Nonpharmacological Self-Management of Migraine Across Social Locations: An Equity-Oriented, Qualitative Analysis.

BACKGROUND: Migraine is a disabling neurological disorder and the sixth biggest cause of disability worldwide. The World Health Organization has declared migraine a major public health problem due to a paucity of knowledge about cause and effective treatment options. Both in incidence and severity, migraine disproportionately affects people occupying marginalized social locations (SL). Managed pharmacologically, migraine is treated with daily preventive and as-needed abortive medications. Both come with high literal and figurative costs: intolerable side effects, medication interactions, and prohibitive prices. Cost prohibitive, ineffective, and unsustainable pharmacological treatment options have contributed to high levels of interest in complementary approaches by people with migraine, but little is known about their motivations, patterns of use or access, or how these may vary by SL. METHOD: We conducted focus groups with 30 people with migraine to explore their desires and recommendations for migraine clinicians and researchers. We used qualitative content analysis to identify themes.Outcomes: We identified 4 themes: a more holistic, collaborative, long-term treatment approach; medication as a short-term solution; high personal and economic costs of medication; and desire for more information and access to natural approaches. Across SL, participants expressed keen interest in integrative approaches and wanted better access to complementary modalities. Participants in marginalized SL described reliance on traditional/folk remedies, including engagement with family and community healers, who they described as more affordable and culturally accessible. CONCLUSIONS: Holistic and integrative approaches were preferred over medication as long-term migraine management strategies. However, people in marginalized SL, while disproportionately disabled by migraine, did not feel as comfortable accessing integrative approaches through currently available channels. Engaging with these communities and using a critical lens to explore barriers to access can develop options to make complementary modalities more approachable, while also attending to systemic blind spots that may unintentionally alienate socially marginalized groups.

A pooled analysis of three studies of nonpharmacological interventions for menopausal hot flashes.

OBJECTIVE: The aim of the study was to conduct a pooled analysis of three published trials of nonpharmacological interventions for menopausal hot flashes to compare the effectiveness of interventions. METHODS: Data from three randomized controlled trials of interventions for hot flashes (two acupuncture trials, one yoga trial) were pooled. All three studies recruited perimenopausal or postmenopausal women experiencing ≥4 hot flashes/d on average. The primary outcome for all three studies was frequency of hot flashes as measured by the Daily Diary of Hot Flashes. Study 1 participants were randomly assigned to 8 weeks of acupuncture treatments (active intervention), sham acupuncture (attention control), or usual care. Study 2 participants were randomly assigned to 10 weeks of yoga classes, health and wellness education classes (attention control), or waitlist control. Study 3 randomly assigned participants to 6 months of acupuncture or waitlist control. To standardize the time frame for these analyses, only the first 8 weeks of intervention from all three studies were used. RESULTS: The three active interventions and the two attention control groups had statistically similar trends in the percentage reduction of hot flashes over 8 weeks, ranging from 35% to 40%. These five groups did not differ significantly from each other, but all showed significantly greater reduction in hot flash frequency compared with the three usual care/waitlist groups. CONCLUSION: Acupuncture, yoga, and health and wellness education classes all demonstrated statistically similar effectiveness in reduction of hot flash frequency compared with controls.

Nonpharmacologic Treatments for Attention-Deficit/Hyperactivity Disorder: A Systematic Review.

CONTEXT: Nonpharmacologic treatments for attention-deficit/hyperactivity disorder (ADHD) encompass a range of care approaches from structured behavioral interventions to complementary medicines. OBJECTIVES: To assess the comparative effectiveness of nonpharmacologic treatments for ADHD among individuals 17 years of age and younger. DATA SOURCES: PubMed, Embase, PsycINFO, and Cochrane Database of Systematic Reviews for relevant English-language studies published from January 1, 2009 through November 7, 2016. STUDY SELECTION: We included studies that compared any ADHD nonpharmacologic treatment strategy with placebo, pharmacologic, or another nonpharmacologic treatment. DATA EXTRACTION: Study design, patient characteristics, intervention approaches, follow-up times, and outcomes were abstracted. For comparisons with at least 3 similar studies, random-effects meta-analysis was used to generate pooled estimates. RESULTS: We identified 54 studies of nonpharmacologic treatments, including neurofeedback, cognitive training, cognitive behavioral therapy, child or parent training, dietary omega fatty acid supplementation, and herbal and/or dietary approaches. No new guidance was identified regarding the comparative effectiveness of nonpharmacologic treatments. Pooled results for omega fatty acids found no significant effects for parent rating of ADHD total symptoms (n = 411; standardized mean difference -0.32; 95% confidence interval -0.80 to 0.15; I2 = 52.4%; P = .10) or teacher-rated total ADHD symptoms (n = 287; standardized mean difference -0.08; 95% confidence interval -0.47 to 0.32; I2 = 0.0%; P = .56). LIMITATIONS: Studies often did not reflect the primary care setting and had short follow-up periods, small sample sizes, variations in outcomes, and inconsistent reporting of comparative statistical analyses. CONCLUSIONS: Despite wide use, there are significant gaps in knowledge regarding the effectiveness of ADHD nonpharmacologic treatments.

