Patricia Langenberg

Effectiveness of Acupuncture as Adjunctive Therapy in Osteoarthritis of the Knee: A Randomized, Controlled Trial

Context Previous studies of acupuncture for osteoarthritis have had conflicting results. This may have occurred because most studies have included small samples, a limited number of treatment sessions, or other limitations. Contribution This randomized, controlled trial compared 24 acupuncture sessions over 26 weeks with sham acupuncture or arthritis education in 570 patients with osteoarthritis of the knee. Acupuncture led to greater improvements in function but not pain after 8 weeks and in both pain and function after 26 weeks. No adverse effects were associated with acupuncture. Cautions Many participants dropped out of the study, so readers should interpret the findings at 26 weeks with caution. The Editors Osteoarthritis is the most common form of arthritis and is a major cause of morbidity, limitation of activity, and health care utilization, especially in elderly patients (1, 2). Pain and functional limitation are the primary clinical manifestations of osteoarthritis of the knee. Current recommendations for managing osteoarthritis, including guidelines published by the American College of Rheumatology (3) and European League of Associations of Rheumatology (4), focus on relieving pain and stiffness and maintaining or improving physical function as important goals of therapy. No curative therapies exist for osteoarthritis; thus, both pharmacologic and nonpharmacologic management focus on controlling pain and reducing functional limitation (5). Nonpharmacologic therapy, which includes patient education, social support, physical and occupational therapy, aerobic and resistive exercises, and weight loss, is the cornerstone of a multidisciplinary approach to osteoarthritis patient management (3). Pharmacologic therapies include nonopioid analgesics (such as acetaminophen), nonsteroidal anti-inflammatory drugs (NSAIDs) (including cyclooxygenase-2 [COX-2] enzyme selective inhibitors), topical analgesics (capsaicin cream), opioid analgesics, and intra-articular steroid and hyaluronate injections. Often, these agents are used in combination for additive analgesic efficacy (6). Pharmacologic management of osteoarthritis is often ineffective, and agents such as NSAIDs may cause unwanted and dangerous side effects (7, 8). Complementary and alternative medicine is another approach to treating osteoarthritis (9-12), particularly in Asian societies (13). Many U.S. patients with osteoarthritis also use complementary and alternative medical therapies (14). A systematic review of acupuncture and knee osteoarthritis (15) identified 7 small randomized, controlled trials published in English. Within the methodologic limitations of the studies, the evidence suggested that acupuncture seemed to alleviate knee pain and function compared with sham acupuncture controls, although 2 trials comparing acupuncture with an active, nonpharmacologic treatment (physical therapy) did not indicate such an effect (16, 17). Before conducting our large-scale trial, we completed both a pilot study (18) and a randomized, single-blind trial (19) of the effect of acupuncture on osteoarthritis of the knee. Participants in the uncontrolled pilot study (n= 12) showed statistically significant improvement in both self-reported pain and physical function, as well as performance measures of physical function after 8 weeks of acupuncture treatment and at 12-week follow-up as compared with their baseline (18). In our larger randomized, single-blind trial (n= 73), which examined the benefit of acupuncture added to standard management with NSAIDs, the acupuncture treatment group experienced statistically significant improvements in self-reported pain and disability scores compared with a standard-care control group as late as 4 weeks after the end of treatment (19). However, this effect diminished within 18 weeks (26 weeks after the beginning of the trial) after the final acupuncture treatment. Together, however, the previously conducted trials (both our preliminary studies [18, 19] and those referenced in the systematic review [15]) have 3 methodologic limitations: lack of credible controls for the placebo effect, inadequate assessment of long-term treatment benefits, and insufficient sample sizes. We tested the hypothesis that an 8-week intensive acupuncture treatment regimen, followed by an 18-week tapering regimen, reduces pain and improves function among patients with knee osteoarthritis as compared with both sham acupuncture and education control groups. Methods Patient Recruitment We recruited patients for this multisite, placebo-controlled trial from March 2000 through December 2003, primarily through print and radio advertisements. The 3 sites were the Integrative Medicine Clinic of the University of Maryland School of Medicine, Baltimore, Maryland; the Innovative Medical Research Center (a private research firm), Towson, Maryland; and the Hospital for Special Surgery, New York