We thank the commentators for their thoughtful points and appreciate the opportunity to contribute to the discussion of how best to design and report acupuncture clinical trials. We sincerely agree on the importance of transparency in published reports so that readers can better understand and interpret results. The STRICTA guidelines are a crucial tool to facilitate this type of responsible reporting.1 While not explicitly referenced, this checklist was used in the reporting of the main paper, and also the reporting of the secondary findings.2,3 There are six main items included in the checklist. These items ensure adequate detail is provided in the following areas: acupuncture rationale; details of needling; treatment regimen; other components of treatment; practitioner background; and control or comparator group.
As emphasized in the sixth area of the STRICTA guidelines and mentioned by Banzoli et al, researchers must carefully consider the potential for placebo responses in designing studies of acupuncture. Our main trial included both a medication and an acupuncture placebo for this very reason3; however, the choice of control can also depend on what type of research question one seeks to answer. In comparative effectiveness research, it is appropriate to use active interventions in ways they are intended to be used.4,5 Whereas placebo effects are a legitimate concern when one tries to quantify the efficacy of treatment due to specific needling, it is part of the normal therapeutic effect of interventions when a patient chooses or is given a treatment in a clinical context. Our study was able to demonstrate that electro-acupuncture and gabapentin, delivered as they would in routine care, are comparable in terms of improving sleep in breast cancer survivors who experience hot flashes.
Lastly, as noted in the limitations section of our paper and highlighted by Banzoli et al, the choice of methods to assess sleep can be a difficult methodological decision to make. This decision very much depends on the specific type of sleep information required. We know that subjective and objective assessments of sleep are not always concordant.6,7 This is due in large part to the subjective nature of “perceived sleep quality” or “satisfaction with sleep,” both of which are best assessed by self-report measures. This is in contrast to other objective sleep metrics such as time spent in different sleep stages or number of awakenings, which are best assessed by polysomnography or actigraphy. From these objective measures, we may be able to infer good sleep but they really do not tell us anything meaningful about how the individual actually experienced their sleep, which is arguably more important to the patient.
For these reasons, it is vital to incorporate comparative effectiveness research with real world application into acupuncture clinical trials. Our study will help patients and providers answer specific patient-oriented questions such as: “I am a breast cancer survivor who is troubled by hot flashes and poor sleep, should I use gabapentin or acupuncture to treat my symptoms?” We now know that the answer is “Both treatments may be equally effective at helping you sleep so it depends on your individual preference.” We feel that this is a considerable step forward in providing individualized patient-oriented care.