Top PDF Efficacy of acupuncture versus sham acupuncture for postprandial distress syndrome: study protocol for a randomized controlled trial

Efficacy of acupuncture versus sham acupuncture for postprandial distress syndrome: study protocol for a randomized controlled trial

Efficacy of acupuncture versus sham acupuncture for postprandial distress syndrome: study protocol for a randomized controlled trial

Patients allocated to the acupuncture group will take treatment with needles inserted at the prespecified acu- puncture points. The protocol including obligatory and additional acupoints was developed from the clinical experience of acupuncture experts. The obligatory acupoints included Baihui (DU20), Danzhong (RN17), Zhongwan (RN12), and Qihai (RN6), and bilateral Tianshu (ST25), Neiguan (PC6), Zusanli (ST36), and Gongsun (SP4). According to different Traditional Chinese Medicine syndromes, additional acupoints could be chosen indi- vidually: Taibai (SP3) for weakness of the qi of the spleen and stomach; Taichong (LR3) for depression of the qi of the liver; and Neiting (ST44) for damp-heat in the stomach. All acupoints are localized according to the WHO Standard Acupuncture Locations and exhibited in Table 1 and Fig. 2. Manipulations of twirling, lifting, and thrusting will be performed on all needles for at least 30 s to reach De qi (a compositional sensation including soreness, numbness, distention, and heaviness), which is believed to be an essential component for acupunc- ture efficacy.
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Acupuncture for postprandial distress syndrome (APDS): study protocol for a randomized controlled trial

Acupuncture for postprandial distress syndrome (APDS): study protocol for a randomized controlled trial

Methods: This is a multi-center, two-arm, blinded (participants), pilot RCT. Forty-two participants who meet the inclusion criteria will be randomly assigned to the verum acupuncture group or minimal acupuncture group in a 1:1 ratio. Both treatments consist of 12 sessions of 20 min duration over four weeks (three sessions per week). The primary outcome measurement is the proportion of persons who improve as assessed using the global outcome by the overall treatment effect (OTE) at end-of-treatment (EOT) (four weeks after randomization). Global assessment at weeks 8 and 16 after randomization is one of the secondary outcomes. The other secondary outcomes including symptoms, disease-specific QoL, and depression and anxiety will be assessed at weeks 4, 8, and 16 after randomization. Discussion: This pilot study will help determine the feasibility and efficacy of acupuncture in patients with PDS. Trial registration: ISRCTN Registry, ISRCTN18135146. Registered on 7 July 2016.
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Effect and safety of acupuncture for Hwa byung, an anger syndrome: a study protocol of a randomized controlled pilot trial

Effect and safety of acupuncture for Hwa byung, an anger syndrome: a study protocol of a randomized controlled pilot trial

Method/design: This randomized, sham-controlled, participant- and assessor-blinded pilot trial aims to determine the study feasibility of acupuncture for HB and to explore its clinical effects and safety. This clinical trial will be conducted with two groups: one treated with real acupuncture and the other with sham acupuncture for 10 sessions over 4 weeks. The experimental group (EG) will receive semi-individualized acupuncture, whereas the control group (CG) will receive sham acupuncture, namely minimal acupuncture on non-acupuncture points. The recruitment, compliance, and completion rate and clinical evaluations, including a Visual Analogue Scale (VAS), the Korean version of the Beck Depression Inventory (BDI), the short form of the Stress Response Inventory (SRI-short form) and the Instrument of the Oriental Medical Evaluation for HB (IOME-HB), will be assessed to evaluate feasibility and possible effects and safety. Four weeks after completing treatment, follow-up assessments will be performed.
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Efficacy and safety of acupuncture for patients with chronic urticaria: study protocol of a randomized, sham controlled pilot trial

Efficacy and safety of acupuncture for patients with chronic urticaria: study protocol of a randomized, sham controlled pilot trial

