Electroacupuncture with intermittent wave stimulation as rehabilitation approach for chronic Bell's palsy: a randomized controlled trial.

PURPOSE: To evaluate the effectiveness and safety of electroacupuncture (EA) using intermittent wave stimulation in enhancing facial symmetry and nerve function in chronic Bell's palsy patients. METHODS: A 6-week assessor-blinded, randomized trial followed by an 18-week observational period was conducted. Sixty individuals with chronic Bell's palsy, showing no signs of recovery after 12 months, were equally divided to receive either 18 sessions of EA using intermittent wave stimulation or Transcutaneous Electrical Stimulation (TES), administered thrice weekly over 6 weeks. The primary outcome measure was the change in the total facial nerve index (TFNI) score from baseline to Week 6, with secondary outcomes including TFNI scores at Weeks 12 and 24, as well as the change in Sunnybrook Facial Grading System (SFG) score from baseline to Week 6, and SFG scores at Weeks 12 and 24. RESULTS: The EA group showed a significant improvement, with a mean total facial nerve index score increase of 24.35 (4.77) by Week 6 compared with 14.21 (5.12) in the Transcutaneous Electrical Stimulation group (P<.001). This superiority persisted during the 24-week follow-up. While no significant difference was observed in the Sunnybrook Facial Grading System score change from baseline to Week 6, variations were noted at Weeks 12 and 24. No major adverse effects were reported. CONCLUSION: EA with intermittent wave stimulation notably enhanced facial symmetry in chronic Bell's palsy patients over Transcutaneous Electrical Stimulation by Week 6, maintaining this edge throughout the follow-up.

Low level light therapy/photobiomodulation for diabetic peripheral neuropathy: protocol of a systematic review and meta-analysis.

INTRODUCTION: Diabetic peripheral neuropathy (DPN) is one of the most common complications of diabetes that strongly impact the patients' quality of life and working ability. Evidence indicated that low level light therapy (LLLT)/photobiomodulation might be effective for neuropathy. However, the effect of LLLT for DPN is not clear. The objective of this systematic review and meta-analysis is to determine the effects and safety of LLLT/photobiomodulation for DPN, in comparison with other methods such as sham light, no treatment, other active treatment and LLLT as an additional treatment compared with another treatment alone. METHODS AND ANALYSIS: We will search eight databases from their inception to the date before the review submission. Randomised controlled trials (RCTs) will be included. Two reviewers will independently extract data using a structured data extraction method and assess the risk of bias in the included studies. Data will be synthesised using standardised mean difference or risk ratio with 95% CIs for continuous and dichotomous data, respectively. The primary outcome will be change in pain and secondary outcomes will include global symptom improvement, functional impairment and disability, impairment of sensation, quality of life, nerve conduction, and adverse events. Sensitivity and subgroup analysis will be employed to explore the influence of possible clinical and methodological characteristics. Publication bias will be assessed using funnel plot. We will conduct meta-analysis with RevMan V.5.4 and evaluate quality of the evidence using GRADE approach. ETHICS AND DISSEMINATION: This study does not require ethics approval. Our findings will be disseminated in the peer-reviewed publications. PROSPERO REGISTRATION NUMBER: CRD42021276056.

[CO2 laser moxibustion for endometriosis related pelvic pain of cold coagulation and blood stasis: a randomized controlled trial].

OBJECTIVE: To observe the clinical therapeutic effect of CO2 laser moxibustion on endometriosis related pelvic pain of cold coagulation and blood stasis. METHODS: A total of 76 patients with endometriosis related pelvic pain of cold coagulation and blood stasis were randomized into a laser moxibustion group and a sham laser moxibustion group, 38 cases in each group. In the laser moxibustion group, moxibustion was applied at bilateral Zigong (EX-CA 1) using CO2 laser moxibustion instrument. In the sham laser moxibustion group, the manipulation of moxibustion was same as the laser moxibustion group, without laser output. The treatment was given once every other day, 30 min each time, 3 times a week for 4 weeks in both groups. Before and after treatment and follow-up of 3 months after treatment, the scores of Gracely box scale (GBS) and visual analogue scale (VAS) were observed, the usage of non-steroidal anti-inflammatory drug for the duration of the treatment and the average days of taking drugs were recorded in both groups. RESULTS: Compared before treatment, the GBS and VAS scores were decreased after treatment and during follow-up in the laser moxibustion group (P<0.05), while those in the sham moxibustion group had no significant differences (P>0.05). Compared with the sham moxibustion group, the GBS and VAS scores were decreased after treatment and during follow-up (P<0.05), the cases and average days of taking drugs were less in the laser moxibustion group (P<0.05). CONCLUSION: CO2 laser moxibustion can improve the pain symptom in patients with endometriosis related pelvic pain of cold coagulation and blood stasis, and reduce the use of analgesic drugs.