Acupuncture for Chronic Pain in the Vermont Medicaid Population: A Prospective, Pragmatic Intervention Trial.

INTRODUCTION: In response to the opioid crisis, the 2016 Vermont legislature commissioned a study to assess acupuncture for patients with chronic pain in the Vermont Medicaid population. OBJECTIVE: To assess the feasibility, acceptability, and effectiveness of acupuncture provided by licensed acupuncturists for Vermont Medicaid patients with chronic pain. METHODS: A total of 156 Medicaid patients with chronic pain were offered up to 12 acupuncture treatments within a 60-day period at the offices of 28 Vermont licensed acupuncturists. PROMIS® questionnaires were administered prior to and at the end of the treatment period to assess changes in pain intensity, pain interference, physical function, fatigue, anxiety, depression, sleep disturbance, and social isolation. Questionnaires also captured patients' overall impressions of treatments as well as self-reported changes in medication use and work function. RESULTS: One hundred eleven women (71%) and 45 men (29%) with a wide range of pain complaints received a mean of 8.2 treatments during the intervention period. Measurements captured prior to and at the end of the treatment period showed significant improvements in group mean pain intensity, pain interference, physical function, fatigue, anxiety, depression, sleep disturbance, and social isolation as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) measures (paired t tests, P < .01). Fifty-seven percent of patients using analgesic (nonopioid) medication reported reductions in use. Thirty-two percent of patients using opioid medication reported reductions in use of opioid medication following the intervention. Seventy-four percent of employed patients reported improved capacity to work. Ninety-six percent of patients said that they would recommend acupuncture to others with chronic pain, and 91% reported qualitative improvements, including physical (31%), functional/behavioral (29%), and psycho-emotional (24%) improvements. CONCLUSIONS: Our findings demonstrate that acupuncture treatment for chronic pain is feasible and well received by patients in the Vermont Medicaid population. Receiving care from Licensed Acupuncturists was associated with significant improvements in physical, functional, psycho-emotional, and occupational outcomes compared with before receiving acupuncture treatments.

Management of Menopause Symptoms with Acupuncture: An Umbrella Systematic Review and Meta-Analysis.

OBJECTIVES: Vasomotor symptoms (VMSs) are the most common symptoms reported during menopause. Although hormone therapy is effective for reducing VMSs, its use is restricted in some women. Many women with VMSs thus seek nonhormonal, nonpharmacologic treatment options such as acupuncture. DESIGN: An umbrella systematic review (SR) was conducted, supplemented by a search of published randomized controlled trials (RCTs), that assessed the effectiveness of acupuncture for VMSs, health-related quality of life (HRQOL), and adverse effects of treatment in perimenopausal or postmenopausal women. Meta-analyses were conducted using a random-effects model when data were sufficient. RESULTS: Three SRs and four new RCTs were identified that met eligibility criteria. Meta-analyses of this study revealed statistically significant standardized mean differences (SMDs) associated with acupuncture compared with no acupuncture at reducing VMS frequency (SMD -0.66, 95% confidence interval [CI] -1.06 to -0.26, I2 = 61.7%, 5 trials) and VMS severity (SMD -0.49, 95% CI -0.85 to -0.13, I2 = 18.1%, 4 trials) and improving HRQOL outcomes (SMD -0.93, 95% CI -1.20 to -0.67, I2 = 0.0%, 3 trials). SMDs were smaller or not statistically significant when acupuncture was compared with sham acupuncture. CONCLUSIONS: Evidence from RCTs supports the use of acupuncture as an adjunctive or stand-alone treatment for reducing VMSs and improving HRQOL outcomes, with the caveat that observed clinical benefit associated with acupuncture may be due, in part, or in whole to nonspecific effects. The safety of acupuncture in the treatment of VMSs has not been rigorously examined, but there is no clear signal for a significant potential for harm.

