Therapeutic effect of Duhuo Jisheng Decoction add-on Tui-na manipulation on osteoarthritis of knee: a randomized controlled trial.

BACKGROUND: Knee osteoarthritis (KOA) is a common degenerative joint condition that causes disability and pain in the elderly population. The prevalence of KOA among persons aged 63 or above is approximately 30%. Previous studies have reported the positive effects of Tui-na treatment and the Chinese herbal formula Du-Huo-Ji-Sheng Decoction (DHJSD) for KOA treatment. The current study aims to evaluate the add-on therapeutic effect of oral administration of DHJSD on KOA in addition to Tui-na. METHODS: We conducted a prospective, randomized, controlled clinical trial. Seventy study subjects with KOA were randomly assigned to the treatment and control groups in a 1:1 ratio. Both two groups received eight sessions of Tui-na manipulation for 4 weeks. The DHJSD was only administered to the study subjects in the treatment group. The primary outcome measure was rated using the WOMAC at the end of treatment (4 weeks). Secondary outcomes were assessed using EQ-5D-5L, a health-related quality of life with 5-level EQ-5D version at end of treatment (week 4) and follow-up (week 8). RESULTS: No statistically significant difference was found between two groups on WOMAC scores at the end of treatment. The mean WOMAC Pain subscale score was significantly lower in the treatment group than control group at week 8 follow up (mean difference, MD - 1.8, 95% CI - 3.5 to - 0.02, P = 0.048). The mean WOMAC Stiffness subscale score was significantly lower in the treatment group than in the control group at week 2 (MD 0.74, 95% CI 0.05 to 1.42, P = 0.035) and week 8 follow up (MD 0.95, 95% CI 0.26 to 1.65, P = 0.008). The mean EQ-5D index value was significantly improved in the treatment group than in the control group at week 2 (MD 0.17, 95% CI 0.02 to 0.31, P = 0.022). The analysis of WOMAC scores and EQ-5D-5L in both groups showed statistically significant improvement with time. No significant adverse effect was found during the trial. CONCLUSION: DHJSD may have an add-on effect in addition to Tui-na manipulation relieving pain and improving stiffness as well as quality of life (QOL) in patients with KOA. The combined treatment was generally safe and well tolerated. Trial registration The study was registered at the ClinicalTrials.gov (website: https://clinicaltrials.gov/ct2/show/NCT04492670 , registry number: NCT04492670), registered on 30 July 2020.

Electroacupuncture with or without combined warm needling for tinnitus: Study protocol for a randomized, waitlist-controlled trial.

BACKGROUND: Tinnitus is a common auditory condition that can lead to serious problems. Clinically, acupuncture and moxibustion have been commonly applied to treat tinnitus in China, with potential therapeutic effects but with limitations in study methodology and high-quality evidence. Therefore, we designed a randomized controlled trial to evaluate the efficacy and safety of either electroacupuncture alone or combined with warm needling for reducing tinnitus loudness and improving quality of life. METHODS: This study is a prospective, multicenter, assessor-blind, 3-arm, parallel-group, randomized, waitlist-controlled trial. In total, 90 patients will be randomly assigned to the electroacupuncture, electroacupuncture and warm needing, or waitlist control group in a 1:1:1 ratio. Patients in the 2 treatment groups will be treated twice a week for a total of 5 weeks. Patients in the control group will not receive treatment during the study period and will be informed that they can receive it for free after a 10-week waiting period. The duration of intervention for this study will be 5 weeks, followed by another 5 weeks for the posttreatment assessment. The primary outcome is the change in the visual analog scale score for tinnitus loudness from baseline until the end of treatment. The secondary outcome is the tinnitus discomfort assessment measured using the Tinnitus Handicap Inventory. Outcome parameters will be assessed at baseline and at weeks 5 and 10. Any adverse events will be observed and recorded for safety assessment. Linear mixed models for repeated measures will be applied in the analysis. DISCUSSION: Acupuncture and moxibustion could be potentially effective treatment alternatives for tinnitus. The study results will provide evidence to determine the efficacy and safety of electroacupuncture with or without warm needling for tinnitus.

