Ka-Kit Hui

Evidence-based effect size estimation:An illustration using the case of acupuncture for cancer-related fatigue

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.

Evaluating the Statistical Significance of Health-Related Quality-Of-Life Change in Individual Patients:

Assessing individual change is feasible and potentially useful in clinical practice. This article provides an overview of the evaluation of statistically significant change in health-related quality of life (HRQOL) for individual patients. We review the standard error of measurement, standard error of prediction, and reliable change indices using a sample of 54 patients receiving care at the UCLA Center for East-West Medicine. The largest amount of change necessary for statistical significance was found for the reliable change index and the smallest change was needed for the standard error of measurement. The amount of change required for statistical significance was intermediate for the standard error of prediction. The median kappa for classifying change (declined, stayed the same, improved) by different indices was .82, indicating a high level of agreement. Future research is needed to determine if one index is most appropriate for evaluating the significance of individual change.

A Randomized Controlled Trial of Tai Chi for Tension Headaches

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-6™) 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.

Patient education integrated with acupuncture for relief of cancer-related fatigue randomized controlled feasibility study.

BackgroundCancer-related fatigue (CRF) is a prominent clinical problem. There are calls for multi-modal interventions.MethodsWe 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.ResultsDue 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 <0.10). Outcomes associated with cognitive dysfunction were not statistically significant.ConclusionsPatient 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 registrationNCT00646633

Reduction in Drug Requirements for Hypertension by Means of a Cognitive-Behavioral Intervention

The purpose of the present study was to test the effectiveness of a cognitive-behavioral intervention as an adjunctive treatment of hypertension. To qualify for the study, subjects had to have an unmedicated clinic diastolic blood pressure > or = 95 mm Hg. After qualification, minimal drug requirements were established using a diuretic and a beta-blocker to control blood pressure at < or = 90 mm Hg. Subjects were then randomized into a 6-week cognitive-behavioral intervention or a measurements-only control group. After the treatment phase, medication levels were reduced in all subjects by means of a systematic stepdown procedure. Subjects were followed for 1 year after the stepdown was completed. Addition of the cognitive-behavioral intervention was twice as effective as the control procedure in reducing drug requirements. At 12-months follow-up, 73% of the treatment group were at lower levels of medication than at the time of randomization, compared to 35% in the control group. Moreover, 55% of the treatment group remained completely free of medication, compared to 30% of the control group, at the 12-month follow-up. The reductions in medication were associated with maintained controlled levels of clinic, ambulatory, and home blood pressure. The addition of a standardized and inexpensive group-administered cognitive-behavioral intervention to the drug treatment of hypertension is beneficial as an adjunctive treatment in reducing drug requirements for patients with hypertension, thereby reducing the costs and potential side effects of antihypertensive medications.

Introducing integrative East-West medicine to medical students and residents.

Over the last several years, many medical schools and residencies have introduced complementary and alternative medicine (CAM) into their curricula, prompting a discussion as to how CAM should be taught. In this paper, we share our experiences teaching medical trainees integrative East-West medicine, an approach to health and disease that brings together modern Western and Chinese medicine. A 2-week clinical rotation that is intimately tied to our busy clinical program is described in detail as we explore some of the challenges and opportunities involved in teaching a CAM-related field to medical trainees. We also demonstrate how such a clinical experience offers an opportunity to impart on our students a broad view of medicine and to discuss novel approaches to clinical problem-solving.

Acupuncture effects on autonomic responses to cold pressor and handgrip exercise in healthy humans.

