Health News Review

The story could have provided more helpful context about potential benefits of the drugs in question.  But the story’s warning about the potential for disease-mongering in this area was especially salient.

Our Review Summary

The story induced some uncomfortable cognitive dissonance that should have been resolved. The publication of a study, and this associated news coverage, implies that there is some “news” about treatments for restless leg syndrome to report. But an expert source goes unchallenged when he says, “There is nothing new here at all.” So either there’s news here which the story doesn’t adequately explain, or the expert source is right and there’s no news. The story would have been better had it firmly addressed this uncertainty.


Why This Matters

According to the National Institute of Neurological Disorders and Stroke, restless legs syndrome is “characterized by throbbing, pulling, creeping, or other unpleasant sensations in the legs and an uncontrollable, and sometimes overwhelming, urge to move them.” Although medications can be helpful, no single medication effectively manages symptoms for all individuals. And medications tend to lose their effect over time. It is important for doctors and patients to know which medications are most likely to be effective for the largest number of people, and what adverse effects these medications produce.

Patients with RLS may or may not be aware that they have the condition. For many patients, during the day, symptoms are minor and have little impact on their lives. For patients who present with symptoms of disturbed sleep, RLS is a less common cause than sleep disordered breathing (sleep apnea). For patients with severe RLS, the frequent leg movements disturb sleep leading to daytime fatigue and drowsiness that can be quite impairing. In such situations, RLS can be documented as part of an overnight sleep study that can also look for other causes such as sleep disordered breathing. For patients with RLS whose symptoms are impairing sleep or very bothersome during the day, medication is considered. This study starts by highlighting a 60% improvement with available medicines, but only later gets into the heart of the issue- specifically, that many patients given placebo (fake medicine) also report major improvement and that side effects from these medications are bothersome enough that 25-50% stop taking them. Finally, the study only mentions in passing that the benefits represent short-term outcomes. Since RLS is generally thought to be a chronic problem and given the high side effect rates, it isn’t clear whether current medications are an effective treatment for longer term use.


Criteria

Satisfactory

Does the story adequately discuss the costs of the intervention?

Satisfactory

The story provides monthly cost information for the drugs discussed, and notes that out of pocket expenses will vary depending upon insurance coverage. One note is that neurontin is available generically and is less costly than the brand name described.

Not Satisfactory

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

Not Satisfactory

The story provides the absolute percentage of patients who experienced at least 50% reduction in symptoms in the treatment groups and control groups. Although it specified that these benefits were “short-term,” we wish the story had quantified the length of these studies more precisely.

See our comments above in the “Why This Matters” section about the framing of the benefit. Short-term 60% vs. 40% reduction in symptoms of at least 50% with 25-50% stopping the medicine over a year. This should have been the first point. Then the results don’t seem quite as remarkable.

Satisfactory

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

Satisfactory

The story lists adverse effects commonly seen with both classes of medication discussed in the story. It adds, “Up to 25 to 50 percent with even moderate to severe and longstanding symptoms stop taking these medications after more than a year due to either side effects or lack of benefit.”

Not Satisfactory

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

Not Satisfactory

The story doesn’t explain what this study adds to our knowledge and why it was considered worthy of publication in a national medical journal. As the quoted expert points out, the study does bear more than a superficial resemblance to another recent review and meta-analysis of restless leg syndromes treatments. The story would have done well to explain what the differences were and why this matters.

What is new was the systematic examination of a number of studies and synthesizing the results.

Satisfactory

Does the story commit disease-mongering?

Satisfactory

The authors warn about the potential for disease-mongering of restless leg syndrome (an issue that others have also called attention to in the past). “Treatments for restless legs syndrome is now frequently advertised direct-to-consumer, and thus while this may enhance awareness it may result in patients seeking treatment for milder or other conditions not well-studied,” he explained.

Satisfactory

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

Satisfactory

The story quotes an outside expert who doesn’t appear to have any conflicts of interest related to this topic.

Not Satisfactory

Does the story compare the new approach with existing alternatives?

Not Satisfactory

Although the story notes that drugs may not be appropriate for individuals with milder symptoms, it didn’t discuss what approaches might be useful. Recommendations from the National Institute of Neurological Disorders include:

  • decreased use of caffeine, alcohol, and tobacco
  • Supplements to correct deficiencies in iron, folate, and magnesium as appropriate
  • Taking a hot bath, massaging the legs, or using a heating pad or ice pack.

The key point is that for many individuals with mild symptoms, the cost, side effects and unclear longer term benefits and harms of these medications indicate that many patients will seek other options including options that are low risk but potentially of limited benefit.


Satisfactory

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

Satisfactory

The story notes that the drugs discussed are all approved by the FDA.

Not Satisfactory

Does the story establish the true novelty of the approach?

Not Satisfactory

As noted above, the most confusing point in the presentation of this story was the point of “what’s new here?”

Satisfactory

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

Satisfactory

It’s clear that the story didn’t rely solely or largely on this press release about the study.

Total Score: 6 of 10 Satisfactory


Comments

Paul Scott posted on March 11, 2013 at 10:35 am

Adding to the confusion, RLS may in fact be a drug side effect (akathisia) as this study assumes outright. http://clinicaltrials.gov/show/NCT00065286

Reply

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