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BackgroundThe efficacy of providing self-acupressure educational materials in reducing stress and improving health-related quality of life (HRQOL) is uncertain. Evidence-based data to recommend for or against self-acupressure as an intervention for reducing stress and improving HRQOL is needed.ObjectiveThe Self-Acupressure for Stress (SAS) trial evaluates whether providing self-acupressure educational materials would reduce stress and improve HRQOL among health care providers (HCPs).DesignRandomized behavioral clinical trial.SettingThe entire study took place remotely.ParticipantsOne hundred fifty-nine adult HCPs with no prior experience or training in acupressure.InterventionThe intervention group received self-acupressure educational materials.MeasurementsPrimary outcomes were perception of stress measured by the Perceived Stress Scale (PSS), as well as scores on the physical and mental components of the 12-item Short Form Health Survey version 2 (SF-12v2).ResultsFrom the baseline to midpoint evaluations, the intervention group significantly reduced their PSS score (P ≤ .001) and increased their SF-12v2 Mental score (P = .002) but not their SF-12v2 Physical score (P = .55). These findings persisted at the final follow-up (both PSS and SF-12v2 Mental changes from baseline P < .001). However the control group also significantly improved their SF-12v2 Mental from baseline to midpoint (P = .01) which was maintained at final follow-up (P = .02), whereas PSS and SF-12v2 Physical did not significantly change from baseline at either mid or final. Finally, the intervention group improved by significantly more than the control group from baseline to final follow-up for both PSS (P = .007) and SF-12v2 Mental (P = .02) HRQOL measures.LimitationThe trial was not blinded.ConclusionAmong HCPs during the coronavirus disease 2019 (COVID-19) pandemic, the provision of self-acupressure educational materials safely improved self-reported assessments of perception of stress and mental health. Self-acupressure represents a promising intervention for other populations. The study findings support the use of self-acupressure to reduce stress and improve HRQOL.Trial registrationClinicalTrials.gov: NCT04472559.

BackgroundThis study evaluated change in health-related quality of life at the group and individual levels in a consecutive series of patients with chronic myofascial neck pain.MethodsFifty patients with chronic neck pain self-administered the Short Form-36 Version 2 (SF-36 v2) before treatment and 6 weeks later. Internal consistency reliability was estimated for the 8 scale scores and Mosier's formula was used to estimate reliability of the physical and mental health composite scores. Significance of group-level change was estimated using within-group t statistics. Significance of individual change was evaluated by reliable change index.ResultsStatistically significant ( P < .05) group mean improvement over time was found for all SF-36 scores. At the individual level, 20% of the possible changes were statistically significant (17% improvement, 3% decline).ConclusionsEstimating the significance of individual change in health-related quality of life adds important information in comparing different treatment modalities for chronic myofascial neck pain.

ObjectiveExplore patterns in patients' disclosures of supplement use and identify provider and patient characteristics associated with disclosures.MethodsCross-sectional study of 61 outpatient primary care, integrative medicine, and complementary medicine providers, and 603 of their patients. Primary outcomes were supplement disclosures (based on audio recorded office visits, post-visit patient surveys and medical record abstractions for the day of the visits).ResultsSeventy-nine percent of 603 patients reported on a post-visit survey that they took a total of 2107 dietary supplements. Of those taking supplements, 232 patients (48.6%) discussed at least one supplement with their provider on the day of their office visit. However, patients disclosed only 714 (33.9%) of the 2107 supplements they were taking. Patients more frequently disclosed supplement use when they saw providers who attributed greater importance to asking about supplements. Patient characteristics such as patient activation, number of medical conditions, and use of prescription medications were not associated with disclosure of supplement use.ConclusionsProvider rating of the importance of asking about supplements is a major factor prompting patients' disclosures of supplement use.Practice implicationsProvider-targeted interventions to encourage provider awareness about potential supplement-drug interactions are needed to increase disclosures about dietary supplement use.

ObjectivesThis study aimed to examine differences in autonomic responses to stress, pain perception, and the role of negative affect in these responses in individuals with irritable bowel syndrome (IBS) according to Traditional Chinese Medicine (TCM) classifications.DesignFifty-nine female patients with IBS age 18-65 years diagnosed by TCM practitioners as showing primarily an excess (n=32) or an overlap (n=27) pattern (mixed excess and deficiency) were assessed for symptom differences, heart rate, and skin conductance responses to a psychosocial stressor and pain perception. SETTINGS/LOCATIONS: University of California in Los Angeles, California.ResultsCompared with the excess group, the overlap group showed significantly greater overall gastrointestinal symptom severity, abdominal pain, and negative affect. The excess group with higher levels of negative affect showed greater reactivity to stress, whereas the overlap group showed an opposite response pattern. The overlap group showed increased cold sensitivity.ConclusionsIBS patients with the overlap pattern have greater disease severity and comorbidity than those with excess alone. Those with excess showed a pattern of increased stress response with greater negative affect, whereas the overlap group with greater deficiency showed lower physiologic arousal with greater negative affect, consistent with depletion resulting from allostatic load.

