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Biomedical subjects

Peter M Wayne

Publications and source records attributed to Peter M Wayne.

12 recordsLinked to original sources

Stop Hypertension with the Acupuncture Research Program (SHARP): results of a randomized, controlled clinical trial.

Case studies and small trials suggest that acupuncture may effectively treat hypertension, but no large randomized trials have been reported. The Stop Hypertension with the Acupuncture Research Program pilot trial enrolled 192 participants with untreated blood pressure (BP) in the range of 140/90 to 179/109 mm Hg. The design of the trial combined rigorous methodology and adherence to principles of traditional Chinese medicine. Participants were weaned off antihypertensives before enrollment and were then randomly assigned to 3 treatments: individualized traditional Chinese acupuncture, standardized acupuncture at preselected points, or invasive sham acupuncture. Participants received < or = 12 acupuncture treatments over 6 to 8 weeks. During the first 10 weeks after random assignment, BP was monitored every 14 days, and antihypertensives were prescribed if BP exceeded 180/110 mm Hg. The mean BP decrease from baseline to 10 weeks, the primary end point, did not differ significantly between participants randomly assigned to active (individualized and standardized) versus sham acupuncture (systolic BP: -3.56 versus -3.84 mm Hg, respectively; 95% CI for the difference: -4.0 to 4.6 mm Hg; P=0.90; diastolic BP: -4.32 versus -2.81 mm Hg, 95% CI for the difference: -3.6 to 0.6 mm Hg; P=0.16). Categorizing participants by age, race, gender, baseline BP, history of antihypertensive use, obesity, or primary traditional Chinese medicine diagnosis did not reveal any subgroups for which the benefits of active acupuncture differed significantly from sham acupuncture. Active acupuncture provided no greater benefit than invasive sham acupuncture in reducing systolic or diastolic BP.

Acupuncture↗

Adolescent endometriosis-related pelvic pain treated with acupuncture: two case reports.

BACKGROUND: Chronic pelvic pain in adolescents accounts for 10% of outpatient gynecology visits, and 70% of adolescent patients whose pelvic pain is unresponsive to initial therapy have endometriosis. To date, there has been no published research investigating the use of acupuncture for adolescents with chronic pelvic pain and/or endometriosis. METHODS: This paper presents two case reports describing the impact of a course of acupuncture on adolescent girls with endometriosis-related chronic pelvic pain of more than 1 year. RESULTS: Both patients, undergoing between 9 and 15 treatments over a 7- to 12-week period, experienced modest improvement in pain as measured by oral self-reports of pain on a scale from 1 to 10, as well as self or family-reported improvement in headaches, nausea and fatigue. No adverse effects were reported. CONCLUSIONS: These case reports provide preliminary evidence that acupuncture may be an acceptable and safe adjunct treatment therapy for some adolescents with endometriosis-related pelvic pain refractory to standard antiendometriosis therapies. These observations suggest that a prospective, randomized controlled trial of the safety and efficacy of acupuncture for this population may be warranted.

Activities of Daily Living↗

Interaction of the onset of spring and elevated atmospheric CO2 on ragweed (Ambrosia artemisiifolia L.) pollen production.

Increasing atmospheric carbon dioxide is responsible for climate changes that are having widespread effects on biological systems. One of the clearest changes is earlier onset of spring and lengthening of the growing season. We designed the present study to examine the interactive effects of timing of dormancy release of seeds with low and high atmospheric CO2 on biomass, reproduction, and phenology in ragweed plants (Ambrosia artemisiifolia L.), which produce highly allergenic pollen. We released ragweed seeds from dormancy at three 15-day intervals and grew plants in climate-controlled glass-houses at either ambient or 700-ppm CO2 concentrations, placing open-top bags over influorescences to capture pollen. Measurements of plant height and weight; inflorescence number, weight, and length; and days to anthesis and anthesis date were made on each plant, and whole-plant pollen productivity was estimated from an allometric-based model. Timing and CO2 interacted to influence pollen production. At ambient CO2 levels, the earlier cohort acquired a greater biomass, a higher average weight per inflorescence, and a larger number of influorescences; flowered earlier; and had 54.8% greater pollen production than did the latest cohort. At high CO2 levels, plants showed greater biomass and reproductive effort compared with those in ambient CO2 but only for later cohorts. In the early cohort, pollen production was similar under ambient and high CO2, but in the middle and late cohorts, high CO2 increased pollen production by 32% and 55%, respectively, compared with ambient CO2 levels. Overall, ragweed pollen production can be expected to increase significantly under predicted future climate conditions.

