Placebo Needles Research Articles

Acupuncture for the Treatment of Pain - A Mega-Placebo?

Several control conditions, such as penetrating sham acupuncture and non-penetrating placebo needles, have been used in clinical trials on acupuncture effects in chronic pain syndromes. All these control conditions are surprisingly effective with regard to their analgesic properties. These findings have fostered a discussion as to whether acupuncture is merely a placebo. Meta-analyses on the clinical effectiveness of placebo revealed that placebo interventions in general have minor, clinically important effects. Only in trials on pain and nausea, including acupuncture studies, did placebo effects vary from negligible to clinically important. At the same time, individual patient meta-analyses confirm that acupuncture is effective for the treatment of chronic pain, including small but statistically significant differences between acupuncture and sham acupuncture. All acupuncture control conditions induce de qi, a distinct stimulation associated with pain and needling which has been shown to be a nociceptive/pain stimulus. Acupuncture therefore probably activates the pain matrix in the brain in a bottom-up fashion via the spino-thalamic tract. Central nervous system effects of acupuncture can be modulated through expectations, which are believed to be a central component of the placebo response. However, further investigation is required to determine how strong the influence of placebo on the attenuation of activity in the pain matrix really is. A meta-analysis of individual participant functional magnetic imaging data reveals only weak effects of placebo on the activity of the pain network. The clinical acupuncture setting is comprised of a combination of a distinct neurophysiological stimulus, the needling stimulus/experience, and a complex treatment situation. A broader definition of placebo, such as that proposed by Howick (2017) acknowledges a role for expectation, treatment context, emotions, learning, and other contextual variables of a treatment situation. The inclusion of particular treatment feature as a definitional element permits a contextual definition of placebo, which in turn can be helpful in constructing future clinical trials on acupuncture.

Efficacy and neural mechanism of acupuncture treatment in older adults with subjective cognitive decline: study protocol for a randomised controlled clinical trial

IntroductionSubjective cognitive decline (SCD) refers to individuals’ perceived decline in memory and/or other cognitive abilities relative to their previous level of performance, while objective neuropsychological deficits are not observed. SCD...

Effects of Electroacupuncture on Expression of PI3K/Akt/Foxo3a in Granulosa Cells from Women with Shen (Kidney) Deficiency Syndrome Undergoing in vitro Fertilization-Embryo Transfer.

To observe the effects of electroacupuncture (EA) on reproductive outcomes in women with Shen (Kidndy) deficiency syndrome after in vitro fertilization-embryo transfer (IVF-ET), and explore the underlying molecular mechanism. Sixty-six infertile patients with Shen deficiency syndrome undergoing IVF-ET were divided into EA or control groups according to a random table, 33 cases in each group. Before undergoing IVF, patients in the EA and control groups received EA therapy and placebo needle puncture, respectively, for 3 menstrual cycles. Shen deficiency syndrome scores were assessed. Other outcome measures included the number of retrieved oocytes and fertilization, high-quality embryo and clinical pregnancy rates. Follicular fluid was collected on the day of oocyte retrieval, and granulosa cell expression of phosphatidylinositide 3-kinases (PI3K), serine-threonine kinase (Akt) and forkhead box O3 (Foxo3a) mRNA were measured by reverse transcribed and quantitative real-time polymerase chain reaction. Syndrome scores for pre- versus post-treatments decreased significantly (16.53±1.75 to 8.67±1.61) in the EA group (P<0.05), but showed no significant change in the control group (17.18±1.58 to 14.74±1.58). A significant difference in score change was found between the EA and control groups (P<0.05). High-quality embryo and clinical pregnancy rates were both increased in the EA group compared with the control group [69.15% (195/282) vs. 60.27% (176/292) and 66.67% (22/33) vs. 42.42% (14/33), respectively, P<0.05]. The fertilization rate was equivalent in EA and control groups. No difference was found in the number of retrieved oocytes between the two groups. Granulosa cell expression levels of PI3K and Akt mRNA were significantly increased in the EA group compared with the control group, while the expression of Foxo3a was reduced (all P<0.05). For infertile patients with Shen deficiency syndrome undergoing IVF, EA for tonifying Shen as an adjunct treatment may alleviate clinical symptoms and improve the high-quality embryo rate. The EA-induced mechanism may involve regulation of PI3K/Akt/Foxo3a expression in granulosa cells to improve the developmental microenvironment of oocytes and inhibit granulosa cell apoptosis, possibly contributing to the improved clinical pregnancy rate (Registration No. ChiCTR 1800016217).

