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Marigold therapy for bunions. An RCT

Discussion in 'Podiatry Trivia' started by Robertisaacs, Nov 27, 2007.


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    WARNING!!! BULLS**T AHEAD

    [​IMG]


    I have often said that i require evidence before "buying into" a treatment or model. Therefore...


    Quote:Marigold therapy for bunion – a randomised controlled study
    Khan M T1, Khan M T2
    1Royal London Homoeopathic Hospital, London, WC1 3HR, UK
    2Centre for Pharmacognosy, School of Pharmacy, University of London, UK
    Objective
    To investigate Marigold therapy in the treatment of unilateral bunion.

    Materials and methods
    In an 8-week randomised, double-blind, placebo-controlled study at the Royal London Homoeopathic Hospital 40 volunteers of mixed gender aged between 18 and 70 years, randomly selected according to inclusion and exclusion criteria and divided into active and placebo groups of 20 each, were treated once weekly in the clinic for 4 weeks, the active group receiving Marigold therapy, the placebo group placebo. Patients continued with home treatment for a further 4 weeks. Swollen soft tissue density and hallux valgus angle were measured by an independent assessor and level of pain by the patients. Data recorded pre- to post-treatment were compared for significant differences using unrelated Student t-test.

    Results
    The active group showed a reduction in swollen soft tissue density of 34.69%, hallux valgus angle 30% and level of pain 100% at P < 0.001. No adverse effects were noted or reported. The placebo group showed no reduction.

    Conclusion
    Marigold therapy is effective for all age-groups in the treatment of unilateral bunion, achieving total relief of pain, reduction of swollen soft tissue density and hallux valgus angle, thereby suggesting its usefulness as a painless, non-invasive alternative to surgery.



    Well there you have it. A Double blinded study showing a 100% decrease in pain in the active group. And indeed A 30% reduction in IM angle (no less).

    And the control group... showed no reduction in pain, swelling or IM angle. Even the placebo effect, usually so reliable, failed.

    Rarely have we seen a study so convincing with data so decisive.

    I hang my head in shame and stand corrected.

    Regards
    Robert
    :D
     
  2. drsarbes

    drsarbes Well-Known Member

    Wow, that's wonderful! The decreased IM angle is VERY impressive.
    Obviously Marigold will soon be used for knock knees, over-bites and scoliosis.
    Where can I get some, I have a rotator cuff that's bothering me.
    Steve
     
  3. Admin2

    Admin2 Administrator Staff Member

  4. R.E.G

    R.E.G Active Member

    Robert,

    In your obsessive attempt to discredit homeopathy you have chosen a very old study, and of course not given enough information for observers to read the actual study. It was published in the predecessor of Pod Now around 14 years ago. At the time it was much criticized.

    However Mr Khan (senior) did go on tho investigate the properties of Marigold (mainly Tagetes, not the usual Calendula) and was awarded a PhD for his efforts. His son Mr Khan (junior) also investigated the product and was awarded a PhD.

    Mr Khan (S) also established a following for Marigold Therapy, and eventually gained an 'special interest group' within the SCP. Many chiropodists use his products and achieve good results.

    Unfortunately Mr Khan (S) died last year so is unable to defend his work.

    I can understand your obsession with exposing homeopathy for the quackery it is, but am confused that you do not apply your critical brain to functional orthotic therapy.

    I would love to hear your analysis of the Vasyli Dananberg 'evolution in orthotic therapy?

    Bob

    Ps Marigold does sometimes work on VPs but then so does a lot of things. Marigold works excellently on chronic NV HDs, is it the marigold or just at last a chiropodist that believes in cure?
     
  5. Hey Bob

    Obsessive you say? Possibly. It is certainly one of my areas of interest. I'm probably just trying to draw attention away from the REAL issue which is, of course THE SOCIETY SELLING OUT OUT the PROFESSION TO AGE CONCERN AND THE NHS PODIATRISTS MAKING IT WORSE THE DESPICABLE SWINE!!!

    I'll try to curb my obsession in the future. ;)

    I did not "choose" the study from a selection of others, it was just something i happened across during a casual literature review of HAV. I was actually looking for a reference on HAV night splints. The reason i did not give observers more information or the actual study was because i don't have it to give. What was there is all i've got.

