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Diseases and Conditions Featured

Guide to living with rheumatoid arthritis: Part 1

July 5, 2017
Have you recently been diagnosed with rheumatoid arthritis? RheumDoctor presents a guide to living with rheumatoid arthritis

Rheumatoid arthritis…  Your rheumatologist diagnosed you with rheumatoid arthritis and you have a lot questions.  What’s rheumatoid arthritis?  Can I get rid of it or will I live with this disease for the rest of my life?  What should I expect?  How do I fight it?  This week I’ll present to you Part 1 of a Guide to living with rheumatoid arthritis.  I’m going to present this as a three-part series.  Part 1 will cover the basics: what is rheumatoid arthritis, the cause, symptoms, diagnosis, treatment, etc.  In Part 2 I’ll cover prognosis, what to expect, diet and exercise.  In Part 3, I’ll be covering the financial side of rheumatoid arthritis: How to get access to medications and how to deal with insurance companies.

I hope you find this information useful.  Be strong, be brave, and know that you’re not alone.

What is rheumatoid arthritis?

Rheumatoid arthritis is an autoimmune disease that causes inflammation throughout the body but mainly affect joints. Without treatment, rheumatoid arthritis can eventually lead to permanent joint destruction.  Autoimmune diseases occur when the immune system loses “tolerance to self”.  What this means is that the immune system can no longer distinguish between healthy cells and cells that don’t belong like bacteria or cancerous cells.

According to the CDC, about 1% of people living in the US suffer from rheumatoid arthritis.  It tends to occur 2-3 times more often in women and tends to start in your sixties but it can start at any age.  [1]

Some common signs and symptoms include:

  • Pain and swelling in the joints. Particularly small joints like the knuckles, wrists, and toes.
  • Morning stiffness that lasts more than one hours
  • Having difficulty opening jars. Weakness in the hands.
  • Fatigue, fevers, unintentional weight loss.

What causes rheumatoid arthritis?

We’re actually unsure.  We do know that in certain cases there is a genetic link. People that have a certain HLA class II genotype (shared epitope) tend to get rheumatoid arthritis more often.  Especially, if they smoke cigarettes.  Moreover, we know that rheumatoid arthritis tends to run in families.  However, most cases of RA happen spontaneously and not everyone who has a genetic risk factor develops RA.

There’s still a lot of work that needs to be done to fully understand what causes rheumatoid arthritis.  Like most autoimmune diseases, our best guess is that people who have RA probably were born with some sort of genetic predisposition for the disease.  Then they get exposed to something in the environment like a virus, trauma, stress, hormonal change, which then triggers the disease to come online.

What are the symptoms of rheumatoid arthritis?

Usually rheumatoid arthritis presents with pain, swelling, and prolonged stiffness involving small joints, like the ones in your hands or feet.  When I mean prolonged, I mean more than one hour.  But RA can present in many ways. These can be divided into typical (90% of cases) and atypical presentations (10% of cases).

Typical

Insidious (55% – 65%): People develop pain, swelling, and prolonged stiffness mainly involving small joints like the toes and knuckles. This progressively worsens over months.

Subacute (15% – 20%): Again small joints are painful, swollen, and stiff but the this develops over weeks. Usually people experience some fatigue.

Acute (10%): Joints suddenly become swollen and tender over days. Some people have a fever, drenching night sweats, and sometimes can lose weight without trying.

Atypical (10% of cases)

Palindromic pattern: This type of presentation isn’t technically considered rheumatoid arthritis. It’s just that 33% to 50% of people with this type of presentation progress to full-blown rheumatoid arthritis. Typically, one joint is involved. It becomes tender and swollen for a few days then gets better on its own. Then a few weeks to a few months later it happens again. The flare can happen in the same joint but not necessarily. Treatment with hydroxychloroquine can decrease the risk of developing full-blown rheumatoid arthritis, so it’s important to start treatment as this stage.

Insidious onset of the elderly: As the name suggests this type of presentation occurs in the elderly, so people aged greater than 65 years. People experience extreme pain and stiffness shoulders and the hips. Sometimes you can see whole hand or foot swelling. Sometimes it’s very difficult to differentiate from polymyalgia rheumatica or remitting seronegative symmetrical synovitis with pitting edema (RS3PE).  People with polymyalgia rheumatica and RS3PE typically do NOT have any positive antibodies.

Rheumatoid nodulosis: Rheumatoid arthritis can cause nodules and bone cysts on radiographs. Usually people also have joint pain and swelling but sometimes all they have are nodules.

Arthritis robustus: This is rather rare. I’ve only seen it once. It typically occurs in men. Essentially the person develops horrible rheumatoid arthritis hand deformities but experiences little or no pain.  I know it’s hard to believe, but it’s possible!

Untreated rheumatoid arthritis

By James Heilman, MD (Own work) [CC BY-SA 3.0 (http://creativecommons.org/licenses/by-sa/3.0) or GFDL (http://www.gnu.org/copyleft/fdl.html)], via Wikimedia Commons

How is rheumatoid arthritis diagnosed?

The diagnosis of rheumatoid arthritis, contrary to popular belief, is primarily a clinical diagnosis. Having a positive antibodies like a rheumatoid factor (RF) does not necessarily mean that you have rheumatoid arthritis because MANY conditions can have a positive rheumatoid factor. Some of these include:

Rheumatoid arthritis, mixed cryoglobulinemia types II and III, sarcoidosis, and other autoimmune diseases like Sjogren’s syndrome. Other non-rheumatology diseases that can cause someone to have a positive rheumatoid factor include infections most notably hepatitis C, tuberculosis, syphilis, HIV, and endocarditis. People suffering from cancer and people with chronic pulmonary and liver diseases, can also have a positive rheumatoid factor.

It’s also important to mention that about 5 – 25% of people aged 60 years and older have a positive rheumatoid factor without any underlying causative disease.

This is why my job as a rheumatologist is so interesting 🙂

The American College of Rheumatology classification criteria for rheumatoid arthritis is as follows:

The 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis[2]

Who to test?

  • People that have at least 1 joint with definite swelling.
  • And the swelling cannot be better explained by another disease.

Classification criteria for RA (a score of ≥ 6/10 is needed for someone to have definite RA)

Category   Score
A Joint involvement

1 large joint

2 – 10 large joints

1 – 3 small joints

4 – 10 small joints

> 10 joints (at least one small joint)

 

0

1

2

3

5

B Antibodies

Negative RF and negative CCP antibodies

Low positive RF or low positive CCP antibodies *

High-positive RF or high positive CCP antibodies #

 

0

2

3

C Inflammation markers

Normal CRP and normal ESR

Abnormal CRP or abnormal ESR

 

0

1

D Duration of symptoms

< 6 weeks

≥ 6 weeks

 

0

1

* Low positive antibodies means any value that is above normal but less than 3 standard deviations above the upper limit of normal.