Electroacupuncture for tapering off long-term benzodiazepine use: A randomized controlled trial

ObjectiveTo evaluate the efficacy of using electroacupuncture as an adjunct treatment in enhancing the benzodiazepine cessation rate in long-term benzodiazepine users. MethodsThis was a randomized, assessor- and subject-blinded, controlled trial. One hundred and forty-four long-term benzodiazepine users were randomly assigned to receive either electroacupuncture or placebo acupuncture (a sham itervention using non-invasive placebo needles) combined with a gradual benzodiazepine tapering schedule for 4 weeks. The primary outcome was the cessation rate of benzodiazepine use. Subjects were assessed on their benzodiazepine usage, benzodiazepine withdrawal symptoms, insomnia severity, and anxiety and depressive symptoms at baseline, week 6 and week 16. ResultsThe cessation rates of the electroacupuncture and placebo acupuncture groups at 12 weeks post-treatment were 9.17% and 10.83%, respectively. Both groups showed a reduction in benzodiazepine usage by a self-completed drug record at week 16 (compared to baseline: electroacupuncture group −40.23% versus placebo acupuncture group −48.76%). However, no significant between-group differences were found in the benzodiazepine cessation rate, reduction in benzodiazepine usage, and other secondary measures across all the study time points. ConclusionsElectroacupuncture showed a similar cessation rate in benzodiazepine use to that of non-invasive placebo acupuncture in long-term users during a 4-week gradual tapering schedule. The evidence did not support advantages of electroacupuncture over non-invasive placebo acupuncture on reducing insomnia, anxiety, depression, or other withdrawal symptoms during the gradual tapering schedule. Despite a 40% decrease in the benzodiazepine usage in both groups, the effects may be attributed to the non-specific effects of acupuncture. Trial RegistrationClinicalTrials.gov # NCT02475538.

Effectiveness of dry needling of rectus abdominis trigger points for the treatment of primary dysmenorrhoea: a randomised parallel-group trial.

To compare the effectiveness of trigger point dry needling (TrP-DN) versus placebo needling, relative to an untreated control group, on pain and quality of life in primary dysmenorrhoea. In this randomised, single blind, parallel-group trial, 56 females with primary dysmenorrhoea were randomly allocated to TrP-DN (n=19), placebo needling (n=18) or no treatment (n=19). Patients in both groups were asked to undertake a stretching exercise of the rectus abdominis daily. The needling group received a single session of TrP-DN to trigger points (TrPs) in the rectus abdominis, and the placebo group received placebo needling. The primary outcome was pain intensity (visual analogue scale). Secondary outcomes were quality of life, use of non-steroidal anti-inflammatory drugs, the number of days with pain, and self-perceived improvement, measured using a Global Rate of Change. Outcomes were assessed at baseline, and 1 and 2 months after the treatment. Females receiving TrP-DN exhibited greater decreases (P<0.001) in pain than those receiving placebo (1 month: Δ-19.8 mm, 25.9 to -13.7; 2 months: Δ-26.0 mm, -33.1 to -18.9) or assigned to the untreated control group (1 month: Δ-26.0mm, -32.5 to -19.5; 2 months: Δ-20.1 mm, -26.4 to -13.8). Females in the TrP-DN group also exhibited a greater decrease in the amount of medications (P<0.001). No differences in the number of days with pain or quality of life were found (all P>0.1). This trial suggests that a single session of TrP-DN of the rectus abdominis combined with stretching was more effective than placebo needling and stretching alone at reducing pain and the amount of medication used in primary dysmenorrhoea. ACTRN12616000170426 .

