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Laser treatment for nail fungus

Discussion in 'General Issues and Discussion Forum' started by Cameron, Jan 4, 2009.

  1. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Press Release:
    Aerolase® Launches New Laser Technology With The LightPod Forte™
    Aerolase® - the company that has reinvented the medical laser - brings podiatrists everywhere breakthrough laser technology in treating nail fungus.
     
  2. Blarney

    Blarney Active Member

    Just heard a radio ad for a clinic in Dublin offering laser treatments for nails for €150!
    Website advertises €300 but radio ad offers €150

    Is this the cheapest laser treatment for mycotic nails available?

    Would be worth flying in from the UK for a days treatment at these prices.

    Akina Beauty and Laser Clinic


    Justin
    podiatry.ie
     
  3. My guess is that light-based fungal toenail treatment will become even more inexpensive as time goes on just due to the number of companies now marketing this therapy. The question is, how long will the nails stay looking better after any of these therapies without becoming reinfected?
     
  4. Nina

    Nina Active Member

    There are plenty of people who will pay to have their teeth whitened only to see them darken again, so I see a time when:-

    The price of the laser treatment x the duration of cosmetic improvement = cost of paliative care. The laser will become the routine treatment for fungal nails.
     
  5. hamish dow

    hamish dow Active Member

    I thought I would post these again because I can and because so many people have an idea about dystrophy, mycosis, recovery and permanent damage which is somewhat inacurrate. FYI female pt, @62 om 10 yrs plus terbinafine (oral) intolerant, image one before PinPointe FootLaser therapy in Dec 2009, image two in January 2011. Please note the difference in mycosis and dystrophy. Personally I think the two images seem a little different.
     

    Attached Files:

  6. Mart

    Mart Well-Known Member

    Thanks Hamish

    Please could you post the dosage (exposure parameters) and frequency of treatment for this case

    thanks

    Martin

    Foot and Ankle Clinic
    1365 Grant Ave.
    Winnipeg Manitoba R3M 1Z8
    phone [204] 837 FOOT (3668)
    fax [204] 774 9918
    www.winnipegfootclinic.com
     
  7. blinda

    blinda MVP


    Nice pics Hamish.

    Would you mind elaborating on who these many people are and which inaccuracies they are postulating?

    I don`t doubt that clinical cure is obtainable with the PinPointe FootLaser in some patients. But, I fail to see how this therapy can alter all of the multi-factoral conditions associated with OM and prevent the high recurrence rate of symptoms in susceptible individuals. Consideration of environmental, genetic, immune system (AMP`s) and a host of other variables, have to be taken into account for prevention of recurrence (as with all anti-fungal treatments), which is key to long term management, IMO.
     
  8. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
  9. hamish dow

    hamish dow Active Member

    Mart:
    Lased on 2 occassions.
    2nd lasing was done at patients request @ 10 months or so after 1st lase. Toe was looking pretty much as it is now, but patient who had had it for a decade wanted "to be sure".
    Dosage was a dot matrix pattern extending from mid distance between eponychium and IPJ to hyponycium area and laterally to @2mm beyond the sulci. This is now over 2 years since primary lase.

    BLinda:
    Conventional wisdom often cited that om "might" be treated, but nail dystrophy is permanent, my experience is different. Other than that it is a significant & potent, non pharmaceutical treatment option for om and bacteria, and has some interesting cosmetic interactions too. Not sure if it is said anywhere that it does the other stuff that you fail to see. It is a tool, needs to be understood and operated well to obtain best results, like most things.
     
  10. blinda

    blinda MVP

    Hi Hamish,

    Thanks for the reply. I guess it depends on the original cause of dystrophy, eh? I do refer pts who are interested in this method of treatment to a private skin clinic here in Winchester for treatment with the PinPointe and have observed impressive results. However, I still believe that other factors, a swell as clinical cure, should be addressed and realistic long term outcomes/recurrence rates explained to pts who are prone to OM.

