Clinical short-term outcomes of articular-sided and bursal-sided partial-thickness rotator cuff tears of less than 50% in a single surgeon series: A protocol of randomized controlled trial

Background:There have been no published randomized clinical trial to assess the clinical outcomes between the articular-sided and bursal-sided tears. Therefore, a comparative analysis of evaluating and comparing the functional outcomes following arthroscopic repair of bursal-sided versus articular-sided partial-thickness rotator cuff tearsis essential.Methods:This study is a present randomized controlled trial which is conducted in our hospital. Consecutive patients with symptomatic articular-sided or bursal-sided partial-thickness rotator cuff tears underwent arthroscopic repair between June 2020 and January 2022. The institutional review board approved the study proposal (with number 10012030), and informed consent was obtained from all patients. Inclusion criteria were existence of an articular- or bursal-sided tear involving <50% of the tendon thickness—confirmed intraoperatively and treated with arthroscopic debridement with or without other decompression surgery (acromioplasty/distal clavicle resection)—and a minimum follow-up of 2 years. All patients followed the same postoperative rehabilitation program. The patients were assessed at baseline preoperatively, and at 1 year and 2 years postoperatively. Outcome parameters were measured at each respective follow-up, which included active range of motion in forward flexion and abduction of the affected shoulder, pain score as measured on the Numeric Pain Rating Scale, as well as outcome scores in terms of the Constant-Murley Score, and Oxford Shoulder Score.Results:Table 1 and Table 2 describe the data indicators that this article wants to evaluate and collect.Conclusions:We hypothesize that both groups of patients will show improvement in range of motion, functional outcome scores, and pain at 2 years, and that results would be similar between the two groups.Trial registration:This study protocol was registered in Research Registry (researchregistry6496).     

Comparison of ventriculoperitoneal shunt to lumboperitoneal shunt in the treatment of idiopathic: A monocentric,assessor-blinded,randomized controlled trial

Background:Ventriculoperitoneal shunt (VPS) and lumboperitoneal shunt (LPS) remain the mainstay of idiopathic normal pressure hydrocephalus (INPH). There are no randomized controlled trials completed to compare the efficacy of these 2 shunt techniques.Methods/design:We will conduct a monocentric, assessor-blinded, and randomized controlled trial titled “Comparison of Ventriculoperitoneal Shunt to Lumboperitoneal Shunt for the treatment of Idiopathic Normal Pressure Hydrocephalus: Phase I (COVLINPH-1)” trial and recruit patients at West China Hospital of Sichuan University since June 2021. And this trial is expected to end in December 2030. Eligible participants will be randomly assigned into LPS group and VPS group at ratio of 1:1 followed by evaluation before surgery, 1 month, 12 months, and 5 years after surgery. The primary outcome is the rate of shunt failure within 5 years. The secondary outcomes include modified Rankin Scale (mRS), INPH grading scale (INPHGS), mini-mental state examination (MMSE), and Evans index. We will calculate the rate of favorable outcome, which is defined as shunt success and an improvement of more than 1 point in the mRS at evaluation point. We will also analyze the complications throughout the study within 5 years after shunt insertion.Discussion:The results of this trial will provide state-of-the-art evidence on the treatment option for patients with INPH, and will also generate the discussion regarding this subject.Trial registration number:ChiCTR2000031555; Pre-results.     

A comparison between Qigong exercise and cycle ergometer exercise for the rehabilitation of chronic obstructive pulmonary disease: A pilot randomized controlled trial (CONSORT)