City, New York. The institutional review boards of the 3 sites approved the study. We determined the sample size (n= 570) by a power analysis based on our randomized pilot study (19), adjusted by the estimated decrease in effect size resulting from the inclusion of a sham acupuncture group designed to control for placebo effects. Patients met the following inclusion criteria: age 50 years or older, a diagnosis of osteoarthritis of the knee, radiographic evidence of at least 1 osteophyte at the tibiofemoral joint (KellgrenLawrence grade 2), moderate or greater clinically significant knee pain on most days during the past month, and willingness to be randomly assigned. Exclusion criteria were the presence of serious medical conditions that precluded participation in study, bleeding disorders that might contraindicate acupuncture, intra-articular corticosteroid or hyaluronate injections (as well as any knee surgeries or concomitant use of topical capsaicin cream) during the past 6 months, previous experience with acupuncture, or any planned events (including total knee replacement) that would interfere with participation in the study during the following 26 weeks. After a brief telephone screening, patients were scheduled to visit 1 of the 3 participating sites to sign an informed consent statement and undergo a brief rheumatologic examination (including radiographic examination of affected knees) by a physician or a nurse practitioner. Because the education course was a group activity, patients were recruited until a cohort of 12 to 21 patients was formed, at which point each cohort at each site was randomly assigned to 1 of 3 groups by a computer-generated process using randomly selected blocks of 3, 6, and 9. We assured allocation concealment by using disguised letter codes that were generated and sent to the site coordinators by a central statistical core. We used this procedure to ensure that approximately equal numbers of participants were in each treatment group across the course of the study, to ensure that each cohort would have participants assigned to all 3 treatment groups, and to make the breaking of the group assignment process more difficult. The research assistants who collected assessments from participants, the participants themselves (in the true acupuncture and sham acupuncture groups), and the statistician were blinded to group assignment. Assessments were conducted at baseline and 4, 8, 14, and 26 weeks after randomization. Study Interventions We developed and modified the acupuncture treatment and sham control protocols from previously reported and validated procedures (18-21). During the trial, 7 acupuncturists were used: 3 at the Integrative Medicine Clinic, 3 at the Innovative Medical Research Center, and 1 at the Hospital for Special Surgery. In general, acupuncturists were assigned to the same participants throughout the 26-week treatment schedule, except for vacation conflicts and staff turnover, and provided approximately the same proportions of true versus sham procedures. All acupuncturists were state-licensed and had at least 2 years of clinical experience. The studys principal acupuncturist trained and supervised the acupuncturists in performing true or sham procedures and avoiding interactions that could inadvertently communicate group assignment. True Acupuncture The true acupuncture (experimental) group underwent 26 weeks of gradually tapering treatment according to the following schedule: 8 weeks of 2 treatments per week followed by 2 weeks of 1 treatment per week, 4 weeks of 1 treatment every other week, and 12 weeks of 1 treatment per month. We based the acupuncture point selections on Traditional Chinese Medicine meridian theory to treat knee joint pain, known as the Bi syndrome. These points consisted of 5 local points (Yanglinquan [gall bladder meridian point 34], Yinlinquan [spleen meridian point 9], Zhusanli [stomach meridian point 36], Dubi [stomach meridian point 35], and extra point Xiyan) and 4 distal points (Kunlun [urinarybladder, meridian point 60], Xuanzhong [gall bladder meridian point 39], Sanyinjiao [spleen meridian point 6], and Taixi [kidney meridian point 3]) on meridians that traverse the area of pain (22, 23). The same points were treated for each affected leg. If both knees were affected, 9 needles were inserted in each leg. (The outcome measures were not specifically targeted to whether the patient had osteoarthritis in 1 or both knees, and we observed no differential effects on the basis of the number of knees treated.) The acupuncturists inserted 1.5-inch (for local points) and 1-inch (for distal points) 32-gauge (0.25-mm diameter) acupuncture needles to a conventional depth of approximately 0.3 to 1.0 inch, depending on point location. All participants in the treatment group achieved the De-Qi sensation, a local sensation of heaviness, numbness, soreness, or paresthesia that accompanies the insertion and manipulation of needles during acupuncture, at these 9 points. Acupuncturists applied electrical stimulati