    Good for them. If you have some of the more recent research by all means pop it up and we'll have a mull.

    I'm not surprised they get good results! 100% success rate for painful HAV? Blinder!
    All joking aside i am aware that homeopathy is growing in popularity in the UK. Its a concern to me. Thats why i throw up the occasional thread on alternative therapies in general and this one in particular for discussion.

    As you say, unfortunate. It does not, however, spare his work from critism. Not to worry, there are plenty of followers to argue his corner.

    Be confused no more. I apply my critical brain (as addled, slow and limited as it is) to biomechanics as well, both here and on David H's forum (where we are presently having great fun chewing over kinetic chain theory). I have yet had the pleasure of the vasyli / dananberg evolution of which you speak. If you would really be interested in my views pop me a reference and they are yours for the asking!

    Kindest regards as always
    Robert
     
  6. R.E.G

    R.E.G Active Member

    Robert,

    Thanks for the link to DHs site, interesting EB stuff there.

    Try Pod Now Sept 2007, page 10, full page advert for Vasyli.

    And if you are going to site research papers do you not think you should do the authors the respect of reading them first?

    I seem to remember the Marigold research was for a BSc hons dissertation. We all had to learn, and at least he made it available to all. Unlike a lot of research.

    I think it is generally recognised that 'good' EB for Podiatric practice is hard to come by. Should we not be trying to build on the mistakes?
     
  7. R.E.G

    R.E.G Active Member

    Robert,

    Post has just arrived, I'm on holiday by the way, and Pod Now came through the door.

    Try December 2007 page 49 and 50.

    Perhaps you would like to write a letter of complaint about this blatant advert for Homeopathy.

    If course this article will not be available to the majority of your friends on DH's site, shame really.

    Interestingly if you look at page 48 it is a full page advert for Vasyli 'shock absorber'. Then try page 3 Clear Zal, look at that study.

    Hope this is enough to keep you busy.

    Bob
     
  8. Craig Payne

    Craig Payne Moderator

    Articles:
    8
    There are plenty of good methodologically sound RCT's that show prefabricated and custom made foot orthotics work. Specifically the results from a large RCT on the use of Vasyli compared to placebo for patellofemoral pain will soon be released (they worked).

    The methodology used in the RCT on marigold therapy is so shonky and does not come close to standing up to scrutiny, proponents of marigold therapy are not doing themselves any favours promoting it, hence the ridicule.
     
  9. R.E.G

    R.E.G Active Member

    Craig,

    Excellent news that there are plenty of RCTs that show that foot orthotics work.

    It will be very good to read the Vasyli RCT then perhaps we can put to bed the argument that casting for orthotics is necessary?

    I have never seen anyone suggest that the methodology for THAT RCT for Marigold therapy stood up to scrutiny.

    I remember my BSc discertation, 12 years ago, and reading the 'reports' of the use of early 'footplates'. They would certainly now be held up to ridicule.

    So foot orthotics work, can you tell me how?

    Bob
     
  10. Craig Payne

    Craig Payne Moderator

    Articles:
    8
    The study I referred to did not campare vasyli to custom made; it just showed Vasyli better than placebo. However, a number of study's have shown no difference in outcomes between custom made and prefabricated - thats old news now. However, there are still contraindications and indications for both in clinical use and I have a problem with anyone who blindly uses one or the other.
    They reduce the stress in damaged tissues to tolerable levels.
    This RCT is still being promoted by supporters of marigold therapy. Khan Jr spoke about it here in Melbourne last year. I guarantee that no one who heard the presentation left the room with any intention of using Marigold therapy and were instead 'rolling their eyes'.
     
    Last edited: Nov 28, 2007
  11. R.E.G

    R.E.G Active Member

    It will of course be interesting to see how much better, and should we not expect 'cure'?. So what are the parameters for indications and contra indications? Do RTC allow for clinical discretion?
    How?
    In which case Mr Khan Jr should be ashamed of himself.

    Do you have a similar promoter of Tea Tree oil, that seems to be popular in the UK and of course their is also Alo Vera. Did all that come from the native Australians or was it the early settlers?

