BackgroundTreatment effects of electroacupuncture for patients with subjective tinnitus has yet to be clarified.ObjectivesTo assess the effect of electroacupuncutre for alleviating the symptoms of subjective tinnitus.MethodsExtensive literature searches were carried out in three English and four Chinese databases (PubMed, EMBASE, Cochrane Library, CNKI, Wanfang Chinese Digital Periodical and Conference Database, VIP, and ChiCTR).The date of the most recent search was 1 June 2014. Randomized controlled trials (RCTs) or quasi-RCTs were included. The titles, abstracts, and keywords of all records were reviewed by two authors independently. The data were collected and extracted by three authors. The risk of bias in the trials was assessed in accordance with the Cochrane Handbook, version 5.1.0. (http://www.handbook.cochrane.org). Eighty-nine studies were retrieved. After discarding 84 articles, five studies with 322 participants were identified. Assessment of the methodological quality of the studies identified weaknesses in all five studies. All studies were judged as having a high risk of selection and performance bias. The attrition bias was high in four studies. Incompleteness bias was low in all studies. Reporting bias was unclear in all studies. Because of the limited number of trials included and the various types of interventions and outcomes, we were unable to conduct pooled analyses.ConclusionsDue to the poor methodological quality of the primary studies and the small sample sizes, no convincing evidence that electroacupuncture is beneficial for treating tinnitus could be found. There is an urgent need for more high-quality trials with large sample sizes for the investigation of electroacupuncture treatment for tinnitus.

BackgroundThe traditional Chinese theory of acupuncture emphasizes that the intensity of acupuncture must reach a threshold to generate de qi (a specific and compound sensation during the acupuncture), which is necessary to achieve the best therapeutic effect. However, the notion that de qi must be achieved for maximum benefit has not been confirmed by modern scientific evidence. This study aims to compare the efficacy of acupuncture with either strong (intended to elicit de qi) or weak stimulation among patients with allergic rhinitis.Methods/DesignThis study compares real versus sham acupuncture in 140 patients with a history of persistent allergic rhinitis (PER) or intermittent allergic rhinitis (IAR) and with a positive skin prick test (SPT). The trial will be conducted in the Teaching Hospital of Chengdu University of Traditional Chinese Medicine (China). In the study, patients will be randomly assigned into two groups by computer-generated randomization and assessed prior to treatment. They will then receive 12 sessions of treatments for 4 consecutive weeks and have a follow-up phase lasting 12 weeks. The main outcome measures include the primary and secondary indicators. Primary indicators are subjective symptoms scores as evaluated by visual analogue scales (VAS), rhinoconjunctivitis quality of life questionnaires (RQLQ), and the Modified Massachusetts General Hospital acupuncture sensation scale, Chinese version (C-MMASS). The secondary indicators are the results of laboratory examinations, such as serum allergen-specific immunoglobulin E (sIgE) nasal inflammatory cells counts (mast cells, eosinophils, and T cells), and nitric oxide concentration in nasal excretion. The use of anti-allergic medication will also be recorded as one of the secondary indicators. Furthermore, adverse events will be recorded and analyzed. Intention-to-treat analysis (ITT) and per-protocol (PP) analysis will be performed to test and verify the results in this trial.DiscussionThe results of this trial will demonstrate the efficacy of using acupuncture to treat allergic rhinitis and verify whether the effectiveness of acupuncture is related to the needle sensation de qi.Trial registrationChinese Clinical Trial Registry: ChiCTR-TRC-13003594 (registered on 16 August 2013, and the first patient was randomized on 27 September 2013).Electronic supplementary materialThe online version of this article (doi:10.1186/1745-6215-15-301) contains supplementary material, which is available to authorized users.

BackgroundCatgut implantation at acupoints has been used in China to treat allergic rhinitis (AR) for a long time. However, its efficacy and safety in the treatment of AR is controversial due to the poor quality of the clinical trial of this therapy. This study aims to identify whether catgut implantation at acupoints is indeed an effective and safe treatment for patients with persistent or intermittent allergic rhinitis (PER or IAR) by comparing with sham catgut implantation treatment.Methods and designThis study compares real versus sham catgut implantation at acupoints in 242 patients with a history of PER or IAR and with a positive skin prick test (SPT). The trial will be conducted in the Teaching Hospital of Chengdu University of Traditional Chinese Medicine. In the study, patients will be randomly assigned by computer-generated randomization list into two groups and assessed prior to treatment. Then, they will receive two sessions of treatments (once per 2 weeks) for 4 consecutive weeks and have a follow-up phase of 12 weeks. The administration of catgut implantation (or sham-control) at acupoints follows the guidelines for clinical research on acupuncture (WHO Regional Publication, Western Pacific Series No.15, 1995), and is performed double-blindly by a well-trained physician in acupuncture. The main outcome measures include the primary and secondary indicators. Primary indicators are subjective symptoms scores evaluated by visual analogue scales (VAS) and Rhinoconjunctivitis Quality of Life Questionnaires (RQLQ). The secondary indicators are the results of laboratory examinations, such as serum allergen-specific IgE, nasal inflammatory cells counts (mast cells, eosinophils, and T cells) and nitric oxide concentration in nasal excretion. The use of anti-allergic medication will also be recorded as one of the secondary indicators. Furthermore, adverse events will be recorded and analyzed. If any participants withdraw from the trial, intention-to-treat analysis (ITT) and per-protocol (PP) analysis will be performed.DiscussionThe important features of this trial include the randomization procedures, large sample, and a standardized protocol of catgut implantation at acupoints. This trial will be the first study with a high evidence level in China in order to assess the efficacy and safety of catgut implantation at acupoints in treatment of AR following a randomized, double-blind sham-controlled method.Trial registrationChinese Clinical Trial Registry: ChiCTR-TRC-12002191