Ambrosia↗

Tai Chi and vestibular rehabilitation improve vestibulopathic gait via different neuromuscular mechanisms: preliminary report.

BACKGROUND: Vestibular rehabilitation (VR) is a well-accepted exercise program intended to remedy balance impairment caused by damage to the peripheral vestibular system. Alternative therapies, such as Tai Chi (TC), have recently gained popularity as a treatment for balance impairment. Although VR and TC can benefit people with vestibulopathy, the degree to which gait improvements may be related to neuromuscular adaptations of the lower extremities for the two different therapies are unknown. METHODS: We examined the relationship between lower extremity neuromuscular function and trunk control in 36 older adults with vestibulopathy, randomized to 10 weeks of either VR or TC exercise. Time-distance measures (gait speed, step length, stance duration and step width), lower extremity sagittal plane mechanical energy expenditures (MEE), and trunk sagittal and frontal plane kinematics (peak and range of linear and angular velocity), were measured. RESULTS: Although gait time-distance measures were improved in both groups following treatment, no significant between-groups differences were observed for the MEE and trunk kinematic measures. Significant within groups changes, however, were observed. The TC group significantly increased ankle MEE contribution and decreased hip MEE contribution to total leg MEE, while no significant changes were found within the VR group. The TC group exhibited a positive relationship between change in leg MEE and change in trunk velocity peak and range, while the VR group exhibited a negative relationship. CONCLUSION: Gait function improved in both groups consistent with expectations of the interventions. Differences in each group's response to therapy appear to suggest that improved gait function may be due to different neuromuscular adaptations resulting from the different interventions. The TC group's improvements were associated with reorganized lower extremity neuromuscular patterns, which appear to promote a faster gait and reduced excessive hip compensation. The VR group's improvements, however, were not the result of lower extremity neuromuscular pattern changes. Lower-extremity MEE increases corresponded to attenuated forward trunk linear and angular movement in the VR group, suggesting better control of upper body motion to minimize loss of balance. These data support a growing body of evidence that Tai Chi may be a valuable complementary treatment for vestibular disorders.

Biomechanical Phenomena↗

Acupuncture for upper-extremity rehabilitation in chronic stroke: a randomized sham-controlled study.

OBJECTIVE: To compare the effects of traditional Chinese acupuncture with sham acupuncture on upper-extremity (UE) function and quality of life (QOL) in patients with chronic hemiparesis from stroke. DESIGN: A prospective, sham-controlled, randomized controlled trial (RCT). SETTING: Patients recruited through a hospital stroke rehabilitation program. PARTICIPANTS: Thirty-three subjects who incurred a stroke 0.8 to 24 years previously and had moderate to severe UE functional impairment. INTERVENTIONS: Active acupuncture tailored to traditional Chinese medicine diagnoses, including electroacupuncture, or sham acupuncture. Up to 20 treatment sessions (mean, 16.9) over a mean of 10.5 weeks. MAIN OUTCOME MEASURES: UE motor function, spasticity, grip strength, range of motion (ROM), activities of daily living, QOL, and mood. All outcomes were measured at baseline and after treatment. RESULTS: Intention-to-treat (ITT) analyses found no statistically significant differences in outcomes between active and sham acupuncture groups. Analyses of protocol-compliant subjects revealed significant improvement in wrist spasticity (P<.01) and both wrist (P<.01) and shoulder (P<.01) ROM in the active acupuncture group, and improvement trends in UE motor function (P=.09) and digit ROM (P=.06). CONCLUSIONS: Based on ITT analyses, we conclude that acupuncture does not improve UE function or QOL in patients with chronic stroke symptoms. However, gains in UE function observed in protocol-compliant subjects suggest traditional Chinese acupuncture may help patients with chronic stroke symptoms. These results must be interpreted cautiously because of small sample sizes and multiple, unadjusted, post hoc comparisons. A larger, more definitive RCT using a similar design is feasible and warranted.

Activities of Daily Living↗

Development of a Chinese medicine assessment measure: an interdisciplinary approach using the delphi method.

