Efficacy of manual acupuncture versus placebo acupuncture for generalized anxiety disorder (GAD) in perimenopause women: study protocol for a randomized controlled trial

Background Generalized anxiety disorder (GAD) is common among perimenopausal women. Acupuncture may be an effective treatment for GAD, but evidence is limited. The pathogenesis of GAD is not yet clear, but it is related to the hypothalamic-pituitary-adrenal axis and its excretion, cortisol (CORT), and adrenocorticotropic hormone (ACTH). The object of this study is to evaluate the efficacy of manual acupuncture (MA) versus placebo acupuncture (PA) for perimenopausal women with GAD. Methods This study is a single-center, randomized, single-blind clinical trial that will be conducted in the First Affiliated Hospital of Guangzhou University of Chinese Medicine. A total of 112 eligible GAD patients will be randomly assigned (1:1) to receive MA (n=56) or PA (n=56) three times per week for 4 weeks. The primary outcome measure will be the HAMA score. The secondary outcome measures will be the GAD-7 and PSQI scores and the levels of CORT and ACTH. The evaluation will be executed at baseline, 2 weeks, the end of the treatment, and a follow-up 3-month period. All main analyses will be carried out based on the intention-to-treat (ITT) principle. Discussion This study intends to compare the efficacy between MA and PA in the treatment of perimenopausal women with GAD and to further study the mechanisms underlying the effect. Trial registration Chinese Clinical Trial Registry ChiCTR2100046604. Registered on 22 May 2021.

Efficacy of Manual Acupuncture Versus Placebo Acupuncture for Generalized Anxiety Disorder (Gad) in Perimenopause Women : Study Protocol for a Randomized Controlled Trial

BackgroundGeneralized anxiety disorder (GAD) is common among perimenopause women. Drug treatment and cognitive behavioral therapy have their pros and cons. Acupuncture may be an effective treatment for GAD, but evidence is limited. The pathogenesis of GAD is not yet clear, but it is related to hypothalamic-pituitary-adrenal axis and its excretion, cortisol (CORT) and adrenocorticotropic hormone (ACTH). The object of this study is to assess the efficacy of manual acupuncture (MA) versus placebo acupuncture (PA) for perimenopause women with GAD. MethodsThis study is a single center, randomized, double blind clinical trial that will be conducted in the First Affiliated Hospital of Guangzhou University of Chinese Medicine. A total of 112 eligible GAD patients will be randomly assigned (1:1) to receive MA (n=56) or PA (n=56) three times per week for four weeks. The primary outcome measure will be the score of GAD-7. The secondary outcome measures will be the score of HAMA and PSQI, and the level of CORT and ACTH. The evaluation will execute at baseline, 2 weeks, the end of the treatment and a follow-up period. All main analyses will be carried out based on the intention-to-treat (ITT) principle. DiscussionThis study intends to conduct to compare the efficacy between MA and PA in the treatment of perimenopause woman with GAD, and to further study the mechanisms of effect. Trial registrationChinese Clinical Trial Registry, ID: ChiCTR2100046604. Registered on 22 May 2021. URL: http://www.chictr.org.cn.

Manual Acupuncture As Prophylaxis For Migraine Without Aura: Study Protocol For A Multi-Center, Randomized, Single Blinded Trial

Background: Migraine is a highly prevalent neurological disorder. It is the third most prevalent disorder and the seventh highest cause of disability worldwide. Acupuncture may be a viable prophylactic treatment option for frequent or uncontrolled migraine. Clinical studies comparing acupuncture and placebo acupuncture have not reached a consistent conclusion in confirming whether acupuncture is effective in migraine prophylaxis. The effect of acupuncture mainly depends on acupoints and needles operation. We found that the design of the placebo acupuncture in previous studies included shallow needling at sham acupoints, non-penetrating needling at sham acupoints, and needling at inactive acupuncture points to achieve the inert effect of control group, but the non-penetrating needling at true acupoints was ignored. This randomized controlled trial aims to use true acupoints for non-penetrating acupuncture as control to evaluate the efficacy of manual acupuncture for the prophylaxis of migraine without aura (MWoA).Methods/design: This is a single-blinded, randomized, controlled, prospective, multi-center trial with two parallel treatment groups. A total of 198 eligible patients with MWoA will be randomly divided into two groups (1:1 allocation ratio). The intervention group will receive manual acupuncture and the control group will receive placebo acupuncture (non-penetrating). Patients will receive three acupuncture treatment sessions per week for 4 consecutive weeks. All patients will then receive a 12-week follow-up.Discussion: In this study, we are evaluating the efficacy and safety of manual acupuncture in the prophylaxis of MWoA. The placebo control is using non-penetrating needling verum acupoints. It is essential to determine an appropriate control method to ensure the methodological quality of a randomized controlled trial.Trial registration: The trial has been registered in the Chinese Clinical Trial Registry (Approval No. ChiCTR2000032308) in April 2020.

