Friday, June 12, 2020

Fibromyalgia at the EULAR 2020 Meeting Online


I have selected a few studies, which were presented at the 2EULAR 2020 Meeting, which has been online because of Covid-19.

The first study has been by B. Kundakci and colleagues [1]: THU0461 THE COMPARATIVE EFFICACY OF NON-PHARMACOLOGICAL INTERVENTIONS FOR FIBROMYALGIA: A SYSTEMATIC REVIEW WITH BAYESIAN NETWORK META-ANALYSIS“.The authors looked at 78 studies (n = 5,639 participants). Multidisciplinary treatment was the best for improving pain, sleep and depression, balneotherapy and exercise were the most effective treatments for FIQ and fatigue. Allow me to intervene, as one doesn't treat the Fibromyalgia Impact Questionnair, but nevertheless one can see improvement in the score of this questionnaire. 47 exercise trials (n = 3,271 participants) were also analysed. Strengthening showed the greatest benefits for FIQ, pain and depression, whereas aerobic exercise was the best for fatigue and sleep. As the effect size tvaries between interventions and outcomes, the authors conclude, that „the results of this study may be used to guide the selection of the most effective non-pharmacological interventions according to the predominant symptom in individual patients.“ Though the approach with comparing effect sizes is a good idea, I doubt that this will happen in real life.

My next selection is the study by L. López-Núñez and colleagues [2]: THU0462 CHARACTERIZATION OF PATIENTS WITH FIBROMYALGIA AFFECTS WITH OR WITHOUT JOINT HYPERLAXITY SYNDROME“. If you have read more on my blog you know about my long lasting interests in hyperlaxity or the benign hypermobility syndrome. In their conclusion the authors point out: „Our work revealed that FM patients with JHS are different from FM without JHS, by manifesting differences in certain clinical, anthropometric, and bone metabolism features.“ The Body Mass Index and Muscle Mass were less in the FM-JHS group. The FM-JHS group also had less bone mineral density (BMD) at total hip DXA, which might be due to the lesser weight. So the study gives interesting data, but implications on treatment are not emminent.

The next study is by S. A. A. Tabra and colleagues [3]: „THU0471 VITAMIN D SUPPLEMENTATION; IS IT EFFECTIVE IN FIBROMYALGIA PATIENTS?“ 100 adult patients of primary FMS (according to the 2010 ACR criteria for FMS) associated with vitamin D insufficiency (21-29 ng/mL) took part in this interventional double-blinded study. 21-29 ng/ml is just below normal and after six months the vitamin D group had a level of just above the lower limit (36.8 +/- 3.9 ng/ml). May this be as it is, there have been differences in the results between the vitamin D group and the placebo group. Gth authors concluded, that „Vitamin D supplement is effective as an adjuvant therapy in improving functional status, quality of life and psychological status in fibromyalgia patients with vitamin D insufficiency.“ Please repeat the study with a higher level of vitamin D as a goal.

A. Negm and J. Alsaleh presented [4]: THU0484 FIBROMYALGIA AND MULTIPLE SWITCHING OF BIOLOGICS IN SPONDYLOARTHRITIS“. The authors looked at 305 patients; but there were only 43 patients with coexisting fibromyalgia. They concluded: „FM coexistence with SpA might impact clinical evaluation of disease activity and possibly negatively affect self-measurement of treatment response. In our study, SPA patients exposed to more biologics if they have coexisting FM; Moreover, they are more frequent switchers among biologics including TNFi and IL17i.“ The study shows that our tools to make treatment decisions in spondyloarthopathies are too inaccurate if it comes to concomitant fibromyalgia.

A. Gomez-Centeno and colleagues presented the folloeing study [5]: AB0952 COENZYME Q10, TRYPTOPHAN AND MAGNESIUM: A NUTRITIONAL SUPPLEMENT IN THE TREATMENT OF FIBROMYALGIA SYMPTOMS“. I don't know if I should already start to whince. The authors studied 23 patients, whereof 3 dropped out. They found an improvement, but: „no statistically significant differences were found among the studied variables.“ If the statistics do not support your hypothesis, it is premature to draw conclusions. Conduct a study of a larger number of patients and do so for at least half a year. My educated guess is that you won't find statically significant differences.

A. Keskin and colleagues asked [6]: AB0954 IS CONNECTIVE TISSUE MASSAGE EFFECTIVE IN INDIVIDUALS WITH FIBROMYALGIA?“ They concluded: „According to our results, connective tissue massage has been shown to be effective in reducing the number of painful areas in addition to the positive effects of clinical pilates exercises in individuals with FM. In order to increase the effectiveness of treatment in individuals with FM, we recommend the use of connective tissue massage as an additional treatment method.“ The authors compared an interventional group of N=15 to a control group of N=17. And they found no statistically significant differences in the Fibromyalgia Impact Questionnare (FIQ), the Health Assessment Questionnare (HAQ), the Beck Anxiety Inventory (BAI), the Short Form-36 (SF-36) and the Cognitive Exercise Therapy Approach (BETY) Scale; there has been a difference in the Pain Location Inventory (p=0.023). This is cherry picking and not science. The authors should have formulated a hypothesis and an endpoint.

