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Study: Poor Results From Lap-Band Surgery

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4 Star

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Study: Poor Results From Lap-Band Surgery

Our Review Summary

This story detailed the long-term outcomes at one institution for obese individuals who had gastric banding surgery.  The story was clear about the drawbacks inherent in the study. For example, that the data were obtained from a relatively small number of patients, and these patients, by virtue of the time at which they had the surgery performed, may differ somewhat from the results in current patients. The story also presented information  useful for setting up realistic expectations about the long-term benefits and potential harms of gastric banding. As more people consider the available options for assisting in obesity management, the information about the amount of weight lost and the lackluster impact on weight-related health conditions, such as type 2 diabetes, hypertension, and sleep apnea, this story serves as an important counterbalance to the direct-to-consumer advertising on the procedure.

 

Why This Matters

Obesity is a significant public health issue and impacts up to one third of American adults. Diet and exercise are still the preferred approach. Drug therapy for obesity remains elusive as evidenced by the recent refusal of the FDA to approve Qnexa. Increasingly, people with morbid obesity are turning to surgical treatments. Patients have two choices in this regard. The standard gastric bypass or placement of an adjustable band around the stomach opening. Both approaches are deemed safe. While the banding approach is simpler and carries fewer immediate risks, the weight loss is not as great as with the bypass procedure. This new study adds to our understanding of the longstanding outcomes of a group of patients who received an earlier generation banding device.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

As with the HealthDay story we reviewed, there was no discussion of costs of the banding procedure nor for regular office visits for band adjustment.  Although these costs were not detailed in the study reported on, this information is readily available.  We think that this is unfortunate given the magnitude of the cost of the procedure. We also would have liked to have seen a comment or two about insurance coverage

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Satisfactory

The only benefit reported on in this story was the average loss of excess weight experienced by those who had had the procedure and in those who still had their Lap-Bands at the end of the study period.

Does the story adequately explain/quantify the harms of the intervention?

Satisfactory

The story did a good job providing information about the common harms, along with the percentage of individuals affected.

Does the story seem to grasp the quality of the evidence?

Satisfactory
The story included a fair amount of information about the study as well as the concerns about the quality of the study voiced by a company spokesperson. Unlike the story we reviewed from HealthDay, this one included information about the number of patients lost to follow up. A key element of the study, however, is the relatively high adverse event rate as compared to earlier studies. Other published studies identified in the paper saw much lower event rates. This point was made by the company spokesperson, but the story should have pointed out that the paper itself notes the discrepancy. This would have provided readers with valuable information.

Does the story commit disease-mongering?

Satisfactory

The story did not engage in overt disease-mongering.

Does the story use independent sources and identify conflicts of interest?

Satisfactory

The story included interview comments from a company spokesperson and one of the authors of the study, both of whom were clearly identified.  The story also included this important detail about the quoted author, which was missed by the HealthDay story we reviewed. “Himpens reports consultant work for Ethicon Endosurgery, which makes another gastric band, Realize, and for Covidien, a health care products company.” In addition, the story had comments from two surgeons who do not appear to have direct ties with either the manufacturer of the product or the study reported on. We were a little concerned about some of the phrasing in the story. It says, “But some, including the manufacturer of the Lap-Band — used in a technique called laparoscopic adjustable gastric banding — take exception to the study, criticizing the small sample size and the number of patients lost to follow-up.The critics also point out that both the device itself and the expertise of surgeons placing it have improved greatly since the patients in the study had their bands placed, in the years 1994 through 1997.” This leads readers to believe that there are mulitple critics out there pointing out flaws in the study. The story itself, though, only quotes one actual critic: the company spokewoman. The criticisms may be valid, but readers deserved a strong independent analysis of the study’s limitations.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

While the story did mention at the very end how the pace of weight loss with the product reported on compared with weight loss following gastric bypass surgery, the story ought to have provided better insight about the long-term outcomes in those who have gastric bypass and those who chose not to have surgery to help manage their excess weight.  That way, readers could compare the two commonly utilized surgical options and understand the differences between them. The story hints at this by paraphrasing a study author saying that Lap-Band patients, “may have less weight loss and more complications than those who choose other weight loss surgeries.” But it never provides any evidence to back that claim. We also would have liked to have seen some comment about diet and exercise.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The story makes it clear that the gastric banding procedure is available and provides a link to information from the National Institutes of Health.

Does the story establish the true novelty of the approach?

Satisfactory

The story was clear that it was not reporting on a new or novel treatment but rather was reporting on the long-term outcomes presented in a recent research paper.

Does the story appear to rely solely or largely on a news release?

Satisfactory

This story does not appear to be based exclusively on a news release.

Total Score: 8 of 10 Satisfactory

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