Literature Watch

Magnetic non-invasive auricular acupuncture during eye-exam for retinopathy of prematurity in preterm infants: a multicentre randomized controlled trial.

Gan KML, Oei JL, Quah-Smith I, et al. Front Pediatr. 2020;8:615008.

An eye examination for retinopathy of prematurity (ROP) is painful, and pharmacologic analgesia might be ineffective. Researchers from Australia, Canada, Malaysia, and The Netherlands hypothesized that magnetic auricular acupuncture (MAA), compared to placebo, would decrease pain experienced by preterm infants during ROP examinations. Researchers conducted a multicenter randomized controlled trial in 3 hospitals in their countries. Eligibility for participation included infants >32 weeks' old undergoing ROP examinations and who were not sedated; and parental consent had to be received.

A total of 100 infants were randomized (1:1) to MAA (n = 50) or placebo (n = 50). MAA stickers or placebo stickers were placed on both ears of each infant by an unblinded investigator. The infant's pain was assessed using the Premature Infant Pain Profile (PIPP). Primary analyses were by intention-to-treat. The mean (standard deviation; SD) gestation, birth weight, and postnatal ages were, respectively, (MAA 28 (3) versus placebo 28 (2) weeks; MAA 1057 (455) versus placebo 952 (273) g; MAA 7 (3) versus placebo 7 (3) weeks. Placebo infants had significantly higher PIPP scores during (mean difference: 1.6 points; 95% CI confidence interval]: 0.1–3.1) and 1 hour with a mean difference of 1.5 points (95% CI: 0.7–2.2) after the procedure (P < 0.03). In MAA infants, the heart rate was lower at 173 (22)/beats per minute (bpm) versus 184 (18)/bpm, and oxygen saturation was higher at 93.8 (6.2)% versus 91.7 (6.1)%; P = 0.05. There were no adverse effects.

MAA could reduce physiologic pain responses during and after ROP examinations in preterm infants. Assessment of long-term effects are warranted.

Clinical trial registration: NCT03650621.

Acupuncture for improving cognitive impairment after stroke: a meta-analysis of randomized controlled trials.

Zhou L, Wang Y, Qiao J, Wang QM, Luo X. Front Psychol. 2020;11:549265.

This meta-analysis evaluated the efficacy of acupuncture for ameliorating cognitive impairment in patients after stroke. Randomized controlled trials (RCTs) investigating the effects of acupuncture, compared with no treatment or sham acupuncture, on poststroke cognitive impairment (PSCI) before December 2019 were identified from databases (PubMed,^® EMBASE, the Ovid library, the Cochrane Library, the Chinese National Knowledge Infrastructure, the VIP Chinese Periodical Database, the Wanfang Database, and SinoMed). Literature searching and data extracting were performed independently by 2 investigators. Study quality was assessed using the Cochrane Handbook for Systematic Reviews of Interventions.* Meta-analyses were performed for eligible RCTs with Revman, version 5.3, software.

Thirty-seven RCTs (with a total of 2869 patients) were included in this meta-analysis. Merged random-effects estimates of the gains noted on the Mini-Mental State Examination (MMSE) or the Montreal Cognitive Assessment (MoCA) were calculated to compare acupuncture to no acupuncture or to sham acupuncture. Following 2–8 weeks of intervention with acupuncture, pooled results revealed significant effects of acupuncture for improving PSCI, as assessed by the MMSE (mean difference [MD]: 95% confidence interval [CI] = 2.88 [2.09–3.66]; P < 0.00001) or the MoCA (MD: 95% CI = 2.66 [1.95–3.37]; P < 0.00001).

These results suggested that acupuncture was effective for ameliorating PSCI and supported the needs for more-rigorous trial designs for large-scale RCTs to determine acupuncture's therapeutic benefits.

Evaluation of the therapeutic effect of Traditional Chinese Medicine on osteoarthritis: a systematic review and meta-analysis.

Wang L, Zhang XF, Zhang X, et al. Pain Res Manag. 2020;2020:5712187.

