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Abstract

Objectives: The objective of this study was to determine whether Yi Ren Medical Qigong (YRMQ) has a positive impact on body weight in people with type 2 diabetes mellitus (T2DM).Design: A secondary analysis was conducted with data collected during a completed randomized, controlled clinical trial study.

Settings/location: Bastyr University Research Institute (Kenmore, WA)

Subjects: Participants (n=32), mean age of 56.3 ± 8.1(SD) years, with diagnosed type 2 diabetes and HbA1C > 7.5%, fasting blood glucose > 7 mmol/l (126 mg/dl).

Interventions: Patients were randomized into a standard care plus YRMQ group, or standard care plus progressive resistance training (PRT group), or standard care alone (control group).

Outcome measures: Outcome measures included body weight, body mass index (BMI), fasting glucose, and homeostasis assessment index estimates of insulin resistance (HOMA-IR).

Results: Both the YRMQ and PRT groups had a significant trend of decrease in body weight and BMI when compared to the control group. For the body weight, the p-values of the rank sum tests for control-PRT, control-YRMQ and PRT-YRMQ are 0.02, 0.10 and 0.55, respectively. For BMI, the p-values of the rank sum tests for control-PRT, control-YRMQ and PRT-YRMQ are 0.01, 0.04 and 0.73, respectively. The Qigong group also showed trends for improvement in insulin resistance while PRT did not, despite the significant body weight loss in the PRT group.

Conclusion: Yi Ren Medical Qigong was associated with trends in weight loss and improvement of insulin resistance in people with type 2 diabetes mellitus.

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Introduction

Type 2 diabetes mellitus (T2DM) is the most common form of diabetes, affecting over 90% of the people with diabetes. T2DM is marked by abnormally high levels of blood glucose, as a result of the bodies’ inability to use blood glucose because of relative insulin deficiency or sustained insulin resistance. There is no cure for T2DM in today’s medical science, and the typical clinical course is for patients to respond to pharmacotherapy initially by normalizing their fasting glucose levels, and then to undergo gradual deterioration in glycemic control despite optimal medical management using a variety of drugs [1].

In the view of Traditional Chinese Medicine (TCM), T2DM is named as “Xiao Ke Zheng”, which refers to excessive drinking and urination” [2]. Its pathogenesis is considered to be the accumulation of “Heat” (Yang) and the consumption of “Yin,” where the Lung, Spleen and Kidney are all directly affected. Treatment focuses on giving comprehensive, individual, and integrated recommendations for the whole body [3]. TCM therapy is usually used as adjuvants in combination with anti-diabetic drugs. However, there is still insufficient evidence to draw definitive conclusions about the efficacy of TCM for diabetes [4].

Qigong (pronounced “chee gung”) is an important part of TCM, and has been reported to prevent and cure disease, and to improve chronic health conditions by self-practice or by receiving qi from a Qigong therapist [5]. In Qigong the term “qi” (or “chi”) means “vital energy of the body” and “gong” means the skill and achievement cultivated through regular and disciplined practice. Although in TCM qigong is considered “energetic medicine”, the practice of qigong combines breathing, movement and meditation, and therefore is often classified by Western providers under the category of “mind/body medicine”. Qigong refers to the mind-body operational skills and techniques that integrate the adjustments (regulations) of mind, body and breathing into Oneness” [6]. Regardless of its classification, previous studies suggest that Qigong may be a beneficial adjunct treatment for individuals with T2DM [2,7-10].There were consistent and statistically significant positive associations between participation in Qigong and blood glucose, triglycerides and total cholesterol [11]. Recently, systematic reviews have found support for a role of Qigong in the management of T2MD [2,10]. However, important to this evaluation, no studies performed thus far have reported evidence of any beneficial effect of Qigong on weight [11]. In order to evaluate whether Qigong has beneficial effects on people with T2DM, we conducted a three-armed, 12-week randomized, controlled clinical trial to compare the biological and psychological responses of Qigong with progressive resistance training (PRT) or standard care in patients with T2DM. Our primary results on blood glucose control [5] and perceived stress [4] have been previously reported. In this study, our specific objective was to perform a secondary analysis of our completed RCT in order to understand potentially beneficial mechanisms of Qigong on body weight and insulin resistance in people with T2DM.

This study used a three-armed, randomized, controlled clinical trial design. All research protocols were approved by the Institutional Review Board (IRB) at Bastyr University and subjects provided Informed Consent. To be eligible, participants had to be between 18 and 65 years of age and diagnosed with type 2 diabetes from their primary care physician, and the participants met the inclusion criteria consisting of an HbA1c level greater than 7.5% and a fasting blood glucose greater than 7 mmol/dL (126 mg/dL). The research team randomly assigned age- and sex-matched participants (N = 32, 13 men and 19 women) to one of three groups for a 12-weekintervention period. None of the participants were taking insulin; however, all were taking oral diabetes medication [5,12].

