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Biomedical subjects

Ted J Kaptchuk

Publications and source records attributed to Ted J Kaptchuk.

At least 19 recordsLinked to original sources
PubMed2006

Sham device v inert pill: randomised controlled trial of two placebo treatments.

OBJECTIVE: To investigate whether a sham device (a validated sham acupuncture needle) has a greater placebo effect than an inert pill in patients with persistent arm pain. DESIGN: A single blind randomised controlled trial created from the two week placebo run-in periods for two nested trials that compared acupuncture and amitriptyline with their respective placebo controls. Comparison of participants who remained on placebo continued beyond the run-in period to the end of the study. SETTING: Academic medical centre. PARTICIPANTS: 270 adults with arm pain due to repetitive use that had lasted at least three months despite treatment and who scored > or =3 on a 10 point pain scale. INTERVENTIONS: Acupuncture with sham device twice a week for six weeks or placebo pill once a day for eight weeks. MAIN OUTCOME MEASURES: Arm pain measured on a 10 point pain scale. Secondary outcomes were symptoms measured by the Levine symptom severity scale, function measured by Pransky's upper extremity function scale, and grip strength. RESULTS: Pain decreased during the two week placebo run-in period in both the sham device and placebo pill groups, but changes were not different between the groups (-0.14, 95% confidence interval -0.52 to 0.25, P = 0.49). Changes in severity scores for arm symptoms and grip strength were similar between groups, but arm function improved more in the placebo pill group (2.0, 0.06 to 3.92, P = 0.04). Longitudinal regression analyses that followed participants throughout the treatment period showed significantly greater downward slopes per week on the 10 point arm pain scale in the sham device group than in the placebo pill group (-0.33 (-0.40 to -0.26) v -0.15 (-0.21 to -0.09), P = 0.0001) and on the symptom severity scale (-0.07 (-0.09 to -0.05) v -0.05 (-0.06 to -0.03), P = 0.02). Differences were not significant, however, on the function scale or for grip strength. Reported adverse effects were different in the two groups. CONCLUSIONS: The sham device had greater effects than the placebo pill on self reported pain and severity of symptoms over the entire course of treatment but not during the two week placebo run in. Placebo effects seem to be malleable and depend on the behaviours embedded in medical rituals.

Acupuncture Analgesia↗
PubMed2006

Investigating placebo effects in irritable bowel syndrome: a novel research design.

Little is known about placebo effects with scientific precision. Poor methodology has confounded our understanding of the magnitude and even the existence of the placebo effect. Investigating placebo effects presents special research challenges including: the design of appropriate controls for studying placebo effects including separating such effects from natural history and regression to the mean, the need for large sample sizes to capture expected small effects, and the need to understand such potential effects from a patient's perspective. This article summarizes the methodology of an ongoing NIH-funded randomized controlled trial aimed at investigating whether the placebo effect in irritable bowel syndrome (IBS) exists and whether the magnitude of such an effect can be manipulated to vary in a manner analogous to "dose dependence." The trial also uses an innovative combination of quantitative and qualitative methods.

Acupuncture Therapy↗
PubMed2006

Brain activity associated with expectancy-enhanced placebo analgesia as measured by functional magnetic resonance imaging.

In this study, a well established expectancy manipulation model was combined with a novel placebo intervention, a validated sham acupuncture needle, to investigate the brain network involved in placebo analgesia. Sixteen subjects completed the experiment. We found that after placebo acupuncture treatment, subjective pain rating reduction (pre minus post) on the placebo-treated side was significantly greater than on the control side. When we calculated the contrast that subtracts the functional magnetic resonance imaging (fMRI) signal difference between post-treatment and pretreatment during pain application on placebo side from the same difference on control side [e.g., placebo (post - pre) - control (post - pre)], significant differences were observed in the bilateral rostral anterior cingulate cortex (rACC), lateral prefrontal cortex, right anterior insula, supramarginal gyrus, and left inferior parietal lobule. The simple regression (correlation) analysis between each subject's fMRI signal difference of post-treatment and pretreatment difference on placebo and control side and the corresponding subjective pain rating difference showed that significant negative correlation was observed in the bilateral lateral/orbital prefrontal cortex, rACC, cerebellum, right fusiform, parahippocampus, and pons. These results are different from a previous study that found decreased activity in pain-sensitive regions such as the thalamus, insula, and ACC when comparing the response to noxious stimuli applied to control and placebo cream-treated areas of the skin. Our results suggest that placebo analgesia may be configured through multiple brain pathways and mechanisms.

Acupuncture Analgesia↗
PubMed2006

Developing a research strategy for acupuncture.