# High positive antibodies means any value that is 3 standard deviations above the upper limit of normal.

It’s important to note that these criteria were NOT meant for clinical practice but rather, were really meant for research trials. Sometimes, rheumatologists do deviate. Other conditions should be ruled out and let’s face it, not everyone fits perfectly into the mold. The criteria also does not account for musculoskeletal ultrasound testing. This imaging test can detect very subtle inflammation of a joint.[3]

Positive antibodies without RA

Now sometimes the workup is completely negative including x-rays. This is not uncommon. It can mean many things. It could mean that the rheumatoid factor is not clinically significant. 5–25% of the population can have a positive rheumatoid factor without any underlying condition or any symptoms. Typically the rheumatoid factor levels are low. It could also mean that you will develop rheumatoid arthritis in the future. Studies have shown that antibodies associated with rheumatoid arthritis can be present over a decade before onset of clinical disease. [4]Unfortunately, we don’t have the tools to precisely determine who will convert and who will not. In this situation, your rheumatologist can help you watch for any change in your condition.

How is rheumatoid arthritis treated?

We treat rheumatoid arthritis with medications called disease modifying anti-rheumatic drugs (DMARDs).  These medications slow down or stop the natural progression of rheumatoid arthritis.

Except for a few special situations, EVERYONE should with rheumatoid arthritis should be treated with a DMARD as soon as possible because permanent joint damage can happen in as little as 3 months after symptoms start.[5]

The following are the medications used to treat rheumatoid arthritis in the United States.  It’s important to work closely with your rheumatologist because they all have possible risks and what may be good for your neighbor may not be safe for you.

I’ve broken them down into conventional DMARDs, biologic DMARDs, and pipeline medications that have not been approved as of yet.

Conventional

  • Methotrexate
  • Leflunomide
  • Sulfasalazine
  • Hydroyxchloroquine

Biologics

  • Etanercept, TNF inhibitor
  • Adalimumab, TNF inhibitor
  • Golimumab, TNF inhibitor
  • Certolizumab pegol, TNF inhibitor
  • Infliximab, TNF inhibitor
  • Abatacept, Co-stimulation inhibitor
  • Tocilizumab, IL-6 inhibitor
  • Sarilumab, IL-6 inhibitor
  • Tofacitinib – JAK inhibitor
  • Rituximab – B cell depletion

Pipeline

  • ABT 494, a new JAK inhibitor
  • Baricitinib, another JAK inhibitor
  • Sirukumab, another IL-6 inhibitor

Biosimilars

It’s also important to note that we are starting to see biosimilar medications in the States. These are medications that are sort of copied from existing biologic medications.  They are NOT generic medications. The problem with biosimilars is that because of their complexity, it literally is impossible to exactly copy a biologic medication. If you want to learn more about biosimilar medications, please check this article.

Supplements

If you’re interested in supplementing, there is some research that suggests high dose turmeric/curcuma and high dose fish oil/omega-3 fatty acids may also be helpful.[6][7] However, supplementation should be used in combination with FDA approved medications that I listed above.

Is there a cure for rheumatoid arthritis?

I honestly wish I had better news for you. Unfortunately there is no cure for rheumatoid arthritis. Treatment primarily focuses on arresting the natural progression of the disease with the use of disease modifying anti-rheumatic agents (DMARDs). Conventional DMARDs such as methotrexate, leflunomide, sulfasalazine, and hydroxychloroquine, modulate the immune system to decrease rheumatoid arthritis activity.  Biologic medications like etanercept use a targeted approach, i.e., suppress a specific cytokine.

The goal of treatment is to put rheumatoid arthritis into remission and decrease the frequency of flares.

This may seem very pessimistic, but recent advances have really improved the prognosis of people living with rheumatoid arthritis.

Nevertheless, DMARDs do not cure rheumatoid arthritis.

How do we win the war against rheumatoid arthritis? Before we can win the war and find a cure, we need to know exactly what causes rheumatoid arthritis in the first place and we need to understand its exact pathophysiology. Believe it or not, despite all our advances, we still cannot answer these two questions. Don’t despair, researchers are actively trying to answer these questions.

Can rheumatoid arthritis become fatal?

Rheumatoid arthritis is a systemic autoimmune mediated disease that primarily affect the joints. Note the primarily bit. It can affect a host of different organs including the eyes, lungs, heart, skin, and bone marrow to name a few.

Untreated or poorly controlled rheumatoid arthritis can cause serious conditions such as interstitial lung disease (i.e., inflammation of the lungs), pericarditis (i.e., inflammation of the “sac” surrounding the heart), as well as something called Felty’s syndrome (i.e., a hematologic condition that can cause white cells to dramatically decrease and causes the spleen to enlarge). These severe manifestations of rheumatoid arthritis that can lead to death are hardly ever seen anymore mainly because we have many highly effective medications called disease modifying anti-rheumatic medications (DMARDs). These medications have completely changed people’s prognosis.

Cardiovascular disease and infection

The most common cause of death in people with rheumatoid arthritis these days includes cardiovascular disease and infection – primarily from medications.[8]

Rheumatoid arthritis increases cardiovascular risk via the interplay of inflammation and lipid metabolism. Studies have shown that people who receive treatment with methotrexate and or tumor necrosis factor inhibitors reduce their cardiovascular risk.[9] A British study also demonstrated that cardiovascular was not increased regardless of the choice of DMARD provided that rheumatoid arthritis was well controlled.[10]

Infection remains an ever-present problem in the world of rheumatology. To treat autoimmunity you need to suppress the immune system. Not too much, not too little, but just right. In some cases this has the unfortunate result in causing serious infections that can lead to death in extreme cases.

Rheumatoid arthritis can become fatal in many other ways, however, for the most part it is medication induced – although the pharmaceutical companies don’t really want you to know that. Just read a package insert. They’re terrifying.

However, I’ve been talking about rheumatoid arthritis fatalities. Untreated or undertreated rheumatoid arthritis is HIGHLY debilitating leading to a significant drop in your quality of life. Early treatment with a DMARD is the best way to improve your odds. You have to fight fire with fire!

Can I stop my medications if I’m feeling better?

No. Rheumatoid arthritis is a life-long disease.  If you’re feeling better, great!  However, it’s probably your medications that are keeping you that way.  If you stop your medications the rheumatoid arthritis will come back.  Maybe not now but soon.  Rheumatoid arthritis subsides spontaneously in a VERY small subset of people.

