Great article in NYT
In the above article, Dr. Sarah Hallberg and Osama Hamdy write:
For
Duke to claim only 3.4% have total regain
after 10 years is blind to all the drop outs not included with intention
to treat formula. A medical trial is required to include everyone who
entered into the trial into it's calculations of the percentage of people who benefited from the drug.
The number of patients in the non-surgical group is 1247.
The number of patients in the RYGB surgical group is 564.
Why does peer review JAMA allow an article like this to be published without intention to treat comparisons?
The commentary above says "it is remarkable that such a low number of gastric bypass patients (3%) regained weight back to within 5% of their baseline weight by 10 years, especially in the context of a follow-up rate of 82%."
The study did 1787 RYGB surgeries. Here is how they got the number 82%.
"In this cohort study, differences in weight change up to 10 years after surgery were estimated in retrospective cohorts of 1787 veterans who underwent RYGB from January 1, 2000, through September 30, 2011
(573 of 700 eligible [81.9%] with 10-year follow-up), and 5305 nonsurgical matches (1274 of 1889 eligible [67.4%] with 10-year follow-up) in mixed-effects models."
The Duke trial compares itself to the Adams et al JAMA 2012; 308(11)
This type of waterfall chart helps us understand the distribution of results that usually occurs in weight loss trials. Even Adams has a drop out of 29 patients that may simply be due to people who gained their weight back.
A third study from Annals.
In the above article, Dr. Sarah Hallberg and Osama Hamdy write:
"Recently, 45 international medical and scientific societies, including the American Diabetes Association, called for bariatric surgery to become a standard option for diabetes treatment.
The procedure, until now seen as a last resort, involves stapling, binding or removing part of the stomach to help people shed weight. It costs $11,500 to $26,000, which many insurance plans won’t pay and which doesn’t include the costs of office visits for maintenance or postoperative complications.
And up to 17 percent of patients will have complications, which can include nutrient deficiencies, infections and intestinal blockages.
It is nonsensical that we’re expected to prescribe these techniques to our patients while the medical guidelines don’t include another better, safer and far cheaper method: a diet low in carbohydrates."
I share Dr Hallberg's frustration in the bias against Atkins or Low carb High fat diets while expensive Bariatric bypass data is not looked at very closely.
For example: New Data from Duke
New Data from Duke in JAMA Surgery 31, 2016 Maciejewski et al.
Only 3.4% have total weight regain 10 years after RYGB (Roux en Y Gastric Bypass )
Only 19 of 564 RYBS
surgical patients gained most of their weight back after 10 years.
However the study did 1787 RYGB surgeries.
What happened to the other 1223 patients that had RYBG surgery?
They probably didn't go back to follow up because they gained their weight back?
Thus the wonderful result of 3.4% is meaningless.
If
intention to treat analysis is done, the regain number would be much
higher.
This is the VA, there must be follow up data on these surgeries?
This is the VA, there must be follow up data on these surgeries?
More data from the Duke trial:
“Patients undergoing RYGB lost 21% (95% CI, 11%-31%) more of their baseline weight at 10 years than nonsurgical matches.
“Patients undergoing RYGB lost 21% (95% CI, 11%-31%) more of their baseline weight at 10 years than nonsurgical matches.
A total of 405 of 564 patients undergoing RYGB (71.8%) had more than 20% estimated weight loss,
and 224 of 564 (39.7%) had more than 30% estimated weight loss at 10 years
compared with 134 of 1247 (10.8%) and 48 of 1247 (3.9%), respectively, of nonsurgical matches."
Amazing waterfall results are?:
Non-surgical patients at 10 years
10.8% had more than 20% weight loss?
3.9% had more than 30% weight loss?
The number of patients in the RYGB surgical group is 564.
Why does peer review JAMA allow an article like this to be published without intention to treat comparisons?
The study did 1787 RYGB surgeries. Here is how they got the number 82%.
"In this cohort study, differences in weight change up to 10 years after surgery were estimated in retrospective cohorts of 1787 veterans who underwent RYGB from January 1, 2000, through September 30, 2011
(573 of 700 eligible [81.9%] with 10-year follow-up), and 5305 nonsurgical matches (1274 of 1889 eligible [67.4%] with 10-year follow-up) in mixed-effects models."
The Duke trial compares itself to the Adams et al JAMA 2012; 308(11)
This type of waterfall chart helps us understand the distribution of results that usually occurs in weight loss trials. Even Adams has a drop out of 29 patients that may simply be due to people who gained their weight back.
The data from Sjostrom et. al. 2007 NEJM 357:741 also had a similar drop out rate and still claimed stellar results.
Gastric bypass started with 265 and in 10 yrs was 58.
Vertical banded bypass started with 1369 and ended with 746
A third study from Annals.
Annals of Surgery:
July 2016 - Volume 264 - Issue 1 - p 121–126
Using a large database, Mehaffey and colleagues identified 1,087 patients who had gastric bypass surgery for morbid obesity between 1985 and 2004.
Ten years later, the authors were able to contact 651 of the patients by phone.
Using a large database, Mehaffey and colleagues identified 1,087 patients who had gastric bypass surgery for morbid obesity between 1985 and 2004.
Ten years later, the authors were able to contact 651 of the patients by phone.
10-Year Outcomes After Roux-en-Y Gastric Bypass
Mehaffey, J. Hunter MD; LaPar, Damien J. MD; Clement,
Kathleen C.; Turrentine, Florence E. PhD, RN; Miller, Michael S. MS;
Hallowell, Peter T. MD; Schirmer, Bruce D. MD
Abstract
Objective(s): The aim of the study was to evaluate the
clinical effectiveness and long-term durability of Roux-en-Y Gastric
Bypass (RYGB) at an accredited center.
Background: Short-term data have established the
effectiveness of RYGB for weight loss and comorbidity amelioration. The
long-term durability of this operation remains infrequently described in
the American population.
Methods: All patients (N = 1087) undergoing RYGB at a
single institution over a 20-year study period (1985–2004) were
evaluated.
Univariate differences in preoperative comorbidities,
operative characteristics (laparoscopic vs. open), postoperative
complications, annual weight loss, and current comorbidities were
analyzed to establish trends and outcomes 10 years after surgery.
Results:
Among 1087 RYGB patients, 651 (60%) had
complete 10-year follow-up, including 335 open RYGB and 316 laparoscopic
RYGB.
Patients undergoing open RYGB had a higher preoperative body mass
index. Otherwise, preoperative characteristics were similar.
Postoperative incisional hernia rates were expectedly higher in open (vs
laparoscopic) RYGB (16.9% vs 4.7%; P = 0.02).
Annual %
reduction in excess body mass index significantly improved over time,
peaking at 74% by 24 months, with a slow trend down to 52% at 10 years.
Importantly, a highly significant decrease
in obesity-related comorbid disease persisted at 10 years of follow-up
after RYGB.
Conclusions: Roux-en-Y Gastric Bypass remains an
excellent and durable operation for long-term weight loss and treatment
of obesity-related comorbid disease.
Laparoscopic RYGB results in highly
favorable outcomes with reduced incisional hernia rates.
These 10-year
data help to more clearly define long-term outcomes and demonstrate
outstanding reduction in comorbid disease following RYGB.
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