Acupuncture for post-stroke depression: a systematic review and network meta-analysis.

BACKGROUND: Patients with post-stroke depression (PSD) usually experience anxiety, hopelessness, and insomnia, which have a negative impact on their daily activities and post-stroke rehabilitation. Acupuncture (AC), as a minimally invasive technique, has become a popular choice for improving depression symptoms. However, it is still unclear which therapy is associated with the best outcomes for PSD. In this review, we aimed to explore the impact of AC in alleviating symptoms of PSD and to evaluate the difference in effectiveness between AC combined with pharmacotherapies and various non-pharmacotherapies. METHODS: Six databases and three clinical trials registration platforms were searched from inception to March 2023. Randomized clinical trial comparing needle-based AC with pharmacotherapy, and other non-pharmacotherapy or invalid group were included. Two independent reviewers identified eligible studies, and collected data using a pre-made form. A Bayesian network meta-analysis was conducted to assess and compare different techniques using RStudio 3.6.0 with the package 'GEMTC' V.0.8.1. The primary outcome was the efficacy for PSD assessed by scales measuring depressive symptoms. The secondary outcomes were effectiveness for neurological function and the quality of life. The ranking probabilities for all treatment interventions was performed using the Surface Under the Cumulative Ranking curve (SUCRA). The risk of bias was assessed by using the Revised Cochrane Risk of Bias tool 2. RESULTS: Sixty-two studies, involving 5308 participants published from 2003 to 2022, were included. The results showed that compared with western medicine (WM) (defined as pharmacotherapy for PSD), AC alone or with repetitive transcranial magnetic stimulation (RTMS), Traditional Chinese medicine (TCM) alone or with WM, were superior for alleviating depression symptoms. Compared to Usual Care, AC alone or plus other therapies could significantly decrease scores on the Hamilton Depression Rating scale. According to result of SUCRA, AC plus RTMS had the highest probability of improving depressive symptoms with a probability of 49.43%. CONCLUSIONS: The results of this study indicate that AC alone or combined with other therapies appears to be effective in improving depression symptoms of stroke survivors. Moreover, in comparison to WM, AC alone or plus RTMS, TCM, TCM with WM, or WM, were more effective in improving depression symptoms of PSD. Also, AC with RTMS seems to be the most effective with the highest probability. REGISTRATION: This study was registered in the International Prospective Register of Systematic Reviews (PROSPERO) database in November 2020 and updated in July 2021. The registration number is CRD42020218752.

Acupuncture combined with auricular acupressure for smoking cessation and its effects on tobacco dependence and smoking behavior among Hong Kong smokers: a multicenter pilot clinical study.

BACKGROUND: Acupuncture combined with auricular acupressure has been used as a complementary and alternative treatment for smoking cessation in Hong Kong for over 10 years. This study aimed to investigate the success rates of smoking cessation posttreatment, and to evaluate treatment effects on tobacco dependence, smoking behavior, anxiety levels, and sleep disturbances between successful and unsuccessful quit smokers in Hong Kong. METHODS: This prospective, multicenter clinical study conducted between September 2020 and February 2022 in Hong Kong was part of the Guangdong-Hong Kong-Macau Greater Bay Area project on smoking cessation. Thirty eligible current smokers (mean age 47.10 years; 40% female) were recruited and received a combination of standardized acupuncture and auricular acupressure treatments twice weekly for 8 weeks. The primary outcome was the success rate of smoking cessation at week 24. The secondary outcomes were the success rates of smoking cessation at weeks 8 and 16, exhaled carbon monoxide (CO) levels, and changes in scores on the Fagerström Test for Nicotine Dependence (FTND), Autonomy Over Smoking Scale (AUTOS), Hamilton Anxiety Rating Scale (HAM-A), Self-rating Anxiety Scale (SAS), and Pittsburgh Sleep Quality Index (PSQI). Adverse events were also recorded. RESULTS: Of 30 eligible participants, 28 completed 6 or more treatment sessions; all completed follow-up assessments. At week 24, the success rate of smoking cessation was 46.67%. The successfully quit rates at weeks 8 and 16 were 36.67% and 43.33%, respectively. The overall change in mean FTND scores from baseline improved significantly from weeks 2 to 24 (P < 0.05), with the successful quit group showing significantly greater improvement between weeks 8 and 24 (P < 0.01). Compared with baseline values, there were significant reductions in mean AUTOS scores from weeks 6 to 24 (P < 0.001), with the successful quit group showing greater improvement at weeks 16 (P = 0.04) and 24 (P < 0.001). No significant changes were detected in exhaled CO levels or HAM-A, SAS, and PSQI scores. No study-related adverse events were observed. CONCLUSIONS: Acupuncture combined with auricular acupressure could be an effective alternative treatment for smoking cessation and reduction of tobacco dependence among Hong Kong smokers. Trial registration Chinese Clinical Trial Registry, No. ChiCTR2000033650. Registered on June 7, 2020. http://www.chictr.org.cn/showproj.aspx?proj=54866.

