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Needling evidence collection.

Discussion in 'General Issues and Discussion Forum' started by R.E.G, Jan 18, 2010.

  1. R.E.G

    R.E.G Active Member


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    You, bob, Could never be called thin skinned. You dish it AND take it with aplomb.

    Robert you are too kind.

    If you were referring to the needling then you are correct, it has no evidence yet although I and a few others are working on generating some.

    Now that is something I'm interested in.

    Are you ready to share your methodology?


    I like your idea of offering money back guarantee. I've been toting with that myself!

    It could be a USP, after all it's only time you are giving away.

    So far I've needled 26 vps, only two have not yet resolved so I could certainly stand to do that. I'm charging the process at £85 a throw. Didn't like to ask for more til I was confident of my results. I'll probably up that a bit presently.

    As I said so far only done two, I'm the worlds worst salesperson, must learn to make it sound fun. £90, so close there and for the same reasons.

    Perhaps it's a demographic thing but OM is just not something my patients seem to have that much of a crisis with!

    If you are talking about NHS patients then that is easy to understand their first port of call would be the GP.

    Bob





    __________________
     
  2. Bob et al.,

    I've used VP needling now on fourteen patients who have difficult intractible lesions. Thirteen have resolved after one Rx, the other resolved after the second Rx. Hasn't quite replaced cryosurgery as my treatment of choice but it's certainly moving in that direction.
     
  3. R.E.G

    R.E.G Active Member

    Mark,

    Knowing your faith in cryo that is interesting.

    Is there anyway we can all describe the case histories of each patient, perhaps looking for common threads, age, type of lesion, personality, time to resolve, pattern of resolution, previous treatments, method of anesthesia, etc etc?

    And last of all 'how much'?

    Have a charming new patient from your neck of the woods, I do not think she was one of yours though.

    Newquay is deeply effected by the recession, times are hard for Pubs, clubs and Pods.

    Surf is good though.

    Have you done any cliff climbing, looks very 'exciting'

    Bob
     
  4. All different ages, both sexes different type of VPs - some single plantar, multiple plantar, digital, mosaic and plain hand warts. Typical resolution in 1-3 weeks. Appearance similar to dermal haematoma - lesion often disappears within a 36 hour period within that timeframe. Previous Rx - differs from cryo to local application of keratolyltics/acids. Anaethesia - local infiltration predominately but also digital and ankle blocks. Don't think their personality has anything to do with it though....
     
  5. That's the real bugger isn't it. If you're using a minor, or topical protocol its easy enough to RCT and not impossible to blind. Tricky to control a needling study. So the best we can really do is an outcome study based on a multi centre trial.

    I suspect Inclusion criteria will tend to be bias in favour of recalcitrant and painful VPs. I suspect people with painless or minor lesions would be quite happy to try popping a bit of duct tape on them to see what happens. Less keen to take a needle in the ankle!

    However, I think it is reasonable to expect a multi centre trial with 50 - 100 patients treated with the same basic protocol and analysed on the basis of a simple "was the lesion fully resolved and gone within 4 months" type outcome measure. It will have to be accepted that the inclusion criteria will probably skew the data in the direction of the tougher lesions.

    VP studies are never perfect, and the increased placebo action inherent to the more dramatic process cannot be fully determined, but I think that's a reasonable place to start at least. Open to suggestions...

    For me, apart from the success rate (which I would not believe had I not seen it myself) one of the big bonuses is the relatively negligable post op pain. My patients have reported at WORST minor soreness after the proceedure. After cryo they report far, far more pain and having tried THAT myself I concur that it really smarts!

    One study I've seen used a protocol of one off cryo (unstated duration in the abstract) followed by DAILY application of 70% sal acid (did'nt say how long). This it described as a "gentle approach". :eek: There's a protocol for the brave! What the hell is their take on an aggressive approach?!
     
  6. hamish dow

    hamish dow Active Member

    Tricky to control a needling study. So the best we can really do is an outcome study based on a multi centre trial."
    Now here's interesting in the laser nail thread this talk is heretical.
    I thought it was double blind peer group review or bust, and it would have to be done by someone who does not use it incase their own mindset impressed iteslf on the outcome. Not mention it can't be done by someone who could have any gain of any type from it. Stop now before you get nailed to the mast for such thoughts
     
  7. blinda

    blinda MVP

    Indeed. A large factor here is the very nature of remission in VPs, hence any trial would be incredibly difficult to undertake. High quality randomized, controlled trials upon which to use evidence based decisions are not available for many treatments, (e.g. VP treatment) Conversely, OM is not self limiting. It does not spontaneously regress without treatment.

