Acupuncture and Doxylamine-Pyridoxine for Nausea and Vomiting in Pregnancy : A Randomized, Controlled, 2 × 2 Factorial Trial.

BACKGROUND: An effective and safe treatment for nausea and vomiting of pregnancy (NVP) is lacking. OBJECTIVE: To assess the efficacy and safety of acupuncture, doxylamine-pyridoxine, and a combination of both in women with moderate to severe NVP. DESIGN: Multicenter, randomized, double-blind, placebo-controlled, 2 × 2 factorial trial. (ClinicalTrials.gov: NCT04401384). SETTING: 13 tertiary hospitals in mainland China from 21 June 2020 to 2 February 2022. PARTICIPANTS: 352 women in early pregnancy with moderate to severe NVP. INTERVENTION: Participants received daily active or sham acupuncture for 30 minutes and doxylamine-pyridoxine or placebo for 14 days. MEASUREMENTS: The primary outcome was the reduction in Pregnancy-Unique Quantification of Emesis (PUQE) score at the end of the intervention at day 15 relative to baseline. Secondary outcomes included quality of life, adverse events, and maternal and perinatal complications. RESULTS: No significant interaction was detected between the interventions (P = 0.69). Participants receiving acupuncture (mean difference [MD], -0.7 [95% CI, -1.3 to -0.1]), doxylamine-pyridoxine (MD, -1.0 [CI, -1.6 to -0.4]), and the combination of both (MD, -1.6 [CI, -2.2 to -0.9]) had a larger reduction in PUQE score over the treatment course than their respective control groups (sham acupuncture, placebo, and sham acupuncture plus placebo). Compared with placebo, a higher risk for births with children who were small for gestational age was observed with doxylamine-pyridoxine (odds ratio, 3.8 [CI, 1.0 to 14.1]). LIMITATION: The placebo effects of the interventions and natural regression of the disease were not evaluated. CONCLUSION: Both acupuncture and doxylamine-pyridoxine alone are efficacious for moderate and severe NVP. However, the clinical importance of this effect is uncertain because of its modest magnitude. The combination of acupuncture and doxylamine-pyridoxine may yield a potentially larger benefit than each treatment alone. PRIMARY FUNDING SOURCE: The National Key R&D Program of China and the Project of Heilongjiang Province "TouYan" Innovation Team.

Acupuncture vs Sham Acupuncture for Chronic Sciatica From Herniated Disk: A Randomized Clinical Trial.

Importance: Sciatica is commonly caused by herniated lumbar disc and contributes to severe pain and prolonged disability. Although acupuncture is widely used by patients with chronic sciatica, the evidence of its efficacy is scarce. Objective: To investigate the efficacy and safety of acupuncture compared with sham acupuncture in patients with chronic sciatica from herniated disk. Design, Settings, and Participants: This was a multicenter 2-arm randomized clinical trial conducted in 6 tertiary-level hospitals in China of patients with chronic sciatica from herniated disk. Participants were recruited from March 25, 2021, to September 23, 2021, with a final follow-up through September 22, 2022. Data analyses were performed from December 2022 to March 2023. Interventions: Participants were randomly assigned to receive 10 sessions of acupuncture (n = 110) or sham acupuncture (n = 110) over 4 weeks. Participants, outcome assessors, and statisticians were blinded. Main Outcomes and Measures: The 2 coprimary outcomes were changes in visual analog scale (VAS) for leg pain and Oswestry Disability Index (ODI) from baseline to week 4. Secondary outcomes were adverse events. Results: A total of 216 patients (mean [SD] age, 51.3 [15.2] years; 147 females [68.1%] and 69 males [31.9%]) were included in the analyses. The VAS for leg pain decreased 30.8 mm in the acupuncture group and 14.9 mm in the sham acupuncture group at week 4 (mean difference, -16.0; 95% CI, -21.3 to -10.6; P < .001). The ODI decreased 13.0 points in the acupuncture group and 4.9 points in the sham acupuncture group at week 4 (mean difference, -8.1; 95% CI, -11.1 to -5.1; P < .001). For both VAS and ODI, the between-group difference became apparent starting in week 2 (mean difference, -7.8; 95% CI, -13.0 to -2.5; P = .004 and -5.3; 95% CI, -8.4 to -2.3; P = .001, respectively) and persisted through week 52 (mean difference, -10.8; [95% CI, -16.3 to -5.2; P < .001; and -4.8; 95% CI, -7.8 to -1.7; P = .003, respectively). No serious adverse events occurred. Conclusions and Relevance: This randomized clinical trial found that in patients with chronic sciatica from herniated disk, acupuncture resulted in less pain and better function compared with sham acupuncture at week 4, and these benefits persisted through week 52. Acupuncture should be considered as a potential treatment option for patients with chronic sciatica from a herniated disk. Trial Registration: Chictr.org Identifier: ChiCTR2100044585.