Effects of Chinese medicine for COVID-19 rehabilitation: a multicenter observational study.

OBJECTIVES: This study aimed to evaluate the effects of Chinese Medicine (CM) on the health condition of the post-COVID-19 patients, particularly with the CM Syndrome diagnosis and Body Constitutions (BC), as well as related clinical characteristics. METHODS: 150 participants who had COVID-19 and discharged from Hong Kong public hospitals were recruited. They were provided with three to six months of CM treatments, during which assessments were made per month and at follow-up on their CM syndromes, BC, lung functions, and other medical conditions. This study was divided into two parts: (1) Retrospective survey: medical history of participants during COVID-19 hospitalization was collected during the baseline visit; (2) Prospective observation and assessments: clinical symptoms, lung functions, and BC status were evaluated in participants receiving CM treatment based on syndrome differentiation and clinical symptoms. RESULTS: The median hospitalization period was 16 days. Symptoms were presented in 145 (96.6%) patients at the day they were diagnosed with COVID-19. Fever, fatigue, and dry cough were the most common symptoms, exhibiting in 59.3% (89 of 150), 55.3% (83 of 150), and 46% (70 of 150) participants, respectively. Among the 150 post-COVID patients, majority (71.3%) were of the two particular post-COVID CM Syndromes (Qi Deficiency of Lung and Spleen, and Qi and Yin Deficiency). Upon CM treatment, there was an observable increase in participants reaching a balanced BC (i.e. healthy body conditions). The increase was observed to be more prominent in those without the particular CM Syndromes compared to those with the CM Syndromes. Main clinical symptoms in participants with the CM Syndromes decreased upon CM treatment. Occurrence of fatigue also dropped after CM treatment though not all accompanied clinical symptoms were resolved fully. Further to the improvement in terms of CM assessments, lung functions of the participants were found to show improvement after treatment. Both the performance in 6MWT and scores in the LFQ improved upon CM treatments (P < 0.05). CONCLUSION: This study provided evidence for individualized CM treatment on COVID-19 rehabilitation concerning the clinical symptoms improvements, lung functions improvement, and achieving a balanced BC. It is believed that CM may be a key to further promote rehabilitation and resolution of residual symptoms. Long-term large scale follow-up studies on sub-categorising post-COVID patients according to different CM syndromes would be required to further elucidate treatment of persistent symptoms that may be associated with long-COVID.

Acupuncture for de Quervain's tenosynovitis: A randomized controlled trial.

