Lack of herbal supplement characterization in published randomized controlled trials.

PURPOSE: Herbal supplements in the United States and abroad have poor quality control and high content variability. We assessed the extent to which recently published randomized controlled trials of herbal supplements characterized and verified the content of the supplement under study. METHODS: We identified all MEDLINE-indexed English language randomized controlled trials evaluating single-herb preparations of echinacea, garlic, ginkgo, saw palmetto, or St. John's wort that were published between January 1, 2000, and February 9, 2004. From each article we extracted information characterizing the herbal supplement studied. RESULTS: Of 81 randomized controlled trials meeting inclusion criteria, 12 (15%) reported performing tests to quantify actual contents, and 3 (4%) provided adequate data to compare actual with expected content values of at least one chemical constituent. In those 3 studies, actual content varied between 80% and 113% of expected values. Studies of higher overall quality (Jadad score > or =3) performed testing somewhat less frequently (5/54; 9%) than those with lower Jadad scores (7/27; 26%) (P = .09). CONCLUSION: Documented characterization of herbal supplements in published randomized controlled trials is inadequate. Investigators may be unaware of the extent to which herbal quality-control issues may detract from the value of otherwise well-designed clinical trials. The scientific and clinical utility of future herbal randomized controlled trials would be enhanced if authors provided evidence that the herbal products studied were of high quality.

Double-blind placebo-controlled trial of static magnets for the treatment of osteoarthritis of the knee: results of a pilot study.

CONTEXT: Outpatient clinical studies of magnet therapy, a complementary therapy commonly used to treat osteoarthritis (OA), have been limited by the absence of a credible placebo control. OBJECTIVE: Our objective was to assess the feasibility and promise of studying static magnetic therapy for knee OA and determine the ability of a new placebo-magnet device to provide concealment of group assignment. DESIGN: Randomized, double-blind, placebo-controlled clinical trial. SETTING: Academic teaching hospital in Boston. PARTICIPANTS: We enrolled 29 subjects with idiopathic or post-traumatic OA of the knee. INTERVENTIONS: Subjects received either high-strength magnetic (active) or placebo-magnetic (placebo) knee sleeve treatment for 4 hours in a monitored setting and self-treatment 6 hours daily for 6 weeks. MAIN OUTCOME MEASURES: Primary outcomes were change in knee pain as measured by the WOMAC Osteoarthritis Index Pain Subscale at 6 weeks and extent of group concealment at study end. RESULTS: At 4 hours, VAS pain scores (+/- SE) on a 5-item scale (0-500, 500 worst) decreased 79 +/- 18 mm in the active group and 10 +/- 21 mm in the placebo group (P < 0.05). There were no significant differences in any primary or secondary measure of efficacy between the treatment groups at 6 weeks. Despite widespread testing for magnetic properties, at study end, 69% of the active group and 77% of the placebo group (P > 0.2) believed that they had been assigned to the active treatment group. CONCLUSION: Despite our small sample size, magnets showed statistically significant efficacy compared to placebo after 4 hours under rigorously controlled conditions. The sustained efficacy of magnetic therapy for knee osteoarthritis could be assessed in an adequately powered trial utilizing an appropriate control such our new placebo-magnet device.

Use of mind-body medical therapies.

OBJECT: Research demonstrating connections between the mind and body has increased interest in the potential of mind-body therapies. Our aim was to examine the use of mind-body therapies, using data available from a national survey. DESIGN: Analysis of a large nationally representative dataset that comprehensively evaluated the use of mind-body therapies in the last year. SETTING: United States households. PATIENTS/PARTICIPANTS: A total of 2055 American adults in 1997-1998. INTERVENTIONS: Random national telephone survey. MEASURES AND MAIN RESULTS: We obtained a 60% weighted overall response rate among eligible respondents. We found that 18.9% of adults had used at least 1 mind-body therapy in the last year, with 20.5% of these therapies involving visits to a mind-body professional. Meditation, imagery, and yoga were the most commonly used techniques. Factors independently and positively associated with the use of mind-body therapies in the last year were being 40 to 49 years old (adjusted odds ratio [AOR], 2.03; 95% confidence interval [CI], 1.33 to 3.10), being not married (AOR, 1.78; 95% CI, 1.34 to 2.36), having an educational level of college or greater (AOR, 2.21; 95% CI, 1.57 to 3.09), having used self-prayer for a medical concern (AOR, 2.53; 95% CI, 1.87 to 3.42), and having used another complementary medicine therapy in the last year (AOR, 3.77; 95% CI, 2.74 to 5.20). While used for the full array of medical conditions, they were used infrequently for chronic pain (used by 20% of those with chronic pain) and insomnia (used by 13% of those with insomnia), conditions for which consensus panels have concluded that mind-body therapies are effective. They were also used by less than 20% of those with heart disease, headaches, back or neck pain, and cancer, conditions for which there is strong research support. Mind-body therapies were generally used concomitantly with conventional care: 90% of those using a mind-body therapy in the last year had seen a physician and 80% of mind-body therapies used were discussed with a physician. CONCLUSIONS: Although mind-body therapies were commonly used, much opportunity exists to increase use of mind-body therapies for indications with demonstrated efficacy.

