Feasibility of implementing acupuncture in medically underserved breast cancer survivors (FAB): A protocol.

Nearly 94% of breast cancer survivors experience one or more symptoms or side effects during or after endocrine therapy. Joint pain, hot flashes, sleep disturbance, fatigue, depression, and anxiety are the most common concurrent symptoms, some of which can persist for 5 to 10 years. Acupuncture is a holistic modality that addresses multiple symptoms and side effects in a single therapy. Acupuncture has not yet been investigated for its effectiveness in treating the multiple symptoms experienced by breast cancer survivors receiving endocrine therapy. Medically underserved breast cancer survivors typically have limited access to acupuncture. The barriers limiting access to acupuncture need to be removed to enable equal access to breast cancer survivors for this evidence-based treatment. Thus, we developed a randomized controlled trial with a 5-week acupuncture intervention versus usual care for medically underserved breast cancer survivors. Mixed methods (semi-structured interviews, surveys, study notes) will be used to obtain in-depth understanding of barriers and facilitators for eventual implementation of the acupuncture intervention. This study will facilitate the widespread implementation, dissemination, and sustained utilization of acupuncture for symptom management among medically underserved breast cancer survivors receiving endocrine therapy.

Developing an Implementation Blueprint for the NIH HEAL Initiative GRACE Trial: Perspectives on Acupuncture and Guided Relaxation for Chronic Sickle Cell Disease Pain.

Objective: This study aimed to explore perspectives of people living with sickle cell disease (SCD) and SCD clinic providers and staff about the use of acupuncture and guided relaxation for treating chronic SCD pain. Data obtained were to inform an implementation blueprint for an effectiveness implementation clinical trial (GRACE Trial) testing whether acupuncture or guided relaxation reduces chronic pain when compared with usual care. Design: Qualitative research design. Methods: We conducted 33 semistructured interviews with people with SCD and SCD clinic providers and staff. Interviews were transcribed and coded. A deductive content analysis process was used to identify themes. Results: Four themes were identified: Receptivity to Acupuncture and Guided Relaxation, Limited Awareness, Complementary and Integrative Health (CIH) Therapy Preference, and Access Barriers. Both patients and clinic providers and staff were open to the use of acupuncture and guided relaxation for chronic pain treatment. After learning about these CIH therapies, some patients expressed a preference for one therapy over the other. They also discussed their ability to successfully engage with each therapy. There is a need to dispel misconceptions about the therapies by increasing understanding of how each therapy is implemented and functions to reduce pain. We identified several potential barriers that might affect the success of the trial and future health system integration, including time, transportation, and technology. Conclusion: This study is one of the first to present perspectives of both patients with SCD and clinic providers and staff on the use of acupuncture and guided relaxation for chronic SCD pain. Stakeholders' early input and perspectives highlighted that they welcome nonpharmacological CIH therapies. Implementation of a clinical trial and future health system integration will require the addressing misinformation and identifying strategies to overcome access barriers. Clinical trial registration number: NCT04906447.

Hybrid effectiveness-implementation trial of guided relaxation and acupuncture for chronic sickle cell disease pain (GRACE): A protocol.

Background: People with sickle cell disease frequently use complementary and integrative therapies to cope with their pain, yet few studies have evaluated their effectiveness. The 3-arm, 3-site pragmatic Hybrid Effectiveness-implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain (GRACE) has 3 priorities: (1) evaluate guided relaxation and acupuncture to improve pain control; (2) determine the most appropriate and effective treatment sequence for any given patient based on their unique characteristics; and (3) describe the processes and structures required to implement guided relaxation and acupuncture within health care systems. Methods: Participants (N = 366) are being recruited and randomized 1:1:1 to one of 2 intervention groups or usual care. The acupuncture intervention group receives 10 sessions over approximately 5 weeks. The guided relaxation intervention group receives access to video sessions ranging from 2 to 20 min each viewed daily over 5 weeks. The usual care group receives the standard of clinical care for sickle cell disease. Participants are re-randomized at 6 weeks depending on their pain impact score. Assessments occur at 6 weeks, 12 weeks, and 24 weeks. The primary outcome is the change in pain impact score and secondary measures include opioid use, anxiety, depression, sleep, pain catastrophizing, substance use, global impression of change, constipation, and hospitalizations. The GRACE study uses the Consolidated Framework for Implementation Research to plan, execute, and evaluate the associated implementation processes. Conclusion: The results from GRACE will represent a critical step toward improving management of pain affecting patients with sickle cell disease.ClinicalTrials.gov Identifier: NCT04906447.

