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 to Improve Symptoms for Stable Angina: Protocol for a Randomized Controlled Trial.

BACKGROUND: Acupuncture has demonstrated physiologic analgesic effects in Chinese patients with stable angina. One proposed mechanism of action for these analgesic effects is the downregulation of M1 macrophages, interleukin 1 beta, interleukin-6, interleukin-18, and tumor necrosis factor alpha. OBJECTIVE: This study aims to test a 10-session, 5-week acupuncture treatment protocol as a complementary therapy for symptoms of stable angina for American patients, who vary from Chinese patients in health care systems and other salient variables. METHODS: We are conducting a randomized controlled trial (RCT) of 69 adults (35 assigned to initial acupuncture and 34 to an attention control condition) with a medically confirmed diagnosis of stable angina, whose pain and associated symptoms have not been controlled to their satisfaction with guideline-directed medical management. Participants in the experimental group will receive a standardized traditional Chinese medicine point prescription. The attention control group will view non-pain-related health education videos over 5 weeks equal to the 10 hours of treatment for the acupuncture group. Participants will complete the McGill Pain Questionnaire and the Seattle Angina Questionnaire-7, as well as have inflammatory cytokines measured at baseline and study completion. The primary outcomes are anginal pain and quality of life. RESULTS: This study has been funded over 2 years by the National Institutes of Health, National Institute for Nursing Research. We are currently recruiting and expect to have initial results by December 2020. CONCLUSIONS: We will generate data on feasibility, acceptability, effect sizes, and protocol revisions for a future fully powered RCT of the protocol. Findings will help determine if patients with persistent ischemic symptoms experience a proinflammatory state and hyperalgesia caused by multiple neural and immune processes not always relieved with medication. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14705.

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.

Do Vulvodynia TCM Patterns Differ by Pain Types? Beginning Evidence Supporting the Concept.

INTRODUCTION: Vulvodynia affects a maximum of 14 million U.S. women; however, it has not been adequately characterized. Traditional Chinese Medicine (TCM) offers pattern diagnoses that may be considered vulvodynia phenotypes and may guide the development of more targeted treatments. OBJECTIVES: In women with vulvodynia, to explore relationships between the TCM patterns and pain. DESIGN/METHODS: In an exploratory study, 36 women diagnosed with vulvodynia had a TCM assessment and completed the Short Form McGill Pain Questionnaire (SF-MPQ). RESULTS: All 36 women were diagnosed with one of the two TCM patterns (excess heat [n = 28] or excess cold [n = 8]). Although not statistically significant, (1) the excess heat pattern group had a higher mean sensory score (14.4 ± 6.0) and mean affective pain score (4.1 ± 2.8) (more pain) compared with the mean sensory score (13.3 ± 5.9) and mean affective score (3.3 ± 1.8) of the excess cold pattern group; (2) there was a higher mean score for neuropathic sensory descriptors in the excess heat pattern group (1.55 ± .58) compared with the excess cold pattern group (1.16 ± 0.72); and (3) there was a higher mean score for nociceptive sensory descriptors in the excess cold pattern group (1.23 ± 0.45) compared with the excess heat pattern group (1.14 ± 0.62). The difference in the hot-burning mean score between the two TCM pattern groups was statistically significant (t [34] = 6.55, p < 0.0001). CONCLUSION: Intriguing trends were observed in the pain scores for the two TCM pattern groups. The possibility that TCM pattern groups have different types of pain (neuropathic vs. nociceptive) deserves further research in larger samples. If these exploratory findings are confirmed, the characterization of TCM patterns could lead to new treatments for vulvodynia.