Lowering Blood Pressure & SPRINT

Imagine that a doctor said: “I’d like you to take this pill. It will reduce your risk of dying by 30%.” You’d pretty seriously consider it, if not jump at the chance…

The story

I happened to be in the car, with Radio 4 tuned in, last Wednesday (3rd Feb 2016) at 3.30pm. Dr. Mark Porter’s programme, Inside Health (the transcript is below the recording), had just started and I heard a researcher saying that his trial had been stopped just over three years into a five year study because the benefit was already so dramatic. This is the holy grail of randomised controlled trials – ‘we just had to stop the trial because it was unethical not to treat the control group because the intervention group was doing so well’. Having seen this happen more than once, it can also happen, funnily enough, when gaps that had emerged between the two groups start to narrow…

The researcher being interviewed was Dr. Paul Whelton. Whelton is the chair of the SPRINT (Systolic blood PRessure INtervention Trial) steering committee. The full paper for the trial can be seen here. (In Figure 3, the data available at four year shows the intervention and control group lines closer together than at the time the trial was stopped; funnily enough).

The trial enrolled over 9,000 people in the US between the dates of November 2010 and March 2013. There were many inclusion and exclusion criteria. These are very important, because they define the profile of people to which the results can apply. All participants had to be over the age of 50. And they had to have systolic blood pressure (the first number of the two e.g. the 140 in 140/90) between 130 and 180. And they had to have had a significant risk factor for cardiovascular disease (already had cardiovascular disease, already got chronic kidney disease and/or had a 10 year risk of 15% of higher on the Framingham scale). Two exclusion criteria were listed – the participant must NOT have diabetes and they must NOT have already had a stroke.

The aim of the trial was quite interesting – it was not to see if blood pressure medications were better than not taking medications. It was to see if what they called “intensive” blood pressure (BP) lowering treatment (to medicate people to get them below 120 systolic BP) was better than “standard” BP lowering treatment (to medicate people to get them below 140 systolic BP). The goal of this trial, therefore, was to see if giving more meds was better than giving fewer. The idea of not giving meds at all was not part of this trial.

The trial participants were also interesting – older people and sicker people – designed to ensure that there would be a decent number of deaths in a short period of time. This is not underhand – if the trial outcome is deaths, you need people to die!

4,678 were analysed for the intensive treatment group; 4,683 were analysed for the standard treatment group. At the time the trial was stopped, 155 people in the intensive treatment group had died and 210 people in the standard treatment group had died. Table 2 in the full paper has the statistics on this. This was presented as a Hazard (risk) Ratio of 0.73, which can be presented as a 27% difference between the two interventions. Indeed, Whelton presented this on Inside Health as “In fact their total mortality was reduced by close to 30% and I’ve never been in a trial where we’ve seen that before.”

Relative risk

That’s relative risk, which I have frequently explained as highly misleading. The absolute risk of dying in any 1 year of the study was approximately 1 in 100. In the intensive treatment group 1.03 people in 100 died; in the standard treatment group 1.37 people in 100 died. That’s 10 people in 1,000 vs. fewer than 14 people in 1,000. That’s hardly “Stop the trial! People are dropping like flies!”

Who didn’t benefit

Then is when it gets even more fun. Figure 4 in the paper is called a forest plot or a blobbogram. I kind of like the second name. All you need to look for in a blobbogram is whether each horizontal line touches or crosses the vertical line, which is drawn at 1.0. Any horizontal line that touches or crosses that vertical line is NOT significant. It could have happened by chance. You should ignore it.

The blobbogram in this paper tells us that, the intensive treatment made a significant difference for:

– all participants grouped together;
– people who didn’t have previous chronic kidney disease;
– people 75 years old or older;
– men;
– non black people;
– people who didn’t have previous cardiovascular disease; and
– people whose starting blood pressure was under, or equal to, 132.

The intensive treatment made NO significant difference for:

– people who did have previous chronic kidney disease;
– people under 75 years old (that’s 82% of participants for starters);
– women;
– black people;
– people who did have previous cardiovascular disease;
– people whose starting blood pressure was greater than 132 (that was 66% of people).

For the majority of people, therefore, there was no benefit from intensive treatment. (As an aside, is it surprising that lowering BP to below 140 makes no difference to people whose starting BP is already below 132?!)

Thanks to Dr. Margaret McCartney on Inside Health, the programme discussed the numbers needed to treat to impact one person. In McCartney’s words: “you had to treat 90 people in order to delay one death over the three year period of the trial.  Now that is important but it means that 89 out of those 90 people did not get benefit from having their death delayed and were at risk of just getting the side effects from the intervention. Is that worth it or is it not?  That’s for the patient to decide, not for me.”

Which brings us nicely on to…

The down sides

The side effects were serious. A Serious Adverse Event is defined as a “Fatal or life threatening event, resulting in significant or persistent disability, requiring or prolonging hospitalization, or judged important medical event.”

The paper reported: “Serious adverse events of hypotension, syncope [fainting], electrolyte abnormalities, and acute kidney injury or acute renal failure… occurred more frequently in the intensive-treatment group than in the standard-treatment group.” “A total of 220 participants in the intensive-treatment group (4.7%) and 118 participants in the standard-treatment group (2.5%) had serious adverse events that were classified as possibly or definitely related to the intervention (hazard ratio, 1.88; P<0.001).”

If you want to report deaths rates as 30% better than the standard treatment group, you should also report side effects as double that of the standard treatment group. Presenting benefit as 30% (relative) and the side effects as 4.7% (absolute) is naughty at best and deliberately misleading at worst. Some of those side effects are serious and nasty as well – acute kidney injury or acute renal failure? What would happen if the trial were kept to five years long, or extended for longer? Would significant numbers of people in the intensive treatment group die of kidney failure? How many will end up on lifelong dialysis as a result of this trial?

