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Vulvodynia affects 7% of American women, yet clinicians often lack awareness of its presentation. It is underdiagnosed and often misdiagnosed as vaginitis. The etiology of vulvodynia remains unknown, making it difficult to identify or develop effective treatment methods. The purpose of this article is to (1) review the presentation and evaluation of vulvodynia, (2) review the research on vulvodynia treatments, and (3) aid the clinician in the selection of vulvodynia treatment methods. The level of evidence to support vulvodynia treatment varies from case series to randomized controlled trials (RCTs). Oral desipramine with 5% lidocaine cream, intravaginal diazepam tablets with intravaginal transcutaneous electric nerve stimulation (TENS), botulinum toxin type A 50 units, enoxaparin sodium subcutaneous injections, intravaginal TENS (as a single therapy), multimodal physical therapy, overnight 5% lidocaine ointment, and acupuncture had the highest level of evidence with at least one RCT or comparative effectiveness trial. Pre to posttest reduction in vulvar pain and/or dyspareunia in non-RCT studies included studies of gabapentin cream, amitriptyline cream, amitriptyline with baclofen cream, up to 6 weeks' oral itraconazole therapy, multimodal physical therapy, vaginal dilators, electromyography biofeedback, hypnotherapy, cognitive behavioral therapy, cold knife vestibulectomy, and laser therapy. There is a lack of rigorous RCTs with large sample sizes for the treatment of vulvodynia, rendering it difficult to determine efficacy of most treatment methods. Clinicians will be guided in the selection of best treatments for vulvodynia that have the highest level of evidence and are least invasive.

BackgroundClinical trial articles often lack detailed descriptions of the methods used to randomize participants, conceal allocation, and blind subjects and investigators to group assignment. We describe our systematic approach to implement and measure blinding success in a double-blind phase 2 randomized controlled trial testing the efficacy of acupuncture for the treatment of vulvodynia.MethodsRandomization stratified by vulvodynia subtype is managed by Research Electronic Data Capture software’s randomization module adapted to achieve complete masking of group allocation. Subject and acupuncturist blinding assessments are conducted multiple times to identify possible correlates of unblinding.ResultsAt present, 48 subjects have been randomized and completed the protocol resulting in 87 subject and 206 acupuncturist blinding assessments.DiscussionOur approach to blinding and blinding assessment has the potential to improve our understanding of unblinding over time in the presence of possible clinical improvement.

CONTEXT: It’s difficult to conduct experiments using a double-blind design in controlled clinical trials of acupuncture. To resolve this problem with blinding, we designed double-blind needles (DBNs) with stuffing to mimic the resistance felt during insertion of a regular acupuncture needle. Results of the past studies using 0.16-mm-diameter DBNs found that the resistance felt by the acupuncturists during insertion successfully blinded them. OBJECTIVE: The study intended to compare the effects on an acupuncturist’s blinding when the practitioner used penetrating DBNs with 0.14, 0.16, 0.18, and 0.20 mm diameters. DESIGN: We conducted a double-blind randomized trial. SETTING: The study took place at the Japan School of Acupuncture, Moxibustion. and Physiotherapy in Tokyo, Japan. PARTICIPANTS: The participant was one licensed acupuncturist who performed 320 needle insertions during acupuncture for 20 healthy students, who were familiar with acupuncture and who attended the Japan School of Acupuncture, Moxibustion, and Physiotherapy. METHODS: The acupuncturist was informed she would administer a penetrating or non-penetrating needle; however, only penetrating needles were used. She inserted the four sizes of needles in both of each student’s dorsal forearms using an alternating twirling technique. This procedure was repeated once more on another day, with at least one day between sessions. PRIMARY OUTCOME MEASURES: After the acupuncturist removed each needle, we asked her to guess: (1) the type of needle inserted, (2) her level of confidence in the guess, and (3) the clues that contributed to her guess. A chi-squared test was used to determine whether the ratio of correctly or incorrectly identified needles met an expected probability of 0.5 for each needle diameter. RESULTS: Of the 320 needle insertions, the acupuncturist correctly identified 54% of 0.14 mm, 45% of 0.16 mm, 46% of 0.18 mm, and 50% of 0.20 mm needle insertions. The correct and incorrect ratios of identified needles were fitted with a probability of 0.5, with no significant differences in the acupuncturist’s confidence (p=0.16). In 99% of the tests, the cue that contributed to the acupuncturist’s guess was the feeling of the needle insertion. CONCLUSION: These findings indicate that the differences in the diameters of DBNs from 0.14 to 0.20 mm didn’t significantly affect the acupuncturist’s blinding.