If your medication is making you feel sick, talk to your rheumatologist.  They’re there to make you feel better and they want to find the perfect treatment plan tailored for you.

Do not stop your medications without consulting your rheumatologist.

Next steps

We’ve covered a lot of material today and there’s a lot more coming your way!  Stay tuned for Part 2.  I’ll be covering topics such as what to expect, what to eat, how to exercise, and strategies on how to reduce stress.  Please leave your comments below.

References

[1] https://www.cdc.gov/arthritis/basics/rheumatoid-arthritis.html

[2] https://www.rheumatology.org/Portals/0/Files/2010_revised_criteria_classification_ra.pdf

[3] Horton SC, et al. Ultrasound-detectable grey scale synovitis predicts future fulfilment of the 2010 ACR/EULAR RA classification criteria in patients with new-onset undifferentiated arthritis. RMD Open. 2017 Mar 30;3(1):e000394. doi: 10.1136/rmdopen-2016-000394. eCollection 2017.

[4] Brink M, et al. Rheumatoid factor isotypes in relation to antibodies against citrullinated peptides and carbamylated proteins before the onset of rheumatoid arthritis. Arthritis Res Ther. 2016 Feb 9;18:43. doi: 10.1186/s13075-016-0940-2.

[5] Raza K, et al. Treating very early rheumatoid arthritis. Best Pract Res Clin Rheumatol. 2006 Oct;20(5):849-63.

[6] van der Tempel H, et al. Effects of fish oil supplementation in rheumatoid arthritis. Ann Rheum Dis. 1990 Feb; 49(2): 76–80.

[7] Ramadan G Al-Kahtani MA, El-Sayed WM. Anti-inflammatory and anti-oxidant properties of Curcuma longa (turmeric) versus Zingiber officiale (ginger) rhizomes in rat adjuvant-induced arthritis. Inflammation. 2011 Aug;34(4):291-301. doi: 10.1007/s10753-010-9278-0.

[8] https://www-ncbi-nlm-nih-gov.elibrary.amc.edu/pubmed/26472415

[9] https://www-ncbi-nlm-nih-gov.elibrary.amc.edu/pubmed/28455580

[10] https://www-ncbi-nlm-nih-gov.elibrary.amc.edu/pubmed/28160488

Medical Disclaimer

This information is offered to educate the general public. The information posted on this website does not replace professional medical advice, but for general information purposes only. There is no Doctor – Patient relationship established. We strongly advised you to speak with your medical professional if you have questions concerning your symptoms, diagnosis and treatment.

Diseases and Conditions

How much alcohol is safe with methotrexate?

April 26, 2017
Is it safe to drink while taking methotrexate?

Can I drink alcohol when I take methotrexate?  This is one of the most often asked questions I’m asked in clinic when starting methotrexate.  I also suspect it is one of the reasons people sometime decline treatment with methotrexate.  This is a shame, because methotrexate the cornerstone medication for rheumatoid arthritis.

You would think the answer to this question is obvious.  Alcohol can cause liver failure and cirrhosis.  Methotrexate can also cause liver inflammation and fibrosis/cirrhosis.  So combining the two doesn’t sound like such a hot idea.  It turns out the answer to the question isn’t so black and white.

Yes, alcohol can cause liver failure, however, not everyone who drinks alcohol gets cirrhosis.  It tends to happen when someone drinks excessively for years.  The same goes for methotrexate.  Not everyone who takes methotrexate gets liver inflammation.

The real question is, how MUCH alcohol is safe to take with methotrexate?  Shockingly there was little if any data addressing this question until recently.  How much alcohol is too much?  How much alcohol is likely safe?

Science to the rescue!  A recent study from the UK specifically addressed this question¹.  But before I get into that, let’s quickly review what a standard unit of alcohol actually is.  “I drink alcohol socially” simply isn’t going to cut it.  “Social” is highly variable!


What is a standard unit of alcohol?

This depends on the country you’re talking about.  Every country defines a unit of alcohol differently.  Since I’m writing based from the US, I define a unit of alcohol as follows:

“NIH standard drink comparison” by the National Institutes of Health is in the public domain in the United States.  This file has been identified as being free of known restrictions under copyright law, including all related and neighboring rights.

Moreover, each country has their own definition for the maximum amount of alcohol per week.  Some countries are more permissive than others.  In the US, defines low risk drinking for women as no more than 3 drinks on a single day and no more than 7 drinks per week.  Men can drink no more than 4 drinks on a single day and no more than 14 drinks per week².

Quantifying the hepatotoxic risk of alcohol consumption in patients with rheumatoid arthritis taking methotrexate

Researchers in the UK recently looked into this matter.  As I alluded to, our current guidelines actually offer no specific guidance about alcohol and methotrexate.  In the UK, “patients taking methotrexate should limit their alcohol intake to well within the UK national recommendations”… whatever that means.  The American College of Rheumatology offers similar non-specific guidance.  When I was training, some mentors would have a strict “no alcohol” policy and some would say, a glass of wine or two per week should be okay.

The aim of the recent study was to quantify the risk of alcohol consumption on hepatotoxicity (liver damage) in a contemporary group of methotrexate users with rheumatoid arthritis, in a large national primary care database.

Methods

The researchers recruited people from the Clinical Practice Research Datalink (CPRD) which is a large database of information gathered by primary care providers.  They looked at all patients identified as having rheumatoid arthritis and starting methotrexate after 1987 up until Feb 2016.  People were included if their liver enzymes were measured at least six times per year.

The researchers want to measure any episode of liver inflammation (transaminitis) defined as a level that was three times the upper limit of normal.  This was called the primary definition of transaminitis.  Since we know that persistently elevated liver inflammation can lead to liver fibrosis, the researchers were also interested in identifying people that that have three back-to-back levels that were above the upper limit of normal.  This was called the secondary definition of transaminitis.

Alcohol consumption was measured first by seeing whether the person drinks alcohol, yes or no.  Then the person’s alcohol consumption was categorized:

  1. Mild: 1-7 units per week
  2. Moderate: 8-14 units per week
  3. Moderate-high: 15-21 units per week
  4. High: > 21 units per week

Results

The researchers identified 44 586 people but only included 11 839 people in the study.  The people that were excluded typically were a little younger, were female, and tended to drink no alcohol or very little alcohol.

Using the primary definition of transaminitis, there were 530 first episodes in 47 090 person-years.  That’s about 11.26 per 1000 person-years.  This rate was similar between drinkers of alcohol and non-drinkers of alcohol.  There was no increased risk in the occurrence of transaminitis in drinkers compared with non-drinkers.  But this is pulling all the data together.  What about people who drank mildly vs moderately vs high?

