[Ethics review characteristics of clinical research of acupuncture and moxibustion].

The elements of ethical review related to clinical research of acupuncture and moxibustion is discussed to provide ideas for various institutions to carry out relevant ethical review. It is believed that the ethical review of clinical research of acupuncture and moxibustion needs to focus on the specificity of acupuncture and moxibustion. Starting from the basic theory of traditional Chinese medicine, the theory of meridians and acupoints and the theory of syndrome differentiation along meridians, the key contents of ethical review such as intervention methods, grouping design and placebo control should be considered, so as to standardize the clinical research of acupuncture and moxibustion and protect the health and rights and interests of participants.

[Discussion of optimization of sham acupuncture setting based on a clinical trial about acupuncture treatment of migraine published in British Medical Journal].

In the randomized controlled clinical trials of acupuncture, the setting of the control group (sham acupuncture) directly affected the interpretations about their outcomes (beyond placebo), and has been being the hot spot and difficult problem. In the present paper, we discussed various types of sham acupuncture (invade and non-invade needling) commonly used nowadays and made an in-depth analysis on the factors contributing to the successful blinding to patients with episodic migraine without aura in a clinical study published in British Medical Journal (2020, 368:m697). Moreover, we put forward some thoughts on how to optimize the setting of sham acupuncture in the treatment of pain diseases. These thoughts are 1) setting different placebo control group for different types of pain, 2) selecting conventional acupoints not associated with the disease, 3) selecting the most sui-table type of placebo acupuncture through pre-tests, 4) choosing the distal non-meridian and non-acupoint not in the same neuronal segment with the pain locus when using non-invade consolation needling, 5) trying best to reduce the patients' doubts about placebo acupuncture operation, 6) selecting subjects with little or without acupuncture experience for multicenter studies, and 7) trying best to select objective indicators and to avoid the subjects' report bias when evaluating the effects of acupuncture and consolation acupuncture.

Comparative effect of electroacupuncture with different frequency on headache attacks in migraine outpatients: study protocol for a randomised placebo-controlled trial.

BACKGROUND: Headache attacks severely impaired life quality and increase the economic burden of migraineurs. Electroacupuncture (EA) has been used worldwidely to treat several pain-related diseases including migraines. However, whether EA with low or high frequency exerts a distinct analgesic effect remains unknown and needs further study. METHODS/DESIGN: This study is a randomised, single-blinded, placebo-controlled trial with three parallel arms. A total of 144 migraine outpatients will be randomly allocated to the 2 Hz EA group, 100 Hz EA group and placebo control group. The duration of the trial is 20 weeks, including a 4-week-long baseline assessment period (weeks - 4-0), a 4-week-long treatment period (weeks 1-4) and a 12-week-long follow-up period (weeks 5-16). Twelve treatment sessions will be performed over a 4-week period (weeks 1-4). The primary outcome will be measured by the frequency of migraine attacks in the past 4 weeks at the end of week 4 post-randomisation. The secondary outcome will be measured by the frequency of migraine attacks in the past 4 weeks at the end of weeks 8, 12 and16 post-randomisation; number of days with migraine; dosage of ibuprofen; the scores of visual analogue scale (VAS); Self-Rating Anxiety Scale (SAS); Self-Rating Depression Scale (SDS); and Migraine Specific Quality of Life questionnaire (MSQ) in the past 4 weeks at the end of weeks 4, 8, 12 and 16 post-randomisation. Safety assessment, compliance and blinding evaluation will be carried out at the end of week 16 post-randomisation. DISCUSSION: The recruitment will be started on 1 June 2021 and expected to finish on 31 May 2023. We aimed to clarify the dominant frequency of EA on headache attacks in a migraineur. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR-1800017259 . Registered on 20 July 2018.

Electroacupuncture Might Promote the Spontaneous Resorption of Lumbar Disc Herniation: A Case Report.