    Cheers,
    Bel
     
  11. hamish dow

    hamish dow Active Member

    One always hope Blinda that one gives an encompassing consultation before one embarks on any form of treatment. We do our best to talk across all options and the client can go away and make an informed decision. What has been very interesting for me is seeing the effects of therapeutic interaction that have not really been witnessed before. Some of the idle speculaton I read from time to time really does not seem to marry up with what is presented to me in the reality of the laser treatments. What has been beneficial to me is the reaction of a number of my patients who have been doing their research and have visited these pages (it being open access to the public) is their horror at reading the tone and content of some postings. There has been real shock expressed, by other professionals upon their reading of the posts. I suppose some people don't know the public look here.
     
  12. Dr. Eric Bornstein

    Dr. Eric Bornstein Active Member

    Colleagues:

    It is with great pride that I can announce the publication of 270 day data from our pivotal onychomycosis trial with the Noveon laser in the Journal of the American Podiatric Medical Association (JAPMA).

    This is the third time that this preeminent peer-reviewed podiatric journal has published study results with the Noveon laser system.

    The Clinical Correspondence published this month (J Am Podiatr Med Assoc 102(2): 169-171, 2012) describes at 270 days, the outcome of the pivotal human onychomycosis trial previously published in JAPMA. That previous paper presented data at 180 days (J Am Podiatr Med Assoc 100(3): 166–177, 2010)

    The data presented in JAPMA from both publications is the following:

    • At Day 180, 85% of the eligible treated toenails in the pivotal study were improved by clear nail linear extent (P = .0015); 65% showed at least 3 mm and 26% showed at least 4 mm of clear nail growth. At Day 270, 35% were determined to have further improved (beyond the day 180 measurement) by direct inspection, in linear clearing or increased clear area of the nail plate, 150 days after the last treatment.

    • In the initial 180 day assessment, negative culture was observed in 42% of the eligible toes after only one treatment and 75% showed negative culture after three treatments. By Day 270, 38% of all treated toes were still considered mycologically cured, 150 days after the last treatment.

    • At Day 180, one treated patient showed complete nail clearance and at Day 270 three patients attained a completely normal appearance, or ‘‘clinical cure’’ 150 days after the last treatment.

    With this data, the authors conclude “In addition, the data clearly show this outcome can be affected regardless of the severity of the disease. As such, it gives strong indication that the Noveon laser offers a unique, low-risk option to potentially eliminate and then control the infecting fungal agent."

    To date, the only study describing an Nd:YAG used on patients for onychomycosis therapy listed in the MEDLINE database treated eight patients, and can be found here: J Cosmet Laser Ther. 2011 Feb;13(1):2-5. Epub 2011 Jan 21. In the 8 patient study, the authors concluded "The optimal number of treatment sessions for each patient needs to be determined."

    To date, complete data from 3 different human onychomycosis human clinical trials performed with the Noveon, have been peer-reviewed and published four times, since 2007.

    The Noveon™ Podiatric Laser is a CE approved and FDA-cleared medical device for Podiatric and Dermatologic use, supported by research and human clinical data, which is fully automatic and completely frees clinicians from manually performing procedures.

    I would suggest that Podiatric and Dermatologic professionals ask ANY laser company to "show me the peer-reviewed data" before making any treatment decision for their patients.

    Best regards,

    Dr. Eric Bornstein
    Chief Science Officer
    Nomir Medical Technologies
    www.noveoninternational.com
    ebornstein@nomirmedical.com
    Cell: 508-380-9866
     
  13. Mart

    Mart Well-Known Member

    Hi Hamish

    Because the effect is is likley dose related and dosage doesnt seem to have been established, anedotes regarding dose may be helpful at this stage. "lased" over the nail is a bit hard to interpret. Could you be specific e.g. J/cm.sec or equivalent.

    cheers

    Martin
     
  14. hamish dow

    hamish dow Active Member

    Martin:
    4 watts
    200 mj per pulse
    repletion rate at 20hz
    pulse width 100 microseconds (10 pulses)
    1mm spot size
    1 longitudinal pass
    1 horizontal pass
    From my own observations there are a series of variable in play and one needs to be adjusting the use of the laser to overcome them on an individual basis, but using past observations as a guide. It has been a very interesting 3 years or so. It has been professionally rewarding to have been involved with it from the begining in this country has led me to change a great many of my previous held views on nails and mycotic involvement.
     