Objective: The purpose of this study was to investigate the changes in blood circulation of tendons and heart rate variability (HRV) during and after acupuncture in order to elucidate the mechanisms of acupuncture-induced changes in tendon blood circulation. Materials and Methods: During 10 minutes of acupuncture treatment and a recovery period of 40 minutes, blood volume (THb) and oxygen saturation (StO(2)) of treated and nontreated tendons were measured using red laser lights. In addition, HRV was also measured during the experimental period. Results: THb and StO(2) of the treated tendons significantly increased during acupuncture, and then remained high during the recovery period. THb and StO(2) of the nontreated tendons did not change during acupuncture but gradually increased during the recovery period. In addition, the increase in THb of the nontreated tendons were significantly correlated with that of the treated tendons during the latter half of the recovery period. Heart rate (HR) continued to decrease during acupuncture and suddenly returned to the initial level after removal of the needle. The low-frequency (LF)/high-frequency (HF) ratio tended to increase during the recovery period. During the latter half of the recovery period, the changes in THb for both the treated and nontreated tendons were negatively correlated with the change in HR but not with changes in the LF/HF ratio. Conclusions: These results suggest that changes in blood circulation of tendons after acupuncture treatment were controlled by the autonomic nervous system, which could not be detected by HRV analysis.

Objective: The purpose of this study was to compare changes in blood circulation (blood volume and oxygen saturation [StO2]) of tendon by acupuncture (insertion depth of the needle was 4 mm) and in...

Objective To investigate the influence of the depth of skin press in blunt tip placebo acupuncture needles on patient blinding and its relationship to needle diameter. Methods Forty healthy volunteers were enrolled as subjects for patient blinding. Four acupuncturists applied the following needles randomly at three points in each forearm: 0.18 mm and 0.25 mm diameter penetrating needles inserted to a depth of 5 mm, and 0.18 mm and 0.25 mm diameter skin-touch needles depressing the skin at the acupoint to a depth of 1 mm and 2 mm from the skin surface. The subjects reported their guesses at the nature of needles they received, and rated needle pain and de qi. A blinding index was calculated to define the success of blinding for subjects. Results The blinding status of subjects for 1 mm press needles of 0.18 mm diameter was “random guess”, but “unblinded” for 1 mm press needles of 0.25 mm diameter. For 2 mm press needles of both diameters, the blinding status was “opposite guess” and the blinding status for penetrating needles of both diameters was “unblinded.” The percentages of “felt pain” with 2 mm press needles of both diameters were similar to that with penetrating needles, but those were not similar for 1 mm press needles. The frequency of de qi occurrence with 2 mm press needles of 0.18 mm diameter was similar to that of penetrating needles of both diameters. Conclusion Placebo needles of 2 mm press made more subjects guess that the needles penetrated the skin than 1 mm press needles. The use of small diameter needles increased patient blinding.

BackgroundAcupuncture has demonstrated physiologic analgesic effects in Chinese patients with stable angina. One proposed mechanism of action for these analgesic effects is the downregulation of M1 macrophages, interleukin 1 beta, interleukin-6, interleukin-18, and tumor necrosis factor alpha.ObjectiveThis study aims to test a 10-session, 5-week acupuncture treatment protocol as a complementary therapy for symptoms of stable angina for American patients, who vary from Chinese patients in health care systems and other salient variables.MethodsWe are conducting a randomized controlled trial (RCT) of 69 adults (35 assigned to initial acupuncture and 34 to an attention control condition) with a medically confirmed diagnosis of stable angina, whose pain and associated symptoms have not been controlled to their satisfaction with guideline-directed medical management. Participants in the experimental group will receive a standardized traditional Chinese medicine point prescription. The attention control group will view non–pain-related health education videos over 5 weeks equal to the 10 hours of treatment for the acupuncture group. Participants will complete the McGill Pain Questionnaire and the Seattle Angina Questionnaire-7, as well as have inflammatory cytokines measured at baseline and study completion. The primary outcomes are anginal pain and quality of life.ResultsThis study has been funded over 2 years by the National Institutes of Health, National Institute for Nursing Research. We are currently recruiting and expect to have initial results by December 2020.ConclusionsWe will generate data on feasibility, acceptability, effect sizes, and protocol revisions for a future fully powered RCT of the protocol. Findings will help determine if patients with persistent ischemic symptoms experience a proinflammatory state and hyperalgesia caused by multiple neural and immune processes not always relieved with medication.International Registered Report Identifier (IRRID)DERR1-10.2196/14705