The honest patient conversation

This kind of trial informs medical policy – it is intended to. That’s why drug companies spend so much money funding research, researchers and research institutions. The messages that are best left in the minds of the medical world are 1) the trial stopped early i.e. you must get your patients on this treatment asap or you will be unethical and 2) there was a 30% difference in mortality i.e. you must get your patients on this treatment asap or you will be unethical.

Then the doctor conversation can be: “I’d like you to take this pill. It will reduce your risk of dying by 30%.”

As McCartney suggested, the good doctor sets out the facts in an understandable way and lets the patient decide if absolute benefit is worth the known (side effect) risk. The honest doctor conversation in this case – only even to be considered with patients over the age of 50 – would be:

“If you are male, or over the age of 75, or have no previous chronic kidney disease, or are not black, or have no previous cardiovascular disease, or have current systolic blood pressure under 132, AND over the age of 50 (because we didn’t test younger people), AND don’t have diabetes (because we didn’t test for people with that), AND haven’t had a stroke (because we didn’t test for people with that) … if you then take 3 pills a day (that was the actual number of pills administered) every day for 3.26 years, you have a 1 in somewhere up to 90 chance (Note 1) of delaying death i.e. you might not die within the 3.26 years – you might die the day after, or sometime after, we don’t know. Oh, and by the way, you double your (relative) risk of some serious side effects including acute kidney failure and you might faint here and there, so don’t idle at the top of staircases.”

Now who would jump at the meds?!

Generalisability

One of the key findings from this meta-analysis was that you can’t take six studies of 2,500 sick men and set dietary guidelines for entire populations. (Except that this is what happened – oh – and the studies themselves did not support the guidelines introduced). Research is said to lack “generalisability” if it is undertaken on, and/or shows results for a small or specific part of the population. Put simply, you can’t study people over 50, find significance for men or over 75s only and then apply guidelines to entire populations…

When McCartney joined the debate, so did Tony Heagerty, introduced as “Professor of Medicine at University of Manchester, who has a special interest in treating high blood pressure.”

Closing the debate, Porter asked Heagerty the key question: “Well this is the big question isn’t it Tony – does this one trial, which has come up with this finding and suggestion that we should be aiming at 120 – is that enough to change our current guidance and practice on it?”

Heagerty replied “I believe it does actually… the National Institute for Health and Clinical Excellence scoped out or looked for a reason to change guidelines in 2015 and the guideline writing committee felt there was no new evidence. I think that in 2016 the British guidelines will have to be readdressed with regard to targets for looking at effective blood pressure control.”

The paper’s own blobbogram confirmed that there was no significant difference for people under 75 years old (82% of the study participants). There was no significant difference for people with previous chronic kidney disease, or people with previous cardiovascular disease. There was no significant difference for women. There was no significant difference for black people and, perhaps most incredibly of all, there was no significant difference for people whose starting blood pressure was greater than 132 (66% of participants).

So there are calls for UK wide guidelines to be changed for all people when absolute risk benefit vs. Serious Adverse Effect cost barely holds up for white men over 75 with no previous CVD and already low blood pressure.

This is when John McEnroe’s legendary comments springs to mind: “You cannot be serious”!

(Note 1) the number needed to treat included women/under 75 year olds etc, who we now know will not benefit, so the number needed to treat will change with the caveats spelled out. Even if you leave out the caveats and tell any non-diabetic/non-stroke patient over 50 they have a 1 in 90 chance of benefit and likelihood of side effects – some serious – I suspect they would decline the kind offer.

 

55 thoughts on “Lowering Blood Pressure & SPRINT

  • avatar
    January 16, 2017 at 3:05 pm
    Permalink

    Hello Zoe. I am desperate for help, I am a 79 year old male since 2003 I have had 2 lung cancer operations–4 Stents put in (2 in October 2016)–TB–Kidney Failure–Kidney Damage—Sepsis–ive got High Blood pressure, low one usually about 60 or 70–high anything from 140 to 240—Angina–Hypothyrodism—Barretts disease–Herniated Disc causing Foot Drop (I stagger and full)–Spinal Erosion–(they wont operate on spine because of heart disease)–enlarged Prosate– I get massive Fatigue and most of time I am to fatigued to do anything–I would like to exercise but as soon as I do I get massive blood pressure headaches—I take Aspirin 75mg (1 a day)–Clopidogrel 75 mg (1 a day)—Doxazosin 1mg (1 a day)–Elantan LA25 (1 a day)–Eicosapentaenoic Acid 460 mg (1 a day)—Ferrous sulfate 200 mg (2 a day)—Lansoprazole 30 mg (1 a day)–Levothyroxine 25 micrograms (1 a day)–Levothyroxine 50 micrograms ( 1 a day)– Ramipril 10 mg (1 a day)–Pregabalin 75 mg (1 a day)—Co-Codamol 15/500 mg (up to 8 a day but I dont take that many) Pregabalin and Co-Codamol for Back—Feet and Ankle pain–I wont take Statins and hate taking any drugs but cant see a way out–any advice please Zoe–I only found you yesterday–Thank you.

    Reply
    • avatar
      January 16, 2017 at 3:59 pm
      Permalink

      Hi Terry
      I’m so sorry to hear about everything you’ve been through and continue to go through. I’m a PhD, not a medical, doctor and a medical doctor wouldn’t advise you without a consultation anyway. With all these meds and treatment, you must be in the system and have a doctor/consultant – probably more than one.