[Functional dyspepsia treated with acupuncture of different frequencies: a randomized controlled trial].

OBJECTIVE: To compare the clinical efficacy of acupuncture with different frequencies in the treatment of patients with functional dyspepsia (FD). METHODS: A total of 90 patients with FD were randomly divided into a 3-time acupuncture treatment per week group (3-A group, 31 cases, 2 cases dropped off), a 1-time acupuncture treatment per week group (1-A group, 30 cases, 2 cases dropped off) and a control group (29 cases, 2 cases dropped off). In the two acupuncture groups, the acupoints were Zhongwan (CV 12) and bilateral Tianshu (ST 25), Neiguan (PC 6), Liangqiu (ST 34), Yanglingquan (GB 34), Zusanli (ST 36) and Taichong (LR 3), stimulated 3 times a week and once a week, respectively; and the treatment was given consecutively for 4 weeks. In the control group, no intervention was adopted, but the compensatory therapy was provided after the end of follow-up. The scores of the symptom index of dyspepsia (SID), self-rating anxiety scale (SAS) and self-rating depression scale (SDS) were compared among the 3 groups before treatment, after 4 weeks of treatment and in 4 and 8 weeks after treatment completion separately. The score of Nepean dyspepsia life quality index (NDLQI) was evaluated before treatment, after 2 and 4 weeks of treatment and in 4 and 8 weeks after treatment completion. RESULTS: After 4 weeks of treatment and in 4 and 8 weeks after treatment completion, the scores of SID, SAS and SDS were all reduced in the 3-A group and the 1-A group when compared with the scores before treatment (P<0.000 1, P<0.05). After 4 weeks of treatment, the scores of SID, SAS and SDS in the two acupuncture groups were lower than those in the control group (P<0.000 1). After 2 and 4 weeks of treatment, the increased values of NDLQI score in the two acupuncture groups were all higher than those in the control group (P<0.05). In 4 and 8 weeks after treatment completion, the scores of SID, SAS and SDS in the 3-A group were lower than those in the 1-A group (P<0.001, P<0.05), and the increased values of NDLQI score in the 3-A group were higher than those in the 1-A group (P<0.000 1). CONCLUSION: Acupuncture given 3 times per week is superior to the treatment given once per week in the aspects of relieving the clinical symptoms, improving the quality of life and regulating the emotional state in patients with FD. This efficacy is persistent for 8 weeks after treatment completion.

[Brief analysis on main indications and compatibility rules of Ciliao (BL 32) based on data mining].

