Neurological and psychological mechanisms of the specific and nonspecific effects of acupuncture on knee osteoarthritis: study protocol for a randomized, controlled, crossover trial

Li, Jinling; Zhang, Na; Yan, Chao-Qun; Tu, Jian‐Feng; Wang, Yu; Qi, You-Sheng; Liu, Junhong; Wang, Xu; Liu, Cun‐Zhi

doi:10.21203/rs.2.24796/v2

Cited by 2 publications

(2 citation statements)

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“…However, the mechanism behind it was unelucidated. 20,21 It could also be possible that the effect of sham acupuncture was regression to the mean because we did not have a waiting list control. However, the previous study testing the effect of acupuncture on TTH showed that it was unlikely to be only an effect of regression to the mean, in which participants in the waiting list control group had a response rate of 4%.…”

Section: Discussionmentioning

confidence: 99%

Acupuncture for Patients With Chronic Tension-Type Headache

et al. 2022

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Background and Objectives:Whether acupuncture is effective for chronic tension-type headache (CTTH) is inconclusive. We aimed to examine the effectiveness of acupuncture with a follow-up period of 32 weeks.Methods:We conducted a randomized controlled trial, and 218 participants who were diagnosed with CTTH were recruited from June 2017 to September 2020. The participants in the intervention group received 20 sessions of true acupuncture (TA group) over 8 weeks. The acupuncture treatments were standardized across participants, and each acupuncture site was needled to achieve deqi sensation. Each treatment session lasted 30 minutes. The participants in the control group received the same sessions and treatment frequency of superficial acupuncture (SA group)—defined as a type of sham control by avoiding deqi sensation at each acupuncture site. The main outcome was the responder rate at 16 weeks after randomization (week 16) and was followed up at week 32. A responder was defined as a participant who reported at least a 50% reduction in the monthly number of headache days (MHDs).Results:Our study included 218 participants (mean age: 43.1 years, mean disease duration: 130 months, MHDs: 21.5 days). The responder rate was 68.2% in the TA group (n=110) versus 48.1% in the SA group (n=108) at week 16 (odds ratio, 2.65; 95%CI, 1.5 to 4.77; p<0.001); and it was 68.2% in the TA group versus 50% in the SA group at week 32 (odds ratio, 2.4; 95%CI, 1.36 to 4.3; p<0.001). The reduction in MHDs was 13.1±9.8 days in the TA group versus 8.8±9.6 days in the SA group at week 16 (mean difference, 4.3 days; 95%CI, 2.0 to 6.5; p<0.001), and the reduction was 14±10.5 days in the TA group versus 9.5±9.3 days in the SA group at week 32 (mean difference, 4.5 days; 95%CI, 2.1 to 6.8; p<0.001). Four mild adverse events were reported; three in the TA group versus one in the SA group.Conclusion:The 8-week TA treatment was effective for the prophylaxis of CTTH. Further studies might focus on the cost-effectiveness of the treatment.TrialRegistration Information: ClinicalTrials.gov: NCT03133884 (https://clinicaltrials.gov/ct2/show/NCT03133884)Classification of Evidence:This study provides Class I evidence that acupuncture (achieving deqi sensation) reduces mean headache days (per month) in patients with chronic tension-type headache.

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Section: Discussionmentioning

confidence: 99%

Acupuncture for Patients With Chronic Tension-Type Headache

et al. 2022

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“…A crossover trial is a good choice in clinical studies because it avoids differences between groups and eliminates differences between individuals, thereby improving the accuracy of efficacy evaluation by evaluating the results in different medical interventions for each patient [29]. Also, the required sample size of a crossover trial is smaller than that of an RCT, which better solves the problem of limited number of subjects and improves the evidence-based medicine evidence for the treatment of CHF with TCM comprehensive intervention [30]. ese will make up the shortcomings of the previous studies and make potential results generalizable.…”

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confidence: 99%

A Single-Central, Randomized, Double-Blinded, Placebo-Controlled, Crossover Trial Protocol: A Clinical Effect Evaluation Study on the TCM Comprehensive Intervention Program for Chronic Heart Failure

Cui

Zhou

et al. 2021

Evidence-Based Complementary and Alternative Medicine

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Background. It is known to all the doctors and patients that both the morality and incidence rate of chronic heart failure (CHF) are quite high among various heart diseases. Traditional Chinese medicine (TCM) comprehensive intervention becomes a rising prospective therapy for patients with CHF. Considering the efficacy of TCM, the study aims to test the safety as well as the validity of TCM comprehensive intervention in patients who are struggling with CHF. Methods. The study is an essentially randomized, single-central, placebo-controlled, double-blinded crossover trial. Eighty-two eligible subjects aged 18–75 years with CHF are supposed to be recruited. According to the subject plan, all the patients will be divided into group A and B. The patients in group A will receive oral Qishen Taohong granules (QTGs) combined with TCM external treatment and standard Western medicine for four weeks. After that, a 2-week washout would be proceeded; this group will be reallocated to another four weeks with oral placebo granules combined with TCM external treatment and standard Western medicine. In contrast, group B will perform the opposite protocol. The primary outcome conforms to the classification from the New York Heart Association (NYHA). Meanwhile, the secondary outcomes are echocardiogram, N-terminal pro-B-type natriuretic peptide (NT-proBNP), Chronic Heart Failure Quality of Life Scale of Integrated Chinese and Western Medicine (CHFQLS), TCM syndrome, symptom, sign, six-minute walk test (6MWT), Pittsburgh Sleep Quality Index (PSQI), Montreal cognitive assessment (MoCA), major adverse cardiovascular events (MACEs), and metabolomics. Discussion. Based on conventional treatments, TCM comprehensive intervention may further improve the patients’ cardiac function and then enhance their quality of life. The results will provide high-quality evidence of TCM comprehensive intervention in treating CHF.

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Neurological and psychological mechanisms of the specific and nonspecific effects of acupuncture on knee osteoarthritis: study protocol for a randomized, controlled, crossover trial

Cited by 2 publications

References 41 publications

Acupuncture for Patients With Chronic Tension-Type Headache

Acupuncture for Patients With Chronic Tension-Type Headache

A Single-Central, Randomized, Double-Blinded, Placebo-Controlled, Crossover Trial Protocol: A Clinical Effect Evaluation Study on the TCM Comprehensive Intervention Program for Chronic Heart Failure

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