All participants were asked to maintain their current activity levels including medications, diet and exercise during the study. Group 1 (n=11) received the Yi Ren Medical Qigong (YRMQ) intervention; group 2 (n=11) received the progressive resistance training (PRT) intervention, as an active comparator; and group 3 (n=10) served as the standard care control group. All interventions lasted 12 weeks and included weekly supervised YRMQ and PRT sessions as well as at-home practice. The intervention consisted of weekly YRMQ or PRT sessions in groups (60 min/wk) that certified instructors led. In addition, the research team asked participants in both active treatment groups to practice at home twice a week for 30 minutes per session [5,12].

Blood glucose and body weight were obtained at baseline, week 4, week 8 and at the end of week 12. HbA1c, insulin, Perceived Stress Scale (PSS) and Beck Depression Inventory (BDI) were measured before and after the intervention as described in our previous report [12]. Blood testing required a 12-hour fast (no food or drink, except water and medications); approximately 20ml of blood was obtained via a venipuncture in the arm with the individual in an upright position and after at least 5 minutes in a resting state. We measured height and weight after an overnight fast with the participant dressed in light clothing and without shoes. Homeostasis assessment index estimates of insulin resistance (HOMA-IR) was calculated using fasting glucose and fasting insulin according to published methods [13].

Data were analyzed using MATLAB (version 7.3, MathWorks, Inc., Natick, MA, USA). Demographic characteristics for each treatment group were described as medians, means and standard deviations for continuous variables, and frequency counts and percentages for categorical variables. To compare the effect of YRMQ and PRT on the major outcome variables to the control group, it is required that any outcome variable has the same distribution among the three groups at the baseline. Thenon-parametric one-way analysis of variance, the Kruskal-Wallis test, was used to check whether an outcome variable had the same distribution among the three groups at baseline. The same approach was used to the test for differences in the outcome variables before and after treatment to find out whether each treatment had the same effect for the outcome variable. The Wilcoxon rank-sum test was employed to determine any differences between any two of YRMQ, PRT and standard care. Considering the feasibility of recruiting and retaining study participants, the sample size for this pilot study is small. If a test is not significant, it may be due to the insufficient statistical power by the small sample size. However, if a test is significant, it has the same interpretation regardless of the sample size. We considered p-values < 0.05 as statistically significant. The original randomization allocation from our primary analyses was maintained in all secondary analyses reported here.

Table 1 summarizes demographic characteristics of study participants. Thirteen men and 19 women had a mean age of 56.3 ± 8.1 yr and mean Body Mass Index (BMI) of 31.8 ± 6.0 kg/m² with Caucasian 59% and non-Caucasian 41%.The mean HbA1c was 8.2 ± 1.1, 8.2 ± 1.2 and 8.1 ± 1.1 in YRMQ, PRT and standard care control groups, respectively. A total of 9 participants dropped out from the study including 2 from standard care control group, 5 from PRT group, and 2 from YRMQ group, corresponding to dropout frequencies of 20%, 45%, and 18%, respectively. Our pilot data demonstrate that it is feasible to implement YRMQ as an adjunct complementary therapy to conventional standard care for treating T2DM. In this study, the completion rate was relatively high at Qigong group (82%) compared with PRT group (55%) and standard care control group (80%). There was no any adverse event related to the intervention.

 Changes in body weight

The body weights at baseline (mean ± SD) were 180.1 ± 44.3, 201.8 ± 30.5 and 194.5 ± 34.9 in YRMQ, PRT and standard care control groups, respectively (p=0.71). The changes of body weight during the intervention in the three groups are plotted in Figure 1A. The body weights in the control group increased in all except two patients; while in the PRT group the body weights of 4 patients decreased, 1 patient remained unchanged and 1 patient experienced weight increase. We observed an interesting phenomenon in the YRMQ group: there was a tendency for patients with high baseline body weights to experience weight reductions and patients with lower baseline body weights to experience weight increases. This indicates that YRMQ may lead to reduction of body weights in more obese individuals. Figure 1B shows that a strong trend towards significant increase over time for the body weight in the control group, but slightly decrease in the YRMQ and PRT groups. The Kruskal-Wallis test comparing the median of changes in the three groups suggests that the three groups are significantly different (p=0.055). Note that the p-value for testing the zero median of the changes in body weights in the untreated conventional standard care group is 0.055, showing that a strong trend towards increased body weight over time during the 12 weeks intervention period. On the other hand, the p-values of the rank sum tests for control-PRT, control-YRMQ and PRT-YRMQ are 0.02, 0.10 and 0.55, respectively. This indicates that YRMQ and PRT have beneficial effect in body weight loss compared to the standard care, although there is no difference in change in weight between YRMQ and PRT.