Trajectories of response to acupuncture for menopausal vasomotor symptoms: the Acupuncture in Menopause study.

OBJECTIVE: To examine the trajectories of responses to acupuncture treatment for menopausal vasomotor symptoms (VMS) and the characteristics of women in each trajectory. METHODS: Two hundred nine perimenopausal and postmenopausal women aged 45 to 60 years experiencing at least four VMS per day were recruited and randomized to receive up to 20 acupuncture treatments within 6 months or to a waitlist control group. The primary outcome was percent change from baseline in the mean daily VMS frequency. Finite mixture modeling was used to identify patterns of percent change in weekly VMS frequencies over the first 8 weeks. The Freeman-Holton test and analysis of variance were used to compare characteristics of women in different trajectories. RESULTS: Analyses revealed four distinct trajectories of change in VMS frequency by week 8 in the acupuncture group. A small group of women (11.6%, n = 19) had an 85% reduction in VMS. The largest group (47%, n = 79) reported a 47% reduction in VMS frequency, 37.3% (n = 65) of the sample showed only a 9.6% reduction in VMS frequency, and a very small group (4.1%, n = 7) had a 100% increase in VMS. Among women in the waitlist control group, 79.5% reported a 10% decrease in VMS frequency at week 8. Baseline number of VMS, number of acupuncture treatments in the first 8 weeks, and traditional Chinese medicine diagnosis were significantly related to trajectory group membership in the acupuncture group. CONCLUSIONS: Approximately half of the treated sample reported a decline in VMS frequency, but identifying clear predictors of clinical response to acupuncture treatment of menopausal VMS remains challenging.

Role of Acupuncture in the Treatment or Prevention of Migraine, Tension-Type Headache, or Chronic Headache Disorders.

OBJECTIVE: To summarize the current evidence that evaluates the effectiveness of acupuncture for the treatment or prevention of migraine, tension-type headache, and chronic headache disorders. METHODS: Findings from selected systematic reviews and meta-analyses are summarized. RESULTS: Recently published systematic reviews and meta-analyses demonstrate that acupuncture is associated with improved clinical outcomes compared to routine care only, medical management, and sham acupuncture 2 months after randomization. The evidence in support of acupuncture's comparative effectiveness at longer follow-up periods is mixed. Cost effectiveness analyses conducted in the United Kingdom and Germany suggest that acupuncture is a cost-effective treatment option in those countries. There are few or no cost-effectiveness studies of acupuncture in the United States. DISCUSSION: This brief review of the current, published evidence does not include a discussion of potential risks or adverse events associated with acupuncture. There is also the question of the extent to which placebo effects might contribute to acupuncture's clinical effectiveness. From a purely comparative effectiveness perspective, however, the evidence from clinical trials and meta-analyses makes a compelling case in support of a potentially important role for acupuncture as part of a treatment plan for patients with migraine, tension-type headache, and several different types of chronic headache disorders.

An evidence map of yoga for low back pain.

OBJECTIVE: Yoga is being increasingly studied as a treatment strategy for a variety of different clinical conditions, including low back pain (LBP). We set out to conduct an evidence map of yoga for the treatment, prevention and recurrence of acute or chronic low back pain (cLBP). METHODS: We searched Medline, Cochrane Database of Systematic Reviews, EMBASE, Allied and Complementary Medicine Database and ClinicalTrials.gov for randomized controlled trials (RCT), systematic reviews or planned studies on the treatment or prevention of acute back pain or cLBP. Two independent reviewers screened papers for inclusion, extracted data and assessed the quality of included studies. RESULTS: Three eligible systematic reviews were identified that included 10 RCTs (n=956) that evaluated yoga for non-specific cLBP. We did not identify additional RCTs beyond those included in the systematic reviews. Our search of ClinicalTrials.gov identified one small (n=10) unpublished trial and one large (n=320) planned clinical trial. The most recent good quality systematic review indicated significant effects for short- and long-term pain reduction (n=6 trials; standardized mean difference [SMD] -0.48; 95% CI, -0.65 to -0.31; I(2)=0% and n=5; SMD -0.33; 95% CI, -0.59 to -0.07; I(2)=48%, respectively). Long-term effects for back specific disability were also identified (n=5; SMD -0.35; 95% CI, -0.55 to -0.15; I(2)=20%). No studies were identified evaluating yoga for prevention or treatment of acute LBP. CONCLUSION: Evidence suggests benefit of yoga in midlife adults with non-specific cLBP for short- and long-term pain and back-specific disability, but the effects of yoga for health-related quality of life, well- being and acute LBP are uncertain. Without additional studies, further systematic reviews are unlikely to be informative.

