Recently, it was announced that the UK's National Health Service (NHS) will fund the provision of a diet-based protocol to any person diagnosed with type 2 diabetes over the preceding 6 years in a bid to push their diabetes into remission.
The plan's announcement follows the unpublished 5-year outcomes of the DiRECT trial, which detailed the impact of a 12-week low-calorie formula diet, often referred to as the "soup and shakes" diet, coupled with ongoing interprofessional counseling on type 2 diabetes remission.
The findings, presented at the Diabetes UK Professional Conference 2023 in Liverpool on April 26, certainly sound fantastic per their press release, with shout-out quotes from the study's lead author, Dr Roy Taylor, exclaiming, "For those who remain free of diabetes, the study has been life-changing. It is difficult for people who do not have type 2 diabetes to appreciate what it means to have escaped from the shadow of this serious condition"; and from someone still in remission, "It's amazing that what I went through all those years ago is still benefiting me today. I'm still in remission and not on any diabetes medication — I can't quite believe how long it's been."
Maybe it's unfair of me and I'm just a curmudgeon, but testimonials in press releases touting life-changingness strike me as a bit of a red flag, and so I popped out my calculator. According to my simple number-crunching of this new completer's analysis of the 2-year DiRECT trial's participants (completers because they are reporting not on an intention-to-treat basis from DiRECT's start but rather only on those who had stayed in the study and achieved remission of their diabetes at year 2), by year 5, just 8% of those who were enrolled in the original DiRECT trial saw remission of their diabetes — 12 whole people.
To show my very basic math: 35% (52 of the 149 patients) in the original DiRECT trial were found to be in remission at the end of 2 years. Of those 52 patients, the new data report that 23%, or 12, were still in remission at the end of 5 years. As an intention-to-treat percentage, those 12 participants represent 8% of the DiRECT trial's originally enrolled treatment arm. Also worth noting is that 3.4% of the DiRECT trial's enrolled control group were also found to be in remission at 5 years.
Is that good? Or to ask this differently, is 4.6% more treated patients than control achieving a 5-year remission fairly characterized as "many patients," as did Professor Jonathan Valabhji, NHS England's national clinical director for diabetes and obesity in announcing the NHS' coverage? He was quoted as saying, "Research is clear that weight loss where indicated goes a long way to helping people stay well and avoiding preventable illness, and in many cases it can be the trigger for putting type 2 diabetes into remission. So I am delighted that thousands more people are making use of this programme, with thousands more set to benefit across England in the coming year."
Also, is the 2017 DiRECT trial, as this latest press release states, "the first (study) to show that remission from type 2 diabetes is possible through a dietary intervention in primary care"?
That might be news to the authors of the Look AHEAD trial's 2016 published 4-year data which demonstrated, if we frame it the same way as these new DiRECT trial outcomes, that at year 4, 38% of those whose diabetes was in remission at the end of year 2 of their intensive lifestyle intervention remained in remission at the end of year 4. In absolute numbers, 3.5% of intensive lifestyle intervention participants were in remission at the end of year 4 vs 0.4% of the control group.
Ultimately, I'm all for funding of interprofessional dietary support for patients with diet-related chronic diseases. What I'm not for is hyperbole coming from press releases, study authors, and public officials about dietary interventions. Honestly, our world is rife with diet quackery and credible people making hyperbolic statements that serve to underwrite the diet zealots' grift by upholding the notion some combination of education and willpower will strongly drive weight loss. The truth, however much the world wants to pretend otherwise, is that weight is influenced by dozens if not hundreds of factors far beyond our direct control, and permanent lifestyle change requires tremendous degrees of privilege to enact in perpetuity. Suggesting otherwise does a disservice to medicine and to people with obesity.
Follow Yoni Freedhoff on Twitter @YoniFreedhoff