Adverse events in the medical group included:
*Two patients had minor gastrointestinal tract adverse effects, and one had persistent diarrhea with metformin.
* One patient developed vasculitic rash, possibly related to rosiglitazone.
* One patient had multiple hypoglycemic episodes.
* One patient was admitted to hospital with angina and a transient cerebral ischemic episode.
* Two patients were intolerant of very low-calorie meal replacement.
Granted all this, how well did the surgery work? The authors state that "Remission of type 2 diabetes was achieved by 26 study participants (43%) at 2 years (22/30 [73%] randomized to the surgical program and 4/30 [13%] to the conventional therapy program) (P less than .001). This represented 76% and 15% remission rates among completers in the surgery and conventional-therapy groups, respectively." Or, more simply, the levels of HbA1c and fasting plasma glucose were significantly lower in the surgical group at two years. And the surgical group lost a lot more weight: The surgical group achieved a mean 20.0% body weight loss at two years, compared with 1.4% among the conventional-therapy group.
The authors conclude: "This randomized trial demonstrates that weight loss associated with adjustable gastric banding results in diabetes remission in the majority of obese participants recently diagnosed as having diabetes and was associated with greater improvements in features of the metabolic syndrome and use of related medications. While caution is required in interpreting the longer-term benefits of surgery and weight loss, this study presents strong evidence to support the early consideration of surgically induced loss of weight in the treatment of obese patients with type 2 diabetes."
These are striking results, and the authors should be congratulated for their efforts.
But should you run out and find a surgeon to band your stomach?
Probably not. If further follow-up shows continued improvement in diabetes control over longer periods of time, and if the results can also be shown in people with more severe diabetes, it may be worthwhile to consider such surgery. However, this study has several built-in biases: the first being that it wasn't double-blinded: everyone knew who got which therapy. Double-blinding such trials is indeed possible, by having all participants get an operation, in which half are banded, and half merely have their belly opened, and no banding - what's called a "sham operation". This concept wasn't mentioned in the publication, and it should be considered for future trials of LAGB for treating T2DM.
Second, the surgeons had extensive experience with the LAGB procedure, and it is well known that there's a correlation between the experience of the LAGB surgical team and incidence of early and late complications. Third, only small numbers of mild cases of T2DM were involved.
The one circumstance where I would be quite comfortable with this idea is if you have the opportunity to participate in a randomized clinical trial, where you would be participating in further study of whether or not the concept works. And of course, in such a case, there'd be a 50-50 chance whether you'd actually get surgery, or perhaps be randomized to receive excellent medical therapy. And if there's sham surgery as part of the trial, you'd definitely get yourself a new scar or two.
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