Nonpharmacologic, nonherbal management of menopause-associated vasomotor symptoms: an umbrella systematic review (protocol).

BACKGROUND: Vasomotor symptoms such as hot flashes and night sweats are a common concern of perimenopausal and postmenopausal women and are associated with a decreased quality of life. These symptoms can be effectively managed with hormone therapy, but safety concerns limit its use. Thus, understanding the effectiveness of nonpharmacologic therapies such as acupuncture or yoga is critical to managing these common symptoms in older women. Our review seeks to address the following question: In women with menopause-associated vasomotor symptoms, what are the effects on health-related quality of life, vasomotor symptoms, and adverse events of the following nonpharmacologic, nonherbal interventions as compared with any inactive control or active comparator: (a) acupuncture, (b) yoga, tai chi, and qigong, (c) structured exercise, and (d) meditation, mindfulness-based practices, and relaxation? METHODS: We describe a protocol for an umbrella review approach, supplemented by evaluating randomized controlled trials (RCTs) published after the most recent good-quality systematic review for each of the eligible interventions. Specific interventions were chosen based on current literature and with input from a technical expert panel and organizational stakeholders. We will conduct a thorough literature search and perform a quality assessment of potentially included systematic reviews and RCTs. DISCUSSION: Our umbrella review, supplemented by an additional search for eligible RCTs, aims to synthesize existing evidence on the use of nonpharmacologic, nonherbal interventions to manage bothersome vasomotor symptoms in perimenopausal and postmenopausal women. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016029335.

Acupuncture in Menopause (AIM) study: a pragmatic, randomized controlled trial.

OBJECTIVE: The aim of the study was to evaluate the short and long-term effects of acupuncture on vasomotor symptoms (VMS) and quality of life-related measures. METHODS: A total of 209 perimenopausal and postmenopausal women aged 45 to 60 years, experiencing four or more VMS per day, were recruited from the community and randomized to receive up to 20 acupuncture treatments within the first 6 months (acupuncture group) or the second 6 months (waitlist control group) of the 12-month study period. The primary outcome was mean daily frequency of VMS. Secondary outcomes were VMS interference with daily life, sleep quality, depressive symptoms, somatic and other symptoms, anxiety, and quality of life. RESULTS: The VMS frequency declined by 36.7% at 6 months in the acupuncture group and increased by 6.0% in the control group (P < 0.001 for between-group comparison). At 12 months, the reduction from baseline in the acupuncture group was 29.4% (P < 0.001 for within-group comparison from baseline to 12 months), suggesting that the reduction was largely maintained after treatment. Statistically significant clinical improvement was observed after three acupuncture treatments, and maximal clinical effects occurred after a median of eight treatments. Persistent improvements were seen in many quality of life-related outcomes in the acupuncture group relative to the control group. CONCLUSIONS: We found that a course of acupuncture treatments was associated with significant reduction in VMS, and several quality-of-life measures, compared with no acupuncture, and that clinical benefit persisted for at least 6 months beyond the end of treatment.

Unanticipated Insights into Biomedicine from the Study of Acupuncture.

Research into acupuncture has had ripple effects beyond the field of acupuncture. This paper identifies five exemplars to illustrate that there is tangible evidence of the way insights gleaned from acupuncture research have informed biomedical research, practice, or policy. The first exemplar documents how early research into acupuncture analgesia has expanded into neuroimaging research, broadening physiologic understanding and treatment of chronic pain. The second describes how the acupuncture needle has become a tool to enhance biomedical knowledge of connective tissue. The third exemplar, which illustrates use of a modified acupuncture needle as a sham device, focuses on emergent understanding of placebo effects and, in turn, on insights into therapeutic encounters in treatments unrelated to acupuncture. The fourth exemplar documents that two medical devices now in widespread use were inspired by acupuncture: transcutaneous electrical nerve stimulators for pain control and antinausea wrist bands. The final exemplar describes how pragmatic clinical trial designs applied in acupuncture research have informed current general interest in comparative effectiveness research. In conclusion, these exemplars of unanticipated outcomes of acupuncture research comprise an additional rationale for continued support of basic and clinical research evaluating acupuncture and other under-researched therapies.

Evidence Map of Yoga for Depression, Anxiety, and Posttraumatic Stress Disorder.