After analyzing the data ever further, the researchers found, unsurprising, that the rate of transaminitis increased with increasing levels of alcohol consumption.  Drinking mild to moderate amounts of alcohol was not associated with transaminitis.  Drinking more than 21 units of alcohol per week tended to be associated with transaminitis.

Alcohol consumption below 14 units per week was associated with a very low probability (0.93%) of having clinically important risk of transaminitis.  Alcohol consumption in excess of 14 units per week was associated with increasing risk of transaminitis.  More specifically, the risk was 33% with moderate-high consumption (15 – 21 units weekly) and 81% with high (>21 units weekly) consumption.

When the researchers used the secondary definition of transaminitis, i.e., 3 or more consecutive episodes of increased liver enzymes above the upper limit of normal, they found similar data: Mild = 0.01%, moderate-high = 8%, and high 17%.

Limitations

No study is perfect.

First, the data came from a primary care database.  This means, it was the PCP or rather the general practitioner that was responsible for coding the diagnosis appropriately, not a rheumatologist.  That being said, some misclassification may have occurred inadvertently.

Another issue was that the amount of amount of alcohol consumption was self-reported.  Most people tend to under report their alcohol consumption, so we can kind of assume that the levels of alcohol reported by the people in the study were actually a lot more than stated.

Another limitation included the fact that many people were excluded because their liver enzymes were measured less than 6 times per year.  Things get a little muddled up here.  People that have their blood tested less often statistically have a decreased chance of having an abnormal test simply because they get tested less.  Then again, having your blood tested 6 times a year is a bit much, unless that person has risk factors that put them at increased risk of developing liver problems.

An important limitation is the fact that the dose of methotrexate was not included.  There could be an increased risk of hepatotoxicity if someone were to take 25 mg of methotrexate weekly versus someone who takes 10 mg.

It’s also unclear whether these results are generalizable to other autoimmune diseases.  Methotrexate is also used to treat psoriasis and psoriatic arthritis.  The study only included people with rheumatoid arthritis.  People with rheumatoid arthritis and psoriasis are not the same.  People with psoriasis tend to have more liver problems in general.  For example, they tend to develop fatty liver.  So the risk of hepatotoxicity with alcohol could be different.

Lastly, some people say that measuring liver function tests (AST and ALT) may be insufficient to actually assess long-term damage from methotrexate because some people develop liver fibrosis without having transaminitis.  The problem with the studies that look at methotrexate and liver fibrosis are for the most part, dated and most looked at people with psoriasis.  As I mentioned, people with psoriasis tend to have more liver problems than people with rheumatoid arthritis.  It’s also important to note that since the 80’s, we’ve changed the way we prescribe methotrexate as well as changed the way we check labs.  Measuring liver function tests, NOT performing serial liver biopsies to monitor methotrexate toxicity, remains current best practice.

On a side note, liver function tests is kind of misnomer because the AST and ALT actually don’t measure liver function.  They measure liver inflammation.

Conclusion

According to this study modest amounts of alcohol consumption when taking methotrexate may not be as harmful as once though.  I would like to remind you that the information provided today does not constitute medical advice.  Please talk to your doctor.  Everyone’s health is unique.  Please leave comments below!

References

  1. Humphreys JH, Warner A, Costello R, Lunt M, Verstappen SM, Dixon WG. Quantifying the hepatotoxic risk of alcohol consumption in patients with rheumatoid arthritis taking methotrexate. Ann Rheum Dis.2017 Mar 23. pii: annrheumdis-2016-210629. doi: 10.1136/annrheumdis-2016-210629. [Epub ahead of print]
  2. https://www.niaaa.nih.gov/alcohol-health/overview-alcohol-consumption/alcohol-facts-and-statistics
Overcoming Inflammation

Tips for family and friends for people living with rheumatoid arthritis

March 15, 2017

Last week I was listening to one of my patients describe their condition in a deeply emotional and revealing way.  He honestly caught me off guard.

He said, that he woke up one day, and felt like a blob.  Like a being without joints, without tendons, ligaments or structure.  He could not walk or move.  He did not feel human anymore.

He was describing Part I of Franz Kafka’s seminal work, The Metamorphosis.  For those who have not read this novella, The Metamorphosis is the story of Gregor, a travelling salesman, who wakes one morning to discover that he has transformed into an insect-like being.  There is no rhyme or reason for his transformation.  It did not happen because he was a bad person or because of something he did.  It simply just happened.  The story deals with his attempts to adjust to his new physical state and his attempts to cling onto his humanity.  It also deals with the transforming relationships he has with various members of his family.  First how some show empathy but then quickly this empathy transforms into a sense burden and then repulsion.

Sound familiar?

When you think about it, it’s kind of depressing, especially for those who suffer from chronic diseases such as rheumatoid arthritis.  In certain cases, it’s a reflection of reality.  One wakes up one day and learns that their body will not let them to do what they used to do.  In the case of rheumatoid arthritis, you didn’t do anything to cause it.  It just happened.  It’s not like you were smoking 3 packs of cigarettes a day for 20 years and then you get diagnosed with emphysema.  That’s called playing with fire.  With RA, it just happens.

So now you find yourself not being able to do what you used to do: do your job, support your family, play with your kids.  It’s not because of a lack of will, your body simply won’t let you… not that you should give up:)  Now you become a burden to your family.  Your relationships change.

Unlike Kafka, I personally refuse to believe that these relationships will inevitably sour.  Healthy relationships with your loved ones can you grow healthier physically, emotionally, and psychologically.

The following are 8 tips to help metamorphose relationships into healthy and supportive ones.  Please share with family and friends!

 

Learn as much as you can about your loved ones disease

Knowledge is power.  It’s easier to have empathy when you have a sense of what’s going on and also what to expect.

But don’t assume you know everything.  You don’t.

No one likes a know-it all.  Don’t assume that you know what your loved one is going through or how they feel.  You can’t learn that in a textbook or from an article.  Be supportive.

Be a good listener

Sometimes people simply need vent.  Listen for cues.

Be adaptable

Life is going to change whether you like it or not.  There’s going to be good days and there’s going to be bad days.  Being rigid about your expectations is not going to get you anywhere.  Be flexible.

Don’t be overprotective

Find balance.  Although you want to help your loved one as much as you can, you also don’t want to strip them of their independence and by being overprotective.

Open communication

Be open about your emotions and thoughts.  A healthy relationship is one free of passive aggressiveness.

