Acupuncture alone and in combination with the antidepressant drug amitriptyline for relief of the pain and muscle weakness experienced by HIV-infected people in their limbs, feet and hands will be examined in a new National Institute of Allergy and Infectious Diseases (NIAID) study.
An estimated 35 to 50 percent of all AIDS patients experience this condition, known as peripheral neuropathy. The most common form of neuropathy, distal symmetric polyneuropathy, initially affects the feet and causes painful sensations, impaired muscle weakness and slowed or absent reflexes in the ankles.
Few studies related to peripheral neuropathy in HIV infection have evaluated the efficacy of different therapies," says Anthony S. Fauci, M.D., director of NIAID. "This study will provide efficacy data and could lead to new treatment options for patients with this debilitating condition."
Five sites of the Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA) will conduct the trial. CPCRA is one of three national AIDS clinical trials networks supported by NIAID.
Therapies for peripheral neuropathy rely on drugs that are often unsatisfactory," adds Lawrence R. Deyton, M.S.P.H., M.D., chief of the community research branch of the Division of AIDS, NIAID. "Finding alternative ways to ease the pain would be of enormous benefit to the well-being of people infected with HIV."
The study drug, amitriptyline, commonly is used to lessen nerve pain in peripheral neuropathy associated with diabetes and hereditary neuropathies. No published studies have documented the drug's effectiveness among people with HIV. Some side effects can occur with this drug, but are less common when lower doses are given.
Acupuncture has been used to prevent and treat diseases in China for two thousand years. This ancient therapy hinges on the belief that a person's state of health depends on the balance and level of energy in the body.
Acupuncture therapy is based on 14 main energy channels in the body, some associated with an organ, and additional secondary channels. During treatment, needles inserted into points along the channels are manipulated to bring the energy flow back into a state of balance and restore the patient's health. Very few adverse effects are associated with acupuncture.
Previous studies of acupuncture for pain relief have been undertaken, but the data have been inconclusive," says Dr. Deyton. However, limited evidence from such studies suggests that 50 to 80 percent of patients appear to benefit from treatment and that some pain relief may be maintained after treatment ends. Results also showed that when given in addition to conventional therapy, acupuncture, in some cases, augments the effects of the other treatment.
"This study represents a major step forward in the scientific evaluation of acupuncture for pain relief," says Mitchell Max, M.D., medical director of the Pain Research Clinic at the National Institute of Dental Research and one of the study investigators. "By enrolling five to ten times more patients than in most previous clinical trials of acupuncture, this CPCRA trial may help answer important questions."
Study investigators plan to enroll 260 people with HIV infection, age 13 or older. Participants must experience peripheral neuropathy in the lower limbs. The patients can have received previous antiretroviral therapy and may take it during the study. People allergic to amitriptyline or being treated for opportunistic infections or malignancies are excluded from the study.
Participants will be randomly assigned to receive initial doses of 25 milligrams (mg.) per day of amitriptyline or placebo. The dose will be increased by 25 mg. every two to three days until 75 mg. per day is reached. All patients will receive acupuncture twice a week for six weeks, then weekly for the following eight weeks. The University of Iowa is supplying amitriptyline and the placebo for the study.
In addition, patients must keep a diary documenting their pain for seven days prior to randomization, during the 14 weeks of treatment and through four weeks of post-treatment follow-up.
The acupuncture protocol, CPCRA 022, is one of 12 studies under way in CPCRA. Established in October 1989, CPCRA involves 17 community-based research programs in 13 U.S. cities, with some 160 affiliated clinical sites. The program includes primary care physicians and nurses who care for large numbers of people with HIV infection in such community settings as hospitals, health centers, private clinics or practices and drug-treatment facilities.
For enrollment information, site location and eligibility requirements for this study, please call 1-800-TRIALS-A, Monday through Friday, 9 a.m. to 7 p.m., E.T.
NIAID, a component of the National Institutes of Health, supports investigators and scientific studies at universities, medical schools, hospitals and research institutions in the United States and abroad aimed at preventing, diagnosing and treating such illnesses as AIDS, tuberculosis, allergy and asthma. NIH is an agency of the U.S. Department of Health and Human Services. For press inquiries only, please call Mary Jane Walker at (301) 402-1663.