    Hamish, I have followed the laser nail thread with much interest. Any treatment that can avoid risks of side effects of systemic medication has to be investigated and I genuinely hope the Multi-Centre Trial by Patholase does produce some meaningful data. Please do keep us posted. That said, I can also understand the reluctance of some posters to embrace the system with confidence. I`m sure you would agree that most practitioners (rightly) believe that until there is enough evidence of efficacy, safety (and of course affordability) then laser tx for OM will remain a point of interest.

    Bob, I also offer a money back guarantee for needling, if 2nd tx does not work. I havent had to refund anything to date :cool: I also only charge for my time so am charging roughly the same as you and Robert.

    Cheers,
    Bel
     
  8. hamish dow

    hamish dow Active Member

    What is the precise technique pray tell, blow by blow (or prod by prod) and what instruments are used please.
     
  9. Hello Hamish

    For plantar VPs - an infiltrative block with 2% lignospan with 1:80,000 adrenaline, then needle the lesion entirely with an 18g short dental needle, making sure you penetrate the dermis and cover the whole lesion by whatever method vertical/horizontal/diagonal you wish to employ. Sterile post op dressing then review 10 days then 3 weeks.
     
  10. hamish dow

    hamish dow Active Member

    so good debridement of the lesion is required first to make the treatment easier?
     
  11. hamish dow

    hamish dow Active Member

    Seems to me that it should be called "Controlled Intra-Dermal Puncture-Wound Therapy" or CIPT for those that like acronyms. Dry needling (as a phrase) was created to make acupuncture acceptable to the medical profession.
     
  12. R.E.G

    R.E.G Active Member

    Belinda.

    You say

    Indeed. A large factor here is the very nature of remission in VPs, hence any trial would be incredibly difficult to undertake. High quality randomized, controlled trials upon which to use evidence based decisions are not available for many treatments, (e.g. VP treatment) Conversely, OM is not self limiting. It does not spontaneously regress without treatment.

    So because of the nature of VP's and their ability to 'remiss' proper RBCs are difficult to perform.

    Just not true, just means there is always the chance of a placebo effect, same chance in the treatment group as the control group.

    Anyway with needling I thougt we were all talking about long standing, non remissing VPs?

    So simple experiment assign the next 30 VPs you come across to two groups one you needle one you do absolutely NOTHING. Record the results at 3 months and 6 months. Crude yes.

    So to the OM. If we all know that OM is not self limiting nor spontaneously resolves what exactly is the point of RBCs? What is the point of the sham treatment?

    In my eyes just a pedantic waste of time. Simple apply the treatment record the results.

    Get lots of centers to repeat the experiment, compare the results. That believe it or not is how some real research is conducted.

    Needling takes me about half an hour, so I'm charging 3 times my hourly rate. What is your hourly rate? Or do you do lots of post op checks?

    Bob
     
  13. Or.... Controlled Intrademal Viral Therapy (CIVT) given that it's used almost exclusively for cutaneous HPV infections. Good debridment? Only so far as to remove any overlying keratosis so you can see the extent of the infected tissue. Interestingly....if the goal is to introduce HPV cells into the dermis to facilitate an immune generated response one would think that secondary lesions would also resolve at the same time as the primary or target infection. This is not always the case and secondary lesions may have to be treated as well. Anyone care to hazzard a guess why this might be so?
     
  14. I really can't see the relevance of the laser. It would be nice if we could keep this thread relevant.

    The point of the Sham treatment is that the laser is not the only part of the treatment. There is also, as Hamish points out, a carefully aggressive debridement and ongoing treatment with topical antifungals. A treatment modality I would expect to yeild results by itself, indeed which HAS yeilded results by itself. Aggressive debridement of ALL the fungal nail (where possible) has in my experiance resulted in the through growth of healthy nail behind it even without the topical.

    So without a control we have no way of knowing how many have resolved because of the debridement and topical antifungal application and how many because of the laser.