Background:Chronic obstructive pulmonary disease (COPD) is a common respiratory disease that is associated with significant morbidity and mortality. Exercise training confers health benefits to people with COPD. The purpose of this study was to compare differences in the rehabilitation of COPD between Qigong exercise (QE) and aerobic exercise using a cycle ergometer (CE).Methods:This study was a randomized single-blind controlled trial. Twenty six participants were recruited and randomized to either the Qigong group or the cycle ergometer group. Both interventions lasted 12 weeks and comprised a 30 minutes supervised training session performed twice a week, that is, 24 sessions in total. The primary outcome measure was the endurance capacity measured by the six-minute walk test (6MWT). The secondary outcome measures were the results of the St. George''s Hospital Respiratory Questionnaire (SGRQ) and the COPD assessment test (CAT).Results:Participants in the group that performed aerobic exercise using a cycle ergometer had significantly improved 6MWT (P = .005), SGRQ (P = .029), and CAT (P = .018) results. Participants in the Qigong exercise group had significant changes in 6MWT (P = .033). However, the differences in 6MWT and SGRQ were not statistically significant between the 2 groups. The changes in CAT scores before and after the intervention were significantly different between the 2 groups (P = .020). There were no reports of adverse events during the course of the trial.Conclusions:There was no difference in the primary outcome between groups. In particular, QE and cycle ergometer exercise had similar rehabilitation effects on the improvement of the cardiopulmonary endurance and quality of life of chronic obstructive pulmonary disease patients. In addition, cycle ergometer exercise may lead to a better trend of improvement in the quality of life and can improve the severity of the clinical symptoms of chronic obstructive pulmonary disease.Trial registration:ChiCTR-TRC-14004404.     

Efficacy and safety of qiming granule combined with laser in the treatment of diabetic retinopathy: A protocol of randomized controlled trial

Background:Diabetic retinopathy is not only the most common complication of diabetes, but also 1 of the main causes of blindness, which seriously affects the physical and mental health of patients. Panretinal photocoagulation is a common method for the treatment of diabetic retinopathy, but it has some defects. Qiming granule has advantages in the treatment of diabetic retinopathy, but there is a lack of standard clinical research to verify it. Therefore, the purpose of this randomized controlled trial is to evaluate the efficacy and safety of qiming granule combined with laser in the treatment of diabetic retinopathy.Methods:This is a prospective randomized controlled trial to study the efficacy and safety of Qiming granule combined with laser in the treatment of diabetic retinopathy. Approved by the Clinical Research Society of our hospital. The patients are randomly divided into a treatment group (Qiming granule combined with laser treatment group) or control group (simple laser treatment group). The patients are followed up for 12 months after 6 months of treatment. Observation indexes include total effective rate, corrected visual acuity, macular fovea thickness, adverse reactions and so on. Data are analyzed using the statistical software package SPSS version 18.0 (Chicago, IL).Discussion:This study will evaluate the clinical efficacy and safety of qiming granule combined with laser in the treatment of diabetic retinopathy. The experimental results of this study will provide a reliable reference basis for clinical use of qiming granule combined with laser in the treatment of diabetic retinopathy.Trial registration:OSF Registration number: DOI 10.17605/OSF.IO/ZEQPB.     

Dexamethasone for the treatment of traumatic brain injured patients with brain contusions and pericontusional edema: Study protocol for a prospective,randomized and double blind trial

Background:Traumatic brain injury (TBI) constitutes a leading cause of death and disability. Patients with TBI and cerebral contusions developing pericontusional edema are occasionally given dexamethasone on the belief that this edema is similar to that of tumors, in which the beneficial effect of dexamethasone has been demonstrated.Methods:The DEXCON TBI trial is a multicenter, pragmatic, randomized, triple-blind, placebo controlled trial to quantify the effects of dexamethasone on the prognosis of TBI patients with brain contusions and pericontusional edema. Adult patients who fulfill the elegibility criteria will be randomized to dexamethasone/placebo in a short and descending course: 4 mg/6 h (2 days); 4 mg/8 hours (2 days); 2 mg/6 hours (2 days); 2 mg/8 hours (2 days); 1 mg/8 hours (2 days); 1 mg/12 hours (2 days). The primary outcome is the Glasgow Scale Outcome Extended (GOSE) performed 1 month and 6 months after TBI. Secondary outcomes are: number of episodes of neurological deterioration; symptoms associated with TBI; adverse events; volume of pericontusional edema before and after 12 days of treatment; results of the neuropsychological tests one month and 6 months after TBI. The main analysis will be on an “intention-to-treat” basis. Logistic regression will estimate the effect of dexamethasone/placebo on GOSE at one month and at 6 months, dichotomized in unfavorable outcome (GOSE 1–6) and favorable outcome (GOSE 7–8). Efficacy will also be analyzed using the ''sliding dichotomy’. An interim and safety analysis will be performed including patients recruited during the first year to calculate the conditional power. A study with 600 patients would have 80% power (2 sided alpha = 5%) to detect a 12% absolute increase (from 50% to 62%) in good recovery.Discussion:This is a confirmative trial to elucidate the therapeutic efficacy of dexamethasone in a very specific group of TBI patients: patients with brain contusions and pericontusional edema. This trial could become an important milestone for TBI patients as nowadays there is no effective treatment in this type of patients.Trial Registration:eudraCT: 2019–004038–41; Clinical Trials.gov: {"type":"clinical-trial","attrs":{"text":"NCT04303065","term_id":"NCT04303065"}}NCT04303065.     