This strategic overview revisits some of the basic assumptions that relate to the clinical evaluation of acupuncture. We look at the evidence available to estimate both the specific and nonspecific effect size of acupuncture (efficacy and effectiveness) and consider the placebo within acupuncture trials, as well as the value of both placebo controlled trials and pragmatic acupuncture studies. We argue for an augmented, mixed methodology that integrates basic mechanism studies, including modern imaging techniques such as functional magnetic resonance, quantitative and qualitative research, as well as safety and health economic data to obtain a more rigorous understanding of acupuncture. We hope that by taking a broad, patient-centered, and rigorous approach we may arrive at a realistic and thoughtful evaluation of its relative value in comparison to placebo treatment, conventional medicine, and its potential for integration into conventional clinical care.

Acupuncture↗
PubMed2005

Systematic review of the effects of ginseng on cardiovascular risk factors.

OBJECTIVE: To examine the evidence for the efficacy of ginseng (Panax spp.) on cardiovascular risk factors, including blood pressure, lipid profiles, and blood glucose, and to summarize reported cardiovascular adverse events. DATA SOURCES: We searched MEDLINE, AMED, BIOSIS, CAB, EMBASE, and the Cochrane Controlled Trials databases through July 2005 and performed hand searches of bibliographies. STUDY SELECTION AND DATA EXTRACTION: Short- or long-term, randomized, controlled trials and nonrandomized studies published in English were included. Data were extracted in a standardized manner, and 2 independent investigators assessed methodologic quality of the studies. Thirty-four studies were identified with results for blood pressure, lipids, and/or blood glucose. Due to heterogeneity of the studies, we were unable to perform a meta-analysis. Data on cardiovascular adverse events were extracted from events reported in identified studies and from case reports. DATA SYNTHESIS: The majority of studies were short term. Ginseng may slightly decrease blood pressure compared with placebo (range 0-4%). We found mixed results for an effect on lipids, with 5 of 9 studies showing improvement in one or more lipid parameters compared with baseline (range 7-44%). We identified several studies showing that ginseng lowers blood glucose, but overall studies were inconsistent. CONCLUSIONS: Current evidence does not support the use of ginseng to treat cardiovascular risk factors. Some studies suggest a small reduction in blood pressure. Despite some evidence showing that ginseng lowers blood glucose and improves lipid profiles, well-designed, randomized, controlled trials evaluating its effects are lacking.

Blood Glucose↗
PubMed2005

Can words hurt? Patient-provider interactions during invasive procedures.

Patients are often prepared for procedural discomforts with descriptions of pain or undesirable experiences. This practice is thought to be compassionate and helpful, but there is little data on the effect of such communicative behavior. This study assesses how such descriptions affect patients' pain and anxiety during medical procedures. The interactions of patients with their healthcare providers during interventional radiological procedures were videotaped during a previously reported 3-arm prospective randomized trial assessing the efficacy of self-hypnotic relaxation. One hundred and fifty-nine videos of the standard care and attention control arms were reviewed. All statements that described painful or undesirable experiences as warning before potentially noxious stimuli or as expression of sympathy afterwards were recorded. Patients' ratings of pain and anxiety on 0-10 numerical scales (0=No Pain, No Anxiety at All and 10=Worst Pain Possible, Terrified) after the painful event and/or sympathizing statement were the basis for this study. Warning the patient in terms of pain or undesirable experiences resulted in greater pain (P<0.05) and greater anxiety (P<0.001) than not doing so. Sympathizing with the patient in such terms after a painful event did not increase reported pain, but resulted in greater anxiety (P<0.05). Contrary to common belief, warning or sympathizing using language that refers to negative experiences may not make patients feel better. This conclusion has implications for the training in medical communication skills and suggests the need for randomized trials testing different patient-practioner interactions.

Adolescent↗
PubMed2005

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↗
PubMed2005

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↗
PubMed2005

Sociodemographic determinants of the utilization of specific types of complementary and alternative medicine: an analysis based on a nationally representative survey sample.

OBJECTIVES: To evaluate the relationships between selected sociodemographic factors and the use of particular types of complementary and alternative medicine (CAM) in the general U.S. population. CAMs make up a heterogeneous group of practices. Although it is well established that sociodemographic factors impact the use of conventional medicine, it is unclear which, if any, influence the use of particular types of CAM. DESIGN: Data from a 1997-1998 nationally representative survey (n = 2055) was examined using descriptive and univariate analyses. RESULTS: The impact of particular sociodemographic factors was found to vary by type of CAM considered. Whites used more CAM than non-Whites except in the case of prayer. Users of CAM tended to be better educated than nonusers with the exception of prayer, self-prayer, and use of a lay midwife. Women used more CAM than men, especially weight-change diet. CONCLUSIONS: As with conventional medicine use, the patterns of CAM use vary by individual type of therapy considered. Analytically, grouping many heterogeneous practices into the CAM category hides important differences in use patterns.