BACKGROUND: Acupuncture has been an alternative approach for de Quervain's tenosynovitis (DQt), but trial evidence is still lacking. PURPOSE: This study aimed to assess the efficacy of acupuncture in patients with DQt. STUDY DESIGN: A randomized controlled trial. METHODS: A total of 68 subjects with DQt were recruited from outpatients of Department of Orthopaedics and Traumatology, and Chinese medicine clinics, The University of Hong Kong, and were randomized into the acupuncture group (n = 34) and the waitlist group (n = 34). Subjects in the acupuncture group received 5 acupuncture sessions over 2 weeks, followed by a 10-week follow-up. The waitlist control group received assessments only in the first 6 weeks of the waiting period and received the same acupuncture treatment and follow-up as the treatment group in the next 12 weeks. The primary outcome was the general pain intensity using the Visual Analogue Scale (VAS) at the end of treatment (week 2). Secondary outcomes were grip and pinch strengths of affected hands, the quick Disabilities of the Arm, Shoulder and Hand Score (Q-DASH), and the World Health Organization Quality of Life-brief Questionnaire (WHOQOL-BREF) at weeks 2 and 6. RESULTS: From baseline to 2 weeks, the mean VAS score decreased by 19.5 points in the acupuncture group and by 3.4 points in the waitlist group. The difference for acupuncture vs waitlist control was -16.2 points (95% CI, -26.7 to -5.6, p = 0.003). Acupuncture effects sustained for 10 weeks (mean difference compared with baseline, -30.6; 95% CI, -39.6 to -21.7). Secondary outcomes showed that acupuncture reduced pain intensity, improved grip and pinch strength of affected hands, and Q-DASH scores, but not the scores of WHOQOL-BREF in patients. No serious adverse event occurred during the study period. CONCLUSIONS: Our findings support that 2-week of acupuncture is safe and effective in the reduction of pain intensity, and improvement of strengths and disabilities of hand in DQt patients. Acupuncture also has long-term effects on DQt. TRIAL REGISTRATION: This study was registered at clinicaltrials.gov (NCT03472443).

Guideline Acupuncture for low back pain: a clinical practice guideline from the Hong Kong taskforce of standardized acupuncture practice.

OBJECTIVE: To develop a clinical practice guideline to guide the treatment of low back pain by acupuncture. METHODS: An integrative approach of systematic review of literature, clinical evidence classification, expert opinion surveying, and consensus establishing via a Delphi program was utilized during the developing process. Both evidence-based practice standards and the personalized features of acupuncture were taken into considerations. RESULTS: Based on clinical evidence and expert opinions, we developed a clinical practice guideline for the treatment of low back pain with acupuncture. These recommendations have a wide coverage spanning from Western Medicine diagnosis and Traditional Chinese Medicine syndrome differentiation, to acupuncture treatment procedures, as well as post treatment care for rehabilitation and follow-ups. The recommendations for acupuncture practice included treatment principles, therapeutic regimens, and operational procedures. The levels of evidence and strength of recommendation were rated for each procedure of practice. CONCLUSION: A clinical practice guideline for acupuncture treating low back pain was developed based on contemporary clinical evidence and experts' consensus to provide best currently agreeable practice guideline for domestic and international stakeholders.

Would integrated Western and traditional Chinese medicine have more benefits for stroke rehabilitation? A systematic review and meta-analysis.

BACKGROUND: Stroke is a major cause of death or long-term disability worldwide. Many patients with stroke receive integrative therapy consisting of Western medicine (WM) and routine rehabilitation in conjunction with Chinese medicine (CM), such as acupuncture and Chinese herbal medicine. However, there is no available evidence on the effectiveness of the combined use of WM and CM interventions in stroke rehabilitation. AIMS: The purpose of this meta-analysis is to evaluate the results of all individual studies to assess the combined use of CM and WM in stroke rehabilitation compared with WM only. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines were followed. MEDLINE, EMBASE, Cochrane and China National Knowledge Infrastructure (CNKI) were searched. The included outcomes were dependency, motor function, depression and swallowing function. Subgroup analysis was performed, and publication bias was assessed using funnel plots. SUMMARY OF REVIEW: 58 studies and 6339 patients were included in the meta-analysis. Subgroup analysis revealed that combined therapy comprising both acupuncture and WM had a superior effect on improving dependency and swallowing function compared with standard WM therapy alone. Potential superiority of combined therapy comprising CM and WM in improving depression compared with standard WM therapy was also found. CONCLUSIONS: Our results indicate that the combined use of CM and WM could be more efficacious in stroke rehabilitation compared with the use of WM therapy alone. However, most studies were short in duration (2 to 4 weeks) and prone to different types of biases, which prevents making any conclusion regarding the long-term effects and raises concerns regarding true efficacy in context of high likelihood of Hawthorn bias. So, more randomised controlled trials with more rigorous design and longer duration of treatment and follow-up need to be conducted to compare WM alone versus WM and CM combined. PROSPERO REGISTRATION NUMBER: CRD42020152050.

