New Update: Vitamin D has No Effect on Knee Osteoarthritis

Vitamin D supplementation for individuals with knee osteoarthritis and low 25-hydroxyvitamin D levels did not reduce knee pain or slow cartilage loss, according to a study appearing in the March 8 issue of JAMA.
 
Symptomatic knee osteoarthritis occurs among 10 percent of men and 13 percent of women age 60 years or older. Currently, there are no disease-modifying therapies for osteoarthritis. Vitamin D can reduce bone turnover and cartilage degradation, thus potentially preventing the development and progression of knee osteoarthritis. Observational studies suggest vitamin D supplementation is associated with benefits for knee osteoarthritis, but current evidence from clinical trials is contradictory.
 
Changhai Ding, MD, PhD, of the University of Tasmania, Hobart, Tasmania, Australia, and colleagues randomly assigned 413 patients with symptomatic knee osteoarthritis and low 25-hydroxyvitamin D to receive monthly treatment with oral vitamin D3 (50,000 IU; n = 209) or an identical placebo (n = 204) for 2 years. The study was conducted in Tasmania and Melbourne, Australia.
 
Of 413 enrolled participants (average age, 63 years; 50 percent women), 340 (82 percent) completed the study. The researchers found that vitamin D supplementation, compared with placebo, did not result in significant differences in change in MRI-measured tibial cartilage volume or a measure of knee pain over 2 years. There were also no significant differences in change of tibiofemoral cartilage defects or change in tibiofemoral bone marrow lesions. Vitamin D levels did increase more in the vitamin D group than in the placebo group over 2 years.
 
“These data suggest a lack of evidence to support vitamin D supplementation for slowing disease progression or structural change in knee osteoarthritis,” the authors write. 

Patients Believe Lab Tests More Than Doctors

A colleague recently made this declaration among a group of rheumatologists. There was a long group pause that made me consider this observation. This is an important issue, because it is sad if true and we may be leaving our patients with the wrong impression. It’s also important as new laws have liberalized the patients’ rights to his/her lab tests and records.

Thus, why do patients believe their labs more so than their doctors? And what do physicians do with this open sharing of lab values? To understand this we should look at both the patient and physician perspective on this issue.

The Patient Perspective

• Trust a doctor or trust a lab number? Doctors are human, occasionally fallible or poorly groomed. Not surprisingly, it takes a while for patients to learn to trust a physician. Urgency and severity don’t engender trust either. My new patient with the melon-sized, swollen, hot knee may trust the prescription given but will trust less when I’m wielding a large needle and 20 cc syringe. Physicians’ lingo also undermines trust. I think patients are perplexed when we deliver the shortest possible message using the longest possible polysyllabic terminology. Medical speak is the third leading cause of patient bewilderment and malpractice suits. Patients are keenly aware that if a doctor cannot speak plainly, there must be something wrong with the doctor, rather than the patient.
• Laboratory tests on the other hand, are numbers - and numbers don’t lie (the latter is likely to be attributed to an accountant or administrator, not Osler). Numbers are countable, incremental and delivered by and/or on computer printouts. Hence, those values that appear in red and are “out of range” are meaningful to the owner or those red values. Even though I try to convince my patients that the red, seemingly elevated BUN/Creatinine ratio is not important, my patients are not easily convinced. I use the analogy that driving at 37 MPH (in a 35 MPH zone) may be considered speeding; no one gets a policeman’s ticket for such a number. Or that the number has to be interpreted in context. So if I’m driving 37 MPH in a school zone full of flashing buses and crossing guards, a penal code prize will be duly served.
• Everyone values free stuff. You don’t always get your money's worth in healthcare and when you don’t, it costs more. These are the built in pitfalls of healthcare and physicians that every patient must cope with. Cognitive dissonance may explain why humans value that which is free, but still I’m amazed when patients are compelled to react (without calling me) to a TV news report or a pharmacy six-page printout or a lab report. These info bits, presumably from authoritative sources, are valued and believable as they are free, personalized and clear in their message. This contrasts with physician messages that are expensive, occasionally uninterpretable and delivered at the end of a rushed medical visit.
• Doctors specialize in messaging that isn’t so clear.  We commonly use statements like, “you’re much better or “this is a setback”. Patients wonder whether “better” is relative to my last visit or other patients on the better to worse scale. This contrasts with lab tests are quantitative and digital. Patients believe that a lab test is a numeric systematic representation their biology and a pivotal arbiter of wellness. This they can understand – or at least look up on Google. My labs say I’m either normal like everyone else or a red number, falling out of range. “Doc my lab must mean I’m at least as abnormal as the test says I am”.
• Doctors are to blame. Patients think labs are important because doctors tell them so. “Let’s wait and see what the labs show” (meaning I can’t make a diagnosis without them). “Your labs are just fine” (implying the patient must be also). “Mr. Sample there’s a problem with your labs” (uh-oh, sell the farm Mr. Sample!). Then Dr. Jekyll becomes Dr. Hyde when the patient wishes to discuss lab abnormalities only to observe the doctor dismiss the labs as either hanging chads in a meaningless election or a result that should never have been reported (because it takes too long to explain why the result in physiologically unimportant even though it may be psychologically damaging). I’m not surprised when my patients struggle and say it’s sometimes hard to tell who I should believe, the lab test or the doctor.

