March 23, 2000 (Washington) -- The painful burning and tingling sensation that many diabetics feel in their legs may be alleviated by a mild electrical shock, but this experimental treatment is being critcized as ineffective by some physicians.
This type of symptom, which results from nerve damage or neuropathy, is a common complication of diabetes, particularly among people who do not have good control over their blood sugar levels. Physicians today treat diabetic neuropathy with a number of drugs that are not approved for the relief of these symptoms, including antidepressants and medications used to stop convulsions, as well as with drugs that are designed to relieve pain.
Some researchers believe that an electrical charge applied to the skin, a process called transcutaneous electric nerve stimulation (TENS), can relieve diabetic pain. TENS is commonly used to treat other muscle or nerve injuries. A new study published in the March issue of the journal Diabetes Care examined the effect of combining TENS with acupuncture needles to which a mild electrical charge had been applied. Each of the 50 people in the study had 10 needles inserted in their legs and feet and received 30-minute charges every week for three weeks. To compare the effect, the researchers also applied needle insertion without the electrical charge for three weeks. All patients were required to have their diabetes under steady control, although the investigators did not monitor the patients for this. Patients were permitted to take typical pain medications as needed.
The study was undertaken by Mohammed A. Hazma, MD, Paul E. White, PhD, MD, and their colleagues in the department of anesthesiology and pain management at the University of Texas Southwestern Medical Center in Dallas. White is the chairman of the department.
Compared with how they felt at the start of the study, the patients reported levels of pain, physical activity, and quality of sleep that were all improved by the end of the study period for the active needles but not for the period of the needle treatment without the electrical charge. Patients also reported a 49% reduction in daily use of pain medication, compared with a 14% reduction during the nonelectrified needle treatment period. Some patients continued having weekly treatments after the study concluded and indicated that they were "willing to pay extra money" for their treatments. None reported side effects.
"Our other research showed this was effective for low back pain," White tells WebMD from Switzerland, where he is a visiting professor in the department of anesthesia at the University of Geneva. "I think there is a potential benefit to [diabetic] patients, but I think it is part of a comprehensive treatment program. It is not a sole treatment," he says. "They need to be on an exercise program. With this, they are feeling more comfortable and less pain. I am not sure how [long] the effects last ... they will still need other analgesics, but it reduced their dependence on them."
The biggest problem in making this therapy more available is the lack of good equipment to generate the electrical charge, White says. White is working with a private firm to develop a device, which would have to be approved by the FDA. A few facilities offer the treatment today and charge $75-125 per treatment, which might be covered by insurance, White says.
However, an endocrinologist and a neurologist who reviewed the study for WebMD both say that it failed to show that the treatment was more effective than placebo.
"Neuropathy is a very bad problem, and anything that could help would be [beneficial]. But the problem is, it is a very short-term study," says George King, MD, director of research at the Joslin Diabetes Center and a professor of medicine at Harvard School of Medicine, both in Boston. "[T]hey can't really do this in a double-blinded fashion [in which the patients don't know which treatment they're receiving]. We don't really know whether this works or not. The ideal treatment is to have a therapeutic agent that prevents or slows down the underlying cause of the problem." He adds that the diabetics who tightly control their blood sugar levels can avoid the risk of neuropathy.
"I am not saying this does not work, but they have not eliminated the placebo effect," says Gary Gerard, MD, director of the Neurology Center of Ohio in Toledo and former vice chairman of the department of neurology and associate professor at the Medical College of Ohio. "The placebo effect in pain of any kind is enormous, and I would say that if they did not eliminate that, it would void the results." Gerard, who was not involved in this study, is conducting studies on medications for neuropathy.
Even if the treatment does work -- and Gerard doubts that it does -- he points out that it would be too costly and impractical, particularly given the prevalence of diabetic neuropathy. "You are talking about three treatments a week, every week -- forever," he says. "To pay for the doctors' time -- it would cost billions."
- Neuropathy, or nerve damage, is a common complication of diabetes, particularly among patients who do not tightly control their blood sugar levels.
- A new technique that applies electrical charges to acupuncture needles could be an effective treatment for neuropathy.
- The treatment has its critics, however, who say the data on its effectiveness are not convincing.