Radio 4’s You and Yours programme has been running a series on Chronic Fatigue Syndrome/ME. Today saw the last in the series and concentrated on ‘alternative treatments’ for patients who do not get ‘satisfaction’ from their GP.
ME is a quack’s dream. It does not have a specific set of diagnostic criteria – it is what left when all other possibilities have been ruled out – follows a cyclical pattern of symptoms, and tends to get better on its own. Kerching. As such, the Radio 4 programme explored the full zoology of quack therapies for ME, including reflexology, nutritional therapy, mickel therapy and, of course, homeopathy.
The first homeopath to be interviewed was Dr Susie Rockwell, who is an NHS GP, but also runs her own private homeopathy clinic. She points out on her website the rather confusing contradiction,
I advise on management and treatment according to NICE guidance. This guidance does not support the use of complementary therapies in CFS/ME as there is currently insufficient evidence for their use. However a wide range of complementary therapies have been tried in CFS/ME and I can advise about which may be useful and how to access them.
Now as most ME sufferers will seek alternative help like this at one of their lower points in their illness, ‘subtle effects’ towards improvement may well take place over a few weeks. It’s called regression to the mean. Dr Rockwell’s assertion that she sees her patients getting better is no evidence that it is anything to do with homeopathy.
One person who has made an honest attempt to improve the evidence base for homeopathic treatment for ME is Shefield University psychologist Dr Elaine Weatherley-Jones.
Dr Weatherley-Jones obviously had high expectations of the trial as she ‘aimed to find a strong clinically significant effect’. Unfortunately, the trial did not yield a strong significant effect. On most measures, there was no significant difference between the placebo group and the homeopathicly treated group. Overall though, “there is weak but equivocal evidence that the effects of homeopathic medicine are superior to placebo. ” Hardly, the ringing endorsement the researchers were looking for. And as DR W-J admits, “further studies are needed to determine whether these differences hold in larger samples. ” It is highly likely that this is just a statistical anomaly.
But, given the very disappointing nature of the trial, does Dr Weatherley-Jones admit that homeopathy may not be the wonder treatment for ME? Of course not, its the trial that was the problem. I think her words speak for themselves, (it is worth quoting at length)
Since completing and reporting on this study, I have reflected on and researched the relevance and appropriateness of the design of this study for investigating homeopathic treatment. (…) At the time of designing this trial, I believed the triple/double-blind placebo randomized controlled trial fit these criteria.
In retrospect, however, it is clear that the presence of a placebo arm in a study of homeopathic treatment can compromise the practice of homeopathy. In a further paper, colleagues and I conclude that “It is not reasonable to assume that the specific effects of homeopathic medicine and the non-specific effects of consultations are independent of each other—specific effects of the medicine (as manifested by patients’ reactions) may influence the nature of subsequent consultations and the non-specific effects of the consultation may enhance or diminish the effects of the medicine.” and that “For clinical trials of homeopathy to be accurate representations of practice, we need modified designs that take into account the complexity of the homeopathic intervention.”.
It is probably the case that the results of the CFS/ME homeopathic treatment trial were influenced by the existence of a placebo arm in the study. (…) They are also a possible explanation why only small effects are seen in placebo-controlled trials of homeopathy.
Whilst placebo-controlled trials of specific homeopathic remedies are valid, it is time to halt the misguided task of conducting placebo-controlled RCTs to test efficacy of individualized treatments; to redirect our energies to analyses of whole-systems health care and to design more relevant and meaningful pragmatic studies of comparative effectiveness, where untested treatments are compared to those where there is evidence of effectiveness.”
Nice article. It seems as if she is saying that the placebo arm is masking any effect of homeopathy. To me, that would suggest that homeopathy works through placebo effects. To her, it obviously suggests something different. Oh dear.
PS. can I be spelling nazi for a sec?
‘mickel therapy’: nickel?
‘Form her writings’: from?
‘mind to much’: too?