Superficial Needling Acupuncture vs Sham Acupuncture for Knee Osteoarthritis: A Randomized Controlled Trial.

BACKGROUND: Acupuncture has been an alternative approach for pain management, but trial evidence is conflicting. METHODS: Eighty-six patients with knee osteoarthritis were randomly assigned in a 1:1 ratio from June 14, 2017, to January 20, 2019, to receive either superficial needling acupuncture treatment or sham acupuncture for 10 sessions over a 4-week treatment period, followed by a 6-week follow-up period. The primary outcome was the change of pain intensity at week 4 measured using a 100-mm visual analogue scale. Secondary outcomes included the Western Ontario and McMaster Universities Osteoarthritis Index and 36-Item Short Form Health Survey. RESULTS: At the end of the 4-week treatment period, mean changes in the visual analogue scale were -30.8 (95% confidence interval [CI], -38.2 to -23.0; p <.001) in the acupuncture group and -26.7 (95% CI, -34.4 to -18.8; P <.001) in the sham group. The difference between the acupuncture group and the sham group was -4.1 (95% CI, -14.4 to 6.2; P = 0.431). At week 10, the difference between the groups was -2.2 (95% CI, -13.1 to 8.8; P =0.699). There was no statistically significant difference in Western Ontario and McMaster Universities Osteoarthritis Index subscores (pain, stiffness, and physical function) and 36-Item Short Form Health Survey-related outcomes across groups from weeks 2 to 10. The incidence of treatment-related adverse events was 4.4% in the acupuncture group and 0.8% in the sham acupuncture group. All adverse events were classified as mild. CONCLUSION: Acupuncture for 4 weeks is not superior to non-penetrating sham acupuncture. The current study cannot confirm that superficial acupuncture has efficacy for the treatment of knee osteoarthritis.

Efficacy of modified Banxia Xiexin decoction in the management of Wei-Pi syndrome (postprandial distress syndrome): study protocol for a randomized, waitlist-controlled trial.

BACKGROUND: Postprandial distress syndrome manifests as a feeling of fullness and early satiation that can significantly reduce the quality of life of the patients. In Chinese medicine (CM), the syndrome is traditionally regarded as the Wei-Pi syndrome, and Banxia Xiexin decoction (BXD) has been used in the empirical treatment of the same for a long time. The current study aims to evaluate the efficacy of modified BXD in the management of Wei-Pi syndrome. METHODS/DESIGN: A randomized, waitlist-controlled trial will be conducted. A total of 84 patients with Wei-Pi syndrome will be randomized into the BXD or waitlist control group in a ratio of 1:1. The patients in the BXD group will receive the semi-individualized BXD on the basis of the syndrome differentiation in CM, for a duration of 3 weeks and will be under follow-up for further 3 weeks after the completion of therapy. Conversely, the patients in the waitlist control group will undergo the same intervention and follow-up after a 3-week waiting period. In the current study, the primary outcome will be the variation in the scores pertaining to the global scale of the Quality of Life Questionnaire for Functional Digestive Disorders after 3 weeks. The secondary outcomes include the variations in the scores pertaining to the Hospital Anxiety and Depression Scale and the EuroQoL 5-dimension 5-level Questionnaire and the results of the liver and kidney function tests. DISCUSSION: This trial will assess the efficacy of modified BXD in improving the clinical symptoms and quality of life of the patients suffering from Wei-Pi syndrome. TRIAL REGISTRATION: ClinicalTrials.gov NCT04398888 . Registered on May 21, 2020.

Efficacy of electroacupuncture plus warm needling therapy for plantar heel pain: a randomised waitlist-controlled trial.