Osteoarthritis (OA) is a common degenerative disease of the bones and joints. It is characterized by damage of articular cartilage and hypertonia, which often occurs in middle-age and elderly patients. Traditional Chinese medicine (TCM) therapy—including acupuncture, oral administration of medicines, and external use of TCMs—can produce a significant therapeutic effect on OA and reduce the occurrence of side-effects. Researchers from China provide a meta-analysis of trials on the treatment of OA with TCM. In the electronic database that was consulted, appropriate articles, without language restrictions on keywords, were selected until August 1, 2019. All trajectories were screened according to certain criteria. The quality of eligible trials for the analysis was also assessed. The researchers created a detailed record of the results of the measurements. The meta-analysis was performed with Revman, version 5.3, software.

Forty-four articles were selected, involving a total of 4014 patients (2012 cases in the experimental group and 2002 cases in the control group) with OA. This analysis focused on OA treatment trials using the general mode of TCM. The quality of these trials was evaluated independently, according to the Cochrane intervention system evaluation manual.

In this meta-analysis, 68.18% of the literature described the conditions for the generation of random-assignment sequences correctly, but only 6.82% of the literature mentioned the hidden details of allocation correctly, and all studies mentioned randomly assigned participants. Compared with Western medicine, the total effective rate (TER) of OA treatment with TCM was significantly increased and the recurrence rate was decreased significantly (P < 0.00001). In addition, the experimental groups were superior to the control groups in indicators of joint activity function, inflammatory-factor content, and various factors affecting bone metabolism.

A network analysis diagram was provided, showing that Aconiti radix, Achyranthis bidentatae radix, and other TCM herbs can inhibit inflammatory stimulation and relieve the pain of patients with OA. ACU at Yinlingquan, Xiyan, and other acupoints can reduce clinical symptoms effectively in patients with OA.

TCM therapy for patients with OA may effectively restore joint function, enhance the TER, and reduce the recurrence rate. However, the results of this analysis should be considered with care due to its existing limitations. Some rigorous randomized controlled trials are needed to confirm these findings.

Acupuncture for persistent atrial fibrillation after catheter ablation: study protocol for a pilot randomized controlled trial.

Lin Y, Wang X, Li XB, et al. Trials. 2021; 22(1):35.

Atrial fibrillation (AF) is a common arrhythmia that is closely related to cardiovascular morbidity and mortality. Although acupuncture is used to treat AF, the evidence for this treatment is insufficient. This pilot trial will be conducted to evaluate the feasibility, preliminary efficacy, and safety of acupuncture for reducing AF burden in patients who have persistent AF after catheter ablation (CA). This will be a multicenter, 3-arm, pilot randomized controlled trial in China. A total of 60 patients will be assigned randomly to a specific-acupoints group, a nonspecific-acupoints group, or a nonacupoints group in a 1:1:1 ratio.

The study duration will be 6 months, including a 3-month treatment period and a 3-month follow-up period. All patients will receive 18 sessions of acupuncture over 12 weeks after CA and appropriate postablation routine treatment. The primary outcome sought will be AF burden at 6 months after CA, as measured by an electrocardiography patch that can record a 7-day continuous ambulatory electrocardiographic monitoring. Secondary outcomes will include AF burden at 3 months after CA, recurrence of AF, quality of life, and other factors. Adverse events will also be recorded.

This pilot study is expected to contribute to evaluating the feasibility, preliminary efficacy, and safety of acupuncture for reducing AF burden for patients with persistent AF after CA. The results will be used for the sample-size calculation of a subsequent large-scale trial.

Trial registration: Chinese Clinical Trial Registry ChiCTR2000030576.

Alternation of EEG characteristics during transcutaneous acupoint electrical stimulation-induced sedation.

Yan F, Song D, Dong Z, et al. Clin EEG Neurosci. 2020;December 1:e-pub ahead of print.

Recent studies have shown that applying acupuncture during general anesthesia can enable a reduction of the dosage of anesthetics. Hence, it is speculated that acupuncture might have a sedative effect. However, existing studies have used acupuncture combined with anesthetics, which makes determining acupuncture's role in inducing sedation difficult. In this study, researchers from Xi'an, China, investigated the sedative effect of acupuncture by using transcutaneous acupoint electrical stimulation (TAES) at bilateral Zusanli (ST 36), Shenmen (HT 7), and Sanyinjiao (SP 6). Using a crossover design, 2 separate sessions—resting and TAES sessions—were conducted for each subject. The sedative effect was quantified by using a bispectral index (BIS). The difference in brain activities between resting and TAES sessions was investigated by analyzing simultaneously recorded electroencephalograph (EEG) signals.