    I am not trying to defend that study, nor the 'science' behind Marigold. It mainly works for me, I and the majority of my patients find Vasyli very uncomfortable, but tolerate another make very well. I had someone return after 4 years with a worn out pair of unmodified Vasyli saying he needed new ones. What had they been doing for the past 3.5 years, he was a postman.
     
    Last edited by a moderator: Nov 28, 2007
  12. Craig Payne

    Craig Payne Moderator

    Articles:
    8
    I will have to pass on that as we have only had snippets of the results from the researchers. The complete data analysis is still being done. Be assured as soon as possible, the results will be posted here
    By changing joint moments --- there is no other way for them to work.
    I will also pass on that one, as not familiar with them. I have seen an occasionaly publication on Tea Tree oil, but it seemed to be directed at showing TTO as having so many anti-everything properties and as a 'cure all' ... whenever I see that the 'snake oil' alarm goes off.
     
  13. This is, of course, the oft lamented problem with this type of research. Almost by definition N can only every = 1. Most comparative studies you see between pre fabs and bespoke compare a single type of pre fab to a single type of bespoke (usually casted shell in STN).

    The problem with this is, of course, that we do not simply provide a series of cookie cutter devices of either type. We assess the patient and prescribe whatever they need with whatever modification seems appropriate. Otherwise we could simply have a technician churning out casts of the foot for everyone with heel pain (for eg) with no sign of assessment anywhere in the process). I have yet to see an outcome study comparing pre fabs with devices of the clinicians choosing (be they casts, simples, pre fabs or whatever). Even were such a study to be done it would have limited value because it would really only be comparing that clinician to a standard.

    This is the challenge of creating EBM for orthotics, pre fab or otherwise.

    Now homeopathy, thats a different ball game. The Khans prescribe their preparation (marigold) for the relevant condition (HAV) and claim a quantativly measureable outcome (reduction in IM angle) as well as a qualativly measueable outcome (pain releif). It appears from my limited knowledge (correct me if i'm wrong) that the treatment is influenced little by the cause of the deformity or the circumstances of the patient, claiming a 100% success rate at pain reduction indicates they consider it to be a "broad spectrum" treatment. It is therefor much easier to apply the standards of EBM to.

    Depends. If the abstract has been offered to the public domain but the full text has not i feel certain observations can be made about the data and conclusions drawn. In this case i feel the results claim speak for themselves, although possibly not saying what the author intended! Its a brave researcher who publishes anything claiming a 100% success rate for pain releif in the active group and a 0% improvement in the control group. Or perhaps a dishonest one...

    Regards
    Robert

    PS
    Still waiting for my pod now. When i get it we'll chew that over if you like!
     
  14. jb

    jb Active Member

    Gee I love Podiatry Arena!
     
  15. davidh

    davidh Podiatry Arena Veteran

    Hi,

    This "research" was a joke at the time:pigs:, and in retrospect seems even funnier now. I for one was amazed the SCP published it:eek:. After all, the Journal of British Pod Med (predecessor to Pod Now) was a refereed Journal:rolleyes:.

    What I don't understand is, if this was part of a first degree how on earth was it allowed past the examiners?

    Anyway, here's what can happen when the Press are fed a story like this:

    "Clinical trials confirm that this curious formula can work. One study of bunion patients showed that swelling diminished by about 25 per cent and pain vanished completely after three months. Those given the placebo treatment showed no improvement. At about £100 for a course of three treatments, marigold therapy compares favourably with surgery, which is painful, has a recovery time of several weeks and costs the NHS about £1,000."
    Ref: http://www.telegraph.co.uk/health/main.jhtml?xml=/health/2002/04/22/hmar22.xml

    This ref may be five years old, but the article was right up towards the top of the first page when I did my Marigold Therapy search this morning.

    Hey-ho.
     
  16. admin

    admin Administrator Staff Member

    I think I need to do some search engine work. This thread ranks 152nd in Google on a search for 'marigold podiatry' ... need to do something about it so it ranks higher for this and other keyword combinations, so people searching on the topic can find this thread to get alternative views.
     