Feasibility of Acupuncture and Exploration of Metabolomic Alterations for Psychoneurological Symptoms Among Breast Cancer Survivors.

OBJECTIVE: Approximately 24-68% of breast cancer survivors report co-occurring psychoneurological symptoms of pain, fatigue, sleep disturbance, depression, and anxiety during and after cancer treatment. This study aimed to assess the feasibility and acceptability of acupuncture for the treatment of multiple psychoneurological symptoms among breast cancer survivors and explore metabolomic changes before and after acupuncture. METHODS: We conducted a single-arm, prospective pilot study of breast cancer survivors with at least two moderate to severe psychoneurological symptoms (>3 on a 0-10 scale). Acupuncture was administered twice weekly for 5 weeks, for 30 minutes per session. Along with Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires, a fasting serum comprehensive hydrophilic metabolites panel was analyzed at baseline and after acupuncture. RESULTS: Eight participants (mean age 52.5 ± 10.9 years; 62.5% Black) were enrolled. Feasibility was supported, with 67% recruitment, 87.5% retention, and 98% acceptability. Post intervention, PROMIS T-scores were reduced for all psychoneurological symptoms. Significant differences in serum metabolites before and after acupuncture were F-1,6/2,6-DP, glutathione disulfide, phosphorylcholine, 6-methylnicotinamide, glutathione, and putrescine (variable importance of projection values larger than 1.5 and p values <0.05). Pathway analysis indicated that glutathione metabolism (p = 0.002, q = 0.071), and arginine and proline metabolisms (p = 0.009, q = 0.166) were potentially involved in mechanisms of acupuncture. CONCLUSIONS: Acupuncture to reduce multiple psychoneurological symptoms among breast cancer survivors was feasible and acceptable. Study findings also shed light on the metabolic pathways involved in the acupuncture response and will be tested in future studies.

Evaluation and Treatment of Vulvodynia: State of the Science.

Vulvodynia affects 7% of American women, yet clinicians often lack awareness of its presentation. It is underdiagnosed and often misdiagnosed as vaginitis. The etiology of vulvodynia remains unknown, making it difficult to identify or develop effective treatment methods. The purpose of this article is to (1) review the presentation and evaluation of vulvodynia, (2) review the research on vulvodynia treatments, and (3) aid the clinician in the selection of vulvodynia treatment methods. The level of evidence to support vulvodynia treatment varies from case series to randomized controlled trials (RCTs). Oral desipramine with 5% lidocaine cream, intravaginal diazepam tablets with intravaginal transcutaneous electric nerve stimulation (TENS), botulinum toxin type A 50 units, enoxaparin sodium subcutaneous injections, intravaginal TENS (as a single therapy), multimodal physical therapy, overnight 5% lidocaine ointment, and acupuncture had the highest level of evidence with at least one RCT or comparative effectiveness trial. Pre to posttest reduction in vulvar pain and/or dyspareunia in non-RCT studies included studies of gabapentin cream, amitriptyline cream, amitriptyline with baclofen cream, up to 6 weeks' oral itraconazole therapy, multimodal physical therapy, vaginal dilators, electromyography biofeedback, hypnotherapy, cognitive behavioral therapy, cold knife vestibulectomy, and laser therapy. There is a lack of rigorous RCTs with large sample sizes for the treatment of vulvodynia, rendering it difficult to determine efficacy of most treatment methods. Clinicians will be guided in the selection of best treatments for vulvodynia that have the highest level of evidence and are least invasive.

Women's Experience of Living with Vulvodynia Pain: Why They Participated in a Randomized Controlled Trial of Acupuncture.