OBJECTIVE: To investigate the therapeutic effects of electroacupuncture plus warm needling (EAWN) therapy on pain and foot function in adults with plantar heel pain (PHP). METHODS: This prospective, randomised, parallel-group, waitlist-controlled trial was conducted at a Chinese medicine centre in Hong Kong between May 2018 and February 2019. Eighty eligible community-dwelling subjects with PHP (mean age 59.7 years; 85% female) were equally randomised to receive EAWN therapy or remain on a waitlist. The treatment group received six 30-min sessions of standardised EAWN therapy over 4 weeks; the control group received no treatment. The outcome measures were the visual analogue scale (VAS) score for first-step pain, foot function index (FFI) scores and global rating of change (GRC) scale scores. Assessments were made at baseline, week 2 and week 4 (primary endpoint). The treatment group underwent additional assessments at week 8. Outcomes were evaluated by intention-to-treat analysis. RESULTS: Patients who received EAWN therapy exhibited greater improvements in the mean first-step pain VAS and all FFI scores than did those in the control group at weeks 2 and 4, with significant between-group differences (all P < 0.001). Compared with baseline, there were significant decreases in mean first-step pain VAS scores at weeks 2 and 4, and FFI scores at week 4, in the treatment group but not in the control group. The improvements in the treatment group continued until week 8. GRC scores at week 4 indicated improvement in all treated patients and only 22.5% of the control group patients (P < 0.001). There were no study-related adverse events. CONCLUSION: EAWN therapy could be an effective treatment for PHP in middle-aged and older adults. TRIAL REGISTRATION NUMBER: ChiCTR1800014906 (Chinese Clinical Trials Registry).

Chinese Herbal Medicine for Reducing Chemotherapy-Associated Side-Effects in Breast Cancer Patients: A Systematic Review and Meta-Analysis.

BACKGROUND: Chemotherapy usually induces a variety of side-effects in cancer treatment as it cannot tell normal cells apart from cancer cells and kills both. Chinese herbal medicine (CHM) has been regarded as a potential effective intervention for relieving the side-effects of chemotherapy in breast cancer patients. OBJECTIVE: This study aims to conduct a comprehensive systematic review and meta-analysis to evaluate the efficacy of CHM as adjuvant therapy for reducing the chemotherapy-induced side-effects in the treatment of breast cancer. METHODS: Main electronic databases were searched up to May 2020 for Randomized Controlled Trials (RCTs) evaluating the effect of CHM on breast cancer patients with chemotherapy. The PRISMA statement was adopted in this study and meta-analyses were performed. RESULTS: The included studies showed unsatisfied quality. Results based on available literature indicated that the adjunctive use of CHM with chemotherapy may reduce the chemotherapeutic agents-associated adverse events, including nausea and vomiting, diarrhea, alopecia, myelosuppression, and impaired immune function. CONCLUSION: A confident conclusion could not be have due to the lack of large scale and high quality trials.

Qigong for the treatment of depressive symptoms: Preliminary evidence of neurobiological mechanisms.

OBJECTIVES: Qigong has been shown to effectively reduce depressive symptoms in older adults with chronic physical illness. Here, we sought to evaluate the effects of qigong on serotonin, cortisol, and Brain-derived Neurotropic Factors (BDNF) levels and test their roles as potential mediators of the effects of qigong on depressive symptoms. METHODS: Thirty older adults with chronic physical illness participated in a randomized clinical trial. They were randomly assigned to a qigong group (n = 14) or a control group for cognitive training of executive function and memory (n = 16). The participants provided blood and saliva samples at baseline and post-intervention. Levels of cortisol were measured from the salvia samples, and serotonin and BDNF were measured from the blood samples. RESULTS: Consistent with the study findings presented in the primary outcome paper, a significant Group × Time interaction effect emerged on depressive symptoms, explained by greater reductions in the qigong group than the control group. Qigong participants had significantly larger increases in serotonin and BDNF, and decreases in cortisol levels, compared with control group participants. Moreover, treatment-related changes in cortisol levels (but not serotonin or BDNF) fully mediated the beneficial effects of qigong on depressive symptoms. CONCLUSION: The findings provide preliminary evidence that treatment-related changes in cortisol may mediate the benefits of qigong on depressive symptoms. Given the limitation of small sample size of the present study, future studies with larger sample sizes and more extended follow-up assessment are warranted to determine the reliability of these findings.

