Direct moxibustion to treat spleen qi and yang deficiency fatigue: a pilot study.

Limited research suggests that indirect moxibustion may be beneficial for treating fatigue, but no studies to evaluate direct moxibustion have been conducted in the United States. Thus, we explored the usefulness of four outcome measures for evaluating the effectiveness of direct moxibustion for patients with spleen qi and yang deficiency fatigue (SQYDF). Eleven female volunteers, ages 25-60 years, were enrolled. Three to five rice grains in thread-sized moxa cones were burned on 11 acupuncture points once per week for 8 weeks. Eight participants completed the study. The most common adverse events (AEs) were temporary worsening of fatigue, lightheadedness, and headache. Symptomatic improvement was seen on the SF-36 energy/fatigue scale (p=0.003), SF-36 social function scale (p=0.008) and Flinders fatigue scale (p=0.014). The skin conductance at acupoints showed no consistent diagnostic baseline meridian patterns. Heart rate variability data showed an improved low frequency/high frequency (LF/HF) ratio in three of four participants. Direct moxibustion is safe in patients with SQYDF. The Flinders Fatigue Scale (FFS) and the SF-36 are useful outcome measures for evaluating the effects of direct moxibustion, and the heart rate variability (HRV) may be, but the skin conductance did not correlate with SQYDF diagnosis or with symptomatic improvement.

Clinical utility of electrodermal activity at acupuncture points: a narrative review.

OBJECTIVES: To provide an in-depth analysis of seven well-reported studies that examined electrodermal activity (EDA) at acupuncture points with regard to three commonly held tenets of acupuncture: (1) EDA at pathology-related acupuncture points is distinguishable from non-pathology-related acupuncture points; (2) EDA at acupuncture points can assist in diagnosing and monitoring therapeutic progress; and (3) EDA at acupuncture points is able to identify substances that are either therapeutically beneficial or toxic to an individual. METHODS: Seven of 29 studies that scored>50% on their quality of reporting 54 essential technical and clinical details of EDA testing in human patients were identified from a previous literature review. Fourteen categories of data were extracted from these seven studies for further discussion. RESULTS: Two studies compared EDA at pathology-related auricular acupuncture points to non-pathology-related sites. Two studies correlated EDA measurements at sites other than auricular acupuncture points with the presence of specific medical conditions. The final three studies assessed changes in EDA at acupuncture points on the fingers and toes when different substances were placed in the electrical circuit with the patient. CONCLUSIONS: This review highlights the heterogeneity of approaches to EDA assessments and the discrepancies between common clinical practice and the scientific evidence to support that practice. It also provides pilot data that suggest EDA testing at auricular acupuncture points may distinguish pathology-related acupuncture points from non-pathology-related points; decreased skin conductance correlates with tiredness or low energy; and EDA testing at the Jing-Well acupuncture points, on the tips of the fingers and toes, may assist in monitoring effectiveness of acupuncture treatment. The evidence does not support the use of VEGA testing for allergic status.

Neurofeedback for insomnia: a pilot study of Z-score SMR and individualized protocols.

Insomnia is an epidemic in the US. Neurofeedback (NFB) is a little used, psychophysiological treatment with demonstrated usefulness for treating insomnia. Our objective was to assess whether two distinct Z-Score NFB protocols, a modified sensorimotor (SMR) protocol and a sequential, quantitative EEG (sQEEG)-guided, individually designed (IND) protocol, would alleviate sleep and associated daytime dysfunctions of participants with insomnia. Both protocols used instantaneous Z scores to determine reward condition administered when awake. Twelve adults with insomnia, free of other mental and uncontrolled physical illnesses, were randomly assigned to the SMR or IND group. Eight completed this randomized, parallel group, single-blind study. Both groups received fifteen 20-min sessions of Z-Score NFB. Pre-post assessments included sQEEG, mental health, quality of life, and insomnia status. ANOVA yielded significant post-treatment improvement for the combined group on all primary insomnia scores: Insomnia Severity Index (ISI p<.005), Pittsburgh Sleep Quality Inventory (PSQI p<.0001), PSQI Sleep Efficiency (p<.007), and Quality of Life Inventory (p<.02). Binomial tests of baseline EEGs indicated a significant proportion of excessively high levels of Delta and Beta power (p<.001) which were lowered post-treatment (paired z-tests p<.001). Baseline EEGs showed excessive sleepiness and hyperarousal, which improved post-treatment. Both Z-Score NFB groups improved in sleep and daytime functioning. Post-treatment, all participants were normal sleepers. Because there were no significant differences in the findings between the two groups, our future large scale studies will utilize the less burdensome to administer Z-Score SMR protocol.

