Clemma Jacobsen

A randomized clinical trial of acupuncture compared with sham acupuncture in fibromyalgia

Context A substantial number of patients use acupuncture to treat the symptoms of fibromyalgia, but previous randomized trials of this intervention are inconclusive, in part because of control groups that did not permit adequate blinding of the patients. Contribution This study randomly assigned 100 patients with fibromyalgia to 12 weeks of either true acupuncture treatment or one of 3 types of sham acupuncture. No differences in pain were identified between acupuncture and sham acupuncture. Cautions The study had too few patients to detect small differences between the groups. Patients could use other fibromyalgia therapies, so this study evaluates acupuncture as adjunctive treatment. The Editors Fibromyalgia is a condition of unknown cause that is characterized by chronic, diffuse pain and tenderness to palpation at specific musculoskeletal sites (1). It is the second most common rheumatologic condition after osteoarthritis, afflicting 2% to 4% of the U.S. population (2). Most randomized, controlled trials of allopathic interventions have not demonstrated sustained benefit, and use of complementary and alternative medicine for fibromyalgia is common (3). For example, 60% to 90% of patients with fibromyalgia report using 1 or more complementary or alternative treatments (4, 5), and 22% of these patients have tried acupuncture (6). Despite skepticism in western cultures, the literature suggests that acupuncture may alleviate chronic pain (7). Randomized, controlled trials of acupuncture face many methodologic challenges, including the identification of appropriate treatment and control groups, blinding of study participants, and the inability to blind practitioners (8). Needle placement and the extent to which needle insertion and stimulation is necessary are also controversial (7-9). In the only rigorous randomized, controlled trial of acupuncture for fibromyalgia, 7 of 8 outcome measures significantly improved after 3 weeks of treatment with electroacupuncture (10). However, because blinding was not assessed and electroacupuncture involves perceptible current, these promising results could reflect a lack of blinding to treatment condition. Moreover, the study followed patients only during treatment. Because fibromyalgia is a chronic condition, longer-term outcomes should be examined. To address these methodologic problems, we performed a randomized, controlled trial of acupuncture to treat fibromyalgia that included 3 sham acupuncture treatments to account for the effects of needle insertion and placement. The adequacy of participant blinding was carefully evaluated. We sought to determine whether directed acupuncture that is designed to treat fibromyalgia relieves pain better than does sham acupuncture in adults with fibromyalgia. On the basis of the scant literature and our clinical experience, we hypothesized a priori that directed acupuncture would result in the greatest clinical improvement. Methods Participants Participants were recruited from the greater Seattle, Washington, metropolitan area between January 2001 and September 2002. Recruitment strategies included dissemination of information on the study through newspapers, television, advertisements, signs posted at university-affiliated hospitals, and letters to local fibromyalgia support groups and health care providers with large caseloads of patients with fibromyalgia. Potential participants were told that they had an equal chance of being assigned to 1 of 4 acupuncture interventions, none of which have been proven but 1 of which was believed to have the most potential to improve the symptoms of fibromyalgia. The institutional review boards at the participating institutions approved the study, and participants provided written informed consent. Eligible participants were English-speaking adults 18 years of age or older in whom fibromyalgia was diagnosed by a physician and who had a prerandomization global pain score of 4 or greater on a visual analogue scale (0 = no pain, 10 = worst pain ever). Participants agreed to undergo randomization and kept use of any fibromyalgia-related pharmacologic and nonpharmacologic therapies constant throughout the study. At the baseline evaluation before randomization, a research coordinator trained in tender-point examination confirmed the diagnosis of fibromyalgia by using the 1990 criteria of the American College of Rheumatology (1). Participants were excluded if they reported other pain-related medical conditions or potential contraindications to acupuncture treatment (such as bleeding disorders or severe needle phobia), were pregnant or breastfeeding, used narcotics (which could blunt the effects of acupuncture), were involved in litigation related to fibromyalgia (which might reduce their incentive for improvement), or had previously received acupuncture (to maximize blinding). Randomization Procedure A research coordinator screened and enrolled participants at an academic research center. After participants completed a baseline evaluation, another research coordinator who was uninvolved with data collection randomly assigned them to 1 of 4 treatment groups by using a computer-generated, blocked random-allocation sequence with a block size of 4. This research coordinator informed the acupuncture clinic of the treatment assignment. Intervention Eight U.S.-trained and licensed acupuncturists with a median of 10 years of experience (range, 4 to 18 years) provided study treatments in their private offices. One investigator trained the acupuncturists in the study procedures to increase their comfort with delivering all 4 treatments and monitored compliance with the protocol throughout the study. Participants were assigned an acupuncturist according to geographic convenience and schedule availability, and every effort was made to have them treated by the same acupuncturist for the entire 12 weeks. The primary acupuncturist was defined as the practitioner from whom a participant received the most treatments. In all groups, participants were asked to attend treatment sessions twice weekly for 12 weeks (24 treatments). We considered participants who attended 80% or more (19 of 24) of acupuncture appointments to have completed a full course of treatment. Outcome measures were collected at regularly scheduled time points from participants who discontinued treatment. Participants received directed acupuncture designed to treat fibromyalgia according to the practice of Traditional Chinese Medicine or 1 of 3 sham acupuncture treatments. One sham intervention, a control for acupoint specificity, involved acupuncture typically used to treat irregular menses or early menses due to Blood Heat (an unrelated condition) according to Traditional Chinese Medicine. Another sham intervention, which was also a control for acupoint specificity, used body locations not recognized as true acupoints or meridians for needling (sham needling). The third sham treatment, a control for needle insertion, consisted of noninsertive simulated acupuncture at the same acupoints used in directed acupuncture (simulated acupuncture). This technique, in which a toothpick in a needle guide-tube is used to mimic needle insertion and withdrawal, has been shown to be indistinguishable from true acupuncture in acupuncture-nave patients with back pain (9). Simulated acupuncture more closely duplicates the needle insertion experience than do techniques using placebo needles that require placing adhesive or plastic foam on the skin (11, 12). Acupoints and sham points (Appendix Figure) were chosen by a study acupuncturist with 15 years of experience in treating fibromyalgia and were approved by 3 other senior acupuncturists. In all groups that underwent needle insertion, needles were retained at standard depths (13) for 30 minutes at each acupoint. Disposable Chinese, Japanese, or Korean needles (34 to 40 gauge) were used, depending on the practitioners preference. In the simulated acupuncture group, participants remained on the table for 30 minutes after simulated insertion and then underwent simulated needle withdrawal. Efforts were made to imitate the sounds of opening needle packs and needle disposal. Acupuncturists were not blinded to the treatments they delivered. To maximize participant blinding, we included only acupuncture-nave persons who could not compare their treatment with previous experiences with acupuncture, limited contact among study participants, restricted conversation between acupuncturists and participants, and blindfolded participants during treatment. All research personnel who collected or analyzed data were unaware of treatment group. At the end of 12 weeks, we collected data to assess the adequacy of blinding. Outcome Measures Demographic measures collected at the baseline evaluation included age, sex, race, education, marital status, and duration of pain and diagnosis of fibromyalgia. Participants also listed the types of therapies they had previously tried for their pain. We grouped this information into manual therapies (physical, ergonometric, chiropractic, or massage therapy), mental health therapies (psychotherapy or cognitive behavioral therapy), dietary changes, or other therapies (nerve blocks, hypnosis, or biofeedback). Outcome measures were collected at baseline; after 1, 4, 8, and 12 weeks of acupuncture treatment; and 3 and 6 months after completion of treatment (weeks 24 and 36). The primary outcome was subjective pain, as measured by a standard 10-cm visual analogue scale (0 = no pain, 10 = worst pain ever). Other outcomes measured by using a visual analogue scale were intensity of fatigue (0 = none, 10 = worst ever), sleep quality (0 = worst ever, 10 = best ever), and overall well-being (0 = worst ever, 10 = best ever). We assessed physical and mental functioning by using the Medical Outcomes Study 36-item Short-Form Health Survey (14), which has high reliability and validity in many patient groups, including those

