Manual acupuncture versus sham acupuncture and usual care for the prevention of primary dysmenorrhea (PD): study protocol for a randomized controlled trial.

BACKGROUND: Primary dysmenorrhea (PD) is a leading cause of dysmenorrhea among adolescent girls. Manual acupuncture may be considered as an effective treatment for PD, but high-quality evidence remains limited. This trial aims to evaluate the efficacy and safety of acupuncture for the prevention of PD as compared with sham acupuncture and usual care. METHODS/DESIGN: This is a three-arm, randomized, controlled clinical trial in which the patients, assessors, and statisticians will be blinded. A total of 300 acupuncture-naive patients who were diagnosed as PD will be randomly allocated to the verum acupuncture, sham acupuncture, or usual care groups in a 2:2:1 ratio. Patients in the verum acupuncture group will receive manual acupuncture at specific acupuncture points with penetrating needling, while those in the sham acupuncture group will receive non-penetrating needling at non-acupuncture points. They will be given five sessions over a menstrual cycle for 3 menstrual cycles. Patients in the usual care group will receive health education and informed to receive manual acupuncture for free after waiting for 7 menstrual cycles. The primary outcome will be the change from baseline in the Cox Menstrual Symptom Scale Score (CMSS). The secondary outcomes will be the changes in Massachusetts General Hospital Acupuncture Sensation Scale (MASS), visual analog scale (VAS), Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2), Pittsburgh Sleep Quality Index (PSQI), Beck Anxiety Inventory (BAI), Beck Depression Inventory II (BDI- II), Acupuncture Expectancy Scale (AES), 60-item NEO Personality Inventory-Short Form (NEO-FFI), and acute medication intake. The adverse events will be recorded at every visit. The analyses will be performed base on a full analysis set (FAS) and a per-protocol set (PPS). DISCUSSION: This study may provide high-quality evidence regarding the efficacy and safety of manual acupuncture for PD. In addition, the results of this study will help to identify the efficacy of acupuncture due to the specific effects of acupuncture or placebo effects of acupuncture ritual. TRIAL REGISTRATION: Clinical Trials.gov NCT02783534 . Registered on 26 May 2016.

Efficacy of Electro-acupuncture in Treatment of Functional Constipation: A Randomized Controlled Trial.

Functional constipation (FC) is a chronic disease that significantly affects the life quality of patients. Acupuncture has been used for the treatment of FC for many years, but its effectiveness has not been scientifically assessed. The present study aimed to evaluate the efficacy of electro-acupuncture (EA) in relieving the symptoms, mental states and quality of life (QOL) of FC patients. A total of 96 FC patients were randomly allocated into EA, mosapride & sham EA group (MS) and mosapride control group (MC). In the EA group, patients were treated with 16 sessions of needling at Quchi (LI11) and Shangjuxu (ST37) bilaterally, 5 times a week in the first 2 weeks, and 3 times a week in the last 2 weeks. In the MC group, patients were treated with 5 mg mosapride citrate three times a day for 4 weeks. In the MS group, patients underwent sham EA and the same mosapride citrate treatment as in the MC group. The primary outcome was the number of weekly spontaneous bowel movements (SBMs). The secondary outcomes included stool consistency, intensity of defecating difficulty, 36-Item Short-Form Health Survey (SF-36), Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), and the validated Patient Assessment of Constipation-Quality of Life (PAC-QOL). The results showed that as compared with the baseline, EA significantly improved the weekly SBMs, stool consistency and intensity of defecating difficulty (P<0.05). It also partly ameliorated the PAC-QOL, SF-36, SDS and SAS scores when compared with MC or MS group (P<0.05). However, no significant difference was observed between MS and MC groups in bowel function outcomes and QOL scores. It was concluded that EA could effectively improve bowel function, mental states and QOL of FC patients.

Manual acupuncture versus sham acupuncture and usual care for prophylaxis of episodic migraine without aura: multicentre, randomised clinical trial.