Reliability of AcuGraph system for measuring skin conductance at acupoints.

OBJECTIVE: There are many commercially available instruments for measuring electrical conductance, but there is little information about their reliability. The aim of this study was to quantify measurement variability and assess reliability of the AcuGraph system-a commonly used electrodermal screening device. METHODS: Four experiments were conducted to measure variability in electrical conductance readings obtained by the AcuGraph system. The first involved measuring known resistors. The second measured non-human organic matter. The third was a test-retest assessment of the Yuan-Source and Jing-Well points in 30 healthy volunteers who were measured by a single operator. The fourth was an interoperator reliability evaluation of seven acupuncturists at the Yuan-Source and Jing-Well acupoints on four individuals at two time points. RESULTS: Against known resistors, the AcuGraph had an average coefficient of variability (CV) of 1.8% between operators and test-retests. On non-human organic material the AcuGraph had an average CV of 0.9% and 2.8%. When a single operator tested 30 participants, the average reliability for the Yuan-Source points was 0.86 and 0.76 for Jing-Well points with a CV of 23.2% and 25.9% respectively. The average CV for the seven acupuncturists was 24.5% on Yuan-Source points and 23.7% on Jing-Well points. CONCLUSIONS: The AcuGraph measures known resistors and organic matter accurately and reliably. Skin conductance at acupoints recorded by one operator was also reliable. There was less consistency in electrodermal recordings obtained by seven different operators. Operator training and technical improvements to the AcuGraph may improve consistency among operators.

Electrodermal activity at acupoints: literature review and recommendations for reporting clinical trials.

Electrodermal activity (EDA) at acupuncture points (acupoints) has been investigated for its utility as a diagnostic aid, a therapeutic monitoring tool, and a physiological outcome measure. The research methodologies reported in published trials, however, vary considerably and publications often lack sufficient details about electrical instrumentation, technical procedures, laboratory conditions, recorded measures, and control comparisons to permit a critical appraisal of the studies or to replicate promising findings. We developed a 10-category (54 subitems) Quality of Reporting scale based on technical issues associated with EDA measurements, publication requirements for reporting EDA in the psychophysiological literature, and recommendations from the CONSORT Statement for reporting clinical trials. Using our Quality of Reporting scale, we extracted data from 29 studies that evaluated EDA at acupoints in patients and generated weighted scores for each of the 10 categories of essential information. Only 9 of the 29 studies reviewed scored a mean of greater than 50% for reporting details of essential information. To rigorously build a program of research on EDA at acupoints we need to standardize research methodology and reporting protocols. We propose a checklist of recommended informational items to report in future clinical trials that record EDA at acupoints.

Skin conductance at 24 Source (Yuan) acupoints in 8637 patients: influence of age, gender and time of day.