  17. This for me sums up the problem with "alternative" medicine.

    I can be pragmatic about the use of treatments which are not backed by good evidence. As many have said before if it works its worth doing. The placebo effect is powerful and shown to be far more effective than no treatment at all. In many conditions (like the common cold) no treatment at all is basically what the mainstream medical profession has to offer. If a sugar pill or distilled water makes my cold 25% better then pass me the homeopathy catalog!

    I also think that these therapies have something to teach us about how we apply what we do. An observation often made in placebo studies is that the treatment is as much about the cultural expectations and the experiance of assessment and contact as the treatment itself. One downside of the "medical" model is that we all to often neglect this aspect of care because we are stuck in the mindset that OUR treatments work whether you beleive in them or not. Perhaps we could make our interventions more effective by learning from what alternative practitioners do so well. I don't know, use expressions like "holistic", "bolstering the bodies defense system", and stuff like that.

    I am even (on a good day) willing to consider the role of these therapies ALONGSIDE the medical model (assuming we cannot incorperate the best of the techniques into it).

    In short, i have no problem with COMPLIMENTARY medicine.

    My argument is with ALTERNATIVE medicine.

    Unfortunatly it seems to be standard marketing practice to big up the alternative stuff by denigrating the mainstream. The above piece is a good example and is by no means rare. There is a growing culture of smug post modernist suspicion of "western medicine" with its "limited understanding" of how the body works fed by marketing machines which we cannot hope to compete with. Doctors have not traditionally considered the need to market themselves, people with a broken leg or an MI don't tend to ask searching questions about whether they are being treated with all natural ingrediants. Perhaps we are now paying the price for that.

    Regards
    Robert
     
  18. perrypod

    perrypod Active Member

    How can one be sure if any RCT is accurate and conclusive?
    Only today doubt was placed on the efficacity of prozac
    There is almost a blind belief by some that RCT's must have been honestly carried out,
    merely because they are seen to be scientific.
    For instance it is easy to prove that water heals 100% of all ulcers
    if all the randomly chosen ulcers were taken from a population with ulcers that were going to heal up in any case. Especially if generous funding from the water board follows
    positive results in the trials!
    Give me some good old phenomenology any day of the week.
    It could be more fun and probably just as accurate.
    Marygold therapy does help a lot of patients.
    The overwhelming proof is that I have just told you so!
    Perrypod
     
  19. DaVinci

    DaVinci Well-Known Member

    By what mechanism does it help bunions?
     
  20. perrypod

    perrypod Active Member

    Dear Da Vinci,
    Thank you for asking this question. Tagates marigold can have an anti- inflammatory effect which may reduce pain and swelling to inflamed joints. Any reduction of alignment or size of the joints treated appears to be due to decrease of soft tissue swelling around the osseous structures.
    There are also many other herbs that can be used in tincture, poultice, cream. ointment and gel. Bellis Perennis and symphytum to name but 2 of many. I have used many natural products and herbs extensively for years. It is always best to do a small patch test if allergy or hyper-sensitivity is suspected. It is also best practice to do so with so called 'conventional' preparations.
    Using tagates hundreds of times I have found intolerance in only 3 patients. These rashes were all contained to the area being treated. Fortunately, none was really severe or painful and all cleared within 48hrs. All these abreactions occurred after application of the paste and could well have been due to either herb or alcohol.
    Nutritionists warn us of the potential dangers of 'artificial additives' in our diet. It makes sense to me to utilise natural remedies especially if they are kind, gentle and efficacious to the skin. Tagates does have a place in podiatry but like all substances is not a universal panacea.
    Best regards
    perrypod
     
  21. davidh

    davidh Podiatry Arena Veteran

    Slightly off topic, but this is yesterdays news (although it seems to have been reheated/rehashed).

    See:
    Kirsch I, Saperstein G. Listening to Prozac, but hearing placebo - a meta-analysis of antidepressant medication.. Prevention and Treatment, Vol 1. June 26 1998. (The Am Psych Assoc).
     
  22. perrypod

    perrypod Active Member

    Dear Davidh,
    I was talking metaphor not meta-analysis
    perryp
     
  23. I've resisted the temptation to reply for... well hours!

    This is a completely illogical argument. Clinical trials are not perfect therefore we can resort to empiricism as being just as good. Does'nt follow.

    One might as well say that miscarrages of justice DO occur therefore we might as well go back to the ducking stool and trial by ordeal! SOME of those warty women were probably witches so why not?