The primary outcome of this study is the cumulative UAS in each group. After a normality test, the total score will be compared using the independent t test (parametric) or the Mann-Whitney U test (non-paramet- ric) according to the normality of the data. In secondary outcome analysis, the VAS score for itching intensity and the DLQI will be used to analyze the difference, and differences between groups in mean change between baseline and measurements made at 1, 2, 3, and 4 weeks will be analyzed by repeated measures two-factor ana- lysis. The HAMA, HAMD, humoral immunity index, and serum total IgE measurement will be compared using the independent t test (parametric) or the Mann-Whitney U test (non-parametric) according to the normality of the data. The χ2 test or logistic regression will be used to analyze dichotomous outcomes. Adverse events will be compared between groups using the χ2 test or Fisher’s exact test. Missing values will be replaced using the method of last observation carried forward. If the partici- pant dropout rate is > 20%, sensitivity analysis will be con- ducted with the data included.
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Effectiveness of De Qi during acupuncture for the treatment of tinnitus: study protocol for a randomized controlled trial

Effectiveness of De Qi during acupuncture for the treatment of tinnitus: study protocol for a randomized controlled trial

Methods and design: This study compares two acupuncture groups (with or without manipulation) in 292 patients with a history of subjective tinnitus. The trial will be conducted in the Teaching Hospital of Chengdu University of Traditional Chinese Medicine. In the study, the patients will be randomly assigned into two groups according to a computer-generated randomization list and assessed prior to treatment. Then, they will receive 5 daily sessions of 30 minutes each time for 4 consecutive weeks and undergo a 12-week follow-up phase. The administration of acupuncture follows the guidelines for clinical research on acupuncture (WHO Regional Publication, Western Pacific Series Number 15, 1995), and is performed double-blind by physicians well-trained in acupuncture. The measures of outcome include the subjective symptoms scores and quantitative sensations of De Qi evaluated by Visual Analog Scales (VAS) and the Chinese version of the ‘ modified ’ Massachusetts General Hospital Acupuncture Sensation Scale (C-MMASS). Furthermore, adverse events are recorded and analyzed. If any subjects are withdrawn from the trial, intention-to-treat analysis (ITT) and per-protocol (PP) analysis will be performed. Discussion: The key features of this trial include the randomization procedures, large sample and the standardized protocol to evaluate De Qi qualitatively and quantitatively in the treatment of acupuncture for tinnitus. The trial will be the first study with a high evidence level in China to assess the efficacy of De Qi in the treatment of tinnitus in a randomized, double-blind, sham-controlled manner.
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Efficacy and safety of manual acupuncture manipulations with different frequencies on epigastric pain syndrome (EPS) in functional dyspepsia (FD) patients: study protocol for a randomized controlled trial

Efficacy and safety of manual acupuncture manipulations with different frequencies on epigastric pain syndrome (EPS) in functional dyspepsia (FD) patients: study protocol for a randomized controlled trial

The main acupoints ST36, PC6, and RN12 will be nee- dled in each group. Additional acupoints will also be used based on symptom differentiation. For stagnation of liver qi, RN17 and LR13 (bilateral) are added; for deficiency of spleen qi and stomach qi, one adds BL20 (bilateral) and BL21 (bilateral); for stomach disorder due to liver qi, LR14 (bilateral) and LR3 (bilateral) are added; for damp heat in middle Jiao, one adds SP9 (bilateral) and ST44 (bilateral). Acupoints will be localized accord- ing to the 2008 World Health Organization standards [12]. Sterilized stainless steel needles (Φ0.25 mm × 25 mm or 0.25 mm × 40 mm, Tianjin Hua Hong Medical Co., Ltd., Tianjin, China) will be used for all acupuncture procedures. The length of the needle will be chosen according to the acupoint.
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Manual acupuncture for the infertile female with polycystic ovary syndrome (PCOS): study protocol for a randomized sham controlled trial

Manual acupuncture for the infertile female with polycystic ovary syndrome (PCOS): study protocol for a randomized sham controlled trial

