Evidence based medicine (EBM) is the conscientious, explicit, judicious and reasonable use of modern, best evidence in making decisions about the care of individual patients and, subsequently, the effectiveness and safety of a given therapy. EBM integrates clinical experience and patient values with the best available research information.

One of the greatest achievements of evidence-based medicine has been the development of systematic reviews and meta-analyses, that is to say methods by which researchers identify multiple studies on a topic, separate the best ones and then critically analyse them to come up with a summary of the best available evidence.

The practice of evidence-based medicine has brought new challenges in the design of acupuncture research, and publication of randomized clinical trials on acupuncture has significantly increased. While systematic reviews of these trials have advanced current knowledge, they have exposed deficiencies in research design and revealed that one design cannot answer all research questions.
Acupuncture must be evaluated using rigorous scientific methods, so that it can continue to play an important role in the health care systems of modern societies.

Despite the important results achieved, Eastern studies have been accused of being methodologically weak, and very often their contributions have not been accepted for publication in high-impact journals.
Therefore, in order to improve the Standards for Reporting Interventions in Clinical Trials of Acupuncture, STRICTA guidelines were issued: they provide authors a way to structure their reports of interventions using a checklist. The aim is to facilitate transparency in published reports, enabling a better understanding and interpretation of results, aiding their critical appraisal, and providing detail that is necessary for replication.

The 2010 version was developed in conjunction with the CONSORT Group Executive, such that the new version of STRICTA has become an official extension to the CONSORT Statement.

Although guidelines are essential for the standardization of research methods in Acupuncture, some problems still exist: is the hierarchical model adequate to give comprehensive answers to the complexity of disease? Are pragmatic trials a reliable method to track the effectiveness of therapy? What epistemological and ontological changes are needed to update a traditional care practice? And finally, which are the factors that play a role in measuring therapy progress, effectiveness and outcomes?

The placebo effect has been a source of fascination, irritation, and confusion within biomedicine over the past 60 years. In 2009, F G Miller suggested the hypothesis that the placebo effect operates predominantly by producing symptomatic relief of illness, such as pain, anxiety, and fatigue, rather than by modifying the pathophysiology of disease. The placebo effect as a clinical phenomenon is characterized as representing the interpersonal component of healing, as distinct from spontaneous natural healing and technological healing dependent on physiologically active pharmaceuticals or procedures.

Determining an appropriate control for use in acupuncture RCTs remains one of the most important methodological challenges acupuncture researchers face.

In clinical research the placebo treatment must be inert, and only when the provided randomization and blinding are properly used, can a trial comparing test treatment to placebo treatment be said as placebo-controlled.

In hands-on therapies like acupuncture what can constitute a valid placebo control treatment? Are there predictable mechanisms by which acupuncture works suggesting which valid placebo can be used? Are there any sham acupuncture interventions that can constitute placebo treatments? Are they credible to be sham treatments? If they are not inert or credible, then how can we perform placebo-controlled trials on acupuncture? Are such trials possible?

These questions raised by Dan Zhu in 2013, and many more, are still unanswered.

Several randomized controlled trials (RCTs) of acupuncture have been conducted in recent years and the comparison of true acupuncture with sham and placebo acupuncture has given contradictory results.

Researchers should investigate the inherent factors that may potentially influence the results of trials, they should ask themselves how to minimize the placebo effect and optimize acupuncture administration in acupuncture clinical studies, and they should investigate what type of placebo control is the most inert, in other words which one is pure and indistinguishable from the study intervention.