Alice Pressman

A Randomized Trial Comparing Acupuncture, Simulated Acupuncture, and Usual Care for Chronic Low Back Pain

BACKGROUND Acupuncture is a popular complementary and alternative treatment for chronic back pain. Recent European trials suggest similar short-term benefits from real and sham acupuncture needling. This trial addresses the importance of needle placement and skin penetration in eliciting acupuncture effects for patients with chronic low back pain. METHODS A total of 638 adults with chronic mechanical low back pain were randomized to individualized acupuncture, standardized acupuncture, simulated acupuncture, or usual care. Ten treatments were provided over 7 weeks by experienced acupuncturists. The primary outcomes were back-related dysfunction (Roland-Morris Disability Questionnaire score; range, 0-23) and symptom bothersomeness (0-10 scale). Outcomes were assessed at baseline and after 8, 26, and 52 weeks. RESULTS At 8 weeks, mean dysfunction scores for the individualized, standardized, and simulated acupuncture groups improved by 4.4, 4.5, and 4.4 points, respectively, compared with 2.1 points for those receiving usual care (P < .001). Participants receiving real or simulated acupuncture were more likely than those receiving usual care to experience clinically meaningful improvements on the dysfunction scale (60% vs 39%; P < .001). Symptoms improved by 1.6 to 1.9 points in the treatment groups compared with 0.7 points in the usual care group (P < .001). After 1 year, participants in the treatment groups were more likely than those receiving usual care to experience clinically meaningful improvements in dysfunction (59% to 65% vs 50%, respectively; P = .02) but not in symptoms (P > .05). CONCLUSIONS Although acupuncture was found effective for chronic low back pain, tailoring needling sites to each patient and penetration of the skin appear to be unimportant in eliciting therapeutic benefits. These findings raise questions about acupunctures purported mechanisms of action. It remains unclear whether acupuncture or our simulated method of acupuncture provide physiologically important stimulation or represent placebo or nonspecific effects.

OSTEOARTHRITIS AND RISK OF FALLS, RATES OF BONE LOSS, AND OSTEOPOROTIC FRACTURES

OBJECTIVE To examine the association between osteoarthritis (OA), as defined by radiographic evidence and self report, and osteoporotic fractures, falls, and bone loss in a cohort of elderly white women. METHODS A cohort of 5,552 elderly women from the Study of Osteoporotic Fractures was followed up prospectively for a mean of 7.4 years. Self-reported, physician-diagnosed OA was recorded at interview, and radiologic OA of the hip and hand were defined from pelvis and hand radiographs obtained at baseline by validated techniques. Prevalent and incident vertebral fractures were detected by vertebral morphometry, and data on incident fractures and falls were collected by postcard surveys; fractures were confirmed by radiography. Bone mineral density (BMD) was measured on 2 occasions at the hip, lumbar spine, and calcaneus, and rates of bone loss were calculated. RESULTS Women with radiographic hip OA had a reduced risk of recurrent falls in the first year (relative risk [RR] 0.7, 95% confidence interval [95% CI] 0.5-0.95). However, those with self-reported OA had an increased risk of falls (RR 1.4, 95% CI 1.2-1.5). Radiographic hip OA was associated with reduced bone loss in the femoral neck compared with controls (mean +/- SD -0.29+/-0.09%/year versus -0.51+/-0.03%/year; P = 0.018). However, radiographic hip OA showed nonsignificant trends toward increased bone loss at the calcaneus and lumbar spine. There was no significant association between self-reported OA or radiographic hand OA with bone loss. No definition of OA was associated with incident nonvertebral fracture, hip fracture, or vertebral fracture. CONCLUSION Despite having increased BMD compared with controls, subjects with OA did not have a significantly reduced risk of osteoporotic fracture, although there was a trend toward a reduced risk of femoral neck fractures in subjects with severe radiographic OA. The failure of the observed increase in BMD to translate into a reduced fracture risk may be due, in part, to the number and type of falls sustained by subjects with OA. Patients with OA should not be considered to be at a lower risk of fracture than the general population. Physicians should be aware that a high BMD in patients with OA may be falsely reassuring.