Based on the data mining technology, the main indications and compatibility rules of Ciliao (BL 32) were analyzed and summarized. The relevant literature was retrieved from the databases of CNKI, Wanfang, VIP, Cochrane Library, SinoMed, Scopus, Web of Science, EMbase and PubMed, from the date of establishment to September 8, 2021. Using the software of SPSS Modeler 18.0 and Gephi0.9.2, the included literature was analyzed by data mining. A total of 218 articles were included, of them, there were 36 articles using single-acupoint prescriptions and 182 articles using compound prescriptions. Acupuncture was the most frequently used intervention of Ciliao (BL 32), followed by electroacupuncture. Dysmenorrhea and labor analgesia were the dominant indications of single-acupoint prescriptions of Ciliao (BL 32), and 9 diseases i.e. dysmenorrhea, urinary incontinence, urinary retention, chronic pelvic inflammatory disease, chronic prostatitis and lumbar disc herniation were the dominant indications of compound prescriptions. The main indications of Ciliao (BL 32) involved diseases of reproductive system, urinary system and waist. There were 92 acupoints in compatibility with Ciliao (BL 32), which were main belonged to the bladder meridian, the conception vessel and the spleen meridian, the most frequently used acupoints were Sanyinjiao (SP 6), Guanyuan (CV 4), Shenshu (BL 23) and Zhongji (CV 3).

[LIU Zhi-shun's experience in treatment of infertility with decreasing ovarian reserve with electroacupuncture].

To summarize LIU Zhi-shun's clinical experience in treatment of infertility with decreasing ovarian reserve (DOR) with electroacupuncture. LIU Zhi-shun believes that the location of infertility with DOR is the uterus, mainly involving the kidney, thoroughfare and conception vessels. He advocates to select acupoints by combining "disease-symptom-position" with prescription, and selects acupoint prescription of Bushen Tiaochong Zhuyun included Guanyuan (CV 4), Zigong (EX-CA 1), Tianshu (ST 25), Sanyinjiao (SP 6), Ciliao (BL 32) and Zhongliao (BL 33) for electroacupuncture treatment. The key points of operation are accurate positioning and deep acupuncture, focusing on regulating mind and getting qi, adopting electroacupuncture treatment and low frequency stimulation and treating slowly for long-term disease.

[Acupuncture as adjuvant therapy for 32 cases of coronavirus disease 2019].

OBJECTIVE: To observe the clinical effect of acupuncture on coronavirus disease 2019 (COVID-19) based on the conventional treatment. METHODS: A total of 35 patients with COVID-19 of mild or ordinary type were involved (3 cases dropped off). Acupuncture was applied on the basis of western medicine and Chinese materia medica treatment. Dazhui (GV 14), Fengchi (GB 20), Kongzui (LU 6), Hegu (LI 4), etc. were selected as the main acupoints, the supplementary acupoints and the reinforcing and reducing manipulations were selected according to syndrome differentiation. Acupuncture treatment was given once a day, 5 times a week. On day 3 and day 7 of acupuncture, relief condition of the main symptoms was observed. Before acupuncture and on day 3 and day 7 of acupuncture, efficacy evaluation scale of TCM on COVID-19 (efficacy evaluation scale) score was recorded. The effects of different intervention time of acupuncture on patients' hospitalization time were compared, the understanding of acupuncture treatment of patients discharged from hospital was recorded, the clinical efficacy and safety of acupuncture treatment were evaluated. RESULTS: On day 3 and day 7 of acupuncture, the symptoms of lung system and non lung system were both relieved; the scores of efficacy evaluation scale were both decreased compared before acupuncture (P<0.05), and the efficacy evaluation scale score of day 7 of acupuncture were lower than day 3 of acupuncture (P<0.05). The average hospitalization time of patients received early acupuncture was shorter than late acupuncture (P<0.05). The total effective rate was 84.4% (27/32) on day 7 of acupuncture, which was higher than 34.4% (11/32) on day 3 of acupuncture (P<0.05). During the acupuncture treatment, there were neither adverse reactions in patients nor occupational exposures in doctors. The patients generally believed that acupuncture could promote the recovery of COVID-19 and recommended acupuncture treatment. CONCLUSION: On the basis of the conventional treatment, acupuncture can effectively relieve the clinical symptoms in patients with COVID-19, early intervention of acupuncture can accelerate the recovery process. Acupuncture has good safety, clinical compliance and recognition of patients.