BACKGROUND Acupuncture has demonstrated physiologic analgesic effects in Chinese patients with stable angina. One proposed mechanism of action for analgesic effects is the downregulation of M1 macrophages, Interleukin-1β, Interleukin-6, Interleukin-18, and tumor necrosis factor alpha (TNF-α). OBJECTIVE The purpose of this study is to test a 10-session, 5-week acupuncture treatment protocol as a complementary therapy for symptoms of stable angina for American patients, who vary from Chinese patients in healthcare systems and other salient variables. METHODS We are conducting a randomized controlled trial (RCT) of 69 adults (35 assigned to initial acupuncture and 34 to an attention control condition) with a medically confirmed diagnosis of stable angina, whose pain and associated symptoms have not been controlled to their satisfaction with guideline-directed medical management. Participants in the experimental group will receive a standardized Traditional Chinese Medicine (TCM) point prescription. The attention control group will view non-pain-related health education videos over 5 weeks equal to the 10 hours of treatment for the acupuncture group. Participants will complete the McGill Pain Questionnaire and the Seattle Angina Questionnaire-7, as well as have inflammatory cytokines measured at baseline and study completion. Primary outcomes are anginal pain and quality of life. RESULTS Results will be available upon completion of the randomized controlled trial and the analysis of the data. CONCLUSIONS We will generate data on feasibility, acceptability, effect sizes, and protocol revisions for a future fully powered RCT of the protocol. Findings will help determine if patients with persistent ischemic symptoms experience a pro-inflammatory state and/or hyperalgesia caused by multiple neural and immune processes not always relieved with medication. CLINICALTRIAL ClinicalTrials.gov Identifier: NCT02914834

Acupuncture and acupressure, 2 modalities of Traditional Chinese Medicine, are based on reducing pain and symptoms of disease through balancing yin and yang. Acupuncture and acupressure have been used in China for reduction of labor pain, labor augmentation, and other intrapartum indications for more than 2 millennia. This article presents a review of the current literature that has addressed the effects of acupuncture and acupressure on intrapartum events. Studies of acupuncture have demonstrated that acupuncture may reduce labor pain, the use of pharmacologic agents, the use of forceps and vacuum-assisted births, and the length of labor. Studies that examined the effect of acupuncture on labor that is induced or augmented for premature rupture of membranes have found that acupuncture may increase the degree of cervical ripening but does not reduce the amount of oxytocin or epidural analgesia administration, nor does it shorten length of induced labor. Acupressure may reduce labor pain and labor duration, but acupressure has not been found to increase cervical ripening or induce labor. There are insufficient studies about acupuncture and acupressure and their effects on labor at this time, and there is need for further research. Areas of uncertainty include efficacy, optimal point selection, best techniques, and length of time for point stimulation.

Background Efficacy of acupuncture is difficult to demonstrate without a feasible double-blind milieu. Double-blind acupuncture needles have been validated in single session protocols with one or two needles but not been tested in a protocol requiring many needles and repeated sessions. Methods We determined the feasibility of a 13-needle, 10-session study protocol. Feasibility focused on (1) enrolling and retaining participants; (2) two acupuncturists accurately implementing a double-blind, multi-needle, multi-session protocol; (3) participants completing measures; and (4) protocol acceptability to participants. In this double-blind randomized controlled pilot study, participants were randomized 1:1 to a penetrating needle group or a skin-touch placebo control group. Results Six women with vulvodynia (mean age 31.5 ± 8 years; five white, non-Latina, one black/African American) met the eligibility requirements, consented to participation, and were enrolled. All six participants (100%) completed the 10-session study protocol in 5 weeks without missing any treatment sessions. Per observed checklist documented technique, two acupuncturists flawlessly administered the 13-needle, 10-session acupuncture protocol; no needles malfunctioned. Six participants attended all sessions and completed 99% of measurement items. One participant did not like acupuncture (60% acceptability score) and five liked acupuncture (100% acceptability scores); the mean acceptability score was 93.3%. Conclusion Study feasibility was supported. This protocol can be used in a double-blind efficacy trial of acupuncture for vulvodynia. Trial registration ClinicalTrials.gov, NCT02704234. Registered 30 November 2015. Electronic supplementary material The online version of this article (10.1186/s40814-018-0265-9) contains supplementary material, which is available to authorized users.

To investigate the acupuncture sensations elicited by the Japanese style of acupuncture, penetrating acupuncture and skin-touch placebo needles were randomly administered at various insertion depths (5 and 10 mm for the penetrating needles and 1 and 2 mm for the placebo needles) at LI4 to 50 healthy subjects. Among the 12 acupuncture sensations in the Massachusetts General Hospital Acupuncture Sensation Scale (MASS), “heaviness” was the strongest and most frequently reported sensation with the 10 mm needles, but not with the 5 mm needles. There were no significant differences in number of sensations elicited, MASS index, range of spreading, and intensity of needle pain for 5 mm penetration versus 1 mm skin press and 10 mm penetration versus 2 mm skin press. The MASS index with 2 mm skin-touch needles was significantly larger than that with 1 mm skin-touch and 5 mm penetrating needles. The factor structures in the 12 acupuncture sensations between penetrating and skin-touch needles were different. The acupuncture sensations obtained in this study under satisfactorily performed double-blind (practitioner–patient) conditions suggest that a slight difference in insertion depth and skin press causes significant differences in quantity and quality of acupuncture sensations.

