Acupuncture for Poststroke Dysphagia: A Pilot, Nonrandomized, Self-Controlled Trial.

OBJECTIVE: To evaluate the effectiveness and safety of acupuncture treatment for dysphagia as a complication of stroke. Methods and Design. This is a multicenter, pragmatic, nonrandomized, self-controlled clinical trial. A total of 39 patients were recruited from several Chinese medicine outpatient clinics and hospital-affiliated speech therapy outpatient clinics in Hong Kong. 26 patients completed all the 24 sessions of acupuncture treatment within two months, and only 12 of them were used as self-control. For the self-control group, the retrospective clinical data was taken from the electronic patient records with patient consent. The descriptive swallowing function data were converted into the quantitative Royal Brisbane Hospital Outcome Measure for Swallowing (RBHOMS) scores by two registered speech therapists through a validation process. And the data were validated by reaching consensus between the two speech therapists. All subjects underwent a baseline assessment before commencement of treatment, and outcome assessments were conducted upon the completion of treatment. The primary outcome measure is the RBHOMS score, which is a swallowing disability rating scale for monitoring difficulties in daily swallowing function. Secondary outcome measures include the Chinese version of the Swallow Quality-of-Life Questionnaire and adverse events. All the primary and secondary outcomes were assessed at baseline as well as at the end of acupuncture treatment (month 2). RESULTS: A total of 39 participants aged 46 to 89 years were enrolled in the study, and the male-to-female ratio was 15 : 11. The mean baseline RBHOMS score of all 39 participants was 5.92 ± 2.23. The mean retrospective RBHOMS score of the 12 subjects who were used as self-control was 5.67 ± 1.72 before enrollment, while the mean RBHOMS score of the 26 participants who completed all the 24 sessions of treatment was 6.92 ± 2.07. There were statistically significant differences between the RBHOMS score at the completion of treatment and baseline (p=0.006), and retrospective data (p=0.042). Moreover, a significant difference was also found in terms of swallow quality-of-life score before and after acupuncture treatment (p < 0.01). CONCLUSIONS: This pilot study provides preliminary evidence for the effectiveness of acupuncture for poststroke dysphagia. The findings from this trial can be used as a foundation for future full-scale randomized controlled clinical trials to assess the efficacy and safety of acupuncture for poststroke dysphagia. Ethics and Dissemination. The ethical approval of the clinical research study was granted by the Research Ethics Committee of both New Territories East and West Cluster of Hong Kong. Written informed consent was obtained from all participants, and the study was undertaken according to the ICH-GCP Guidelines. Trial Registration. This trial is registered with ChiCTR-TRC-12002621 and the registration date is 2012-10-26.

Effectiveness and safety of acupuncture for elderly overactive bladder population in Hong Kong: study protocol for a randomized controlled trial.

BACKGROUND: Overactive bladder (OAB) is defined as "urgency, with or without urge incontinence, usually with frequency and nocturia". Acupuncture is one of the most popular alternative treatment methods for OAB. Little established evidence is available to support the effectiveness of acupuncture for OAB. This study is a pioneer randomized, double-blinded, sham-controlled trial to assess the effectiveness and safety of acupuncture in the elderly population with overactive bladder in Hong Kong. METHODS/DESIGN: This is a randomized, double-center, patient and outcome assessor blinded, sham-controlled trial. The study sample size is 100 patients. Eligible subjects aged between 60 to 90 years old will be recruited into this study. All subjects will be randomly allocated into the active acupuncture group or sham acupuncture group in a 1: 1 ratio. Participants who are allocated into the active acupuncture group will receive a standardized 30-min real acupuncture treatment session for a total of 16 sessions on the top of standard routine care, whilst those who are randomized to the sham acupuncture arm will receive sham acupuncture in addition to standard routine care. Non-penetrating needles will be utilized as sham acupuncture. The primary outcome measure is the 7-day voiding diary and the secondary outcome measures are urine nerve growth factor (NGF) level, the Incontinence Impact Questionnaire (IIQ-7), Urogenital Distress Inventory (UDI-6) and OAB Symptom Score (OABSS). All outcome measures will be collected at baseline, the end of treatment and 3 months after treatment completion. DISCUSSION: The objectives of this study include (1) to evaluate the effectiveness and safety of acupuncture treatment in patients with OAB on reduction in the frequency of incontinence episodes as derived from a 7-day voiding diary, (2) to evaluate whether acupuncture treatment could improve subjective symptoms in patients with OAB and (3) to examine the feasibility of using NGF as a biomarker for overactive bladder and test correlation with the effectiveness of acupuncture intervention. The finding of this study will provide preliminary evidence on the effectiveness and safety of acupuncture for treatment of OAB. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-INR-16010048 . Registered on 29 Nov 2016.