Acupuncture treatment of hypertension with insomnia: A protocol for randomized,double-blind,placebo controlled trial research

Introduction:Hypertension patients often suffered from insomnia problems which lowered the quality of life. Studies have shown that acupuncture is effective to treat perimenopausal and cancer-related insomnia. However, there is a lack of randomized controlled trials to support the effectiveness of acupuncture on insomnia of hypertension patients.Methods and analysis:This study is a randomized, double-blind (patients and evaluators), and placebo-controlled clinical trial to investigate the effect of acupuncture in hypertension patients’ insomnia management. We will recruit 158 hypertension patients suffering from insomnia in Bao’an People''s Hospital, Shenzhen and randomly assign them into treatment group (antihypertensive drugs + acupuncture) and control group (antihypertensive drugs + sham acupuncture) in a 1:1 ratio. The patients will receive acupuncture 3 times a week for 12 weeks, and then a 6-months follow-up will be conducted after the treatment. The primary outcome is the Pittsburgh Sleep Quality Index. The secondary outcomes include sleep parameters, blood pressure dropping, sleeping pill dosage, Rating Depression Scale score, and Self-Rating Anxiety Scale score. The primary outcome will be evaluated at baseline, 4, 8, and 12 weeks, and 1, 3, and 6 months following the end of treatment. The secondary outcomes will be assessed at baseline and 12 weeks of the treatment period.     

Study for cerebral central network mechanism of acupuncture stimulation quantity based on changes of cerebral functional connection of fMRI

Background:Ischemic stroke is a major chronic noninfectious disease that seriously endangers health. Acupuncture is effective for ischemic stroke and less adverse reactions. However, there is not enough clinical trial data and solid evidence could confirm how acupuncture work to cerebral functional connectivity changes, and whether the changes is related to the different stimulation quantity.Design:This is a multicenter, central-randomized, controlled, double-blind, noninferiority, 2 factors and 3 levels orthogonal clinical trial. A total of 100 participants with ischemic stroke aged from 40 to 80 were randomized into experimental group and control group, the experimental group was divided into 9 groups (A1-A9) according to different factors or levels, and each group have 10 participants. The whole study period is 17 days, including 1 week for baseline observation, 3 days treatment and observation, and 1 week follow-up. Primary outcome is the fMRI based on blood oxygenation level dependent. Secondary outcomes included National Institute of Health Stroke Scale, Modified Barthel Index, Brunnstrom stroke recovery, stroke Chinese medicine symptom. Clinical assessments will be evaluated at before and the 0 hour, 24 hours, 36 hours after treatment, and 1 week follow-up. The primary outcome of the postacupuncture effect were investigated by paired T-test, and the continuous outcome variables will be analyzed with univariate repetitive measurement deviation analysis. Adverse events will be noted and recorded for the safety evaluation.Conclusion:The purpose of this study was to evaluate the central mechanism of acupuncture stimulation quantity using time and frequency as control conditions. This study will provide reasonable stimulation parameters and strong mechanism evidence of cerebral central network for the use of acupuncture for ischemic stroke.CHICTR registration number:ChiCTR1900023169. Registered 15 May 2019.     

Acupuncture for amnestic mild cognitive impairment: A pilot multicenter,randomized, parallel controlled trial

