Category: Archive

Can coffee really be good for you?

As you see we are trying to post less often on the blog so that you have more time to read and discuss the posts. The following blog post is a bit of a cheat as I have reviewed three papers. However, they are all related to coffee and are relevant to pwMS and their families.


Are you addicted to coffee? If you are, don’t worry, the latest research suggests it may be good for you. However, if you have urinary symptoms, anxiety, tremor or sleep problems there may be a downside. 






The good news is that coffee consumption seems safe. The study published last week in the BMJ indicates a reduction in the risk of various health outcomes at three to four cups a day. These results don’t necessarily mean that coffee consumption is causal; i.e. in itself responsible for the reduction. Coffee drinkers may be different to non-coffee drinkers and this rather than the coffee per se may be the reason for the reduction in risk. The evidence suggests that coffee could be tested as an intervention without significant risk of causing harm in the disease studied. This analysis did not cover MS. Maybe MS is too uncommon to have been noticed by this research group? 


However, a Swedish study has looked at coffee consumption and MS risk. If you are a coffee drinker it appears you reduce your risks of getting MS by ~30% compared to non-coffee drinkers. Again is this simply an association or causation? Is there something that coffee-drinkers do those non-coffee drinkers don’t that protects them from getting MS (association)? Or, do the genetic factors that increase your risk of getting MS simply increase your affinity for coffee, and your chances of becoming addicted to coffee (association)? Or is there something in coffee that alters the immune system and reduces your risk of getting MS (causation)? If the observation is causal what is it in coffee that reduces your chances of getting MS? Could it be caffeine? If it is caffeine then other caffeinated drinks should also reduce your risks of getting MS; e.g. tea, energy drinks, cola, etc. Apart from being a stimulant, we know that caffeine has many biological effects including immunological and neuroprotective effects.


Coffee not only reduces your chances of getting MS but is protective for Parkinson’s and Alzheimer’s disease as well. The latter observations alone make it worthwhile taking up the habit. Which is the reason I give for my habit of drinking 6-8 espresso shots per day. Did you know that on a global level caffeine is the most prevalent human addiction? Could coffee be another lifestyle factor to take into account when optimising your brain health? 


There are downsides to caffeine if you have MS. Too much can make anxiety worse and could exacerbate tremor. If you take too much caffeine, particularly late in the day, it can cause insomnia. This is why I have my last coffee no later than ~3pm. Caffeine is also a mild diuretic and causes increased urine production (see paper 3 below). This may exacerbate bladder problems. I have many patients who report that just one coffee affects their bladder function (urinary urgency and frequency).

How much coffee do you have? Does it help you? 


Coffee and general health:


Poole et al. Coffee consumption and health: umbrella review of meta-analyses of multiple health outcomes. BMJ 2017;359:j5024.


Objectives: To evaluate the existing evidence for associations between coffee consumption and multiple health outcomes.


Design: Umbrella review of the evidence across meta-analyses of observational and interventional studies of coffee consumption and any health outcome.


Data sources: PubMed, Embase, CINAHL, Cochrane Database of Systematic Reviews, and screening of references.


Eligibility criteria for selecting studies: Meta-analyses of both observational and interventional studies that examined the associations between coffee consumption and any health outcome in any adult population in all countries and all settings. Studies of genetic polymorphisms for coffee metabolism were excluded.


Results: The umbrella review identified 201 meta-analyses of observational research with 67 unique health outcomes and 17 meta-analyses of interventional research with nine unique outcomes. Coffee consumption was more often associated with benefit than harm for a range of health outcomes across exposures including high versus low, any versus none, and one extra cup a day. There was evidence of a non-linear association between consumption and some outcomes, with summary estimates indicating largest relative risk reduction at intakes of three to four cups a day versus none, including all cause mortality (relative risk 0.83, 95% confidence interval 0.83 to 0.88), cardiovascular mortality (0.81, 0.72 to 0.90), and cardiovascular disease (0.85, 0.80 to 0.90). High versus low consumption was associated with an 18% lower risk of incident cancer (0.82, 0.74 to 0.89). Consumption was also associated with a lower risk of several specific cancers and neurological, metabolic, and liver conditions. Harmful associations were largely nullified by adequate adjustment for smoking, except in pregnancy, where high versus low/no consumption was associated with low birth weight (odds ratio 1.31, 95% confidence interval 1.03 to 1.67), preterm birth in the first (1.22, 1.00 to 1.49) and second (1.12, 1.02 to 1.22) trimester, and pregnancy loss (1.46, 1.06 to 1.99). There was also an association between coffee drinking and risk of fracture in women but not in men.