Effectiveness and Safety of Acupuncture for Poststroke Dysphagia: Study Protocol for a Pragmatic Multicenter Nonrandomized Controlled Trial.

Background. Dysphagia is one of the most common complications of stroke. Acupuncture is widely employed to treat poststroke dysphagia in East Asia. No evidence is established to support such treatment approach. This proposed study aims to evaluate the effectiveness and safety of acupuncture for the treatment of poststroke dysphagia. Methods and Design. This is a multicenter, pragmatic, single-blinded, nonrandomized controlled clinical trial. A total of 140 eligible patients will be enrolled in the study. Subjects who are eligible in study but refuse to have acupuncture treatment will be put on the no-acupuncture control arm. Both groups of patients will receive standard routine care, while the patients of intervention group will receive add-on standardized acupuncture treatment. Each participant in intervention group will receive a total of 24 sessions of acupuncture treatment (three times per week). The primary outcome measure is the Royal Brisbane Hospital Outcome Measure for Swallowing (RBHOMS). Secondary outcome measures include functional oral intake scale, swallow quality-of-life questionnaire in Chinese version, BMI of the participant, and adverse events. All outcome measures will be assessed at baseline, at the end of acupuncture treatment (month 2), and at two months after treatment (month 4). Ethics and Dissemination. The ethics approval of clinical research study was granted by the Research Ethics Committee of both New Territories East and West Cluster of Hong Kong. Written informed consent will be obtained from all participants and the study will be undertaken according to the ICH-GCP Guidelines. Trial Registration. This trial is registered with chictr.org (registration number: ChiCTR-TRC-12002621 and registration date: 2012-10-26).

Electroacupuncture for older adults with mild cognitive impairment: study protocol for a randomized controlled trial.

BACKGROUND: Mild cognitive impairment is an intermediary state between normal aging and clinical Alzheimer's disease. Early intervention of mild cognitive impairment may be an important strategy in the management of Alzheimer's disease. The proposal aims to evaluate if electroacupuncture would optimize cognitive function in subjects with mild cognitive impairment and understand the role of electroacupuncture in the treatment of Alzheimer's disease. METHODS/DESIGN: A randomised patient- and assessor-blind sham-controlled trial is designed to assess whether electroacupuncture intervention decreases the rate of cognitive decline amongst older adults with mild cognitive impairment. One hundred and fifty subjects aged 65 years of age or over with a diagnosis of mild cognitive impairment are recruited from the community and elderly centre in Hong Kong. All subjects are randomly allocated into two groups (75 subjects each group): the electroacupuncture group and sham control. Participants in the electroacupuncture group receive electroacupuncture stimulation by sterile, disposable acupuncture needles inserted to the acupoints with a depth of 1 to 3 cm. The acupuncture needles are subjected to 2 Hz electroacupuncture with an intensity of 5 to 10 mA. Each participant receives electroacupuncture for 8 weeks (once a day, 3 days a week) and the treatment lasts for 30 minutes each time. For sham electroacupuncture, needles are inserted to a depth of 1 to 2 mm, and connected to the electroacupuncture device without any current passing through. Outcome measures (including primary and secondary outcome measures) are collected at baseline, at the end day of intervention, and months 4 and 6 after intervention. The primary outcome is measured by the Alzheimer Disease Assessment Scale-Cognitive subscale. Secondary outcomes are measured by the mini-mental state examination, category fluency text and the Short Form 12. DISCUSSION: The study will provide evidence for evaluating and understanding the role of electroacupuncture in the treatment of Alzheimer's disease. TRIAL REGISTRATION: This trial is registered with chictr.org (registration number: ChiCTR-TRC-12002414 . Registration date: 11 August 2012.