Moxibustion, a form of traditional Chinese medicine (TCM), is the burning of the herb moxa (Folium Artemisiae argyi or mugwort) over acupuncture points. It is often used in China to facilitate cephalic version of breech presentation. This article reviews the history, philosophy, therapeutic use, possible mechanisms of action, and literature pertaining to its use for this indication. For moxibustion, moxa can be rolled into stick form, placed directly on the skin, or placed on an acupuncture needle and ignited to warm acupuncture points. Studies have demonstrated that moxibustion may promote cephalic version of breech presentation and may facilitate external cephalic version. However, there is currently a paucity of research on the effects of moxibustion on cephalic version of breech presentation, and thus there is a need for further studies. Areas needing more investigation include efficacy, safety, optimal technique, and best protocol for cephalic version of breech presentation.

Acupuncture sensations are considered essential in producing the treatment effect of acupuncture. The Massachusetts General Hospital Acupuncture Sensation Scale (MASS) is a frequently used scale in acupuncture research to measure acupuncture sensations. We translated the MASS into Japanese (Japanese MASS) based on Beaton’s guidelines. 30 acupuncturists evaluated the relevancy and meaning of the 12 descriptors included in the Japanese MASS. The content validity ratios for 10 of the 12 descriptors were 0.33 or greater. 42 healthy subjects then evaluated acupuncture sensations evoked by manual acupuncture at LI4 using the Japanese MASS. Cronbach’s alpha was 0.86. The correlation coefficient of total MASS scores and total Short Form McGill Pain Questionnaire scores and MASS indices and sensory visual analogue scores were 0.78 and 0.80, respectively. Factor analysis loaded the 12 descriptors onto two meaningful factors. This study demonstrated that the Japanese MASS has good reliability, content validity, criterion-related validity, and construct validity. Therefore, the Japanese MASS is a valid and reliable instrument for use with Japanese populations.

Background: Whether acupuncture treatment employing multiple penetrating, skin-touch placebo, or no-touch placebo needles designed for double blinding actually do blind practitioners and patients has not been investigated. We aimed to investigate this question. Subjects: 120 patients with functional neck/shoulder stiffness but in otherwise healthy condition were randomly assigned to a treatment using four penetrating, four skin-touch placebo, or four no-touch placebo needles. Each of six acupuncturists applied four needles to four acupoints in the neck/shoulder of 20 patients. Acupuncturists and patients were asked to guess the treatment mode and their confidence in their guesses on 100 mm visual analog scales. Results: The kappa coefficients between practitioner guesses and treatment type and between patient guesses and treatment type were 0.15 and 0.44, respectively. The median score of practitioner confidence was 46.8, and no significant difference in confidence between correct and incorrect guesses was revealed for any treatment. The median score of patient confidence for correct guesses was 77.6. The kappa coefficient between practitioner and patient guesses was 0.06. Conclusions: The practitioners were blinded to the nature of treatment using the same multiple needles, but patient blinding was insufficient. Further improvement is necessary to achieve satisfactory patient blinding with these acupuncture needles.

In acupuncture studies, it is necessary to expose blinded patients to control devices such as placebo/sham needles with a blunt tip, which allows the skin to be touched but not penetrated. Several recent systematic reviews have investigated the success of patient blinding with Streitberger, Park and Takakura placebo/sham needles in a series of validation and clinical trials using Bang’s blinding index (BI),1 2 which indicates the degree of potential unblinding beyond balance for each arm of real and placebo treatment.2 In a review papers, it was pointed out that the BIs for Takakura needles for double blinding were unavailable.1 Further, for study Ib (see table 1),3 Moroz et al reported the BIs of patients calculated from the number of subjects who did, or did not, experience the sensation of skin penetration,2 which differed from the BIs calculated from the number of correct and incorrect guesses, even though we reported that “none of the subjects commented in the questionnaire that they had received a non-penetrating needle”. …

