By Kathy Santangelo
Not content with traditional pharmacologic or nonpharmacologic therapies, Western physicians, often spurred on by patients’ interest and demand, are seeking solutions to often difficult clinical problems with acupuncture, supplementations, and other complementary and alternative medicine (CAM). Clinical trials to prove CAM’s efficacy and safety have lagged behind demand, but evidence is accumulating. Two new trials were recently published, adding to evidence-based CAM.
Between 1999 and 2001, 185 patients in 2 hospitals in the United Kingdom (Southampton General and Salisbury District) were randomized to receive either acupuncture (Western style) or placebo for chronic mechanical neck pain (Ann Intern Med. 2004;141:911-919). Peter White, PhD, BSc, of the University of Southampton, and colleagues enrolled patients, aged 18 to 80, with a pain score of >30 mm on a visual analogue scale (VAS) for 5 of 7 pretreatment days. Patients were told that 2 treatments would be used: acupuncture with needles and a machine used to stimulate acupuncture points through skin electrodes.
Treated twice a week for 4 weeks, participants were allowed to use acetaminophen alone for pain but not any other treatment, including exercises or stretches during the study and 2 months afterward. Diaries, using the VAS assessment tool, recorded pain and acetaminophen use at 1 and 8 weeks after treatment. Other questionnaires, such as the Neck Disability Index (NDI) and the Short Form (SF-36) quality-of-life measure, also were used.
Outcomes were measured using the VAS score for pain 1 week after treatment. Longitudinal analysis of this primary outcome showed a significant difference between groups at 5 weeks (P = .011) and 12 weeks (P = .005) after randomization. But the magnitude of the difference in pain experience between groups was only 12% or 6 mm on the VAS, which did not reach the researchers’ definition of clinically significant. Secondary outcomes were similar for both acupuncture and sham groups.
Because pain in both groups diminished by similarly significant amounts, the researchers concluded that improved scores were not specifically caused by acupuncture. They postulated the placebo group could have been receiving active treatment because of the electrode’s light palpation of the acupuncture point. Because of the enhanced magnitude of the placebo plus other nonspecific effects of the acupuncture (ie, women responded better on the VAS and SF-36 assessments; 1 practitioner was seen every week for both groups, and the group at 1 hospital had better responses), the researchers concluded that although acupuncture was clearly effective for neck pain, improvement was due to specific as well as nonspecific effects.
A clinical prediction rule, used to identify patients with low back pain who would benefit from spinal manipulation, was tested by Maj John D. Childs, PhD, PT, and colleagues at 8 US Air Force regional clinics in the United States (Ann Intern Med. 2004;141:920-928).
The rule, developed by Timothy Flynn, PT, PhD, of Regis University, Denver, Colo, and colleagues (Spine. 2002;27:2835-2843), identifies 5 factors that predict a 50% improvement in disability within 1 week with 2 spinal manipulation treatments. The factors are <16 days of symptoms, no symptoms distal to the knee, score <19 on a fear-avoidance measurement, at least 1 hypomobile lumbar segment, and 1 hip with >35 degrees of rotation.
Patients were judged positive on the clinical prediction rule (ie, 4 of 5 criteria met) or negative. After randomization, 131 patients (aged 18-60 years) were assigned to manipulation by a physical therapist plus exercise or exercise alone, for 4 weeks. Disability was assessed at 1 and 4 weeks and again at 6 months via the mail. Inclusion criteria, aside from age, were a primary symptom of low back pain and an Oswestry Disability Questionnaire score of at least 30%.
Patients positive on the rule who received exercise and manipulation decreased their use of health care resources at the end of 6 months. The odds of successful outcomes for this group were 60.8 (95% CI, 5.2-704.7); 2.4 for those negative on the rule who received manipulation and exercise and only 1.0 for those negative on the rule who recived exercise alone.
The researchers agreed that the decision rule proved an invaluable tool in deciding which intervention to use for patients with low back pain.