    Or that some people still die in traffic accidents even when they wear seat belts so there is no point in wearing one.

    Yes some research can be misleading by accident or design, but that just means we must analyse it critically and judge it accordingly.

    COULD be more fun?!?! PROBABLY just as accurate?!?!

    Without research to back it, this is a random claim with no validity. If i said hanging a dog poo around your neck cures Tinea Pedis would you beleive me?

    Chewing lemon peel has an anagesic effect.

    Sucking golf balls cures hair loss.

    Without research all of these claims have equal validity to "marigold has an anti inflammatory effect.:deadhorse:

    Unless you want to show me some research to the contrary? Please?

    Regards
    Robert
     
  24. DaVinci

    DaVinci Well-Known Member

    Are you seriously trying to tell us that a derivative of a flower can overcome the mechanical force pushing the hallux into valgus? :craig::craig::craig: Not surprised this thread is filed under snake oil !
     
  25. LOL

    You did'nt know? Da Vinci you should pay more attention. HAV is clearly caused by
    .
    NOT mechanical force pushing the hallux into valgus. THAT is how an (alledged) antinflammatory can release this force and reduce the IM angle. So i don't know where you get this crazy idea about mechanical force from.

    Its true because i say so.

    Oh and go easy on the :craig: . There is a reason it appears in text as "craig". You can only do it for so long....

    Regards
    Robert
     
  26. perrypod

    perrypod Active Member

    To Doubting Thomas,
    Get hold of some HTS 081 tincture paste and oil. Use it as the manufacturer recommends on at least 10 volunteers and see for yourself. I do not think that empiricism is as good as RCT,s I think it's much better
    perrypod
    ducking stools, golf balls, dogs poo, seat belts......I really didn't know I had the power to wind Robert up!
     
  27. Oh you do!. Mind you don't get too excited, that particular gift you share with half the english speaking world!

    Great plan. I'll put this up in my waiting room
    I'm sure they'll be beating my door down!
    I don't beleive you. I think you think that YOUR experiance is much better than everyone elses experiance plus any RCTs floating around.

    I doubt you would take other peoples empiricism or research so seriously if it contradicted your own.

    You are doing my hypertension no favours friend, I'm off to pop some more verapermil (or possibly chew some ylang ylang)

    Regards
    Robert
     
  28. davidh

    davidh Podiatry Arena Veteran

    Hey Robert,

    You forgot the bag of lizard bones:D.

    ps - does dog poo really work with Tinea?
    :D:D:D

    Cheers,
     
  29. Depends. I've tried it with 10 patients 7 of whose tinea improved over the next 6 weeks. So empirically YES.

    You could try it on ten of your patients, see if it works for them. If it does then its as good as prooven!

    Of course to find out for real we'd have to try it with lots of patients and compare it with CAT poo and with nothing at all to see if that performs any differently.

    Regards

    RObert;)

    PS did you see how subtley and seamlessly i wove my point about needing a clinical trial in there? And how you'd be a fool to try an unsupported treatment just on my say so?
     
  30. perrypod

    perrypod Active Member

    Dear Robert,

    How did you ascertain that I may be a sanitary engineer without subjecting me to a RCT? I do hope the ylang ylang worked and you are now calm and compliant. If you only accept the evidence of proper random clinical trials before submitting scientific judgement, please post your research on Khan's Marigold Therapy. If there is a problem with the product, please let us know what your trials have concluded and what exactly they have revealed. After this is submitted we can then draw our own conclusions as to the viability of your research. I really have used marigold therapy on many occasions. I have successfully utilised it for pain reduction and to help the reduction of swelling. I have not noted any increase or decrease in IM angle. Believe it or not, I do not mind criticism, especially from great researchers such as yourself.

    Your Loyal Empirical Phenomenological Nosologist and Sanitary Engineer .... perrypod

    PS: Eating dog poo with humble pie has done my tinea pedis a world of good!
     
  31. :pigs:

    Did'nt. I said you COULD be for all i know.

    again, :pigs:

    I can't be bothered to dig them all up but every serious Blinded RCT clinical trial ever done has shown SOME benifit to the placebo group from the placebo effect. The study in question showed NO improvement in swelling, IM angle or pain. From that i extrapolate that based on the vast preponderance of evidence placebos have SOME effect, and from the fact that the Khan study did not that it was significantly flawed.