Sorry, I can’t help myself.
Thanks Ambrielle.
I have no idea what she is saying about the effect of the placebo arm. This is where people like Milgrom get involved and talk bollocks about quantum entanglement.
If any homeopath out there reads thus (and I know you do my lovelies) two clear paragraphs explaining why placebo-based trials cannot work would be wonderful.
PS And no talk of ‘holistic’ or ‘complex’ treatments or the like. Simply – why is not not possible to simply randomise the pills at the point of dispensary? You can do whatever consultation you like, take as long as you like, repeat as often as you like – just not know what it is the patient receives.
PPS Thx for the spelling. I tend to blog, post and then check. Impatient! But, mickel therapy it really is. A future blog post no doubt!
“In retrospect, however, it is clear that the presence of a placebo arm in a study of homeopathic treatment can compromise the practice of homeopathy.”
I bet it does.
If homeopathy differs from talk therapy, and is based substantially on the substances given, placebo controls should be perfectly approriate. I don’t get her point at all.
I would love to see a five-armed study: No treatment; placebo only; homeopathic remedy only; placebo plus homeopathic consultations, and homeopathic remedy plus homeopathic consultations. With the homeopathic or placebo part double blind (obviously you can’t blind the other bits).
I think doing all five arms in one study would make it crystal clear what the effects of the consultation, as opposed to the pills, are. I know no treatment vs placebo is a well known result, but I suspect that the only way to win the argument is to have one set of results in the same place. You’d need huge numbers, and the ethics of repeating research is questionable, but hey, I can dream.
I work for one of the NHS Trusts with a homeopathc hospital. And despite the nominal commitment to Clinical Governance, Evidence-Based Practice and all the other buzz words, there is a telling gap in our research portfolio.
L.
The black duck writes:
“Given their is insufficient evidence to support homeopathy for ME, one has to wonder how the doctor is able to offer ‘useful’ advice. However, Dr Rockwell charges £110 for a session…”
Wonder no more. It’s a nice little earner.
L
Personally, I think that clinical research into homeopathy is an utter waste of time and even counterproductive. A future blog post…
Frankly, the only thing that amazed me about DR W-J is that she has not trumpeted her trial as a roaring success given that 1 out of 5 measures showed an improvement under homeopathy.
Sounds like an interesting programme. Take your point about CFS/ME not being typically fatal but Sophie Mirza’s death was attributed to CFS/ME according to a coroner in UK in 2006.
Liverpool Leftovers has good discussion of Reverse Therapy – the root from which Mickel Therapy split.
Excellent article.
“… It is not reasonable to assume that the specific effects of homeopathic medicine and the non-specific effects of consultations are independent of each other …”
This proposed interaction between the success of the intervention and subsequent consultations would surely happen with conventional treatments as well. So homeopathic treatments are no worse off in an RCT than any other.
I would also have thought that the interaction would be a positive one: you give me a pill, I feel better, when I come back I’m more positive about the process?
This would seem to favour an effective treatment over a placebo.
Very interesting. Regarding the private fees for this kind of thing, I wonder does having paid rather a lot of money for homeopathy or whatever have any influence on patients’ perception of efficacy/improvement? As in, might they be less willing to be sceptical? Might be an interesting trial.
Mickel therapy…a treasure trove of bad puns!
The problem she sees appears to be a consequence of the treatment regime being a repeated cycle of consultations and prescriptions.
If the homoeopathic remedy itself has a positive effect, then patients on real homoeopathy come along to the next consultation having got a bit better and the practitioner says ‘it’s all going well, carry on.’ Those on placebo turn up not so much better and the doc says ‘hmmm, this is a tricky one, let’s think a bit harder and try this instead.’
If the character of the latter type of consultation leads to more effective psychological-placebo-type recovery, then the effect of the remedy itself is confounded to some extent. Yes this would also be a problem with conventional medicine, but trials there tend to be in the format of single consultation + course of medication rather than the ‘keep trying until we think we’ve cracked it’ model.