      In my view, you’re certainly right to be resisting statins – not least because the patient leaflet cautions against over 70s taking them (because cholesterol is known to be even more beneficial to older people (it’s life vital to younger people too!)). You need to raise all of this with your doctor(s) and don’t be fobbed off. It sounds like you have no quality of life at the moment and they need to see which, if any, drugs may be worsening fatigue or harming more than they’re helping.

      The best you can do for yourself (you will know all this) is to not smoke, drink moderately (wine, not beer/spirits) and eat real food (no junk) and try to find movement that you can do – even if you may not think of it as exercise. My dad dislocated his hip recently and we worked out all sorts of squeezes and pressing into the bed/chair that he could do, so that his muscles built up around the damaged area.

      I hope you get some positive help from the system asap.
      Best wishes – Zoe

      Reply
      • avatar
        January 16, 2017 at 6:50 pm
        Permalink

        Ok thank you Zoe. yes I am well in the system but its difficult to see my GP for ten minutes for one of my health problems let alone all of them. the Surgery quite often only have one regular GP the rest, which are not many, are Locums so you never seem to see same person. Because I am still getting Angina even after having two Stents in October 2016 I am waiting for an MRI Scan on my Heart.
        I desperatly need some help and although I am a poor pensioner I would try to pay for a consultation with a top medical consultant but dont know how to go about this.
        Although you are unable to help me I will continue to follow your posts–Thank you–Terry.

        Reply
        • avatar
          January 16, 2017 at 7:28 pm
          Permalink

          Hi again Terry – you paint a very visual picture or the problems in primary care – GP times are too short and people don’t get to see the same person, so you’re starting again from scratch every time and that must be the appointment gone.

          I know that you can get private healthcare by paying direct (i.e.not having private insurance). This is often the best option for older people anyway, as the premiums are so high after 70. I don’t have experience going about this either, but, if you google “Private healthcare near me”, you get this kind of thing (http://www.privatehealth.co.uk/hospitals-and-clinics/).

          You could always ask your GP for a referral (I think some places will insist on a GP referral, even if you are going to pay) and use the 10 min appointment to explore who best to see and what costs you could expect. Angina really should put you high up the list for being seen (even though they will probably just want to give you statins not having read the patient leaflet). You could try to push for an NHS consultant appointment and then you’re at least on the list. The top tip I’ve heard then is to let the consultant’s admin know you’ll come in any time/whatever the notice and make sure you’re on the cancellation list. People cancel for all sorts of reasons all the time and the NHS wants to avoid the waste.

          I’m sorry I can’t be more help – the NHS just doesn’t seem able to cope generally at the moment, as I wrote about here. (http://www.zoeharcombe.com/2017/01/the-nhs-whats-the-future/)
          Best wishes – Zoe

          Reply
  • avatar
    June 3, 2016 at 12:00 pm
    Permalink

    Thanks for Information about Lowering Blood Pressure & SPRINT. Your Article is impressive and very informative. I am now regular visitor of your website and bookmarked it.

    Reply
    • avatar
      June 3, 2016 at 1:58 pm
      Permalink

      Thank you Bruce! My PhD supervisor was called Bruce – a wise man ;-)

      Reply
  • avatar
    May 28, 2016 at 7:59 am
    Permalink

    How can you lower bp. On 2 meds. Stopped one about a week ago. Blood pressure 160 over 90 at the moment. Should I restart the one I’ve stopped or wait for it to stablished. Been seeing a he herbalist for 5 months but what she is giving me doesn’t seem to be working. Have you any views on this.

    Reply
    • avatar
      May 28, 2016 at 9:54 am
      Permalink

      Hi Connie
      I can’t give advice – I can give a view, as you helpfully put it.

      First – your BP is not as high as you may be led to believe that it is. This may be of interest: http://www.zoeharcombe.com/2014/06/diabetes-cholesterol-bp-normal-is-no-longer-normal/
      For the true normal blood pressure to be 140/90 (as it is) – some people need to be above normal and some people need to be below. That’s what a normal distribution is.

      I see blood pressure as the body trying to tell you something – my interest would be in what it’s trying to tell you. Are you elderly? BP rises with age and there is some benefit in this as low blood pressure is one of the main triggers of falls in the elderly, which can set off a chain of events leading to immobility/death. Are you very overweight? Put more stuff in a pressure cooker and the pressure goes up. The human body is not so different. Do you eat more than 100g of carbohydrate a day? People can drop BP quite quickly by following a low carb diet for a few days (<50g may be needed), as the water held with stored glucose (glycogen) drops rapidly and this eases pressure in the body. Are you very stressed at the moment? Can you do anything to help with this? meditation? yoga? pilates? walking a dog etc.

      There can be many reasons for high BP. Yours isn't that high, but is your body trying to tell you something?

      Best wishes - Zoe

      Reply
      • avatar
        May 29, 2016 at 8:50 am
        Permalink

        Hi I am 56. Take 2 melds but have stopped one a week ago that’s why it’s gone up to 160 over 90. Am not obese. Weigh about 11 stone and am 5 foot 6. Do try to stick to low carbs. Cutting down on alcohol. Not sure what else to do

        Reply
        • avatar
          May 29, 2016 at 9:12 am
          Permalink

          Hi Connie
          So you’re not elderly; not even overweight, let alone obese; doing well to limit carbs and alcohol. Natural activity is another good thing to do – walking/dancing/gardening – not running triathlons – and that’s about it. I’m back to – your BP is on the normal distribution, which means it’s normal. Some people will be higher than average, some people will be lower. That’s what a distribution is. The powers that be want us to all have the same (below average) BP – that’s not how averages work!