Conclusion: Coffee consumption seems generally safe within usual levels of intake, with summary estimates indicating largest risk reduction for various health outcomes at three to four cups a day, and more likely to benefit health than harm. Robust randomised controlled trials are needed to understand whether the observed associations are causal. Importantly, outside of pregnancy, existing evidence suggests that coffee could be tested as an intervention without significant risk of causing harm. Women at increased risk of fracture should possibly be excluded.


Coffee and MS Risk:


Hedström et al. High consumption of coffee is associated with decreased multiple sclerosis risk; results from two independent studies. J Neurol Neurosurg Psychiatry doi:10.1136/jnnp-2015-312176


Objective: Previous studies on consumption of caffeine and risk of multiple sclerosis (MS) have yielded inconclusive results. We aimed to investigate whether consumption of coffee is associated with risk of MS.


Methods: Using two population-representative case–control studies (a Swedish study comprising 1620 cases and 2788 controls, and a US study comprising 1159 cases and 1172 controls), participants with different habits of coffee consumption based on retrospective data collection were compared regarding risk of MS, by calculating ORs with 95% CIs. Logistic regression models were adjusted for a broad range of potential confounding factors.


Results: Compared with those who reported no coffee consumption, the risk of MS was substantially reduced among those who reported a high consumption of coffee exceeding 900 mL daily (OR 0.70 (95% CI 0.49 to 0.99) in the Swedish study, and OR 0.69 (95% CI 0.50 to 0.96) in the US study). Lower odds of MS with increasing consumption of coffee were observed, regardless of whether coffee consumption at disease onset or 5 or 10 years prior to disease onset was considered.
Conclusions: In accordance with studies in animal models of MS, high consumption of coffee may decrease the risk of developing MS. Caffeine, one component of coffee, has neuroprotective properties, and has been shown to suppress the production of proinflammatory cytokines, which may be mechanisms underlying the observed association. However, further investigations are needed to determine whether exposure to caffeine underlies the observed association and, if so, to evaluate its mechanisms of action.

Caffeine and urinary symptoms:

Bradley et al. Evidence of the Impact of Diet, Fluid Intake, Caffeine, Alcohol and Tobacco on Lower Urinary Tract Symptoms: A Systematic Review. J Urol. 2017 Nov;198(5):1010-1020.


PURPOSE: Diet, fluid intake and caffeine, alcohol and tobacco use may have effects on lower urinary tract symptoms. Constructive changes in these modifiable nonurological factors are suggested to improve lower urinary tract symptoms. To better understand the relationship between nonurological factors and lower urinary tract symptoms, we performed a systematic literature review to examine, grade and summarize reported associations between lower urinary tract symptoms and diet, fluid intake and caffeine, tobacco and alcohol use.


MATERIALS AND METHODS: We performed PubMed® searches for eligible articles providing evidence on associations between 1 or more nonurological factors and lower urinary tract symptoms. A modified Oxford scale was used to grade the evidence.


RESULTS: We reviewed 111 articles addressing diet (28 studies), fluid intake (21) and caffeine (21), alcohol (26) and tobacco use (44). The evidence grade was generally low (6% level 1, 24% level 2, 11% level 3 and 59% level 4). Fluid intake and caffeine use were associated with urinary frequency and urgency in men and women. Modest alcohol use was associated with decreased likelihood of benign prostatic hyperplasia diagnosis and reduced lower urinary tract symptoms in men. Associations between lower urinary tract symptoms and ingestion of certain foods and tobacco were inconsistent.


CONCLUSIONS: Evidence of associations between lower urinary tract symptoms and diet, fluid intake and caffeine, alcohol and tobacco use is sparse and mostly observational. However, there is evidence of associations between an increased fluid and caffeine intake and urinary frequency/urgency, and between modest alcohol intake and decreased benign prostatic hyperplasia diagnosis and lower urinary tract symptoms. Given the importance of these nonurological factors in daily life, and their perceived impact on lower urinary tract symptoms, higher quality evidence is needed.