Acupuncture and Traditional Chinese Medicine (TCM) methods have a long history of use for gynecological dis- eases [9] and the related research has increased in the past 20 years [10]. A prevalence study [11] reported that 29% of 428 infertile couples in eight community and academic infertility practices had used a complementary and alter- native medicine (CAM) treatment for infertility, 22% had tried acupuncture, and 17% had tried herbal therapy. A re- view [12] investigated whether utility of TCM would be a feasible method to improve the outcome of female infertil- ity treatment because of inadequate evidence. A meta-ana- lysis [13] demonstrated that co-treatment with TCM and letrozole was more effective than letrozole monotherapy in the treatment of PCOS. Yanjing et al. [14] found that Chinese herbal formula combined with Electroacupunc- ture (EA) can remarkably improve the menstrual cycle, re- duces body weight and the levels of luteinizing hormone (LH), LH/ follicle-stimulating hormone (FSH), total tes- tosterone (T), anti-Mullerian hormone (AMH), improve ovulation, and pregnancy rates. We therefore selected Chinese herbal medicine as a basic treatment.
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Evaluating the efficacy of dexamethasone in the treatment of patients with persistent acute respiratory distress syndrome: study protocol for a randomized controlled trial

Evaluating the efficacy of dexamethasone in the treatment of patients with persistent acute respiratory distress syndrome: study protocol for a randomized controlled trial

Corticoids seemed to be an ideal therapy for the acute lung injury in ARDS, given their potent anti-inflammatory and antifibrotic properties [3]. They switch off genes that encode pro-inflammatory cytokines and switch on genes that encode anti-inflammatory cytokines. It has been reported that low doses of corticosteroids prevent an extended cytokine response and might accelerate the resolution of pulmonary and systemic inflammation in pneumonia [4]. Several clinical trials have evaluated the utility of methylprednisolone in ARDS [5–15]. None of them has demonstrated a definitive benefit due to small sample sizes, selection bias, patient heterogeneity, and time of initiation of treatment or duration of therapy. The ARDS Network performed the largest random- ized trial of methylprednisolone versus placebo in 180 patients with ARDS of at least 7 days duration [13]. Although there was no survival benefit in the steroid group, methylprednisolone increased the number of ventilator-free days (VFDs) and intensive care unit (ICU)- free days during the first month. Also, a meta-analysis of selected trials showed that prolonged administration of systemic steroids is associated with favorable out- comes and survival benefit when given before day 14 of ARDS [16].
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Efficacy of acupuncture for chronic asthma: study protocol for a randomized controlled trial

Efficacy of acupuncture for chronic asthma: study protocol for a randomized controlled trial

Background: Although asthma symptoms can be temporarily controlled, it is recommended to use effective low-risk, non-drug strategies to constitute a significant advance in asthma management. Acupuncture has been traditionally used to treat asthma; however, the evidence for the efficacy of this treatment is still lacking. Previous clinical trials of acupuncture in treating asthma were limited by methodological defects; therefore, high-quality research is required. Methods/Design: This trial is designed as a multi-center, randomized, double-blind, parallel-group controlled trial. Patients with mild to moderate asthma will be randomly allocated to either a verum acupuncture plus as-needed salbutamol aerosol and/or prednisone tablets group or a sham acupuncture plus as-needed salbutamol aerosol and/or prednisone tablets group. Acupoints used in the verum acupuncture group are GV14 (Da Zhui), BL12 (Feng Men), BL13 (Fei Shu) and acupoints used in the sham acupuncture group are DU08 (Jin Suo), BL18 (Gan Shu), BL19 (Dan Shu). After a baseline period of 1 week, the patients in both groups will receive verum/sham acupuncture once every other day with a total of 20 treatment sessions in 6 weeks and a 3-month follow-up. The primary outcome will be measured by using the asthma control test and the secondary outcomes will be measured by using the percentage of symptom-free days, the average dosage of salbutamol aerosol and/or prednisone tablets, lung functions, daily asthma symptom scores, asthma quality of life questionnaire, and so on.
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Randomized study exploring the combination of radiotherapy with two types of acupuncture treatment (ROSETTA): study protocol for a randomized controlled trial

