Miho Takayama

Double blinding with a new placebo needle: a validation study on participant blinding

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, p<0.01). Conclusions 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.

Double blinding with a new placebo needle: a further validation study

Background The masking properties of a new, non-penetrating, double-blind placebo acupuncture needle were demonstrated. Practitioners correctly identified some of the needles; if they were confident in this opinion, they would be unblinded. Objective To investigate the clues that led to correct identification, and the confidence in this decision. Methods Ten acupuncture practitioners, blindly and randomly, applied 10 each of three types of needle to the shoulder: blunt, non-penetrating needles that pressed the skin (‘skin-touch placebo needle’); new non-penetrating needles that penetrated soft material (stuffing) but did not reach the skin (‘non-touch control needle’); matching penetrating needles. Afterwards, practitioners were asked to judge the type of needle, their confidence in their decision and what clues led them to their judgements. Results Of the 30 judgements made by each practitioner, the mean number of correct, incorrect and unidentifiable answers were 10.4 (SD 3.7), 15.2 (SD 4.9) and 4.4 (SD 6.1), respectively. There was no significant difference in the confidence scores for 104 correct (mean, 54.0 (SD 20.2)%) and 152 incorrect (mean, 50.3 (SD 24.3)%) judgements. Twelve needles were identified with 100% confidence—three correct, and nine incorrect. For needles correctly identified, the proportions of non-touch (p = 0.14) and skin-touch (p = 0.17), needles were no greater than chance, but the proportion of penetrating needles correctly identified exceeded chance (p < 0.01). 53% of judgements were made from the “feeling of needle insertion”, but 57% of these were wrong. Conclusion Practitioners had a slight tendency to guess the penetrating needles correctly, but were uncertain about most of their judgments, posing only a very small risk to double blinding.

Can Acupuncture Treatment Be Double-Blinded? An Evaluation of Double-Blind Acupuncture Treatment of Postoperative Pain

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 double-blinding. 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 double-blinded which is similar to observations in pharmacological studies. Still, the non-penetrating 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.

Changes in Blood Circulation of the Contralateral Achilles Tendon During and After Acupuncture and Heating

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.

Double-Blind Acupuncture Needle: A Potential Tool to Investigate the Nature of Pain and Pleasure

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.

Tapping-in Method (Skin Penetration Technique) with a Placebo Needle for Double-Blind Acupuncture Trials

ObjectivesThis 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 Japanesestyle acupuncture.Design, subjects, and interventionsAn acupuncturist applied a penetrating, a skin-touch placebo, and a notouch control needle designed to blind both practitioners and patients in the forearm in 80 healthy subjects (patients) by tapping-in method.SettingThe setting was a practice room of the Japan School of Acupuncture, Moxibustion and Physiotherapy, Tokyo, Japan.Outcome measuresThe 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.ResultsThe 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.ConclusionsThe 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.

Is Skin-Touch Sham Needle Not Placebo? A Double-Blind Crossover Study on Pain Alleviation

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.

Acupuncture and Acupressure in Labor

&NA; 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.

The Potential of Double Blinding with Two Placebo Acupuncture Needles: A Randomized Controlled Pilot-Trial

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.

Analgesia Is Enhanced by Providing Information regarding Good Outcomes Associated with an Odor: Placebo Effects in Aromatherapy?

No previous report has described whether information regarding an odor used in aromatherapy has placebo effects. We investigated whether placebo analgesia was engendered by verbal information regarding the analgesic effects of an odor. Twelve of 24 subjects were provided with the information that a lavender odor would reduce pain (informed), whereas the other 12 subjects were not (not-informed). Concurrent with respiration recording, the subjects were administered a lavender-odor or no-odor treatment during application of painful stimulation to the forefinger. The subjects reported their experience of pain and its unpleasantness on a visual analogue scale after the painful stimulation. The lavender-odor treatment significantly alleviated pain and unpleasantness compared with the no-odor treatment in the informed (P < 0.01) and not-informed groups (P < 0.05). The no-odor treatment in the informed group significantly alleviated pain and unpleasantness compared with both the no-odor and lavender-odor treatments in the not-informed group (P < 0.05). Rapid and shallow breathing induced by the painful stimulation became slow and deep during the lavender-odor and no-odor treatments in both groups. Information regarding a lavender odor, the lavender odor itself, and slower breathing contributed to reduced perceptions of pain and unpleasantness during painful stimulation, suggesting that placebo effects significantly contribute to analgesia in aromatherapy.