Join a support group

There are many support groups out there.  Let me tell you, I’ve been there.  Not for RA though.  All of a sudden the person you love and depend on, gets diagnosed with this terrible disease.  And EVERYTHING changes.  There’s nothing worse than the deep sense of loneliness that comes along.  Support groups can help overcome the isolation.  Find a support group near you!

Unconditional love

Whatever life throws at us, we will deal with it together.  I promise not to scream at you because I’m having a bad day.  I promise not to blame you for the money problems we have now.  I love you, I will support, and advocate for you no matter what conditions.  This is unconditional love.

 

I hope this has been helpful. Please leave any comments below.  I’m interested in hearing your thoughts and experiences.

 

Diseases and Conditions

What are the risks vs. benefits of biologic therapy?

March 8, 2017

Some of you may recall one of my previous posts where I attempted to dispel some of the myths commonly associated methotrexate.  Don’t get me wrong, I frequently use methotrexate.  It is considered gold standard for the treatment of rheumatoid arthritis.  And this is despite the armada of new fancy medications coming onto the market.  The American College of Rheumatology doesn’t call it the gold standard for nothing.

But sometimes it isn’t enough.

It’s estimated that about 30% of people achieve either remission or very minimal disease activity with methotrexate alone.  That leaves the other 70%.  Maybe this includes you?  In this situation, your rheumatologist may either recommend you to combine methotrexate with another conventional disease modifying anti-rheumatic drug (DMARD) or either to combine it with a biologic DMARD.  The decision is very complex and will vary from person-to-person and from rheumatologist-to-rheumatologist.  Were there issues with the ability to tolerate the medication, allergies, other medical conditions, insurance coverage, safety profile concerns, etc?  And then there’s just style.

DMARDs

In the best of situations, ALL people diagnosed with rheumatoid arthritis should be started on a DMARD as quickly as possible.  For those who don’t really know me, the tone of this statement is very uncharacteristic of me.  I loathe dogma and authoritarian statements in general.  But when it comes to DMARDs and rheumatoid arthritis, people that receive these medications as soon as possible do better and have less joint damage.  It’s important to achieve remission or have very minimal disease activity as soon as possible and as long as possible.

So what is a DMARD? For a medication to be considered a DMARD it has to change the course of the disease, for the better:), for at least one year.  There should be improvement in either physical function, decreased swelling, or slowing/prevention of joint damage.

To understand why your doctor may want to start a biologic medication, it’s important to understand what is meant by a conventional vs. a biologic DMARD.

I would say there are two main differences between conventional DMARDs and biologic DMARDs: mechanism of action and cost.  Conventional DMARDs do NOT directly target a specific type of inflammation.  Biologics do.  This means that biologics are a lot more molecular complex.  This also means that they are A LOT more expensive.  Even in countries like Canada, where the single payer system has the ability to negotiate prices with pharmaceutical companies, the price is still very high.  I could on and on with this subject, but I’ll leave that for another post.

Conventional DMARDs

  • Often used
    • Hydroxychloroquine
    • Methotrexate
    • Leflunomide
    • Sulfasalazine
  • Not really used
    • Azathioprine
    • Mycophenolate, sometimes used for rheumatoid arthritis affecting the lungs
    • Cyclophosphide, used for life or organ threatening disease
    • Cyclosporine
    • Gold injections

Biologic DMARDs

  • Tumor necrosis factor inhibitors
    • Etanercept
    • Adalimumab
    • Golimumab
    • Certolizumab pegol
    • Infliximab
  • Interleukin-6 inhibitors
    • Tocilizumab
  • Co-stimulation inhibitors
    • Abatacept
  • JAK inhibitors
    • Tofacitinib
  • B cell depletion
    • Rituximab

There are other medications that are coming down the pipeline, but these are the ones that are FDA approved and commercially available for the treatment of rheumatoid arthritis.  There are other biologic medications like belimumab, apremilast, ustekinumab, and secukinumab that are used for other diseases like systemic lupus erythmatosus, psoriatic arthritis, and ankylosing spondylitis.

Triple therapy vs. methotrexate + biologic

Generally triple therapy refers to the simultaneous use of methotrexate + sulfasalazine + hydroxychloroquine for the treatment of rheumatoid arthritis.  A Cochrane meta-analysis recently found that triple therapy typically is just as effective as methotrexate + a biologic or tofacitinib alone.  So why is your doctor proposing going to a biologic medication instead of going to triple therapy?  It certainly would be cheaper.

This is where I would say is one of the potential benefits of biologics: the ability to tolerate treatment long-term.  Let’s put things into perspective.  When you take an antibiotic, you may end up with some GI discomfort, diarrhea, some nausea, etc.  You receive 7 days worth of treatment, the infection is gone, it usually takes a few more days for things to settle down, but then it’s done.  When it comes to the vast majority of rheumatic conditions like rheumatoid arthritis, some form of medication is consistently needed to keep the disease in remission. If you stop, the disease flares.  Don’t get me wrong, there are exceptions.  Sometimes the disease goes into permanent remission or “burns out”.  This is rare and definitely is not the rule.

The problem with triple therapy is that it tends to be very difficult to tolerate long-term.  Most people could tolerate a few weeks, but we’re talking years, decades, lifetime.  Many people stop one or more of the medications without telling their doctor, others take them sporadically.  Basically, there’s a lot of non-compliance with treatment when people receive triple therapy.

It isn’t necessarily because those people are irresponsible.  It’s that the medicines are making them feel sicker than their actual disease!

Simply put, biologics tend to be a lot easier to tolerate long-term and to bout SOME can be used as monotherapy i.e., you don’t need to combine with methotrexate.

Onset of action

I wouldn’t say that this is necessarily the most important factor when making a decision to go with a biologic instead of sticking to conventional DMARDs but I guess it could help tip the balance in certain situations.  In general biologic DMARDs tend to work a little more quickly that conventional.  This greatly varies from biologic-to-biologic.  Generally conventional DMARDs taking between 3 – 6 months to fully work.  It tends to be closer to the 3 month mark.  For most biologics it can take up to 3 months.  Certain ones like abatacept can take up to 6 months as well.

Cost

Most biologics cost over $ 1 100 per month.  Mind you, hardly anyone actually pays $ 1,100 per month.  Before starting a biologic medication, you doctor’s office will obtain authorization from your insurance company prior to prescribing the medication.  When the medication is authorized, your doctor will send it to your prescription mail-order company, and then it will be mailed to you.  Co-pays vary from $5 a script to a few hundred dollars in extreme cases.  It really depends on your insurance coverage.  It’s very important to keep your doctor but also your doctor’s medical secretary and if your doctor is extra lucky, your doctor’s patient advocate, appraised of all changes to your insurance.  It can mean the difference between a $5 co-pay and a second mortgage.  Most pharmaceutical companies have patient assistance programs.  Some are better than others… and some are better advertised than others.