It is well known that acupuncture has pain-relieving effects, but the contribution of specific and especially non-specific factors to acupuncture analgesia is less clear. One hundred and one patients who developed pain ≥ 3 on a visual analog scale (VAS, 0-10) following third molar surgery were randomized to receive active acupuncture, placebo acupuncture, or no treatment for 30 min with acupuncture needles with potential for double-blinding. Patients’ perception of the treatment (active or placebo), and expected pain levels (VAS) were assessed prior to and halfway through the treatment. Looking at actual treatment allocation, there was no specific effect of active acupuncture (P = 0.240), but a large and significant non-specific effect of placebo acupuncture (P < 0.001), which increased over time. Interestingly, however, looking at perceived treatment allocation, there was a significant effect of acupuncture (P < 0.001) indicating that patients who believed they received active acupuncture had significantly lower pain levels than those who believed they received placebo acupuncture. Expected pain levels accounted for significant and progressively larger amounts of the variance in pain ratings following both active and placebo acupuncture (up to 69.8%), This is the first study to show that under optimized blinding conditions non-specific factors such as patients’ perception of and expectations toward treatment are central to the efficacy of acupuncture analgesia and that these factors may contribute to self-reinforcing effects in acupuncture treatment To obtain an effect of acupuncture in clinical practice it may, therefore, be important to incorporate and optimize these factors.

Background. Most of our knowledge about similarities in the neural processing of painful and pleasant sensations in the brain derives from studying each phenomenon separately. Patients often feel pain induced by acupuncture, which is noxious stimulation having the symbolic message of the cure, as pleasant. Objectives. We investigated whether the double-blind acupuncture needles are a potential tool to investigate coinciding pain and pleasant events. Methods. Participants were 109 healthy acupuncture students. An acupuncturist applied the double-blind placebo and the matching penetrating needle at bilateral forearm of each subject, one needle on each side of the arm. We asked the subjects to rate the pain associated with needle application and its unpleasantness or pleasantness on a visual analogue scale. Results. Of 65 penetrating needle applications that elicited pain, 29 (45%) subjects did not describe the pain as being unpleasant, and interestingly, 18 (28%) subjects described the needle insertion as pleasant. There was no significant difference in reported pain intensity between penetrating needles elicited pain that elicited a pleasant sensation and those that elicited an unpleasant sensation (P=0.34). Conclusions. The double-blind acupuncture needles can be a potential tool for investigating the concomitant hedonic (pleasure) experience of pain.

Background A no-touch control needle in which the needle tip cannot reach the skin has been designed, and has been validated for practitioner blinding in a previous study but not for participant blinding. Objective To test whether the no-touch control needle can effectively blind subjects. Methods An acupuncturist applied, in turn, a no-touch control, skin-touch placebo and penetrating needle in one forearm of 80 healthy subjects. After removing each needle, the subjects were asked to judge the type of needle and rate the sensation of skin penetration/penetration-like or skin pressure/pressure-like pain on a 100 mm visual analogue scale. Results The subjects correctly identified 67% of needles overall. 17 of the 80 no-touch control needles were judged as skin-touch, and one as penetrating. In addition, six skin-touch placebo needles, and no penetrating needles, were judged as no-touch. Half of the 80 skin-touch placebo needles and 65 of the 80 penetrating needles and two no-touch control needles elicited pain. Of 240 needles, the practitioner identified 120 correctly that did not fit the probability of 1/3 (χ2=30.00, pConclusions The no-touch control needles may be used as a blind control for the acupuncture procedure, or to test the physiological effect of the skin-touch needles, but are not suitable for double-blind testing of the needle effect.

Background Vibration-induced finger flexion reflex (VFR) in the upper extremity is inhibited by needle insertion acupuncture to the large intestine 4 (LI4) at the hand. This claim has a limitation because the inhibitory effect is deduced only from reduction in the maximum finger flexion (FF) force during the tonic flexion reflex by vibratory stimulation after acupuncture. Methods The study was a crossover design with two conditions—acupuncture and control—to which 16 healthy volunteers were subjected. VFR in the upper extremity was induced by applying vibratory stimulation on the volar side of the middle fingertip of the right hand, before and after acupuncture at the right LI4 in 16 healthy volunteers. We measured the area under the curve (AUC) of finger flexion force and surface electromyogram (EMG) in the flexor muscles, in addition to the maximum FF force during vibratory stimulation. We compared AUC, surface EMG and maximum FF force in the acupuncture condition with those in the control condition. We also estimated the correlation between AUC, surface EMG and maximum FF force. Results AUC, surface EMG and maximum FF force were significantly reduced (p Conclusions Acupuncture at ipsilateral LI4 inhibited tonic activities in the finger flexor muscles during VFR, which suggests that afferent input with needle penetration has inhibitory effect on the motor neuronal activities in the reflex circuits of VFR.