Introduction: Vulvodynia is vulvar pain lasting at least 3-months without clear identifiable cause that may have other associated factors. The aim, to explore motivations of women participating in a double-blind randomized controlled trial of acupuncture for vulvodynia. Methods: Responses to the question: "Tell me about why you decided to participate in this study" were analyzed using conceptual content analysis to identify patterns in motivation for study participation. Results: Four patterns emerged: 1) desire to address uncontrolled pain, 2) desire for understanding, 3) wish to contribute to knowledge generation, and 4) need to remove cost barriers. Conclusion: Motivations indicate vulvodynia-specific aspects of acceptability of acupuncture. Clinical Trial Registration: NCT03364127.

Protocol for double-blind RCT of acupuncture for vulvodynia.

Background: Vulvodynia, vulvar pain of unknown origin lasting at least 3 months, affects 7% of American women. Dyspareunia, its frequent companion, renders sexual intercourse virtually impossible. Although few therapies are efficacious and rapid pain relief is rarely possible, there have been no sham/placebo-controlled studies of acupuncture for vulvodynia. Aims are to: 1) determine efficacy of acupuncture for vulvodynia, 2) explore duration of the acupuncture effect. Methods: In a pretest/posttest randomized controlled, double-blind (practitioner-patient) efficacy trial of a standardized acupuncture protocol, we will randomize 80 participants 1:1 to either penetrating needle or skin-touch placebo needle groups. Both types of needles are designed to blind both the acupuncturist and participant. Participants with vulvodynia will insert and remove a tampon as a standardized stimulus and complete primary measures of vulvar pain (pain intensity) and secondary measures of dyspareunia (Female Sexual Function Index, FSFI dyspareunia subscale score) and sexual function (FSFI total score) pretreatment, after the 10th acupuncture session, and pain measures weekly until return to pretest levels. Upon study completion control group participants will be offered 10 free real acupuncture sessions. Discussion: This is the first multi-needle multi-session RCT using double-blind acupuncture needles as a reliable sham. We hypothesize that controlling for baseline, at posttest there will be statistically significant less vulvar pain and dyspareunia and more sexual function over five weeks in the penetrating needle group compared to the skin touch placebo group. Conclusion: This study is responsive to the need for efficacious pain management for women with vulvodynia.ClinicalTrials.gov Identifier: NCT03364127.

Feasibility and preliminary efficacy of acupuncture for angina in an underserved diverse population.

PURPOSE: Stable angina is ischemic chest pain on exertion or with emotional stress. Despite guideline-directed therapy, up to 30% of patients have suboptimal pain relief. The aims of this study were to: (1) determine the feasibility and acceptability of a randomized controlled trial (RCT) of acupuncture; and (2) evaluate preliminary efficacy of acupuncture with respect to reduction of pain and increased functional status and health-related quality of life (HRQoL). METHODS: Participants with stable angina for ⩾1 month received either a standardized acupuncture protocol, twice per week for 5 weeks, or an attention control protocol. Measures included the McGill Pain Questionnaire (average pain intensity (API), pain now) and the Seattle Angina Questionnaire-7 (functional status, symptoms, and HRQoL). Feasibility was defined as ⩾80% recruitment, ⩾75% retention following enrollment, and ⩾80% completion. Descriptive statistics and mixed-effects linear regression were used for analysis. RESULTS: The sample (n = 24) had a mean age of 59 ± 12 years, was predominantly female (63%), and represented minority groups (8% White, 52% Black, 33% Hispanic, and 8% Other). Feasibility was supported by 79% retention and 89% completion rates. The recruitment rate (68%) was slightly lower than expected. Acceptability scores were 87.9% for the acupuncture group and 51.7% for the control group. Outcomes were significantly better for the acupuncture versus control groups (API, b = -2.1 (1.1), p = 0.047; functional status, b = 27.6 (7.2), p < 0.001; and HRQoL, b = 38.8 (11.9), p = 0.001). CONCLUSIONS AND IMPLICATIONS: Acupuncture was feasible and acceptable in our diverse sample. We were slightly under the recruitment target of 80%, but participants who started the study had a high likelihood of completing it. Acupuncture shows promise for stable angina, but its effectiveness needs to be confirmed by a larger, adequately powered RCT. TRIAL REGISTRATION NUMBER: NCT02914834 (ClinicalTrials.gov).

Acupuncture Improves Multiple Treatment-Related Symptoms in Breast Cancer Survivors: A Systematic Review and Meta-Analysis.