  15. Mart

    Mart Well-Known Member

    Thanks Hamish

    It seems likely that it will be difficult to do any kind of meta-analysis unless forthcoming studies have some way to normalize the dose. I see this as being problematic unless the actual energy transmitted can be properly measured and I am not sure if the manufacturers specs have been validated. It seems that the exposure parameters you used, those cited in the thread's initial paper and those we have recently tried here vary considerably.

    My impression is that the therapeutic effect may be more related to tissue heating rather than other phenomena. If this is true then perhaps we should be more concerned with the measurable temperature effect than actual "photon dose".Did you attempt to monitor surface temperatures during your treatments?

    We are planning to audit a series n= 80 mostly severe onychomycosis cases where the variable we were trying to loosely control was a dose which created maximum tolerated tissue heating. This seemed to be within range of surface measurement of 32-38 degrees C.

    It would be great if others could post audit results even if not properly conducted studies. A bit "loosey goosey" but I will post some statistics of our audit results after we evaluate in about three months for anyone interested.

    Perhaps at this stage that may provide some clues for most relevant variables.

    Cheers

    Martin

    Foot and Ankle Clinic
    1365 Grant Ave.
    Winnipeg Manitoba R3M 1Z8
    phone [204] 837 FOOT (3668)
    fax [204] 774 9918
    www.winnipegfootclinic.com
     
  16. hamish dow

    hamish dow Active Member

    Martin, my simple answer to you question about the surface temp, no. The PinPointe generates temp differently to the large spot retro engineered tat and hair lasers, and you are not alone in thinking the temp has a bearing on matters. I think creating a study from patient volunteers will be a different kettle of fish than that of pulling the info from treatments from paying patients. This is something which needs to be born in mind while disecting retro studies of my offerings. I am more interested in gaining experience and insight into how one clinically adapts to the infinately varying presentation and response, and then improving it. I am happy to offer the odd insight here and there from my work with this over the last 3 years or so but good luck to those who are interested in a pure acedemic pursuit. I shall watch with mild interest to see how they get on.
     
  17. yesireebob

    yesireebob Member

    Does anyone know the cost of the various machines?

    Apologies if already asked.

    Bob
     
  18. björn

    björn Active Member

    I'm pretty sure I read on a brochure by a supplier somewhere recently about A53k ?
     
  19. MAG1064

    MAG1064 Member

    Since I was in this market the last few years and things may change. I will list approximate prices then and leave off the names of the devices. But this will give you an idea. Most of the following have 1064 wavelength

    30-35K for a device that was relatively portable FDA cleared and has no disposables

    35-40K for a moderately high powered portable device modified to be marketed to DPMs (Some features removed) about 50-53 K for the full strength and full featured device.

    40-42K for another moderately high powered less portable device, FDA cleared

    ~50K for a device that hit the market early and has FDA clearance. Used to have fees per use and mandatory marketing requirements, that I believe were finally decided to be a very bad idea. Some disposables

    ~20K(Quoted several years ago) for a non 1064 device that does not require the doctor to stay in the room during a somewhat lengthy treatment //also had severe per use expenses and expensive disposables and marketing requirements that have been modified or done away with.

    ~60- 70K for another device that is FDA cleared and marketed to podiatry

    ~60K for another non1064 device

    At one time I was told, that to buy certain devices, $4,000 monthly marketing was a contract requirement and a per use fee of $600 was imposed. So as always, be careful with initial pricing when the goal is to get you on along term obligation that prohibits your ability to be competitive if the market in your area suddenly drops to $400 per treatment.

    used or nonFDA regulated devices can be found on various webs sites. The Non FDA cleared devices listed above are all FDA approved or cleared for podiatry indications, just not nails specifically. If you burn a patient with a device not reviewed by the FDA, I would be worried.
     
