The purpose of this study was to achieve consensus among a panel of prestigious acupuncture experts on specific clinical issues and develop a relatively optimized and standardized acupuncture protocol in the treatment of IBS via a Delphi consensus study. Ultimately, 19 items categorized into 3 main domains reached consensus. In view of the theoretical background of acupuncture, some statements in the final expert consensus are specific to the TCM meridian terms. Nevertheless, this expert consensus may still provide some practical and generalized recommendations for clinical acupuncturists.
According to the final consensus statements, most of the experts (> 90%) agreed that acupuncture could be used to relieve clinical symptoms and improve the quality of daily life in mild and moderate IBS. The recommendations are consistent with the results of a previous clinical trial that compared acupuncture plus usual care with usual care alone. This study concluded that acupuncture could reduce IBS Symptom Severity Score and improve the proportion of successful treatment . Two SRs indicated that acupuncture produced a preferable therapeutic effect in improving IBS patients’ quality of life compared with sham acupuncture or western medicine [35, 36]. Of note, a latest published high-quality study including 531 patients found that acupuncture showed more effective results in reducing IBS symptoms and improving quality of life compared with pharmacologic therapies . In addition, these effects could last up to 3 months, which is also in line with our consensus statement that relief of IBS symptoms can be maintained for 1 to 6 months after one course of acupuncture treatment. As a disease with a sort of psychiatric disorder, refractory IBS symptoms can exacerbate patients’ coexisting psychological distress . The experts reached a complete consensus (100%) that acupuncture could ameliorate the psychological or psychiatric conditions of patients. In light of the absence of corresponding evidence, we suggest that the outcomes of mental state should be focused on in more future studies, so as to verify the efficacy of acupuncture in this respect.
Based on the classical Meridian theory, specific acupoints are specially defined points on the 14 main meridians, which may have their specific therapeutic effects. Specific acupoint selection is very critical that different specific acupoints should be applied in different diseases, and stimulation on relevant specific acupoints in a certain disease can result in more outstanding effects than other acupoints [40, 41]. Therefore, in particular, we laid stress on the application of specific acupoints and set 3 items to discuss these issues. The recommended specific acupoints in this consensus were Tianshu (ST25), Zusanli (ST36), and Zhongwan (CV12). Of note, this result is concordant with the founding of two SRs that these acupoints were 3 of the top 6 most commonly adopted acupoints [38, 42]. Although the 3 specific acupoints are always taken into consideration for the treatment of gastrointestinal diseases and supported by the Chinese Medicine theory, further clinical trials are still needed to confirm their superiority over other acupoints in treating IBS. In addition, the overwhelming majority of experts acknowledged Mu acupoints and Xiahe acupoints as the common species of specific acupoints, and Xiahe-Mu combination as the common acupoint combination, which is in line with the traditional concept that Mu acupoints and Xiahe acupoints are the preferred choices in treating Zangfu diseases such as IBS . Because acupoint selection and combination plays a crucial role in enhancing the efficacy of acupuncture, we suggest that not only clinical practice but also new trial designing may refer to these expert consensus statements.
Due to its innate feature as a kind of intricate intervention, the relevant acupuncture parameters also have impact on the actual efficacy of acupuncture. Unfortunately, these parameters reported within the existing distinct papers vary greatly, which may cast uncertainty on the comparability with each other. It has been supported by published literatures that better clinical outcomes produced by acupuncture may be dose-dependent and influenced by appropriate acupuncture protocols . Nevertheless, this point is always overlooked by most of RCTs that focus much more on validity assessment but are of less note regarding the optimal protocol . There were 5 items discussed to ensure the adequate stimulation of acupuncture for achieving the ideal therapeutic effects, including course of treatment, acupuncture manipulation, number of acupoints per session, duration time of needle retention, and treatment frequency. Although more than 80% of the experts considered that it was reasonable about these acupuncture parameters in the final statements, we suggest more studies to explore their reliability.
As a kind of chronic and recurrent disease, IBS patients may always need long-term treatment. Given this, there is no wonder that safety should be of great concern among patients and clinicians. Patients have to be faced with the increased risk of adverse drug reactions, especially after long-term utilization. The consensus agrees that adverse events are uncommon in the treatment of IBS with acupuncture, which is another superiority of acupuncture demonstrated by previous SRs [17, 35]. Therefore, physical therapy like acupuncture may be considerable for patients suffering from IBS for a long time.