    Particularly important because the debridement and topical regime is one well within the facilities of most podiatrists. So if even a part of the 88% success rate is down to that then it would be of great benefit to the profession to know it!

    The other bit of the needling treatment, besides the enhanced placebo effect i mentioned, is a simple debride such as we do before ANY treatment topical or otherwise. So we have an idea of the effect of that (viz, not a lot).

    So if we MUST make a comparison, the protocol for both studies would be to do the same with both groups, up to the point of the area under scrutiny.

    So both nails and VPs, select a group (the next 60 who walk in)

    Assign half to the control group which for VPs would be the debridement and an ankle block and for the nails would be the debridement and the regular application of antifungals.

    Assign the other half to the active treatment group which would be debride + needling / debride + antifungals + laser

    Compare the outcomes.

    Its apples and oranges. If the needling protocol was debride and topical treatment AND needling we'd need to do the same to that in order to exclude the effect of the topicals. Not so?

    It might be pedantic, but not, I think, without reason.
     
  15. In research methodology we tend to use the term "rigourous" as opposed to "pedantic".
     
  16. R.E.G

    R.E.G Active Member

    I really can't see the relevance of the laser. It would be nice if we could keep this thread relevant.

    Robert I think Hamish is trying to make a point about theory v's practice.

    Quote:
    What is the point of the sham treatment?

    In my eyes just a pedantic waste of time. Simple apply the treatment record the results.
    The point of the Sham treatment is that the laser is not the only part of the treatment. There is also, as Hamish points out, a carefully aggressive debridement and ongoing treatment with topical antifungals. A treatment modality I would expect to yeild results by itself, indeed which HAS yeilded results by itself. Aggressive debridement of ALL the fungal nail (where possible) has in my experiance resulted in the through growth of healthy nail behind it even without the topical.

    So without a control we have no way of knowing how many have resolved because of the debridement and topical antifungal application and how many because of the laser.

    Good point, except of course you are ignoring, as so many RCBs do the inclusion criteria. So far Hamish has only talked about treating patients for which all of the other treatments have failed. I suspect he would also be prepared to exclude the debridement and topicals if it made life simpler.if

    Particularly important because the debridement and topical regime is one well within the facilities of most podiatrists. So if even a part of the 88% success rate is down to that then it would be of great benefit to the profession to know it!



    The other bit of the needling treatment, besides the enhanced placebo effect i mentioned, is a simple debride such as we do before ANY treatment topical or otherwise. So we have an idea of the effect of that (viz, not a lot).

    So if we MUST make a comparison, the protocol for both studies would be to do the same with both groups, up to the point of the area under scrutiny.

    So both nails and VPs, select a group (the next 60 who walk in)

    Assign half to the control group which for VPs would be the debridement and an ankle block and for the nails would be the debridement and the regular application of antifungals.

    Assign the other half to the active treatment group which would be debride + needling / debride + antifungals + laser

    Compare the outcomes.

    So those are the only variables you would control for? Giving a Local for the sake of research would not get past the ethics committee.

    Its apples and oranges.

    I do not get this unless you are trying to say compare VPs and OM,?


    If the needling protocol was debride and topical treatment AND needling we'd need to do the same to that in order to exclude the effect of the topicals. Not so?

    Yes, what exactly is your point?


    It might be pedantic, but not, I think, without reason.

    Nothing wrong with pedantry, and yes I think it is very important to control for variables, hence am not convinced of your simplistic example.

    Is it worth debating a research question and methodology design or is the whole thing just too obvious.

    Bob

    __________________
    Robert Isaacs
    Specialist in Biomechanical Therapies
    www.Footprintspodiatrysolutions.co.uk.
     
  17. Actually that’s not my experience.

    I've had a few fantastic "cascade" responses. Sometimes takes a little longer but I can think of a few which have done this.

    One in particular presented with a large "primary" on his left foot and a right foot and both hands plastered with "secondary’s". Dozens of em. Needled the primary and within 6 weeks the treated lesion and ALL of the secondary’s on the feet and hands had all resolved.

    I've got some photos which I can put up if I get time.

    Personally I still prefer "percutaneous immune system stimulation" as a moniker but the acronym isn't great.