Randomized study exploring the combination of radiotherapy with two types of acupuncture treatment (ROSETTA): study protocol for a randomized controlled trial

Background: Adverse effects such as fatigue, pain, erythema, nausea and vomiting are commonly known in patients undergoing irradiation (RT) alone or in combination with chemotherapy (RCHT). Patients suffering from these symptoms are limited in their daily life and their quality of life (QOL) is often reduced. As addressed in several trials, acupuncture can cause amelioration of these specific disorders. Especially for pain symptoms, several groups have shown efficacy of acupuncture. To what extent the difference between traditional acupuncture ( verum acupuncture) and false acupuncture ( sham acupuncture) is in reducing side effects and improvement of QOL is not clear.
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Efficacy of acupuncture and electroacupuncture in patients with nonspecific low back pain: study protocol for a randomized controlled trial

Efficacy of acupuncture and electroacupuncture in patients with nonspecific low back pain: study protocol for a randomized controlled trial

Data normality will be tested through visual inspection of histograms. The statistical analysis of our study will follow intention-to-treat principles. Repeated measures analysis of variance (ANOVA) will be used to investigate the effect of treatment (Acupuncture vs Electroacupuncture), time (baseline, post-treatment, 3 months follow up), and interaction terms between treatment group versus time. If differences between groups were identified, the Turkey- test for multiple comparison will be conducted. Two-sided paired t tests will use for within-group comparisons (comparing baseline to follow up). If we found non- normally distributed data, we will use the Kurtosis-Wallis test. For all of these analyses, we will use the SPSS version 21 software (SPSS Inc, Chicago, Illinois).The confidence interval will be established at 95%, and the significance level at 0.05.
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The combination effects of body acupuncture and auricular acupressure compared to sham acupuncture for body weight control: study protocol for a randomized controlled trial

The combination effects of body acupuncture and auricular acupressure compared to sham acupuncture for body weight control: study protocol for a randomized controlled trial

This single-blinded, randomized controlled clinical trial aims to evaluate the efficacy and safety of acupuncture on body weight control in Hong Kong. It will be the first such study on the Hong Kong population and will obtain evidence for utilizing acupuncture in obesity treatment especially for patients with Hong Kong diet patterns and health conditions. In order to achieve a higher thera- peutic efficacy, we will integrate electro-acupuncture with auricular acupressure. Except for acupuncture point stimulation on the body and ears, we will not apply any interventions such as CHM, diet or physical activities to the subjects. Therefore, the effects of acupuncture alone will be observed. The outcome measures will include the change in body weight and body fat percentage, which will provide data to us on analysis of the treatment’s po- tential benefit on body fat mass.
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Efficacy of acupuncture for chronic prostatitis/chronic pelvic pain syndromes: study protocol for a randomized, sham acupuncture controlled trial

Efficacy of acupuncture for chronic prostatitis/chronic pelvic pain syndromes: study protocol for a randomized, sham acupuncture controlled trial

According to records in the ancient Traditional Chinese Medicine work Huangdi Neijing, acupuncture points be- longing to bladder meridian (BL) have a noticeable effect on urinary disease. Furthermore, spleen meridian (SP), kidney meridian (KI), and liver meridian (LR) intersect at Sanyinjiao (SP 6), one of the most frequently used acupuncture points for urogenital disease [19, 20]. In addition, the treatment was based on the theory of neuroanatomy [10, 21, 22] and consensus among acu- puncture experts in Guang’anmen Hospital. Therefore, we chose the following acupuncture points: Zhongliao (BL 33), Shenshu (BL 23), Huiyang (BL 35), and Sanyin- jiao (SP 6) (Table 1). After the patients are relaxed and in a prone position, acupuncturists will use 75 % alcohol pads to sterilize the skin around the acupuncture points and then insert steel needles (Huatuo, Suzhou, China 0.3 mm*40 mm/0.3 mm*75 mm) into the acupuncture
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Use acupuncture to relieve perimenopausal syndrome: study protocol of a randomized controlled trial