The clinical practice of recording skin conductance (SC) at acupuncture points (acupoints), as a diagnostic and/or therapeutic monitoring aid may have scientific merit. However, influences of age, gender and time of day on these recordings are unknown and it is unclear whether SC at acupoints differs from SC levels in general (as reported in psychophysiology research). This paper summarizes SC data obtained with the AcuGraph 3 Digital Meridian Imaging System between June 2005 and March 31, 2010. An initial dataset of 117,725 SC examinations was scrubbed to include only the first SC examination on individual patients and exclude potentially faulty data. The final dataset consists of SC recordings at the 24 Source (Yuan) acupoints in 8637 patients, collected by 311 practitioners. Twelve left/right average conductance measures and an overall average of the 24 acupoints were assessed. Statistical analyses included two sample t tests, three way analyses of variance and linear regression. Results indicate that mean SC at acupoints, similar to SC in general, is higher in males, higher in afternoons and declines with age. Not previously reported, the rate of SC decline with age differs at different acupoints between males and females. These findings have substantial implications for acupuncture research and practice.

Randomized Controlled Trials of Acupuncture (1997-2007): An Assessment of Reporting Quality with a CONSORT- and STRICTA-Based Instrument.

The present study describes the development of a comprehensive quality of reporting assessment tool and its application to acupuncture RCTs from 1997-2007. This Oregon CONSORT STRICTA Instrument (OCSI) is based on the revised CONSORT guidelines as modified by the STRICTA recommendations for acupuncture trials. Each of the resulting 27 OCSI items were applied to English language prospective RCTs that compared acupuncture, using manual and/or electro-stimulation, to no treatment, a sham procedure, or usual biomedical care. The 333 RCTs that met inclusion criteria were dispersed among 27 countries and 141 journals. Mean quality of reporting score for all articles was 63.0% (SD 16.5). Mean OCSI scores revealed a 30.9% improvement over the ten-year period (P < .001). Our findings suggest that to enhance quality of reporting, authors should better attend to seven specific OCSI items in three categories: practitioner training, adverse events, and aspects of randomization and blinding (n = 5). The broad diversity in geographical origin, publication site and quality of reporting, viewed in light of the considerable room for improvement in mean OCSI scores, emphasizes the importance of making STRICTA as well as CONSORT more widely known to journals and to the acupuncture research community.

Static magnetic field therapy for carpal tunnel syndrome: a feasibility study.

OBJECTIVES: To assess the feasibility of conducting trials of static magnetic field (SMF) therapy for carpal tunnel syndrome (CTS), to collect preliminary data on the effectiveness of 2 SMF dosages, and to explore the influence of an SMF on median nerve conduction. DESIGN: Randomized, double-blind, sham-controlled trial with a 6-week intervention and a 12-week follow-up. SETTING: University hospital outpatient clinics. PARTICIPANTS: Women and men (N=60), ages 21 to 65 years, with an electrophysiologically confirmed CTS diagnosis recruited from the general population. INTERVENTIONS: Participants wore nightly either neodymium magnets that delivered either 15 or 45 mTesla (mT) to the contents of the carpal canal or a nonmagnetic disk. MAIN OUTCOME MEASURES: Symptom Severity Scale (SSS) and Function Severity Scale (FSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) and 4 median nerve parameters: sensory distal latency, sensory nerve action potential amplitude, motor distal latency and compound motor action potential amplitude. RESULTS: Fifty-eight of 60 randomized participants completed the study. There were no significant between-group differences for change in the primary endpoint SSS or for FSS or median nerve conduction parameters. For the SSS and the FSS, each group showed a reduction at 6 weeks indicating improvement in symptoms. CONCLUSIONS: This study showed the feasibility and safety of testing SMF therapy for CTS. There were no between-group differences observed for the BCTQ or median nerve parameters after 6 weeks of SMF therapy. Significant within-group, symptomatic improvements of the same magnitude were experienced by participants in both active and sham magnet groups. Future studies are needed to optimize SMF dosimetry and resolve issues related to the use of sham controls in SMF trials.

Current options for nonsurgical management of carpal tunnel syndrome.