BACKGROUND: This study describes evidence of yoga's effectiveness for depressive disorders, general anxiety disorder (GAD), panic disorder (PD), and posttraumatic stress disorder (PTSD) in adults. We also address adverse events associated with yoga. METHODS: We searched multiple electronic databases for systematic reviews (SRs) published between 2008 and July 2014, randomized controlled trials (RCTs) not identified in eligible SRs, and ongoing RCTs registered with ClincalTrials.gov. RESULTS: We identified 1 SR on depression, 1 for adverse events, and 3 addressing multiple conditions. The high-quality depression SR included 12 RCTs (n = 619) that showed improved short-term depressive symptoms (standardized mean difference, -0.69, 95% confidence interval, -0.99 to -0.39), but there was substantial variability (I2 = 86%) and a high risk of bias for 9 studies. Three SRs addressing multiple conditions identified 4 nonrandomized studies (n = 174) for GAD/PD and 1 RCT (n = 8) and 2 nonrandomized studies (n = 22) for PTSD. We separately found 1 RCT (n = 13) for GAD and 2 RCTs (n = 102) for PTSD. Collectively, these studies were inconclusive for the effectiveness of yoga in treating GAD/PD and PTSD. The high-quality SR for adverse events included 37 primary reports (n = 76) in which inversion postures were most often implicated. We found 5 ongoing trials (3 for PTSD). CONCLUSIONS: Yoga may improve short-term depressive symptoms, but evidence for GAD, PD, and PTSD remain inconclusive.

Treatment of chronic conditions with traditional Chinese medicine: findings from traditional Chinese medicine hospitals in Hubei, China.

OBJECTIVES: This study aimed to document clinical use of Traditional Chinese Medicine (TCM) for chronic conditions in all TCM hospitals in a Chinese province and to recommend treatments most in need of evaluation for use in community health centers. DESIGN: A cross-sectional survey was conducted in the summer of 2010. It included 119 of 132 TCM hospitals in Hubei Province, China. TCM physicians were asked to recommend specific TCM treatments for common chronic conditions. Nine types of chronic conditions recommended more than 3.7 times (mean of frequencies of chronic conditions) are included in this analysis. Frequency of each TCM treatment and the number of visits by type of chronic conditions were calculated. RESULTS: The total number of recommendations by TCM physicians was 411. For seven types of treatments, six were recommended for musculoskeletal pain, five for soft tissue injuries, four for visceral pain and fractures, three for stroke and asthma, two for hemorrhoids, and one for hypertension. The most frequently recommended treatments for specific conditions include orally ingested herbs for visceral pain (n=3), type 2 diabetes (n=5), and hypertension (n=7); herbs for external use for soft tissue injuries (n=10), asthma (n=6), and hemorrhoids (n=8); acupuncture for musculoskeletal pains (n=43) and for stroke (n=10); and Chinese external fixation for fractures (n=24). The number of visits for recommended treatments per year of was 671,759. The most frequently recommended treatments for specific chronic conditions have most visits, except for chronic conditions such as musculoskeletal pains, visceral pains, soft tissue injuries, and asthma. CONCLUSIONS: Patients with musculoskeletal pain have more treatment options than other patients. Herbal medicine is the option most commonly used for chronic conditions. These treatments for these conditions should be targeted for further evaluation of effectiveness and, only if found effective, considered for use in primary care settings.

Acupuncture for the treatment or management of chronic pain.

Evidence supports the safety and efficacy of acupuncture compared with no treatment, but it is unclear what role the placebo effect plays in acupuncture's efficacy. In determining whether acupuncture is indicated for a given individual or patient population, clinicians should consider acupuncture's effectiveness compared with no acupuncture--as well as the effectiveness, safety, and cost of alternative types of treatment.

Credibility of low-strength static magnet therapy as an attention control intervention for a randomized controlled study of CranioSacral therapy for migraine headaches.