Background The double blind, non-penetrating placebo needle is effective in masking patients who are not informed that they may receive a placebo needle. In this study, we aimed to examine whether such needles are effective in masking subjects who have been so informed. Methods One hundred and fourteen informed, consenting, healthy volunteers were recruited. An experienced acupuncturist applied one of the following needle pairs – penetrating/non-penetrating, non-penetrating/non-penetrating, penetrating/penetrating – randomly at bilateral TE5 points in subjects who were informed that they would receive either a non-penetrating or a penetrating needle. After the application of a pair of needles, the subjects reported for each arm on whether they identified the needle as non-penetrating or penetrating. The patients also rated skin penetration/penetration-like pain and the deep dull pain ( de qi) associated with the needle application on a visual analogue scale (VAS). The chi squared goodness of fit test was used to determine the probability of the number of correctly and incorrectly identified needles. Statistical comparisons for VAS scores for skin penetration pain and de qi were made using Mann-Whitney's U test. Results Of the 114 non-penetrating needle applications, the subjects identified 64 incorrectly and 50 correctly, fitting a probability of 0.5 (χ2=1.72, P=0.19). Most interestingly, the subjects identified 36 (32%) of 114 penetrating needle applications incorrectly. Skin penetration/penetration-like pain and de qi scores did not differ significantly (P=0.87 and P=0.17, respectively) between the 114 non-penetrating and 114 penetrating needles. Conclusions The non-penetrating placebo needle was effective in masking fully informed subjects. When used together with the matched penetrating needle, it has potential for use in double blind (patient and practitioner blind) studies.

Background: Double-blind (practitioner–patient masking) studies were impossible to perform before the introduction of matched acupuncture needles. Their efficacy in conducting double-blind studies is not well known. Objective: To investigate whether patients' reactions during double-blind needle insertion reveal needle authenticity to the practitioner. Design, Setting, and Participants: Thirty healthy volunteers (24 men, 6 women) were needled with a pair of penetrating needles at bilateral TE 5 points. The study was conducted in Tokyo, Japan, in 2002. Main Outcome Measures: The practitioner, who was informed about the possible use of non-penetrating needles, guessed whether the needle was penetrating after each needle removal. He then provided clues to the needle's authenticity and rated his confidence in identification on a numerical rating scale (0–100). Results: Of the 60 penetrating needles, 16 (27%) were correctly identified and 44 (73%) were incorrectly identified by the practitioner. Most ...

Blinding protects against bias but the success of blinding is seldom assessed and reported in clinical trials including studies of acupuncture where blinding represents a major challenge. Recently, needles with the potential for double-blinding were developed, so we tested if acupuncture can be double-blinded in a randomized study of sixty-seven patients with acute pain ≥ 3 (0-10 scale following third molar removal) who received active acupuncture with a penetrating needle or placebo acupuncture with a non-penetrating needle. To test if acupuncture was administered double-blind, patients and acupuncturists were asked about perceived treatment allocation at the end of the study. To test if there were clues which led to identification of the treatment, deep dull pain associated with needle application and rotation (termed "de qi" in East Asian medicine), and patients' pain levels were assessed. Perceived treatment allocation depended on actual group allocation (p < 0.015) for both patients and acupuncturists, indicating that the needles were not successful in doubleblinding. Up to 68% of patients and 83% of acupuncturists correctly identified the treatment, but for patients the distribution was not far from 50/50. Also, there was a significant interaction between actual or perceived treatment and the experience of de qi (p = 0.027), suggesting that the experience of de qi and possible non-verbal clues contributed to correct identification of the treatment. Yet, of the patients who perceived the treatment as active or placebo, 50% and 23%, respectively, reported de qi. Patients' acute pain levels did not influence the perceived treatment. In conclusion, acupuncture treatment was not fully dou-ble- blinded which is similar to observations in pharmacological studies. Still, the nonpenetrating needle is the only needle that allows some degree of practitioner blinding. The study raises questions about alternatives to double-blind randomized clinical trials in the assessment of acupuncture treatment.

It remains an open question whether placebo/sham acupuncture, in which the needle tip presses the skin, can be used as a placebo device for research on pain. We compare the analgesic effect of the skin-touch placebo needle with that of the no-touch placebo needle, in which the needle tip does not touch the skin, in a double-blind crossover manner including no-treatment control in 23 healthy volunteers. The subjects received painful electrical stimulation in the forearm before and during needle retention to the LI 4 acupoint and after the removal of the needle and rated pain intensity using a visual analogue scale. We found no significant difference in analgesic effects among the skin-touch placebo needle, no-touch placebo needle, and no-treatment control at every point before, during, and after the treatments (p>0.05). The results indicate that the skin-touch placebo needle can be used as a placebo device in clinical studies on pain.