Salivary cortisol among American Indians with and without posttraumatic stress disorder (PTSD): Gender and alcohol influences

Disruptions in hypothalamic-pituitary-adrenal regulation and immunity have been associated with posttraumatic stress disorder (PTSD). We examined the association of PTSD with diurnal rhythms in salivary cortisol in a convenience sample from a population-based study of male and female American Indians. Subjects with and without PTSD were identified from American Indians living on/near a Northern Plains reservation as part of a larger study. Over two days diurnal saliva samples were collected by staff at the University of Colorado Denver Clinical Research Center at waking, 30min after waking, before lunch, and before dinner. Generalized estimating equations linear regression models investigated the influence of PTSD on cortisol over time. The association of a lifetime diagnosis of PTSD with salivary cortisol level was assessed in subjects with complete data (PTSD: n=27; no PTSD n=32) for age, gender, and alcohol consumption in the past month. Subject mean age was 44 years, and 71% were women. When stratified by gender, women with a lifetime diagnosis of PTSD had significantly higher mean cortisol levels throughout the day than women without PTSD (p=0.01); but there was no significant association between PTSD and cortisol levels in men (p=0.36). The cortisol awakening response - the difference in cortisol levels from waking to 30min after waking - was not associated with PTSD in men or women. A lifetime diagnosis of PTSD may influence diurnal cortisol among American Indian women. These effects were independent of influences of current alcohol use/abuse. The unexpected elevation in cortisol in American Indian women with a lifetime diagnosis of PTSD may reflect acute anxiety associated with experiencing a number of novel tests in a strange location (e.g., cardiac imaging, medical, dental exams, etc.), or concurrent depression.