[Minimal clinically important difference of the frequency of bowel movement for patients with chronic severe functional constipation treated with acupuncture].

OBJECTIVE: To estimate the minimal clinically important difference (MCID) of the frequency of bowel movement for the patients with chronic severe functional constipation treated with acupuncture so as to provide the evidence for the clinical decision. METHODS: In this study, 813 patients with chronic severe functional constipation treated with acupuncture in two previous randomized controlled trials were included. Through the anchor-based method (anchored by the item 28 "satisfaction with previous treatment" of the patient assessment of constipation-quality of life [PAC-QOL]) and the distribution-based method, the MCID of the weekly frequency of complete spontaneous bowel movement (CSBM) and spontaneous bowel movement (SBM) was analyzed statistically in the patients. RESULTS: The MCID of the mean weekly frequency of CSBM and SBM was 1.3 times and 1.6 times in patients with chronic severe functional constipation treated with acupuncture, respectively. CONCLUSION: The mean increase of the weekly CSMB is ≥ 1.3 times and that of SBM is ≥ 1.6 times after treatment when compared with the baseline respectively, suggesting the clinical significance.

Acupuncture for chronic sciatica: protocol for a multicenter randomised controlled trial.

BACKGROUND: Chronic Sciatica is a disabling condition causing considerable medical, social and financial implications. Currently, there is no recognised long-term effective treatment to alleviate sciatica. Acupuncture has been widely used for treating chronic pains with persistent analgesic effects. We aim to evaluate the efficacy and safety of acupuncture for chronic sciatica with follow-up in 52 weeks. METHODS AND ANALYSIS: This is a multicenter randomised sham-controlled trial. A total of 216 patients with chronic sciatica will be enrolled and randomly assigned to the acupuncture or sham acupuncture group. There will be 10 treatment sessions applied in 4 weeks with frequency decreased over time. Patients will complete follow-ups during 52 weeks. The primary outcomes are changes in leg pain intensity and disability from baseline to week 4. Secondary outcomes include back pain intensity, frequency and bothersomeness, quality of life, and global perceived effect. Adverse events will be recorded in detail. ETHICS AND DISSEMINATION: Ethical approval of this trial was granted from the ethics committee of Beijing University of Chinese Medicine and all study centres (No. 2020BZYLL0803). Written informed consent will be obtained from enrolled patients. Trial results will be disseminated in peer-reviewed publications. TRIAL REGISTRATION NUMBER: ChiCTR2100044585 (Chinese Clinical Trial Registry, http://www.chictr.org.cn, registered on 24 March 2021); preresults.

Effect of Electroacupuncture on Gut Microbiota in Participants With Knee Osteoarthritis.

A close relationship between knee osteoarthritis (KOA) and gut microbiota has recently been described. Herein, we aim to investigate the effect of electroacupuncture (EA) on gut microbiota in participants with KOA. We conducted a study of 60 participants with KOA and 30 matched healthy controls (HCs). Sixty participants were allocated to either EA group (n=30) or sham acupuncture (SA) group (n=30). Five obligatory acupoints and three adjunct acupoints were punctured in the EA group. Eight non-acupoints that were separated from conventional acupoints or meridians were used for the SA group. Participants in both groups received 24 sessions within eight weeks. Fecal microbial analyses by 16S ribosomal RNA gene sequencing were carried out after collecting stools at T0 and T8 weeks (Four samples with changed defecation habits were excluded). The results showed that both Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score (P=0.043) and NRS score (P=0.002) decreased more in EA group than those in SA group. Moreover, EA could reverse more KOA-related bacteria including Bacteroides, [Eubacterium]_hallii_group, Agathobacter and Streptococcus. The number of significantly different genera between KOA patients and HCs were less after EA treatment than that after SA treatment. This meant that EA modified the composition of the gut microbiome, making it closer to healthy people, while not significantly affecting the microbial diversity. Two genera including Agathobacter (P=0.0163), Lachnoclostridium (P=0.0144) were statistically increased than baseline in EA group (paired Wilcoxon rank sum test). After EA treatment, Bacteroides (P=0.0394) was more abundant and Streptococcus (P=0.0306) was significantly reduced in patients who demonstrated adequate response than in those with inadequate response (Wilcoxon rank-sum test). Spearman correlation test between gut microbe and KOA clinical outcomes indicated that Bacteroides and Agathobacter was negatively correlated with NRS score, WOMAC total score, and WOMAC pain, stiffness and pain scores (P<0.001 or 0.05 or 0.01), while Streptococcus was positively correlated with them (P<0.05 or 0.01). Our study suggests that EA contributes to the improvement of KOA and gut microbiota could be a potential therapeutic target.