Acupuncture versus placebo acupuncture for in vitro fertilisation: a systematic review and meta-analysis

Objective: To evaluate the efficacy of acupuncture compared to placebo acupuncture for women undergoing in vitro fertilisation (IVF) in a systematic review and meta-analysis. Methods: A search was conducted in seven English-language biomedical databases from their inception to 3 April 2019 to identify studies evaluating acupuncture as an adjunct to IVF treatment. Randomised controlled trials (RCTs) that compared acupuncture with placebo acupuncture using a non-invasive placebo acupuncture device in women undergoing a fresh or frozen IVF cycle were eligible, as were studies that tested placebo acupuncture as the intervention. Outcomes were clinical pregnancy rate, ongoing pregnancy rate, miscarriage rate, live birth rate and adverse events. Results: Eight RCTs involving 3607 women were included. Studies were judged to be low risk for most of the risk of bias domains. Acupuncture around the time of embryo transfer was not significantly different to placebo acupuncture in terms of the clinical pregnancy rate (6 RCTs, 2473 women, risk ratio (RR) = 0.99 (95% confidence interval (CI) = 0.88, 1.11), I2 = 51%, moderate certainty evidence), ongoing pregnancy rate (4 RCTs, 1459 women, RR = 0.88 (95% CI = 0.75, 1.02), I2 = 50%, moderate certainty evidence), miscarriage rate (4 RCTs, 502 women, RR = 1.23 (95% CI = 0.89, 1.71), I2 = 30%, high certainty evidence) or live birth rate (4 RCTs, 1835 women, RR = 0.87 (95% CI = 0.75, 1.01), I2 = 0%, high certainty evidence). Outcomes with placebo acupuncture were not significantly different to usual care. Adverse events relating to acupuncture, such as discomfort and bruising, were mild to moderate. Conclusion: Acupuncture administered around the time of embryo transfer did not have a statistically significant effect on IVF outcomes compared with placebo acupuncture.

Acupuncture for Relief of Gag Reflex in Patients Undergoing Transoesophageal Echocardiography—A Protocol for a Randomized Placebo-Controlled Trial

Background: Gagging during transesophageal echocardiography examination (TEE) can be distressing and even dangerous for patients. The needling of acupuncture point CV24 was described to be effective in reducing the gag reflex during TEE in patients with ischemic stroke or transient ischemic attack. Methods: We describe a proposal for a prospective, randomized, patient, practitioner and assessor-blinded, single-center trial with two arms/groups; real acupuncture will be compared to placebo acupuncture. A total of 60 (30 per group) patients scheduled for elective TEE in order to exclude a cardiac embolic source, endocarditis or for valve failure evaluation will be recruited according to patients’ selection criteria and receive either indwelling fixed intradermal needles at acupoints CV24 and bilateral PC6 or placebo needles at the same areas. Patients, the practitioners who will perform the TEE procedure, and the assessor of the outcome measures will be unaware of the group’s (real or placebo) allocation. Results: The primary outcome is the intensity of gagging, measured using verbal rating scale (VRS-11) from 0 = no gagging to 10 = intolerable gagging. Secondary outcomes include the incidence of gagging, the use of rescue medication, patients’ satisfaction with relief of unwanted side effects during TEE procedure, success of patients’ blinding (patients’ opinion to group allocation), heart rate and oxygen saturation measured by pulse oxymetry. Conclusions: To study the effects of acupuncture against gagging during TEE, we test the needling of acupoints CV24 and PC6 bilaterally. A placebo acupuncture is used for the control group. Trial registration number: NCT NCT0382142.