  20. Mart

    Mart Well-Known Member

    Thanks Hamish. At this stage I feel that anecdotal evidence is important; bit like treatment of verruca vulgaris, there is likely wide range of response and currently we don't even have a useful range of exposure to guide treatment. In the end tx parameters may need to be "titrated" and efficacy entirely empirical.

    We should however strive for some objective measure of probability of success.

    Cheers

    Martin

    Foot and Ankle Clinic
    1365 Grant Ave.
    Winnipeg Manitoba R3M 1Z8
    phone [204] 837 FOOT (3668)
    fax [204] 774 9918
    www.winnipegfootclinic.com
     
  21. yesireebob

    yesireebob Member

    Thanks Mag, sounds a bit dodgey.
    Are any of the devices cleared for use in Australia?
    I have noticed a practice in Sydney marketing laser usage for OM.
     
  22. Paul Bowles

    Paul Bowles Well-Known Member

    To my knowledge there at least two practices in Sydney - each have a different laser. One uses the PinPointe system the other the Cutera.

    I think you have to have the appropriote training (which the companies I believe provide) and also the appropriote signage around the clinic indicating laser usage for OH and S purposes. To my knowledge in NSW there are no restrictions on who uses the laser (Podiatrist or otherwise) if they have the appropriote training.

    Own a nail salon? Maybe a good investment! ;)
     
  23. Mart

    Mart Well-Known Member

    We have recently audited the effect of using the manufacturer recommended protocol for treatment of onychomycosis on approximately 80 cases using ND:YAG 1064 nm laser at four months follow up.

    Unequivocally the results were poor. We were unable to find any significant improvement in any cases.

    I think this begs the question why this seems so disparate from the few published papers and we are unable to explain this other than our selection process was different in 2 ways.

    We intentionally selected patients with severe involvement because this would be typical of our clinical needs.

    We omitted lab testing to confirm dermatophytes. Despite this we feel that the clinical presentation was very typical for onychomycosis evidenced by deep striated yellow disruption in majority cases so that appearance likely did not represent psoriatic cause of dystrophy in majority of cases.

    Mechanical debridement prior to treatment was thorough and extensive as tolerated to nail bed so this was not a limiting factor.

    The vast majority of cases seemed compliant to using antifungal foot powder BID to mitigate re-infection; frankly, given lack of any improvement in most I think that this measure was moot.

    Cheers

    Martin

    Foot and Ankle Clinic
    1365 Grant Ave.
    Winnipeg Manitoba R3M 1Z8
    phone [204] 837 FOOT (3668)
    fax [204] 774 9918
    www.winnipegfootclinic.com
     
  24. facfsfapwca

    facfsfapwca Active Member

    A simple double blind study can be performed. I would imagine a cold laser Helium neon type beam is used for targeting. This beam can be left on the active beam can be set to only turn on on every other patient in secret so the practioner is not aware that the effective beam is on or not. Then compare the two groups.
    Has such a study been done ever or are they just comparing treated and untreated patients. I know many Dr.s using a laser are in addition treating with debridements and topical products that improve the appearance of the nail. Doing a true double blind study would eliminate this effect as both groups would get same topical care.
     
  25. Mart

    Mart Well-Known Member

    I agree that a DBS would be ideal; problem I see though is that there needs to be some consensus regarding measuring dose. As I already mentioned this seems problematic and I feel that some "cruder" research is needed to evaluate likely useful dose range. Also, if as I suspect, to find out if there is strong evidence to suggest that ONLY superficial or very small zone of infection is likely to be responsive as seemed to be the case in our case audit. If you look at published data there seems to be a carefully selected cohort with mild infection.