It’s hard to see how to address this (other than by throwing up one’s hands and saying ‘Gah!!!’) You could put homoeopathy head-to-head with conventional medicine in the same format, but then it wouldn’t be blind – which leads to all kinds of problems for a condition like ME. One has to think though that if homoeopathy were SO great, the effects would be big enough to outweigh this kind of second-order stuff…
Yes, I see the issue, but if this is what Dr WJ is on about then it is tantamount to admiting that homeopathy+placebo = superplacebo.
Placebos (super or not) have limits, and while they may have significant effects for ME, homeopaths make much stronger claims than this. If WJ wants to come clean and say it is a placebo, then great. But I don’t think she will.
I have always been fascinated by a comment that one of my hospital rheumatologists regarding ME/CFS, namely that ME “does not exist in the solitary. It is impossible to have ME and not have a supporting partner/ parent/ child to ‘support’ one during their illness”. Anecdotally (ie much higher level of evidence than homeopathy) I find this absolutely true. I have yet to find a patient without some frantically worried carer supporting them…..
The incredible hostility of the ME/CFS lot to any suggestion of trying psychological therapies (“You’re trying to say I’m mad”) is quote striking. They resemble the electrosensitivity crew. The only bloggers more routinely crazed are the anti-vaccine / “Mercury Militia” / MMR lot and finally the HIV denialists, who I think are just about the barking-est of the bunch.
Incidentally, the academic “Godfather” in the UK of the arguments that placebo trials are “inappropriate” for examining homeopathy is George Lewith, see e.g. here.
Lewith often pops up in the British Medical Journal defending CAM and homeopathy, e.g. this week (Nov 10th),and is an old adversary of David Colquhoun’s. Lewith is a GP and runs a “Complementary Medicine Research Unit” at the Univ of Southampton. He also works as a private homeopathic doctor at a London clinic. If you see something medical academic-y looking excusing homeopathy’s failure in a blinded trial, it is usually penned by Lewith.
Has Dr Lewith responded to this recommendation from the recent House Of Lords report? (http://www.publications.parliament.uk/pa/ld200607/ldselect/ldsctech/166/16611.htm#a82 ). Validated outcome measures for homeopathy compared with conventional treatments might not, I’m guessing, look too good.
“…8.33.We recommend that robust research into the use of complementary diagnostic tests and treatments for allergy should examine the holistic needs of the patient, assessing not only the clinical improvement of allergy symptoms, but also analysing the impact of these methods upon patient wellbeing. Such trials should have clear hypotheses, validated outcome measures, risk-benefit and cost-effectiveness comparisons made with conventional treatments. Allergy centres (para 9.40) will allow the collection of information about any indirect consequences of misdiagnoses or delayed treatment…”
CAM ceaslessly and enthusiastically advertises itself for allergic disease and asthma and there are estimates that between 50-70% of such patients use some form, mostly (one hopes)alongside conventional treatments. As the House of Lords report highlighted, there is a well documented deficiency in provision of specialist clincal allergy care in the NHS. Something many promoters of CAM seem keen to exploit, e.g the unintentionally hilarious press release from SoH after the publication of the HoL 6th report (which seems no longer to be available on their website).
If this is what conventional trials of homeopathic treatments find, I think I have some insight into Dr L’s discomfiture (concerns electrodermal ‘allergy testing’, used in homeopathy – source: http://www.bmj.com/cgi/content/abstract/bmj%3b322/7279/131):
“Results: All the non-atopic participants completed all 3 testing sessions (810 individual tests); 774 (95.5%) of the individual tests conducted on the atopic participants complied with the testing protocol. The results of the electrodermal tests did not correlate with those of the skin prick tests. Electrodermal testing could not distinguish between atopic and non-atopic participants. No operator of the Vegatest device was better than any other, and no single participant’s atopic status was consistently correctly diagnosed.
