Monday, 31 March 2014

What should we do about complementary medicine?

Where to next with complementary medicines? #MSBlog #MSResearch


"We have posted on complementary and alternative medicine (CAM) in the past and have debated whether or not it works. I don't have a problem with CAM provided it can be shown to be safe and the motivation about its use is not to make some quack wealthy. Modern medicine has it roots in CAM; i.e. a large number of classes of medicines come from herbal extracts that were shown to work in the past by trial and error. What is lacking however with CAM is the rigorous science that is underpinned by hypothesis testing and the class of evidence regulatory bodies need to show a treatment is safe and effective."

"Primum non nocere; first do no harm. This is one of the maxims that underpins the modern Hippocratic oath. If something does harm it needs to be effective and on average the efficacy must outweigh the harm. The following is an evidence-based guideline produced by the American Academy of Neurology (AAN) to guide neurologists regarding CAM. Interesting a large section of the guideline refers to cannabis and nabiximols (aka cabinnoids), when there is pretty good evidence of their effectiveness in pain, spasticity and cancer-associated anorexia. May be the AAN are trying to detoxify cannabis for US-based clinicians. The take-home message is that if you want the medical community to accept CAM you need to  get them interested enough to do  the necessary research to show they are safe and effective. This is easier said than done and takes time and resource. It may take as long as 15 years to have enough evidence to show a treatment works and that it is safe to administer to MSers. The costs associated with this latter are only worth it if you can make money from the CAM. This is why CAM are unlikely to gain mainstream traction anytime soon. What do you think?"



OBJECTIVE: To develop evidence-based recommendations for complementary and alternative medicine (CAM) in MS.

METHODS: We searched the literature (1970-March 2011; March 2011-September 2013 MEDLINE search), classified articles, and linked recommendations to evidence.

RESULTS AND RECOMMENDATIONS
  1. Clinicians might offer oral cannabis extract for spasticity symptoms and pain (excluding central neuropathic pain) (Level A). 
  2. Clinicians might offer tetrahydrocannabinol for spasticity symptoms and pain (excluding central neuropathic pain) (Level B). 
  3. Clinicians should counsel MSers that these agents are probably ineffective for objective spasticity (short-term)/tremor (Level B) and possibly effective for spasticity and pain (long-term) (Level C). 
  4. Clinicians might offer Sativex oromucosal cannabinoid spray (nabiximols) for spasticity symptoms, pain, and urinary frequency (Level B). 
  5. Clinicians should counsel MSers that these agents are probably ineffective for objective spasticity/urinary incontinence (Level B). 
  6. Clinicians might choose not to offer these agents for tremor (Level C). 
  7. Clinicians might counsel MSers that magnetic therapy is probably effective for fatigue and probably ineffective for depression (Level B).
  8. Fish oil is probably ineffective for relapses, disability, fatigue, MRI lesions, and quality of life (QOL) (Level B).
  9. Ginkgo biloba is ineffective for cognition (Level A) and possibly effective for fatigue (Level C). 
  10. Reflexology is possibly effective for paresthesia (Level C).
  11. Cari Loder regimen is possibly ineffective for disability, symptoms, depression, and fatigue (Level C).
  12. Bee sting therapy is possibly ineffective for relapses, disability, fatigue, lesion burden/volume, and health-related QOL (Level C). 
  13. Cannabinoids may cause adverse effects. Clinicians should exercise caution regarding standardized vs nonstandardized cannabis extracts and overall CAM quality control/nonregulation. 
  14. Safety/efficacy of other CAM/CAM interaction with MS disease-modifying therapies is unknown.
Conclusions: Although it is sometimes hard to define, complementary and alternative medicine (CAM) refers to health care approaches that are developed outside of mainstream and conventional medicine. "Complementary" and "alternative" are often used interchangeably, but there are some differences. "Complementary medicine" generally refers to using a non-mainstream approach together with conventional medicine. "Alternative medicine" refers to using a non-mainstream approach in place of conventional medicine. The boundaries between complementary and conventional medicine can overlap and even change with time. Most CAM therapies are not regulated by the US Food and Drug Administration, which means the quality and purity of CAM therapies may vary significantly.