Use acupuncture to relieve perimenopausal syndrome: study protocol of a randomized controlled trial

One recent RCT found that traditional acupuncture continued relieving the vasomotor symptoms through- out the 3-month treatment period, while the sham acu- puncture was tending towards stability after the first month [17]. A longer duration of treatment was hypoth- esized to be a superior effect between traditional and sham acupuncture. Accordingly, in order to observe a significant effectiveness of acupuncture, participants in our study will receive 3 months of treatment. Another study indicated that the effectiveness of acupuncture on perimenopausal syndrome was superior to HRT during the 6-month follow-up period [43]. Therefore, it is ne- cessary to conduct a longer period of follow-up to ob- verse the continuous effects of acupuncture compared with positive drug, and also to assess the safety after treatment. Before this trial we conducted a questionnaire survey of 156 women with perimenopausal syndrome in the First Affiliated Hospital of Chengdu University of TCM to obtain the public’s acceptance and understand- ing of acupuncture treatment for perimenopausal prob- lems (the detail of this survey will be available soon). According to the results of the survey, previous RCTs and the opinions of experts, we designed this protocol for better treatment and follow-up arrangements.
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Efficacy of electro acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: study protocol for a randomised controlled trial

Efficacy of electro acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: study protocol for a randomised controlled trial

The obligatory acupoints include dubi (ST35), neixi- yan (EX-LE5), ququan (LR8), xiyangguan (GB33) and an ashi point (the point where the patient feels most pain). Adjunct acupoints will be chosen by the acupuncturists according to traditional Chinese medicine. If pain occurs in the anterior aspect of the affected knee joint, the pa- tient has yangming meridian syndrome. Three adjunct acupoints will be chosen from futu (ST32), liangqiu (ST34), heding (EX-LE2), zusanli (ST36) and fenglong (ST40). If pain occurs in the medial aspect of the af- fected knee joint, the patient has three-yin meridian syn- drome. Three adjunct acupoints will be chosen from xuehai (SP10), yingu (KI10), yinlingquan (SP9), xiguan (LR7), sanyinjiao (SP6), taixi (KI3), taichong (LR3) and gongsun (SP4). If pain occurs in the posterior aspect of the affected knee joint, the patient has taiyang meridian syndrome. Three adjunct acupoints will be chosen from weiyang (BL39), weizhong (BL40), chengshan (BL57) and kunlun (BL60). If pain occurs on the lateral aspect of the affected knee joint, the patient has shaoyang meridian syndrome. Three adjunct acupoints will be chosen from fengshi (GB31), yanglingquan (GB34), waiqiu (GB36), xuanzhong (GB39) and zulinqi (GB41). If more than two aspects are affected, three adjunct acupoints will be chosen from those for the relevant syndromes. All acu- points are localised according to the WHO Standard
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Efficacy of electro acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: statistical analysis plan for a randomized controlled trial

Efficacy of electro acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: statistical analysis plan for a randomized controlled trial

This three-arm randomized sham-controlled trial has been approved by the ethics committees at each of the nine participating hospitals. Eligible KOA participants, di- agnosed according to the American College of Rheuma- tology criteria [19], are randomly assigned (1:1:1) to receive 24 sessions of EA, MA, or SA over 8 weeks. The block randomization, with block sizes of 6 and 9, is strati- fied by study center and is performed via a web-based randomization system. Superficial insertion at non- acupoints with no electric current will be used for the SA group, which is one of the most commonly used ap- proaches for administering sham treatments in acupunc- ture trials. The nature of acupuncture means that acupuncturists are not blinded to treatment allocation; however, patients, outcome assessors, and statisticians will remain masked. Informed consent will be obtained from each participant before randomization. The trial has been registered with ClinicalTrials.gov (NCT03366363).
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Wrist ankle acupuncture (WAA) for precompetition nervous syndrome: study protocol for a randomized controlled trial

