This study is designed to run an RCT on ACE for AO. Ninety-two participants will be recruited from outpatient at the Kunming Municipal Hospital of Traditional Chinese Medicine and The Sports Trauma Specialist Hospital of Yunnan Province between 2018 and 2020. Patients will be randomly assigned equally to the acupoint group and sham group. The trial will be conducted once every two weeks, three times for one course. There will be a total of two courses in the whole treatment, and a follow-up will be performed. The assessment of outcomes will be carried out at the end of each course. The flow chart of the trial is shown in figure 1and the study period is shown in table 1.
Participants who meet all the following criteria can be included: (1) aged between 18 and 60 years old with simple obesity and without gender differences; (2) BMI between 28–39.9kg/m2, male WC≥90cm, female WC≥80cm ;(3) agreed to participate in this study and signed written informed consent for this trial and catgut embedding therapy; (4) did not participate in other trials within past 3 months.
Participants will be excluded from one of the following items: (1) BMI≥40 kg/m2; (2) secondary obesity, such as obesity caused by endocrine disease (Cushing syndrome, thyroid disease, hypothalamic disease, pituitary disease, gonadal disease, etc.) and medication (glucocorticoid or antipsychotics); (3) pregnancy, lactation and childbirth within past 6 months; (4) heart disease, hematopoietic system, liver, kidney and other important organ diseases; hypertension without effectively controlled; (5) patients with severe mental and neurological diseases who are unable or unwilling to cooperate; (6) allergic to alcohol and animal protein or immune diseases; received other weight loss treatment within past 3 months.
Criteria for elimination
Those who meet the following criteria should be expelled: (1) misdiagnosis and misrepresentation; (2) poor treatment tendency; (3) involved with other treatment after selected; (4) participants’ withdrawal before the first test recording.
The randomized method uses central randomization and is undertaken by the Center for Clinical Research, Yunnan University of Traditional Chinese Medicine, for central randomization and data management. The data center administrators of each medical center can apply for random treatment allocation to the Central Randomization System of Yunnan University of Traditional Chinese Medicine by mail. The random center will report the randomly assigned information of the selected cases to the medical center data administrators via email. Each medical center data administrator collects the e-mail about the random allocation information and checks the information, prints the randomly assigned e-mail, and forwards it to the operator to paste it on the back of the case observation form.
Because of the selected participants has less knowledge of acupoint and they cannot distinguish accurately acupoint and sham, so they did not know which group they have been. As the generation and distribution of the random number are operated by the center, the acupuncture doctors, outcome assessors and statistical evaluators will be blinded. Concealment will keep until the trial is complete.
According to the existing literature , the mean BMI of simple obesity is 32.30kg/m2, while after 12 weeks and 6 times treatment of acupuncture combined with low energy diet, the mean BMI is 30.98kg/m2, and the improvement value was 1.32 kg/m2. In the meantime, the improvement value is 1.02 kg/m2 in control group with the variation from 32.74 kg/m2 to 31.73 kg/m2 treated by sham acupuncture combined with low energy diet with, and the deviation value of the two groups is 0.31kg/m2. In this project, the expected improvement value of the mean BMI of shu-mu point embedding group after treatment is 1.14kg/m2, and that of non-acupoint embedding group is 0.9kg/m2, with the standard deviation of each group is 0.31kg/m2. The significant level is ɑ = 0.05, the power of a test is 1-β = 0.95. The sample size is 84 with F test using German G*power software3.1.24 According to 10% drop out, the total sample is 92 cases, and 46 cases will be assigned to each group.
Shu-mu point group
The trial adopted the combination of back-shu and front-mu, the points are BL20(Pishu), BL21(Weishu), BL25(Dachangshu), RN12(Zhongwan), ST25(Tianshu), LR13(Zhangmen), only one side of Zhongwan, a total of 11 points. The location of these points is shown in Table 2 and Figure 2 Marked as black points.
The study chooses six points besides the shu-mu point as non-acupoints, and they are labelled NA1, NA2, NA3, NA4, NA5 and NA6. These acupoints are taken from both sides (except NA4), with a total of 11. The location of these points is shown in table 3 and figure 2 Marked as red points.
The thread-embedding needle used in this study is 8# disposable needle (Jiangxi glance medical equipment co. Ltd. Production), and the medical protein string is an absorbable collagen line with the specification of 2–0, 2cm*20 length (Jiangxi longteng biotechnology co. LTD).
All acupoint embedding manipulations are performed by doctors with national medical qualifications. The specific manipulation is as follows: the patient was placed in an appropriate position, and the acupoint skin was routinely disinfected. Take a sterile protein string with a length of 1–2cm (the length depends on the location of the acupoint), placed it on the front end of the trocar, then connect the needle core, lifted the partial skin with the thumb and forefinger of one hand, pierced the needle with the other hand. When the piercing reaches the desired depth, apply appropriate push-and-twist techniques, then the needle core was pushed and the needle tube removed, implant the sterile protein string in the subcutaneous tissue or muscle layer of the acupoint. After removing the needle, pressed the needle hole with a dry cotton ball for half a minute to stop bleeding. Meanwhile, check that there is no thread residue exposure, no bleeding, and then paste a bandage to protect the needle hole. It is recommended that patients did not take a bath for 24 hours and keep the embedding place dry.
Postoperative reaction and treatment of acupoint embedding
Some patients will have some reactions after ACE. Due to the stimulation of injury and catgut, local aseptic inflammation reaction may occur within 1–5 days, such as redness, swelling, fever and pain. A small number of patients will have a serious reaction, the wound will ooze out in a small amount. This is normal and generally does not need to be dealt with. If patients have more exudate and the skin surface is convex, they can squeeze out all the milky white exudate, dry it with 75% alcohol cotton ball and cover with sterile gauze. Postoperative patients may experience local temperature rise for 3–7 days. A few patients may have elevated body temperature, usually around 38°C，without local infection. The body temperature will return to normal after 2–4 days. All of these are normal postoperative reactions. However, individual patients may have some adverse reactions that need to be addressed accordingly. A small number of patients are infected with the nonstandard operation and improper wound protection by doctors, resulting in local redness, swelling and increased pain. They need local hot compress and anti-inflammation treatment. Some patients may be allergic to catgut, with allergic reactions such as local redness, pruritus, fever, even catgut overflow, fat liquefaction of the wound, etc. They should be given appropriate anti-anaphylactic treatment. Very few people may suffer from nerve damage. Sensory nerve injury can cause skin sensory disturbance in the nerve distribution area, and the dominant nerve group paralyzed will appear in the motor nerve injury. In the case of this, the catgut should be taken out with operation in time, and given appropriate treatment.
The outcomes of this study will be evaluated before treatment, after 1 course, 2 courses of treatment and after follow up. At the same time, the treatment times and shedding cases will be recorded to assess patient compliance. The primary outcomes are weight and waist circumference (WC). The secondary outcomes are BMI, hip circumference (HC), Quality of Life Scale (SF–36), Zung Self-Rating Anxiety Scale (SAS) and the Zung Self-Rating Depression Scale (SDS).
All data will be analyzed by SPSS 19.0 statistical software (IBM SPSS Statistics, New York, NY, USA). Measurement data will be shown as the means ± standard deviation (M ± SD). A paired t-test will be used to compare before and after the intervention of catgut embedding. Covariance analysis will be used to compare the data of multiple groups of sample data. The baseline indicators will be used as covariant and the center will be used as a correction factor. Least Significant Difference (LSD) test will be used to a pairwise comparison between groups, and p<0.05 will be considered the statistically significant difference.