Abstract Background Cancer-related fatigue (CRF) is a prominent clinical problem. There are calls for multi-modal interventions. Methods We assessed the feasibility of delivering patient education integrated with acupuncture for relief of CRF in a pilot randomized controlled trial (RCT) with breast cancer survivors using usual care as control. Social cognitive and integrative medicine theories guided integration of patient education with acupuncture into a coherent treatment protocol. The intervention consisted of two parts. First, patients were taught to improve self-care by optimizing exercise routines, improving nutrition, implementing some additional evidence-based cognitive behavioral techniques such as stress management in four weekly 50-minute sessions. Second, patients received eight weekly 50-minute acupuncture sessions. The pre-specified primary outcome, CRF, was assessed with the Brief Fatigue Inventory (BFI). Secondary outcomes included three dimensions of cognitive impairment assessed with the FACT-COGv2. Results Due to difficulties in recruitment, we tried several methods that led to the development of a tailored recruitment strategy: we enlisted oncologists into the core research team and recruited patients completing treatment from oncology waiting rooms. Compared to usual care control, the intervention was associated with a 2.38-point decline in fatigue as measured by the BFI (90% Confidence Interval from 0.586 to 5.014; p

While the use of complementary, alternative and integrative medicine (CAIM) is substantial, it continues to exist at the periphery of allopathic medicine. Understanding the attitudes of medical students toward CAIM will be useful in understanding future integration of CAIM and allopathic medicine. This study was conducted to develop and evaluate an instrument and assess medical students' attitudes toward CAIM. The Complementary, Alternative and Integrative Medicine Attitudes Questionnaire (CAIMAQ) was developed by a panel of experts in CAIM, allopathic medicine, medical education and survey development. A total of 1770 CAIMAQ surveys (51% of US medical schools participated) were obtained in a national sample of medical students in 2007. Factor analysis of the CAIMAQ revealed five distinct attitudinal domains: desirability of CAIM therapies, progressive patient/physician health care roles, mind-body-spirit connection, principles of allostasis and a holistic understanding of disease. The students held the most positive attitude for the "mind-body-spirit connection" and the least positive for the "desirability of CAIM therapies". This study provided initial support for the reliability of the CAIMAQ. The survey results indicated that in general students responded more positively to the principles of CAIM than to CAIM treatment. A higher quality of CAIM-related medical education and expanded research into CAIM therapies would facilitate appropriate integration of CAIM into medical curricula. The most significant limitation of this study is a low response rate, and further work is required to assess more representative populations in order to determine whether the relationships found in this study are generalizable.

BackgroundEstimating a realistic effect size is an important issue in the planning of clinical studies of complementary and alternative medicine therapies. When a minimally important difference is not available, researchers may estimate effect size using the published literature. This evidence-based effect size estimation may be used to produce a range of empirically-informed effect size and consequent sample size estimates. We provide an illustration of deriving plausible effect size ranges for a study of acupuncture in the relief of post-chemotherapy fatigue in breast cancer patients.MethodsA PubMed search identified three uncontrolled studies reporting the effect of acupuncture in relieving fatigue. A separate search identified five randomized controlled trials (RCTs) with a wait-list control of breast cancer patients receiving standard care that reported data on fatigue. We use these published data to produce best, average, and worst-case effect size estimates and related sample size estimates for a trial of acupuncture in the relief of cancer-related fatigue relative to a wait-list control receiving standard care.ResultsUse of evidence-based effect size estimation to calculate sample size requirements for a study of acupuncture in relieving fatigue in breast cancer survivors relative to a wait-list control receiving standard care suggests that an adequately-powered phase III randomized controlled trial comprised of two arms would require at least 101 subjects (52 per arm) if a strong effect is assumed for acupuncture and 235 (118 per arm) if a moderate effect is assumed.ConclusionEvidence-based effect size estimation helps justify assumptions in light of empirical evidence and can lead to more realistic sample size calculations, an outcome that would be of great benefit for the field of complementary and alternative medicine.