    [/QUOTE]

    As you know EBM does not work that way. The onus is on the person who is promoting the project to show that it works not on everyone else to prove that it does not!! I i did say that eating dung cures heamaroids you don't have to conduct a study to show it does not!

    Seems odd. Are you using the same protocol as the khans? Because they DO have a reduction in IM angle. I wonder why that discrepancy exists. More, however, I wonder why YOU think that discrepancy exists.

    ick. Thats what happens when you take the word of someone on the net. You don't eat it silly, you hang it on a string around your neck!

    To answer the point of your (quite funny:drinks) post. You don't need evidence for everything. You don't need it to prove something does NOT work. But you DO need it to back up huge claims made on the basis of no actual rationale. If you are going to say "it works but we don't know why" you'd better be damn sure it DOES work!!

    And i'm no great researcher as you know. But i have a tremendous respect for the brave and noble souls who are. And i feel their efforts are worthy of a spirited defence against those who would masquerade as being a part of that group.


    Regards

    Your hypertensive, pedantic, irritable substitious podiatrist Robert
     
  32. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Popular Alternative Therapy For Psoriasis Performs No Better Than Placebo
    Full story
     
  33. perrypod

    perrypod Active Member

    I submit:- that if we expect people to carry out their own research, on their own products, there will always be those who will claim operator bias.
     
  34. W J Liggins

    W J Liggins Well-Known Member

    Which is the whole point of double blinded trials.

    Bill Liggins
     
  35. perrypod

    perrypod Active Member

    Dear Bill,

    Yes, I agree that this is the whole point of double blind trials. Unfortunately, these can be sometimes fiddled around with by interested parties! Take the case, a number of years back, of a G.P. who rigged a double blind drugs trial. He was supposed to submit an electrocardiogram for each person, to check their hearts were not being put to risk. He submitted the same cardiogram print out for each patient! A bit stupid and perhaps even dangerous! Makes you wonder, however, if there are those who have falsified more ingeniously and not yet been found out. Triple blind trials are supposed to be even more reliable than double blind, but can we be absolutely sure that all statisticians are not open to bribery? Hopefully, the vast majority of researchers are ethical enough to put their interests to one side. Perhaps the only certainties in this life are death and taxes!
     
  36. W J Liggins

    W J Liggins Well-Known Member

    Hello Perrypod

    There will always be those who seek to gain personal advantage by dubious methods. Such people are cheats, frauds and contemptible, and properly so described. I am sure that you would so describe the person in the case which you have cited. However, it is an oxymoron to claim that those who cheat under a scientific aegis (and who were presumably discovered by peer review) are any more or less cheats and frauds than those who do not use scientific means. The difference is that the scientist is forced to follow the scientific pathway or be proclaimed a cheat. The "crystal therapist" and their ilk rely on nothing but superstition and are frequently known to voiciferously object when described as cheats, frauds and contemptible.

    Whilst agreeing with you about taxes and death, there are, incoveniently, other constants such as mathematics and statistics which at least serve to protect us from magic and superstition.

    All the best

    Bill
     
    Last edited: Mar 4, 2008
  37. perrypod

    perrypod Active Member

    Dear Bill,
    I do not find anything in the least inconvenient in either mathematics or statistics. They are both very interesting subjects and often very informative. I would also not be at all surprised if insulting a group of scientists and then insulting a group of crystal therapists would bring about a similar outcome! I agree that scientists who cheat are no better or worse than anyone else that cheats. I have not tried to claim otherwise.
     
  38. W J Liggins

    W J Liggins Well-Known Member

    Sadly, you miss the point.

    Mathematics and statistics are constants, hence they are always informative.

    Some scientists knowingly cheat and should be brought to book for doing so.

    All who rely on 'magic' and superstition cheat - even if through delusion. Thus crystal therapists and the like are always fraudulent.

    Bill
     
  39. perrypod

    perrypod Active Member

    Are there not mathematical variables as well as constants?
     
  40. Ah, a blast from the past.


    Its now 21st. Good work Craig:drinks
     
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