[Randomized controlled clinical trails on treatment of knee osteoarthritis with acupuncture combined with blood-letting therapy].

OBJECTIVE: To observe the therapeutic effect of acupuncture combined with blood-letting therapy for knee osteoarthritis (KOA) and to analyze the synergism of the blood-letting therapy. METHODS: Sixty-three cases of KOA patients were randomized into a treatment group (n=31) and a control group (n=32). Patients of treatment group were treated with routine acupuncture at Ashi-points, Dubi (ST 35) and Neixiyan (EX-LE 4), Zusanli (ST 36), Yanglingquan (GB 34), etc. on the affected side, 3 times a week for 4 weeks, in combination with blood-letting (at the superficial veins around popliteal fossa) once a week for 4 weeks. Patients of control group were treated with routine acupuncture only. Western Ontario and McMaster Universities osteoarthritis index scores (WOMAC) and clinical therapeutic effects served as the objective indexes for evaluating the efficacy of blood-letting therapy. RESULTS: After the treatment, of the 32 and 31 KOA patients in control and treatment groups, 4 (12.50%) and 5 (16. 13) were under control in their symptoms, 14 (43.75%) and 17(54.84%) experienced marked improvement, 10 (31.25%) and 6 (19.35%) had an improvement, and 4 (12.50%) and 3 (9.68%) were failed, with the total effective rates being 87.50% and 90.32% respectively. No significant difference was found between the two groups in the therapeutic effect (P > 0.05). In comparison with pre-treatment, WOMAC scores, pain index, and physiological integral scores in treatment and control groups after the first and the last treatment decreased significantly (P < 0.001), and their joint stiffness index of the last treatment also lowered considerably (P < 0.001). The difference values of the integral scores between post- and pre-treatment in WOMAC, pain index, and physiological function of treatment group were remarkably higher than those of control group (P < 0.05). CONCLUSION: Acupuncture combined with blood-letting therapy can effectively improve KOA patients' physiological function and reduce joint pain especially in the early stage.

[Comprehensive therapeutic protocol of electroacupuncture combined with Chinese herbs and rehabilitation training for treatment of cerebral infarction: a multi-center randomized controlled trial].

OBJECTIVE: To evaluate the therapeutic effect of comprehensive therapeutic protocol of electroacupuncture combined with active-blood-and-dissolve-stasis herbs and rehabilitation training for cerebral infarction. METHODS: A multi-center randomized controlled trial was done, three hundred and twenty cases were divided into four groups: electroacupuncture combined with active-blood and dissolve-stasis herbs and rehabilitation training group (group A), electroacupuncture combined with rehabilitation training group (group B), herbs combined with rehabilitation training group (group C) and rehabilitation training group (group D), 80 cases in each group. The following two groups of acupoints were used alternatively in electroacupuncture treatment: the first group including Vasomotor Area, Jianyu (LI 15), Biguan (ST 31), Hegu (LI 4) and Taichong (LR 3); the second group including Motor Area, Quchi (LI 11), Yanglingquan (GB 34) and Shenshu (BL 23). 20 mL Xiangdan injection and 250 mL 5% glucose injection or 250 mL 0.9% sodium chloride injection were used by intravenous drip in herbs treatment once a day. The rehabilitation training was performed by the professional physical therapist. Each group was treated with corresponding treatment protocol. The therapeutic effect was evaluated by index of the mortality or disability rate 3 months after the onset of disease. The intention to treat analysis (ITT) was used in data. RESULTS: The mortality or handicap rate 3 months after the onset of disease of four groups were 17.5% (14/80) in group A, 22.5% (18/80) in group B, 40. 0% (32/80) in group C, and 31.3% (25/80) in group D, respectively. The group A has a best therapeutic effect (vs group C, group D, both P<0.05), and there was no adverse event. CONCLUSION: The combined application of electroacupuncture, active-blood and dissolve-stasis herbs and rehabilitation training is a better treatment for cerebral infarction in clinic.

