This topic holds significant clinical value and offers a robust research framework for evaluating the therapeutic efficacy of acupuncture.
First, this study lacks a sham acupuncture control group, which may hinder the ability to exclude placebo effects and attention bias [2].
To demonstrate “synergistic interaction”, a 2 × 2 factorial design is typically required, including four groups: blank control, diet alone, acupuncture alone, and acupuncture+diet [5].
Since this study lacks a pure acupuncture group, the current data more appropriately suggest that acupuncture exhibits an “additive effect”.
Furthermore, the data imply that the diet has minimal impact on alleviating depression, with improvements in mental health likely driven predominantly by acupuncture rather than by a “synergistic interaction”.
We read with great interest the study by Irandoost et al. [1] entitled “The effects of an anti-inflammatory diet alone or in combination with acupuncture on mental health, anthropometric indices, and metabolic status in diabetic patients with depression: a randomized, controlled clinical trial.” This study investigates the potential of acupuncture to enhance both the physical and mental health of patients with type 2 diabetes mellitus who also experience mild to moderate depression. This topic holds significant clinical value and offers a robust research framework for evaluating the therapeutic efficacy of acupuncture. However, after a thorough review of the study’s design and data interpretation, we identify several issues that require further refinement in future related research.
First, this study lacks a sham acupuncture control group, which may hinder the ability to exclude placebo effects and attention bias [2]. Although the paper states that “complete blinding was unfeasible due to the nature of the intervention,” the absence of a sham acupuncture group prevents us from determining whether the reduction in depression scores (MADRS) is attributable to the specific physiological effects of acupoints or merely to the non-specific psychological effects of “being treated”—that is, the placebo effect.
Secondly, the study reported that after an 8-week intervention, the combined treatment group exhibited a significant reduction in glycated hemoglobin (HbA1c) levels. HbA1c serves as an indicator of the average blood glucose levels throughout the lifespan of red blood cells, which is approximately 120 days. While the intensive 8-week intervention may begin to influence HbA1c, the significant changes observed within such a brief timeframe, along with the absence of statistically significant differences in fasting blood sugar (FBS) between groups during the same period, suggest that these results may be influenced by short-term fluctuations in water balance or other acute metabolic changes, rather than accurately reflecting the effects of glycemic control [3].
Third, the heterogeneity of antidiabetic drugs was not adequately controlled. Although patients using insulin and liraglutide were excluded, the category of ‘oral antidiabetic drugs’ encompasses multiple medications with distinct pharmacological mechanisms. If randomization failed to balance the distribution of drugs that possess weight-loss and anti-inflammatory effects across groups [4], the advantages observed in the combination therapy group regarding waist circumference and metabolic indicators might be partially confounded by indication bias.
Fourth, the statistical design did not provide sufficient support for the claim of “synergistic interaction”. To demonstrate “synergistic interaction”, a 2 × 2 factorial design is typically required, including four groups: blank control, diet alone, acupuncture alone, and acupuncture+diet [5]. Since this study lacks a pure acupuncture group, the current data more appropriately suggest that acupuncture exhibits an “additive effect”. Furthermore, the data imply that the diet has minimal impact on alleviating depression, with improvements in mental health likely driven predominantly by acupuncture rather than by a “synergistic interaction”.
