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A Randomised Controlled Trial in the Management of Migraine Headaches

A Randomised Controlled Trial in the Management of Migraine Headaches
Writer and expert2 years ago
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In the largest-ever double-blind randomised controlled trial (the gold standard for medical research) of live bacteria supplements in both chronic and episodic migraine sufferers, dramatic improvements in symptoms have been reported.

The ground-breaking clinical study was published in Cephalalgia, one of the world’s leading headache journals. The trial results showed that a multi-strain live bacteria supplement significantly reduced the frequency and intensity of migraines in those suffering from episodic (<15/month) and chronic (15+/month) migraines compared to the placebo, as well as reducing the reliance on medication in as little as 8 weeks.


100 patients suffering from migraines (50 CM and 50EM) received either a multi-strain live bacteria supplement (14 bacterial strains; 4 billion CFU per day) or a placebo for 8-10 weeks.

  • By the end of the trial, the mean frequency of migraine attacks had significantly decreased in the live bacteria groups compared to placebo; 40% in the EM groupand 45% in the CM group.
  • Migraine intensity was also significantly improved in the live bacteria groups compared to placebo; 29% in the EM and 31% in CM.
  • In addition, the use of abortive medication was greatlyreduced in both live bacteria groups and attack duration was also significantly reduced in the CM live bacteria group.


Dr Katy Munro, headache specialist at the National Migraine Centre said: ‘There is certainly a link between migraine and the functioning of the gut, as many sufferers tell us at the National Migraine Centre about their digestive symptoms. It is an interesting new approach to look at better gut health by the use of probiotics. This small study suggests further research is necessary and we look forward to seeing the results of a larger scale trial.’

Professor Glenn Gibson, professor of food microbiology at the University of Reading, and leading gut health expert said: ‘We are finding out more and more about the role of the gut microbiome in health and disease.

As long ago as the 1800's, Arbuthnott Lane - a Scottish physician, suggested that the gut could be involved in migraine and schizophrenia, these predictions were not taken seriously, at the time, but they are now.

The gut microbiome is central to many disorders which previously we did not feel were linked. Principle among these are cognitive issues with anxiety, depression, autism and dementias all on the research agenda.

This excellent study shows how alteration of the microbiome through a safe and efficacious live bacteria mixture can positively help migraine suffers. This brings such hope to the millions of sufferers in the UK.

Knowing that our gut microbiome can be changed with such interventions is a major area of research with massive clinical implications. I especially liked the mechanistic science that underpinned the research done here.’

Dr Ashton Harper, Medical Director at ADM Protexin Healthcare adds: ‘This ground-breaking trial is the first of its kind to show that an oral live bacterial product is capable of improving multiple aspects of migraine headaches.

These results support exciting research developments in the microbiome-gut-brain axis - the bidirectional communication between the gut and brain - which have identified the fascinating potential of our gut bacteria to influence neurological health and disease.

The single most meaningful result of this current study was the substantial reduction in frequency of migraine attacks for those taking the live bacteria supplement. Although this area of research is relatively novel, and further confirmatory studies are required, it does hold promise for improving multiple symptoms in one of the world’s most disabling illnesses.’

Martami, F., Togha, M., Seifishahpar, M et al The effects of a multispecies probiotic supplement on inflammatory markers and episodic and chronic migraine characteristics: A randomized double-blind controlled trial. Cephalalgia. Jan 2019

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