Methodological challenges in design and conduct of randomised controlled trials in acupuncture

Fei, Yutong; Cao, Huijuan; Xia, Ruyu; Chai, Qianyun; Liang, Changhao; Feng, Yuting; Du, Yi-Ran; Yu, Min; Guyatt, Gordon; Thabane, Lehana; Lao, Lixing; Liu, Jianping; Zhang, Yuqing

doi:10.1136/bmj-2021-064345

Cited by 46 publications

(37 citation statements)

References 32 publications

(58 reference statements)

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“…Moreover, there was no significant effect in the subgroup of conducting acupuncture <5 times, which might imply that fewer acupuncture times had insufficient efficacy on pregnancy outcomes of FET. Finally, it showed no statistical effect in the subgroup of the unclear population, which might result from therapeutic protocols and doctor-patient interactions, and so on (40). Nevertheless, we found acupuncture adjuvant to FET could be significantly beneficial to the populations such as recurrent implantation failure, polycystic ovary syndrome, and elderly women.…”

Section: Heterogeneity Analysesmentioning

confidence: 71%

Effects of acupuncture on the pregnancy outcomes of frozen-thawed embryo transfer: A systematic review and meta-analysis

Zhu

Xia

Huang

et al. 2022

Front. Public Health

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BackgroundAcupuncture is increasingly used as adjuvant therapy for infertile women undergoing frozen-thawed embryo transfer (FET); however, its effects and safety are highly controversial. This study aimed to evaluate the pooled effects of adjuvant acupuncture on FET pregnancy outcomes.MethodsWe considered only randomized controlled trials (RCTs) that compared acupuncture with sham acupuncture or no adjuvant treatment during FET and the primary outcome was clinical pregnancy rate. Two authors separately selected studies, extracted data, and performed a risk of bias assessment. Pooled data were expressed as risk ratio (RR) or mean difference (MD), with a 95% confidence interval (CI). In addition, we conducted subgroup and sensitivity analyses to investigate the sources of heterogeneity, and we also constructed funnel plots to assess the likelihood of publication bias. Finally, Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) was applied to evaluate the quality of evidence.ResultsA total of 14 RCTs with a total of 1,130 participants were included in the study. We found significant effects of acupuncture adjuvant to FET on the outcomes of clinical pregnancy rate (RR = 1.54, 95% CI [1.28, 1.85], I2 = 34%; 14 trials), biochemical pregnancy rate (RR = 1.51, 95% CI [1.21, 1.89]; 5 trials), endometrial thickness (MD = 0.97, 95% CI [0.43, 1.51]; 12 trials), and endometrial pattern (RR = 1.41, 95% CI [1.13, 1.75]; 7 trials). For live birth rate (RR = 1.48, 95% CI [0.90, 2.43], 4 trials), there were no statistical effectiveness. For subgroup analyses, most variables had tolerable heterogeneity (I2 = 0%) except for trials that were sham-controlled, performed acupuncture only after FET, or <5 times, which appeared to interpret most of the heterogeneity. Additionally, the quality of evidence of all outcomes in this review ranged from low to moderate.ConclusionAcupuncture could be instrumental in the pregnancy outcomes of FET, and has very few risks of severe adverse events; however, the quality of evidence is unsatisfactory. Further research with rigorous methodological quality should be considered, and the protocols of acupuncture also need more investigations (e.g., appropriate control groups, sessions, and times).

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Section: Heterogeneity Analysesmentioning

confidence: 71%

Effects of acupuncture on the pregnancy outcomes of frozen-thawed embryo transfer: A systematic review and meta-analysis

Zhu

Xia

Huang

et al. 2022

Front. Public Health

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“…However, placebo effect of acupuncture treatment was conflicting in other studies ( Sunay et al, 2011 ; Zhang et al, 2019 ). And trials using sham acupuncture may underestimate acupuncture’s treatment effect in some cases ( Fei et al, 2022 ). Moreover, some of the pooled results continued to exhibit high levels of heterogeneity and were unstable in the sensitivity analysis, although we restricted the criteria for study enrollment and performed subgroup analyses.…”

Section: Discussionmentioning

confidence: 99%

Effect of acupuncture for non-motor symptoms in patients with Parkinson’s disease: A systematic review and meta-analysis

Wang

et al. 2022

Front. Aging Neurosci.