Effects of acupuncture on uremic pruritus in patients undergoing hemodialysis

Uremic pruritus is a problem in patients undergoing hemodialysis because it reduces their quality of life. Even with several advancements in dialysis techniques, recent therapies do not provide optimum results. Acupuncture is a complementary therapy to alleviate the symptoms of uremic pruritus in patients undergoing hemodialysis. This study identified the effects of acupuncture therapy in patients undergoing hemodialysis. Thirty-seven patients with uremic pruritus undergoing hemodialysis were randomly divided into two groups: acupuncture group (n = 18), who received acupuncture treatment at a single point (LI11 Quchi), and control group (n = 19), who received acupuncture treatment using a placebo needle (the Park Sham Device). This was performed simultaneously with hemodialysis therapy twice a week for 12 times. Pruritus scores were assessed using 5D pruritus questionnaire before treatment; after the 4th, 8th, and 12th acupuncture treatment; and at 4 and 8 weeks follow-up. Significant differences were observed in the 5D pruritus scores of the acupuncture and control groups after the end of acupuncture treatment (7.89±0.832 vs 10.63±3.166; p = 0.003) and at 4 weeks follow-up (8.06±1.830 vs. 10.95±3.341; p = 0.001). Acupuncture treatment is effective in lowering the pruritus score of patients with uremic pruritus undergoing hemodialysis twice a week.

How Placebo Needles Differ From Placebo Pills?

Because acupuncture treatment is defined by the process of needles penetrating the body, placebo needles were originally developed with non-penetrating mechanisms. However, whether placebo needles are valid controls in acupuncture research is subject of an ongoing debate. The present review provides an overview of the characteristics of placebo needles and how they differ from placebo pills in two aspects: (1) physiological response and (2) blinding efficacy. We argue that placebo needles elicit physiological responses similar to real acupuncture and therefore provide similar clinical efficacy. We also demonstrate that this efficacy is further supported by ineffective blinding (even in acupuncture-naïve patients) which may lead to opposite guesses that will further enhances efficacy, as compared to no-treatment, e.g., with waiting list controls. Additionally, the manner in which placebo needles can exhibit therapeutic effects relative to placebo pills include enhanced touch sensations, direct stimulation of the somatosensory system and activation of multiple brain systems. We finally discuss alternative control strategies for the placebo effects in acupuncture therapy.

Can self-care by means of contact needles gently applied to the skin relieve menstrual pain?

The efficacy of complementary and alternative medicine to relieve menstrual pain so far has lacked adequate evidence. We conducted a randomized, placebo-controlled, double-blind, comparative study in order to evaluate the efficacy of self-care by application of contact needles for menstrual pain relief. 19 women who experienced menstrual pain were randomly assigned to a contact needle or placebo needle group. Participants were allowed to settle contact or placebo needles on acupuncture points (BL37, BL55, and BL56) in their lower extremities on the first and second days of 4 menstrual cycles. The primary objective was the change in menstrual pain intensity, which was compared between the groups. In the 14 participants (contact needle group: n=8, placebo needle group: n=6) who completed the study, the mean change in menstrual pain was assessed by using a 100-mm Visual Analogue Scale: −17.31 mm in the contact needle group and -18.83 mm in the placebo needle group. There was no intergroup difference (p=0.87, Cohen’s d=0.09). Our findings suggest that self-care by contact needle therapy relieves menstrual pain. However, given that its effect on menstrual pain was equivalent to that of self-care by placebo needle therapy, the pain relief observed in this study is likely to have been due to non-specific effects, such as placebo effects and acupressure effects.

A Double-Blind Study on Acupuncture Sensations with Japanese Style of Acupuncture: Comparison between Penetrating and Placebo Needles.

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.

Pregnancy outcomes of women randomized to receive real versus placebo acupuncture on the day of fresh or frozen-thawed embryo transfer

IntroductionAcupuncture is commonly used in various aspect of Western medicine in recent years including in-vitro fertilization (IVF) treatment. Although there are many clinical trials of acupuncture in IVF and the Cochrane meta-analysis did not find benefit of adjuvant acupuncture for IVF, there is no report on the pregnancy outcomes of women who had received acupuncture during their IVF treatment. ObjectivesTo compare the pregnancy outcomes of women randomized to receive real versus placebo acupuncture during their IVF treatment. MethodsA retrospective chart review was performed on the 212 women with on-going pregnancies after receiving real or placebo acupuncture by sterile disposable stainless steel needles or Streitberger’s placebo needles to the acupoints before and after the embryo transfer on the day of fresh or frozen-thawed embryo transfer. The pregnancy outcomes were obtained from the Hospital Authority Clinical Management System for deliveries in the public sector or from a self-returned questionnaire if those in the private sector. ResultsNo significant differences were found between the demographics of the two groups including their age, gravida, parity and the duration of subfertility. Maternal adverse outcomes including gestational diabetes and hypertensive disorder were comparable for the real acupuncture group (35.3% and 4.4% respectively) and the placebo acupuncture group (39.7% and 5.5% respectively). None of the patients had placenta accreta. The preterm delivery (<37 weeks gestation) rate in the real acupuncture group (23/86, 26.7%) was similar to that in the placebo acupuncture group (25/97, 25.8%). No statistical significant difference was found in the mode of delivery. There were no significant differences between the two groups for Apgar scores and birthweight. ConclusionAcupuncture during IVF treatment does not influence pregnancy outcomes.

