Dietary supplementation in Sjögren’s Syndrome -  Proposed UK Study 

 

 

CSSA Meeting, Community Room, Tesco, Bar Hill, Nr Cambridge

11am-1pm, 13 November 2018

 

 

-CSSA (Sjogrens Cambrisgeshire)  group now at 50 members

-aim to include article on PLRH & study in next BSSA newsletter (January 2018)

-Dr Frances Hall, Dr Natasha Jordan, Dr James Grey – rheumatologists with Sjögren’s interest at Addenbrooke’s Hospital, Cambridge, UK.

 

 

Study Outline:

  • Internet-based: website, smartphone, tablet
    • Include postal and telephone service for patients without email/internet access

 

  • Patients register own profile on secure website

 

  • Patients answer an initial survey about themselves
    • Study Team will decide what questions to ask, for example:
      • symptoms, medications, supplements, past experience (benefit/side effects), allergies, monthly/seasonal fluctuation in symptoms, specific environmental concerns, exercise, Primary vs. Secondary Sjögren’s Syndrome diagnosis, other disease diagnosis, etc
    • Patients will need to update their profile with any changes to medication (e.g. “combi meds” dependent on season), or change in routine that may affect treatment
    • Researchers will be able to see if a supplement works better/worse for patients with specific diagnosis, other diagnosis, medication, etc
    • All data is anonymised, so researchers will not have access to any personal or identifiable patient information (e.g. ‘patient 1’ received ‘treatment A’; researchers will be able to review ‘patient 1’ survey answers but will not be able to identify who the patient is)

 

  • Once patients complete their profile and survey, they will receive information on the study and supplements
    • Paper, pictures, videos available to ensure all patients understand the study
    • Contact details of the researchers will be provided for any further questions

 

  • Patients agree to participate in the study (provide “informed consent”) online or via telephone

 

  • Patient is assigned to one treatment (they will not know which one)

 

  • Capsules are shipped to patient’s personal address; patients request more as needed

 

  • Patients complete monthly questionnaires (can possibly make these more frequent) to assess how they are feeling, and how much eye/saliva substitution products they are using

 

  • Patients take supplements for 12 months

 

  • Researchers analyse the data and compose a scientific report

 

  • Results can be shared through CSSA, BSSA networks (including Facebook, etc)

 

 

Potential interventions:

  1. Omega 3 
  2. Vitamin D 
  3. Turmeric, Omega 7, Cannabis Oil, Boswellic Acid (Laura will look into these)
  4. Placebo 

 

  • Medical and academic experts will have final decision on which supplements are included, and how much the daily dose is. All supplements must already be proven to be safe, and available without prescription. 
  • Information on each supplement and the importance of the placebo will be made clear on the website. 

 

 

Outcomes:

  • Patients will be asked to report how they have felt, on average, for the preceding month
    • Symptoms to include: dry eyes, dry mouth, dysphasia (trouble speaking), cough, muscle pain, fatigue, digestion, itchy skin, brain fog, exhaustion (‘brick wall’), etc
    • Patients can rate each symptom individually (score 0-10), and also general quality of life

 

  • Patients will also be asked how much eye/saliva products they have used in the month (i.e if they feel the same but are using less product, this may also indicate that the supplement is helping)

 

  • Standardised questionnaires may also be used (e.g. Sjögren's Syndrome Inventory, Profile of Fatigue & Discomfort, Sjögren's Syndrome Clinical Activity Index, Sjögren's Syndrome Damage Index)

 

  • We will consider home-tests where patients can test saliva or tear production at home, and update the website with their results

 

 

Funding: 

  • BSSA annual research funding of £30 000, to apply May/June 2018
  • ‘Research for Patient Benefit’ funding from National Institute for Health Research

 

  • We will need to fund (for example):
    • Website/smartphone design (PLRH has already applied for a technology grant that could help with this)
    • Purchase supplements and placebo
    • Shipping costs to send capsules to patients
    • Salary for researchers (PLRH has already applied for funding for a 6 month placement for a PhD student, but we would need to extend this) 

 

 

Next steps:

  1. Refine the study design and survey
  2. Contact the BSSA to see if they are interested in supporting the project 
  3. Create an initial survey to send to BSSA members, to see if the wider patient population would be interested in participating
  4. Form a working group to further develop the study (ideally with 6-10 patients)
  5. Formally contact rheumatologists (e.g. Natasha Jordan & Frances Hall) for their advice and support
  6. Submit study to University of Cambridge ethics committee for advice
  7. Apply for funding 
  8. Develop website
  9. Advertise widely to UK or EU Sjögren’s Syndrome patients
  10. Initiate study