The Physician Perspective

Laboratory testing is usually an integral part of comprehensive healthcare delivery. Testing can be used to assess a patients metabolic status, organ function, immunologic abnormalities, disease risk, drug safety or toxicity, and occasionally a diagnosis.

Labs are important. But a lab is meaningless without a symptom narrative, list of diagnoses or drugs, or a detailed patient examination. Clinicians need labs to answer specific questions and use them as adjunctive “info bits” to enhance their understanding of the disease, management of the patient and safety of therapies given.

Patients want and should have their lab results. But it is the physician’s responsibility to educate their patients about labs, why they are being done, what is being examined and looked for. Here are a few principles of lab testing that clinicians need clearly communicate to their patients and payers of labs:

• A lab test does not equal a diagnosis. Hence, while we would like to see a positive rheumatoid factor in someone with suspected of rheumatoid arthritis, this test is not required to establish the diagnosis.
• More labs means more chances for an abnormal finding. The more lab tests that are ordered, the more likely one or more will fall out of normal range. Normal values of a particular lab reflect the bell curve limits established in a large number of “normal” people. Values that fall “out of range” beg the question, “when is abnormal really abnormal?” Explaining the difference between a random spurious finding and a pathologic result can be difficult, but requires trust and communication between patient and physician.
• Monitoring and serial labs. Labs are important when monitoring disease status (e.g., sed rate or creatinine) or drug toxicity. This is why repeated or serial labs may be necessary.
• Once is enough!  Many autoimmune laboratory tests need only be done once or confirmed by a second by different lab. Hence there is no value in repeating and following the following tests: ANA, RF, CCP, ENA or ANCA as these have not been shown to change as the disease does. There are other tests often used as a “disease activity” measure – these can be quite valuable in certain clinical situations.
• Result communication.  Physicians and patients need to have an agreed upon plan addressing how the patient will learn about his/her lab results.
• Patient folders.  Patients need to keep copies of their labs in a folder, bring these to all medical visits and share the results with all caregivers.

Patients should understand their labs and believe that they are being used to effectively diagnose and treat their medical predicament. They should be given copies and encouraged to maintain a file of their wellness and labs to share with other doctors. Patients who are overly fixated on a specific lab result are that way because we made them that way! It’s the physicians’ responsibility to educate the patient on which labs are needed or important and when concern over a lab results is appropriate.

Diabolical Negativism

I’m often perplexed when I say one thing, but my patient hears something totally different. Where did my advice get derailed? Or was my advice too weak or too wild to take seriously? Is it the patients’ perspective, or education, or am I not clear in my messaging?

“Here’s your new medicine, hydroxychloroquine. It’s quite effective (at controlling joint and skin symptoms) and is one of the safest medicines we prescribe.”  That was my lead sentence; but instead the patient heard and clung to the last sentence: “Oh, and it rarely affects the eyes. So you’ll need to have an annual eye exam to assure the drug’s safety.”  The subtext became a headline and the patient heard “potential blindness”.  Importance is justified when you find she makes her living as a sharp-shooter and her grandmother had macular degeneration.

Negative thinking is the constitutive skepticism that comes with new diagnoses, new drugs, car salesmen and prospective suitors. It is an anchor for self-preservation, especially in such naïve situations. However, in the case of medical care it can be diabolical, destructive and damaging to outcomes. Such thinking is not devilish or ill-intended; instead it is misinformed, pessimistic and restraining. Left unchecked, it stagnates care, averts interventions and drives nonadherence – much to the detriment of the worried patient.

Research on patient compliance and drug adherence has shown that nearly all patients have some degree of noncompliance, with medication compliance ranging from 50-70% in most.  We see this in patients who confess to taking their etanercept once every two weeks or sleep apnea patients who admit to using CPAP, but only once a week when their spouse nags them to do it.

There are two approaches to negative thinking physicians need to consider proactively. First, is the need to teach the consequences of not treating a problem or disorder and second, teaching the patient how to correct the negative narrative they tell and convince themselves of.

The Consequences
Teaching the consequences is easy, but it takes time and pastoral patience. Patients can easily comprehend the consequences of not treating HIV, a cancer or mental illness. But applying the same clarity to their own clinical situation requires coaching and simple logic. 