Adult↗
PubMed2005

Viewpoint: what is the best and most ethical model for the relationship between mainstream and alternative medicine: opposition, integration, or pluralism?

Despite radical improvements in medicine over the past 60 years, patients maintain multiple health care pathways that include high utilization of unconventional treatments. The authors examine three possible relationships between mainstream and alternative medicine: opposition, integration, and pluralism. Opposition, the traditional ethical position that the medical profession must eradicate unconventional medicine for the good of the patient, has withered away. Integration of mainstream and alternative medicine is increasingly advocated in tandem with hospital-based programs that amalgamate the use of conventional and alternative therapies. While advocates of integrative medicine often speak of "evidence-based" complementary and alternative medicine (CAM), integration fosters double standards for validating conventional and unconventional treatments. Integration also ignores unbridgeable epistemological beliefs and practices between mainstream and alternative medicine. Pluralism, which has been relatively ignored, calls for cooperation between the different medical systems rather than their integration. By recognizing the value of freedom of choice in medical options, pluralism is compatible with the principle of patient autonomy. Nonetheless, the pluralistic model does not amount to a relativistic stance according in which there would be no objective standards for comparing the therapeutic merit of conventional and CAM treatments. As an ethical model, pluralism realizes that physicians must be prepared to disagree with patient choices to pursue alternative therapies, and urge patients not to forgo medically indicated treatment. Pluralism encourages cooperation, research, and open communication and respect between practitioners despite the possible existence of honest disagreement, and preserves the integrity of each of the treatment systems involved.

Clinical Medicine↗
PubMed2005

Patient expectations in placebo-controlled randomized clinical trials.

OBJECTIVE: To explore participants' experience in placebo-controlled randomized clinical trials (RCTs) specifically in relationship to their expectations. BACKGROUND: Aspects of being in RCTs, such as informed consent, perception of benefit and understanding of randomization, have been examined. In contrast, little is known concerning the formation of patient expectations before and during trials. METHODS: Qualitative methods using in-depth interviews with a semi-structured interview guide of nine patients from four different RCTs. Data analysis was conducted using a codebook format arranging participant responses under broad analytical headings. The interviewer used a semi-structured interview guide to direct the conversation from one broad topic to the next within the context of the ongoing conversation. A checklist of topics encouraged participants to describe their experiences in RCTs. Narratives concerning expectation, blinding and placebo were compared to identify common themes. RESULTS: Patient anticipatory processes were influenced and modified both before and during the trial from multiple inputs. Such factors as past experiences in RCTs, past experiences of ineffective treatment, stress of being off regular medications, fear of being a 'placebo responder', input of non-study doctors or other health professionals, the experience of other participants, measurements of health parameters made during the trial and the presence or absence of side-effects all affected patient expectation. CONCLUSION: Expectations in RCTs are not fixed and instead may be viewed as continuously shaped by multiple inputs that include experience and information received both before and during the trial. Variability in placebo response observed in previous studies may be related to the fluid nature of expectations. Trying to control and equalize expectations in RCTs may be more difficult than previously assumed.

Adult↗
PubMed2005

A randomized, controlled trial of acupuncture for chronic daily headache.

BACKGROUND: Approximately 4% of adults experience headaches nearly every day. Nonpharmacologic interventions for frequent headaches may be appropriate because medical management alone is often ineffective. OBJECTIVE: To assess the efficacy of acupuncture as an adjunct to medical management for chronic daily headache (CDH). METHODS: We conducted a randomized, controlled trial of 74 patients with CDH that compared medical management provided by neurologists to medical management plus 10 acupuncture treatments. Primary outcome measures were daily pain severity and headache-related quality of life (QoL). RESULTS: Patients who received only medical management did not demonstrate improvement in any of the standardized measures. Daily pain severity scores trended downward but did not differ between treatment groups (P= .60). Relative to medical management only, medical management plus acupuncture was associated with an improvement of 3.0 points (95% CI, 1.0 to 4.9) on the Headache Impact Test and an increase of 8 or more points on the role limitations due to physical problems, social functioning, and general mental health domains of the Short Form 36 Health Survey. Patients who received acupuncture were 3.7 times more likely (CI, 1.7 to 8.1) to report less suffering from headaches at 6 weeks (absolute risk reduction 46%; number needed to treat 2). CONCLUSION: Headache-specialty medical management alone was not associated with improved clinical outcomes among our study population. Supplementing medical management with acupuncture, however, resulted in improvements in health-related QoL and the perception by patients that they suffered less from headaches.