    Robert
     
  18. Yep - I've had multiple resolution too, in two patients simultaneously and delayed in one patient. Three patients with <5 VPs had one Rx to the primary - which resolved after three weeks and then underwent subsequent Rx to the secondary lesions - which then resolved. I'm thinking there may be a localised mechanism which often produces a systemic immune response, but not always. That said there are many variables, which is why your suggestion is paramount.

    Love the acronym.....can just see it used for marketing and promotion......

    As far as fees are concerned, consultant dermatologist reimbursments for VPs consultations are £490 in my local private hospital - which usually involves Rx with Cimetidine or one treatment with LN2. Subsequent follow-ups are billed seperately at the same rate. This is the region where podiatry should be aiming for reimbursment for this treatment.
     
  19. Sorry already been discussed remove post
     
  20. I suspect you are right. I will certainly be upping it when I am fully confident of my outcomes, probably with the money back guarentee that Bob alluded to.

    Actually I did talk about inclusion criteria, but never mind. That is the only major wrinkle I see in evidence for the laser. An outcome study of 50 fungal nails treated with the laser alone (no fungals, no debridement) would certainly make life simpler and would pretty much convince me if the results held steady at 12 months!

    Actually, a few simple before and after case histories with the laser alone I would find interesting!

    Agreed. Would'nt get many willing volunteers either. Just if i was being pedantic / rigerous.

    I thought that was one of yours!

    I think it is.

    Ok. Here's a framework. Outcome study for needling. Inclusion criteria, anyone willing with a confirmed VP. Numbers, 50 patients. Protocol, needling with a 27 g needle under LA until no resistance is felt.

    I think that would be a good start.

    And if I was to do one on the fungal I personnally would be happy with 50 patients, same inclusion as the needling study (willing and diagnosed) laser ONLY (no debride or fungals)

    OR

    100 patients RCT 50 with debride and topical and 50 debride topical AND laser. Blinding would be easy by using a deactivated laser (leave it unplugged) or a laser we agree would have no antifungal properties (like a LIL) . Double blinding harder and I could live without it in the interests of pragmatism.

    How about it. I'll show you mine if you show me yours (ooo er missus).
     
  21. Yep, lets do an outcome study for fungal nails with "no fungals"- Shurely Shome Mishtake, Missh Moneypenny.;)

    Although I concur, it would make life simpler.

    I'm getting confused, does this laser eradicate the fungus or not? Oops sorry, wrong thread ;)
     
  22. Asy mistake to make.

    Fungus, it would seem, can spread...
     
  23. hamish dow

    hamish dow Active Member

    Question:
    how many vp's in total each have the idividuals posting, performed ?

    Mr. Isaacs the poor point I made in relevance was that there seemed to be double standards in double blind trials vs multicentre ones. For these types of trials to evaluate clinical performance I am sure multicentre stacks up. I have never seen placebo work with the substantial OM infections nor have I seen spontaneous remission of similar heavier infections, VP's tend to be different and can spontaneously resolve. Perhaps they occur in very small numbers that could be statistically allowed for as could a sum for potential placebo. But for a pilot study to evaluate the efficacy i see no problem.
    What you ar talking of many have anecdotally witnessed have we not over years in practice, with damaged VP tissue or infection by bacteria following injury resolving. So to try and deliberatly invoke a healing response has logic. It interests me.
    Costs well if @£400 for less than an hours work with minimal outlay is starting to sound ok, £650 for heavy outlay and over 3 hours in total sounds reasonable to me. We are supposed to make a profit it is not a hobby and a profit is not a luxury it is a necessity.
    Re the "other thread" in this thread, what a shame non of you were at the Harrogate conference. All the Patholase senior players were there including Dr. McDowell who conducted the first study and Professor Harris. His results were obtained on an all commers approach. Heavy contamination was included. all major pharmaceutical tests limit inclusions so I think the multicentre trial will ape pharmaceutical parameters. no debridement took place and no antifungal preparations after either. Professor Harris is a research scientist by profession and has conducted this type of researcha and the type you are talking of initiating for decades. The new trial application is to be found in the clinicaltrials .gov website. Researchers will have no problems finding it.
     
  24. R.E.G

    R.E.G Active Member

    Sorry gang Ii've been a bit distracted, had to process my slaughtered free range rare bread pig. Gloucester Old spot, before you ask.

    I think this thread has the potential to beat the OM record, especially if we concentrate on wise cracks rather than the theme.

