ABSTRACT
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.
Subject(s)
Acupuncture Therapy , Biomedical Research , Ethical Review , Moxibustion , Acupuncture Points , Humans , MeridiansABSTRACT
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.
Subject(s)
Acupuncture Therapy , Acupuncture , Migraine Disorders , Acupuncture Points , Humans , Migraine Disorders/therapyABSTRACT
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.