Carpal tunnel syndrome (CTS) is the most common of the entrapment neuropathies. Surgical decompression is commonly performed and has traditionally been considered the defnitive treatment for CTS. Conservative treatment options include physical therapy, bracing, steroid injections and alternative medicine. While CTS is often progressive, patients may get better without formal treatment. The resolution of symptoms is not necessarily related to the severity of the clinical findings and self-limited activity is common. The current literature suggests that bracing and corticosteroid injections may be useful in the nonsurgical treatment of CTS, although the benefits may be short term. There is limited evidence regarding the efficacy of other treatments, such as therapy, exercise, yoga, acupuncture, lasers and magnets, and further studies are needed. Surgery is recommended for progressive functional deficits and significant pain.

An 8-channel skin impedance measurement system for acupuncture research.

An 8-channel skin impedance measurement system for acupuncture research has been developed. The underlying model of the skin used is a parallel R & C network. Pulses are used to measure the R and C values. The measurement circuit is time multiplexed across the 8 channels at the rate of 2 measurements per second, leading to a complete set of measurements every 4 seconds. In static tests, the system has been operational for over 2 days of continuous measurements. In preliminary human tests, measurements over 2 hours have been collected per subject.

Static magnetic field therapy: a critical review of treatment parameters.

Static magnetic field (SMF) therapy, applied via a permanent magnet attached to the skin, is used by people worldwide for self-care. Despite a lack of established SMF dosage and treatment regimens, multiple studies are conducted to evaluate SMF therapy effectiveness. Our objectives in conducting this review are to:(i) summarize SMF research conducted in humans; (ii) critically evaluate reporting quality of SMF dosages and treatment parameters and (iii) propose a set of criteria for reporting SMF treatment parameters in future clinical trials. We searched 27 electronic databases and reference lists. Only English language human studies were included. Excluded were studies of electromagnetic fields, transcranial magnetic stimulation, magnets placed on acupuncture points, animal studies, abstracts, posters and editorials. Data were extracted on clinical indication, study design and 10 essential SMF parameters. Three reviewers assessed quality of reporting and calculated a quality assessment score for each of the 10 treatment parameters. Fifty-six studies were reviewed, 42 conducted in patient populations and 14 in healthy volunteers. The SMF treatment parameters most often and most completely described were site of application, magnet support device and frequency and duration of application. Least often and least completely described were characteristics of the SMF: magnet dimensions, measured field strength and estimated distance of the magnet from the target tissue. Thirty-four (61%) of studies failed to provide enough detail about SMF dosage to permit protocol replication by other investigators. Our findings highlight the need to optimize SMF dosing parameters for individual clinical conditions before proceeding to a full-scale clinical trial.

A multichannel system for continuous measurements of skin resistance and capacitance at acupuncture points.

Electrodermal screening (EDS) is based on three commonly held assumptions: acupuncture points (APs) have lower electrical resistance than non-APs; resistance at APs varies with health and disease; and effective acupuncture treatments are associated with normalization of resistance at APs. Although evidence confirming these assumptions is limited, EDS is frequently practiced worldwide. Researchers are also beginning to assess EDS' utility as an outcome measure in acupuncture trials. Fundamental in developing EDS as a research tool is the need for an accurate and reliable measurement. We developed an automated multichannel prototype system, the Octopus, and recorded electrical resistance and capacitance at eight skin sites in 33 healthy participants over 2 hours. The Octopus accurately measured against known resistors (within 2.5% of the mean value) and capacitors (within 10% of the mean value), and yielded repeatable readings at all eight skin sites: LR 1 (r=0.79), SP 1 (r=0.79), toe non-AP (r=0.77), LU 9 (r=0.97), PC 6 (r=0.96), wrist non-APs (r=0.97), SP 6 (r=0.96), and leg non-APs (r=0.97). Resistance at APs was significantly lower than the nearby non-APs in one out of three comparisons.

Skin impedance measurements for acupuncture research: development of a continuous recording system.