Objectives To investigate if traditional Chinese medicine (TCM) auricular point acupressure (APA) can alleviate and (or) reduce the pain (including injection site pain, headache, other muscle and joint pain), fatigue, and gastrointestinal adverse reactions (including nausea, vomiting, diarrhea), after the injection of novel coronavirus-19 vaccines (NCVs). Trial design The study is designed as a multicentre, parallel-group, three-arm, single-blind, prospective, randomized (1:1:1 ratio) study. Participants More than 360 participants will be recruited from healthy people who vaccinate NCVs in 5 community healthcare centres in the Sichuan province of China and 1 university hospital (Hospital of Chengdu University of Traditional Chinese Medicine). Inclusion criteria: ①Vaccinators meets the conditions of NCVs injection and have no contraindications to it. The details shall be subject to the instructions of the NCVs used and the statement of medical institutions. The first dose of NCVs injection shall be completed within 24 hours from the time of injection to the time of enrolment; ②No redness, swelling, injury or infection of the skin or soft tissue of both ears, which is not suitable for APA; ③No history of alcohol and adhesive tape contact allergy; ④18-59 years old, regardless of gender; ⑤Those who were able to complete the questionnaire independently at the time of the first and second dose of NCVs and on the 3rd, 7th and 15th day after the first and second dose of NCVs respectively; ⑥Those who agree to participate in the trial and sign the informed consent, and can seriously abide by the precautions after the injection of NCVs and the requirements of traditional Chinese medicine auricular point plasters sticking and acupressure. Exclusion criteria: ①Those who are not suitable to be vaccinated because they belong to the contraindication or cautious population; ②Those who have participated in other clinical trials within 4 weeks before the start of this study; ③No chronic/habitual/persistent headache, Muscle or joint pain, fatigue, diarrhea, nausea, retching or vomiting before the injection of NCVs, and no related diseases present (details of this item is listed in full protocol); ④Those who are in use or have received TCMAPA within 2 weeks before the trial; ⑤Pregnant or lactating women; ⑥Participants with other serious primary diseases and psychosis. Intervention and comparator ①Auricular point acupressure group: participants receive bilateral, symptom-specific TCMAPA in 5 auricular points (per side, 10 points bilateral) for 5 days, 3-4 times (about 1 min each time) of self-acupressure per day, after each NCVs injection (10 days in total). ②Sham auricular point acupressure group: participants receive bilateral, none symptom-specific, sham APA in 5 auricular points (per side, 10 points bilateral) for 5 days, 3-4 times (about 1 min each time) of self-acupressure per day, after each NCVs injection (10 days in total). ③Blank control group: Non-intervention blank control. The Hebei medical device Co. Ltd, Hebei, China manufactured the auricular point sticking plasters. Main outcomes Primary outcomes are all scores of visual analogue scale (VAS) based on subjective judgment of the participants included, including VAS score of pain at injection site, headache, muscle and joint pain, fatigue, nausea, retching, vomiting and diarrhea. Time points for outcomes above are the same: ①Immediately after first and second injection of the vaccine (Baseline assessment); ②Three days after first and second injection of the vaccine; ③Seven days after first and second injection of the vaccine; ④Fifteen days after first and second injection of the vaccine. Randomisation Participants will be randomized in 1:1:1 ratio to each group by computerized random number generator, and independently in each sub-centre. Blinding (masking) Participants, information collectors and statistical evaluators will be blinded between APA group and sham APA group. No blinding in the control group. Numbers to be randomised (sample size) No less than 360 participants will be randomized in 1:1:1 ratio to each group. Trial Status Protocol version 2.0 of February 3rd, 2021. Recruitment is expected to start on February 18th, 2021, and to finish on March 12th, 2021. Trial registration This trial was registered in the China Clinical Trial Registry (ChiCTR) (ChiCTR2100043210) on 8th February, 2021. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

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