Patterns and perceptions of care for treatment of back and neck pain: results of a national survey.

STUDY DESIGN: We conducted a nationally representative random household telephone survey to assess therapies used to treat back or neck pain. OBJECTIVES: The main outcome was complementary therapies used in the last year to treat back or neck pain. SUMMARY OF BACKGROUND DATA: Back pain and neck pain are common medical conditions that cause substantial morbidity. Despite the presumed importance of complementary therapies for these conditions, studies of care for back and neck pain have not gathered information about the use of complementary therapies. METHODS: Our nationally representative survey sampled 2055 adults. The survey gathered detailed information about medical conditions, conventional and complementary therapies used to treat those conditions, and the perceived helpfulness of those therapies. RESULTS: We found that of those reporting back or neck pain in the last 12 months, 37% had seen a conventional provider and 54% had used complementary therapies to treat their condition. Chiropractic, massage, and relaxation techniques were the most commonly used complementary treatments for back or neck pain (20%, 14%, and 12%, respectively, of those with back or neck pain). Chiropractic, massage, and relaxation techniques were rated as "very helpful" for back or neck pain among users (61%, 65%, and 43%, respectively), whereas conventional providers were rated as "very helpful" by 27% of users. We estimate that nearly one-third of all complementary provider visits in 1997 (203 million of 629 million) were made specifically for the treatment of back or neck pain. CONCLUSIONS: Chiropractic, massage, relaxation techniques, and other complementary methods all play an important role in the care of patients with back or neck pain. Treatment for back and neck pain was responsible for a large proportion of all complementary provider visits made in 1997. The frequent use and perceived helpfulness of commonly used complementary methods for these conditions warrant further investigation.

Insurance coverage, medical conditions, and visits to alternative medicine providers: results of a national survey.

BACKGROUND: In 1997, patients made an estimated 629 million visits to complementary and alternative medicine (CAM) providers; however, little is known about factors associated with visits to CAM providers. OBJECTIVE: To examine the effect of insurance coverage on frequency of use of CAM providers. METHODS: We conducted a nationally representative, random household telephone survey of 2055 adults. MAIN OUTCOME MEASURE: The number of visits made to CAM providers. RESULTS: An estimated 44% of the US population used at least 1 CAM therapy in 1997. Of those using CAM, 52% had seen at least 1 CAM provider in the last year. Among those who used a CAM therapy, factors independently associated with seeing a provider were having been in the upper quartile of visits to conventional providers in the last year (adjusted odds ratio [AOR], 2.00; 95% confidence interval [CI], 1.33-3.01), female sex (AOR, 1.67; 95% CI, 1.17-2.38), and having used the therapy to treat diabetes (AOR, 5.20; 95% CI, 1.40-19.40), cancer (AOR, 2.99; 95% CI, 1.04-8.62), or back or neck problems (AOR, 1.51; 95% CI, 1.02-2.23). Factors independently associated with frequent use (. or = 8 visits per year) of a CAM provider were full insurance coverage of the CAM provider (AOR, 5.06; 95% CI, 2.45-10.47), partial insurance coverage (AOR, 3.26; 95% CI, 1.72-6.19), having used the therapy for wellness (AOR, 2.85; 95% CI, 1.63-4.98), and having seen the provider for back or neck problems (AOR, 2.26; 95% CI, 1.29-3.94). Conservative extrapolation to national estimates suggests that 8.9% of the population (17.5 million adults) accounted for more than 75% of the 629 million visits made to CAM providers in 1997. CONCLUSIONS: A small minority of persons accounted for more than 75% of visits to CAM providers. Extent of insurance coverage for CAM providers and use for wellness are strong correlates of frequent use of CAM providers.