Chinese‐white differences in the distribution of occlusive cerebrovascular disease

The distribution of cerebrovascular lesions is affected by race. Blacks and Japanese have more intracranial occlusive cerebrovascular disease, while whites have more extracranial disease. Despite a high incidence of stroke in China, there are few formal studies of the distribution of vascular occlusive disease in Chinese populations. We compared clinical and angiographic features of 24 white and 24 Chinese patients with symptomatic occlusive cerebrovascular disease. In symptomatic vascular territories, whites had more severe (≥50% stenosis) extracranial lesions, while Chinese had more severe intracranial lesions. When we counted mild and severe lesions in a symptomatic territory, whites had more extracranial lesions while Chinese had more intracranial lesions. When we combined symptomatic and asymptomatic temtories, whites had more extracranial lesions, while Chinese had more intracranial lesions. White patients reported more transient ischemic attacks. The distribution of lesions, however, was not explained by differences in incidence of transient ischemia, hypertension, diabetes, hypercholesterol-emia, or ischemic heart disease between the groups. The preponderance of intracranial vascular lesions in Chinese patients is similar to that seen in blacks and Japanese. Racial differences in the occurrence of extracranial and intracranial lesions raise the possibility of a different underlying pathophysiology for the 2 locations.

The fellow eye in NAION: Report from the Ischemic Optic neuropathy decompression Trial Follow-up study

PURPOSE To examine the prevalence and incidence of second eye nonarteritic anterior ischemic optic neuropathy (NAION) and associated patient characteristics in patients enrolled in the Ischemic Optic Neuropathy Decompression Trial (IONDT) Follow-up Study. DESIGN Randomized clinical trial with observational cohort. METHODS Patients randomized to optic nerve sheath decompression surgery or careful follow-up had a diagnosis of acute unilateral NAION, visual acuity between 20/64 and light perception, and were aged 50 years or older. Eligible patients who declined randomization or whose visual acuity was better than 20/64 were not randomized but followed as part of an observational cohort. Follow-up examinations took place at 3, 6, 12, 18, and 24 months and annually thereafter. RESULTS Four hundred eighteen patients were enrolled; 258 randomized and 160 observed. Previous NAION or other optic neuropathy was present in the fellow eye of 21.1% (88/418) of patients at baseline. Four patients developed optic neuropathy in the fellow eye at follow up that could not be conclusively diagnosed as NAION. New NAION in the fellow eye occurred in 14.7% (48/326) of patients at risk during a median follow up of 5.1 years. Randomized patients experienced a higher incidence (35/201; 17.4%) than nonrandomized patients (13/125; 10.4%). A history of diabetes and baseline visual acuity of 20/200 or worse in the study eye, but not age, sex, aspirin use, or smoking were significantly associated with new NAION in the fellow eye. Final fellow eye visual acuity was significantly worse in those patients with new fellow eye NAION whose baseline study eye visual acuity was 20/200 or worse. CONCLUSIONS Follow-up data from the IONDT cohort provide evidence that the incidence of fellow eye NAION is lower than expected: new NAION was diagnosed in 14.7% of IONDT patients over approximately 5 years. Increased incidence is associated with poor baseline visual acuity in the study eye and diabetes, but not age, sex, smoking history, or aspirin use.

