Suzuki M, Muro S, Ando Y, et al. A randomized, placebo-controlled trial of acupuncture in patients with chronic obstructive pulmonary disease (COPD). Arch Intern Med. 2012 May 14. [Epub ahead of print]
Prospective, single-blinded randomized, placebo-controlled trial with matched pairing of participants. One half of the participants received “real acupuncture” while the other half received “sham acupuncture” over a 12-week period. The study was conducted from July of 2006 to March of 2009 within 6 different medical facilities in the Kansai region of Japan.
Of a total of 68 patients who participated in the study, 34 were randomly allocated to the placebo acupuncture group and 34 randomly allocated to the real acupuncture group. All participants were already taking standard medications for the management of their disease (anticholinergis, b2 agonists, and/or corticosteroids). Inclusion criteria was diagnosis of stage II, III or IV COPD; symptom of grade II or higher dyspnea; no history of recent infections, symptom exacerbation or medication adjustments; unassisted ambulatory outpatient status.
Comparative results of the Borg scale for breathlessness after a 6-minute walking test (6MWT), 6-minute walking distance (6MWD), lowest oxygen saturation (SpO2) during 6MWT, FEV1, and quality of life questionnaire taken as baseline and at the end of study 12 weeks later.
Primary Outcome Measures
How well participants tolerated the 6MWT in regards to severity of dyspnea on exertion (DOE).
Patient symptoms as expressed on the modified Borg scale improved by more than 50% in the real acupuncture group after 12 weeks, while there was no improvement noted in the sham acupuncture group. Additionally, objective measures of the 6MWD improved significantly, as did SpO2 during the 6MWT compared to the sham acupuncture group. FEV1 did not improve significantly in either group.
The authors of the current study had previously demonstrated efficacy of using acupuncture for relief of dyspnea in patients with COPD; however, their earlier study was neither blinded nor randomized.1 In this current study, Suzuki et al confirmed their earlier results in a single-blinded, randomized trial. They found that acupuncture delivered over a 12-week period was able to provide statistically significant relief to the participants in the real acupuncture group, while little benefit was noted in the placebo acupuncture group. This is the first known randomized placebo-controlled study on acupuncture for the treatment of dyspnea in patients with COPD.
Dyspnea is a common complaint in the general care setting, as well as the most common complaint patients with chronic obstructive pulmonary disease (COPD) express to their healthcare providers.2,3 While pharmaceutical advances have reduced mortality and morbidity, quality of life (QOL) remains markedly reduced by the severity of dyspnea. Furthermore, shortness of breath has been shown to have just as severe an impact on QOL as a diagnosis of cancer, in regard to the number of symptoms, degree of distress, and prevalence of depression experienced by both groups.4 Therefore, additional areas of support for patients living with COPD are desperately needed in order to reduce suffering as well as to improve cost-benefit outcomes for this population.5
Newer therapies, such as surgery, are being proposed to improve QOL and thus far, surgical intervention appears to have significant benefit for this patient population;6 however many with COPD are elderly and not surgical candidates. In addition to standard of care therapies, physical medicine modalities such as massage, electrical stimulation, acupressure, and acupuncture have previously been shown to provide symptomatic relief and improved disease management for respiratory distress.7–17
Newer therapies such as surgery are being proposed to improve QOL and thus far, surgical intervention appears to have significant benefit for this patient population, however many with COPD are elderly and not surgical candidates.
Pre-determined acupuncture points were selected based on the clinical experience of physicians designing the study, including points that are located within or near accessory muscles used for respiration. The acupuncture points were needled with either real or sham devices; the real acupuncture group received active manipulation of each needle for 3–4 minutes over the course of each 60-minute treatment; the placebo group did not have additional manipulation.