    Robert and Simon, I have to admit my degree from Plymouth was the first year of the honours course and quite frankly the 'research methods' module was pretty weak. So please bear with me I appreciate your help.

    It seems to me that the process of 'research' involves various stages.

    An idea, or question, what ever.

    Followed by information gathering/ literature search etc to see if the idea/question has already been answered.

    If not then one does a pilot study to look at the I/Q

    Depending on what you find directs your research question or hypothesis. (this is where I get a little confused)

    One then designs a Question and a methodology to investigate /test that Q/H.

    It seems to me that the question at the end of the day 'limits' what can be concluded from the data. Unless of course you buy into the conclusions which often acknowledge the limitations of the study but speculate on what may be inferred ( I used to call it extrapolation) .

    So again forgive me I have probably committed so may sins my degree should be revoked, my preference would always be for very tight inclusion criteria.

    So for the needling,
    Minimum age of 25, the theory being that under that the immune system may still kick in.
    All other 'accepted' methods have been tried and failed, lets say caustics and cryo.
    A detailed history of the infection should be recorded.
    A detailed description of the type ( I known there is no agreed type) of VP.
    A description of the person agreeing to the procedure, amazingly subjective.
    A detailed description of the procedure.
    A detailed description of after care.
    A detailed description of the lesion/s resolution.

    I'm sure there is more.

    I would suggest this is the equivalent of the pilot study.

    (I am also very interested in the 'failures' I'm informed there is a whole branch of research devoted to this. My adviser is a mature stats graduate who I needled after she had 2 years of NHS treatment, including insoles for corns. She now wears high heels I digress.)

    When it has been done then it may be possible to formulate a meaningful question.

    At the end of the day what do we want to know?

    Does it work?

    How often does it work?.

    Why does it work?.

    What makes it not work?.

    And finally why has it taken me over a quarter of a century to weight 210 lbs and my pigs take 4 months to go from 10 lbs to 170 lbs?


    See I do humour

    Bob
     
  25. Any black puddings?
     
  26. R.E.G

    R.E.G Active Member

    Ah Simon,

    Black pudding spoken as a true Midlander.

    At this stage no.

    These are only the second lot of pigs I have raised.

    They are truly free range and 'home slaughtered'.

    Now it's not fun but as humain as I can get.

    The collection of the blood and the subsequent treatment involved is complicated, so still working on the process.

    I do however pride myself in using as much as possible of the animal as I can, even to the point of purchasing the 'Testicle cook book'.

    So as a fellow midlander, actually a Brummy, I make very good fagots, will not share the recipe, scratchings, and now into bacon and ham. I produce dripping for frying chips in and the roasters are brilliant.

    My legless butcher/ slaughter man makes excellent sausages, and tomorrow I will saw open the head to get at the brains.

    I ate home raised Goose at xmas, a client helped me with the processing.

    Not bad for a lad from a council house in South Birmingham eh?

    Now back to research and needling?

    bob

    Have to admit trotters and pigs ears (al a Hugh Fernley W) have beaten me.
     
  27. Do you hold a slaughterman's license then? How do you get one of these? I'm guessing you didn't slit it's carotid with a d15?

    edit: re-read your post and realised your mate does it for you.
     
  28. Paul Bowles

    Paul Bowles Well-Known Member

    The difference here is that I am not charging $1335AUD to "supposedly" get rid of an issue that could potentially come back.

    End of story.

    You can't compare apples and oranges.
     
  29. R.E.G

    R.E.G Active Member

    Simon

    We seem to be cross posting.

    I've had lots of careers, I have cooked professionally and taken students to national cooking competitions and won.

    Your link did not work.

    The testicle cook book is fascinating as is testicle cooking. There is a US anually testicle cooking competition and did you know Turkeys have testicles?

    Where are they?

    Certainly not where you would normally look.

    Appreciate your culinary help but really and truly it's your research brain that interests me.

    bob
     
  30. R.E.G

    R.E.G Active Member

    Paul;

    Holding a Bachelor of Applied Science (Podiatry), a Diploma of Health Science (Podiatry) and a Masters Degree in Podiatry, Paul has positioned himself to be one of the highest trained podiatrists not only in NSW, but in Australia. Paul is also currently pursuing his PhD.

    I applaud your ambition, and all within 12 years.