Conclusion: Electrodermal testing cannot be used to diagnose environmental allergies.”
I think most doctors who deal in long-term chronic disease involving medications with possible side effects have to deal patients keen to use CAM, and simply to condemn patients for entertaining unproven therapies doesn’t seem to work very well. For example, one of my sisters has Lupus, a nasty disease though thankfully (due to improved medications!) no longer the dread diagnosis it once was. Her variant behaves like rheumatoid arthritis and earlier this year she was put on methotrexate as the milder medications were not controlling the disease. Not a step her rheumatologist took lightly (a second opinion was obtained) and my sister could really have done without ‘helpful’ people warning her of the possible terrible side effects she was risking and urging her to try god knows what. She has of course discussed CAM with her doctor, whose attitude is: “if you want to pursue an unorthodox treatment, I can’t stop you, but please inform me and above all don’t abandon conventional treatment”.
I’ve had the pleasure of reading the “Mickel Therapy” book, and you lot would have a lot of fun with it. I knew a few people who have had the treatment too, and judging from their accounts and the book this is how the treatment works…
You write down words on pieces of paper, happy words and negative words. You throw the pieces of paper with the nagative words on it away and carry the ones with the happy words around with you. Now this might seem like your average psycho-placebo bollocks, but it is so much more. You see, the water in your body reacts when it is around happy words and happy music, the molecules change into beautiful snowflake shapes (some of you might remember one of the Bad Science columns from a few years ago talking about a “study” similar to this, well, Mickel therapy is based on it. Here’s the BS link http://www.badscience.net/2005/05/literate-molecules/ ). Snowflakes are happy shapes and happy shapes make you healthy, and your body is mostly water, you see. You do wonder if it’s water and it’s in the shape of a snowflake then maybe it IS a snowflake and Dr Mickel wants to turn us all into an army of snowman warriors or something.
I’ve had ME for 7 years and you would not believe the cures that people suggest on ME forums I visit. Being incurable ME seems very susceptible to these kinds of charlatans, who know exactly how desperate we are to get better. I’ve seen garlic tablets, asthma-controlling breathing techniques, pills that cure AIDS and the menopause along with ME, bizarre hypnotherapy things that cut its patients off from everyone else in a cult-like way, practices that will “retrain your hypothalamus so that you only produce the good sort of adrenaline”, pills with 900% RDA of certain vitamins, and no end of vague treatments like Mickel Therapy and Eaton Therapy and Reverse Therapy and L1ghtn1ng Pr0c3ss that turn out to be completely nuts once you find out what they really are. And I’m usually on my own trying to persuade people (young people who have usually been too ill with ME to go to school and learn basic science) why these things might not work as well as the website suggests they do. And it breaks my heart to see so many people pay thousands on these things (Mickel Therapy costs 100 quid a session and lasts 8 sessions, all done by a completely non-accredited medical “professional”), which often tire them out so much it takes them months to get back to their normal level of illness.
Cindy Crawford on Oprah Show: We are VERY pleased that Cindy Crawford chose to HIGHLIGHT the fact that she calls herself a “big fan of homeopathy” and that she uses it to treat a wide variety of ailments of her children and her animals. This is fabulous…and it adds just one more person who is smart and successful and who could choose to use ANY form of healing…but SHE chooses
HOMEOPATHY.. .with good reason. The bottomline is that she emphasized thatshe doesn’t leave home with her homeopathic medicines. Fab again.
Well you haven’t met me, but my wife had a diagnosis of ME when we first started going out. One evening she simply collapsed in the dinner queue and had to be carried up to her room.
Contrary to your hypothesis she got better a few months later, after I had made her pregnant 😉 (and married her of course, I am a gentleman). But think about it, pregnancy is a gradual, no taking days off, fitness program.
And I was worried about her, but I didn’t do things like go with her to the doctor and harangue him. I did cheer her up afterwards though.