Skin impedance at acupuncture points (APs) has been used as a diagnostic/therapeutic aid for more than 50 years. Currently, researchers are evaluating the electrophysiologic properties of APs as a possible means of understanding acupuncture's mechanism. To comprehensively assess the diagnostic, therapeutic and mechanistic implications of acupuncture point skin impedance, a device capable of reliably recording impedances from 100 kOmega to 50 MOmega at multiple APs over extended time periods is needed. This article describes design considerations, development and testing of a single channel skin impedance system (hardware, control software and customized electrodes). The system was tested for accuracy against known resistors and capacitors. Two electrodes (the AMI and the ORI) were compared for reliability of recording over 30 min. Two APs (LU 9 and PC 6) and a nearby non-AP site were measured simultaneously in four individuals for 60 min. Our measurement system performed accurately (within 5%) against known resistors (580 kOmega-10 MOmega) and capacitors (10 nF-150 nF). Both the AMI electrode and the modified ORI electrode recorded skin impedance reliably on the volar surface of the forearm (r = 0.87 and r = 0.79, respectively). In four of four volunteers tested, skin impedance at LU 9 was less than at the nearby non-AP site. In three of four volunteers skin impedance was less at PC 6 than at the nearby non-AP site. We conclude that our system is a suitable device upon which we can develop a fully automated multi-channel device capable of recording skin impedance at multiple APs simultaneously over 24 h.

Magnets applied to acupuncture points as therapy - a literature review.

OBJECTIVES: To summarise the acu-magnet therapy literature and determine if the evidence justifies further investigation of acu-magnet therapy for specific clinical indications. METHODS: Using various search strategies, a professional librarian searched six electronic databases (PubMed, AMED, ScienceDirect College Edition, China Academic Journals, Acubriefs, and the in-house Journal Article Index maintained by the Oregon College of Oriental Medicine Library). English and Chinese language human studies with all study designs and for all clinical indications were included. Excluded were experimental and animal studies, electroacupuncture and transcranial magnetic stimulation. Data were extracted on clinical indication, study design, number, age and gender of subjects, magnetic devices used, acu-magnet dosing regimens (acu-point site of magnet application and frequency and duration of treatment), control devices and control groups, outcomes, and adverse events. RESULTS: Three hundred and eight citations were retrieved and 50 studies met our inclusion criteria. We were able to obtain and translate (when necessary) 42 studies. The language of 31 studies was English and 11 studies were in Chinese. The 42 studies reported on 32 different clinical conditions in 6453 patients from 19862007. A variety of magnetic devices, dosing regimens and control devices were used. Thirty seven of 42 studies (88%) reported therapeutic benefit. The only adverse events reported were exacerbation of hot flushes and skin irritation from adhesives. CONCLUSIONS: Based on this literature review we believe further investigation of acu-magnet therapy is warranted particularly for the management of diabetes and insomnia. The overall poor quality of the controlled trials precludes any evidence based treatment recommendations at this time.

Static magnetic field therapy: dosimetry considerations.

The widespread use of static magnetic field (SMF) therapy as a self-care physical intervention has led to the conduct of numerous randomized controlled trials (RCTs). A recent systematic review of SMF trials for pain reduction concluded that the evidence does not support the use of permanent magnets for pain relief. We argue that this conclusion is unwarranted if the SMF dosage was inadequate or inappropriate for the clinical condition treated. The purpose of this communication is to (1) provide a rationale and an explanation for each of 10 essential SMF dosing parameters that should be considered when conducting trials of SMF therapy, and (2) advocate for the conduct of Phase I studies to optimize SMF dosimetry for each condition prior to implementing a large-scale RCT. A previous critical review of SMF dosimetry in 56 clinical studies found that reporting SMF dosages in a majority of those studies was of such poor quality that the magnetic field exposure at the target tissue could not be characterized. Without knowing what magnetic field actually reached the target, it is impossible to judge dosage adequacy. In order to quantify SMF exposure at the site of pathology (target tissue/s), that site must be clearly named; the distance of the permanent magnet surface from the target must be delineated; the physical parameters of the applied permanent magnet must be described; and the dosing regimen must be precisely reported. If the SMF dosimetry is inadequate, any inferences drawn from reported negative findings are questionable.