A. Moshrif and colleagues presented a study on vertical nail ridging [7]: AB0956 VERTICAL NAIL RIDGING IN PATIENTS WITH FIBROMYALGIA: FREQUENCY, PROPOSED GRADING AND CORRELATION WITH OTHER DISEASE FEATURES.“ The authors concluded: „vertical nail ridging is a frequent finding and can be considered helpful for diagnosis of patients with FM.“ The authors found 98.6% vertical nail ridging in the fibromyalgia group, and they found vertical nail ridging in 76.2% of the control group. If vertical nail ridging is related to stressful conditions, why not look there in the first place? Of what use is a test, if the control group shows the same sign in a high proportion of patients? Maybe the next study shows a correlation between number of freckles in red haired fibromyalgia patients and the development of the FIQ score in the next six months. And please look for a study on vertical nail ridging on PubMed; there is none. The reference in the study [8] is a talk, which has been held in 2007, concerning vertical nail ridging it says: „Another stress-related nail habit that Dr. Mayoral discussed is people who rub their fingers over their thumb nail, which can create a ridge across the nail. This rubbing causes a distortion of the nail plate, and when the nail grows, a raised ridge forms in the middle of the nail.“ I guess looking for vertical nail ridging won't make it into the ACR Fibromyalgia Criteria.

M. Giovale and colleagues presented the following study [9]: „LOW-ENERGY PULSED ELECTROMAGNETIC FIELD THERAPY REDUCES PAIN IN FIBROMYALGIA: A RANDOMIZED SINGLE-BLIND CONTROLLED PILOT STUDY.“ 21 women with fibromyalgia were evaluated in TWO groups, one receiving active treatment under single-blinded condition. Makes me whince again. „In all endpoints, we observed a general reduction at T4 and T8 compared to T0 also for FIQ, VAS pain, SS, SF-36, regardless of the treatment arm and the decrease was higher in the active treatment arm compared to the placebo group, albeit not reaching statistical significance.“ I haven't found the definition of an endpoint. The authors concluded: „The results of our pilot study show that PEMF is more effective than placebo in reducing widespread pain in fibromyalgia while confirming that a placebo effect is clear in this complex disease.“ No, that is what the sponsor of the study likes to hear. The study showed no statistically significant difference between the two groups.

Hoping for better studies in future meetings concernig fibromyalgia.


References:
[1] Kundakci B, Kaur J, Shim SR, et al: THU0461 THE COMPARATIVE EFFICACY OF NON-PHARMACOLOGICAL INTERVENTIONS FOR FIBROMYALGIA: A SYSTEMATIC REVIEW WITH BAYESIAN NETWORK META-ANALYSIS. Annals of the Rheumatic Diseases 2020;79:463-464. http://dx.doi.org/10.1136/annrheumdis-2020-eular.803
[2] López-Núñez L, Blanch J, Ciria Recasens M, et al: THU0462 CHARACTERIZATION OF PATIENTS WITH FIBROMYALGIA AFFECTS WITH OR WITHOUT JOINT HYPERLAXITY SYNDROME. Annals of the Rheumatic Diseases 2020;79:464. http://dx.doi.org/10.1136/annrheumdis-2020-eular.4115
[3] Tabra SAA, Abu-Zaid MH, Hablas S: THU0471 VITAMIN D SUPPLEMENTATION; IS IT EFFECTIVE IN FIBROMYALGIA PATIENTS? Annals of the Rheumatic Diseases 2020;79:468-469. http://dx.doi.org/10.1136/annrheumdis-2020-eular.487
[4] Negm A, Alsaleh J: THU0484 FIBROMYALGIA AND MULTIPLE SWITCHING OF BIOLOGICS IN SPONDYLOARTHRITIS. Annals of the Rheumatic Diseases 2020;79:475-476. http://dx.doi.org/10.1136/annrheumdis-2020-eular.6224
[5] Gomez-Centeno A, Ramentol M, Gonzalez MJ, et al: AB0952 COENZYME Q10, TRYPTOPHAN AND MAGNESIUM: A NUTRITIONAL SUPPLEMENT IN THE TREATMENT OF FIBROMYALGIA SYMPTOMS. Annals of the Rheumatic Diseases 2020;79:1769-1770. http://dx.doi.org/10.1136/annrheumdis-2020-eular.5531
[6] Keskin A, Basakci Calik B, Gur Kabul E, et al: AB0954 IS CONNECTIVE TISSUE MASSAGE EFFECTIVE IN INDIVIDUALS WITH FIBROMYALGIA? Annals of the Rheumatic Diseases 2020;79:1770-1771. http://dx.doi.org/10.1136/annrheumdis-2020-eular.6316
[7] Moshrif A, Abdelkareem M, Moneer M, et al: AB0956 VERTICAL NAIL RIDGING IN PATIENTS WITH FIBROMYALGIA: FREQUENCY, PROPOSED GRADING AND CORRELATION WITH OTHER DISEASE FEATURES. Annals of the Rheumatic Diseases 2020;79:1771. http://dx.doi.org/10.1136/annrheumdis-2020-eular.5317
[8] American Academy of Dermatology. (2007, November 12). Feeling Stressed? How Your Skin, Hair And Nails Can Show It. Science Daily. Retrieved December 30, 2019 from www.sciencedaily.com/releases/2007/11/071109194053.htm
[9] Giovale M, Novelli L, Rampoldi S, et al: AB0958 LOW-ENERGY PULSED ELECTROMAGNETIC FIELD THERAPY REDUCES PAIN IN FIBROMYALGIA: A RANDOMIZED SINGLE-BLIND CONTROLLED PILOT STUDY. Annals of the Rheumatic Diseases 2020;79:1772. http://dx.doi.org/10.1136/annrheumdis-2020-eular.6409

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