Efficacy of Intensive Acupuncture Versus Sham Acupuncture in Knee Osteoarthritis: A Randomized Controlled Trial.

OBJECTIVE: To assess the efficacy of intensive acupuncture (3 times weekly for 8 weeks) versus sham acupuncture for knee osteoarthritis (OA). METHODS: In this multicenter, randomized, sham-controlled trial, patients with knee OA were randomly assigned to receive electroacupuncture (EA), manual acupuncture (MA), or sham acupuncture (SA) 3 times weekly for 8 weeks. Participants, outcome assessors, and statisticians were blinded with regard to treatment group assignment. The primary outcome measure was response rate, which is the proportion of participants who simultaneously achieved minimal clinically important improvement in pain and function by week 8. The primary analysis was conducted using a Z test for proportions in the modified intent-to-treat population, which included all randomized participants who had ≥1 post-baseline measurement. RESULTS: Of the 480 participants recruited in the trial, 442 were evaluated for efficacy. The response rates at week 8 were 60.3% (91 of 151), 58.6% (85 of 145), and 47.3% (69 of 146) in the EA, MA, and SA groups, respectively. The between-group differences were 13.0% (97.5% confidence interval [97.5% CI] 0.2%, 25.9%; P = 0.0234) for EA versus SA and 11.3% (97.5% CI -1.6%, 24.4%; P = 0.0507) for MA versus SA. The response rates in the EA and MA groups were both significantly higher than those in the SA group at weeks 16 and 26. CONCLUSION: Among patients with knee OA, intensive EA resulted in less pain and better function at week 8, compared with SA, and these effects persisted though week 26. Intensive MA had no benefit for knee OA at week 8, although it showed benefits during follow-up.

[Long-term efficacy and safety of electroacupuncture on improving MMSE in patients with Alzheimer's disease].

OBJECTIVE: To observe the efficacy and safety of electroacupuncture (EA) on improving mini-mental state examination (MMSE) in patients with Alzheimer's disease (AD), and to evaluate the efficacy during follow-up visit. METHODS: Forty patients were randomly divided into a treatment group and a control group, 20 patients in each one (3 patients dropped off in the treatment group and 4 patients in the control group). The patients in the treatment group were treated with acupuncture at Baihui (GV 20), Fengfu (GV 16), Shenting (GV 24), Taiyang (EX-HN 5), Shangyintang (Extra 3) and Dazhong (KI 14); besides, EA was applied at Taiyang (EX-HN 5), Baihui (GV 20) and Shenting (GV 24) with dilatational wave, 10 Hz/50 Hz in frequency, 0.5 to 5.0 mA in intensity, once every two days, three treatments per week. The patients in the control group were treated with oral administration of donepezil hydrochloride tablets, once a day, taken before sleep. The treatment was given for 12 weeks in the two groups. The MMSE was evaluated before treatment, 12 weeks±3 days into treatment, and 24 weeks±7 days after treatment, respectively. RESULTS: The difference of total score of MMSE before and 12 weeks±3 days into treatment was not significant between the two groups (P>0.05); the total score of MMSE after treatment was higher than that before treatment (both P<0.05); compared before treatment, the short-term memory score was increased in the treatment group (P<0.05), and the increasing range was superior to that in the control group (P<0.05). Compared before treatment, the total score of MMSE in the two groups were reduced 24 weeks ±7 days after treatment (both P<0.05), and the reduction in the treatment group was less than that in the control group (P<0.05); the differences of short-term memory score before and after treatment was significant between the two groups (P<0.05). No adverse reaction occurred in the two groups. CONCLUSION: The effect of EA on improving MMSE in patients with AD is similar to donepezil supported by evidence-based medicine. The effect of EA may have a certain continuous effect, and may have advantages in instantaneous memory. In addition, the EA is safe.