Efficacy and safety of electroacupuncture plus warm needling therapy for heel pain: study protocol for a randomized controlled trial.

BACKGROUND: Heel pain is a common foot disorder that causes pain and functional limitations. The prevalence of disabling foot pain will increase as the population ages. Previous studies have reported the positive therapeutic effects of electroacupuncture, warm needling, or the combination of both for heel pain but with limitations in the study methodologies. The current study is a rigorously designed randomized controlled trial that aims to evaluate the clinical efficacy and safety of electroacupuncture plus warm needling therapy in patients with heel pain. METHODS/DESIGN: The study protocol describes a prospective, open-label, parallel-group, randomized controlled trial to be conducted in Hong Kong. Eighty patients aged 50-80 years who have reported heel pain and first-step pain equal to or exceeding 50 mm on the 100-mm visual analog scale (VAS) will be recruited. They will be randomly assigned (1:1 ratio) to the electroacupuncture plus warm needling therapy (i.e., treatment) group or the waitlist (i.e., control) group. The treatment group will undergo six treatment sessions in 4 weeks. The control group will receive no treatment during the study period. The primary outcome measure is a mean change in the first-step pain VAS score from the baseline to week 4. Secondary outcome measures include a mean change in first-step pain VAS score from the baseline to week 2, a mean change in Foot Function Index (FFI) subscale scores and the total score from the baseline to week 2 and week 4, and patients' self-reported level of improvement at week 4. Additional week 8 follow-up assessments with first-step pain VAS and FFI measurements will be arranged for the treatment group. Any adverse events will be recorded throughout the study to evaluate safety. An intention-to-treat approach will be used to analyze the study results. DISCUSSION: This study will provide evidence on the efficacy and safety of electroacupuncture plus warm needling therapy as an alternative treatment method for heel pain. The findings will determine whether the treatment protocol is efficacious in relieving pain and improving foot function among older adults with heel pain. The study will also provide information for subsequent large-scale randomized controlled trials in the future. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR1800014906 . Registered on 12 February 2018.

A Guideline for Randomized Controlled Trials of Acupuncture.

Guidelines for clinical trials of acupuncture are scarce, particularly in their guidance on choosing an adequate control in an acupuncture trial. This guideline was developed to address the research methodology for clinical research in acupuncture which contains the essential elements to be considered in the design, preparation and reporting of an acupuncture RCT. Particularly, investigators focused on the control design because of the unique feature of acupuncture. As one size does not fit all, one single design cannot answer all research questions. Therefore, we recommend that the clinical questions be answered in different stages of trials by choosing the appropriate control or comparator. This concept is adapted from classical drug trials developed by the Food and Drug Administration (FDA) of USA in which trials are staged in four phages in order to address different research questions. From the points listed above, this guideline offers the specific recommendations in an acupuncture RCT.

Sinew acupuncture for knee osteoarthritis: study protocol for a randomized sham-controlled trial.

BACKGROUND: Sinew acupuncture is a new modality of acupuncture in which needles are inserted into acupoints, ashi points or spasm points of sinew and muscles along the meridian sinew pathway. A previous observational study revealed that sinew acupuncture has immediate analgesic effects on various soft tissue injuries, including knee injuries. However, no rigorous trials have been conducted. This study aims to examine whether sinew acupuncture can safely relieve pain and symptoms of knee osteoarthritis (KOA) and improve patients' functional movement and quality of life. METHODS/DESIGN: A randomized, sham-controlled, patient- and assessor-blinded trial will be conducted to compare the efficacy of sinew acupuncture and sham acupuncture. Subjects will be assessed by the physician and acupuncturists. A sample of eighty-six eligible subjects will be randomized into either the sinew acupuncture group or the sham acupuncture group. The intervention will be performed in the Hong Kong Tuberculosis Association Chinese Medicine Clinic cum Training Centre of the University of Hong Kong by acupuncturists with over 3 years of acupuncture experience. Subjects will receive 10 sessions of interventions for 4 weeks, followed by a 6-week follow-up. The visual analogue scale (VAS) score at week 4 will be the primary outcome. The Western Ontario and McMasters University Osteoarthritis Index (WOMAC), Timed Up & Go Test (TUG), 8-step Stair Climb Test (SCT) and the 36-Item Short Form Survey (SF-36) will be secondary outcomes. DISCUSSION: Sinew acupuncture is a potential alternative non-pharmacological therapy for KOA. This rigorous trial will expand our knowledge of whether sinew acupuncture reduces pain intensity and improves symptoms, functional movements, and quality of life of KOA patients. TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov (Identifier: NCT03099317) in March 2017.

