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Cheaters May Seriously Skew Clinical Trial Results


Clinical trials are the cornerstone of medical research. Until a new drug or treatment has been tested against existing therapies, physicians are reluctant to use it. But what happens if the patients in the trial cheat?

If it occurs often, cheating could call into question the results of many trials.

A new report by researchers from UCLA and Johns Hopkins University suggests that the problem may be more serious than previously believed. They found that 30% of the volunteer patients in a study of an inhaled asthma drug were simply dumping the drug rather than using it.

The researchers were studying the regular use of metered-dose inhalers to deliver a bronchodilator that the team hoped would slow the progression of chronic obstructive pulmonary disease. Normally, the canisters are weighed at each patient visit to determine how much drug has been used and to correlate that with the patient's own report of drug use.

But preliminary studies had found that some patients engaged in a deceptive practice called "dumping," in which individuals discharge all the medication from the canister so it will appear they have been taking it as instructed.

To examine this practice, the team equipped the inhalers used by 241 participants with small electronic monitors that recorded the exact time and date of each use; 101 were not told about the recorders, while the rest were.

At the end of a year of study, the team reports in the August issue of the journal Chest, 30 of the 101 patients who did not know about the monitor were found to have committed at least one dumping, a number that the team described as "an unexpectedly large and disturbing figure." By contrast, only one of those in the group who were aware of the recorder was caught dumping.

No one knows if similar abuses occur in other clinical trials, but it is safe to assume that they may. Dr. Michael Simmons of UCLA, one of the authors, urged that electronic monitors be used in clinical trials whenever possible to ensure the validity of data.

Zinc as Cold Fighter: It's All in the Dosage

Despite the claims of proponents that zinc lozenges can ease the symptoms of colds, clinical trials have shown distinctly mixed results, with five studies reporting benefits and five reporting none. A new study, however, breaks the tie, suggesting a powerful benefit if the zinc is used in large enough doses.

Dr. Pranatharthi Chandrasekar and his colleagues at the Detroit Medical Center studied 50 cold sufferers, giving half of them a zinc lozenge containing 12.8 milligrams of zinc acetate every two to three hours while they were awake for as long as they had symptoms. The rest received a placebo.

The team reported in the Aug. 15 Annals of Internal Medicine that patients taking the zinc had shorter durations of coughing (3.1 days compared to 6.3), nasal discharge (4.1 days compared to 5.8) and overall symptoms (4.5 days compared to 8.1). All of their cold symptoms, moreover, were less severe than those of the patients taking placebos.

X-Ray Tests Fail to Cut Lung-Cancer Death Rate

The use of frequent chest X-rays to screen for lung cancer does not lower the death rate from the disease, but does lead to a larger number of unnecessary medical procedures to check out benign tumors, according to a massive study by researchers at the Mayo Clinic.

The team enrolled 9,211 men between 1971 and 1983, following them for an average of 20 years. Half received free chest X-rays and saliva tests three times a year for six years. The rest received the same tests once per year.

The team reported in the Aug. 16 Journal of the National Cancer Institute that the mortality rates in the two groups were virtually identical: 337 men in the frequent test group died, compared to 303 in the "usual care" group. But those in the frequent screening group underwent a significantly larger number of biopsies and exploratory procedures that revealed benign tumors.

The study did not look at the newer, more sensitive screening test known as spiral CT scanning. But the authors speculated that this technique would also reveal many more benign tumors. Lung cancer is diagnosed in an estimated 164,100 people each year, and kills 156,900.

Forehead Lifts Helped Some Migraine Sufferers

In a surprising finding, Ohio researchers have discovered that a forehead lift, a common cosmetic surgical procedure, can somehow relieve disabling migraine headaches.

Dr. Bahman Guyuron and his colleagues at Case Western Reserve University studied the records of 314 patients who had undergone the procedure to remove the corrugator supercilii muscle, which is responsible for frown lines.

Thirty-nine of the patients suffered from migraines before the surgery. Of these, 31 had significant improvements in their symptoms immediately after the surgery and, in half of those, the headaches were eliminated completely. The benefits persisted for an average of four years, the group reported in the August issue of Plastic and Reconstructive Surgery.

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