Is sham acupuncture a real placebo: Skeptical for sham acupuncture

Since acupuncture came to western countries, research has been done to try and prove whether or not it is effective. Current Acupuncture research is most often based on the sham needle which was first designed by K Streitberger and J Kleinhenz in 1998. The sham acupuncture needles are developed for the control group and do not penetrate the skin. Sham acupuncture has been used in randomized controlled trial (RCT) for diseases which normally benefit from acupuncture treatment. The sham needle is not the best placebo needle though. Because of the use of sham acupuncture, the result of those research shows acupuncture having no effect or it shows there is no significant difference between real acupuncture (verum) and sham acupuncture (placebo). However, a detailed introduction of the Nine Classical Needles (ancient) and the Nine Modern Needles (SHI's nine needles) shows that the use of sham acupuncture in RCT research is flawed by design. This then casts doubt on the findings and conclusions reached by using sham acupuncture in RCT acupuncture research.

Rewiring the primary somatosensory cortex in carpal tunnel syndrome with acupuncture.

Carpal tunnel syndrome is the most common entrapment neuropathy, affecting the median nerve at the wrist. Acupuncture is a minimally-invasive and conservative therapeutic option, and while rooted in a complex practice ritual, acupuncture overlaps significantly with many conventional peripherally-focused neuromodulatory therapies. However, the neurophysiological mechanisms by which acupuncture impacts accepted subjective/psychological and objective/physiological outcomes are not well understood. Eligible patients (n = 80, 65 female, age: 49.3 ± 8.6 years) were enrolled and randomized into three intervention arms: (i) verum electro-acupuncture 'local' to the more affected hand; (ii) verum electro-acupuncture at 'distal' body sites, near the ankle contralesional to the more affected hand; and (iii) local sham electro-acupuncture using non-penetrating placebo needles. Acupuncture therapy was provided for 16 sessions over 8 weeks. Boston Carpal Tunnel Syndrome Questionnaire assessed pain and paraesthesia symptoms at baseline, following therapy and at 3-month follow-up. Nerve conduction studies assessing median nerve sensory latency and brain imaging data were acquired at baseline and following therapy. Functional magnetic resonance imaging assessed somatotopy in the primary somatosensory cortex using vibrotactile stimulation over three digits (2, 3 and 5). While all three acupuncture interventions reduced symptom severity, verum (local and distal) acupuncture was superior to sham in producing improvements in neurophysiological outcomes, both local to the wrist (i.e. median sensory nerve conduction latency) and in the brain (i.e. digit 2/3 cortical separation distance). Moreover, greater improvement in second/third interdigit cortical separation distance following verum acupuncture predicted sustained improvements in symptom severity at 3-month follow-up. We further explored potential differential mechanisms of local versus distal acupuncture using diffusion tensor imaging of white matter microstructure adjacent to the primary somatosensory cortex. Compared to healthy adults (n = 34, 28 female, 49.7 ± 9.9 years old), patients with carpal tunnel syndrome demonstrated increased fractional anisotropy in several regions and, for these regions we found that improvement in median nerve latency was associated with reduction of fractional anisotropy near (i) contralesional hand area following verum, but not sham, acupuncture; (ii) ipsilesional hand area following local, but not distal or sham, acupuncture; and (iii) ipsilesional leg area following distal, but not local or sham, acupuncture. As these primary somatosensory cortex subregions are distinctly targeted by local versus distal acupuncture electrostimulation, acupuncture at local versus distal sites may improve median nerve function at the wrist by somatotopically distinct neuroplasticity in the primary somatosensory cortex following therapy. Our study further suggests that improvements in primary somatosensory cortex somatotopy can predict long-term clinical outcomes for carpal tunnel syndrome.

Auricular Acupuncture for Exam Anxiety in Medical Students-A Randomized Crossover Investigation.