[Clinically randomized controlled study on abdominal acupuncture for treatment of cervical spondylosis].

OBJECTIVE: To compare clinical therapeutic effects of abdominal acupuncture and traditional acupuncture on cervical spondylosis (CS). METHODS: Sixty-two cases of neck or nerve-root type CS were randomly divided into an observation group (n=32) treated by abdominal acupuncture at Zhongwan (CV 12), Guanyuan (CV 4) and others, and a control group (n=30) treated by traditional acupuncture at Fengchi (GB 20) and cervical Jiaji (EX-B 2), etc.. Simplified McGill Pain Questionnaire (MPQ) and clinical therapeutic effects were served as the objective indexes. Their clinical therapeutic effects were compared after the first session of treatment, at the end of therapeutic course and 3 months after the end of treatment. RESULTS: The two groups had a same effective rate of 100.0%. All items of MPQ in these two groups after treatment and 3 months after the end of treatment significantly improved, and in the observation group the differences in the PRI feeling score before and after the first treatment, and the difference of the total PRI scores after the first treatment, at the end of therapeutic course and 3 months after the end of treatment significantly improved as compared with the control group (P < 0.05). CONCLUSION: Abdominal acupuncture can better reduce the pain of the patient caused by CS, with transient pain-alleviating effect, but whether or not the clinical therapeutic effect of abdominal acupuncture is better than the traditional acupuncture still can not be proved.

[Observation on short-term therapeutic effect of Bo's abdominal acupuncture on chronic urticaria].

OBJECTIVE: To observe short-term therapeutic effect and safety of Bo's abdominal acupuncture for treatment of chronic urticaria. METHODS: Sixty-one cases of chronic urticaria were randomly divided into an observation group (n = 31) and a control group (n = 30). They were treated respectively with Bo's abdominal acupuncture and cetirizine. Their therapeutic effects were compared. RESULTS: The effective rate was 80.7% in the observation group and 76.7% in the control group with no significant difference, but no adverse effect was found in the observation group, and the adverse effects such as sleepiness, headache, thirsty and so on were found in the control group. CONCLUSION: Bo's abdominal acupuncture has a short-term therapeutic effect similar to cetirizine on chronic urticaria, and has no adverse effect of anti-histamine agents, being more safe.

[Randomized controlled study on picking therapy for treatment of cervical spondylosis].

OBJECTIVE: To use randomized controlled clinical research method to assess therapeutic effect of picking therapy on cervical spondylosis. METHODS: One hundred and fifty-eight cases were randomly divided into a picking therapy group (n=56), a routine acupuncture group (n=55) and a local anesthesia group (n=47). They were treated respectively with picking therapy, routine acupuncture and local anesthesia at Jing bailao (EX HN 15), Dazhui (GV 14), Jianjing (GB 21), etc. Brief McGill Pain Questionaire was used for score, which was combined with clinical symptoms and signs to analyze the therapeutic effect. RESULTS: The cured rate was 57.1% in the picking therapy group, better than 23.6% in the acupuncture group and 14.9% in the local anesthesia group (P < 0.01), and adverse reaction was basically not found in the picking therapy group. CONCLUSION: Picking therapy is a highly effective and safe therapy for cervical spondylosis.

[Clinically controlled study on phased integral needling method for treatment of cerebral infarction].

OBJECTIVE: To compare clinical therapeutic effects of phased integral acupuncture and routine acupuncture on patients with cerebral infarction. METHODS: One hundred and thirteen cases were randomly divided into a treatment group (n = 63) treated by phased integral acupuncture and a control group (n = 50) treated by routine acupuncture. Their clinical therapeutic effects were compared after treatment. RESULTS: The treatment group in the decreases of both the diagnostic score for TCM diseases of stroke and the score for neurological function defect, and the therapeutic effect was superior to the control group with significant differences (all P < 0.05). CONCLUSION: The phased integral acupuncture is an effective therapy with a therapeutic effect better than that of the routine acupuncture for treatment of hemiplegia due to cerebral infarction.