Data anomalies and apparent reporting errors in ‘Randomized controlled trial testing weight loss and abdominal obesity outcomes of moxibustion’

Abstract

Randomized controlled trials (RCTs) are the best method to determine causal effects for treatments if they are well done and well reported. Good evidence about proposed treatments for obesity is needed, and Hsieh et al. [1] are to be commended for putting moxibustion to the test. However, careful evaluation of the paper, similar to a prior review of another paper on moxibustion [2], reveals inconsistencies and apparent reporting errors, which raise doubts about conclusions from the study.The primary concern relates to the randomization process. Table 1 in Hsieh et al., which describes baseline anthropometrics of both groups in their study, showed that baseline body weight (BW) differed with a high degree of statistical significance (p < 0.001) based on the comparison of groups using a t test [1], which, by definition, is very unlikely to occur under randomization [3][4][5][6]. We also note that the baseline variances for BW were significantly heterogeneous (Bartlett's test; χ 2 = 6.86, df = 1, p = 0.0088 ), which is again, by definition, highly unlikely under randomization. These baseline distribution differences by group raise questions as to whether the randomization was properly performed. Results might be influenced by any problem in the randomization process, which could bias the estimated treatment effects [6]. The details of the randomization process were not clear, and we found no Abstract Randomized Controlled Trials (RCTs) are the best method to determine causal effects for treatments if they are well done and well reported. Good evidence about proposed treatments for obesity is needed, and Hsieh et al. (Biomed Eng Online 17:149, 2018) are to be commended for putting moxibustion to the test. However, careful evaluation of the paper reveals inconsistencies and apparent reporting errors, which raise doubts about conclusions from the study.

Errors in the implementation, analysis, and reporting of randomization within obesity and nutrition research: a guide to their avoidance

“…Conclusions from secondary analyses were affected, however, such as the 5-year change in body weight and waist circumference, which changed statistical significance for the olive oil group [24]. Use of statistical principles to examine the likelihood that randomization was properly implemented has flagged other studies related to nutrition and obesity, too [25][26][27][28]. In at least four cases, publications were retracted [22,26,29,30].…”

Moxibustion combined with characteristic lifestyle intervention of Traditional Chinese Medicine in the treatment of abdominal obesity

“…[ 19 , 20 ] In one previous clinical trial, Mestre et al found that obesity index decreased and the rate of body weight gain was slowed after the moxibustion treatment. [ 21 ] Another study conducted by Huang et al [ 22 ] showed that moxibustion was effective in reducing blood lipid indexes and the levels of Leptin, Resistin for the patients with obesity complicated with hyperlipidemia. All of these results suggest that moxibustion has beneficial effects on both body weight management and blood lipids.…”