Association between low bone density and stroke in elderly women. The study of osteoporotic fractures.

Background and Purpose To determine whether women with low bone mineral density are at increased risk of stroke, the present study was conducted. Methods We studied 4024 ambulatory women aged 65 years or older participating in the prospective Study of Osteoporotic Fractures. Bone mineral density was measured at baseline using single photon absorptiometry; strokes were ascertained using a computerized Medicare data base and death certificates. Results During a mean of 1.98 years of follow-up, 83 women suffered first strokes (five fatal). Osteopenia was associated with an increased stroke risk: Each SD decrease in bone mineral density at the calcaneus (0.09 g/cm2) was associated with a 1.31-fold increase in stroke (95% confidence interval, 1.03-1.65), adjusted for age, follow-up time, and several potential confounders, including diabetes, systolic blood pressure, use of alcohol, cigarettes or postmenopausal estrogens, cognitive ability, grip strength, and functional ability. The observed relation between bone density and stroke was strongest for intracerebral hemorrhages and occlusions. Conclusions Most likely, low bone density does not cause stroke; some other process probably results in both osteopenia and cerebrovascular disease.

Serum estrogen levels, cognitive performance, and risk of cognitive decline in older community women

OBJECTIVE: To determine the association between serum estrogen levels, cognitive performance, and risk of cognitive decline in older women.

Persistence with weekly alendronate therapy among postmenopausal women

IntroductionAlthough clinical trials indicate that oral bisphosphonates reduce osteoporotic fracture risk, compliance with bisphosphonate therapy in practice is suboptimal, with 1-year discontinuation rates exceeding 50%.MethodsWe conducted a retrospective cohort study among female members of a large integrated health care delivery system (Kaiser Permanente of Northern California), age 45 years and older, to determine their persistence with weekly alendronate (defined as continuous use, allowing for a refill gap of 60 days), predictors of discontinuation, and subsequent osteoporosis therapy. We also examined the effect of varying the refill gap from 30 to 120 days on the discontinuation rate. From 2002 through 2003, we identified 13,455 women (age 68.8±10.4 years) who initiated weekly oral alendronate therapy.ResultsUsing a 60-day refill gap, the 1-year discontinuation rate was 49.6% [95% confidence interval (CI) 48.8–50.4%]; this increased to 58.0% (CI 57.2–58.8%) with a 30-day gap and decreased to 42.2% (CI 41.1–43.0%) with a 120-day gap. Among those who discontinued therapy, about one-third restarted alendronate or another osteoporosis drug within 6 months. Baseline factors associated with alendronate discontinuation included prior bone mineral density testing [adjusted odds ratio (OR) 0.64, CI 0.60–0.69], prior postmenopausal hormone therapy (OR 0.78, CI 0.73–0.84), prior high-dose oral glucocorticoid therapy (OR 1.26, CI 1.05–1.51), prior gastrointestinal diagnoses (OR 1.21, CI 1.09–1.36), and high number of therapeutic classes of prescriptions filled in the prior year (OR 1.21, CI 1.10–1.32), although the final model had limited explanatory power.ConclusionsWe conclude that apparent discontinuation rates are high within 1 year after treatment initiation, although a subset of women appears to restart bisphosphonate or other osteoporosis therapy. Because intermittent use and/or poor adherence is common, discontinuation rates based on data from administrative databases are sensitive to the refill gap length. In addition, we identified no clinical factors highly predictive of discontinuation.

