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.
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.
- 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.
- 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.
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!
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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.