As regular readers know, I’m always on the lookout for “things you can do now.” I’m especially happy then when actual clinical trials happen as we can get some idea of the effectiveness of treatments. About 18 months ago, a paper was published reviewing studies that looked at the use of probiotics in fibromyalgia syndrome (FMS) and chronic fatigue syndrome (CFS). [i] I’ve written before (here and here, for example) about bacterial microbiome changes that have been noted in both illnesses, but have not had much opportunity to write about what can be done about it. Unfortunately, as it turns out, there’s a reason for that.
First a quick review for those unfamiliar: fibromyalgia is a chronic pain disorder of unknown origin. The primary symptoms are body wide muscle pain, morning stiffness, fatigue, sleeping issues and it is more often than not, accompanied by both gastrointestinal symptoms (about 81% of patients report issues) and all too often, depression and anxiety. In fact, a large percentage of those with FMS fit the diagnostic criteria for irritable bowel syndrome. There is tremendous overlap with chronic fatigue, which is also a chronic condition of unknown origin characterized by persistent fatigue, which is the predominant symptom, as opposed to the pain of FMS. That said, both illnesses involve pain and fatigue, and like FMS, CFS is also, more often than not, accompanied by GI symptoms (92% fit the criteria for IBS). CFS too often produces affective issues, including depression and anxiety, and in both illnesses, nervousness, memory loss, confusion are not uncommon.
Some research has shown that those with CFS have intestinal overgrowth of d-lactic acid producing bacteria which, if you remember (from this post of mine awhile back ), often produces cognitive dysfunction and neurological issues. Research published in 2004 showed that small intestinal bacterial overgrowth (SIBO) occurs 100% of the time in those with FMS, compared to 84% of the time in those with IBS and 20% of the time in healthy controls. SIBO is, as you know (from this post), difficult to diagnose accurately and may or may not result in symptoms, as shown yet again by the fact that 20% of healthy controls in this study are asymptomatic. However, this does give a good picture of the relationship of biome alterations to the disease, FMS. It makes sense then that probiotics might help those suffering from these illnesses.
The researchers in this review study looked for randomized controlled clinical trials and pilot studies using probiotics in humans with FMS or CFS performed in the previous 10 years, so between 2006 and 2016. While originally coming up with 537 articles on CFS and FMS using their search terms, they ended up with a whopping 2 that actually met the necessary criteria to be included. These were both 8 week long studies on adults, randomized and double-blinded. Neither study looked at FMS at all, only CFS. One had 35 participants, the other 48.
The first study found that Lactobacillus casei (Shirota strain, such as is found in Yakult) had beneficial effect on anxiety but not depression) in those with CFS. This, by the way, completely coincides with the research I wrote about in the past, on stress and anxiety and probiotics. The second study used B. infantis, and the scientists found that treatment led to decreased inflammatory markers, including C-reactive protein (CRP), tumor necrosis factor alpha and interleukin-6. (I’ve also written in the past about B. infantis and its ability to reduce inflammation resulting from stress.)
The researchers conclude the obvious: “The available research concerning the potential usefulness of probiotic treatment for FMS or CFS is limited.” (Ya think?) “Nevertheless, it seems, from the results of the two studies review here…that some probiotic strains might improve the symptoms of anxiety and inflammation in these populations.” They go on to point out that neither study actually focused on fatigue…the core symptom of CFS. Other studies, not included in their review because they did not meet the necessary criteria, have also not demonstrated improvements in fatigue. For example, one trial tested several Lactobacillus and Bifido species on 15 CFS patients, and while improvements in short-term memory and concentration were noted, there were no significant benefits in health. Another study done on those with spondyloarthritis (Ankylosing, psoriatic, etc.) with a combination of B.lactis, L.acidophilus and a strain of Streptococcus, also showed no improvement in fatigue.
Toward the end of the paper, the researchers note that new clinical trials may help further research into this area, including “…the one that Roman and colleagues are performing from 2017.”
So, I had a look and indeed, found this trial which is now published.[ii] This was an 8 week long double-blind, placebo-controlled, randomized trial of a multi-species probiotic on 40 patients with FMS (although only 31 ended up finishing). The scientists looked at cognition, emotional symptoms, quality of life, anxiety and depression: “Our results indicated that probiotics improved impulsivity and decision-making in these patients.” There were no statistical differences between the placebo and the treatment group in self-reported symptoms of FMS, including physical function, depression and anxiety: “Expectation of symptom improvement could be the primary factor underlying this ‘placebo effect.'” The only statistically significant improvement in the treatment group was in cognitive performance.
There was, by the way, a major drawback in this study, as I see it. Diet was not accounted for, meaning that probiotic containing foods like yogurt were not prohibited in the control group. That surprised me as it really could potentially explain the lack of statistical significance in results from the treatment and placebo groups – which these authors acknowledge. Seems to me that this is poor study design…but what do I know.
For those interested, this is the probiotic used in the study, which seems to be low potency (only 6 million units) containing the following strains, Lactobacillus rhamnosus GG ATCC 53103, Lactobacillus paracasei LMG P-21380, Lactobacillus acidophilus DSM 21717, Bifidobacterium bifidum DSM 22892. The subjects took 2 pills at least 30 minutes before breakfast and 2 pills at least 30 minutes before dinner. I do not know why they selected this particular probiotic, and not one including the strains in the 2 studies mentioned above.
So to conclude: we know basically nothing about how probiotics may or may not be used to treat either CFS or FMS. For the moment, we are on our own.
[i] Roman, P, Carrillo-Trabalon, F, Sanchez-Labraca, N, Canadas, F, Estevez, AF, Cardona, D. Are probiotic treatments useful on fibromyalgia syndrome or chronic fatigue syndrome patients? A systematic review. Beneficial Microbes. 2018:9(4);603-611. doi: 10.3920/BM2017.0125
[ii] Roman, P, Estevez, A, Miras, A, Sanchez-Labraca, N, Canadas, F, Vivas, AB, Cardona, D. A pilot randomized controlled trial to explore cognitive and emotional effects of probiotics in fibromyalgia. Scientific Reports. 2018;8(1). DOI: 10.1038/s41598-018-29388-5