    Cheers

    Martin

    Foot and Ankle Clinic
    1365 Grant Ave.
    Winnipeg Manitoba R3M 1Z8
    phone [204] 837 FOOT (3668)
    fax [204] 774 9918
    www.winnipegfootclinic.com
     
  26. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Treating onychomycoses of the toenail: clinical efficacy of the sub-millisecond 1,064 nm Nd: YAG laser using a 5 mm spot diameter.
    Kimura U, Takeuchi K, Kino****a A, Takamori K, Hiruma M, Suga Y.
    J Drugs Dermatol. 2012 Apr;11(4):496-504.
     
  27. Mart

    Mart Well-Known Member

    Interestingly we used similar intended dosage; in Kimura U et al the study the repetition varied between 1-3 X at four weeks intervals; we did 2 doses at two month interval. If you subdivide the Kimura et al cohort into hallux and the rest the results for the Hallux were extremely poor compared to lesser toes. We mostly did mostly Hallux onychomycosis.

    Cheers

    Martin

    Foot and Ankle Clinic
    1365 Grant Ave.
    Winnipeg Manitoba R3M 1Z8
    phone [204] 837 FOOT (3668)
    fax [204] 774 9918
    www.winnipegfootclinic.com
     
  28. horseman

    horseman Active Member

    thats what we were taught as well, leave the cuticle alone...
     
  29. Mart

    Mart Well-Known Member

    take a look at the images used for illustrative evidence of dramatic improvement, the hallux example looks like a traumatic nail outgrowth so the treatment may be moot, the other hallux example is minor involvement at onset. The superfical lesser toe mycosis seemed to respond well - this may also be true for topical drug approach for selective cohort. There is no example of deep severe infection illustrated which suggests that this was not seen.




    Cheers

    Martin



    Foot and Ankle Clinic
    1365 Grant Ave.
    Winnipeg Manitoba R3M 1Z8
    phone [204] 837 FOOT (3668)
    fax [204] 774 9918
    www.winnipegfootclinic.com
     

    Attached Files:

  30. Paul Bowles

    Paul Bowles Well-Known Member

    Hi Mart

    We have been collecting data now for several months (including images) on patients managed with the 1064nm laser. The laser was the same unit, used by the same practitioner, with the same settings for each patient. I will send you some examples of severe infections before/after treatment and throughout treatment for your perousal.

    I havent seen any comparisons yet as I dont want to form an opinion either way. I have had some of the patients email me though from the "severe" infection group (defined as all toes, pathology positive, no clear nail not infected) carrying on about the changes they are seeing in their nails....changes dont mean success though so I am sitting on the fence until I see some results.

    We also have a less severe group (i.e. only partial infection of a single hallux nail with positive pathology and clear nail visible proximally). So we are trying to collect data from multiple groups.

    TIme will tell. I'll update when I can.
     
  31. Mart

    Mart Well-Known Member

    Great . . . . thanks Paul, it will be interesting to see your results.

    Do you think might be useful at this stage of investigating the efficacy of light for treating onychomycosis to do more basic science?

    What I have in mind is taking severely infected nails (post TNA material) cutting them into say 5X5 mm chunks, doing a culture, irradiating with different doses and then re-culturing to attempt identifying what the dose relationship might amount to also possibly if there is differential effect on different dermatophytes.

    To my knowledge this has not been done with nail material.

    Cheers

    Martin


    Foot and Ankle Clinic
    1365 Grant Ave.
    Winnipeg Manitoba R3M 1Z8
    phone [204] 837 FOOT (3668)
    fax [204] 774 9918
    www.winnipegfootclinic.com
     
  32. Paul Bowles

    Paul Bowles Well-Known Member


    The concept as far as I can see is purely thermal: i.e. destruction of material. The guides seem fairly set for each laser - and as far as I have seen you set them at an output which seems tolerable to the patient without causing marked pain. After delivery of the total dose you can physically feel the heat on the toenail and the patient starts to reports some discomfort. From my clinical experience looking at the 1064nm laser so far it would seem that this "discomfort" is somewhat a desired reported result.