Introduction: Acupuncture has demonstrated effectiveness for symptom management among breast cancer survivors. This meta-analysis aims to evaluate the effect of acupuncture on treatment-related symptoms among breast cancer survivors. Methods: The authors searched PubMed, CINAHL, and EMBASE for relevant randomized clinical trials (RCTs) of acupuncture for managing treatment-related symptoms published in English through June 2021. They appraised the quality of each article using the Cochrane Collaboration Risk of Bias Criteria. The primary outcomes were pain, hot flashes, sleep disturbance, fatigue, depression, lymphedema, and neuropathy as individual symptoms. They also evaluated adverse events reported in acupuncture studies. Results: Of 26 selected trials (2055 patients), 20 (1709 patients) were included in the meta-analysis. Acupuncture was more effective than control groups in improving pain intensity [standardized mean difference (SMD) = -0.60, 95% confidence intervals (CI) -1.06 to -0.15], fatigue [SMD = -0.62, 95% CI -1.03 to -0.20], and hot flash severity [SMD = -0.52, 95% CI -0.82 to -0.22]. The subgroup analysis indicated that acupuncture showed trends but not significant effects on all the treatment-related symptoms compared with the sham acupuncture groups. Compared with waitlist control and usual care groups, the acupuncture groups showed significant reductions in pain intensity, fatigue, depression, hot flash severity, and neuropathy. No serious adverse events were reported related to acupuncture intervention. Mild adverse events (i.e., bruising, pain, swelling, skin infection, hematoma, headache, menstrual bleeding) were reported in 11 studies. Conclusion: This systematic review and meta-analysis suggest that acupuncture significantly reduces multiple treatment-related symptoms compared with the usual care or waitlist control group among breast cancer survivors. The safety of acupuncture was inadequately reported in the included studies. Based on the available data, acupuncture seems to be generally a safe treatment with some mild adverse events. These findings provide evidence-based recommendations for incorporating acupuncture into clinical breast cancer symptom management. Due to the high risk of bias and blinding issues in some RCTs, more rigorous trials are needed to confirm the efficacy of acupuncture in reducing multiple treatment-related symptoms among breast cancer survivors.

Acupuncture for chronic pain in adults with sickle cell disease: a mixed-methods pilot study.

OBJECTIVE: Chronic pain is a common symptom experienced among patients with sickle cell disease (SCD). Our aims were to assess the feasibility and acceptability of performing acupuncture for the treatment of chronic pain in adults with SCD. METHODS: This was a single-arm, prospective pilot study of six adults with SCD. Participants reported ⩾ 3 months of chronic pain and were > 18 years of age. Per protocol, acupuncture was to be administered twice per week for 5 weeks, for 30 min per session. All treatments were performed in the acupuncture treatment laboratory at the University of Illinois Chicago College of Nursing. Pain intensity, pain interference, and other symptoms were measured at baseline and after the intervention. Participants completed a semi-structured interview and a protocol acceptability questionnaire after the acupuncture intervention. RESULTS: Six participants (mean age 52.5 years, six Black) were enrolled. Although the study was suspended due to COVID-19 and not all participants completed the 10-session protocol, completion rates were high with no missed appointments. One participant did not complete the study due to hospitalization unrelated to acupuncture. No adverse events were reported. At completion of the intervention at 4-5 weeks post-baseline, all participants had reduced pain intensity and pain interference. The mean acceptability score on the protocol acceptability questionnaire was 82%. CONCLUSION: It was feasible and acceptable to implement acupuncture in adults with SCD. This study can be used to guide a larger randomized controlled trial to evaluate the effect of acupuncture on reducing chronic pain in adults with SCD.Trial registration number: NCT04156399 (ClinicalTrials.gov).

Effects on Acupuncturist Blinding: Different Diameters of Double-blind Acupuncture Needles.