We studied the effects of non-pain transcutaneous electrical stimulation (TES) and pain-eliciting TES on vibration-induced finger flexion reflex (VFR) in 12 healthy volunteers. Tonic finger flexion reflex in the upper limb was induced by the application of vibratory stimulation on the volar side of the middle fingertip in the right hand before and after TES. Non-pain TES or pain-eliciting TES was applied on the skin between the bases of the first and second metacarpals in the right hand dorsal area in a crossover design. Pain-eliciting TES inhibited VFRs significantly (Fisher's PLSD, p < 0.01), compared to those of the time-control group during and after TES. VFRs were reduced approximately to 63.8% and 78.6% of prestimulation flexion force during and after pain-eliciting TES, respectively. Nonpain TES did not inhibit VFR. These results suggest that pain-conducting afferent fibers have inhibitory neuronal connection over the ipsilateral reflex circuits of VFR in the upper limb.

Background Functional neck/shoulder stiffness is one of the most well-known indications for acupuncture treatment in Japan. There is little evidence for the effectiveness of acupuncture treatment for functional neck/shoulder stiffness. Research using two different placebos may allow an efficient method to tease apart the components of real acupuncture from various kinds of ‘non-specific’ effects such as ritual with touch or ritual alone. Herein, we describe a protocol of an ongoing, single-centre, randomised, placebo-controlled trial which aims to assess whether, in functional neck/shoulder stiffness, acupuncture treatment with skin piercing has a specific effect over two types of placebo: skin-touching plus ritual or ritual alone. Methods Six acupuncturists and 400 patients with functional neck/shoulder stiffness are randomly assigned to four treatment groups: genuine acupuncture penetrating the skin, skin-touch placebo or no-touch placebo needles in a double-blind manner (practitioner-patient blinding) or no-treatment control group. Each acupuncturist applies a needle to each of four acupoints (Bladder10, Small Intestine14, Gallbladder21 and Bladder42) in the neck/shoulder to 50 patients. Before, immediately after and 24 hours after the treatment, patients are asked about the intensity of their neck/shoulder stiffness. After the treatment, practitioners and patients are asked to guess whether the treatment is “penetrating”, “skin-touch” or “no-touch” or to record “cannot identify the treatment”. Discussion In addition to intention-to-treat analysis, we will conduct subgroup analysis based on practitioners’ or patients’ guesses to discuss the efficacy and effectiveness of treatments with skin piercing and various placebo controls. The results of practitioner and patient blinding will be discussed. We believe this study will further distinguish the role of different components of acupuncture. Trial registration Current Controlled Trial ISRCTN76896018

Vibration-induced finger flexion reflex (VFR) is inhibited with acupuncture to TE 5 or LI 4 at the skin innervated by the radial nerve.The aim of this study was to determine if acupoints in regions innervated by the radial nerve are specific to inhibit VFR.This experiment was performed using a crossover design with 3 acupuncture groups (needle insertion to the right LU 11, PC 9, or SI 1) and a control group (no needle treatment). Each acupoint was randomly needled on separate days. Ten healthy volunteers were recruited for this study. VFR was induced by applying vibration on the volar side of the right middle fingertip. An acupuncture needle was inserted in the acupoint and retained for 5 minutes. For the main outcome measure, maximum finger flexion force (MFFF) was measured during vibration and was compared among four groups.MFFFs in the acupuncture groups were significantly lower (Acupuncture to the right LU 11, PC 9, or SI 1 point inhibited the ipsilateral VFR, which suggests that afferent inputs from the radial nerve with needle insertion were not specific, compared with those from the median and ulnar nerves to suppress neuronal activities in the VFR reflex circuits.

四季の変動が非常に大きいわが国において, 人の肌色は四季の変化に従って変動することが推定されるが, その変化が太陽光量の増減による皮膚メラニン量の変化によるものか, 温度変化による皮膚血流の変化によるものかは, 非常に興味深い点である。ある種の生物では, 季節の変動を太陽光の量で認識して, 来たる季節に備えることが知られているが, 我々はヒトには太陽光の変化により, 来たる季節に向かって皮膚血流量が変動をきたす「季節先取りプログラム」ともいうべき働きの存在を想定し, それに伴って肌色が変化すると仮定した。そこで今回, 太陽光の変化曲線と一致する「東洋の季節」に従った測定時期を設定し, 色彩色差計を用いて肌色の季節変動を測定した。男性の通年測定データから, 肌色の色相が「東洋の季節」に於ける春夏と秋冬で二相性に変動するという結果が得られた。またその変曲点は立春, 立秋の頃と推定された。興味あることに, この変動は, 顔面等の露出部位だけでなく, 前腕や上腕のような非露出部でも認められた。この結果から, 肌色の季節変動の主原因は生体側の血流動態の変化によるもので, 外部からの直接的な光刺激に伴う皮膚メラニンの増加ではないと考えられる。この事から, 長時間人工光環境にさらされているヒトにも, 太陽光の変化を感知し, 生理反応を示す「動物」としての季節対応システムが今なお残されていることが示唆された。女性においては, 頬の色相変化は男性と同様の変化を示したが, 額部では夏から冬にかけて色相値の変動はほとんど見られなかった。この違いは, 女性の日焼け防止に対する意識や行動, 性周期に伴う肌色変動などが影響しているものと考えられる。今回の実験結果を, 化粧品的な立場から考えた場合, 肌色は春分, 秋分にはすでに夏型, 冬型となっていることから, 季節によって変化する肌色に合わせたメーキャップを行うためには, 東洋の季節に合わせて, 現状よりも1-2ヵ月早めに, 色号数の取り替えを行うことを提案したいと考える。