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BackgroundAlthough non-motor symptoms of Parkinson’s disease (PD) are serious, effective treatments are still lacking. Acupuncture may have clinical benefits for non-motor symptoms of PD patients, but high-quality evidence supporting this possibility is still limited. Hence, we conducted this meta-analysis to evaluate the effect of acupuncture treatment on non-motor symptoms in patients with PD.MethodsRandomized controlled trials (RCTs) of acupuncture treatment for PD were retrieved from the following electronic databases: Medline (OVID), Embase (OVID), Cochrane Library, Web of Science, China National Knowledge Infrastructure, Chinese BioMedical Literature Database, Chonqing VIP (CQVIP), and Wangfang database. Studies evaluating non-motor symptoms of PD were retrieved. Methodological quality was assessed using the Cochrane Handbook for Systematic Reviews of Interventions.ResultsA total of 27 RCTs were included, among which 8 outcomes related to non-motor symptoms were evaluated. The results showed that acupuncture combined with medication had benefits for PD-related insomnia relative to medication alone or sham acupuncture [standardized mean difference (SMD) = 0.517; 95% confidence interval (CI) = 0.242–0.793; p = 0.000], and acupuncture treatment had benefits at 8 weeks (SMD = 0.519; 95% CI = 0.181–0.857; p = 0.003). Regarding depression, acupuncture treatment was more effective (SMD = −0.353; 95% CI = −0.669 to −0.037; p = 0.029) within 2 months (SMD = −0.671; 95% CI = −1.332 to −0.011; p = 0.046). Regarding cognition, quality of life, and Unified Parkinson’s Disease Rating Scale (UPDRS) I and II scores, acupuncture treatment was effective [SMD = 0.878, 95% CI = 0.046–1.711, p = 0.039; SMD = −0.690, 95% CI = −1.226 to −0.155, p = 0.011; weighted mean difference (WMD) = −1.536, 95% CI = −2.201 to −0.871, p = 0.000; WMD = −2.071, 95% CI = −3.792 to −0.351, p = 0.018; respectively]. A significant difference was not found in terms of PD-related constipation. Only one study evaluated PD-related fatigue.ConclusionThe results of the analysis suggested that acupuncture treatment could ameliorate the symptoms of depression, quality of life, cognition, total mentation, behavior and mood, and activities of daily living in PD patients. Nevertheless, more prospective, well-designed RCTs with larger sample sizes are required to confirm our findings.

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“…Nevertheless, in line with previous neuroimaging studies without the control group ( 22 , 25 , 54 ), our results indicated the possible mechanisms of the modulatory effects of acupuncture on SD. Furthermore, it is a challenge to set up sham acupuncture, which is not only difficult to implement but also has some specific efficacy, thus underestimating the therapeutic effect of acupuncture in the trial ( 55 ). Finally, numerous studies suggested that longer resting-state scans could improve reliability and replicability ( 56 , 57 ).…”

Section: Discussionmentioning

confidence: 99%

The altered intrinsic functional connectivity after acupuncture at shenmen (HT7) in acute sleep deprivation

Ning

Zheng²,

Feng³

et al. 2022

Front. Neurol.

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IntroductionAccumulating evidence has shown that acupuncture could significantly improve the sleep quality and cognitive function of individuals suffering from insufficient sleep. Numerous animal studies have confirmed the effects and mechanisms of acupuncture on acute sleep deprivation (SD). However, the role of acupuncture on individuals after acute SD remains unclear.MethodsIn the current study, we recruited 30 healthy subjects with regular sleep. All subjects received resting-state fMRI scans during the rested wakefulness (RW) state and after 24 h of total SD. The scan after 24 h of total SD included two resting-state fMRI sessions before and after needling at Shenmen (HT7). Both edge-based and large-scale network FCs were calculated.ResultsThe edge-based results showed the suprathreshold edges with abnormal between-network FC involving all paired networks except somatosensory motor network (SMN)-SCN between the SD and RW state, while both decreased and increased between-network FC of edges involving all paired networks except frontoparietal network (FPN)-subcortical network (SCN) between before and after acupuncture at HT7. Compared with the RW state, the large-scale brain network results showed decreased between-network FC in SMN-Default Mode Network (DMN), SMN-FPN, and SMN-ventral attention network (VAN), and increased between-network FC in Dorsal Attention Network (DAN)-VAN, DAN-SMN between the RW state and after 24 h of total SD. After acupuncture at HT7, the large-scale brain network results showed decreased between-network FC in DAN-VAN and increased between-network FC in SMN-VAN.ConclusionAcupuncture could widely modulate extensive brain networks and reverse the specific between-network FC. The altered FC after acupuncture at HT7 may provide new evidence to interpret neuroimaging mechanisms of the acupuncture effect on acute SD.

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Methodological challenges in design and conduct of randomised controlled trials in acupuncture

Cited by 46 publications

References 32 publications

Effects of acupuncture on the pregnancy outcomes of frozen-thawed embryo transfer: A systematic review and meta-analysis

Effects of acupuncture on the pregnancy outcomes of frozen-thawed embryo transfer: A systematic review and meta-analysis

Effect of acupuncture for non-motor symptoms in patients with Parkinson’s disease: A systematic review and meta-analysis

The altered intrinsic functional connectivity after acupuncture at shenmen (HT7) in acute sleep deprivation

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