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

BACKGROUND: Knee osteoarthritis (KOA) is one of the most common musculoskeletal disorders. Although the available evidence for its efficacy is inconclusive, acupuncture is used as an alternative therapy for KOA. The aim of this trial is to determine the efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for KOA. METHODS/DESIGN: This is a study protocol for a randomised, three-arm, multicentre, clinical trial. A total of 480 patients with KOA will be randomly assigned to the electro-acupuncture group, the manual acupuncture group or the sham acupuncture group in a 1:1:1 ratio. All patients will receive 24 sessions over 8 weeks. Participants will complete the trial by visiting the research centre at week 26 for a follow-up assessment. The primary outcome is the success rate: the proportion of patients achieving a minimal clinically important improvement, which is defined as ≥2 points on the numerical rating scale and ≥6 points on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score at week 8 compared with baseline. Secondary outcomes include the numerical rating scale, WOMAC score, global patient assessment and quality of life at weeks 4, 8, 16 and 26 after randomisation. DISCUSSION: This trial may provide high-quality evidence for the efficacy of acupuncture in the treatment of KOA. The results of this study will be published in peer-reviewed journals. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03274713 . Registered on 20 November 2017.

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

After publication of the original article [1], the authors have notified us that the Trial registration number NCT03274713 should be replaced by NCT03366363 in the Abstract section of the paper.

A Multicenter, Randomized, Controlled Trial of Electroacupuncture for Perimenopause Women with Mild-Moderate Depression.

OBJECTIVE: Up to 62% of perimenopausal women have depression symptoms. However, there is no efficacy treatment. The aim of this study is to compare the clinical efficacy and safety of EA therapy and escitalopram on perimenopause women with mild-moderate depressive symptom. METHOD: A multicenter, randomized, positive-controlled clinical trial was conducted at 6 hospitals in China. 242 perimenopause women with mild-moderate depressive symptom were recruited and randomly assigned to receive 36 sessions of EA treatment or escitalopram treatment. The primary outcome measure was the 17-item Hamilton Depression Rating Scale (HAMD-17). The secondary outcome measures include menopause-specific quality of life (MENQOL) and serum sexual hormones which include estrogen, follicle-stimulating hormone, and luteinizing hormone. RESULTS: 221 (91.3%) completed the study, including 116 in the EA group and 105 in the escitalopram group. The baseline levels of demographic and outcome measurements were similar in the two groups. In the intervention period, there was no difference between two groups. However, in the follow-up, both HAMD-17 and MENQOL were significantly decreased, and at week 24 the mean differences were -2.23 and -8.97, respectively. There were no significant differences in the change of serum sexual hormones between the two groups. No serious adverse events occurred. CONCLUSION: EA treatment is effective and safe in relieving depression symptom and improving the quality of life in the perimenopausal depression. Further research is needed to understand long-term efficacy and explore the mechanism of this intervention. This study is registered with ClinicalTrials.gov NCT02423694.

Pivotal factors concerned in design of acupuncture clinical research: From two articles in JAMA.