    Sorry to hear about your hiatus.

    Ps you are in the wrong thread, this one is about needling, possibly?
     
  31. Yeah, I got one of those and several other things. Did you slaughter the pig at home, or do you have to take it to a licensed abattoir?
     
  32. R.E.G

    R.E.G Active Member

    pax Simon.

    Another link that did not work.

    Why cannot you help on this one?

    You have the answers, it is not going to cost you anything.

    Yes I can read all the stuff, I can ask my family, a double PhD and a University lecturer, but they are not Pods.

    And truthfully at the end of the day it does not matter a jot to me what the outcome is.

    I could advertise any old tosh I wanted and create a demand.

    Sadly I have a conscience, and do not need the money so continue to try to practice ethically and liaise with my colleagues.

    Bob
     
  33. I don't understand why you can't get the links to work Bob, they work just fine for me. What do you want me to say that would help you?
     
  34. R.E.G

    R.E.G Active Member

    Simon,

    I thought I made it clear my pigs were 'home slaughtered'.

    A licensed slaughter man who has his legs amputated at the hip through smoking bought a professional slaughter man to my small holding. The pigs were electrically stuned then their throats cut, death is by blood loss. not for the squeamish but they never regain consciousness, and the ones in the 'queue do not fret.

    They then have to be emersedin a tank of 65 degree C water to loosen the skin. the skin is then scraped off and the carcuss shaved of any remaining hair.

    the pig is then disemboweled and the offle and intestines separated. If you wish you can process the intestines to produce sausage skins or chitlings, a bit time consuming and smelly, they are full of poo.

    All of this ius very time consuming and last weekend involved lots of bogged down vehicles. And the cost to skaugter and butcher £30.

    Disgustingly cheap.

    At the end of the day because they are home slaughtered I cannot sell the meat.

    It is quite legal for me to kill my own pig, however I choose to use a professional.i

    I spent alot of time reading about this before I started.

    My pork is excellent.

    bob
     
  35. Bob, I'm only asking because I'm interested in perhaps doing it myself one day.
     
  36. R.E.G

    R.E.G Active Member

    Simon,

    Suddenly the links work.

    Ok it's the Jackie Campbell guide, I followed all the journal guides to research and I've read extensively but can you honestly say that any researcher does it in isolation?

    So if a sad old PP working in the arse end of the country wants to 'get involved' how do they go about it?

    I have lots of questions I have spoken to people in the 'system' nothing.

    If you are not in education or work for the NHS you are isolated?

    I know you believe I'm a sponger, and want something for nothing, fair enough.

    However I'm always happy to share, and ask for nothing in return.

    So what would I like, perhaps an arbitrator/ mentor for me and Robert to 'argue a research question.

    Robert and I have a longish history but some mutual respect.

    Bob
     
  37. R.E.G

    R.E.G Active Member

    Ok Simon,

    I'm more than happy to talk self sufficiency, and animal husbandry, small holdings and self build green house.

    Over many years I've had Rabbits, ducks goats horse, now hens geese and pigs.

    One piece of advice sheep are for shepheards.

    I lust after a house cow but need to retire first.

    There is something very satisfying about feeding your animals in the dark before you rush into work, then in my case rspeting the meat I eat because I knew the animal.

    Caution at least half your clients will think you are evil. (guess that would not bother you:drinks

    Bob
     
  38. You probably won't find this in Jackie's book, but: they get off their arses and do it. I'm a sad old PP working in the arse end of the country, I currently have a paper accepted for publication in JAPMA (written with two private practice colleagues from this forum), and I'm currently working on a couple of other research projects. I tend to self fund my researchs, but I'm currently working on a project which should piggy back onto some university funding. Also, behind the scenes, I try to work with up and coming podiatrists who I feel have potential and I try to encourage them to publish their first scientific paper or present at conference and give them a helping hand with this if I can, I think of this as my "invisible" contribution- but happy to help where I can, gratis. What do want to research? What can you bring to the party?
    I don't know what you mean here.
    Only as isolated as you choose to make yourself. I know of several private practitioners in the UK and further afield who are involved in research and publication.
    You don't know what I believe of you.

    Good, I'll have your faggot recipe please.
    That is what the arena is so good at- argue away.

    Good, he can watch his own back from here on in.;)
     
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