Training the next generation of UK’s MSologists

Tony Blair is famously quoted as saying ‘Education, education, education, …’ and putting education at the centre of New Labour’s manifesto in 1997. However, is it the type or the quality of education that makes the difference and changes the world?






We are trying to change the world of MS treatment.



I have learned that information in itself may pique attention, but it rarely changes behaviour.

I have been very impressed by the feedback we have had from our initial two MS Academies. Healthcare delegates participate in a 3-day course. They then go to a research or service development project or even an audit in relation to MS. The act of going away and doing something active makes delegates think about their MS practice and consider the service(s) they provide for their patients with MS. In other words, the doing induces a change in behaviour and complements the educational element of the course in changing behaviour.

Doing makes a difference!

If you are interested in joining the MS Academy and attending an MS Masterclass please register your interest via the MS Academy website. Please note these courses are open to non-UK clinicians and having HCPs from other countries helps NHS employees. After all aren’t we still European, or even better citizens of the world?




CoI: At present, the Neurology Academy is supported by an unrestricted educational grant from Biogen. Biogen has no input into the design and running of the Academy that is based on the very influential Parkinson’s Disease Academy, which has been running for more than a decade. We are also looking for additional sponsors.  

Have you been involved in shared-decision making?

A recent study published in the British Medical Journal (BMJ) proposes a simple three talk model for shared-decision making in the clinic. 


Have you been involved in a shared-decision making process, or have you simply been told what is best for you? 


Please have your say.




My problem is that in reality, very few MSologists practise shared-decision making. They tend to pay lip service to it. For example, I recently co-chaired a teaching course during which we discussed several case scenarios. The objective was to select an appropriate DMT for the cases presented. The problem is that none of the patients were in the room, so how could we engage them in shared-decision making? In other words, you make a decision for the patient and then you encourage them to agree with you. This is called paternalism. 


The model is simple enough and should be easy to implement:
  1. Team Talk: Let’s work as a team to make a decision that suits you best.
  2. Option Talk: Let’s compare the possible options.
  3. Decision Talk: Tell me what matters most to you for this decision.


Elwyn et al. A three-talk model for shared decision making: multistage consultation process. BMJ 2017;359:j4891


Objectives: To revise an existing three-talk model for learning how to achieve shared decision making, and to consult with relevant stakeholders to update and obtain wider engagement.


Design: Multistage consultation process.


Setting: Key informant group, communities of interest, and survey of clinical specialities.


Participants: 19 key informants, 153 member responses from multiple communities of interest, and 316 responses to an online survey from medically qualified clinicians from six specialities.


Results: After extended consultation over three iterations, we revised the three-talk model by making changes to one talk category, adding the need to elicit patient goals, providing a clear set of tasks for each talk category, and adding suggested scripts to illustrate each step. A new three-talk model of shared decision making is proposed, based on “team talk,” “option talk,” and “decision talk,” to depict a process of collaboration and deliberation. Team talk places emphasis on the need to provide support to patients when they are made aware of choices, and to elicit their goals as a means of guiding decision-making processes. Option talk refers to the task of comparing alternatives, using risk communication principles. Decision talk refers to the task of arriving at decisions that reflect the informed preferences of patients, guided by the experience and expertise of health professionals.


Conclusions: The revised three-talk model of shared decision making depicts conversational steps, initiated by providing support when introducing options, followed by strategies to compare and discuss trade-offs, before deliberation based on informed preferences.

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Latest natalizumab PML risk update

The latest PML risk figures from Biogen. If you are on natalizumab and are JCV seropositive this post is for you.


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Ocrelizumab news: finally two eagles have landed

Landmark decision by the CHMP; ocrelizumab gets licensed for both relapsing and primary progressive MS.






 For all those pwPPMS who have been waiting for a treatment for their disease. Your wait is almost over. After many anxious months, and against the opinion of many naysayers, the CHMP (Committe for Medicinal Products for Human Use) have greenlighted ocrelizumab for the treatment of PPMS in Europe. It is not quite the liberal license of other countries, but it is a start. 