          I certainly wouldn’t worry if I were you.
          Best wishes – Zoe
          p.s. I have low BP and it can be a real pain – some days I nearly pass out doing my boot laces! I’m not trying to raise it – it is what it is

          Reply
  • avatar
    May 20, 2016 at 8:52 am
    Permalink

    Dear Zoë,
    What does it mean to be black, or non-white. This is not a flippant question, ok. I am serious. What determines if a person is black, how much “black blood” (whatever that is) do they have to have to be considered black and how much does this affect these studies. I mean if Hallie Berry or Barack Obama entered these test, would they be considered to be black for the test? Most blacks born in the “not-so-new-world” are “mixed.” (I use all these terms relatively, being a “black child of the “not-so-new-world.) But it is a question I have thought about, and what constitues “black” or “non-white” in these studies.
    Thanks
    Gwen

    Reply
    • avatar
      May 20, 2016 at 3:44 pm
      Permalink

      Hi Gwen
      Good question! I’ve looked at the paper as – ideally – there would be a definition of how the categories were defined. There isn’t one. Hence I would guess that it’s done on the basis of self reporting. When people fill in census surveys, they are invited to tick the box that best describes them.
      Best wishes – Zoe

      Reply
  • avatar
    February 24, 2016 at 12:46 pm
    Permalink

    Zoe, have you listened to the interview with Dr Malhotra on Today today, at 8.20am, about the proposed review of the influence of pharma on the NHS? I thought Michelle Hussain was unfairly hostile to Dr Maholtra from the start. When he was giving stats for deaths related to overprescribing in the USA and EU, she interrupted: So, you have no evidence of what you are saying for the UK? We have evidence, he countered. But then the kicker: MH:You wrote in the BMJ about the side effects of statins, and had to withdraw the figure of 20%. You were wrong before , how do we know you aren’t wrong now? Dr M started countering this, saying he and others had written another editorial. She interrupted: But the 20% was wrong! Dr M: in fact, now we find it was probably underestimated, and the side effects are greater, and I will tell you why…
    But he never got to tell us why as she cut him off to interview the other point of view by Sir Robert Lechler.
    If the BBC is going to make such a damning criticism of someone, they are owed a right of reply to counter that fully, and if she knew the time constraints wouldn’t allow that then maybe she shouldn’t have pursued that line in the first place.
    http://www.bbc.co.uk/programmes/b071ftsq

    Reply
    • avatar
      February 24, 2016 at 1:25 pm
      Permalink

      Hi Amie
      Wow – I’m away at the moment so didn’t catch this – will listen when I get back
      Many thanks – Zoe

      Reply
  • avatar
    February 16, 2016 at 5:45 pm
    Permalink

    Zoe, you start off by referring to Dr Mark Porter’s programme for BBC Radio 4. He’s also the health columnist for The Times and I think today’s article might interest you.

    In January Dr Mark Porter embarked on a lower carb diet and today he reported the results in his column under the slightly odd title ‘The diet that’s almost as good as statins – and I’m proof that it works’.

    Dr Porter reports:

    “At the start of the year I embarked on a six-week trial to see whether cutting back on carbohydrates could improve my poor cholesterol profile. The results are in and I’m bowled over: I shed half a stone in weight, my cholesterol level dropped by 20 per cent, my triglycerides level by 30 per cent and, according to the risk calculator favoured by the NHS, my odds of succumbing to an early heart attack or stroke have dropped by nearly 15 per cent.” Surprisingly, he then adds, “Not quite the benefit you might expect from taking a statin, but as near as dammit.”

    Dr Porter stopped taking statins after suffering memory lapses, but he still seems to feel they have a ‘benefit’. Not sure how that makes sense.

    Dr Porter urges readers to take a close look at a lower carb diet. He still takes sugar with his coffee and describes his diet as “at the upper end of what most people would regard as a low carb diet, but it was a significant reduction for me”. Disappointingly, he still thinks eating butter is bad for his cholesterol, , but says he ate more meat, eggs and cheese without damaging his cholesterol profile. He concludes, “My only regret is that I wish I had tried this in my twenties. . . . My local bakery and sandwich shop may regret my decision but it is low carbs for me from now on.”

    Reply
    • avatar
      February 16, 2016 at 5:57 pm
      Permalink

      Hi there
      Many thanks for this – I picked a paper up this afternoon – will get time after dinner to read it hopefully! I had an exchange with Dr MP on twitter about it this afternoon – asking why he cared about cholesterol. He does, end of, was the reply! Oh well – much progress has been made trying the low carb route so let’s always celebrate the good things :-)

      Best wishes – Zoe

      Reply
      • avatar
        February 17, 2016 at 7:16 pm
        Permalink

        I agree. Let’s take the good news from the article. He does seem a bit muddled about fat and cholesterol. I get the feeling of someone half way down a road. Butter’s still bad but cheese, eggs and lean meat are good. He thinks his previous diet was healthy, but it sounds terrible to me (65% carbs). I couldn’t help wondering how much better his blood profile and heart risk would be if he reduced his sugar and carb consumption further? But his diet represents the sort of feasible progress that many people could achieve without feeling too deprived of bread and other things we’ve been eating since childhood. A diet of 25% carbs is too high for me, but it would be massive progress for many. It might be enough to take us back to 1960s levels of obesity and diabetes?

        Off topic, my daughter has been told by her new employer (the NHS) that she’ll be expected to have the flu vaccine. I think last year’s was close to useless and I’m getting increasingly sceptical about vaccines, particularly with young children. I’d appreciate people’s views?

        Reply
        • avatar
          February 18, 2016 at 8:29 am
          Permalink

          Hi Stephen
          Last year’s was close to useless, but will have caused some harm. No drug on the planet has only 1 effect. Most have multiple effects – hopefully the intended effect – plus unintended effects. which we call side effects, but they’re all just effects.