Predictors of physical activity in community-dwelling elderly white women

OBJECTIVE: To describe patterns of physical activity and to determine factors associated with engaging in regular exercise, especially walking, in elderly white women. DESIGN: Cross-sectional study of 9,442 independently living elderly white women aged 65 years and over participating in the Study of Osteoporotic Fractures. MEASUREMENTS AND MAIN RESULTS: We studied the association between lifestyle habits, social factors, health status and self-reported physical activity (assessed by modified Paffenbarger scale) during the past twelve months. Walking was the most common form of exercise: 4,837 (51%) women reported doing so a mean of 12 (SD=10) blocks per day, 3.9 (SD=2.9) times per week. Other common activities were gardening (35%), swimming (16%), and bicycling (13%). Less than a third of women reported engaging in medium- or high-intensity exercise in the past year. In a multivariate age-adjusted analysis, factors independently (P<.01) associated with walking for exercise included greater than high school education (52% vs 48%), history of physical activity for exercise at ages 30 years (51% vs 46%) and 50 years (51% vs 45%), and stronger social network (51% vs 47%). Women who were current smokers, obese, or depressed were less likely to take walks for exercise. Marital status, self-reported arthritis, current estrogen use, and a history of falls in the past year were not independently associated with taking walks for exercise. CONCLUSIONS: In this healthy cohort, walking for exercise is associated with other positive health behaviors. Given the mounting evidence about the health benefits of walking, and since many of these community dwelling women can and do walk for exercise, but rarely engage in other common prescribed physical activities, clinicians might best focus their efforts on encouraging walking.

Neuropsychiatric Function and Dehydroepiandrosterone Sulfate in Elderly Women: A Prospective Study

BACKGROUND Though among the most abundant human steroid hormones, the physiologic role of dehydroepiandrosterone and its sulfate (DHEAS) is not known. Our goal was to determine if DHEAS is associated with cognition and mood in older women, and if baseline DHEAS levels are predictive of cognitive decline. METHODS In a prospective cohort, we studied 394 randomly selected community-dwelling women, aged 65 years or older, currently enrolled in the Study of Osteoporotic Fractures. Subjects were administered a modified Mini-Mental State Exam, Trials B, Digit Symbol, and the Geriatric Depression Scale-Shortened (GDSS), at study onset and 4-6 years later. Serum was obtained at study initiation for DHEAS analysis. RESULTS DHEAS levels declined with age, as expected. There was no consistent association of DHEAS quartile or log DHEAS with any of the four outcomes, even after multivariate adjustment. Change in cognitive performance overtime was not associated with DHEAS levels. Analysis of the 32 women without any detectable DHEAS compared to those with detectable levels revealed higher measures on the GDSS (mean score 3.4 +/- 3.6 compared with 1.6 +/- 2.3, p = .028) and a higher percentage with depression (21.7% compared with 4.6%, p = .001). CONCLUSIONS Serum DHEAS is not a sensitive predictor of cognitive performance or decline on a selected neuropsychological battery in elderly community women; however, nondetectable levels may be associated with depression.

Effect of age on reasons for initiation and discontinuation of hormone replacement therapy.

OBJECTIVE The purpose of this study was to examine age-related differences in reasons that postmenopausal women began and stopped hormone replacement therapy (HRT). DESIGN Two identical telephone surveys were conducted of women members of Kaiser Foundation Health Plan who had begun HRT within the previous 3 years. The first, in 1997, was of 604 older women aged 65 years or older; the second, in 1998, was of 866 younger women aged 50-55 years. Prescription records for both groups provided the means for determining continuation of therapy. RESULTS Among older women, 35% reported prevention or treatment of osteoporosis as the primary reason for starting HRT. Younger women were less likely (14%) to report this (p < 0.001). Relief of vasomotor menopausal symptoms was the most frequently reported reason that younger women gave for starting HRT; it was the primary reason in 34%. In contrast, only 7% of older women reported relief of vasomotor symptoms as the primary reason for starting HRT (p < 0.001). Older women were more likely than younger women to discontinue HRT; after 12 months, the probabilities of discontinuation were 62% and 48% (relative risk = 1.4; 95% confidence interval = 1.2-1.6). Treatment-related side effects were most often the reason given for stopping HRT; 87% of older women and 64% of younger women who stopped reported that a treatment side effect was their primary reason (p < 0.001). Among treatment side effects, vaginal bleeding was the most frequently reported reason for stopping HRT; it was the primary reason for stopping in 52% of older women and 29% of younger women (p < 0.001). CONCLUSIONS Older women differ from younger women in their reasons for starting and stopping HRT. Whereas osteoporosis is the predominant reason that older women begin HRT, relief of vasomotor symptoms is the major reason that younger women begin. Early discontinuation of HRT is common and is greater among older women. Intolerance of treatment, particularly vaginal bleeding, is the predominant reason for stopping HRT.