“Ocrevus is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis
(RMS) with active disease defined by clinical or imaging features (see section 5.1). 


Ocrevus is indicated for the treatment of adult patients with early primary progressive multiple
sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features
characteristic of inflammatory activity (see section 5.1).”

 The question I have for Roche is will they take up our #ThinkHand challenge and do a trial in people with more advanced MS, i.e. those who are in wheelchairs? 

 I personally would like to thank all the pwMS who participated in both the relapsing (Opera 1 & 2) and primary progressive (Oratorio) trials; without you we wouldn’t have gotten here. Progressive MS is now a tractable problem, what we now need is combination therapy trials. 



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Will Biogen walk-the-talk and do another natalizumab SPMS trial?

At #MSParis207 I presented a new analysis of the data of the ASCEND trial (natalizumab in SPMS) that shows natalizumab is very effective in protecting upper limb function, and to a lesser extent lower limb function, in people with more advanced MS (majority needing walking aids). 




Will Biogen learn from this analysis and do an ASCEND-2 trial? If they cared about people with more advanced MS they would do this study. I also anticipate that in the future PML will not be a problem; we will have antivirals that will clear the body of JCV and the risk of PML as a complication of natalizumab treatment will become very, very, low. The latter is another reason for doing this study.

YouTube Webinar:
SlideShare slides: 
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Guest post: will the COMBAT-MS study disrupt the MS market?

You may be aware that people living with MS in resource-poor environments are often not treated with disease-modifying therapies. To address this we have been promoting a Barts-MS Essential Off-label list of DMTs. The problem with this list is that it is often not backed by a so-called ‘class 1 evidence’. 

 To address this lack of evidence, trials such as COMBAT-MS are being performed to provide data from real-life practice to support off-label prescribing. We are therefore privileged to have a guest post from the team running the COMBAT-MS trial explaining what the trial is about.




COMBAT-MS STUDY


We keep getting at least one new approved MS disease-modifying drug per year. You might think this would help tailor therapy to individual needs. Unfortunately, this doesn’t really seem to be the case. Patients are switching therapies now more than ever. MS experts can’t seem to agree which drug is the best even for the same types of patients. Treatment practices vary widely, not only across countries but all the way down to regions, clinics and even individual doctors. Perhaps the most important cause of these wide variations in care is the lack of long-term real-world data. 


Loads of money has been invested into randomized clinical trials and they are really important. However, randomized controlled trials don’t give the whole picture. These trials are conducted over a relatively short period of time, in mostly treatment-naive patients who are otherwise healthy and do not want to get pregnant. The drugs are usually compared only to placebo rather than to the other drugs patients have to choose from. These studies also do not consider patient-reported outcomes like quality of life. 

 In the real world, many patients don’t fit this picture. They may have tried other therapies before, have health issues other than MS, want to get pregnant soon and/or (of course) value the impact the drug may have on their quality of life (QoL). Short of a cure, they desire a highly effective treatment, that is reasonably safe and well-tolerated even if they need to take it for decades. Unfortunately, we can´t rely on the pharmaceutical industry to support us in answering these questions. And academic registry-based studies have inherent weaknesses that prevent them from satisfactorily addressing these issues. 

Aside from a prohibitively expense and complex randomized controlled trial, is there a middle way? Yes, perhaps. The US federally-funded Patient-Centered Outcomes Research Institute (PCORI) last year gave a big award to a US-Swedish initiative for a hybrid study between a traditional retrospective cohort and a structured, prospective cohort study. Sweden has a nationwide MS registry which includes >90% of patients and nearly complete information on MS drugs used, physical disability outcomes and the ability to link to national health registries to detect major safety signals. However, much of the other key variables like patient-reported outcomes and MRI data have over 20% missing data, which would make effects of treatments on these outcomes difficult to interpret. Therefore, a prospective trial (COMBAT-MS; clinicaltrials.gov NCT03193866) has recently launched. 