CONTEXT: It's difficult to conduct experiments using a double-blind design in controlled clinical trials of acupuncture. To resolve this problem with blinding, we designed double-blind needles (DBNs) with stuffing to mimic the resistance felt during insertion of a regular acupuncture needle. Results of the past studies using 0.16 mm diameter DBNs found that the resistance felt by the acupuncturists during insertion successfully blinded them. OBJECTIVE: The study intended to compare the effects on an acupuncturist's blinding when the practitioner used penetrating DBNs with 0.14, 0.16, 0.18, and 0.20 mm diameters. DESIGN: We conducted a double-blind randomized trial. SETTING: The study took place at the Japan School of Acupuncture, Moxibustion. and Physiotherapy in Tokyo, Japan. PARTICIPANTS: The participant was one licensed acupuncturist who performed 320 needle insertions during acupuncture for 20 healthy students, who were familiar with acupuncture and who attended the Japan School of Acupuncture, Moxibustion, and Physiotherapy. METHODS: The acupuncturist was informed she would administer a penetrating or non-penetrating needle; however, only penetrating needles were used. She inserted the four sizes of needles in both of each student's dorsal forearms using an alternating twirling technique. This procedure was repeated once more on another day, with at least one day between sessions. PRIMARY OUTCOME MEASURES: After the acupuncturist removed each needle, we asked her to guess: (1) the type of needle inserted, (2) her level of confidence in the guess, and (3) the clues that contributed to her guess. A chi-squared test was used to determine whether the ratio of correctly or incorrectly identified needles met an expected probability of 0.5 for each needle diameter. RESULTS: Of the 320 needle insertions, the acupuncturist correctly identified 54% of 0.14 mm, 45% of 0.16 mm, 46% of 0.18 mm, and 50% of 0.20 mm needle insertions. The correct and incorrect ratios of identified needles were fitted with a probability of 0.5, with no significant differences in the acupuncturist's confidence (P = .16). In 99% of the tests, the cue that contributed to the acupuncturist's guess was the feeling of the needle insertion. CONCLUSION: These findings indicate that the differences in the diameters of DBNs from 0.14 to 0.20 mm didn't significantly affect the acupuncturist's blinding.

Double-blinding of an acupuncture randomized controlled trial optimized with clinical translational science award resources.

BACKGROUND: Clinical trial articles often lack detailed descriptions of the methods used to randomize participants, conceal allocation, and blind subjects and investigators to group assignment. We describe our systematic approach to implement and measure blinding success in a double-blind phase 2 randomized controlled trial testing the efficacy of acupuncture for the treatment of vulvodynia. METHODS: Randomization stratified by vulvodynia subtype is managed by Research Electronic Data Capture software's randomization module adapted to achieve complete masking of group allocation. Subject and acupuncturist blinding assessments are conducted multiple times to identify possible correlates of unblinding. RESULTS: At present, 48 subjects have been randomized and completed the protocol resulting in 87 subject and 206 acupuncturist blinding assessments. DISCUSSION: Our approach to blinding and blinding assessment has the potential to improve our understanding of unblinding over time in the presence of possible clinical improvement.

Vulvodynia, "A Really Great Torturer": A Mixed Methods Pilot Study Examining Pain Experiences and Drug/Non-drug Pain Relief Strategies.

