ABSTRACT
BACKGROUND: Diabetic peripheral neuropathy (DPN) is a chronic complication of diabetes mellitus, which is the most common neuropathy worldwide. Owing to the inadequacies of existing treatment methods, managing DPN remains a significant challenge. Studies suggest that electroacupuncture (EA) could potentially serve as a beneficial alternative treatment for this condition. Nevertheless, there is still inadequate proof of its therapeutic effectiveness and safety. As a result, the goal of this protocol is to methodically compile the data pertaining to the effectiveness and security of EA in the management of DPN. METHODS: To find appropriate randomized controlled trials (RCTs), nine reliable databases in the English and Chinese languages will be examined. RevMan5.3 will be used to combine the retrieved data and perform meta-analyses. The methodological quality of the included RCTs will be evaluated using the Cochrane Risk of Bias Assessment 2.0 tool. The Grades of Recommendations, Assessment, Development, and Evaluation (GRADE) system will be utilized to evaluate the degree of strength and certainty of the evidence. We will also perform publication bias, sensitivity and subgroup analyses. DISCUSSION: This protocol describes the intended scope and approach for a forthcoming systematic review and meta-analysis that will inform therapeutic decision-making by offering current information on the efficacy and safety of EA in the treatment of DPN. The results of the study will help standardize strategies for EA in the treatment of DPN.
Subject(s)
Diabetic Neuropathies , Electroacupuncture , Meta-Analysis as Topic , Systematic Reviews as Topic , Electroacupuncture/methods , Electroacupuncture/adverse effects , Humans , Diabetic Neuropathies/therapy , Treatment Outcome , Randomized Controlled Trials as Topic , Research DesignABSTRACT
Gastroesophageal reflux disease (GERD) has a high prevalence worldwide. Li et al performed a well-designed study on the efficacy of modified Xiaochaihu decoction (MXD) for GERD, which showed that MXD is an optional therapy for GERD beyond proton pump inhibitors (PPIs). The herbal granule administration mode minimized the bias from traditional herbal formula in clinical trials. One limitation of that study was that it lacked records of side effects and rescue medication. As a chronic disease with recurrent symptoms, GERD rehabilitation requires prolonged observation of the clinical course with MXD therapy.
Subject(s)
Drugs, Chinese Herbal , Gastroesophageal Reflux , Drugs, Chinese Herbal/therapeutic use , Gastroesophageal Reflux/diagnosis , Gastroesophageal Reflux/drug therapy , Humans , Medicine, Chinese Traditional , Proton Pump Inhibitors/therapeutic useABSTRACT
BACKGROUND: Facial expression muscles atrophy is one kind of sequelae after peripheral facial paralysis. It causes critical problems in facial appearance of patient as well as social and psychological problems. This study aims to evaluate the efficacy and safety of Thread-embedding acupuncture (TEA) for the management of facial expression muscles atrophy after peripheral facial paralysis. METHODS: This is a patient-assessor blinded, randomized, sham-controlled trial. A total of fifty-six eligible patients will be randomly divided into TEA (n=28) and sham TEA (STEA) (n=28) groups. Both groups will receive TEA or STEA treatment at the frontal muscle and the depressor anguli oris muscle, at one predefined points once a week for eight weeks. Additionally, both groups will receive traditional acupuncture treatment at ten acupoints (GB20, LI4, LR3, GB12, ST7, SI18, LI20, BL2, SJ23, ST4) twice a week for eight weeks as a concurrent treatment. B-mode ultrasonography will be used to assess the changes in facial expression muscle thickness ratio of the affected/healthy side at baseline and at 10 weeks after screening, as the primary outcome. House-Brackmann Grade and lip mobility score will be measured and analyzed at baseline and 4, 8, 10, and 12 weeks after screening, as secondary outcomes. DISCUSSION: The study will compare TEA with sham TEA to explore the feasibility for TEA in improving facial expression muscles atrophy after peripheral facial paralysis. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR1900027170. Registered on 3 November 2019, http://www.chictr.org.cn/edit.aspx?pid=45173&htm=4.