OBJECTIVE: To assess the efficacy of manual acupuncture as prophylactic treatment for acupuncture naive patients with episodic migraine without aura. DESIGN: Multicentre, randomised, controlled clinical trial with blinded participants, outcome assessment, and statistician. SETTING: Seven hospitals in China, 5 June 2016 to 15 November 2018. PARTICIPANTS: 150 acupuncture naive patients with episodic migraine without aura. INTERVENTIONS: 20 sessions of manual acupuncture at true acupuncture points plus usual care, 20 sessions of non-penetrating sham acupuncture at heterosegmental non-acupuncture points plus usual care, or usual care alone over 8 weeks. MAIN OUTCOME MEASURES: Change in migraine days and migraine attacks per four weeks during weeks 1-20 after randomisation compared with baseline (four weeks before randomisation). RESULTS: Among 150 randomised patients (mean age 36.5 (SD 11.4) years; 123 (82%) women), 147 were included in the full analysis set. Compared with sham acupuncture, manual acupuncture resulted in a significantly greater reduction in migraine days at weeks 13 to 20 and a significantly greater reduction in migraine attacks at weeks 17 to 20. The reduction in mean number of migraine days was 3.5 (SD 2.5) for manual versus 2.4 (3.4) for sham (adjusted difference -1.4, 95% confidence interval -2.4 to -0.3; P=0.005) at weeks 13 to 16 and 3.9 (3.0) for manual versus 2.2 (3.2) for sham (adjusted difference -2.1, -2.9 to -1.2; P<0.001) at weeks 17 to 20. At weeks 17 to 20, the reduction in mean number of attacks was 2.3 (1.7) for manual versus 1.6 (2.5) for sham (adjusted difference -1.0, -1.5 to -0.5; P<0.001). No severe adverse events were reported. No significant difference was seen in the proportion of patients perceiving needle penetration between manual acupuncture and sham acupuncture (79% v 75%; P=0.891). CONCLUSIONS: Twenty sessions of manual acupuncture was superior to sham acupuncture and usual care for the prophylaxis of episodic migraine without aura. These results support the use of manual acupuncture in patients who are reluctant to use prophylactic drugs or when prophylactic drugs are ineffective, and it should be considered in future guidelines. TRIAL REGISTRATION: Clinicaltrials.gov NCT02765581.

Acupuncture for chronic fatigue syndrome: a systematic review and meta-analysis.

OBJECTIVE: To evaluate evidence for the efficacy of acupuncture for chronic fatigue syndrome (CFS). METHODS: Randomized controlled trials (RCTs) comparing acupuncture with sham acupuncture, other interventions that may have a therapeutic effect, or no intervention, for the treatment of CFS, were searched for in the following databases up to March 2018: Pubmed; Embase; the Cochrane Library; Web of Science; Wanfang database; China National Knowledge Infrastructure (CNKI); Chinese Biomedicine (CBM) database; and VIP database. Risk of bias was determined using the Cochrane tool. Meta-analyses were performed using RevMan V.5.3 software. The GRADE approach (Grading of Recommendations Assessment, Development and Evaluation) was adopted for levels of evidence. RESULTS: Sixteen studies with 1346 subjects were included. Most studies had low methodological quality. Meta-analyses showed a favourable effect of acupuncture on overall response rate compared with sham acupuncture (four studies, 281 participants, RR=2.08, 95% CI 1.4 to 3.1, I2=64%, low certainty) and Chinese herbal medicine (three studies, 290 participants, RR=1.17, 95% CI 1.07 to 1.29, I2=0%, low certainty). Acupuncture also appeared to significantly reduce fatigue severity measured by Chalder's Fatigue Scale and the Fatigue Severity Scale compared with other types of control. CONCLUSION: Our review indicated that acupuncture was more effective than sham acupuncture and other interventions (Chinese herbal medicine, mainly), but no firm conclusion could be reached owing to limited data, poor quality and potentially exaggerated effect size evaluation. Further large, rigorously designed and reported RCTs are required.

