penetrated the skin just like the real thing. Surely this was an adequate placebo! The acupuncturists repeated their studies but, to their utter dismay, they found again that both groups improved and the difference in outcome between their new placebo and true acupuncture was minimal.
WE TOLD YOU THAT ACUPUNCTURE WAS NOT EFFECTIVE! DO YOU FINALLY AGREE?
Certainly not, they replied. We have thought long and hard about these intriguing findings and believe that they can be explained just like the last set of results: the non-penetrating needles touch the skin; this touch provides a stimulus powerful enough to have an effect on the brain; the non-penetrating placebo-needles are not inert and therefore the results merely depict a comparison of two effective treatments.
YOU MUST BE JOKING! HOW ARE YOU GOING TO PROVE THAT BIZARRE HYPOTHESIS?
We had many discussions and consensus meeting amongst the most brilliant brains in acupuncture about this issue and have arrived at the conclusion that your obsession with placebo, cause and effect etc. is ridiculous and entirely misplaced. In real life, we don’t use placebos. So, let’s instead address the ‘real life’ question: is acupuncture better than usual treatment? We have conducted pragmatic studies where one group of patients gets treatment as usual and the other group receives acupuncture in addition. These studies show that acupuncture is effective. This is all the evidence we need. Why can you not believe us?
NOW WE HAVE ARRIVED EXACTLY AT THE POINT WHERE WE HAVE BEEN A LONG TIME AGO. SUCH A STUDY-DESIGN CANNOT ESTABLISH CAUSE AND EFFECT. YOU OBVIOUSLY CANNOT DEMONSTRATE THAT ACUPUNCTURE CAUSES CLINICAL IMPROVEMENT. THEREFORE YOU OPT TO PRETEND THAT CAUSE AND EFFECT ARE IRRELEVANT. YOU USE SOME IMITATION OF SCIENCE TO ‘PROVE’ THAT YOUR PRECONCEIVED IDEAS ARE CORRECT. YOU DO NOT SEEM TO BE INTERESTED IN THE TRUTH ABOUT ACUPUNCTURE AT ALL.
Postoperative ileus (POI), the phenomenon that after an operation the intestines tend to be inactive for a few days, can cause intense pain and thus contributes significantly to human suffering. It also prolongs hospital stay and increases the risks of post-operative complications. There is no known effective treatment for POI.
In China, POI is often treated with acupuncture, and due to this fact acupuncture became known in the West: James Reston, a journalist who accompanied Nixon on his first trip to China, had to have an appendectomy in a Beijing hospital, he subsequently suffered from POI, was treated with acupuncture and moxibustion, experienced symptom-relief, and subsequently wrote about it in the New York Times. This was the beginning of the present acupuncture-boom.
Since then, thousands of acupuncture trials have been published but, intriguingly, very few have tested the effectiveness of acupuncture for POI. Now researchers from the Sloan Kettering Cancer Center in New York have conducted a randomized, sham-controlled trial to test whether acupuncture reduces POI more effectively than sham acupuncture.
Ninety colon cancer patients undergoing elective colectomy were randomized to receive 30 min of true or sham acupuncture twice daily during their first three postoperative days. GI-3 (the later of the following two events: time that the patient first tolerated solid food, AND time that the patient first passed flatus OR a bowel movement) and GI-2 (the later of the following two events: time patient first tolerated solid food AND time patient first passed a bowel movement) were determined. Pain, nausea, vomiting, and use of pain medications were evaluated daily for the first three postoperative days. Eighty-one patients received the allocated intervention: 39 the true acupuncture and 42 the sham acupuncture. The mean time to GI-3 was 149 hours and 146 hours for the acupuncture group and the sham acupuncture group. No significant differences were found between groups for secondary endpoints.
The authors’ conclusion was clear: True acupuncture as provided in this study did not reduce POI more significantly than sham acupuncture.
So, did a mere misunderstanding start the present acupuncture boom? POI inevitably normalises with time. Did the journalist just imagine that acupuncture helped, while nature cured the condition? It would seem so, according to this study. But perhaps things are not just black or white. Almost at the same time as the New York trial, another study was emerged.
Researchers from Hong Kong conducted an RCT with 165 patients undergoing elective laparoscopic surgery for colonic and upper rectal cancer. Patients were assigned randomly to receive electroacupuncture (n = 55) or sham acupuncture (n = 55), once daily from postoperative days 1-4, or no acupuncture (n = 55). The primary outcome was time to defecation. Secondary outcomes included postoperative analgesic requirement, time to ambulation, and length of hospital stay. The results showed that patients who received electroacupuncture had a shorter time to defecation than patients who received no acupuncture (85.9 ± 36.1 vs 122.1 ± 53.5 h) and length of hospital stay (6.5 ± 2.2 vs 8.5 ± 4.8 days). Patients who received electroacupuncture also had a shorter time to defecation than patients who received sham acupuncture (85.9 ± 36.1 vs 107.5 ± 46.2 h). Electroacupuncture was more effective than no or sham acupuncture in reducing postoperative analgesic requirement and time to ambulation.
The Chinese researchers’ conclusion is equally clear: electroacupuncture reduced the duration of postoperative ileus, time to ambulation, and postoperative analgesic requirement, compared with no or sham acupuncture, after laparoscopic surgery for colorectal cancer.
The only other trial I know in this area failed to show that acupuncture shortens POI. What should we make of these data? A systematic review would be nice, of course, but, to the best of my knowledge, none is currently available.
Is this a question of everyone being able to pick and chose the evidence they like? Is it a question of who we trust, the researchers in New York or those in China? Is it a question of where the treatment was done authentically? Is it a question of critically analysing which study had the higher risks of bias? Or is it a question of simply saying that two negative studies are more than one positive trial?
Confused? Me too, a little!
Whatever answers we chose, several things seems fairly certain to me. It would be wrong to say that there is good evidence for acupuncture as a treatment of POI. And the acupuncture-boom that ensued after Reston’s article was to a very large degree built on a simple misunderstanding: POI is a condition that resolves literally into thin air whether we treat it or not.