Auricular acupuncture (AA) is effective in the treatment of preoperative anxiety. The aim was to investigate whether AA can reduce exam anxiety as compared to placebo and no intervention. Forty-four medical students were randomized to receive AA, placebo, or no intervention in a crossover manner and subsequently completed three comparable oral anatomy exams with an interval of 1 month between the exams/interventions. AA was applied using indwelling fixed needles bilaterally at points MA-IC1, MA-TF1, MA-SC, MA-AT1 and MA-TG one day prior to each exam. Placebo needles were used as control. Levels of anxiety were measured using a visual analogue scale before and after each intervention as well as before each exam. Additional measures included the State-Trait-Anxiety Inventory, duration of sleep at night, blood pressure, heart rate and the extent of participant blinding. All included participants finished the study. Anxiety levels were reduced after AA and placebo intervention compared to baseline and the no intervention condition (p < 0.003). AA was better at reducing anxiety than placebo in the evening before the exam (p = 0.018). Participants were able to distinguish between AA and placebo intervention. Both AA and placebo interventions reduced exam anxiety in medical students. The superiority of AA over placebo may be due to insufficient blinding of participants.

Efecto de Zhubin (KI9) para reducir el deseo de consumir alcohol en pacientes alcohólicos: un ensayo aleatorizado con grupo de placebo y control

ObjectiveTo examine the effect of acupuncture on Zhubin (KI9) in reducing alcohol craving in alcohol-dependent patients. MethodsTwenty male alcohol-dependent patients were randomly assigned to two groups, a treatment group (10 cases, age 43.0±6.8 years) and a placebo group (10 cases, age 44.5±7.9 years). The treatment group was treated with real needle acupuncture on Zhubin (KI9) twice a week for 4 weeks, and the control group was treated with placebo needle acupuncture. Both groups were given acupuncture treatment using Park Sham Device (PSD). Alcohol craving was measured by the Visual Analogue Scale (VAS) before treatment to establish a baseline, and after 1, 2, and 4 weeks of treatment. Repeated measures ANOVA was used to determine the main and interaction effects of time and on the outcome measure (VAS). ResultsThere was a significant effect of time on VAS score (df=3; F=13.3; P<.01). Main effect of group on VAS score was significant (df=1; F=10.9; P<.01) and the time símbolo de multiplicación group interaction was also significant (df=3; F=4.7; P<.01). ConclusionsReal-needle acupuncture therapy on Zhubin (KI9) showed effectiveness in reducing alcohol craving. These results strongly suggest the usefulness of acupuncture therapy on Zhubin (KI9) in preventing a relapse in alcohol dependent patients.

La aguja de Streitberger: ¿es un buen placebo en acupuntura?

The placebo effect is a bias factor in the interpretation of the results of a therapeutic treatment. This complicates the evaluation of the efficacy of acupuncture in randomized controlled studies. Since the establishment of the NIH Consensus, the standardization of these studies has become a priority goal, together with the reduction in the variability and subjectivity of the results. One possibility would be to clearly define a control concept for acupuncture treatments. Since the insertion of a needle in any part of the body surface evokes physiological effects, even in points far away from classical acupuncture points, it would be interesting to find a device in which the application over an acupuncture point did not provoke therapeutic effects. The Streitberger needle may be of interest in this regard. This needle is attached to a guide tube and the needle handle is retractable. When pressure is applied, the patient cannot distinguish it from a real needle penetrating the skin. Although there are many studies which support the use of the Streitberger needle, no general consensus regarding its effects has been reported. Apart from the Streitberger needle, other placebo needles are currently being developed for application in double blind assays.

Moderators of acupuncture effectiveness in breast cancer survivors: Randomized clinical trial (RCT).

162 Background: The popularity of acupuncture among cancer patients highlights the need for studying its effectiveness for mitigating side effects of cancer treatments. Insomnia is prevalent among cancer patients and is associated with fatigue and reduced quality of life (QOL). It is also closely linked with depression, sleep apnea, and circadian disruption. Using data form an RCT of acupuncture for insomnia among breast cancer survivors, we examined depression, apnea and circadian factors as moderators of acupuncture effectiveness. Methods: 68 breast cancer survivors (54 years, SD = 9) experiencing insomnia symptoms were randomized to receive 12 sessions of acupuncture (N = 34) or sham (N = 34; using placebo needles). Measures included the Insomnia Severity Index, Brief Fatigue Inventory, and FACT—G, obtained at baseline, mid-treatment (3 weeks), end of treatment (6 weeks), and follow-up (10 weeks). Results: Although acupuncture produced significant improvements from baseline to follow-up in insomnia symptoms, fatigue, and QOL, these improvements did not differ from sham. Compared to sham, the acupuncture produced significantly greater improvements in: 1) insomnia severity (p = 0.03) and QOL (p = 0.02) among those with greater tendency for morning chronotype; 2) fatigue (p = 0.01) among those with lower apnea risk; and 3) QOL (p &lt; 0.001) among those with lower depression scores at baseline. Conclusions: These findings suggest that acupuncture might be more effective among certain subgroups of patients. Moderators of insomnia, fatigue, and QOL include morningness tendency, lower risk for sleep apnea and lower depression scores, respectively. Our findings on depression are in line with prior research that has found that patients with less severe depression may have a greater capacity for acupuncture response perhaps due to higher availability of serotonin. Additional research is needed to test whether acupuncture is a viable treatment option for subgroups of cancer survivors with insomnia. Clinical trial information: NCT01162018.