[Progress of fMRI Research on "Deqi" of Acupuncture and Our Considerations About Further Studies].

The objectification of "Deqi" of acupuncture is a hot topic in acupuncture research at present, and functional magnetic resonance imaging (fMRI) is one of the most frequently-used techniques for revealing its brain responses. We searched literature about "Deqi" from PubMed in recent 10 years by using key words "Deqi""acupuncture sensation""needling sensation" and fMRI, trying to expound the central mechanism of "Deqi" and to put forward our understandings. Acupuncture "Deqi" evoked deactivation of the limbic-paralimbic-neocortical network (LPNN)/ default mode network (DMN), including medial prefrontal cortex (frontal pole, anterior cingulate), temporal lobe (amygdala, hippocampus, parahippocampus gyrus, temporal pole), and apparent activation of brain regions as the somatosensory cortex, thalamic-somatosensory area-insular lobe, orbitofrontal cortex, etc., which may enhance the connectivity of brain networks and function in analgesia, anti-anxiety, anti-depression, etc., but the activated and deactivated brain regions are different from study to study possibly due to the stimulated different acupoints, subjects' psychophysical conditions, scanning parameters, image acquiring sequences, etc. It is recommended that the coming stu-dies should pay more attention to the influence of acupuncture "Deqi" on brain functions in subjects suffering from diseases, the brain response characteristics of the longer post-effects and the accumulated effects of acupuncture treatment.

[Acupuncture expectation and its clinical evaluation].

Acupuncture expectation refers to the subjective estimation for the effect of acupuncture to be applied. As sham acupuncture is usually used in acupuncture randomized clinical trials,there exists the effect of acupuncture expectation on subjects. It is necessary to evaluate and standardize it. The factors that influence the evaluation standard of acupuncture expectations are different acupuncture expectation value evaluations,evaluation criterions and time points. They will affect the evaluation of clinical efficacy. It is urgent to establish a unified evaluation standard to improve its reliability.

Electroacupuncture for Functional Constipation: A Multicenter, Randomized, Control Trial.

Background and Aim. To investigate the efficacy and safety of electroacupuncture (EA) with different current intensities for functional constipation (FC) and to assess whether the effects of EA with different current intensities are superior to the mosapride. Methods. Patients with FC were randomly divided into low current intensity group (LCI), high current intensity group (HCI), and mosapride group (MC). The primary outcome was three or more spontaneous bowel movements (SBMs) per week and an increase of one or more SBMs from baseline during at least 3 of the 4 weeks. Results. The primary outcome was reached by 53.45%, 66.15%, and 52.24% of the patients who received LCI, HCI, and mosapride, respectively. EA can significantly improve the weekly SBMs and stool consistency and reduce straining severity (p < 0.0001, all). HCI improved the quality of life better than mosapride (p < 0.05) and reduced the proportion of severe constipation more than LCI and mosapride (p < 0.05, both). Conclusions. EA is effective and safe at both current intensities for FC; therapeutic effects of LCI and HCI are not superior to mosapride. EA is superior to mosapride in improving patients' life quality and satisfaction level of treatment; EA has fewer adverse events than mosapride.

Needle Sensation and Personality Factors Influence Therapeutic Effect of Acupuncture for Treating Bell's Palsy: A Secondary Analysis of a Multicenter Randomized Controlled Trial.

