Study design
The foregone study was undertaken between July 2018 and March 2020, without the gender requirement (n = 137). With the supplemented female samples (n = 22) between April 2020 and June 2022. Eighty AO patients received Shu-mu ACE intervention and 79 AO participants received non-acupoints catgut embedding (NACE) intervention. Finally, 71 participants (MA subgroup 35, SA subgroup 36) who received Shu-mu ACE and 74 participants (MA subgroup 31, SA subgroup 43) who received NACE were included in this secondary analysis. Every participant received a 12-week intervention period and a 4-week follow-up. Appetite was measured at baseline, 6, 12, and 16 weeks after the intervention. Possible adverse events were carefully monitored from 1 to 16 weeks. The flow chart was shown in Fig. 1.
This study was registered in Chinese Clinical Trial Registry (ChiCTR1800016947). Ethics was approved by the Hospital Ethics Committee of Sports Trauma Specialist Hospital of Yunnan Province (2018CK-001). All participants were fully informed and signed written informed consent forms.
Participant
All participants were recruited from the outpatient department in 4 Chinese clinical centers: Second Affiliated Hospital of Yunnan University of Chinese Medicine, Kunming Hospital of Traditional Chinese Medicine, Sports Trauma Specialist Hospital of Yunnan Province and ShengAi Hospital of Traditional Chinese Medicine.
According to the diagnostic criteria of AO by Chinese Medical Association, waist circumference (WC) is used to diagnose AO. In this study, the main inclusion criteria was: WC ≥ 90 cm in males and ≥ 85 cm in females. The measurement method of WC: standing position, the circumference of the waist was measured at the horizontal position of the lower costal edge of the midaxillary line and the midpoint of the iliac crest line [7]. The second inclusion criteria included body mass index (BMI) ≥ 24 kg/m2, aged between 18 and 60, and simply overweight or obese [8].
The exclusion criteria were: WC < 90 cm in males and < 85 cm in females, BMI < 24 kg/m2; secondary obesity caused by medication or endocrine disease; pregnancy, lactation and childbirth within the past 6 months; chronic obstructive pulmonary disease, coronary heart disease, liver cirrhosis, nephritis and other serious organ diseases; participants with severe mental and neurological diseases; hypertension without effectively controlled; allergic to alcohol or catgut; received weight loss treatment within past 3 months.
Randomization and blinding
The randomization was computer generated by the Clinical Research Center of Yunnan University of Chinese Medicine. Stratified randomization was performed in the 4 clinical centers. Opaque envelopes with a random number were managed by an independent coordinator. Participants, inspector and analyst were all blinded to the allocation. The acupuncturist performed the catgut embedding after the assistant lays the drapes. Therefore, the acupuncturists were also blinded to the allocation.
Interventions
Participants received catgut embedding intervention every 2 weeks for 6 sessions. Catgut embedding manipulations were performed by an acupuncturist with national medical qualifications. The acupoints of the Shu-mu ACE group were Zhongwan (CV12), Tianshu (ST25), Zhangmen (LR13), Pishu (BL20), Weishu (BL21) and Dachangshu (BL25). The non-acupoints were beside the acupoints, which were labeled NA1 (1.5 cun to the left of the Zhongwan), NA2 (1 cun outward from the Tianshu), NA3 (2 cun forward from the Zhangmen), NA4 (2 cun outward from the Pishu), NA5 (2 cun outward from the Weishu) and NA6 (2 cun outward from the Dachangshu).
The assistant marked the position of acupoints and non-acupoints, conventionally disinfected the skin of the operation area, and then layed the sterile drapes. Took the sterile medical catgut 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 connected the needle core, lifted the partial skin with the thumb and forefinger of one hand, pierced the needle with another hand. When the piercing reached the desired depth, implanted the catgut in the subcutaneous tissue or muscle layer. After the needle was removed, pressed the needle hole with a dry cotton ball for half a minute to stop bleeding, and then pasted a bandage to protect the needle hole. Participants were requested not to bathe for 24 hours and keep the embedding area dry.
The thread-embedded needle was 8# disposable needle (Jiangxi Glance Medical Equipment Co. Ltd. Production, Nanchang, China). The medical catgut was an absorbable collagen line with the specification of 2 − 0, 2 cm*20 length (Jiangxi Longteng Biotechnology co., LTD, Nanchang, China).
Participants’ diet and physical activity were not restricted during the whole course, they could continue their lifestyle.
Outcome measures
Outcome measurements were performed at baseline, 6 and 12 weeks in the intervention period, and 16 weeks in follow-up. No eating or drinking for 2 hours before the test. The outcome of this secondary analysis was the visual analogue scale (VAS) of appetite. Assessed appetite by VAS as reported in the article [9]. As shown in Fig. 2, no appetite and minimal intake (0 score). Slight appetite and small amount of intake (1–3 score). Moderate appetite and moderate intake (4–6 score). Strong appetite and large intake (7–10 score).
Statistical analysis
All data were analyzed by SPSS (vers 28.0, SPSS Institute, Chicago, IL, USA) and GraphPad Prism (vers 7.0, GraphPad Software, San Diego, CA, USA). The outcomes described and baseline characteristics were based on the intention-to-treat (ITT) population, which included participants who have received the whole intervention. Continuous data were presented as the mean and standard deviation (SD). Categorical variables were described as numbers and percentages. As the missing data were all in follow-up, the last observation was carried forward and the expectation maximization method was not suitable. Therefore, the missing data was disposed by listwise deletion. The significance level for the statistical analysis was 5% with 2-tailed testing.
Normality of continuous variables was determined by Shapiro-Wilk test, Kolmogorov-Smirnov test. Homogeneity of continuous variables was determined by F test. Independent-Sample t-test was used when compared between every two groups. One-way ANOVA test was used to compare the repeated measurements (≥ 3) within the group. The χ2 test was performed to evaluate the significance of the difference For the categorical data.