A randomized sham-controlled trial of manual acupuncture for infertile women with polycystic ovary syndrome.

BACKGROUND: Polycystic ovary syndrome (PCOS) is a complex polygenic disease and is one of the most common endocrinological and reproductive disorders. The purpose of this study was to evaluate the efficacy of acupuncture combined with herbal medicine among infertile females with polycystic ovary syndrome (PCOS). METHOD: A total of 86 women with PCOS, experiencing infertility, were recruited and randomly assigned to receive either manual acupuncture (MA) or sham acupuncture (SA) twice per week for three menstrual cycles. Both groups received herbal medication. The evaluations were conducted after three menstrual cycles and 24 weeks' follow-up. RESULTS: The trial was completed by 79 (91.86%) of the 86 randomly selected patients. During this study, the pregnancy rate in the MA group (46.34%) was significantly higher than the SA group (18.42%), with a P-value of 0.008. Moreover, the ovulation rate of the MA group (58.14%) was higher than that of the SA group (45.74%), with a P-value of 0.046. The improvement rate of PCOS score and testosterone level showed a statistical difference between the two groups (P-values were <0.05). There were no other differences between the two groups. Sex hormones level, including E2, T, P, LH, and LH/FSH were significantly lower after intervention in the MA group (P-values were <0.05) compared with baseline, while only the progesterone level was reduced in the SA group (P-value = 0.008). CONCLUSION: Manual acupuncture combined with herbal medicine may be clinically useful for infertile women with PCOS in improving pregnancy and ovulation rate. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR1800014997.

Comparing the efficacy of two different temperature stimulation in warm acupuncture on acute low back pain: A randomized controlled trial.

BACKGROUND: Warm acupuncture, a combination of the mechanical stimulation of acupuncture and thermal stimulation of moxibustion, is commonly used in treating acute low back pain (LBP). This trial aimed to compare the efficacy of stronger (above 43°C) and weaker (above 40°C) heat stimulation in warm acupuncture on the function and pain in patients with acute LBP due to lumbosacral disc degeneration (LDD). METHODS: One hundred and fifty-nine adults were randomly assigned to receive warm acupuncture treatment with silver needle (SvN) or with stainless steel needle (SSN) (1:1). Both groups received a 3-week therapy with 3 sessions per week. The primary outcome was the modified Oswestry Disability Index at week 4. The secondary outcomes included average pain, three physical sign tests and adverse events. Participants were followed up at week 16 and week 28 after randomization. RESULTS: The LBP related disability and pain intensity significantly relieved more in the SvN warm acupuncture group than in the SSN group, in both the short and long term (p<0.001). The between-groups difference in physical signs showed statistical significance only in the short term (p = 0.024), but not in long term (p = 0.081; p = 0.069). CONCLUSION: Compared with warm acupuncture with stainless-steel needle at above 40°C, warm acupuncture with silver needle at above 43°C relieved more disability and pain in patients with acute LBP due to LDD. STUDY REGISTRATION: Chinese Clinical Trial Registry (ChiCTR1800019051).

Comparison of 10.6 µm Laser Moxibustion with Traditional Moxibustion in Knee Osteoarthritic Therapy: A Randomized Noninferiority Clinical Trial.