Recognize that many patients will not take a drug or even fill the prescription.  Consumer Reports states that half of patients assume grave risks by skipping doses, taking expired medications or not filling a prescription. Several sources indicate that 23-33% of all prescriptions go unfilled, especially in the elderly, low-income groups, chronic conditions and expensive drugs. Nonadherence is willful inaction owing to risk aversion, bolstered by inexperience in making value-based choices.  

Patients struggle with the balance of potential benefits and risks of a particular therapy. Many believe there is more harm in taking meds than in avoiding meds. When confronted with new, confusing or ambiguous situations, decision avoidance may appear to be the easiest and safest option. Worse is the belief that all adverse events are likely for those with the misfortune of having an autoimmune (or like) chronic condition.  An RA patient may immediately reject the appropriate option of rituximab because of the very rare risk of progressive multifocal leukoencephalopathy (PML).  When informed that the risk of getting PML from rituximab is 1 in 30,000; such patients quip “oh don’t worry, I’m unlucky enough to get it!”  They truly don’t accept that their individual risk is the same as the next RA patient, 1 in 30,000. 

Unfortunately, such magical thinking (rooted in what is not known) and non-treatment is predictably rewarded with poor outcomes and more difficulty and distress for all. This is where an experienced clinician can teach the likely consequence of not treating (active lupus nephritis, inflammatory symptoms of PMR or swollen joints with RA). Patients can be counseled that:

1. they are often avoiding that which they are misinformed or know little about;
2. they are stuck and without a plan to fix their problem;
3. that time and natural cures/interventions were prevalent at the turn of the century when the average life span was 48 years; and
4. it is wrong to view or equally consider information that is free (internet, sales people, television) versus that which is the best money can buy (consultation with a specialist). 

Risk communication takes time and careful wording.  But I like to end my rationale for a prescriptive plan with proclaiming this medicine was made for them and their situation, it cost $1-2 billion dollars to develop and has been given to thousands or millions of patients for the same reason AND that my research and 30 years of experience are on your side for the best possible outcome.  Reinforce that the patient needs to read, do research and have a voice.  But at some point, they will have to trust someone (of their choosing) to guide them as they forge ahead through scary waters. Who will guide them?  A website, vitamin maker, and brother-in-law surgeon, or the rheumatologist they’ve chosen to see?   

The Negative Narrator
We all have a narrator in our head and at times, it just won’t quit. “You’re not good enough”. “That would be a bad choice.”  “Let someone else go first”. The narrative inside your head is often negative and constraining and while it may be self-protective, it can also be a detriment to health and happiness. 

The television series “Ray Donovan” is about a nefarious Irish family who moves from Boston to Los Angeles and becomes involved in a fast paced, shady sub-culture. The lead character, Ray Donovan (played by Liev Schreiber), is a “fixer” or “mechanic” of bad predicaments that happen to good and bad people.  When asked what his job is, he proclaims, “I change the story” (meaning he delivers the desired outcome he is paid for). 

Changing the story, especially the story patients tell themselves, can be done with clarity, guidance, risk communication and recognition of the negative narrator within. Instea of thinking, "dang! I've got to take this drug for the rest of my life?" the inner voice should be taught to think, "thank goodness there is a long-term treatment so that I can have long-term normalcy!" 

Michael Hyatt is an author, publisher, mentor and podcaster who speaks on many areas of self-improvement. One of his podcasts (listen here(link is external)) covers how to  “change your story” and in essence, deal with the negative narrative in a more productive and planful way.

Tenets to Changing the Story include:

1. Recognize that there is a narrator/voice within;
2. Jot down what that voice tells you – “don’t take that medication, you’ll be the one in 30,000 to get that deadly brain infection”;
3. Evaluate the “story” – is it holding you back or empowering you forward; is it leading to action or stagnation;
4. Write a different story – with a better or more informed outcome. What you should tell yourself or what your doctor would tell you.

Patients need to recognize the voice isn’t always positive or productive.  The narrator often leaves you stuck where you are with what you don’t know.  The patient needs to know what are the consequences? What is at stake?  What choices leave you the victim or the one in control? Also, remind them it’s unwise to make judgments (or listen to the narrator) when they are stressed, tired, in pain or after hearing bad news.  A good night's sleep and repeat conversation is likely to be more productive.

Lastly, and most importantly, physicians need to prescribe more than the drug. They need to deliver hope and be clear about their expectations and how this patient’s story will play out. Patients desperately want to hear “the rest of the story”, when and what will happen when the right choices are made. Tell them what it is about their situation makes them ideal or suboptimal candidates for your prescribed plan.

Give them the positive voice they need to move forward!