Abstract.Acupuncture at P6, Liv 3 and Li 4 attenuates the increase in blood pressure during mental stress in healthy humans. The purpose of this study was to test the hypothesis that acupuncture at these points has a generalized depressor effect seen during other stimuli to the autonomic nervous system. Thirty-eight healthy humans (mean age 33 ± 13 years) performed handgrip exercise (n = 20) or the cold pressor test (n = 18) before and after acupuncture at P6, Liv 3 and Li4. To control for repeated interventions, subjects underwent an identical protocol on a different day, during which acupuncture was replaced by quiet rest. Blood pressure and heart rate increased similarly during the first and repeat intervention (handgrip or cold pressor test). Acupuncture did not attenuate the increase in blood pressure (delta mean arterial pressure [MAP] 9.3 ± 1.8 vs 7.3 ± 3.1 mmHg) or the increase in heart rate (delta heart rate [HR] 6.7 ± 2.1 vs 6.0 ± 2.0 bpm) during handgrip exercise. Similarly, acupuncture did not attenuate the increase in blood pressure (delta mean arterial pressure [MAP] 14.8 ± 5.0 vs 14.8 ± 4.8 mmHg) or the increase in heart rate (delta heart rate [HR] 5.3 ± 2.1 vs 8.7 ± 3.6 bpm) during the cold pressor test. In summary, in normal healthy humans, acupuncture at P6, Liv 3 and Li 4 does not attenuate the blood pressure or heart rate responses during handgrip exercise or the cold pressor test.

The Potential of a Person-Centered Approach in Caring for Patients With Cancer: A Perspective From the UCLA Center for East-West Medicine

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 into clinical oncology. Traditional Chinese medicine (TCM) has been used in conjunction with conventional biomedicine in the prevention and treatment of cancer in China for several decades. Methods: The authors, through select review of the existing literature and by drawing on clinical experience, describe a person-centered approach to care of patients with cancer that incorporates TCM concepts and techniques. Two cases are used to illustrate how this approach might address unmet needs and enhance quality of life for patients with cancer. Results: TCM’s emphasis on a comprehensive understanding of imbalance in various systems and resultant compromise of homeostatic reserve as well as its ability to treat them with distinctive therapeutic modalities can add unique value to the overall management of the patient with cancer. Conclusions: TCM can be used adjunctively to improve quality of life and functional status during a patient’s struggle with cancer. An approach integrating both medicines that is guided by scientific evidence, safety, and patient preferences has the potential to improve modern oncologic care.

Blood pressure morning surge and hostility

This study examined the effects of hostility on blood pressure (BP) during the early morning hours before awakening and several hours afterward. Our objective was to determine whether the pattern of BP change and the slope of the morning BP surge were related to hostility. The subjects were 32 patients with a history of Stage 1 hypertension. The morning surge in BP was derived from ambulatory BP monitoring of sleeping and waking hours, which were averaged per subject and centered around the wake-up hour. The periods used were 3 h before and 3 h after awakening. Only systolic blood pressure (SBP) is being reported on in this paper as this is the primary measure found relevant to the morning surge phenomenon. Hostility was assessed by the Buss-Durkee Hostility Inventory (total score). The results revealed significant differences between low and high hostility subjects for overall levels of sleep SBP: 120 +/- 11.4 mm Hg for low hostility and 131.3 +/- 14.9 mm Hg for high hostility subjects (P = .02). Low hostility subjects showed a steep rise in SBP from sleeping to waking while high hostility subjects had almost reached their post-sleep level of SBP in the hours immediately before waking up (P = .03). These data indicate that individual differences in hostility are related to different patterns of BP during sleep and the early morning hours, a period of the day that has been associated with an increased risk of cardiovascular incidents. The data also suggest the need for further study of the significance of hostility and other personality traits and the relationship of these traits to the mechanisms of the morning surge and the risk of cardiovascular events.

Acupuncture for Chemotherapy-Associated Cognitive Dysfunction: A Hypothesis-Generating Literature Review to Inform Clinical Advice

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 acupuncture for symptom relief. A clinical question thus arises: What should physicians advise their patients regarding the use of acupuncture to alleviate or ameliorate chemotherapy-associated cognitive dysfunction? The authors review and synthesize 2 bodies of relevant research literature: (1) the developing literature on the etiology and nature of chemotherapy-associated cognitive dysfunction and (2) the literature concerning acupuncture for neurological diseases and psychological issues. There is evidence that acupuncture may be effectively used to manage a range of psychoneurological issues, some of which are similar to those experienced by patients with chemotherapy-associated cognitive dysfunction. The evidence of efficacy is more promising for psychological than neurological conditions. Given evidence of possible efficacy combined with evidence of demonstrated safety, we suggest that physicians should support patient decisions to use acupuncture services for chemotherapy-associated cognitive dysfunction, especially given the lack of proven alternatives.