          Vaccines have undoubtedly done much good but I am shocked at the zero tolerance that has developed for even being able to discuss side effects. Have you read Dr Malcolm Kendrick’s Doctoring Data? Great section on vaccines – not so much about vaccines – but about the fact that we seem to have been banned from talking about vaccines in anything other than a glowing light. There are huge funds set aside for vaccine lawsuits – so it is known that they can harm and that liability will need to be answered for, yet we can’t talk about this.

          I personally would therefore seek balance to the current completely unbalanced position from the government. The Weston Price Foundation (http://www.westonaprice.org/uncategorized/wapf-position-on-vaccinations/) will provide a counter balance – as will What Doctors Don’t Tell You. I saw an HPV vaccine article there recently (plus one in the Mail of all places from a mum about to make the HPV decision) – very interesting thoughts…

          Keep reading!
          Best wishes – Zoe
          p.s. the Mail mum concluded – on balance – the risks of the HPV vaccine were not worth any possible benefit

          Reply
          • avatar
            February 18, 2016 at 11:58 am
            Permalink

            I strongly urge you to watch Dr John Bermgan’s talks on vaccines before having one.

            https://www.youtube.com/user/johnbchiro/videos

            I’ll ruin the surprise and tell you he is very anti. I have two children (3 and 1) and they have not had a single vaccine between them. No point going into a lengthy post here as Zoe’s site is about nutrition and obesity I guess and not vaccines (plus no other subject brings out such flame/hate/spam).

            Although I did have a dream once where Zoe woke up one day and dropped obesity and nutrition and focused her great talents on the vaccine schedule LOL :-)

            Oliver.

          • avatar
            February 18, 2016 at 9:26 pm
            Permalink

            Quite, vaccines are inevitably going to harm SOME people, the question is whether they are likely to do more harm than the diseases.

            Back in my day, mothers would hold “measles parties” in order to get the infectious childhood diseases out of the way ASAP. In my case this was unnecessary, just going to school was enough. I soon caught mumps, and before I was out of “quarantine” I got chickenpox. Hadn’t been back at school for long and I was off again with measles.

            I sometimes wonder if the onslaught of all these viruses damaged my pancreas beyond repair, or if it was just coincidence that I started having chronic symptoms around that time – after all as I now know diabetes, “prediabetes”, “metabolic syndrome”, insulin resistance or however you choose to describe it, runs through one side of my family, predominantly but not exclusively in males and without overweight. Maybe if MMR was around then I might have benefited, I’ll never know.

            What I DO know is that in the now eleven years I’ve been low carbing and have effectively improved if not normalised all my metabolic factors I’ve NEVER had the flu, and last year was the first time in ages I actually had a cold – at most I may feel like I’m going to get a cold soon,and then that I have had a cold without actually *getting* the cold – my bowels are regular as a digital clock and even when I do stuff like pull/tear a muscle, as I did the other day, it heals much more rapidly than it used to.

            I put all this down to greatly reduced inflammation and a properly functioning immune system, a far cry from how I spent the preceding few high carb low fat decades.

            Back in the day when we ate Real Food there was very little obesity, especially childhood obesity, and far fewer cases of Type 1, asthma. allergies and a whole bunch of other stuff so common today. OK in retrospect I couldn’t handle the carbs but most people didn’t have nearly the same problems that they do today.

            We were only vaccinated against truly serious diseases like polio and diptheria, and smallpox before it was “eradicated”. I can’t help feeling that the dietary and other changes since then have mangled our immune systems to the extent that we *need* all the vaccinations against diseases we can no longer fend off on our own. Look how many other people report the same type of health improvements when they stop eating “low fat”.

          • avatar
            February 22, 2016 at 6:09 pm
            Permalink

            I just had a further memory – in secondary school we had the BCG, for tuberculosis. I was one of a few kids who reacted to the skin test: we were all packed off to see the doctor and have chest X-rays and AFAICR none of us actually showed signs of ever having been infected. We were told we were “naturally immune” but I wonder if we were actually exposed to the bacillus and our immune systems threw it off without help.

            As a corollary, they used to drag all the old folks in for their flu jabs at the same time, leaving them sitting around in the waiting room for hours happily exchanging viruses and bacteria, so even when the vaccine worked and they didn’t get the flu, a lot of them came down with colds and other infections instead.

          • avatar
            February 23, 2016 at 10:23 am
            Permalink

            Hi Chris
            I remember one of the jabs the girls had early teens? Upper arm – something about pregnancy protection – many were left with well ugly scars! Mine isn’t too bad thankfully but we were all sheep dipped and ever thought to question it!
            Best wishes – Zoe

        • avatar
          February 18, 2016 at 10:11 am
          Permalink

          Stephen,
          Recommend that you take a look at http://drsuzanne.net/ and http://www.dissolvingillusions.com.

          As you’ll see Dr. Humphries has written a book Dissolving Illusions (review here http://www.westonaprice.org/book-reviews/dissolving-illusions-by-suzanne-humphries-roman-bystrianyk/ ) which covers the history of vaccines to the present day. It’s not what most people expect. You’ll also learn about how vaccines change the way we respond to an infection. The second website provides an overview plus much better graph presentation than in the book.

          Personally I wouldn’t have the flu vaccine – I think it’s a total waste of time. Dr Mercola has the data (plus others) showing that those having the flu jab experience more flu than those that don’t (not taking into account those that think they have the flu but in reality only have a bad cold). The flu jab, at best, can only provide protection against the strain in it and as the virus is constantly mutating you’re chasing a moving target. Here’s a link to Mercola’s vaccine section http://vaccines.mercola.com/ .