Acupuncture for insomnia with short sleep duration: protocol for a randomised controlled trial

IntroductionInsomnia with short sleep duration has a more serious negative impact on patient health. The existing literature suggests that medication therapy is more effective for this phenotype of insomnia compared with cognitive–behavioural therapy. However, the potential side effects of hypnotic medications hinder their clinical application. Acupuncture has been widely used in the treatment of insomnia, but it remains unclear whether it has therapeutic efficacy for insomnia with short sleep duration. The purpose of this trial is to evaluate the efficacy and safety of acupuncture for insomnia with short sleep duration.Methods and analysisThis study is designed as a randomised, single-centre, single-blinded, placebo acupuncture controlled trial involving 152 participants. Eligible patients will be divided into two groups according to the objective total sleep time: insomnia with normal sleep duration group and insomnia with short sleep duration group. Then, patients in each group will be randomly assigned to two subgroups, the treatment group (acupuncture) and the control group (placebo acupuncture), in a 1:1 ratio with 38 subjects in each subgroup. The primary outcome is the Pittsburgh Sleep Quality Index and the Insomnia Severity Index. Secondary outcomes are actigraphy, the Beck Anxiety Inventory, the Beck Depression Inventory and the Fatigue Severity Scale. All adverse effects will be assessed by the Treatment Emergent Symptom Scale. Outcomes will be evaluated at baseline, post treatment, as well as at 1-week and 1-month follow-up.Ethics and disseminationThis protocol has been approved by the ethics committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine (no. 2019-17). Written informed consent will be obtained from all participants. The results will be disseminated through peer-reviewed journals for publications.Trial registration numberChiCTR1900023473; Pre-results.

The selection of dermatomes for sham (placebo) acupuncture points is relevant for the outcome of acupuncture studies: a systematic review of sham (placebo)-controlled randomized acupuncture trials

Background: Many randomized controlled trials (RCTs) of acupuncture reveal no significant differences between acupuncture and so-called placebo acupuncture. There is a strong tendency to replace the term “placebo” by the term “sham,” because any needling stimulates a certain physiological response. However, neither concept accounts for the great diversity of results in RCTs comparing verum acupuncture and sham (placebo) acupuncture. Some trials have shown little or no difference, while other studies have found statistically significant differences. Objective: Verum acupuncture and sham (placebo) acupuncture may achieve similar results to the extent that they share active constituents. We identified these common active constituents as dermatomes: the segmental structure of the human body. In our study, we tested the hypothesis that the more verum and sham (placebo) acupuncture share the same dermatomes, the closer the clinical outcomes will be, and vice versa. Methods: All major databases were searched for RCTs that tested acupuncture versus sham (placebo) acupuncture. The dermatome charts of Hansen and Schliack were used to verify verum and sham (placebo) needling locations. Reported clinical outcomes were assessed in relation to the percentage of overlap between the dermatomes stimulated by acupuncture and sham (placebo) acupuncture. Results: Our literature search yielded a total of 1738 references. Thirty-four studies met the inclusion criteria. The effects of sham (placebo) acupuncture varied according to the dermatomes stimulated: high overlap with those stimulated by verum acupuncture resulted in almost identical efficacy, while low overlap resulted in significant differences in efficacy. Clinical outcomes were similar when verum acupuncture and sham (placebo) acupuncture shared the same dermatomes (p < 0.01). Discussion: The findings of this review confirm our hypothesis. Acupuncture studies that employed verum and sham locations on overlapping dermatomes helped to create a mediocre to negative picture of acupuncture’s efficacy. The segmental structure of the body with its interconnected reflex system offers an additional neurophysiological explanation for the effectiveness of acupuncture applied to structures segmentally innervated by the spinal and visceral nervous system. Further comparative acupuncture studies should be based on knowledge of segmental anatomy. In testing verum acupuncture versus sham acupuncture, the chosen sham acupuncture needling locations should be situated on non-overlapping dermatomes.