Risk factors for HPV infection among American Indian and white women in the Northern Plains.

OBJECTIVE American Indian (AI) women living in the Northern Plains have high incidence and mortality rates for cervical cancer. We assessed risk factors for human papillomavirus (HPV) infection among AI and White women. METHODS We tested cervical samples for HPV infection obtained from women ages 18-65 years attending 2 rural AI reservation clinics in South Dakota (n=235) and an urban clinic serving predominantly White women (n=246). Patients self-reported information on HPV risk factors. We used percentages and chi-square tests to compare risk factors, and logistic regression with HPV status as the outcome to quantify the association between HPV and risk factors. RESULTS AI women had more risk factors than White women, including younger age, less education, less vegetable consumption, more sexual partners, younger age at first sexual experience and first pregnancy, and more pregnancies (p values≤0.003). AI women more often endorsed recreational drug use, history of sexually transmitted diseases, and current smoking; White women reported more alcohol consumption (p values<0.001). In multivariate analysis, younger age and current smoking were associated with higher odds of HPV infection in AI women, whereas a higher number of sexual partners was associated with higher odds of HPV infection in White women. CONCLUSIONS AI women have a high burden of risk factors for HPV disease, and associations with HPV infection appear to differ by community. Knowledge of specific risk factors in AI populations may provide targets for public health officials to decrease HPV infection and disease.

Functional disability and associated factors among older Zuni Indians.

Few studies have focused on American Indian elderly and functional disability, and none have explored potential moderating or mediating factors that may lend themselves to subsequent intervention. The purpose of this study was to describe the extent of functional disability in elders and to determine which factors were associated with a higher number of Activities of Daily Living (ADL) limitations. The study was a secondary data analysis of an existing survey of American Indian elders in one southwest tribe. Functional disability was defined as limitations in ADLs and was measured by the percent of respondents reporting specific limitations and by the mean total ADL limitations. Multiple linear regression analyses were used to determine the demographic, socioeconomic and health factors associated with ADL limitations. In the 90 elders surveyed, 40 percent of respondents reported a limitation with bathing, 31 percent with walking, and 22 percent with dressing. Only 6 percent of the elders surveyed, however, reported their health status as “poor” on a 5-point scale. Factors associated with more ADL limitations included poorer health status, less frequent exercise, and more elder care services used. Rates of functional disability in this tribe were higher than those found in the U.S. for all races. Further studies are needed to understand functional disability in American Indian elders and their need for long-term care services.

Bone mineral density of American Indian and Alaska Native women compared with non-Hispanic white women: results from the Women's Health Initiative Study.

Objective: To compare bone mineral density (BMD) of American Indian/Alaska Native (AI/AN) women with that of non-Hispanic white women. Design: This cross-sectional study compared mean BMD between AI/AN women and a random sample of non-Hispanic white women matched on geographic region in the Womens Health Initiative Study, a prospective study of postmenopausal women. We analyzed baseline BMD measurements for the total hip, spine, and whole body from 139 AI/AN women and 1,431 non-Hispanic white women. Results: Unadjusted mean spine and whole body BMDs were not significantly different between the two races. Controlling for age, education, and hormone therapy use, adjusted mean BMD was similar by race among women who were underweight, normal, or obese. We found a significant interaction of race by body mass index on spine (P = 0.003) and whole body (P = 0.0003) BMD; thus, analyses were stratified by body mass index. Overweight AI/AN women had slightly lower adjusted mean whole body and spine BMD than overweight non-Hispanic white women (whole body: 0.97 vs 1.03 g/cm2, P = 0.02; spine: 0.96 versus 1.03 g/cm2, P = 0.001). Among extremely obese (body mass index: ≥40.0 kg/m2) women, adjusted mean total hip BMD was higher in the AI/AN women (1.07 vs 0.97 g/cm2, respectively, P = 0.03). Conclusions: Overall, AI/AN and non-Hispanic white women had similar BMDs. This study suggests that extremely obese AI/AN women may have higher BMD at certain skeletal sites compared with extremely obese non-Hispanic white women. However, these results need to be confirmed by additional research.