Objective: To investigate the noninferiority of 10.6 µm laser moxibustion (LM) to traditional moxibustion (TM) in knee osteoarthritis (KOA). Methods: Ninety-two patients were recruited and randomly placed into one of two groups: 10.6 µm LM or TM in a 1:1 ratio. Each patient received 12 sessions of LM or TM, focusing on the ST-35 and Ashi acupoint. The sessions took place over 4 weeks, three times a week, and were followed up over 8 weeks. The endpoint outcomes were separated into two categories, primary and secondary. The primary endpoint was assessed at the end of the 4-week treatment, using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score. The secondary endpoint was evaluated at the end of the trial and consisted of the WOMAC function and stiffness score, visual analog pain [visual analog scale (VAS)] score, and 15-m walking time test. In addition, safety evaluation was performed throughout the trial. Results: Among the 92 randomized participants, 86 (93.48%) completed the trial; 43 in each group. The WOMAC pain score improved dramatically between the LM and TM groups, with a mean difference of 20.61 [95% confidence interval (CI): -2.28 to 43.50]. Given that the lower boundary of 95% CI was greater than -18.49, noninferiority was established. In addition, both LM and TM significantly decreased the WOMAC (pain, function and stiffness) score, VAS score (p < 0.05), and the 15-m walking time at the end of the trial. Interestingly, there were not significant differences between LM and TM (p > 0.05), suggesting that both are equally effective in treating KOA. Finally, among the 92 patients, 17 (18.48%) adverse effects were documented, namely 5 (10.87%) in the LM-treated group and 11 (26.09%) in the TM-treated group. Conclusions: 10.6 µm LM is not inferior to TM in treating KOA. Moreover, both LM and TM dramatically alleviated knee pain and enhanced function of knees. Clinical Trial Registration number: ISRCTN registry trial identifier: 14604492.

The efficacy of jade moxibustion in knee osteoarthritis.

INTRODUCTION: This study aims to compare clinical effect between Jade moxibustion and traditional moxibustion, and to determine the clinical effect of Jade moxibustion on knee osteoarthritis (KOA). METHODS/DESIGN: This is a 2-parallel-group, randomized controlled trial. A total of 148 subjects with KOA (Kellgren-Lawrence grade II or III) will be recruited and randomized to receive Jade moxibustion treatment or a traditional moxibustion treatment in a 1:1 ratio. Jade moxibustion group: The affected knee of the subjects will be covered with jade kneepad. Traditional moxibustion group: Chosen the ST35, ST34, EX-LE4, SP10 and Ashi points at the affected knee. The subjects will receive treatment three times a week, altogether 12 times in 4 weeks. The main outcomes are WOMAC knee pain score, knee function score and SF-36 quality of life questionnaire changes at the 4th week. Secondary outcomes include WOMAC knee pain score and knee function score, overall clinical efficacy evaluation, medication, safety evaluation at the 2nd, 12th, and 24th week, and cytokines related to osteoarthritis in serum. DISCUSSION: This randomized controlled trial used traditional moxibustion as a control group to provide rigorous evidence for the clinical efficacy and safety of Jade moxibustion in treatment of KOA. TRIAL REGISTRATION: ISRCTN registry, No 21174552. Registered on 28 February 2020.

Comparison of the effects of 10.6-µm infrared laser and traditional moxibustion in the treatment of knee osteoarthritis.

Based on two separate randomized controlled trials (RCTs) on traditional Chinese medicine (TCM) moxibustion and 10.6-µm infrared laser moxibustion in treating knee osteoarthritis (OA), we did an indirect and preliminary comparison of the effects of the 10.6-µm laser moxibustion with the traditional moxibustion for knee osteoarthritis. The objective was to see whether the laser moxibustion is non-inferior to the traditional moxibustion in alleviating symptoms of knee osteoarthritis such as pain, stiffness, and joint dysfunction as well as improving quality of life for the patients with knee osteoarthritis, and whether a further RCT directly comparing the laser and traditional moxibustion is necessary. Pooled data from two RCTs in patients with knee osteoarthritis, trial ISRCTN68475405 and trial ISRCTN26065334, were used. In the two RCTs, the eligibility criteria were almost identical, the treatment procedure (i.e., sessions, duration, and points) were similar, and the outcome measurements (i.e., WOMAC for symptoms and SF-36 for quality of life) were the same. The double robustness method was used for the WOMAC scale and the SF-36 endpoints to detect the difference between traditional and laser moxibustion. The analysis comprised 55 patients from ISRCTN68475405 in real moxibustion arm (moxibustion group) and 88 patients from ISRCTN26065334 in real laser moxibustion arm (laser group). Demographic characteristics and course of disease were similar between the two groups. Causal inference, using the doubly robust estimating approach to correct for bias due to baseline differences, showed that there was no statistically significant difference in the WOMAC pain, stiffness, and physical function between the two treatments at midterm, end of treatment, and 4 weeks after the end of treatment (P > 0.05). The exception was that there was statistically significantly more benefit associated with laser moxibustion compared with traditional moxibustion in physical function at the follow-up of 4 weeks after the end of treatment (P=0.006). There was no statistically significant difference in most SF-36 endpoints (P > 0.05) except that physical functioning (PF), mental health (MH), and bodily pain (BP) were statistically significantly better in the laser group than in the traditional moxibustion group at the follow-up of 4 weeks after the end of treatment (P = 0.005, 0.034, 0.002). The benefits of 10.6-µm infrared laser moxibustion and the traditional moxibustion for knee osteoarthritis were comparable in pain, stiffness, physical dysfunction, and in most of the quality of life subdimensions. The laser moxibustion might be more beneficial in terms of physical function, body pain, and mental health in the long term. RCTs directly comparing 10.6-µm laser moxibustion with traditional moxibustion are warranted.