BACKGROUND: Women with vulvodynia, a chronic pain condition, experience vulvar pain and dyspareunia. Few studies examine the range and combination of treatment strategies that women are actually using to reduce vulvodynia. AIM: To describe pain experiences and pain relief strategies of women with vulvodynia. METHODS: Convenience sample, 60 women with vulvodynia (median age 32.5 [interquartile range {IQR} 8.5] years; 50 white, 10 racial/ethnic minorities) completed PAINReportIt and reported use of drugs and alcohol and responded to open-ended questions. Univariate descriptive statistics and bivariate inferential tests were used to describe average pain intensity scores, alcohol use, smoking, number of pain relief strategies, and their associations. Women's open-ended responses about their pain experiences and drug and non-drug pain relief strategies (NDPRS) were analyzed for patterns. OUTCOMES: Our mixed methods analysis connected data from pain measures, prescribed treatments and self-reported behaviors with women's free responses. This enabled nuanced insights into women's vulvodynia pain experiences. RESULTS: Women's descriptions of their pain and suffering aligned with their reported severe pain and attempts to control their pain, with a median pain intensity of 6.7 (IQR 2.0) despite use of adjuvant drugs (median 2.0 [IQR 2.0]), and opioids (median 1.0 [IQR 2.0]). 36 women (60%) used alcohol to lessen their pain. 26 women (43%) listed combining analgesics and alcohol to relieve their pain. 30 women (50%) smoked cigarettes. 54 women (90%) used ≥1 NDPRS. The mean number of NDPRS used was 2.1 ± 1.3 (range 0-6). The 5 most common NDPRS from women's comments were herbal medicine (40%), acupuncture (27%), massage (22%), hypnosis (15%), and mental healthcare (13%). CLINICAL IMPLICATIONS: Severe pain in women with vulvodynia may be a clinical indicator of those at higher risk of combining prescription pain medications with alcohol, which are all central nervous system depressants and may potentiate overdose. STRENGTHS AND LIMITATIONS: This pilot study demonstrated that the mixed methods approach to help understand the complexity of vulvodynia was feasible. We identified data showing a reliance on a high-risk mix of prescriptions and alcohol to reduce vulvodynia pain and a high prevalence of cigarette smoking. However, as a pilot study, these results are considered preliminary; the sample may not be representative. Perhaps only women at the extreme end of the pain continuum participated, or women took the survey twice because identifiers were not collected. CONCLUSION: Despite attempts to reduce pain using multiple therapies, including alcohol, women's vulvodynia pain is severe and not controlled. Schlaeger JM, Pauls HA, Powell-Roach KL, et al. Vulvodynia, "A Really Great Torturer": A Mixed Methods Pilot Study Examining Pain Experiences and Drug/Non-drug Pain Relief Strategies. J Sex Med 2019;16:1255-1263.

Effect of electro-acupuncture on lateralization of the human swallowing motor cortex excitability in healthy subjects: study protocol for a single-blind, randomized controlled trial.

BACKGROUND: Numerous randomized controlled trials on the effects of electro-acupuncture have been conducted to treat dysphagia as a sequela of stroke. However, the normal physiological mechanisms of swallowing and the pathological mechanisms of dysphagia are not fully understood. The purpose of this study is to investigate whether lateralization of the human swallowing motor cortex excitability in healthy subjects will be influenced by electro-acupuncture to Lianquan (CV 23) and Fengfu (GV 16), which may provide insight into the pathological mechanisms of dysphagia after stroke. METHODS: We designed a single-blind, randomized, sham-controlled trial in which 40 healthy subjects will be recruited. Subjects will be randomized 1:1 into two groups: the electro-acupuncture group and the sham-control electro-acupuncture group. The swallowing motor cortex will be located in both groups using a neuroimaging navigation system. Then left and right cortical stimulation will be measured by transcranial magnetic stimulation (TMS) before and after electro-acupuncture or sham electro-acupuncture. The electro-acupuncture or sham electro-acupuncture interventions will last for 15 min. The primary outcome measure will be percent change in the resting motor threshold (RMT) of the mylohyoid. The secondary outcome measures will be the amplitude (µV) and latency (ms) of the motor evoked potential (MEP) of the mylohyoid as a proxy for the TMS evoked potential. All outcomes will be measured at baseline and after the electro-acupuncture or sham electro-acupuncture treatment. DISCUSSION: The aim of this trial is to explore whether lateralization of the human swallowing motor cortex excitability in healthy subjects is present, and to determine if electro-acupuncture to acupuncture points Lianquan (CV 23) and Fengfu (GV 16) will exert an effect on it under normal physiological conditions. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-IOR-17011359 . Registered on 11 May 2017.

Moxibustion for Cephalic Version of Breech Presentation.

Moxibustion, a form of traditional Chinese medicine (TCM), is the burning of the herb moxa (Folium Artemisiae argyi or mugwort) over acupuncture points. It is often used in China to facilitate cephalic version of breech presentation. This article reviews the history, philosophy, therapeutic use, possible mechanisms of action, and literature pertaining to its use for this indication. For moxibustion, moxa can be rolled into stick form, placed directly on the skin, or placed on an acupuncture needle and ignited to warm acupuncture points. Studies have demonstrated that moxibustion may promote cephalic version of breech presentation and may facilitate external cephalic version. However, there is currently a paucity of research on the effects of moxibustion on cephalic version of breech presentation, and thus there is a need for further studies. Areas needing more investigation include efficacy, safety, optimal technique, and best protocol for cephalic version of breech presentation.