Researchers examining the efficacy of medical procedures make assumptions about the nature of placebo. From these assumptions they select the sham interventions to be used in their trials. However, placebo is not well defined. A number of definitions are contradictory and sometimes misleading. This leads to problems in sham-controlled studies of medical procedures and difficulties interpreting their results. The author explores some of the contradictory definitions of placebo and assumptions and consequences of these. Principal among these is the assumption that the placebo is inert when it is not, which introduces bias against the tested medical procedures and devices. To illustrate the problem, the author examines the use of sham procedures in clinical trials of the medical procedures surgery and acupuncture in which the sham was assumed to be inert but was not. Trials of surgery and acupuncture should be re-examined in light of this.

Introduction: As positive evidence emerges for the use of an intervention to treat a health problem, the intervention gradually becomes incorporated into treatment guidelines (TGs) or clinical practice guidelines (CPGs) that are related to that health problem. To assess whether this general hypothesis can apply to acupuncture, 96 health problems were identified for which positive conclusions in systematic reviews and meta-analyses regarding the effectiveness of acupuncture have been made and then searched for TGs or CPGs that have recommended the use of acupuncture. Methods: Through August 31, 2017, searches were performed in relevant medical databases and Google using “treatment guideline,” “clinical practice guideline,” and the names of the 96 medical conditions as search terms. A “snow-balling” search approach was adopted. All positive recommendations were added into the registry. Results: A total of 1311 publications were found that recommended using acupuncture published between 1991 and 2017. The number per year reached 50 in 2005 and 100 in 2009. In addition, 2189 positive recommendations were found for the use of acupuncture. Of these, 1486 were related to 107 pain indications and 703 were related to 97 nonpain indications. These recommendations were made by a wide range of groups, such as government health institutions, national guideline, and medical specialty groups. The recommendations came from around the world but were especially abundant in North America, Europe, and Australasia. Discussion and Conclusion: Considerably more recommendations were found for the use of acupuncture than are known within the acupuncture or medical communities. A trend by year was also found; a rise in the number of positive statements about acupuncture was typically followed by a rise in the number of recommendations of acupuncture. Thus, the recommendations followed the emergent evidence for acupuncture. Better implementation plans need to be developed for the CPG/TG recommendations about acupuncture to be more effective/efficient.

Trials of acupuncture in the West began before textbooks about acupuncture were generally available. This placed trials at risk of possible faulty assumptions about the practice of acupuncture and adoption of problematic research assumptions and methods. Further, this lack of information has had an influence on the theories of developing a valid and reliable sham control treatment in clinical trials of acupuncture. This commentary explores these issues. Literature review focussing on the time line of developments in the field, developments of sham interventions and use thereof and knowledge of physiological effects of needling. Early trials demonstrated a lack of knowledge about acupuncture. As the methodology of trials improved, new sham treatment methods were developed and adopted; however, the sham treatment methods were implemented without physiological studies exploring their potential physiological effects and without examining the broader practice of acupuncture internationally. Mistaken assumptions about the practice of acupuncture reinforced by paucity of physiological investigations are factors that led to use of inappropriate sham interventions for acupuncture trials. These not only lead to confusing or misleading trial results, they, as far as we can see underestimate the effects of acupuncture leading to bias against acupuncture. There are significant problems with sham interventions and how they are applied in trials of acupuncture. Further research is needed to explore the effects of this both for future trials and for interpreting existing evidence.

Breast cancer (BC) is the most common cancer in women and is a serious threat to women’s health. Cancer-related fatigue (CRF) is a distressing symptom in BC patients during and after chemotherapy or radiation therapy that severely affects quality of life (QoL). AT is widely used for fatigue management. However, the effect of AT on CRF is still uncertain. This study aimed to evaluate the efficacy and safety of AT in the management of CRF in patients with BC. Eleven databases were searched through June 2022. Two researchers independently performed the database search, study selection, data extraction, and risk of bias assessment. Study selection was performed based on predefined Participants, Intervention, Comparators, Outcomes, Study design (PICOS) criteria, and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed when reporting the results. A meta-analysis was performed according to the Cochrane systematic review method using RevMan 5.3. A total of 12 studies including a total of 1084 participants were included. The results showed that AT had a beneficial effect compared with sham AT (n = 256, SMD = −0.26, 95% CI [−0.51, −0.01], p = 0.04, I² = 0%) and a long-term effect on fatigue score (n = 209, MD = −0.32, 95% CI [–0.59, −0.04], p = 0.02, I² = 0%). Meta-analysis showed that AT had a beneficial effect compared with usual care (UC) on fatigue scores (n = 238, SMD = −0.39, 95% CI [−0.66 to −0.12], p = 0.005, I² = 0%). Of the 12 articles, 3 articles were judged as having a low risk of bias in all domains and hence were of high quality. No serious adverse effects were identified. AT is an effective and safe treatment for CRF, and AT is more effective than sham AT or UC or wait-list control (WLC). Nevertheless, the methodological quality of most of these studies was low, and the included studies/sample sizes were small, so the ability to derive decisive implications was limited. Further research is needed to confirm these findings.

Recently research on acupuncture for cancer related symptoms has significantly increased. To what extent have medical professionals recommended to use acupuncture in light of that evidence? Evidence of effectiveness and safety was found by searching Pubmed for reviews to identify for what conditions and general results. Publications that recommend acupuncture in oncology were searched in the database of an ongoing general search for publications that recommend acupuncture. This database was developed by searching google for publications that recommend the use of acupuncture with the terms 'name of symptom' and 'clinical practice guideline' or 'treatment guideline'. Acupuncture is moderately or weakly effective for 19 symptoms in patients with cancer and cancer survivors. Acupuncture is a safe therapy in cancer care if administered by trained acupuncturists. Acupuncture is targeted to improve symptoms associated with the cancer and different cancer treatments, not to treat the cancer itself. More than 350 publications by clinical practice guideline groups and expert groups, including public health statements made by national and government agencies recommended the use of acupuncture for 61 cancer related symptoms many with positive evidence of effectiveness. The strength of evidence is weak for many indications, however the evidence for many standard therapies is either not very strong or if stronger, the incidence of adverse events is more, which makes acupuncture a treatment option despite the weak evidence. We have found evidence that many oncologists around the world have started to incorporate acupuncture into the treatment of various cancer related symptoms.