Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: statistical analysis plan for a randomized controlled trial.
Tu JF, Yang JW, Wang LQ, et al. Trials. 2019;20(1):394.
This protocol was published recently by researchers from Beijing. Acupuncture is used widely to treat knee osteoarthritis (OA), despite contradictory evidence for this treatment. This study is designed to determine the efficacy of electroacupuncture (EA) and manual acupuncture versus sham acupuncture for knee OA. This is a multicenter, three-armed, randomized controlled trial. It will involve 480 participants with knee OA from China. These participants will be randomly assigned 1:1:1 to receive 24 sessions of EA, manual acupuncture, or sham acupuncture over an 8-week period.
The primary outcome will be the response rate, which is the proportion of patients who achieve the minimal clinically important improvement in pain and function at 8 weeks. This primary outcome will be analyzed via a Z-test for the intention-to-treat set. Secondary outcomes will include pain, function, global patient assessment, and quality of life. Full details of the statistical analysis plan for the primary and secondary outcomes have been provided. The statistical analysis plan was written and submitted without knowledge of the study data. The data will be analyzed according to this prespecified statistical analysis plan to avoid data-driven analysis and to enhance transparency of this trial. The trial's aim is to provide high-quality evidence on the efficacy of acupuncture for patients with knee OA.
Trial registration: Clinicaltrials.gov, NCT03366363. Registered on November 20, 2017.
Self-administered acupressure for chronic low back pain: a randomized controlled pilot trial.
Murphy SL, Harris RE, Keshavarzi NR, Zick SM. Pain Med. 2019;June 25:e-pub ahead of print.
Chronic low-back pain (CLBP) is associated with fatigue, pain, poor sleep, and disability. Acupressure is a low-risk treatment option for managing symptoms in patients with other conditions. However, but its efficacy, particularly for addressing fatigue and sleep, is unknown in CLBP. This study examined the preliminary effects of two types of self-administered acupressure (relaxing and stimulating) on fatigue, pain, sleep, and reported disability. The study was a randomized pilot trial that was conducted in which participants (N = 67) were randomized into 6 weeks of relaxing acupressure, stimulating acupressure, or usual care. Fatigue was measured by the Brief Fatigue Inventory, pain was measured by the Brief Pain Inventory, sleep was measured by the Pittsburgh Sleep Quality Index, and reported disability was measured by the Roland Morris Scale. Baseline characteristics were similar across groups.
An intent-to-treat analysis, using general linear models, showed positive reductions in pain in the acupressure groups, compared to the group who received usual care. Pain was reduced by 35%–36% in the acupressure groups. Reduction in fatigue was also found in the stimulating acupressure acupuncture group, compared with the group who received usual care. Adverse events were minimal and related to application of too much pressure. Although this was a small study, acupressure showed promising preliminary support of efficacy for pain and fatigue reduction in patients with CLBP.
Acupuncture and dry eye: current perspectives. A double-blinded randomized controlled trial and review of the literature.
Dhaliwal DK, Zhou S, Samudre SS, Lo NJ, Rhee MK. Clin Ophthalmol. 2019;13:731–740.
Dry-eye disease is a common disorder that affects vision and quality of life negatively. Prior studies have shown that acupuncture is of some benefit for patients with dry eye, but very few of these studies have included control group to mitigate a placebo effect. This study was designed by researchers from the United States to include a sham acupuncture control group in order to evaluate true acupuncture's treatment effect, creating a prospective, randomized, double-blinded, sham-acupuncture controlled trial. Acupuncture treatment for dry eye was performed according to the Niemtzow protocol for this condition. Twenty-four patients received true acupuncture and 25 received sham acupuncture. Treatment efficacy was assessed by the Ocular Surface Disease Index (OSDI) Questionnaire, ocular surface staining, tear flow, tear film break-up time (TBUT), and a general questionnaire. Atmospheric data were collected to control for the effect of atmospheric conditions on symptoms of dry eye.
OSDI scores in the treatment group improved, compared to baseline (1 week, P < 0.01; 1 month, P < 0.05; 3 months, P < 0.05; and 6 months, P < 0.01). OSDI scores in the control group improved, but did not reach significance (P = 0.09). Secondary outcome measures showed no significant improvement in TBUT, Schiermer's Test, ocular-surface grading, or artificial tear applications. However, at 3 months, a significant reduction in the frequency of eye closing was observed among participants receiving the true acupuncture treatment, compared to baseline (P = 0.002). Furthermore, intragroup analysis showed significant reductions in symptoms of discomfort (P = 0.01), dryness (P = 0.001), scratchiness (P = 0.001), and redness (P = 0.01) in the true acupuncture group at 3 months. Both true and sham acupuncture improved OSDI scores at 1 week after treatment; however, this improvement significantly greater in the true treatment groups than in the sham group at 6 months after acupuncture.
True acupuncture treatment improved many subjective assessments of dry-eye symptoms; however, other common indicators used to assess dry eye objectively (tear flow, corneal staining, and TBUT) remained unchanged. While there were trends toward improvement in the sham acupuncture group, this did not reach statistical significance during the study period. These results suggest a true treatment effect of acupuncture rather than a placebo effect. Acupuncture can, therefore, be considered as an effective adjunct to routine clinical treatment of dry eye.