BackgroundEstimating a realistic effect size is an important issue in the planning of clinical studies of complementary and alternative medicine therapies. When a minimally important difference is not available, researchers may estimate effect size using the published literature. This evidence-based effect size estimation may be used to produce a range of empirically-informed effect size and consequent sample size estimates. We provide an illustration of deriving plausible effect size ranges for a study of acupuncture in the relief of post-chemotherapy fatigue in breast cancer patients.MethodsA PubMed search identified three uncontrolled studies reporting the effect of acupuncture in relieving fatigue. A separate search identified five randomized controlled trials (RCTs) with a wait-list control of breast cancer patients receiving standard care that reported data on fatigue. We use these published data to produce best, average, and worst-case effect size estimates and related sample size estimates for a trial of acupuncture in the relief of cancer-related fatigue relative to a wait-list control receiving standard care.ResultsUse of evidence-based effect size estimation to calculate sample size requirements for a study of acupuncture in relieving fatigue in breast cancer survivors relative to a wait-list control receiving standard care suggests that an adequately-powered phase III randomized controlled trial comprised of two arms would require at least 101 subjects (52 per arm) if a strong effect is assumed for acupuncture and 235 (118 per arm) if a moderate effect is assumed.ConclusionEvidence-based effect size estimation helps justify assumptions in light of empirical evidence and can lead to more realistic sample size calculations, an outcome that would be of great benefit for the field of complementary and alternative medicine.

This study examined whether a traditional low-impact mind-body exercise, Tai Chi, affects health-related quality-of-life (HRQOL) and headache impact in an adult population suffering from tension-type headaches. Forty-seven participants were randomly assigned to either a 15 week intervention program of Tai Chi instruction or a wait-list control group. HRQOL (SF-36v2) and headache status (HIT-6trade mark) were obtained at baseline and at 5, 10 and 15 weeks post-baseline during the intervention period. Statistically significant (P < 0.05) improvements in favor of the intervention were present for the HIT score and the SF-36 pain, energy/fatigue, social functioning, emotional well-being and mental health summary scores. A 15 week intervention of Tai Chi practice was effective in reducing headache impact and also effective in improving perceptions of some aspects of physical and mental health.

There is an emerging consensus that between one fifth and one half of breast cancer patients experience chemotherapy-associated cognitive dysfunction. Research shows that patients with cancer are often interested in [...]

Background: Evolving patient preferences as well as an expanding evidence base for commonly used complementary and alternative medicine therapies for patients with cancer have led to inroads by integrative medicine [...]

Abstract Background Cancer-related fatigue (CRF) is a prominent clinical problem. There are calls for multi-modal interventions. Methods We assessed the feasibility of delivering patient education integrated with acupuncture for relief of CRF in a pilot randomized controlled trial (RCT) with breast cancer survivors using usual care as control. Social cognitive and integrative medicine theories guided integration of patient education with acupuncture into a coherent treatment protocol. The intervention consisted of two parts. First, patients were taught to improve self-care by optimizing exercise routines, improving nutrition, implementing some additional evidence-based cognitive behavioral techniques such as stress management in four weekly 50-minute sessions. Second, patients received eight weekly 50-minute acupuncture sessions. The pre-specified primary outcome, CRF, was assessed with the Brief Fatigue Inventory (BFI). Secondary outcomes included three dimensions of cognitive impairment assessed with the FACT-COGv2. Results Due to difficulties in recruitment, we tried several methods that led to the development of a tailored recruitment strategy: we enlisted oncologists into the core research team and recruited patients completing treatment from oncology waiting rooms. Compared to usual care control, the intervention was associated with a 2.38-point decline in fatigue as measured by the BFI (90% Confidence Interval from 0.586 to 5.014; p Conclusions Patient education integrated with acupuncture had a very promising effect that warrants conducting a larger RCT to confirm findings. An effective recruitment strategy will be essential for the successful execution of a larger-scale trial. Trial registration NCT00646633

Abstract Background Estimating a realistic effect size is an important issue in the planning of clinical studies of complementary and alternative medicine therapies. When a minimally important difference is not available, researchers may estimate effect size using the published literature. This evidence-based effect size estimation may be used to produce a range of empirically-informed effect size and consequent sample size estimates. We provide an illustration of deriving plausible effect size ranges for a study of acupuncture in the relief of post-chemotherapy fatigue in breast cancer patients. Methods A PubMed search identified three uncontrolled studies reporting the effect of acupuncture in relieving fatigue. A separate search identified five randomized controlled trials (RCTs) with a wait-list control of breast cancer patients receiving standard care that reported data on fatigue. We use these published data to produce best, average, and worst-case effect size estimates and related sample size estimates for a trial of acupuncture in the relief of cancer-related fatigue relative to a wait-list control receiving standard care. Results Use of evidence-based effect size estimation to calculate sample size requirements for a study of acupuncture in relieving fatigue in breast cancer survivors relative to a wait-list control receiving standard care suggests that an adequately-powered phase III randomized controlled trial comprised of two arms would require at least 101 subjects (52 per arm) if a strong effect is assumed for acupuncture and 235 (118 per arm) if a moderate effect is assumed. Conclusion Evidence-based effect size estimation helps justify assumptions in light of empirical evidence and can lead to more realistic sample size calculations, an outcome that would be of great benefit for the field of complementary and alternative medicine.