Effectiveness of hysterectomy

Objective To measure the effectiveness of hysterectomy in relieving adverse symptoms and to identify factors associated with lack of symptom relief. Methods In a 2-year prospective study, data were collected before and at 3, 6, 12, 18, and 24 months after hysterectomy in 1299 women who had hysterectomies for benign conditions at 28 hospitals across Maryland. Effectiveness was measured in terms of relief of symptoms such as problematic vaginal bleeding, pelvic pain, and urinary incontinence. Psychologic function and quality of life before and after surgery also were assessed. Results Symptom severity, depression, and anxiety levels decreased significantly after hysterectomy and quality of life improved, particularly in the area of social function. However, 8% of women had at least as many symptoms at problematic-severe levels 1 and 2 years after hysterectomy as before. In multiple logistic regression, several presurgical patient characteristics predicted lack of symptom relief, including therapy for emotional or psychologic problems, depression, and household income of

Effects of acupuncture on rates of pregnancy and live birth among women undergoing in vitro fertilisation: systematic review and meta-analysis.

35,000 or less. Bilateral oophorectomy predicted lack of symptom relief at 24 months but not at 12 months after hysterectomy. Conclusion Significant improvements were seen after hysterectomy for all three aspects of health status (symptoms, psychologic function, and quality of life), which persisted or continued to improve throughout the 2 years of follow-up. However, hysterectomy did not relieve symptoms for some women, particularly those who had low incomes or were in therapy at the time of hysterectomy.

Chronic gynecological conditions reported by US women: findings from the National Health Interview Survey, 1984 to 1992.

Objective To evaluate whether acupuncture improves rates of pregnancy and live birth when used as an adjuvant treatment to embryo transfer in women undergoing in vitro fertilisation. Design Systematic review and meta-analysis. Data sources Medline, Cochrane Central, Embase, Chinese Biomedical Database, hand searched abstracts, and reference lists. Review methods Eligible studies were randomised controlled trials that compared needle acupuncture administered within one day of embryo transfer with sham acupuncture or no adjuvant treatment, with reported outcomes of at least one of clinical pregnancy, ongoing pregnancy, or live birth. Two reviewers independently agreed on eligibility; assessed methodological quality; and extracted outcome data. For all trials, investigators contributed additional data not included in the original publication (such as live births). Meta-analyses included all randomised patients. Data synthesis Seven trials with 1366 women undergoing in vitro fertilisation were included in the meta-analyses. There was little clinical heterogeneity. Trials with sham acupuncture and no adjuvant treatment as controls were pooled for the primary analysis. Complementing the embryo transfer process with acupuncture was associated with significant and clinically relevant improvements in clinical pregnancy (odds ratio 1.65, 95% confidence interval 1.27 to 2.14; number needed to treat (NNT) 10 (7 to 17); seven trials), ongoing pregnancy (1.87, 1.40 to 2.49; NNT 9 (6 to 15); five trials), and live birth (1.91, 1.39 to 2.64; NNT 9 (6 to 17); four trials). Because we were unable to obtain outcome data on live births for three of the included trials, the pooled odds ratio for clinical pregnancy more accurately represents the true combined effect from these trials rather than the odds ratio for live birth. The results were robust to sensitivity analyses on study validity variables. A prespecified subgroup analysis restricted to the three trials with the higher rates of clinical pregnancy in the control group, however, suggested a smaller non-significant benefit of acupuncture (odds ratio 1.24, 0.86 to 1.77). Conclusions Current preliminary evidence suggests that acupuncture given with embryo transfer improves rates of pregnancy and live birth among women undergoing in vitro fertilisation.