BACKGROUND: The diagnostic framework and clinical reasoning process in Chinese medicine emphasizes the contextual and qualitative nature of a patient's illness. Chinese medicine assessment data may help interpret clinical outcomes. OBJECTIVES: As part of a study aimed at assessing the validity and improving the inter-rater reliability of the Chinese diagnostic process, a structured assessment instrument was developed for use in clinical trials of acupuncture and other Chinese medical therapies. STUDY DESIGN: To foster collaboration and maximize resources and information, an interdisciplinary advisory team was assembled. Under the guidance of two group process facilitators, and in order to establish whether the assessment instrument was consistent with accepted Chinese medicine diagnostic categories (face validity) and included the full range of each concept's meaning (content validity), a panel of Traditional Chinese Medicine (TCM) expert clinicians was convened and their responses were organized using the Delphi process, an iterative, anonymous, idea-generating and consensus-building process. An aggregate rating measure was obtained by taking the mean of mean ratings for each question across all 10 experts. RESULTS: Over three rounds, the overall rating increased from 7.4 (SD = 1.3) in Round 1 to 9.1 (SD = 0.5) in Round 3. The level of agreement among clinicians was measured by a decrease in SD. CONCLUSIONS: The final instrument TEAMSI-TCM (Traditional East Asian Medicine Structured Interview, TCM version) uses the pattern differentiation model characteristic of TCM. This modular, dynamic version was specifically designed to assess women, with a focus on gynecologic conditions; with modifications it can be adapted for use with other populations and conditions. TEAMSI-TCM is a prescriptive instrument that guides clinicians to use the proper indicators, combine them in a systematic manner, and generate conclusions. In conjunction with treatment manualization and training it may serve to increase inter-rater reliability and inter-trial reproducibility in Chinese medicine clinical trials. Testing of the validity and reliability of this instrument currently is underway.

Data Interpretation, Statistical↗

Effects of tai chi mind-body movement therapy on functional status and exercise capacity in patients with chronic heart failure: a randomized controlled trial.

PURPOSE: To examine the effects of a 12-week tai chi program on quality of life and exercise capacity in patients with heart failure. METHODS: Thirty patients with chronic stable heart failure and left ventricular ejection fraction < or =40% (mean [+/- SD] age, 64 +/- 13 years; mean baseline ejection fraction, 23% +/- 7%; median New York Heart Association class, 2 [range, 1 to 4]) were randomly assigned to receive usual care (n = 15), which included pharmacologic therapy and dietary and exercise counseling, or 12 weeks of tai chi training (n = 15) in addition to usual care. Tai chi training consisted of a 1-hour class held twice weekly. Primary outcomes included quality of life and exercise capacity. Secondary outcomes included serum B-type natriuretic peptide and plasma catecholamine levels. For 3 control patients with missing data items at 12 weeks, previous values were carried forward. RESULTS: At 12 weeks, patients in the tai chi group showed improved quality-of-life scores (mean between-group difference in change, -25 points, P = 0.001), increased distance walked in 6 minutes (135 meters, P = 0.001), and decreased serum B-type natriuretic peptide levels (-138 pg/mL, P = 0.03) compared with patients in the control group. A trend towards improvement was seen in peak oxygen uptake. No differences were detected in catecholamine levels. CONCLUSION: Tai chi may be a beneficial adjunctive treatment that enhances quality of life and functional capacity in patients with chronic heart failure who are already receiving standard medical therapy.

Aged↗

Stop Hypertension with the Acupuncture Research Program (SHARP): clinical trial design and screening results.