BACKGROUND: Although acupuncture is effective in the treatment of lumbar disc herniation (LDH), based on comprehensive literature review, reports of the resorption of large herniated discs in LDH patients treated merely by acupuncture are very rare. CASE REPORT: A 49-year-old patient presented with distending pain in the left lower limb and numbness on the dorsum of the left foot. Physical examination revealed positive signs associated with mechanical compression by herniated lumbar discs. Magnetic resonance imaging (MRI) at symptom onset confirmed the diagnosis of LDH at L4-L5 and L5-S1. Electroacupuncture was administered on local acupoints combined with distal acupoints. His clinical symptoms gradually improved with time throughout acupuncture treatment, verified by increased Japanese Orthopaedic Association scores. The patient was discharged after a total of 20 acupuncture sessions within 1 month. Follow-up indicated that his symptoms had disappeared completely at 1.5 months after discharge and had not recurred since then. At the 10-month follow-up, MRI re-examination confirmed that the herniated discs had been resorbed significantly. CONCLUSION: Electroacupuncture could significantly improve clinical symptoms and might promote the spontaneous resorption of herniated discs in LDH patients. Thus, for LDH patients suitable for conservative treatment, electroacupuncture could be a favourable option recommended to patients.

[Herb-separated moxibustion on dysmenorrhea in ovarian endometriosis: a randomized controlled trial].

OBJECTIVE: To observe the clinical therapeutic effect of herb-separated moxibustion on dysmenorrhea in ovarian endometriosis. METHODS: A total of 54 patients with ovarian endometriosis dysmenorrhea were randomized into a herb-separated moxibustion group and a waiting-list group, 27 cases in each one (3 cases dropped off in the herb-separated moxibustion group, 4 cases dropped off in the waiting-list group). Herb-separated moxibustion was applied at hypogastrium and lumbosacral area for 30 min in the herb-separated moxibustion group, once a week for 3 months, and oral ibuprofen sustained-release capsule was given to relieve pain when necessary. Excepting giving ibuprofen sustained-release capsule when necessary, no more intervention was adopted in the waiting-list group. Before and after treatment and in 3 months follow-up, visual analogue scale (VAS) score, days of dysmenorrhea, total dose of oral painkiller were observed. RESULTS: Compared before treatment, the VAS scores after tratment and in follow-up were decreased in the herb-separated moxibustion group (P<0.05), and were less than those in the waiting-list group (P<0.05); the days of dysmenorrhea and the total doses of oral painkiller after tratment and in follow-up were decreased in the herb-separated moxibustion group (P<0.05), and were less than those in the waiting-list group (P<0.05). CONCLUSION: Herb-separated moxibustion can effectively improve dysmenorrhea symptom and shorten dysmenorrhea days in patients with ovarian endometriosis.

[Analysis on the dominant diseases treated with spreading moxibustion therapy based on randomized controlled trials].

OBJECTIVE: To analyze the indications and dominant diseases of the spreading moxibustion therapy. METHODS: By retrieving 7 databases of both Chinese and English version, such as CNKI, WANFANG, VIP and PubMed, the eligible articles of randomized controlled trials (RCTs) treated with spreading moxibustion therapy were collected. The number of annual publications, the number of each disease system, the indications and dominant diseases involved in the related articles were analyzed statistically, as well as the number of cases and the corresponding clinical effective rates. RESULTS: A total of 182 articles were included, including 40 indications for the spreading moxibustion and covering 9 major disease systems. Specially, the indications in the motor system were maximal in number, accounting for 17.50% (7/40) of the total number of indications. The number of indications in the digestive system was on the second top, accounting for 15.00% (6/40). The dominant diseases were mainly distributed in motor system, respiratory system, nervous system and gynecological system. There were 3 dominant diseases in motor system, i.e. ankylosing spondylitis, back pain and rheumatoid arthritis; 1 dominant disease, i.e. chronic obstructive pulmonary disease in the respiratory system, 1 dominant disease, i.e. primary dysmenorrheal in the gynecological system and 1 dominant disease, i.e. post-stroke paralysis in the nervous system. CONCLUSION: At present, the indications of the spreading moxibustion therapy are widely distributed and the dominant diseases are concentrated, representatively by ankylosing spondylitis. But, the indications and the dominant diseases of spreading moxibustion are changeable dynamically and the disease spectrum of spreading moxibustion needs to be further explored.