Efficacy of abdominal acupuncture for neck pain: A randomized controlled trial.

OBJECTIVE: This study aims to provide evidence regarding the clinical efficacy of abdominal acupuncture for neck pain. METHODS: This randomized, patient and assessor-blind, sham-controlled trial was conducted at a Chinese medicine center in Hong Kong between November 2014 and March 2016. A total of 154 eligible participants (age range, 18-65 years) with neck pain were randomly assigned to receive abdominal (n = 77) or non-penetrating sham abdominal (sham group; n = 77) acupuncture. Each participant was administered treatment over six sessions by Registered Chinese Medicine Practitioners, in accordance with a standardized protocol. The primary outcome was mean improvement in neck pain disability scores evaluated by the Northwick Park Neck Pain Questionnaire (NPQ). Secondary outcomes included intensity of neck pain and health-related quality-of-life measures. The outcomes were assessed at baseline and at 2 and 6 weeks from baseline. Patients in the abdominal acupuncture group received additional follow-up evaluation at 14 weeks from baseline. Outcomes were evaluated by intention-to-treat analysis. RESULTS: All participants provided informed consent for treatment and follow-up evaluation. Patients who received abdominal acupuncture exhibited greater improvement in NPQ scores than those who received sham treatment at both 2 and 6 weeks from baseline (intergroup mean differences, -5.75; 95% confidence interval [CI], -9.48 to -2.03; P = 0.008 and -8.65; 95% CI, -12.13 to -5.16; P < 0.001, respectively). The improvement in NPQ scores in the abdominal acupuncture group was even more significant at 14 weeks from baseline. Patients in the abdominal acupuncture group also exhibited significantly greater improvements in intensity of neck pain and a few quality-of-life measures than those in the sham abdominal acupuncture group, without any serious adverse events. CONCLUSION: These findings suggest that abdominal acupuncture is an effective alternative treatment for neck pain. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR-TRC-14004932.

Types of Control in Acupuncture Clinical Trials Might Affect the Conclusion of the Trials: A Review of Acupuncture on Pain Management.

Analgesic effects of acupuncture have been extensively studied in various clinical trials. However, the conclusion remains controversial, even among large scale randomized controlled trials. This study aimed to evaluate the association between the conclusion of the trials and the types of control used in those trials via systematic review. Published randomized controlled trials of acupuncture for pain were retrieved from electronic databases (Medline, AMED, Cochrane libraries, EMBASE, PsycINFO, Clinicaltrials.gov, and CAB Abstracts) using a prespecified search strategy. One hundred and thirty-nine studies leading to 166 pairs of acupuncture-control treatment effect comparisons (26 studies comprised of 53 intervention-control pairs) were analyzed based on the proportion of positive conclusions in different control designs. We found that treatment effects of acupuncture compared with nontreatment controls had the highest tendency to yield a positive conclusion (84.3%), compared with nonneedle-insertion controls (53.3%). Whereas with needle-insertion controls, the lowest tendency of positive conclusions was observed (37.8%). Consistently, in studies reporting successful blinding, a higher tendency of positive findings on the treatment effect of acupuncture was found in the noninsertion sham controls compared with that in the insertion sham controls. We conclude that the type of control is likely to affect the conclusion in acupuncture analgesic trials. Appropriate control should be chosen according to the aims of studies.