Acupuncture Therapy↗
PubMed2004

A systematic study of acupuncture practice: acupoint usage in an outpatient setting in Beijing, China.

Acupuncture textbooks mention a wide assortment of indications for each acupuncture point and, conversely, each disease or indication can be treated by a wide assortment of acupoints. However, little systematic information exists on how acupuncture is actually used in practice: i.e. which points are actually selected and for which conditions. This study prospectively gathered data on acupuncture point usage in two primarily acupuncture hospital clinics in Beijing, China. Of the more than 150 unique acupoints, the 30 most commonly used points represented 68% of the total number of acupoints needled at the first clinic, and 63% of points needled at the second clinic. While acupuncturists use a similar set of most prevalent points, such as LI-4 (used in >65% of treatments at both clinic sites), this core of points only partially overlaps. These results support the hypothesis that while the most commonly used points are similar from one acupuncturist to another, each practitioner tends to have certain acupoints, which are favorites as core points or to round out the point prescription. In addition, the results of this study are consistent with the recent development of "manualized" protocols in randomized controlled trials of acupuncture where a fixed set of acupoints are augmented depending on individualized signs and symptoms (TCM patterns).

Acupuncture Points↗
PubMed2004

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↗
PubMed2004

Patient characteristics for outpatient acupuncture in Beijing, China.

OBJECTIVES: This study quantifies and compares patient characteristics in outpatient acupuncture. SETTING/DESIGN: Prospective primary source evidence was gathered at two prominent outpatient acupuncture clinics in Beijing, China (n = 563, n = 233). RESULTS: The most common condition was Bell's palsy, which represented 20.6% and 25.3% of total cases at the two clinics, respectively. The second most common condition was cerebrovascular accident (CVA) rehabilitation. These treatments represented 11.9% and 12.0% of treatments at the two clinics, respectively. Other trends at the clinics included the following: (1) neurologic complaints predominated; (2) doctors see a large number of patients per day; (3) the majority of patients overall were female; while (4) the majority of patients treated for CVAs rehabilitation were male. As cultural and socioeconomic differences in perceptions of acupuncture exist between peoples of different countries, this study also compared patient main complaints in China to available data on acupuncture patients seen in other parts of China, Germany, the United Kingdom, Australia, and the United States. Except for the German clinic data, Western clinic acupuncturists saw more musculoskeletal complaints compared to China, where neurologic complaints predominated. Another significant difference between Asian and Western clinics was the number of patients seen per hour. While acupuncturists were reported to see 1.2 patients per hour in U. S. clinics, acupuncturists at the two Beijing, China, clinics saw 7.0 and 10.4 patients per hour, respectively. CONCLUSION: The main complaints seen in acupuncture outpatient clinics throughout the world likely result from a combination of inherent disease prevalence as well as patients' attitudes toward what acupuncture can treat successfully.

Acupuncture Therapy↗
PubMed2004

Yin scores and yang scores: A new method for quantitative diagnostic evaluation in traditional Chinese medicine research.

OBJECTIVE: To develop and evaluate a method for quantitative evaluation of yin and yang (yin and yang scores) in human subjects for the purposes of research. This method aims to classify subjects into groups allowing future quantitative testing of key research questions such as: do different groups of patients respond differently to acupuncture treatments or Chinese herb formulas? METHODS: In a pilot study of inter-rater reliability, 12 volunteers were each successively interviewed and examined by 6 acupuncturists on the same day. Each acupuncturist gave each volunteer a score for yin and a score for yang on a scale of -10 to +10, zero representing a "balanced" score. Acupuncturists were blinded to each other's scores. RESULTS: Overall mean (+/-standard deviation [SD]) yin and yang scores were -1.86 +/- 0.90 and -0.68 +/- 1.23 respectively. Intraclass correlations (ICCs) associated with a single acupuncturist's ratings were 0.35 (yin) and 0.36 (yang). ICC's for subject's mean scores based on the six acupuncturists were 0.77 (yin) and 0.78 (yang). Significant differences in mean scores across subjects were detected for yin (p < 0.001) and yang (p < 0.001) (repeated-measures analysis of variance [ANOVA]) based on the multiple acupuncturists' ratings. CONCLUSION: These results indicate that (1) yin and yang can be quantified in a reliable manner, but evaluation by multiple acupuncturists is necessary to obtain a reliable score; (2) yin and yang scores can be used to group individuals for the purposes of statistical analysis. Further evaluation of yin and yang scores in a greater number and wider variety of patients will be needed to evaluate the potential usefulness of this measurement tool in acupuncture clinical trials and basic physiologic research.

Acupuncture↗