Study design
This is a randomized, participant-blind trial. Ninety-two participants will be recruited from outpatient at 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 by sealed envelopes with random numbers. The treatment will be conducted once every two weeks, three times for one course. Each patient will have a two treatment courses and one time of follow up after three weeks of the second course. The assessment of outcomes will be performed before treatment at the end of each treatment course and after the follow-up period. The flow chart of this trial is shown in figure 1 and the study period is shown in table 1.
Participants
Inclusion criteria
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≥28kg/m2, male WC≥90cm, female WC≥85cm(q7) [22]; (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.
Exclusion criteria
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.
Randomization
The randomized method uses central randomization and is undertaken by the Center of Clinical Research of Yunnan University of Traditional Chinese Medicine. Random number of allocation sequence will be computer-generated with the SPSS 19.0 software (IBM SPSS Statistics, New York, NY, USA). All eligible patients will be randomly assigned to the shu-mu point embedding group and non-acupoint embedding group in a 1:1 ratio. The random center will report the randomly assigned information of the selected cases to the medical center data administrators via e-mail. 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.
Blinding
Due to the nature of acupuncture, blinding of acupuncturist is impossible. Patients blinding is feasible because of the selected participants has less knowledge of acupoint and they cannot distinguish accurately acupoint and sham point. Outcome assessors, statistical evaluators and outcome interpreters will also be blinded. Concealment will keep until the trial is complete.
Sample size
According to the existing literature [23], 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 of 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.
Interventions
Shu-mu point group
The trial will adopte the combination of back-shu and front-mu, and 11 points will be used. They are BL20(Pishu), BL21(Weishu), BL25(Dachangshu), RN12(Zhongwan), ST25(Tianshu), LR13(Zhangmen) on both sides, and Zhongwan on only on side. The location of these points is shown in Table 2 and Figure 2 Marked as black points.
Non-acupoint group
The study chooses 11 points besides the shu-mu point as non-acupoints, and they are labelled NA1, NA2, NA3, NA6, NA5 on both sides and NA4 on one side. The location of these points is shown in table 3 and figure 2 and they are marked as red points.
Operation instruments
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 specially made of 2-0, 2cm*20 length (Jiangxi longteng biotechnology co. LTD).
Manipulation
All acupoint embedding manipulations are performed by well-trained doctors. The specific manipulation is as follows: the patient will be placed in an appropriate position, and the acupoint skin will be routinely disinfected. Take a sterile protein string with a length of 1-2cm (the length depends on the location of the acupoint), place it on the front end of the trocar, then connect the needle core, lift the partial skin with the thumb and forefinger of one hand, pierce the needle with the other hand. When the piercing reaches the desired depth, apply appropriate push-and-twist techniques, then the needle core will be pushed out and the needle tube will be removed, and the sterile protein string will be implanted in the subcutaneous tissue or muscle layer of the acupoint. After removing the needle, press the needle hole with a dry cotton ball for half a minute to prevent 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 do not take bath in 24 hours and the embedding place should be kept 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 relatively serious reaction, the wound will be a small amount of leakage. 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 fall back 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. Some patients may be allergic to catgut. Symptoms including 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 damages. Sensory nerve injury can cause skin sensory disturbance in the nerve distribution area, and motor nerve injury will result in paralysis of dominant nerve group. In this case, the catgut should be taken out in time, and patient will have appropriate treatment.
Outcomes
The outcomes will be evaluated before treatment, after each course 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).
Statistical analysis
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.