Subject(s)
Acupuncture Therapy , Facial Paralysis , Acupuncture Therapy/adverse effects , Atrophy , Facial Expression , Facial Paralysis/diagnosis , Facial Paralysis/therapy , Humans , Muscles , Randomized Controlled Trials as Topic , Treatment OutcomeABSTRACT
OBJECTIVE: To compare the clinical effects of thick-needle therapy (TNT) and acupuncture therapy (AT) on patients with Bell's palsy (BP) at the recovery stage. METHODS: A total of 146 eligible participants from 3 hospitals in China were randomized into the TNT group (73 cases) and the AT group (73 cases) using a central randomization. Both groups received Western medicine thrice a day for 4 weeks. Moreover, patients in the TNT group received subcutaneous insertion of a thick needle into Shendao (GV 11) acupoint, while patients in the AT group received AT at acupoints of Cuanzhu (BL 2), Yangbai (GB 14), Dicang (ST 4), Xiaguan (ST 7), Jiache (ST 6), Yingxiang (LI 20) and Hegu (LI 4), 4 times a week, for 4 weeks. Both groups received 2 follow-up visits, which were arranged at 1 month and 3 months after treatment, respectively. The primary outcome measure was House-Brackmann Facial Nerve Grading System (HBFNGS) grade. And the clinical recovery rates of both groups were evaluated according to the HBFNGS grades after treatment. The secondary outcome measures included the facial disability index (FDI) and electroneurogram (EnoG). The adverse events were observed and recorded in both groups. RESULTS: Three cases withdrew from the trial, 2 in the TNT group and 1 in the AT group. There was no signifificant difference in the clinical recovery rates between the TNT and AT groups after 4-week treatment [40.85% (29/71) vs. 34.72% (25/72), P>0.05]. At the 2nd follow-up visit, more patients in the TNT group showed reduced HBFNGS grades than those in the AT group (P<0.01). No significant difference was observed between the two groups in FDI score, EnoG latency and maximum amplitude ratio at all time points (all P>0.05). CONCLUSION: The clinical effect of TNT was equivalent to that of AT in patients with BP at recovery stage, while the post-treatment effect of TNT was superior to that of AT. (Registration No. ChiCTR-INR-16008409).
Subject(s)
Acupuncture Therapy/instrumentation , Acupuncture Therapy/methods , Bell Palsy/therapy , Needles , Acupuncture Points , Adult , Disability Evaluation , Female , Humans , Male , Middle AgedABSTRACT
OBJECTIVE: To evaluate the efficacy of abdominal acupuncture for adhesion-stage shoulder periarthritis. METHODS: One hundred and fifty-seven cases of shoulder periarthritis were randomly divided into an abdominal acupuncture group (79 cases) and a body acupuncture group (78 cases). The abdominal acupuncture was applied at Zhongwan (CV 12), Shangqu (KI 17) and Huaroumen (ST 24) in the abdominal acupuncture group while conventional acupuncture was applied at Jianyu (LI 15), Jianliao (TE 14) and Jianzhen (SI 9) in the body acupuncture group. The treatment was given three times a week for both groups and ten times made an observation course. Before and after treatment, visual analogue scale (VAS) was adopted for pain assessment and functional activity score (Mallet score) was used for shoulder joint function assessment for all the patients. Also the efficacy of both groups was compared. RESULTS: The total effective rate in the abdominal acupuncture group was 92.4% (73/79), which was superior to 71.8% (56/78) in the body acupuncture group. The score of VAS after the treatment was 2.58 +/- 1.64 in the abdominal acupuncture group while 3.12 +/- 1.93 in the body acupuncture group, which had no statistical significance between each other (P > 0.05). The functional activity score after the treatment was 8.34 +/- 3.02 in the abdominal acupuncture group while 7.49 +/- 3.36 in the body acupuncture group, which had no statistical significance between each other (P > 0.05). CONCLUSION: The abdominal acupuncture is an ideal treatment for adhesion-stage shoulder periarthritis, which has better total efficacy than conventional acupuncture. It achieves the same effect in relieving pain and improving functional activity as conventional acupuncture, but also has an advantage at fast selection of acupoint and less discomfort of needling sensation.