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.

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.

Effect of blinding with a new pragmatic placebo needle: a randomized controlled crossover study.

Placebo control is a useful method for determining the efficacy of a therapy. In acupuncture researches, the preferred method for placebo control is acupuncture using a placebo needle that has a blunt tip and achieves no skin penetration.We performed a crossover study to validate the blinding effect of a new type of placebo needle. Sixty volunteers were randomized to receive acupuncture using 2 types of needles with different sequences: sequence AB, involving first the pragmatic placebo needle and then the real needle, and sequence BA, in a reverse order. Placebo acupuncture was performed by administering the placebo needle through an adhesive pad without skin penetration on the acupoints LI4, RN12, BL25, and BL36. Real acupuncture was performed by needling through the pad and penetrating the skin to 15 mm using a real needle on the same acupoints. The acupuncture was administered every other day with 3 sessions for 1 type of needle. The primary outcome was the perception of needle penetration. Besides degree of acupuncture pain, type, and degree of needle sensation, needle acceptability and factors influencing the subject blinding effect were assessed.Needle penetration was felt by 100%, 90% (54/60), 88.3% (53/60), and 95% (57/60) of volunteers receiving placebo acupuncture and 98.3% (59/60), 96.7% (58/60), 95% (57/60), and 95% (57/60) of volunteers receiving real acupuncture on LI4, RN12, BL25, and BL36, respectively. Differences of the volunteers’ perception of needle penetration between the placebo needle and real needle were not significant for the 4 acupoints (all P > 0.05). Volunteers experienced fewer distension sensations (P = 0.01), a lower degree of needle sensation (P = 0.007), and less pain (P = 0.006) during placebo acupuncture than during real acupuncture. The placebo needle was more easily accepted than the real needle (OR = 1.63, 95% CI, 1.01–2.64). The influences of age, sex, educational level, acupuncture experience, needle sensation, acupuncture pain, and needle acceptability on volunteers’ perception of needle penetration were not significant.The pragmatic placebo needle is a valid control for acupuncture research. It produces a good subject blinding effect with a similar appearance to conventional acupuncture needles and no skin penetration when applied.

Effect of Zhubin (KI9) acupuncture in reducing alcohol craving in patients with alcohol dependence: A randomized placebo-controlled trial

To examine the effect of acupuncture on Zhubin (KI9) in reducing alcohol craving in alcohol-dependent patients. Twenty male alcohol-dependent patients were randomly assigned to two groups, a treatment group (10 cases, age 43.0±6.8 years) and a placebo group (10 cases, age 44.5±7.9 years). The treatment group was treated with real needle acupuncture on Zhubin (KI9) twice a week for 4 weeks, and the control group was treated with placebo needle acupuncture. Both groups were given acupuncture treatment using Park Sham Device (PSD). Alcohol craving was measured by the Visual Analogue Scale (VAS) before treatment to establish a baseline, and after 1, 2, and 4 weeks of treatment. Repeated measures ANOVA was used to determine the main and interaction effects of time and on the outcome measure (VAS). There was a significant effect of time on VAS score (df=3, F=13.3, P<0.01). Main effect of group on VAS score was significant (df=1, F=10.9, P<0.01) and the time×group interaction was also significant (df=3, F=4.7, P<0.01). Real-needle acupuncture therapy on Zhubin (KI9) showed effectiveness in reducing alcohol craving. These results strongly suggest the usefulness of acupuncture therapy on Zhubin (KI9) in preventing a relapse in alcohol dependent patients.