Wrist ankle acupuncture (WAA) for precompetition nervous syndrome: study protocol for a randomized controlled trial

Sham acupuncture group: sham acupuncture was admin- istered on point 1 at the wrists, 3 hours before the track event sessions. The needle was retained for 30 minutes. The subjects were asked to stay in the sitting position and to wear an eye mask. The target site was also disin- fected with an iodophor disinfectant (Shanghai Likang Disinfectant Hi-tech Co. Ltd., Shanghai, China). The tip and most of the body of the disposable sterile acupuncture needle (0.25 mm in diameter and 25 mm in length, Suzhou Medical Appliance Factory, Jiangsu Province, China) (Fig. 3) was cut off and blunted. Only 2–3 mm of the length of the needle body remained. The processed needles were also held with three right-hand fingers (thumb, index finger, and middle finger). The skin near the target site was gently pressed with the left thumb to make it slightly taut. The needle tip swiftly punctured the skin at the target point at a30° angle (the tip was not
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Efficacy and safety of acupuncture for chronic dizziness: study protocol for a randomized controlled trial

Efficacy and safety of acupuncture for chronic dizziness: study protocol for a randomized controlled trial

Dizziness is one of the most challenging symptoms in medicine, and the prevalence has been reported to be between 11.1% and 28.9% [1]. It is associated with func- tional disability, and 10 to 20% of sufferers fall because of their symptoms [2]. Although spontaneous remission is possible, many patients experience delays in vestibular compensation, which lead to chronic symptoms that inter- fere with everyday functional tasks [3]. Over 66% of dizzy patients also experience psychological distress, often re- sulting in a vicious cycle of fear, avoidance of symptom- provoking movements, and increased handicap, retarding recovery even further [4,5].
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Acupuncture in the treatment of rheumatoid arthritis: a double blind controlled pilot study

Acupuncture in the treatment of rheumatoid arthritis: a double blind controlled pilot study

superficial insertion of needles into non-classical points [22], and real acupuncture point but no skin puncture [11]. However, some of these acupuncture points that were used may still be effective [21]. The retractable type of sham needle [23,24] has been intended for use in acu- puncture-naïve subjects or subjects with limited acupunc- ture experience. However, in a Japanese study [25], 60% of the subjects could distinguish between sham and genu- ine needling, probably due to the fact that most people in Asian countries have more knowledge and experience with acupuncture. Our group found that sham sites and superficial punctures lead to inadequate blinding since more than 50–85% of recipients could immediately rec- ognize that they are not receiving real acupuncture. The special device we used which hide the distal end of the needle was effective as 85% patients who received acu- puncture in the hand and 90% patients who received acu- puncture in the leg were unable to distinguish whether they were receiving real or sham acupuncture [15]. There was no significant difference between those who had received previous acupuncture or not [15]. In this study, there is no significant treatment effect demonstrated in the sham acupuncture group as all the outcome measures remained unchanged except the patient's global score. Moreover, significantly more patients from the sham acu- puncture group dropped out prematurely due to ineffi- cacy compared to the 2 acupuncture groups.
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Pain management with acupuncture in osteoarthritis: a systematic review and meta analysis

Pain management with acupuncture in osteoarthritis: a systematic review and meta analysis

One previous review [1] concluded reduced pain but no change in function. Some of these reviews included a sub- set of the trials included in this review and/or analyzed data from trials with substantial variability in the defin- ition and application of acupuncture. Inconsistent findings may also relate to the inclusion of trials comparing trad- itional acupuncture to minimal/superficial acupuncture as well as trials studying electro-acupuncture. Electrical needle stimulation can enhance the effects of acupuncture [19,45], and thus equating electro-acupuncture to traditional acu- puncture is not an accurate representation of the efficacy of acupuncture. Previous inclusion of non-randomized trials or quasi-experiments may have also exaggerated effect esti- mate [21]. In our systematic review we excluded non ran- domized trials, trials in which superficially penetrating needles were used as sham acupuncture, and trials where electrical needle stimulation was performed in the treat- ment arm.
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