Evidence-based medicine, especially RCTs and SRs, is essential for medical research and clinical practice. Meanwhile, they may have several intrinsic weaknesses. Generally speaking, they have strict inclusion and exclusion criteria to limit the study population and may not be generalizable to common clinical treatment . Additionally, there are as well some clinical measures such as parameters of acupuncture and acupoint selection, which acupuncturists actually and urgently concern about in real practice but have not been answered by published articles. These existent complicated clinical issues are hardly solvable by RCTs and SRs in a short time, either. A study of expert consensus sets up a structured process to collect information from a series of semi-open questions of interest with controlled feedback, followed by multi-round expert votes to achieve agreement on specific issues . The Delphi methodology has a specific advantage that it can even be carried out securely while current research evidence is insufficient or there exists uncertainty in a certain field [44–46]. The Delphi survey can synthesize experts’ opinions in a high-quality and scientific way and provides a considerable approach in determining the solution to some controversial clinical issues . Notwithstanding, aiming to run this study more systematically, before the formal expert consensus vote, we carried out a two-round clinical issue investigation to comprehensively understand the real need for acupuncture in the treatment of IBS among acupuncturists from different regions of China. Simultaneously, we still sought evidence from SRs and presented it as well as the results from the clinical investigation to provide the expert panel with more information for making decisions.
It is arguable about the method of expert selection and that the evidences are insufficient (or absent) for many items under discussion in this consensus survey. We totally consent that a multidisciplinary expert panel is preferable for ensuring the balance of perspectives to generate an objective consensus. Consensus reached by an expert board including participants who are professionals in IBS but do not necessarily practice acupuncture can achieve a higher credibility. However, this survey is about a complicated intervention whose primary intention is to acquire some pragmatic answers from reputable experts for specific clinical issues under the circumstance that the relevant evidences are really too scarce. Almost 70% of the items voted in the consensus study are closely associated with the concrete acupuncture procedures that are necessary to be standardized and optimized. These recommendations are also what acupuncture practitioners really want to learn about in daily practice. Without referable evidences, these items have to be discussed among experts with background and actual clinical experience on acupuncture. It is difficult for experts who have never practiced acupuncture in IBS’s treatment to make a judgement on these actual issues, especially in the absence or lack of available evidences from the published literatures. Therefore, only authoritative acupuncture experts were recruited in our study. Nonetheless, to counteract the potential bias as possible, we set a more rigorous criterion (over 80% agreement) for consensus achievement in our study rather than 70% or 75% in usual [47, 48]. Moreover, we double the sample size of experts needed, while the minimum allowed sample size in Delphi survey is 12 ~ 15 [28, 49, 50]. The final expert panel is also a mix of practitioners and academics. On the other hand, evidences are indeed very essential in establishing guidelines for clinical practitioners. For a long time, alternative and complementary techniques are criticized and prone to base on ideology, beliefs, and personal experience, rather than on proper and well-built evidence. Although numerous acupuncture clinical trials have emerged in recent decades, most of these studies only focused on assessing the efficacy of acupuncture, and the fact that acupuncture is one kind of intricate intervention whose therapeutic effects can be influenced by a series of factors is always overlooked. The concrete acupuncture protocols vary greatly in distinct papers, which may confound the exact interpretation of their results. Due to scarce or absent evidences in the field, the comprehensive experts’ opinions collected with the assistance of Delphi method may provide another source of reference for acupuncturists to base their treatment on at present. Although many items in this consensus are the specialist’s recommendations rather than a guideline, and their validities still need further verification, these items can point out the reference directions for future studies at least, and make researchers know what can be taken into consideration in better designing the new study protocol and which optimal acupuncture parameters should be further explored.
There are several potential limitations within the study. The major limitation is that only Chinese as opposed to international acupuncture experts participated in the survey, although they came from different areas of China. Hence, the transferability of our study to other countries may be hindered by the circumscribed background of participants. In spite of the careful expert panel selection and the rigorous Delphi method followed, it is likely that the consensus does not cover the entire acupuncture community’s opinion. Another limitation is that most of the final statements were based on the individual opinions and clinical experience of experts. The expert opinion is regarded as the lowest valuable source of evidence level system . Thus, the agreement of a certain item is at a particular point in time and may be changed with emerging new evidence and experience. In addition, even though there may exist some diversity between doctors’ and patients’ opinions toward the treatment , our clinical issue investigation was conducted only among clinicians, which means the consensus was based on doctors’ general perspective but not patient specific.
Given the limitations mentioned above, the current survey is more a preliminary dialectical consensus than a proper evidence-based guideline in some degree, which needs to be viewed with extreme caution by the readers. Notwithstanding, we still look forward to more proper RCTs and robust SRs, which can verify the experts’ recommendations and further underlay an ideal expert consensus or clinical guideline. When more emerging evidences can be provided in the future, an updated version of multidisciplinary, international, and thoroughly evidence-based expert consensus survey will be feasible and indispensable.