Initiation of Osteoporosis Treatment after Bone Mineral Density Testing

Abstract: The aim of the study was to describe initiation of osteoporosis drug therapy after bone mineral density (BMD) testing and to determine any association with BMD test results obtained, physician factors, or both. The setting was the Kaiser Foundation Health Plan (KFHP), a large health maintenance organization (HMO) in Northern California. Data were collected from bone densitometry centers at four KFHP medical centers sites in Sacramento, San Rafael, Fresno, and Oakland. We identified 17 290 women aged ≥45 years who had BMD testing between January 1, 1997 and June 30, 1999. After excluding those for whom any osteoporosis drugs were prescribed in the year before testing, 8020 women were available for analysis. Using logistic regression, we examined the association between BMD diagnosis (i.e., osteoporosis or osteopenia versus normal) and initiation of drug therapy for osteoporosis (including hormone replacement therapy (HRT), alendronate, etidronate, raloxifene and calcitonin) within 6 months after the test. Among the 8020 women, 1934 (24%) filled a prescription for an osteoporosis drug within 6 months after BMD testing. Compared with women who had a normal BMD test result, women diagnosed with osteopenia were nearly 4 times more likely (OR = 3.7; CI = 3.0–4.4), and women diagnosed with osteoporosis were 15 times more likely (OR = 15.0; CI = 12.5–18.1), to fill a prescription for an osteoporosis drug within 6 months after BMD testing. Women with high exposure to corticosteroid agents were twice as likely (OR = 2.1; CI = 1.7–2.7) to start osteoporosis drug therapy compared with women who were not similarly exposed; women diagnosed with recent osteoporotic fractures were 50% more likely (OR = 1.5; CI = 1.2–1.9) to begin therapy than women without such fractures. Despite the strong association between BMD and initiating treatment, nearly half the osteoporotic women did not initiate treatment. In addition, we found that age strongly influenced choice of osteoporotic drug. Compared with osteoporotic women aged 45–54 years, women aged 55–64 years who started drug therapy were 40% more likely (OR = 1.4; CI = 1.0–2.2) and women aged ≥65 years were twice as likely (OR = 2.0; CI = 1.4–2.8) to start non-HRT drugs. BMD test results indicating osteoporosis were thus strongly associated with increased likelihood of beginning drug therapy, and half of such women initiated therapy. Drug initiation was also associated with other factors, including age, use of corticosteroid agents, recent fracture, and physician characteristics. However, these factors showed much weaker associations than those found for BMD. Health care providers must consider whether test results will influence treatment decisions, and our data indicate that results of BMD testing do influence management decisions regarding osteoporosis drug use for women.

Diagnosis of symptomatic postmenopausal women by traditional Chinese medicine practitioners.

Objective To learn more about the way that practitioners of traditional Chinese medicine (TCM) diagnose women who have menopausal symptoms. Design We assembled a cohort of 23 postmenopausal women who had hot flushes and were otherwise healthy. Each woman was examined independently by nine practitioners of TCM on the same day. Examination consisted of medical history and physical examination. Diagnoses were recorded and counted. Results The most frequent diagnosis made by the practitioners of TCM was kidney yin deficiency, which was the diagnosis made after 168 of 207 visits (81%); 23 women seen by nine TCM practitioners. Practitioners showed good agreement regarding presence of kidney yin deficiency: in 12 women (52%), this diagnosis was made by eight of nine practitioners; in 16 women (70%), seven of nine practitioners made this diagnosis; and in all 23 women (100%), at least five of nine practitioners made this diagnosis. Conclusions Practitioners of TCM who diagnose postmenopausal women with vasomotor symptoms are likely to make a diagnosis that includes kidney yin deficiency. (Menopause 2000;7:129‐134.