          I think you are right to be sceptical about young children and vaccines. The number of vaccines that are being pumped into babies and toddlers these days (especially in the US) is ridiculous see http://www.cdc.gov/vaccines/schedules/ . The immune system of a young person just cannot cope with the sudden onslaught of vaccines and the contaminants they contain. In real life exposure to a raft of infectious agents at the same time, let alone the chemical contaminants, just does not occur. I don’t think it is just a coincidence that the huge increase in medical issues in young children we are witnessing is unconnected. Nor should we forget that the diet of so many mothers during pregnancy is poor – which directly affects the foetus – plus following birth babies are frequently raised on a diet of formula milk etc. plus not benefiting from a mother’s milk and the initial boost to the babies immune system. Poor little souls get hit all ways – not that the drug and food industries give a toss. Try this site for more info http://www.vaccinationcouncil.org/ .

          Reply
          • avatar
            February 18, 2016 at 12:04 pm
            Permalink

            Great post, Barry.

            I have been reading recently about the link between the mother’s low vitamin D levels and neurological birth problems.

            I can’t understand why mother’s don’t breastfeed (we went to 20 months on our first and second is still going). If the mother is unable to produce milk, then that is problem to be looked at for that person, not just concede and whip out the formula. If the mother can’t breastfeed due to work/financial issues, then something has gone seriously wrong with society there too.

            What’s worse is they get the genetically modified soya formula, put it in a plastic bottle then heat it up in a microwave. What o what are we doing to our children.

            Needless to say I have not vaccinated any of my children.

            Cheers,
            Oliver

          • avatar
            February 18, 2016 at 10:55 pm
            Permalink

            Zoe, Oliver and Barry, I very much appreciate your advice and I’ll be following your leads. I now watched several hours of Suzanne Humphries’ talks on YouTube and she’s really swimming against the tide. What a courageous woman.

            I now question the orthodoxy on diet, statins, diabetes, CABG and even cancer. It looks like I might have to add vaccines to the list. It’s getting like the X-Files. If I keep looking, I wonder if there will be anything left that stands up to scrutiny.

    • avatar
      March 5, 2016 at 6:54 pm
      Permalink

      Hello
      Out of curiosity, I looked up the Mark Porter article. Think he would be well advised to read Zoe H and Malcolm K. And he is a doctor and The Times health correspondent? And he gave butter for the lipid profile?,

      Reply
    • avatar
      March 6, 2016 at 2:13 pm
      Permalink

      There are two Dr Mark Porters – one who writes for the Times and is a GP, I think he also does the BBC programme, and another who is the BMA Chair. This is how the Times Dr Mark Porter describes himself on Twitter: NHS GP, columnist @TheTimes, inquisitive presenter #insidehealth @BBCRadio4 & BBC One Show. Not the one from @BMA. But all work + no play.. My own views anyway: https://twitter.com/drmarkporter

      Reply
  • avatar
    February 15, 2016 at 7:49 am
    Permalink

    Hi Zoë, Just in case you haven’t seen it. Spacedoc’s latest on BP (http://www.spacedoc.com/articles/blood-pressure-and-heart-disease & http://www.spacedoc.com/articles/blood-pressure-how-low-is-too-low) with a link to https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3008373/ showing lower is not necessarily better is pertinent to your current blog.

    The significant variations in BP that occur doing things that many people would think have little influence may be of particular interest to readers diagnosed with high BP.

    Best wishes, Barry

    Reply
    • avatar
      February 15, 2016 at 8:23 am
      Permalink

      Hi Barry
      Many thanks for this and many thanks to the spam filter! Normally blocks anything with a link in – it must like Spacedoc – clever filter :-)
      Best wishes – Zoe

      Reply
  • avatar
    February 11, 2016 at 12:58 am
    Permalink

    Hi Zoe I’m so glad I found your webpage, I could not be more identified with your comment about being in a plane crash at 95, I’ m really afraid to be in the hands of physicians, meds, hospitals. I was diagnosed HBP about ten years ago, I know exactly why I had that crisis, reasons? Matters of the heart, and at that time I didn’t find someone to open my heart with, so I shut my mouth and the pressure went high up, the doctor I went to, prescribed me with meds forever and ever, which I hate but continue to take out of fear, as he frightened me saying that if I didn’t take them I might have a brain stroke, can you believe?

    Reply
  • avatar
    February 10, 2016 at 10:17 pm
    Permalink

    Zoe, brilliant analysis. I refused blood pressure medication after reading Dr Kendrick’s review of the evidence. This sort of nonsense just bewilders the public and pushes them where the drug industry wants them.

    I’ve got my brother off statins, but now he has Irritable Bowel Syndrome. I’ve told him to stop eating wheat and sugar, but I know a lot less about this subject and I’m unsure what else to say? Is LCHF the way for him to go? Can anyone point me to evidence a non-medical man might read on IBS?

    Steve

    Reply
    • avatar
      February 12, 2016 at 8:42 am
      Permalink

      Hi Stephen
      Thank you! I would recommend Wheat Belly by Dr William Davis and/or Grain Brain by David Perlmutter to enlighten someone about wheat. Wheat Belly does get a bit technical in places (he is a cardiologist), but most is still very readable and informative. The sugar book has to be the John Yudkin Pure White & Deadly classic – 1972 original – reprinted a couple of years ago with Robert Lustig’s help. The other one I really enjoyed was Fibre Menace (https://www.gutsense.org/fibermenace/about_fm.html). This was recommended to me by someone on twitter – great fun book! You’ll never bother with ‘roughage’ again – which is really not helping IBS/Crohns and all sorts of other avoidable, modern, gastric illness