BACKGROUND: Developing valid control groups that generate similar perceptions and expectations to experimental complementary and alternative (CAM) treatments can be challenging. The perceived credibility of treatment and outcome expectancy often contributes to positive clinical responses to CAM therapies, thereby confounding efficacy data. As part of a clinical feasibility study, credibility and expectancy data were obtained from subjects suffering from migraine who received either CranioSacral therapy (CST) or an attention-control, sham, and low-strength magnet (LSSM) intervention. OBJECTIVE: The objective of this study was to evaluate whether the LSSM intervention generated similar levels of subject credibility and expectancy compared to CST. DESIGN: This was a two-arm randomized controlled trial. SUBJECTS: Sixty-five (65) adults with moderate to severe migraine were the subjects of this study. INTERVENTIONS: After an 8-week baseline, subjects were randomized to eight weekly treatments of either CST (n=36) or LSSM (n=29). The latter involved the use of a magnet-treatment protocol using inactive and low-strength static magnets designed to mimic the CST protocol in terms of setting, visit timing, body positioning, and therapist-subject interaction. OUTCOME MEASURES: A four-item, self-administered credibility/expectancy questionnaire, based on a validated instrument, was completed after the first visit. RESULTS: Using a 0-9 rating scale, the mean score for perceived logicality of treatment was significantly less for LSSM (5.03, standard deviation [SD] 2.34) compared to CST (6.64, SD 2.19). Subject confidence that migraine would improve was greater for CST (5.94, SD 2.01) than for LSSM (4.9, SD 2.21), a difference that was not statistically significant. Significantly more subjects receiving CST (6.08, SD 2.27) would confidently recommend treatment to a friend than those receiving LSSM (4.69, SD 2.49). CONCLUSIONS: Although LSSM did not achieve a comparable level of credibility and expectancy to the CST, several design and implementation factors may have contributed to the disparity. Based on analysis of these factors, the design and implementation of a future study may be improved.

Auriculotherapy for pain management: a systematic review and meta-analysis of randomized controlled trials.

OBJECTIVES: Side-effects of standard pain medications can limit their use. Therefore, nonpharmacologic pain relief techniques such as auriculotherapy may play an important role in pain management. Our aim was to conduct a systematic review and meta-analysis of studies evaluating auriculotherapy for pain management. DESIGN: MEDLINE,(®) ISI Web of Science, CINAHL, AMED, and Cochrane Library were searched through December 2008. Randomized trials comparing auriculotherapy to sham, placebo, or standard-of-care control were included that measured outcomes of pain or medication use and were published in English. Two (2) reviewers independently assessed trial eligibility, quality, and abstracted data to a standardized form. Standardized mean differences (SMD) were calculated for studies using a pain score or analgesic requirement as a primary outcome. RESULTS: Seventeen (17) studies met inclusion criteria (8 perioperative, 4 acute, and 5 chronic pain). Auriculotherapy was superior to controls for studies evaluating pain intensity (SMD, 1.56 [95% confidence interval (CI): 0.85, 2.26]; 8 studies). For perioperative pain, auriculotherapy reduced analgesic use (SMD, 0.54 [95% CI: 0.30, 0.77]; 5 studies). For acute pain and chronic pain, auriculotherapy reduced pain intensity (SMD for acute pain, 1.35 [95% CI: 0.08, 2.64], 2 studies; SMD for chronic pain, 1.84 [95% CI: 0.60, 3.07], 5 studies). Removal of poor quality studies did not alter the conclusions. Significant heterogeneity existed among studies of acute and chronic pain, but not perioperative pain. CONCLUSIONS: Auriculotherapy may be effective for the treatment of a variety of types of pain, especially postoperative pain. However, a more accurate estimate of the effect will require further large, well-designed trials.

Patient-based outcome assessment instruments in acupuncture research.

BACKGROUND: Outcome assessment can support the therapeutic process by providing a way to track symptoms and functionality over time, providing insights to clinicians and patients, as well as offering a common language to discuss patient behavior/functioning. OBJECTIVES: In this article, we examine the patient-based outcome assessment (PBOA) instruments that have been used to determine outcomes in acupuncture clinical research and highlight measures that are feasible, practical, economical, reliable, valid, and responsive to clinical change. The aims of this review were to assess and identify the commonly available PBOA measures, describe a framework for identifying appropriate sets of measures, and address the challenges associated with these measures and acupuncture. Instruments were evaluated in terms of feasibility, practicality, economy, reliability, validity, and responsiveness to clinical change. METHODS: This study was a systematic review. A total of 582 abstracts were reviewed using PubMed (from inception through April 2009). RESULTS: A total of 582 citations were identified. After screening of title/abstract, 212 articles were excluded. From the remaining 370 citations, 258 manuscripts identified explicit PBOA; 112 abstracts did not include any PBOA. The five most common PBOA instruments identified were the Visual Analog Scale, Symptom Diary, Numerical Pain Rating Scales, SF-36, and depression scales such as the Beck Depression Inventory. CONCLUSIONS: The way a questionnaire or scale is administered can have an effect on the outcome. Also, developing and validating outcome measures can be costly and difficult. Therefore, reviewing the literature on existing measures before creating or modifying PBOA instruments can significantly reduce the burden of developing a new measure.