Two randomized controlled trials of acupuncture concerning polycystic ovary syndrome (PCOS) and stress urinary incontinence (SUI) were published simultaneously in the 24th issue, 2017 of The Journal of the American Medical Association (JAMA). A trial involving PCOS indicated that active acupuncture did not increase live birth compared with sham acupuncture; meanwhile, another trial referring to SUI showed that electroacupuncture resulted in less urine leakage compared with sham electroacupuncture. With an eye to the negative and positive results of acupuncture, three pivotal factors should be contemplated: (1) proper illness for acupuncture, that is, a problem need to be solved in current medical science, and acupuncture may really work for it; (2) proper pre-studied primary outcome, which is better be objective and repeatedly measurable to reveal the therapeutic effect of acupuncture truly and objectively; (3) proper sham control, which can blind the patients to the upmost extent with minimal biological effects. Through the publication of clinical trials of acupuncture in high-impact journals in recent years, researchers should have confidence in their clinical trials by pondering over these three pivotal factors.

Electroacupuncture for patients with diarrhea-predominant irritable bowel syndrome or functional diarrhea: A randomized controlled trial.

Diarrhea-predominant irritable bowel syndrome (IBS-D) and functional diarrhea (FD) are highly prevalent, and the effectiveness of acupuncture for managing IBS-D and FD is still unknown.The aim of this study was to compare the effectiveness of electroacupuncture with loperamide.It was a prospective, randomized, parallel group controlled trial.A total of 448 participants were randomly assigned to He electroacupuncture group (n = 113), Shu-Mu electroacupuncture group (n = 111), He-Shu-Mu electroacupuncture group (n = 112), or loperamide group (n = 112). Participants in the 3 acupuncture groups received 16 sessions of electroacupuncture during a 4-week treatment phase, whereas participants in the loperamide group received oral loperamide 2 mg thrice daily. The primary outcome was the change from baseline in stool frequency at the end of the 4-weeks treatment. The secondary outcomes were the Bristol scale, the MOS 36-item short form health survey (SF-36), the weekly average number of days with normal defecations and the proportion of adverse events.Stool frequency was significantly reduced at the end of the 4-week treatment in the 4 groups (mean change from baseline, 5.35 times/week). No significant difference was found between the 3 electroacupuncture groups and the loperamide group in the primary outcome (He vs. loperamide group [mean difference 0.6, 95% CI, -1.2 to 2.4]; Shu-Mu vs. loperamide group [0.4, 95% CI, -1.4 to 2.3]; He-Shu-Mu vs. loperamide group [0.0, 95% CI, -1.8 to 1.8]). Both electroacupuncture and loperamide significantly improved the mean score of Bristol scale and increased the weekly average number of days with normal defecations and the mean scores of SF-36; they were equivalent in these outcomes. However, the participants in electroacupuncture groups did not report fewer adverse events than those in the loperamide group. Similar results were found in a subgroup analysis of separating patients with IBS-D and FD patients.Electroacupuncture is equivalent to loperamide for reducing stool frequency in IBS-D and FD patients. Further studies on cost effectiveness of acupuncture are warranted.

Efficacy of electroacupuncture in the treatment of functional constipation: A randomized controlled pilot trial.

OBJECTIVE: To evaluate the efficacy and safety of electroacupuncture at Tianshu (ST25) for patients with functional constipation (FC). METHODS: Ninety-six patients with FC were randomized to receive deep needling on bilateral ST25 (group A, 48 cases) or shallow needling on bilateral ST25 (group B, 48 cases) with electroacupuncture once daily for 4 weeks. The proportion of patients with four or more complete spontaneous bowel movements (CSBMs) per week, and scores of constipation symptoms and satisfaction with treatment were compared between two groups. Safety was also assessed. RESULTS: The proportion of patients with four or more CSBMs per week was 52.1% in group A, significantly higher than 25.0% in group B during the 4-week treatment (P<0.05). The constipation symptom score of patients were significantly improved in group A as compared with group B at week 2-4 (P<0.05). Patients in group A were more satisfied with their treatment compared with those in group B at week 1-4 (P<0.05). Five patients in group A felt significant pain and discomfort. No other adverse reaction was observed in both groups. CONCLUSION: Using electroacupuncture at ST25 to treat patients with FC is effectively, and deep needling had more stable effect than shallow needling.