The points consisted of Zhongfu (LU1), Taiyuan (LU9), Futu (LI18), Guanyuan (CV4), Zhongwan (CV12), Zhusanli (ST36), Taixi (KI3), Wangu (GB12), Feishu (BL13), Pishu (BL20), and Shenshu (BL23). Zhongfu (embedded in the pectoralis muscles) translates as “central treasury”, alluding to its function of storing lung qi—energy required for normal lung function. Taiyuan (just lateral to the radial pulse) translates as “deep pond” or “supreme abyss” and has the function of generating the lung qi. Futu (next to the larynx) translates as “to assist the protuberance” referring to the normal functioning of the upper airway and its ability to relax muscles and in the area, thus assisting respiration. Guanyuan (approximately halfway between the umbilicus and the symphysis pubis) translates as “passage” or “gate” of “central qi,” a point used to increase energy production in the body. Zhongwan (midway between the umbilicus and the sternocostal angle) translates as “central vent” or “middle cavity,” referring to its location, as well as the concept that the middle organs are the basis for sustaining life (stomach and pancreas) and must be considered in supporting qi; it is also one of the 9 points for “returning yang”—symptoms of breathlessness, collapse, and loss of consciousness. Zhusanli (below the knee and lateral to the tibia) translates as “three-foot mile”; this point has many associations and uses, but the one most appropriate for the purpose of this discussion is the concept of allowing weary travelers on foot to travel an additional three miles. Taixi (near the medial maleolus) translates as “great stream” or “great mountain” and is another one of the 9 points for “returning yang.” It is often used to reduce dyspnea and other respiratory diseases. Wangu (just below the mastoid process) translates as “intact” or “completed bone,” the ancient name for the mastoid process; it is embedded in the insertion of the sternocleidomastoid muscle and is used to calm the mind and regulate stiffness and pain in the neck. Feishu (lateral and just inferior to T3) translates as “lung point” as it is a major point for all disorders of the respiratory system and is embedded in the trapezius muscle. Pishu (lateral and just inferior to T11) translates as “spleen point”; treatment at this location is an example of addressing the source to benefit the extension, as the spleen organ network is considered the source for the lung network. Lastly, Shenshu (lateral and just inferior to L2) translates as “kidney point” and is considered a key point for supporting the yang energy of the body and providing energy for activities of daily living commonly associated with adrenal support in Western medicine.
Researchers used previously established acceptable methodologies for measuring performance among patients with COPD:18–20 a modified Borg Scale to rate breathlessness during the 6MWT and the 6MWD, the maximal distance achieved by participants walking unassisted and un-coached. Additional parameters of resting arterial blood gasses, FEV1, pre-albumin, and a quality of life questionnaire were included.
The results of the study were dramatic in that there was statistically significant improvement in almost all parameters measured in the real acupuncture group (Borg Scale rating for breathlessness during the 6MWT reduced by over 50%; 6MWD increased by 63 meters; lowest SpO2 increased by 3.5%; pre-albumin increased by 2.4 points; respiratory strength increased by almost 40%; QOL indices improved over 30%). The placebo acupuncture group did not change significantly, except some worsening of symptoms was noted. The leading theory behind this improvement is the relaxation of inspiratory muscles that, when constantly stimulated, as with regular dyspnea, will shorten significantly; acupuncture may have helped to relax and return these muscle groups' normal resting state, allowing greater inspiratory volume (vital capacity) and thus greater air exchange.
Several studies have shown sham acupuncture with false needles to be an acceptable approach to blinding study participants.21–25 This particular study used a previously verified sham acupuncture needle, the Park sham device.26 This cleverly engineered tool is made up of a guide tube with either a real acupuncture needle or a sham needle inside. The false sub-type telescopes inward once applied to the skin, giving the sensation of a “prick” or “poke,” but nothing more. For real acupuncture to be effective De Qi must be attained; this term is used to describe the sensation felt by the patient when an acupuncture needle reaches its intended destination of the acupuncture point (most often a dull ache, nerve-like sensation, or heavy pressure inconsistent with the amount being exerted by the needle). The sensation would not be felt in a sham location or if a sham needle were to be used over a real acupuncture point. Providers of this study in the real acupuncture group ensured attainment of De Qi during each treatment by asking participants what they felt; participants in the placebo acupuncture group stated they felt a pricking or poking sensation but did not feel “De Qi.” Furthermore, follow-up inquiry into both groups revealed most participants did not know whether they were receiving real acupuncture or placebo (26 the placebo acupuncture group stated they did not know; 25 in the real acupuncture group stated they did not know).
Overall, there were several areas of improvement noted in the real acupuncture group; however a more subtle association could be inferred in regards to the functional improvements noted. The lack of FEV1 improvement in the real acupuncture group, despite significant improvement in subjective findings, underscores the importance of considering functional aspects and changes in therapeutic outcomes as well as the physiologic and anatomic impact of therapy: When a patient feels better, there are often fewer comorbidities.27