Conventional DMARDs are a lot cheaper.  For example, methotrexate comes in 2.5 mg tablets.  20 tablets cost a little over $25.  This is the price if you had no insurance and were paying completely out of pocket.  Someone taking oral methotrexate will typical take between 24 to 40 tablets per month.  For most people this is doable even without any insurance.

Conversely, if you were receiving etanercept and had no insurance, your out of pocket cost would be about $3,500 per month.  Again, your doctor’s team will work to have the medication covered, but it’s still something to think about.

Method of delivery

This may be a non-issue for many people but it may be for some.  Most biologics need to either be injected or infused.  So far, only tofacitinib (rheumatoid arthritis) and apremilast (psoriatic arthritis) are taken orally.  There are pros and cons for both injections and infusions but generally, if your needle phobic, this may be a problem.  Infusions are time consuming because you need to come to the clinic to receive the infusion.  They typically last between an hour to half a day depending on the medication.  Some are dosed every month others every 8 weeks.  Rituximab is every 6 months but this is an exception.  Most injections are either given every week or every other week.  Some are a lot less frequent like ustekinumab, but again this is an exception.

Conversely, all the conventional DMARDs are oral except for cyclosphosphamide and gold.  I’ve never prescribe cyclophosphamide for rheumatoid arthritis… ever.  First, we simply do not encounter many people with life-threatening complications caused by rheumatoid arthritis anymore because the vast majority of people with the condition are treated with DMARDs very early into their disease.  Second, there are many other medications on the market that are a whole like better.  Don’t get me wrong, there are certain very serious indicated clinical situations.  Just wrote an order for it last week… my first in a year and it wasn’t for RA!

Infection risk

One of the big differences between conventional DMARDs and biologics is the infection risk.  Biologic medications generally are a lot more immunosuppressive than conventional DMARDs.  Again there are exceptions.  For example, abatacept is generally thought to have less of an infection risk.

I have to stress that this does not mean that people taking biologics get a ton of infections.  But it becomes extra important to keep up with routine vaccinations, adhere to proper hand washing, and try to stay away from high risk situations as much as possible.  It may also not be such a great idea to be on a biologic if you are prone to getting infections.  Let’s face it, no one wants 10 sinus infections in one year.  It also may not be such a great idea to be one some of these biologics if you have very serious lung problems.  I probably will try to avoid most biologics if someone has severe COPD requiring extra oxygen.  Pneumonia could be life-threatening in this situation.

Another important noteworthy point, certain biologics can re-activate dormant infections such as tuberculosis, hepatitis B+C, and zoster.  It’s important to screen for both tuberculosis and hepatitis B+C prior to initiation of therapy.   You may need to start therapy for these latent infection prior to treatment with biologics.  For zoster also known as shingles, you may benefit from the shot one month prior to treatment with biologics.  The shingles shot is a live vaccine and should NOT be given while taking a biologic medication.  Like I said, you need to wait a month.  Please contact your rheumatologist for more information.

Miscellaneous

There are a few other items of concern but these vary from medication to medication irrespective of whether that medication is a conventional DMARD or a biologic.  The following are items to consider when choosing the most appropriate medications.

  • History of hepatitis C
  • History of HIV
  • History of a demyelinating disease like multiple sclerosis
  • History of severe congestive heart failure
  • History of lymphoma or leukemia
  • History of melanoma
  • History of a solid cancer within the last 5 years (e.g., breast cancer)
  • History serious liver disease
  • History of a serious kidney disease
  • History of serious lung disease
  • History of serious diverticulitis or bowel perforation
  • History of gastric bypass surgery
  • History of macular degeneration
  • History of organ transplant
  • Allergy history
  • Current medications.  Are there any possible drug interactions? (e.g., azathioprine and allopurinol should not be combined)

Having one of these does NOT mean you cannot take any biologic medication safely.  It simply means that certain ones may not be such a good idea.  For example, tumor necrosis inhibitors should not be taken by people suffering from multiple sclerosis.

Conclusion

I hope this helps clarify a few concerns that you may have had regarding biologic medications.  Maybe I’ve caused you to think about things you had not thought about before?  Choosing the best course of therapy can be very complex.  There are so many things to think about and the down stream effects could be very serious.

Open communication and knowledge are key!

References

Rheumatology Secrets 3rd edition

Hazlewood GS, et al. Methotrexate monotherapy and methotrexate combination therapy with traditional and biologic disease modifying anti-rheumatic drugs for rheumatoid arthritis: A network meta-analysis. Cochrane Database Syst Rev. 2016 Aug 29;(8):CD010227. doi: 10.1002/14651858.CD010227.pub2.

https://www.drugs.com/price-guide/methotrexate

Diseases and Conditions

10 frequently asked questions when starting methotrexate

February 22, 2017
Methotrexate is one of the mostly frequently prescribed medications in rheumatology. It has great joint-saving potential but also has a considerable list of potential side effects. In this week's edition of RheumDoctor, we address frequently asked questions when starting methotrexate.

Hands down, methotrexate is one of the most frequently prescribed medications in the field of rheumatology as it is the cornerstone medication for rheumatoid arthritis.  As a rheumatologist, I tend to classify time as, “the time before methotrexate” and “the time after methotrexate”.

Methotrexate was first reported by Sidney Farber in 1948 for the use of childhood leukemia.  By 1951, Gubner observed that people with rheumatoid arthritis and psoriasis improved while taking the medication and soon worsened after stopping it.  Unfortunately and fortunately, during this time Dr. Phillip Hench received a Nobel prize for the discovery of corticosteroids.  At that point, interest for methotrexate waned.  It’s only in the mid-1980’s that a renewed interest for this paradigm-shifting medication occurred.  The rest is history.

I don’t believe anyone can argue the significant benefits methotrexate can give.  The scientific evidence is overwhelming.  But it also boasts a considerable list of potential side effects.  In this week’s edition of RheumDoctor, I address frequently asked questions when starting methotrexate.

Before starting, the information below does not constitute medical advice.  Every person and every situation is unique.  Please address questions about your care with your rheumatologist.