This study investigated the effect of acupuncture needles developed for double-blind (practitioner-patient blinding) trials employing a tapping-in method that is commonly used to penetrate the skin in Japanese-style acupuncture. DESIGN, SUBJECTS, AND INTERVENTIONS: An acupuncturist applied a penetrating, a skin-touch placebo, and a no-touch control needle designed to blind both practitioners and patients in the forearm in 80 healthy subjects (patients) by tapping-in method.The setting was a practice room of the Japan School of Acupuncture, Moxibustion and Physiotherapy, Tokyo, Japan.The outcome measures were the acupuncturist's and subjects' guesses at the type of needles and confidence of their guesses on a 100-mm visual analogue scale (VAS). The subjects were asked about pain with needle application.The number of correct/incorrect guesses (the latter including unidentified) of the acupuncturist were 73/167 with a confidence of 55.2 ± 16.9 (mean ± standard deviation) on the VAS. The subjects identified 148 needles correctly and 92 needles incorrectly, the mean confidence being 71.0 ± 28.4. There were a few penetrating and skin-touch placebo needles that the subjects guessed as "no-touch." Whereas few of the 80 no-touch control needles were guessed as "penetrating," 16% of them were guessed as "skin-touch" and 11% were reported as "unidentifiable" by the subjects. Forty percent (40%) of the penetrating needles and 50% of the skin-touch placebo needles did not elicit skin penetration pain.The effect of practitioner blinding employing the needles for double blinding with the tapping-in method was satisfactory. It was difficult to blind the subjects when no-touch control needles together with penetrating and skin-touch placebo needles were used.

The purpose of this study was to investigate the effects of acupuncture and heating (application of hot pack) treatments on blood circulation in the contralateral Achilles tendon. During the treatments (10 min for acupuncture, 20 min for heating) and recovery period (40 min), the blood volume (THb) and oxygen saturation (StO2) of the treated and the non-treated tendons were measured using red laser lights. During both treatments, THb and StO2 of the treated tendon increased significantly from the resting level. The increased THb and StO2 of the treated tendon were maintained until the end of the recovery period after removal of the acupuncture needle, although these values decreased after removal of the hot pack. Although THb of the non-treated sides did not change during both acupuncture and heating treatments, it increased gradually after removal of the acupuncture needle or the hot pack. For both treatments, the amount of increase in THb of the non-treated tendon was significantly correlated to that of the treated tendon during the last phase of recovery period. These results obtained from the healthy subjects imply that blood circulation in the injured tendon in a plaster cast may be improved by applying acupuncture or heating treatments to the contralateral healthy limb.

The purpose of this study was to compare the effect of the Sparrow Pecking (SP) technique with that of the In-Situ (IS) technique of acupuncture on vibration-induced finger flexion reflex (VFR). Subjects were 30 healthy adults. VFR, flexion movement of the vibrated finger, was induced by vibrating the volar side of the middle finger tip. The acupuncture point was the right Hoku point. Both techniques of acupuncture inhibited VFR in the ipsilateral and contralateral sides, but inhibition with SP was significantly greater than that with IS (percentage control force of VFR, mean ± SD: with SP right, 62.1±24.6%, left, 60.6±27.9%, with IS right, 74.9±26.6%, left, 78.1±29.5%, P

It is well known that acupuncture has pain-relieving effects, but the contribution of specific and especially nonspecific factors to acupuncture analgesia is less clear. One hundred one patients who developed pain of P3 on a visual analog scale (VAS, 0 to 10) after third molar surgery were randomized to receive active acupuncture, placebo acupuncture, or no treatment for 30 min with acupuncture needles with potential for double-blinding. Patients' perception of the treatment (active or placebo) and expected pain levels (VAS) were assessed before and halfway through the treatment. Looking at actual treatment allocation, there was no specific effect of active acupuncture (P = .240), but there was a large and significant nonspecific effect of placebo acupuncture (P