      Hope this helps
      Best wishes – Zoe

      Reply
  • avatar
    February 9, 2016 at 12:24 pm
    Permalink

    HI Zoe
    Thanks so much for this – I am a GP and listening to this programme last week certainly raised my blood pressure!! Like yourself my skepticism (?cynicism) levels rise as soon as a trial is stopped early given stopping trials earlier significantly increases the chance of the result being biased see http://www.ncbi.nlm.nih.gov/pubmed/20332404

    Reply
    • avatar
      February 9, 2016 at 12:55 pm
      Permalink

      Hi Dave
      Many thanks for the link – I hadn’t seen that one – much appreciated
      Best wishes – Zoe

      Reply
  • avatar
    February 9, 2016 at 10:53 am
    Permalink

    Hi Zoë,
    My criteria for determining the basic worth of any study/paper is that is it quotes absolute risk and not relative risk. Using relative risk to invoke a favourable response to the conclusions of the study always makes me think qui bono? If the use of a certain drug or procedure is so beneficial why do the authors need distort the presentation to make it appear better than it actually is? The answer is, usually, that it is to meet the outcome desired by those funding the study. As you so clearly point out the risk/benefit doesn’t make any sense when you look at the details (there’s more detail in the appendix http://www.nejm.org/doi/suppl/10.1056/NEJMoa1511939/suppl_file/nejmoa1511939_appendix.pdf).

    I think we know what will happen here – new guidelines will be issued and then, as with statins, the drug companies will use “mission creep” to push for ever lower “normal” BP on the basis of lower is better. Adverse effects will be ignored or used to push even more drugs.

    I question the actual health status of the study population with respect to excluding those with clinically defined (by currently accepted definitions) diabetes (T2D) as the acceptance criteria allows for the inclusion of people who are borderline diabetic (see http://care.diabetesjournals.org/content/27/suppl_1/s5.full). If you believe Joseph Kraft M.D. then everyone in the study with CVD is diabetic quote “Those with cardiovascular disease not identified with diabetes are simply undiagnosed.”.

    However the real problem is that, as with so many health issues, the emphasis is on treating the symptom and not the root cause. Dr Kendrick covered the issue of blood pressure here http://drmalcolmkendrick.org/2012/04/02/does-treating-high-blood-pressure-do-any-good/ . Bottom line – unless really high it’s a waste of time.

    There are numerous reasons as to why blood pressure is elevated above what is deemed normal but the overwhelming reason in our modern society is the “food” we eat and the effect it has upon our biochemistry and thus the structure of our body. This is the elephant in the room that almost everyone ignores despite all of the evidence that is staring them in the face and our government plus associated official bodies are perhaps the worse examples of wilful ignorance coupled with damaging advice.

    I suspect that there are many doctors and other health professionals who would like to advise their patients to change diet to prevent and resolve many issues but they are restricted by official guidelines and risk their careers if they do not follow them (many examples of this happening). Plus too many patients will not see the error of their ways (the everybody does it so it can’t be bad brigade) and demand a pill for an ill.

    Reply
    • avatar
      February 9, 2016 at 11:14 am
      Permalink

      Hi Barry
      I need to get a like button on blog comments – I like that!
      Best wishes – Zoe

      Reply
      • avatar
        February 9, 2016 at 4:51 pm
        Permalink

        +1

        My BP was steadily rising, as I now know along with my BG and insulin levels and insulin resistance, as shown by my “diabetic” dyslipidemia – low HDL, high LDL, sky high trigs.

        When I was finally diagnosed with “just a touch of prediabetes” I soon discovered thanks to my glucometer which I was expressly told not to use, and “cranks on the internet” that I was expressly told not to listen to, including the likes of Gerald Reaven, Ron Krauss and Richard Bernstein (“didn’t he write West Side story?” – a friend’s joke) that if I ate the EXACT OPPOSITE of what I was told, and controlled my BG, all the rest fell back into place.

        When I went hypERthyroid my BP went through the roof, and this has done some temporary and probably some permanent damage. I’m not afraid of drugs when they actually address a problem, just not when they are antidotes to the wrong diet: carbimazole for the thyroid has had at least as much effect as amlodipine for the BP.

        I suspect hyperinsulinemia is behind most of the hypertension. Bring that into line through a low carb diet and then fine tune the effects IF NECESSARY with minimal meds. Oh but wait, that adversely effects the profits of the drug companies and the foodlike substance manufacturers. Hence the need for such studies and their trumpeting in the media, and their roll-out as “evidence-based” medicine.

        Reply
  • avatar
    February 9, 2016 at 8:48 am
    Permalink

    Hello Zoe – great post. Thank you.
    Now then, I am a 73 year old female, mody diabetic for 58 years but, give or take, fit and healthy (for my age) And there we have it. – for my age. My eyes aren’t what they were, my hair is turning grey, food isn’t as tasty as it used to be, I feel stiff in the mornings and younger people can run rings rounds me on the tennis court. WHY should I expect to have the blood pressure of a 20 year old. Everything else deteriorates, so what’s special about blood vessels.
    Am I missing something?
    Cheers
    Jan

    Reply
    • avatar
      February 9, 2016 at 9:32 am
      Permalink

      Hi Jan
      You’re missing nothing! Still got a smart mind clearly ;-)

      Blood pressure naturally rises with age – interiors stiffen as well as exteriors and more pressure is needed to pump things round when you’re older. Plus – low blood pressure is so serious in older people. Low blood pressure is more likely to lead to falls and, as I replied to Hugh, falls are too often the start of a fatal spiral of decline. When I was on the board of the NHS in Wales a programme called “slips, trips and falls” was launched – trying to prevent falls in older people – because the consequences were well known. Should have just slashed the BP meds in older people!

