The combination effects of body acupuncture and auricular acupressure compared to sham acupuncture for body weight control: Study protocol for a randomized controlled trial

Abstract

Background: Obesity is an increasingly prevalent chronic condition that is associated with serious morbidity and mortality. Excess body weight is a risk factor contributing to diseases such as hypertension, heart disease, hypercholesterolaemia, diabetes mellitus, cerebrovascular disease, gall bladder disease, and some types of cancer. Almost all the Western anti-obesity drugs have adverse effects or body weight is regained upon cessation of therapy. Recent studies have found that acupuncture had a similar efficacy as the Western anti-obesity drugs with fewer reported adverse effects. However, these conclusions were limited due to the small sample size and low quality of methodologies of these studies. Therefore, we design this study to explore the effectiveness and safety of acupuncture on weight control. Methods/design: This is a pilot single-blinded, randomized, sham-controlled trial on acupuncture for body weight control. Seventy-two participants are randomly assigned to the acupuncture group or the control group. Tianshu (ST-25), Daheng (SP-15), Daimai (GB-26), Qihai (CV-6), Zhongwan (CV-12), Zusanli (ST-36), Fenglong (ST-40), and Sanyinjiao (SP-6) are selected as acupuncture points. For the acupuncture group, disposable acupuncture needles will be inserted at a depth of 10-25 mm into the points and electrical stimulation with dense-disperse waves at 50 Hz and 10 V will be applied on the abdominal points. The bodily needles will be retained for 30 minutes. For subjects assigned to the control group, Streitberger's non-invasive acupuncture needles will be applied to serve as the sham control at the same acupoints with the same stimulation modality, except that the needles are only adhered to the skin instead of inserted. The duration of the treatment is 8 weeks with two sessions per week, and the follow-up period is 8 weeks. The primary outcome is the change in body weight before and after treatment. The secondary outcomes include changes in body mass index, waist circumference, hip circumference, and body fat percentage during the treatment and follow-up period. Discussion: The study will compare the efficacy and safety of acupuncture with sham acupuncture on weight control, in the hope of obtaining evidence for utilizing acupuncture for body weight control. Trial registration:NCT02516878. Registered on 30 July 2015.