    Technically you can increase the power output on all the lasers I have seen and you can burn tissue very easily. It cauterizes tissue very well and I can see applications beyond fungus and warts, even as far as partial nail avulsions and cautery during foot surgery.

    I think your idea is potentially interesting!
     
  33. Dr. Eric Bornstein

    Dr. Eric Bornstein Active Member

    Dear International Colleagues and International Distribution Agents:

    Please allow me to introduce the new President and CEO of Nomir Medical Technologies, Dr Jack Kay.

    As you know, Nomir Medical is the developer and manufacturer of the sole and exclusive medical laser in the world that has published, peer-reviewed, scientific data to back up its claims in the field of onychomycosis (toenail fungus).

    If you have a desire to distribute or purchase the Noveon Nail laser outside of the United States, please contact Jack Kay, so that he can determine how best to proceed with you.

    Best Regards,
    Dr Eric Bornstein
    Chief Science Officer
    Nomir Medical Technologies



    Jack Kay, PhD
    President and CEO
    Nomir Medical Technologies, Inc.
    4 Station Plaza
    Woodmere, NY 11598
    www.noveoninternational.com
    Office: +1.516.54NOMIR, Ext. 100
    Fax: +1.516.545.0300
    Cell: +1.617.875.1472
    mailto: jack@nomirmedical.com
     
  34. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Press Release:
    Nomir Medical Announces 510(k) Application to FDA for the Temporary Increase of Clear Nail in Patients with Onychomycosis (Toenail Fungus) with the Noveon™ Laser
     
  35. falconegian

    falconegian Active Member

    Which is the best protocol for laser treatment in terms Of number Of application and distance from each application?
    How many Joules must be' delivered for cm2?

    Gianluca
     
  36. Tess Bowen

    Tess Bowen Member

    At last some common sense around fungal nails, improve the nail environment first then there is a chance, with tenacity, that the fungas won't be able to survive.
    I file them down if they are thick,apply something to waterproof the nail and use lavenda oil. Remove whatever is causing the pressure on the nail and causing the distortion.
    One Dermatologist who is very keen to use his "laser" on all sorts admitted that the nails he treated with the laser appeared to have lost the fungas but still remained distorted ! and the patients were coming back when the fungas took up residence again ! he was after some advice around prevention of reinfection.
     
  37. blinda

    blinda MVP

    Hi Tess,

    I agree, environmental factors should be considered as lower limb biomechanics and footwear requires examination in cases of trauma induced nail pathology and subsequent infection of OM. We know that dermatophytes are opportunistic pathogens and will take advantage of a traumatised/compromised nail plate. However, other variables such as systemic (congenital, hereditary or acquired) disease associated with compromised immunity and drug side effects/reactions should also enter the equation, IMO.

    Can you expand on your clinical reasoning for this regime?

    Cheers,
    Bel
     
  38. Tess Bowen

    Tess Bowen Member

    Hi Bel,
    I started using Lavendar oil when I found out it had fungastatic properties comparable to most other topical treatments on the market. Keeping water out ,Cleaning with Alc. wipes then applying the oil changes the environment that dermatophytes need to grow.
    I can't remember where I saw the research as it was many years ago. I know there are some warnings around the use of Lavendar oil during pregnancy and with young boys.
    I have been doing this for 25 years after many arguments with (friendly discussions) GP's dermatologists about the overuse of referrals for pathology tests and prescriptions of liver toxic drugs such as grisiofulvin,
    One lecture I attended in Wollongong had a Dermo stand up and say he prescribed Grisofulvin for one of his partner's wife, to treat her fungal nail and then bumped into her in the street in the following weeks when he noticed she had developed Jaundice. He actually joked about it ! You could call this over kill medicine.
    thanks for being interested in my rant.
     