Manual acupuncture for the infertile female with polycystic ovary syndrome (PCOS): study protocol for a randomized sham-controlled trial.

BACKGROUND: Polycystic ovary syndrome (PCOS) is one of the most common endocrine diseases for women. Acupuncture is widely used for the infertile female because of it is non-invasive and has fewer side effects, but the powerful evidence for the clinic is still insufficient. Our study intends to explore the effect of manual acupuncture (MA) in the infertile female with PCOS. METHODS: This study is a randomized, sham-controlled, patient-and assessor-blinded trial and aims to evaluate the effect of MA in women with PCOS and infertility. We will recruit 86 women aged 20-40 years with a diagnosis of infertility with PCOS. Participants will be randomly allocated in a 1:1 ratio to the MA group and the sham acupuncture (SA) group. Both groups will receive real herbal medicine treatment as a basic treatment twice a day for three menstrual cycles, the MA group receive real acupuncture treatment and the SA group received placebo acupuncture treatment (non-penetrating). All patients will receive acupuncture treatment twice per week for three menstrual cycles. The primary outcome is pregnancy rate and secondary outcomes include ovulation rate, sex hormones, insulin resistance index (IRI), PCOS symptoms, and Traditional Chinese Medicine (TCM) syndrome scores. Outcome measures will be collected at baseline, each menstrual cycle, the end of treatments, and six months after the last acupuncture treatment. The present protocol followed the SPIRIT guidelines and fulfilled the SPIRIT checklist. DISCUSSION: This study will be conducted to compare the efficacy of MA versus SA. This trial will help to evaluate whether MA is effective in increasing pregnancy and ovulation rates of the infertile female with polycystic ovary syndrome. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR1800014997 . Registered on 27 February 2018.

Evaluation of clinical efficacy of silver-needle warm acupuncture in treating adults with acute low back pain due to lumbosacral disc herniation: study protocol for a randomized controlled trial.

BACKGROUND: As a common cause of low back pain, lumbosacral disc herniation (LDH) is usually dealt with using non-surgical interventions. In the face of concerns about prescription opioid abuse, alternative and complementary treatments may be promising, among which silver-needle warm acupuncture is considered as an upgrading option for its potential anti-inflammatory and strong analgesic effect for patients with chronic pain. In this proposed study, we aim to assess its clinical efficacy in comparison with conventional stainless steel filiform-needle warm acupuncture. METHODS/DESIGN: This is a randomized, two-armed, patient- and assessor-blinded trial. One hundred and sixty eligible patients recruited from December 2018 to June 2020 in three centers will be assigned for warm acupuncture treatment with either stainless steel filiform or silver needles. Nine sessions of 20-min treatment will be conducted during 3 consecutive weeks. Assessments with instruments including the Oswestry Disability Index, the visual analog scale, and the Japanese Orthopedic Association Back Pain Evaluation Questionnaire will be performed at four time points to explore the difference of clinical efficacy between two groups. DISCUSSION: If the results show that participants treated with silver-needle warm acupuncture gain a greater improvement in terms of pain intensity, physical function, and quality of life, this study is expected to offer reliable evidence to widely push this treatment for LDH in clinical practice. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR1800019051 . Registered on 24 October 2018.

[Application and development of translational medicine in modern acupuncture and moxibustion].

In recent years, translational medicine, which is characterized by advanced concepts and methods, developes rapidly and playes a strategic role in the development of TCM acupuncture and moxibustion. Therefore, it is worth studying by acupuncturists. Through the background, development, features and research model of translational medicine, the present situation and problems of TCM acupuncture research are analyzed. Several cases of translational Chinese medicine and acupuncture are listed with the consideration of the concept of translational medicine. Studies and thoughts on translational acupuncture are expounded as well. Thus, it is suggested that combined with characteristics of acupuncture, the concept of translational medicine should be utilized to instruct the clinical treatment and research of acupuncture, foster researchers of translational medicine as well as establish the related research teams.