Hypertension is a major public health problem with serious medical and financial consequences. Barriers to successful conventional pharmacological treatment include side effects, out-of-pocket expenses, patient noncompliance and insufficient dosages. Acupuncture has been studied as an alternative therapy for controlling blood pressure (BP) but previous studies have serious methodological limitations. This paper describes the design of the Stop Hypertension with the Acupuncture Research Program (SHARP) trial, a pilot randomized clinical trial designed to gather preliminary data regarding the efficacy of traditional Chinese medicine (TCM)-based acupuncture for control of essential hypertension. The design of the SHARP trial balanced rigorous clinical trial methodology with principles of TCM. Eligible participants had systolic BP (SBP) 140-179 mm Hg and diastolic BP (DBP) 90-109 mm Hg in the absence of antihypertensive therapy. Following screening, participants were randomized to one of three groups: individualized, standardized or control acupuncture. Treatments were designed according to principles of TCM; nonspecific effects associated with the interventions were standardized across the randomized groups. For individualized acupuncture, points were tailored to each participant. Standardized acupuncture used a prespecified set of points. The invasive sham control acupuncture regimen was designed to be non-active. Each participant received a "prescription" for individualized acupuncture from an acupuncturist who was masked to treatment assignment, and was subsequently treated by an independent acupuncturist. Patients and those assessing BP were masked to treatment group. Acupuncture was delivered twice a week for 6 weeks. Follow-up visits were every 2 weeks to week 10 and then at months 4, 6, 9 and 12. The primary endpoint will be change in SBP from baseline to 10 weeks. DBP, BP trajectories over the 12-month follow-up and antihypertensive medication requirements will also be examined. Initial contact was documented for 1442 prospective participants from March 2001 to April 2002; 424 provided informed consent and 192 were ultimately randomized.

Acupuncture Therapy↗

Can Tai Chi improve vestibulopathic postural control?

OBJECTIVES: To evaluate the rationale and scientific support for Tai Chi as an intervention for vestibulopathy and to offer recommendations for future studies. DATA SOURCES: A computer-aided search, including MEDLINE and Science Citation Index, to identify original Tai Chi studies published in English; relevant references cited in the retrieved articles were also included. STUDY SELECTION: A preliminary screening selected all randomized controlled trials (RCTs), non-RCTs, case-control studies, and case series that included Tai Chi as an intervention and had at least 1 outcome variable relevant to postural stability. DATA EXTRACTION: Authors critically reviewed studies and summarized study designs and outcomes in a summary table. DATA SYNTHESIS: Twenty-four Tai Chi studies met screening criteria. No studies specifically studying Tai Chi for vestibulopathy were found. Collectively, the 24 studies provide sometimes contradictory but generally supportive evidence that Tai Chi may have beneficial effects for balance and postural impairments, especially those associated with aging. Ten RCTs were found, of which 8 provide support that Tai Chi practiced alone, or in combination with other therapies, can reduce risk of falls, and/or impact factors associated with postural control, including improved balance and dynamic stability, increased musculoskeletal strength and flexibility, improved performance of activities of daily living (ADLs), reduced fear of falling, and general improvement in psychologic well-being. Studies using other designs support the results observed in RCTs. CONCLUSIONS: At present, few data exist to support the contention that Tai Chi specifically targets the impairments, functional limitations, disability, and quality of life associated with peripheral vestibulopathy. There are, however, compelling reasons to further investigate Tai Chi for vestibulopathy, in part because Tai Chi appears useful for a variety of nonvestibulopathy etiologic balance disorders, and is safe. Especially needed are studies that integrate measures of balance relevant to ADLs with other psychologic and cognitive measures; these might help identify specific mechanisms whereby Tai Chi can remedy balance disorders.

Humans↗

Tai Chi and vestibular rehabilitation effects on gaze and whole-body stability.

Tai Chi (TC) is a comparatively new intervention for peripheral vestibular hypofunction, which is often treated with vestibular rehabilitation (VR). We compared gaze stability (GZS), whole-body stability (WBS) and footfall stability (FFS) during locomotion among 26 people with vestibulopathy (VSP), randomized into two treatment arms (13 TC and 13 VR). Each intervention program was offered for 10 weeks. GZS improved more for VR than for TC, but WBS (and FFS) improved more for TC than for VR. There was a significant relationship between changes in GZS and WBS for the VR subjects (r=0.60, p=0.01), but not for TC subjects. There was a significant relationship between changes in WBS and FFS for both VR (r=0.65, p <0.01) and TC (r=0.58, p=0.02) groups; the relationship disappeared in the VR but not the TC group when controlling for GZS. These findings suggest that VR and TC both benefit patients with VSP but via differing mechanisms. Moreover, these data are the first to test the assumption that improving gaze control among patients with VSP perforce improves postural stability: it does not. We conclude that GZS is most improved in those who receive VR, but that TC improves WBS and FFS without improving GZS, suggesting patients with VSP can rely on non-gaze related mechanisms to improve postural control.

Female↗