A statistically significant difference in BIS values was noted between resting and TAES sessions, which suggested that TAES alone was capable of inducing observable sedation. Using a power spectrum analysis, the researchers showed that TAES-induced sedation was accompanied by a reduction in α-band power and an increment in ∂-band power. Permutation entropy was lower during the TAES sessions, which suggested that TAES reduced the complexity of the EEG signals. Moreover, a significant reduction in the global strength of brain functional connections was observed during TAES.

These findings suggest that TAES alone can induce observable sedative effects and that this sedation effect is accompanied by changes in brain activities that have been correlated with consciousness.

Mechanisms of acupuncture in the regulation of oxidative stress in treating ischemic stroke.

Su XT, Wang L, Ma SM, et al. Oxid Med Cell Longev. 2020;2020:7875396.

Ischemic stroke is the major type of cerebrovascular disease, usually resulting in death or disability among aging patients globally. Oxidative stress has been closely linked with ischemic stroke. Disequilibrium between excessive production of reactive oxygen species (ROS) and inherent antioxidant capacity leads to subsequent oxidative damage in the pathologic progression of ischemic brain injury. Acupuncture has been applied widely for treating cerebrovascular diseases from time immemorial in China. This review mainly emphasizes the evidence to illuminate the possible mechanisms of acupuncture therapy in treating ischemic stroke through regulating oxidative stress.

Researchers from China and the United States found that, by regulating a battery of molecular-signaling pathways involved in redox modulation, acupuncture not only activated the inherent antioxidant enzyme system but also inhibited excessive generation of ROS. Acupuncture therapy has the potential to alleviate oxidative stress caused by cerebral ischemia; this effect might be linked with the neuroprotective effect of acupuncture.

Acupuncture vs. pharmacological prophylaxis of migraine: a systematic review of randomized controlled trials.

Giovanardi CM, Cinquini M, Aguggia M, et al. Front Neurol. 2020;11:576272.

Migraine is a chronic paroxysmal neurologic disorder characterized by attacks of moderate-to-severe headache and reversible neurologic and systemic symptoms. Treatment for migraine includes acute therapies to reduce the intensity of pain in each attack and preventive therapies to decrease the frequency of headache recurrences. This systematic review assessed the efficacy and safety of acupuncture, compared to pharmacologic treatment, for the prevention of episodic or chronic migraine in adult patients.

For the analysis, researchers from Italy included randomized controlled trials published in Western languages that compared any treatment involving needle insertion (with or without manual or electrical stimulation) at acupuncture points, pain points, or trigger points, with any pharmacologic prophylaxis in adults (≥ 18 years' old) who had chronic or episodic migraine with or without auras, according to the criteria of the International Headache Society.

Nine randomized trials were included encompassing a total of 1484 patients. At the end of the intervention, there was a small reduction in favor of acupuncture for the number of days with migraine per month: (standardized mean difference [SMD]: −0.37; 95% confidence interval [CI]: −1.64 to −0.11) and for response rate (RR: 1.46; 95% CI: 1.16 to 1.84). There was a moderate effect in reduction of pain intensity in favor of acupuncture (SMD: −0.36; 95% CI:–0.60 to −0.13), and a large reduction in favor of acupuncture in both dropout rate for any reason (RR: 0.39; 95% CI: 0.18 to 0.84) and dropout rate due to adverse events (RR: 0.26; 95% CI: 0.09 to 0.74). The quality of evidence was moderate for all of these primary outcomes. Results at longest follow-up confirmed these effects.

Based on this moderate certainty of evidence, the researchers concluded that acupuncture was mildly more effective and much safer than medication for prophylaxis against migraine.

*

Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA, eds. Cochrane Handbook for Systematic Reviews of Interventions, 2nd ed. Chichester, UK: John Wiley & Sons; 2019.