Mindfulness intervention for child abuse survivors

OBJECTIVES This study sought to describe prevalence rates of chronic gynecological conditions and correlates of these conditions in a representative sample of US women. METHODS National Health Interview Survey data from 1984 through 1992 for women aged 18 to 50 were used. RESULTS The estimated annual prevalence rate for the reported presence of one or more gynecological conditions was 97.1 per 1,000 women. Menstrual disorders were most common, with an annual prevalence rate of 53.0 per 1,000 women. Adnexal conditions and fibroids were the next most common conditions, with rates per 1,000 women of 16.6 and 9.2, respectively. Prolapse, endometriosis, and fibroids were the conditions most likely to lead to hysterectomy within the year prior to the interview. More than three quarters (77.1%) of women with gynecological conditions had talked with a doctor in the previous year concerning their condition, and 28.8% reported spending 1 or more days in bed in the previous year because of their condition. CONCLUSIONS Nearly a tenth of American women aged 18 to 50 report having one or more chronic gynecological conditions annually, the most common being disorders of menstruation.

Pedestrian injuries and vehicle type in Maryland, 1995-1999

Twenty-seven adult survivors of childhood sexual abuse participated in a pilot study comprising an 8-week mindfulness meditation-based stress reduction (MBSR) program and daily home practice of mindfulness skills. Three refresher classes were provided through final follow-up at 24 weeks. Assessments of depressive symptoms, post-traumatic stress disorder (PTSD), anxiety, and mindfulness, were conducted at baseline, 4, 8, and 24 weeks. At 8 weeks, depressive symptoms were reduced by 65%. Statistically significant improvements were observed in all outcomes post-MBSR, with effect sizes above 1.0. Improvements were largely sustained until 24 weeks. Of three PTSD symptom criteria, symptoms of avoidance/numbing were most greatly reduced. Compliance to class attendance and home practice was high, with the intervention proving safe and acceptable to participants. These results warrant further investigation of the MBSR approach in a randomized, controlled trial in this patient population.

Final results of the Maryland WIC 5-A-day promotion program

Pedestrian deaths constitute the second largest category of motor vehicle deaths in the US. The present study examined how pedestrian injury is associated with vehicle type, while controlling for vehicle weight and speed.Police, trauma registry, and autopsy data were linked for injured pedestrians. Logistic regression analyses were performed to control for vehicle weight and speed. Outcomes included pedestrian mortality, injury severity score, and injuries to specific body regions. Compared to conventional cars, pedestrians hit by sport utility vehicles and pick-up trucks were more likely to have higher injury severity scores (odds ratio=1.48; 95% confidence interval: 1.18-1.87) and to die (odds ratio=1.72; 95% confidence interval: 1.31-2.28). These relationships diminished when vehicle weight and speed were controlled for. At lower speeds, pedestrians struck by sport utility vehicles, pick-up trucks, and vans were approximately two times as likely to have traumatic brain, thoracic, and abdominal injuries; at higher speeds, there was no such association. The overall increased danger sport utility vehicles and pick-up trucks present to pedestrians may be explained by larger vehicle masses and faster speeds. At slower speeds being hit by sport utility vehicles, and pick-up trucks, and vans resulted in specific injuries, indicating that vehicle design may contribute to different injury patterns.

Vitamin E prophylaxis to reduce retinopathy of prematurity: A reappraisal of published trials

OBJECTIVES This National Cancer Institute-funded study sought to increase fruit and vegetable consumption among women served by the WIC program in Maryland. METHODS Over a 2-year period, a multifaceted intervention program using a randomized crossover design sought to increase fruit and vegetable consumption at 16 WIC program sites in Baltimore City and 6 Maryland counties. Participants were surveyed at baseline, 2 months postintervention, and 1 year later. RESULTS Two months postintervention, mean daily consumption had increased by 0.56 +/- 0.11 servings in intervention participants and 0.13 +/- 0.07 servings in control participants (P = .002). Intervention participants also showed greater changes in stages of change, knowledge, attitudes, and self-efficacy. Changes in consumption were closely related to number of nutrition sessions attended, baseline stage of change, race, and education. One year later, mean consumption had increased by an additional 0.27 servings in both intervention and control participants. CONCLUSIONS Dietary changes to prevent cancer can be achieved and sustained in this hard-to-reach, low-income population. However, many obstacles must be overcome to achieve such changes.