Electrical properties of acupuncture points and meridians: a systematic review.

According to conventional wisdom within the acupuncture community, acupuncture points and meridians are special conduits for electrical signals. This view gained popularity after anecdotal reports and clinical studies asserted that these anatomical structures are characterized by lower electrical impedance compared to adjacent controls. To ascertain whether evidence exists to support or refute this claim, we conducted a systematic review of studies directly evaluating the electrical characteristics of acupuncture structures and appropriate controls. We searched seven electronic databases until August 2007, hand-searched references, and consulted technical experts. We limited the review to primary data human studies published in English. A quality scoring system was created and employed for this review. A total of 16 articles representing 18 studies met inclusion criteria: 9 examining acupuncture points and 9 examining meridians. Five out of 9 point studies showed positive association between acupuncture points and lower electrical resistance and impedance, while 7 out of 9 meridian studies showed positive association between acupuncture meridians and lower electrical impedance and higher capacitance. The studies were generally poor in quality and limited by small sample size and multiple confounders. Based on this review, the evidence does not conclusively support the claim that acupuncture points or meridians are electrically distinguishable. However, the preliminary findings are suggestive and offer future directions for research based on in-depth interpretation of the data.

Electrical skin impedance at acupuncture points.

OBJECTIVES: To test whether electrical skin impedance at each of three acupuncture points (APs) is significantly lower than at nearby sites on the meridian (MP) and off the meridian (NP). DESIGN: Two instruments - Prognos (MedPrevent GmbH, Waldershof, Germany), a constant-current (DC) device, and PT Probe (designed for this study), a 100-Hz sinusoidal-current (AC) device-were used to record electrical impedance at three APs (right Gallbladder 14, right Pericardium 8, and left Triple Energizer 1), and two control sites for each AP. Each AP, MP, and NP was measured four times in random order with each device. SETTING: The study was conducted over a period of 4 days at the Oregon College of Oriental Medicine (OCOM). SUBJECTS: Twenty (20) healthy adults (14 women and 6 men), all recruited from the OCOM student body and faculty, participated in the study. RESULTS: The Prognos measurements had an intraclass correlation (ICC) = 0.84 and coefficient of variation (CV) = 0.43. The PT Probe had ICC = 0.81 and CV = 0.31. Impedance values at APs were not significantly less than at MPs or NPs. Impedance values at MPs were also not significantly less than NPs, although their individual p values were <0.05 in 4 of 6 cases. There was a significant trend of increasing impedance with repeated measurements with both the Prognos (p =0.003) and the PT Probe (p= 0.003). CONCLUSIONS: Within the reliability limits of our study methods, none of the three APs tested has lower skin impedance than at either of the nearby control points. These results are not consistent with previous studies that detected lower skin impedance at APs than nearby sites. Further study is necessary to determine whether MPs have lower skin impedance than nearby NPs. Our study suggests caution is warranted when developing, using, and interpreting results from electrodermal screening devices. Further studies are needed to clarify the clinically important and controversial hypothesis that APs are sites of lower impedance.

Correlating heart rate variability with skin impedance measurements.

To determine the interaction between skin impedance, measured at acupuncture points, and autonomic nervous response, as expressed through heart rate variability (HRV), we propose a method for correlating frequency components of non-uniformly sampled R-R intervals and the impedance measurements. Since vagal response typically manifests itself in the High Frequency (HF) range of HRV, Lomb-Welch periodograms (LWp) are used to evaluate accurately the HF band spectral components. The resampling rate of the LWp is adjusted according to the window/filter used to meet a -20dB antialiasing requirement. The record length of each individual LWp is then chosen such that the frequency component resampling rate matches the impedance sampling rate. Since it is not feasible to use the phase information, the magnitudes of the frequency component samples are used in the evaluation of the cross-covariances between the HRV components and the impedance signals.