We aim to recruit up to 3,700 MS patients at all of Sweden´s seven university clinics (serving about 50% of the total population) who are starting their first MS therapy or switching therapies. By doing the same structured follow-ups with annual disability scorings, MRIs and patient-reported QoL outcomes the study will generate high quality, real-world long-term efficacy outcomes. This will help us sort out which drugs work or don’t work so well in real-world MS patients. To address safety concerns, we will obtain data from Swedish national healthcare registries, as well as from Kaiser Permanente Southern California. By combining these resources, we will be able to address major risks, such as cancer, as well as transient treatable concerns like recurring bladder infections and bothersome skin rashes. So, which of the approved MS drugs will be the winner? Perhaps none! 

Over the last few years, there has been a dramatic shift in Sweden and Kaiser Permanente toward rituximab. One in two MS patients in Sweden now chooses to start rituximab. The data produced so far show that rituximab beats all approved MS drugs in terms of providing MS patients with an effective, safe and tolerable drug. The fact that rituximab is much cheaper than other MS drugs also makes it an attractive option in resource-limited countries, where access to brand name MS drugs is out of reach for most patients. 


Fredrik Piehl, Annette Langer-Gould, Jessica Smith and Anna Fogdell Hahn on behalf of the COMBAT-MS investigators and steering committee



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Cognition: to measure routinely or not?

At ECTRIMS I gave a short TED-type talk on why I think we need to measure cognition in people with MS in routine clinical practice. Do you agree?



Podcast: 


 The following are my slides and the accompanying script. What are your thoughts on the issue?




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News: daclizumab handcuffed by the EMA

After a second person with early RRMS died from fulminant liver failure whilst being treated with daclizumab the EMA are restricting daclizumab’s use. 



The following statement was released last Friday on the EMA’s website. It is reassuring that the EMA has decided not to withdraw daclizumab product from the market. I still think there will be a group of pwMS who will benefit from the therapy. For example, patients at (1) high-risk of PML transitioning from natalizumab, those with (2) PML post-natalizumab and (3) patients with high-disease activity who don’t want an irreversible therapy nor therapies that cause continuous immunosuppression. The elephant in the room is that in both fatal cases, those who died of liver failure on daclizumab also received concomitant tizanidine. Could tizanidine, or other hepatotoxic drugs, when used in combination with daclizumab, be the problem? I suspect the use of daclizumab will now be so low we won’t be able to answer this question with post-marketing surveillance. 

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommends further restrictions for multiple sclerosis medicine Zinbryta due to risk of serious liver damage. 27 July 2017.

Zinbryta to be used only in a restricted patient group, with strict liver monitoring

PRAC is recommending further restrictions on the use of the multiple sclerosis medicine Zinbryta (daclizumab) following a review of the medicine’s effects on the liver.

The review found that unpredictable and potentially fatal immune-mediated liver injury can occur during treatment with Zinbryta and for up to 6 months after stopping treatment. In clinical trials, 1.7% of patients receiving Zinbryta had a serious liver reaction.

In order to reduce the risks, doctors should now only prescribe Zinbryta for relapsing forms of multiple sclerosis in patients who have had an inadequate response to at least two disease-modifying therapies (DMTs) and cannot be treated with other DMTs.

In addition, doctors should monitor patients’ liver function (ALT, AST and bilirubin) at least once a month as closely as possible before each treatment and continue monitoring them for up to 6 months after treatments have stopped.

If the patient does not comply with monitoring requirements or the response to treatment is inadequate, doctors should consider stopping treatment.

It is recommended that the doctor should stop treatment if a patient has liver enzyme levels over 3 times the normal limit and refer any patients with signs and symptoms of liver damage to a liver specialist.

Patients who test positive for hepatitis B or C infection should also be referred to a specialist.

Zinbryta must not be used in patients with pre-existing liver disease and should not be started in new patients with over 2 times the normal limit of liver enzymes. It is recommended that doctors do not use Zinbryta in patients with other autoimmune conditions.

The PRAC is also recommending that in addition to the current educational material, patients and healthcare professionals in the EU should be given an acknowledgement form. The form will be used to confirm that doctors have discussed the risk with their patients and that the patients understand the importance of monitoring and checking for signs of liver damage.

These recommendations, which strengthen provisional measures introduced in July 2017, will now be sent to EMA’s Committee for Medicinal Products for Human Use (CHMP), which will adopt the Agency’s final opinion.


ProfG    
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