[Comparison of efficacy on functional constipation treated with electroacupuncture of different acupoint prescriptions: a randomized controlled pilot trial].

OBJECTIVE: To evaluate preliminarily the efficacy on functional constipation treated with electroacupuncture of different acupoint prescriptions. METHODS: One hundred and four patients were randomized into a front-mu and back-shu points group (19 cases), a he-sea points group (34 cases), a he-sea, front-mu and back-shu points group (26 cases) and a western medication control group (25 cases). In the front-mu and back-shu points group, electroacupuncture was applied at bilateral Tianshu (ST 25) and Dachangshu (BL 25). In the he-sea points group, electroacupuncture was applied at bilateral Quchi (LI 11) and Shangjuxu (ST 37). In the he-sea, front-mu and back-shu points group, electroacupuncture was applied at unilateral Tianshu (ST 25), Dachangshu (BL 25), Quchi (LI 11) and Shangjuxu (ST 37). In the three groups above, the treatment was given 5 times a week in the first two weeks and 3 times a week in the next two weeks. In the western medication control group, mosapride citrate tablets were prescribed for oral administration, 1 table (5 mg) each time, 3 times a day, continuously for 4 weeks. The period of research was 9 weeks, including 1 week for baseline evaluation, 4 weeks for treatment and 4 weeks for follow-up. The weekly defecation frequency was taken as primary index, while the defecation difficulty and life quality score were taken as the secondary indices for the efficacy evaluation after treatment and in follow-up. RESULTS: According to the intention-to-treat (ITT) analytic principle, 104 cases were all enrolled in the final analysis. (1) After treatment, the weekly frequency of defecation was all increased significantly in the four groups (P < 0.05, P < 0.01). The efficacy of the three electroacupuncture groups was similar to that of western medication control group (P > 0.05). In follow-up, the increasing effect on the weekly frequency of defecation was maintained in the he-sea points group (P < 0.01), superior to the front-mu and back-shu points group and the western medication control group (P < 0.05, P < 0.01); the weekly frequency of defecation was not improved in the rest three groups (P > 0.05). (2) After treatment, defecation difficulty was relieved in the he-sea points group, the he-sea, front-mu and back-shu points group and the western medication control group (P < 0.05, P < 0.01). In follow-up, the improvements were still significant in the he-sea points group and the he-sea, front-mu and back-shu points group (both P < 0.01). (3) After treatment, the life quality score was significantly improved in the patients of the he-sea points group (P < 0.05). The difference was not significant in the rest three groups as compared with that before treatment (all P > 0.05). CONCLUSION: The weekly frequency of defecation is increased effectively after treatment in the three electroacupuncture groups and the efficacy is similar to mosapride citrate tablets. The bilateral Quchi (LI 11) and Shangjuxu (ST 37) in he-sea acupoints increase significantly the weekly frequency of defecation, relieve defecation difficulty and improve life quality. Acupuncture efficacy is sustained for 4 weeks. This acupoints prescription is the best in the treatment of functional constipation.

[On-site quality control of acupuncture randomized controlled trial: design of content and checklist of quality control based on PICOST].

To effectively guarantee quality of randomized controlld trial (RCT) of acupuncture and develop reasonable content and checklist of on-site quality control, influencing factors on quality of acupuncture RCT are analyzed and scientificity of quality control content and feasibility of on-site manipulation are put into overall consideration. Based on content and checklist of on-site quality control in National 11th Five-Year Plan Project Optimization of Comprehensive Treatment Plan for TCM in Prevention and Treatment of Serious Disease and Clinical Assessment on Generic Technology and Quality Control Research, it is proposed that on-site quality control of acupuncture RCT should be conducted with PICOST (patient, intervention, comparison, out come, site and time) as core, especially on quality control of interveners' skills and outcome assessment of blinding, and checklist of on-site quality control is developed to provide references for undertaking groups of the project.