      Best wishes – Zoe

      Reply
  • avatar
    February 8, 2016 at 7:18 pm
    Permalink

    Why the rush to get BP so low? IIRC, back some 30 or so years ago it was expected that BP would rise with age and one’s systolic pressure was calculated as 100+ your age (- 5 for women), so a 60yo man had normal systolic pressure at 160 and a 60yo woman would be “normal” at 155.

    No medication is without side effects. I wonder if perhaps the prevalence of falls in the elderly is in part due to hypotension and the accompanying dizziness.

    I’ve had hypertension since I was about 40 (BP low 140ish/90ish) which has been stubbornly resistant to any medication that I could tolerate.

    Reply
    • avatar
      February 8, 2016 at 7:48 pm
      Permalink

      Hi Hugh
      I laugh every time I see your name ;-)

      Your BP is thus entirely normal http://www.zoeharcombe.com/2014/06/diabetes-cholesterol-bp-normal-is-no-longer-normal/
      It’s just that normal has been redefined :-)

      Absolutely I would expect falls in the elderly to be hypotension – the dudes in this trial were fainting FGS! My uncle was a super fit 80 something golfer still running his gas station business in N America. Had a fall and was dead within a few weeks – serious fracture/immobile/infection/circulatory problems – not sure what was on the death cert but it should have been fall :-(

      Best wishes – Zoe

      Reply
      • avatar
        February 9, 2016 at 3:54 pm
        Permalink

        I’m glad you like my alias :)

        I’m due for my annual physical next month and we’ll go over the same old same old: No, I won’t take a statin. No I’m not going to go for aggressive BP reduction (even if they can find something that works without side effects). Sure, I could lose more weight and get more exercise. They think my diabetes is “well controlled” as long as my A1c is less than 7.0 (and are surprised that it’s been running between 5.6 and 6.2 with no meds for the past 8 years) I’d like it lower, but haven’t quite found the magic combination of LCHF and exercise that will get me there.

        Given the choice, I’d rather have a fatal heart attack than cancer. I’d also like to make it to 100 (assuming I can keep in reasonable shape) but if I drop dead tomorrow… Oh darn. What I DO NOT WANT is to linger at the mercy of medical care unable to do more than stare at the ceiling.

        Reply
        • avatar
          February 9, 2016 at 4:00 pm
          Permalink

          Dr Malc Kendrick says the same – bang with a heart attack rather than the cancer linger any day. I fancy a plane crash at 95 or something :-)

          Reply
          • avatar
            February 10, 2016 at 3:29 pm
            Permalink

            Dr Kendrick is the other person whose blog I read on a regular basis. Like you, he’s more concerned with scientific accuracy than conventional “wisdom”.

          • avatar
            February 10, 2016 at 4:00 pm
            Permalink

            Gosh – I’m honoured! Dr Malc is one of my heroes! Do you have Doctoring Data? Can send you a copy if not
            Best wishes – Zoe

          • avatar
            February 11, 2016 at 2:52 pm
            Permalink

            Yes. I have both Doctoring Data and The Great Cholesterol Con.

            I also have your books.

          • avatar
            February 11, 2016 at 4:40 pm
            Permalink

            :-)

  • avatar
    February 8, 2016 at 2:49 pm
    Permalink

    As usual with Inside Health, I’m always left dissatisfied that they offer any real criticism of this kind of research. The programme producers often wheel out McCartney to articulate “the other side” but she seems constrained by the usual BBC fairness and impartiality obsession, inevitably leading to a robust position from the study authors counterposed with a somewhat wishy-washy critique.

    I’m so glad you posted this. I remember at the time thinking this smelled fishy and that the programme makers were not providing a decent rebuttal. It’s a shame that almost everyone who heard that programme will not come across a strong take-down like this post provides. Thanks again.

    Reply
  • avatar
    February 8, 2016 at 1:20 pm
    Permalink

    I too listened to the radio program and spent most of the day delving deeper, and eventually came to the same conclusions as yourself. It is of great concern that an eminent and influential professor of medicine (isn’t he a consultant to the Japanese pharmaceutical company: Daiichi Sankyo) believes that, as a result of this (flawed) trial, promotion of more aggressive treatment of hypertension in general is necessary and suggests that NICE should change the current guidelines. OK, I agree with the professor that over time a successful treatment will bring down the NNT, but on the other hand, side effects tend to increase over time, and these effects should not be ignored as the medication is taken for life.
    Clearly, managing hypertension is a serious matter indeed, having seen the devastation caused by CVD, but an aggressive approach does not apply to the whole population, as the results of this trial demonstrate. Treating numbers is one thing, treating people is another. Clearly, doctors must exercise clinical judgement, and in this day and age discuss uncertainties with patients. As a GP (now retired) my aim is/was to maintain or improve the quality of life for my patients. I fear that Professor Heagerty’s prediction that NICE will need to lower the target BP for GPs to achieve will, in many cases, lead to more complications and a poorer quality of life. Remember statins?

    Reply
    • avatar
      February 8, 2016 at 7:28 pm
      Permalink

      MOST physicians (allopathic) due to their training, (some would call it indoctrination) resort first and foremost to drug “treatment” of a patents symptoms.

      High blood pressure is the symptom of an underlying problem, it is not the THE problem.

      Endlessly handing out band-aids to a self harmer will not solve the problem.

      Reply
      • avatar
        February 8, 2016 at 7:44 pm
        Permalink

        Hi Brian
        Hear hear! I have said the same many times – the body is trying to tell us something and we shut it up with meds – what’s the real problem!?
        Best wishes – Zoe

        Reply
        • avatar
          February 8, 2016 at 10:47 pm
          Permalink

          I’d say the real problem is insulin resistance. That, and age. (Which isn’t really a problem. Unless you get unhappier with increasing age. ;-)

          Reply

Leave a Reply

Your email address will not be published. Required fields are marked *