In guidelines and other publications, recommendation for a clinical service is classified by the balance of risk versus benefit of the service and the level of evidence on which this information is based. The U.S. Preventive Services Task Force uses:

Level A: Good scientific evidence suggests that the benefits of the clinical service substantially outweigh the potential risks. Clinicians should discuss the service with eligible patients.

Level B: At least fair scientific evidence suggests that the benefits of the clinical service outweighs the potential risks. Clinicians should discuss the service with eligible patients.

Level C: At least fair scientific evidence suggests that there are benefits provided by the clinical service, but the balance between benefits and risks are too close for making general recommendations. Clinicians need not offer it unless there are individual considerations.
Level D: At least fair scientific evidence suggests that the risks of the clinical service outweighs 
potential benefits. Clinicians should not routinely offer the service to asymptomatic patients.

Level I: Scientific evidence is lacking, of poor quality, or conflicting, such that the risk versus benefit balance cannot be assessed. Clinicians should help patients understand the uncertainty surrounding the clinical service.

9 comments:

  1. Isn't the Hippocratic oath out of date? If you believe in doing no harm how can you prescribe Tysabri and Lemtrada?

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    Replies
    1. Remember this is relative to the percieved benfit

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    2. Re: "Isn't the Hippocratic oath out of date? If you believe in doing no harm how can you prescribe Tysabri and Lemtrada?"

      I have posted on this; I am beginning to view MS DMTs like vaccination. To make a big difference to MS outcomes you need to treat as many people as possible with early, highly-efficacious treatments. Unfortunately, there will be some people who will be harmed by this approach. The important thing is make them aware of the potential for harm before they are treated.

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  2. Prof. G, did you know that the author of this study (Prof. V. Yadav, from the Oregon H&S University) is actually leading 2 clinical trials on Alpha Lipoic Acid (nutraceutical as you name it) on MS?

    One of them is for optic neuritis attacks (http://www.clinicaltrials.gov/ct2/show/NCT01294176?term=alpha+lipoic+acid+multiple+sclerosis&rank=6),

    and the second one is called "A Study of the Pharmacokinetics and Immunologic Effects of Lipoic Acid in Multiple Sclerosis" (http://www.clinicaltrials.gov/ct2/show/NCT00676156?term=alpha+lipoic+acid+multiple+sclerosis&rank=3)

    She did previously publish studies on the effect of ALA on rodents (EAE) and on the pharmacokinetics of ALA on MS patients.

    Just to point out that not everybody (MSologists) is so skeptical on the use of CAM. Dr. Yadav is definitely brave carrying out these trials. Even if, as a part of the AAN, she then publishes plain facts and non-first class evidence conclusions, which show that results are not spectacular.

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    Replies
    1. We have no issue with CAM but what we ask is for class I evidence just as we ask this of non-CAM because without solid evidence it is hard to justify prescription. However we need to ensure that the trials are robust such they can inform otherwise we end up with internet sensations. The trials you mentioned will not be big enough to interest the regulators in approving the approach so more studies will be needed

      If the hope is that you do a good trial and every one adopts it because it is cheap but what happens if the trials are not of the best quality what then. Therefore before embarking on underpowered trials we

      and I believe would probably be

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    2. Re; "... nutraceuticals."

      Just to support MDs position. Nutraceuticals are no necessarily CAMs; if they have class 1 evidence that has been reproduced and are safe why should they be licensed to treat MS. The problem is getting the funding to the trials. Vitamin D is an example of this; the basic science supporting its use is compelling, but we need class 1 data. The funding has not been forthcoming; although there are a number of smaller studies currently running.

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  3. No mention of Hyperbaric Oxygen Therapy which I would have thought comes under the umbrella of CAM. Very interesting blog though. My view for what its worth is I have Tysabri to try to stop things getting worse and use CAM's on a trial and error basis, to see what helps with my legacy damage from earlier relapses. A case of a blend of treatments rather than either/or.

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    Replies
    1. HBO the question is, where is the evidence?

      It was studied as a DMT and found wanting? However is that really what it should be doing..I doubt it

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    2. Re: "Hyperbaric Oxygen Therapy."

      Unfortunately, it was tried in a time when we didn't know how to do MS trials. They were underpowered. I heard Prof. Ken Smith give a great talk on Saturday around his hypoxic theory. It be time to revisit hyperbaric oxygen with properly powered and blinded studies.

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