BACKGROUND: It has not been solved what kind of needle sensation might influence outcomes of acupuncture treatment. Effects of personality factors on the therapeutic effect of acupuncture have not been investigated. This study aimed to find the effects of the traits of personality on the objective outcome when different acupuncture techniques were used in treating patients with Bell's palsy. METHODS: We performed a secondary analysis of a prospective multicenter randomized controlled trial of acupuncture for Bell's palsy. Patients were randomly assigned to the de qi and control groups, respectively. The primary outcome was facial nerve function at month 6. The intensity of each needle sensation was rated by a visual analog scale. Psychosocial factors were assessed by the pretreatment mediator questionnaire; 16 Personality Factor Questionnaire (16PF) was used for assessing personality factors and digit cancellation test for assessing attention. RESULTS: After 6 months, patients in the de qi group had better facial function (adjusted odds ratio [OR]: 4.16, 95% confidence interval [CI]: 2.23-7.78). Path analysis showed that intensity of needle sensation of fullness had direct effect on House-Brackmann (HB) score at month 6. In de qi group, the low HB score on day 1 (OR: 0.13, 95% CI: 0.03-0.45) and the low Social Boldness score (OR: 0.63, 95% CI: 0.41-0.97) in 16PF were associated with better facial function. In control group, low HB score on day 1 (OR: 0.25, 95% CI: 0.13-0.50), low Vigilance score (OR: 0.66, 95% CI: 0.50-0.88), and high Tension score (OR: 1.41, 95% CI: 1.12-1.77) in 16PF were related to better facial function. CONCLUSIONS: The needle sensation of fullness could predict better facial function and personality traits might influence outcomes of acupuncture treatment. Both of them should be considered seriously in acupuncture treatment and research.

De qi, a threshold of the stimulus intensity, elicits the specific response of acupoints and intrinsic change of human brain to acupuncture.

Objectives. De qi is the subjective constellation of sensations perceived by the acupuncturists and patients as described in several literatures, but the absence of quantitative evaluation methods in de qi restricts the use of acupuncture treatment widely in the world. In the present study, we tried to investigate the intrinsic property of de qi is and how evaluate it quantitatively. Methods. 30 healthy adult volunteers were determined to investigate intrinsic changes in the human body after acupuncture with de qi. Results. Acupuncture treatment with de qi apparently increased acupoint blood flow, tissue displacement, and the amplitude of myoelectricity after de qi on acupoints. Furthermore, acupuncture treatment induced fMRI signal increase/decrease in different brain regions although no significant change in electroencephalography. Interpretation. The intrinsic change of the subjects representing the specific response of acupoints and human brain to acupuncture indicated that de qi might be evaluated quantitatively by those above aspects, which facilitated the confirmation in validity and propagation of this treatment modality widely in the world.

Effectiveness of strengthened stimulation during acupuncture for the treatment of Bell palsy: a randomized controlled trial.

BACKGROUND: The traditional Chinese theory of acupuncture emphasizes that the intensity of acupuncture must reach a threshold to generate de qi, which is necessary to achieve the best therapeutic effect. De qi is an internal compound sensation of soreness, tingling, fullness, aching, cool, warmth and heaviness, and a radiating sensation at and around the acupoints. However, the notion that de qi must be achieved for maximum benefit has not been confirmed by modern scientific evidence. METHODS: We performed a prospective multicentre randomized controlled trial involving patients with Bell palsy. Patients were randomly assigned to the de qi (n = 167) or control (n = 171) group. Both groups received acupuncture: in the de qi group, the needles were manipulated manually until de qi was reached, whereas in the control group, the needles were inserted without any manipulation. All patients received prednisone as a basic treatment. The primary outcome was facial nerve function at month 6. We also assessed disability and quality of life 6 months after randomization. RESULTS: After 6 months, patients in the de qi group had better facial function (adjusted odds ratio [OR] 4.16, 95% confidence interval [CI] 2.23-7.78), better disability assessment (differences of least squares means 9.80, 95% CI 6.29-13.30) and better quality of life (differences of least squares means 29.86, 95% CI 22.33-37.38). Logistic regression analysis showed a positive effect of the de qi score on facial-nerve function (adjusted OR 1.07, 95% CI 1.04-1.09). INTERPRETATION: Among patients with Bell palsy, acupuncture with strong stimulation that elicited de qi had a greater therapeutic effect, and stronger intensity of de qi was associated with the better therapeutic effects. TRIAL REGISTRATION: Clinicaltrials.gov no. NCT00685789.