Influence of Graphic Format on Comprehension of Risk Information among American Indians

Background. Presentation of risk information influences patients’ ability to interpret health care options. Little is known about this relationship between risk presentation and interpretation among American Indians. Methods. Three hundred American Indian employees on a western American Indian reservation were invited to complete an anonymous written survey. All surveys included a vignette presenting baseline risk information about a hypothetical cancer and possible benefits of 2 prevention plans. Risk interpretation was assessed by correct answers to 3 questions evaluating the risk reduction associated with the plans. Numeric information was the same in all surveys, but framing varied; half expressed prevention benefits in terms of relative risk reduction and half in terms of absolute risk reduction. All surveys used text to describe the benefits of the 2 plans, but half included a graphic image. Surveys were distributed randomly. Responses were analyzed using binary logistic regression with the robust variance estimator to account for clustering of outcomes within participant. Results. Use of a graphic image was associated with higher odds of correctly answering 3 risk interpretation questions (odds ratio = 2.5, 95% confidence interval = 1.5–4.0, P < 0.001) compared to the text-only format. These findings were similar to those of previous studies carried out in the general population. Neither framing information as relative compared to absolute risk nor the interaction between graphic image and relative risk presentation was associated with risk interpretation. Conclusion. One type of graphic image was associated with increased understanding of risk in a small sample of American Indian adults. The authors recommend further investigation of the effectiveness of other types of graphic displays for conveying health risk information to this population.

Health Numeracy and Understanding of Risk Among Older American Indians and Alaska Natives

American Indian and Alaska Native people suffer extreme health disparities and remain underrepresented in health research. This population needs adequate numeracy skills to make informed decisions about health care and research participation, yet little is known about their numeracy skills. Participants were 91 American Indian and Alaska Native elders who completed an anonymous survey that measured numeracy and the correlation between framing of risk and comprehension of risk. The authors measured numeracy by a previously developed 3-item scale that assessed basic probability skills and the ability to manipulate percentages and proportions. Risk comprehension was measured by 3 items on treatment benefits, which were variously framed in terms of relative risk reduction, absolute risk reduction, and number needed to treat. Framing in terms of relative risk was associated with higher odds of correct interpretation compared to absolute risk (OR = 1.8, 95% CI = 1.2–2.9) and number needed to treat (OR = 2.0, 95% CI = 1.2–3.5). This association persisted after adjusting for covariates, including baseline numeracy skills. Our results underscore the need for clinicians to consider how health information is framed and to check carefully for understanding when communicating risk information to patients.

Is Psychological Distress a Risk Factor for the Incidence of Diabetes Among American Indians? The Strong Heart Study

This study was conducted to determine if psychological distress increases the risk of type2 diabetes in American Indians. A prospective cohort study of 919 individuals free of diabetes from 13 Native communities was conducted to determine who developed diabetes. Psychological distress was assessed at baseline (1993-1995) by the Mental Component Summary (MCS) of the Short Form-36. The risk of diabetes was estimated at follow-up (1997-1999) according to quartiles of the MCS score. There was no evidence of a trend between psychological distress and the development of diabetes (ptrend = .73). The risk of diabetes in individuals in the highest quartile (17.5%) was nearly identical to that in the lowest quartile (16.5%) (odds ratio = 1.1, 95% confidence interval 0.7-1.7). The absence of association persisted even after adjustment for known risk factors for diabetes. Thus the study concludes that psychological distress is not related to the incidence of diabetes in American Indians.

Physical Activity and Cervical Cancer Testing among American Indian Women.

PURPOSE Studies have shown that women who engage in high levels of physical activity have higher rates of cancer screening, including Papanicalaou (Pap) tests. Because American Indian (AI) women are at high risk for cervical cancer morbidity and mortality, we examined Pap screening prevalence and assessed whether physical activity was associated with screening adherence among AI women from 2 culturally distinct regions in the Northern Plains and the Southwest. METHODS A total of 1,979 AI women at least 18 years of age participating in a cross-sectional cohort study reported whether they received a Pap test within the previous 3 years. Physical activity level was expressed as total metabolic equivalent (MET) scores and grouped into quartiles. We used binary logistic regression to model the association of Pap testing and MET quartile, adjusting for demographic and health factors. FINDINGS Overall, 60% of women received a Pap test within the previous 3 years. After controlling for covariates, increased physical activity was associated with higher odds of Pap screening (OR = 1.1 per increase in MET quartile; 95% CI = 1.1, 1.2). CONCLUSIONS This is the first study to examine physical activity patterns and receipt of cancer screening in AIs. While recent Pap testing was more common among physically active AI women, prevalence was still quite low in all subgroups. Efforts are needed to increase awareness of the importance of cervical cancer screening among AI women.