  39. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Newly Approved Laser Systems for Onychomycosis
    Aditya K. Gupta and Fiona Simpson
    J Am Podiatr Med Assoc 2012;102 428-430
     
  40. blinda

    blinda MVP

    Hi Tess,
    Thanks for taking the time to reply. Please don`t take any questions on my part as an attack on your clinical skills; I am genuinely interested in exploring the reasons why many pods choose to use the perceived `natural` route in prescribing distilled essential oils for dermatological complaints, as opposed to evidenced based products. Good to see FDA approval for laser tx.

    Did this piece of research state HOW it compared to other topical anti-fungals, with regard to efficacy and safety?

    Interesting. `Tis true that there are anti-fungal products available which claim to make it difficult for dermatophytes to thrive by altering the environment or pH of the nail apparatus. However, the trials are questionable in methodology and recruitment. It would be useful have access to the research that you refer to. A cursory search on the `net found this article which indicates that the mode of action is fungicidal due to the active component Linalool, which is a terpenoid. Terpenoids are also the anti-microbial properties in tea tree oil and are known sensitizers for contact dermatitis, increasing in risk of adverse reaction with oxidation. Wiki states: Linalool gradually breaks down when in contact with oxygen, forming an oxidized by-product that may cause allergic reactions...

    So, yes. You`re right when you say;
    As with all other essential oil remedies, the above article raises concern for irritant or allergenic skin reactions with the use of lavender oil. This warning is echoed in `Potential of plant oils as inhibitors of Candida albicans growth` , which states All the oils inhibiting growth showed fungicidal activity except Jasmine and Lavender oils. However, if they are to be considered in topical preparations a careful exploration of their probable irritating and other undesirable effects in humans need to be undertaken. So, not only could lavender oil induce contact dermatitis, it does not appear to be effective in OM associated with Candida species.


    I don’t understand what you mean by `overuse of referrals`. Do you not agree that microscopy and culture is required for pathogen specific treatment?

    With respect, Griseofulvin has been declared safe through many RCT`s. This article concludes; No cases of acute liver failure or chronic bile duct injury have been reported due to griseofulvin. With regard to Hepatotoxicity it states;Transient mild-to-moderate elevations in serum aminotransferase levels occur in up to 5% of patients treated with griseofulvin, but these abnormalities are usually asymptomatic and resolve even with continuation of the medication. Clinically apparent hepatotoxicity is rare. The liver injury from griseofulvin is typically cholestatic and usually arises within the first few months of therapy. Signs of hypersensitivity such as fever, rash and eosinophilia are rare. Case reports of griseofulvin induced liver injury have all been self-limited, recovery requiring 1 to 3 months. ......

    There are many drugs that have an adverse effect on the liver, see here. In fact, Hepatotoxicity is the most common reason for a drug to be withdrawn from the market. Examples of drugs that more commonly cause elevations of liver enzymes in the blood include the statins, antibiotics, some antidepressants, and some medications used for treating diabetes, tacrine, aspirin, and quinidine. However, those elevations of enzymes are usually considered clinically safe and liver function tests are performed to monitor the levels, as with oral anti-fungal treatment regimes.

    One oral fungicide that has previously received bad press with associated hepatotoxicity is terbinafine. This has been also been declared safe after many trials, such as these;

    Postmarketing surveillance of oral terbinafine in the UK: report of a large cohort study

    Safety and efficacy of oral terbinafine in the treatment of onychomycosis: analysis of the elderly subgroup in Improving Results in ONychomycosis-Concomitant Lamisil and Debridement (IRON-CLAD), an open-label, randomized trial.

    Ultimately, it is up to you how you incorporate evidence based medicine into your practice. However, I`m sure that you would agree that it is of uppermost importance that we utilise products that have been proven to be effacacious, safe and justifiable in the unfortunate incident of patient litigation. Just a thought.

    That said, if you can locate the research that you referred to, I would certainly be interested in reading it.

    Cheers,
    Bel
     
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