1. Why do I have to take methotrexate?  I went online and it sounds dangerous.

Do an image Google search with the term “rheumatoid arthritis”.  Yep, not so pretty.  Remember when I said that I tend to classify time as, “the time before methotrexate” and “the time after methotrexate”.  There’s a pretty good chance that the people with the gnarly hands are the people who received methotrexate very late into their diagnosis.  Methotrexate is a disease modifying anti-rheumatic drug (DMARD).  What this means, is that it potentially halts the natural progression of rheumatoid arthritis.  If left untreated, rheumatoid arthritis causes joint deformities and permanent joint destruction.  Deformities can occur within 3 months of disease onset.  That’s fast!  Uncontrolled rheumatoid arthritis increases the risk of cardiovascular disease and can also directly affect major organs such as the lungs, eyes, and bone marrow.  Methotrexate has a good chance of preventing all the above.

Untreated rheumatoid arthritis

By James Heilman, MD (Own work) [CC BY-SA 3.0 (http://creativecommons.org/licenses/by-sa/3.0) or GFDL (http://www.gnu.org/copyleft/fdl.html)], via Wikimedia Commons

2. Why do I have to take folic acid with methotrexate?

Methotrexate competitively inhibits dihydrofolate reductase (DHFR).  This is in turn decreases the amount of bioavailable folic acid in your body.  You need folic acid to make new cells.  What does this mean?  Side effects: mouth ulcers, hair loss, nausea, heartburn, abdominal pain, fatigue, anemia, liver problems.  By taking supplemental folic acid, you are trying to overwhelm the system with folic acid so that you don’t develop side effects.  It’s important to note, that if you take too much folic acid, it will negate the therapeutic benefits of your medication.

3. Why must I have bloods drawn on regular intervals while I’m taking methotrexate?

Simply put, safety. Before starting methotrexate you need to screen for hepatitis B and hepatitis C.  This isn’t personal, it’s just safe.  You will also need a chest x-ray done before starting the medication.  Methotrexate can cause you to develop lung nodules and rarely can cause inflammation of the lungs.  Basically, you want to make sure that everything is okay before starting the medication.  For example, if I find many lung nodules before doing anything, I’ll probably want to start treatment with a different DMARD.  It’s also important to check a complete blood panel and check your liver and kidney levels before starting methotrexate.  This is for the same reasons as the chest x-ray, safety.

Now once you are on methotrexate, it’s important to watch for side effects.  Typically, you need bloods every 3-4 weeks in the beginning and then every 3 months once you are on a stable dose.  This is important because you may not necessarily physically feel you are becoming more anemic or that your liver is inflamed.

On a side note, if you check the bill you received from your insurance company, you might see the code “high risk medication monitoring – Z79.899”.  This does NOT mean you are participating in questionable or “high risk activities”, if you know what I mean.  It simply means that your doctor needs to check your labs on a frequent basis because of the medications you are taking.

4. What about combining other medications with methotrexate?  Is it safe?

Methotrexate is commonly combined with other medications.  About 1/3 of people treated with methotrexate for rheumatoid arthritis will either have very little symptoms or will go into remission.  The other 2/3 will need to use combination therapy.  Methotrexate is commonly called the “anchor” in rheumatoid arthritis treatment regimens.  Some medications are safe to combine and some are not.  This will depend on many factors like lifestyle choices, your other different medications, liver status, and your other medical conditions.

5. How much alcohol is safe for me to drink with methotrexate?

Methotrexate can potentially cause inflammation of the liver.  So technically, it’s probably not a good idea to drink any alcohol while taking methotrexate.  That being said, drinking one standard glass of alcohol once a week probably is safe.  This is a bit of a touchy subject, and you should discuss this more with your doctor.  If you click the following link, I have a full article dedicated to this topic.

These are the NIH's standard alcohol units

By National Institutes of Health [Public domain], via Wikimedia Commons

6. Do I have to worry about infections with methotrexate?

Whether methotrexate significantly increases your risk of infections is poorly understood and there is a lot of conflicting data out there.  Most serious infections tend to occur in people receiving both methotrexate and prednisone or with another biologic agent at the same time.  To be extra cautious I would say, low dose methotrexate (i.e., max 25 mg once weekly) could predispose you to have more infections but the risk is probably very small.  In fact, recent data even suggests that continuing methotrexate during the time around orthopedic surgeries is probably fine.  More data is needed though.  That being said, it’s important to be up-to-date with vaccines and to regularly wash your hands especially during flu season.

7. What do I do if I’m planning to become pregnant?

Methotrexate can cause miscarriages and can cause fetal abnormalities.

You absolutely, cannot be on this medication during pregnancy.

It sticks around your body for a long time.  If you plan to become pregnant, you need to come off the medication 3 months before trying to conceive.  Before making any changes, please discuss with your rheumatologist.  Open communication is key!

8. What does my husband do if we want to have children and he is on methotrexate?

Same as the above.  The rules for men are the same for women.

9. Is breast-feeding safe while taking methotrexate?

No.

10. Does methotrexate cause cancer?

To answer this question, I need to discuss methotrexate dosage.  In rheumatology, we use low doses of methotrexate (i.e., max 25 mg once a week).  When using methotrexate for cancer, we’re talking a dose of at least 500 mg/m².  The doses vary from cancer to cancer but we’re talking massively larger doses than for rheumatoid arthritis.  Increased risk of malignancy caused by methotrexate has been described in people with concurrent Epstein Barr infection and lymphoma as well as MALT (mucosa-associated lymphoid tissue) lymphomas.  Moreover, MALT lymphomas tend to regress when you stop methotrexate.  There actually isn’t any good quality data supporting the theory that low dose methotrexate directly causes solid cancer, skin cancers, or leukemias.

This isn’t to say that you will not develop cancer while taking low dose methotrexate.  It’s just that it probably wasn’t the methotrexate that caused the cancer.

It all boils down to benefit versus risk.  What is the risk of not treating rheumatoid arthritis?  What is the risk of developing a serious side effect from methotrexate?  Does methotrexate have a good chance of halting the progression of rheumatoid arthritis?  The answer to these questions is different for everyone.

What I would say is that the potential benefits of methotrexate more often than not, vastly outweigh the risks.  Again, this is an important discussion you should have with your doctor.

References

Weinblatt ME. Methotrexate in rheumatoid arthritis: a quarter century of development. Trans Am Clin Climatol Assoc. 2013;124:16-25.

Rheumatology Secrets, 3rd edition

Saitoh M, Matsushita K. Prevention of surgical site infection for orthopedic surgery in rheumatoid arthritis. Nihon Rinsho. 2016 Jun;74(6):993-9.

Malaviya AN. Low-dose methotrexate (LD-MTX) in Rheumatology Practice – A widely misunderstood drug. Curr Rheumatol Rev. 2016;12(3):168-176.