Baihui point laser acupuncture ameliorates cognitive impairment, motor deficit, and neuronal loss partly via antioxidant and anti-inflammatory effects in an animal model of focal ischemic stroke.
Jittiwat J. Evid Based Complement Alternat Med. 2019;2019:1204709.
This researcher from Asia stated that stroke is recognized as one of the most dangerous killer diseases in Thailand and other countries worldwide. Development of a novel way to treat patients who have strokes is therefore urgently required. This study investigated the effect of laser acupuncture at the Baihui point on cognitive and functional recovery, neuronal loss, antioxidant-enzyme activities, and interleukin-6 (IL-6) activity in the hippocampus in an animal model of focal ischemic stroke.
Male Wistar rats were randomly divided into 4 groups: (1) sham operation; (2) permanent occlusion of the right middle cerebral artery (Rt.MCAO); (3) Rt.MCAO with sham laser acupuncture; and (4) Rt.MCAO with Baihui-point laser acupuncture. Laser acupuncture at the Baihui point and sham acupuncture at a nonacupoint were performed once daily (10 minutes at each point) for 14 days after Rt.MCAO. A 810 nm-laser beam (Weberneedle® Lauenförde, Germany) delivered a laser-spot diameter of 100 μm at the acupoint and nonacupoint, with a laser module output of 100 mW, as pulsed waves (50% duty cycle). Half of the rats in each group were examined to determine neuron density by Cresyl violet staining, while the other half were examined by biochemical assays to measure glutathione peroxidase (GSH-Px) in the hippocampus, superoxide dismutase (SOD) in the mitochondria and IL-6 activity in the hippocampus.
Laser acupuncture treatment was found to significantly enhance memory and neuron density in CA1 and CA3. Improved neurologic score, improved GSH-Px and SOD activities, and a decreased density ratio of IL-6:β-actin were also observed in the hippocampus. The researchers concluded that Baihui-point laser acupuncture alleviated cognitive impairment and motor deficits via antioxidant and anti-inflammatory effects in focal ischemic rats. Further study is warranted to investigate other possible mechanisms of action.
The effects of acupuncture on pregnancy outcomes of in vitro fertilization with embryo transfer: an interdisciplinary systematic review.
Gu YE, Zhang X, Zhang Q, Dai MC, Wu Y, Zhou Y, Qu F. J Gynecol Obstet Hum Reprod. 2019;July 2:e-pub ahead of print.
This systematic review from Chinese researchers was designed to summarize the evidence on the effect of acupuncture on pregnancy outcomes in women receiving in vitro fertilization with embryo transfer (IVF-ET). The reviewers searched MEDLINE,® the Wanfang Database, the China Academic Journal Electronic Full-text Database in the China National Knowledge Infrastructure, and the Index to Chinese Periodical Literature. Randomized controlled trials with intervention groups using acupuncture and control groups consisting of no acupuncture or sham (placebo) acupuncture in IVF-ET treatment were selected. Study characteristics were examined from these studies and an intention-to-treat approach was used to extract outcome data from each study.
In total, 31 articles, including studies involving a total of 4450 women, met the selection criteria. The legitimacy, characteristics, and IVF-ET outcomes of the included trials were summarized. The reviewers concluded that additional Traditional Chinese Medicine (TCM) theory–based, standardized, large-size, randomized, and multicenter trials are necessary before any conclusions can be made on whether or not TCM can improve IVF-ET outcomes.
Traditional Chinese Medicine self-care and lifestyle medicine outside of Asia: a systematic literature review.
Harvie A, Steel A, Wardle J. J Altern Complement Med. 2019;July 8;e-pub ahead of print.
Traditional Chinese Medicine (TCM), when applied as a whole system of care, incorporates self-care techniques and patient understanding as key aspects of patient recovery and health maintenance. This review, performed by Australian researchers, explored the literature to date on TCM self-care in settings outside of Asia—beyond the sole application of t'ai chi or Qigong—to consider simple self-care techniques as health care interventions that may be generalized to a wider population. AMED [Allied and Complementary Medicine Database], CINAHL [Cumulative Index to Nursing and Allied Health Literature], EMBASE, PubMed, and MEDLINE® databases were searched for articles from inception to July 2018. Studies were included if they were performed in settings outside of Asia and/or Asian communities, and were excluded if they solely examined t'ai chi or Qigong.
Findings of the included studies (N = 37) were categorized into 4 key areas related to the TCM self-care component evaluated: (1) self-acupressure; (2) self-acupuncture; (3) self-moxibustion; and (4) prescribed lifestyle, diet, and exercise based on a TCM diagnosis. The studies included randomized clinical trials, case studies, hospital audits, and qualitative evaluations. The studies assessed TCM self-care for a wide range of health conditions, with the majority of studies concluding with positive findings.
This review drew attention to the potential role of TCM self-care techniques, in settings outside of Asia—beyond the sole practices of t'ai chi and Qigong—as an adjunct to health maintenance and recovery. Only tentative conclusions could be drawn from existing research, however, due to variability across the studies in reporting transparency and the overall low number of studies retrieved. Further research is warranted.