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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

Supplements

How to boost joint wellness with turmeric

December 19, 2016

A few years back, my mother-in-law brought me a grocery bag full of supplements.  You heard it, a GROCERY BAG of supplements.  To boot, this was her monthly supply.  Not lifetime, not yearly, her monthly supply.  Every month, she was ingesting a grocery bag full pills for various ailments.  That’s a lot pills.  I was concerned.  First, this must be costing $$$?  But most importantly, she had very little, if any knowledge of what she actually was taking.  What were some of the potential side effects?  Were any these interacting with each other?  Were these interacting with her prescribed medications for diabetes and thyroid disease?

Now, I don’t know about you but the world of supplements is downright daunting.  How do you know whether a supplement works for its intended purpose and is it safe?  There’s so much conflicting data out there.

Today, I’d like to show you how I approach assessing the efficacy and safety of any supplement, medication, or procedure.

I’m going to use turmeric, also known as Curcuma, as an example.  This is a supplement that is rapidly becoming an important player in the world of supplements.  It’s used to treat various different conditions such as osteoarthritis.

 

 

Safety First!

First, here are a few safety tips.  Herbal supplements are regulated by the FDA but they fall under a category called dietary supplements.  When it comes to dietary supplements, manufacturers don’t have to seek FDA approval to put their product on the market.  They don’t even need to prove that their product actually works.  Manufacturers must follow good manufacturing practices to make sure that the supplement is processed consistently and meets quality standards.

For example, they aren’t allowed to cut their product with pesticides and heavy metals.  In the event that they do, the FDA is allowed to take action against the manufacturer or distributor and have the product recalled.  Basically the FDA has to make sure dietary supplements aren’t harming or killing anyone.

High risk situations include: you’re pregnant or breast-feeding, you’re about to have surgery, you’re younger than 18 or older than 65, or you’re already taking other medications.  Herbal supplements may interact with your other medications and these interactions could be harmful or life-threatening.

The following are items that should always be made available on the labels of all herbal supplements:

  • The name of the supplement
  • The name and address of the manufacturer or distributor
  • A complete list of ingredients
  • Serving size, amount, and the active ingredient

 

When in doubt, ask your doctor or your pharmacist.  That’s what they’re there for.  I argue that, you should ALWAYS ask your doctor or pharmacist.

Anything you put in your mouth, whether it be FDA approved, regulated, or not, is considered medicine and has the potential to cause good but also cause harm.

Of note, the FDA regulates American manufacturers and distributors.  If the supplement comes from anywhere else, all bets are off.  Many countries really don’t care whether supplements contain poison.  I’m not saying that their supplements necessarily do contain poison, you just can’t really be sure.  I’ve included a few websites in the reference section, to help you with your research.

The Efficacy of Turmeric Extracts and Curcumin for Alleviating the Symptoms of Joint Arthritis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

Osteoarthritis is super common.  It affects about a quarter of the worldwide population.  There are no known cures.  Well maybe joint replacement but that’s kind of extreme and even then, it’s not a magic bullet.  Turmeric is a spice that has been used in cooking for a really really long time.  Millenia…  This spice has different bioactive components, the most important one being curcumin.

Curcumin is actually really interesting.  It modulates a completely different inflammatory pathway as compared to standard arthritis medications like naproxen, ibuprofen, or celecoxib.  It modifies something called NF-κβ signaling.  This pathway is involved in maintaining normal immunity, but it also has been linked to cancer and other diseases such as heart disease, asthma, inflammatory bowel disease, and osteoarthritis.  Don’t get me wrong, abnormal NF-κβ activity DOES NOT cause cancer or osteoarthritis.  It simply appears to be active when these diseases are present.

Methods

That really long header you just read, is the title of a recent study that sought to look at all prospective randomized clinical studies using turmeric for the treatment of arthritis.  This type of study is a meta-analysis.  The researchers managed to find eight studies: four high quality studies and four moderate quality studies.  The severity of arthritis was determined by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).  This is how bad the arthritis is general, how it limits your quality of life.  Pain was measured with the pain visual analogue score (PVAS).  Thankfully the dose of turmeric was similar across the studies: about 1 gram/day without pain killers and about 500 mg/day with pain killers.

Results

What the researchers found was that people receiving turmeric had lower WOMAC scores compared to placebo.  People receiving turmeric reported improved morning stiffness and overall ability to move.  Moreover, the improvement seen in the turmeric groups were similar to those achieved in ibuprofen and diclofenac groups.  These are standard arthritis medications.  The problem with them is that they can cause stomach problems, they can affect the liver and kidneys, and they should not be used when someone has coronary artery disease or is on blood thinners.  The nice thing about turmeric is that it is not associated with any of these nasty side effects.  At high doses it can cause some diarrhea and it has NOT been studied in pregnant or lactating women.

So basically, the study concluded that turmeric or Curcuma more specifically, at dose of 1000 mg per day can help the decrease arthritis symptoms.  They also mentioned that the sample size (i.e., number of people) of the various studies they included were rather small and some of the studies weren’t top notch quality.

“Therefore, turmeric extracts and curcumin can be cautiously recommended for alleviating the symptoms of arthritis, especially osteoarthritis.”

A few words of caution:

  • Always carefully read the packaging.
  • More is not necessarily better. 8 -12 grams of curcumin can cause diarrhea and can cause anemia.
  • Notify your doctor when you decide to start a new supplement.

Are there other natural supplements that block NF-κβ?

We know that osteoarthritis is exacerbated by the activation of NF-κβ.  So the question is, are there other natural supplements that block NF-κβ?  It turns out, there may be: green tea, rosehip, and resveratrol.  Whether theory translates into clinical efficacy?  Please stay tuned for more!

References

NIH Dietary Supplement Label Database: https://dsld.nlm.nih.gov/dsld/

National Center for Complementary and Integrative Health: https://nccih.nih.gov/

Office of Dietary Supplements: https://ods.od.nih.gov/

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

Daily JM, Yang M, Park S. Efficacy of turmeric extracts and curcumin for alleviating the symptoms of joint arthritis: a systematic review and meta-analysis of randomized clinical trials. J Med Food. 2016 Aug;19(8):717-29.

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