Hellgren K, et al. Rheumatoid arthritis and risk of malignant lymphoma- Is the risk still increased? Arthritis Rheumatol. 2016 Dec 19. doi: 10.1002/art.40017.

Diseases and Conditions Supplements

How to read and analyze medical research

January 16, 2017

 

Reading medical journal articles is not considered light reading.  They’re written in a funny sort of way, they have a lot of statistics, and they tend to be devoid of “normal English”.  Sometimes I feel they were actually written for robots as opposed to human beings.  The thing is, evidence-based medicine offers us the most unbiased scientific information out there.  It’s important to note that not all research is unbiased.  A lot of it is!  Knowing how to read, understand, and analyze primary scientific research is paramount.  It’s the difference between getting a story from a friend of a friend, as opposed to actually being in the story.

This week I’d like to invite you to go through the process I use to read through a medical journal so that when someone tells you, “research says”, you can read, understand, and analyze that actual data yourself.

Rheumatoid Arthritis

One of the most common conditions encountered in a rheumatology practice is rheumatoid arthritis (RA).  This is not your typical type of arthritis.  RA is a systemic autoimmune disease that tends to first attack small joints in the hands and feet.  If left untreated, it can spread to other joints, other organs, and can lead to permanent joint destruction.

Rheumatoid arthritis is treated with medications collectively called, disease-modifying agents (DMARDs).  These are medications that change the way the immune system works.  Fight fire with fire.  Simple right?  Problem is, most of these medications have scary potential side effects.  They’re the ones with the commercials ending with, “risks may include nausea, vomiting, hair loss… oh yes and death.  Please consult your physician for further information”.  Oh yes, I totally want that medication.  Don’t get me wrong, these medications have GREATLY improved the health and lives of people suffering from autoimmune diseases.

Increasingly, people have been interested in complementing their prescribed treatment with more natural interventions.  Notice, I said complementing, not replacing.  The CDC actually looked into this and did what they always do… crunch numbers.  They wanted to know what percentage of people suffering from musculoskeletal pain disorders use complementary health approaches.  What they found was that 54.5% of people have a musculoskeletal pain disorder in the US and of these, 24.7% use natural products.  Now, RA only accounts for a small fraction of people suffering from joint diseases but other reports have shown a similar trend in RA sufferers.

So without further adieu…

 

A multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Tong Luo Hua Shi capsule, a modernized Tibetan medicine, in patients with rheumatoid arthritis

Let me put this out there, doctors like to be really descriptive and unoriginal when choosing a title for their article.  So sorry for the never-ending header.

Tong luo hua shi is a modern herbal supplement akin to wu-wei-gan-lu, an herb that has been used in Chinese medicine to treat RA for hundreds of years.  Chinese researchers conducted a multicenter, randomized, double-blind, placebo-controlled, dose-finding trial with tong luo hua shi (TLHS) in people suffering from RA.  This is the type of info you want: multicenter, randomized, double-blind, and you want the study drug to be compared to a placebo.  The researchers are basically trying to decrease bias.

They studied 236 people with RA according to guidelines set by the American College of Rheumatology.  People were excluded if they had another autoimmune conditions, if their RA was very advanced, if they had another severe disease like advanced kidney disease, if they were pregnant – duh, or if they had a psychological disease.  Basically, you want all your participants to be the same, compare apples with apples, and you want the study to be safe.

The participants had to come off their inflammatory meds like ibuprofen but they were allowed to stay on a stable dose of steroids and their DMARD.

The participants were then randomized to the following groups: TLHS 4.8 grams/daily, TLHS 3.6 grams/daily, TLHS 2.4 grams/daily, and placebo.  It’s important to have a placebo group.  Sometimes the placebo can be a fake pill and more often researchers use a medication that is considered standard of care.   When reading an article, you want to make sure that both the researchers and the participants were blinded.  This means that the people doing the research and the people receiving the intervention, did not know who was getting what.  This reduces a considerable amount of bias.

The study lasted 8 weeks.  If they were doing terribly 2 weeks into the study, the treating physician was allowed to prescribe diclofenac (i.e., a powerful anti-inflammatory) and/or leflunomide (i.e., a DMARD).  The baseline characteristics of the participants were similar across all four treatment groups.

This is the beauty of randomization.  It’s essential for treatment groups to be similar.  For example, if the study group had a lot more women, then you could blame whatever outcome because of sex instead of the actual intervention.

What they found was that people who received TLHS 4.8 grams daily did better compared to all groups.  Moreover, the TLHS groups tended to use less diclofenac.  Importantly, there weren’t any serious side effects.  Some insomnia, gastrointestinal intolerance, a minor liver lesion, and a participant in the placebo group experienced some minor liver dysfunction.  Then again, a lot of these people were being exposed to diclofenac and leflunomide, both of which are known to cause liver problems.  So really, who knows what caused what.

Study Evaluation

Study findings

  • TLHS seems to be effective in relieving symptoms caused by rheumatoid arthritis, especially at higher doses.
  • TLHS appears to be safe up to a dose of 4.6 grams daily. More than that, who knows?
  • Pregnancy safety data is not available.

Limitations

  • Participants were allowed to stay on their prior existing DMARD. They never said, which ones exactly.  Were the people receiving the higher dose of TLHS, also receiving a more powerful DMARD than the people who received placebo?  I can see that confusing the picture.
  • The sample size was rather small.
  • The study lasted only 8 weeks. This is VERY short.  RA studies typically last 30+ weeks because the medications typically takes months to take effect.
  • Participants were allowed to have leflunomide and diclofenac added to their treatment plan, two weeks into the study. This is a big no-no for very obvious reasons.  How are you supposed to know what’s causing what?  Typically if participants are doing terribly in a study, they either have to a. white knuckle through, b. opt out of the study, or c. depending on the study design are allowed to crossover to the treatment group if they were on placebo.

Parting Words

Now this is the part where I’m supposed to tell you whether tong luo hua shi is effective in complementing standard rheumatoid arthritis treatment.  But, I’m not going to do that.

I want you to analyze the data yourself.

I want you to think for yourself.

Happy researching and stay safe!

If you want to keep on learning, please subscribe to my mailing list.

References

Clarke TC. Use of complementary health approaches for musculoskeletal pain disorders among adults: United States, 2012. Available at: http://www.cdc.gov/nchs/data/nhsr/nhsr098.pdf. Accessed October 18, 2016

Liu W, et al. A multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Tong Luo Hua Shi capsule, a modernized Tibetan medicine, in patients with rheumatoid arthritis. Trials. 2016 Jul 27;17:359.

Pubmed: https://www.ncbi.nlm.nih.gov/pubmed

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