Effect of vitamin B12 on the symptom severity and psychological profile of fibromyalgia patients; a prospective pre-post study, 2022, Gharibpoor et al

Andy

Andy

Retired committee member
Abstract

Background
Fibromyalgia (FM) as a prototypical nociplastic pain condition displays a difficult therapeutic situation in many cases. Given the promising data on the effect of vitamin B12 in improving pain and cognitive functions in various nociplastic pain conditions, we aimed to determine the efficacy of 1000 mcg daily dose of oral vitamin B12 on the symptom severity and psychological profile of FM patients.

Methods
This open-label, pre-post study was performed on FM patients whose diagnoses were confirmed by a rheumatologist based on the 2016 American College of Rheumatology (ACR). Patients were instructed to take a daily dose of 1000mcg vitamin B12 for fifty days. Outcome measures including the Revised Fibromyalgia Impact Questionnaire (FIQR), Hospital Anxiety and Depression Scale (HADS), 12-item Short-Form health survey (SF-12), and pain Visual Analog Scale (pain-VAS) were fulfilled by patients before and after the treatment.

Results
Of 30 eligible patients, 28 patients completed the study protocol. Patients were female with a mean age of 47.50 ± 8.47 years. FIQR scores in all domains improved significantly after treatment (total FIQR: 49.8 ± 21.86 vs 40.00 ± 18.36, p value < 0.01; function: 13.17 ± 7.33 vs 10.30 ± 5.84, p value: 0.01; overall: 10.32 ± 6.22 vs 8.25 ± 6.22, p value: 0.03; symptoms: 26.30 ± 10.39 vs 21.44 ± 8.58, p value < 0.01). Vitamin B12 also improved anxiety scores from 9.33 ± 4.30 to 7.70 ± 3.60, p value: 0.01. Depression, pain-VAS, and SF-12 didn’t improve following the treatment. The Generalized estimating equations (GEE) analysis showed the improvement in total FIQR score is not cofounded by the improvement of anxiety and patients’ baseline characteristics.

Conclusions
This study showed a short course of sublingual vitamin B12, 1000 mcg daily, significantly improves the severity of FM and anxiety score. We postulate that vitamin B12 has a strong potential to consider, at least, as adjunctive therapy of FM.

Open access, https://bmcrheumatol.biomedcentral.com/articles/10.1186/s41927-022-00282-y
 
Would it have been that much harder to do a double blind study which would give results that could be relied on? At best this can only be regarded as a feasibility study for a meaningful trial.

As someone with ME who also experiences B12 deficiency, please do studies that give unambiguous results.

Note. The authors do seem overconfident in the usefulness of their experimental design, despite their awareness of its limitations:

Our study had some limitations. First, only female patients from one tertiary care center with a relatively small sample size were recruited; thus, the study findings cannot be extrapolated to the general FM population. Secondly, we did not have a placebo arm to compare with the treatment arm. Providing the placebo form of sublingual vitamin B12 similar to the original drug was very difficult. So, we decided the study design be based on the pre-post intervention model. Although the study design is not randomized, the results of this type of study as a quasi-experimental study could still give us a relatively high level of evidence. Thirdly, this study was an open label trial delimiting our results for the interpretation with high confidence. Furthermore, we used vitamin B12 as an adjuvant drug with patients’ current treatment regimen such as FDA-approved FM drugs. It may change or attenuate the effect of vitamin B12 on the outcomes. So, future randomized control trial needs to address this potential confounding factor in evaluating more realized vitamin B12 effect.
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Arnie Pye said:
What on earth is a pre-post study?
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A quick google suggests it's a study without a control group. I guess it just sounds better than non-controlled.

So, complete waste of a study. The whole thing where psychosomatics functions as a jobs program for people who can't do their actual job is really lousy and terrible.

I 'member when peptic ulcers used to be the prototypical psychosomatic disorder. Somehow the entire field of psychosomatics pretends it never happens and the rest of the profession just lets them. What a waste of human potential.
 
Yup, no control group and a massive amount of placebo effect. Which is when it is "open-label." You know what you are taking, it's on the bottle and you can look it up on the internet.

Doesn't lead to any expectation of getting massively better or cured! now would it.

This isn't research.
 
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