Introduction:Patients with amnesic mild cognitive impairment (aMCI) are more likely to develop Alzheimer disease than corresponding age normal population. Because Alzheimer disease is irreversible, early intervention for aMCI patients seems important and urgent. We have designed a pilot multicenter, randomized, parallel controlled trial to assess the efficacy and safety of acupuncture on aMCI, explore the feasibility of acupuncture in the treatment of aMCI, so as to provide a reference for large-sample clinical trials in the next stage.Method:We designed a pilot multicenter, randomized, parallel controlled trial. This trial aims to test the feasibility of carrying out a large-sample clinical trial. In this trial, 50 eligible patients with aMCI will be included and allocated to acupuncture group (n = 25) or sham acupuncture group (n = 25) at random. Subjects will accept treatment 2 times a week for 12 weeks continuously, with a total of 24 treatment sessions. We will select 6 acupoints (GV20, GV14, bilateral BL18, bilateral BL23). For the clinical outcomes, the primary outcome is Montreal cognitive assessment, which will be assessed from baseline to the end of this trial. And the secondary outcomes are Mini-mental State Examination, Delayed Story Recall, Clinical Dementia Rating scale, Global Deterioration Scale, Activity of Daily Life, Alzheimer Disease Assessment Scale-Cognitive Section, brain magnetic resonance imaging, brain functional magnetic resonance imaging, and event-related potential P300, which will be assessed before and after treatment. In addition, we will assess the safety outcomes from baseline to the end of this trial and feasibility outcome after treatment. We will evaluate neuropsychological assessment scale (Montreal cognitive assessment, Mini-mental State Examination, Alzheimer Disease Assessment Scale-Cognitive Section) at 3 months and 6 months after treatment.Discussion:This pilot trial aims to explore the feasibility of the trial, verify essential information of its efficacy and safety. This pilot study will provide a preliminary basis for carrying out a larger clinical trial of acupuncture on aMCI in near future.     

Zhengqing fengtongning sustained-release tablets prevents gout flares in the process of ULT: A randomized,positive control,double-blind,double-simulation,multicenter trial

Introduction:When initiating urate-lowering therapy, using anti-inflammatory prophylaxis therapy for at least 3 to 6 months is strongly recommended. Previous studies have found that zhengqing fengtongning sustained-release tablets (sinomenine) can improve inflammation in the acute phase of gout; however, the efficacy of urate-lowering therapy in reducing frequency of acute flares still needs to be investigated. The aim of the present study is to explore the efficacy and safety of sinomenine for prophylaxis of acute flares when initiating urate-lowering therapy.Methods and analysis:This randomized, placebo-controlled, double-blinded trial will include a total of 210 gout patients who meet the study criteria. The patients will be randomized (1:1) to the test group and the control group. The intervention is planned to be performed for 12 weeks with a follow-up of 12 weeks. All patients would be administered febuxostat (40 mg/d) and concomitant anti-inflammatory prophylaxis therapy. Sinomenine and colchicine placebo are administered in the sinomenine group, sinomenine placebo and colchicine are administered in the colchicine group. The primary outcome is the rate of acute gout flares in subjects within 12 weeks of the treatment period. The secondary outcomes include the times of acute gout flares and the duration of each acute flares within 12 weeks; the compliance rate in patients whose UA levels ≤6.0 mg/dL (360 μmol/L) at the weekend of 2nd, 4th, 8th, and 12th week in each group; the proportion of patients with ≥1 and ≥2 gout flares within 12 weeks; average visual analogue scale/score pain score during gout flares; and the oral dose of etoricoxib will be used to control the onset of acute flares within 12 weeks.Ethics and dissemination:The Institutional Medical Ethics Committee have approved the trial protocol. We plan to publish the results of this study in a peer-reviewed journal.Trial registration:ChiCTR, ChiCTR2100045114, Registered 8 April 2021 http://www.chictr.org.cn/showproj.aspx?proj=124688     

Effectiveness and safety of acupotomy on lumbar spinal stenosis: A pragmatic randomized,controlled, pilot clinical trial: A study protocol

Introduction:Lumbar spinal stenosis (LSS) is a pathological condition that causes a variety of neurological symptoms due to narrowing of the anatomical structures; usually, conservative treatment is recommended, rather than surgical treatment. Acupotomy combines conventional acupuncture with small scalpels; the procedure can be considered minimally invasive, and has recently received considerable attention in clinical practice. Still, there is a lack of data and randomized controlled trials regarding acupotomy related to LSS. Additional studies are necessary, considering the low methodological quality and small size of the study.Methods and analysis:This is a pragmatic, pilot, randomized controlled trial. The trial comprises 8 weeks of treatment, with 16 visits and a 4-week follow-up period. Forty participants diagnosed with LSS will be randomly assigned to either the experimental or control groups; both groups will receive acupuncture and interferential current therapy twice a week for 8 weeks, while the experimental group will receive an additional acupotomy intervention once a week for 8 weeks. The primary outcome will be assessed using the visual analog scale; the secondary outcome will be measured by self-rated walking distance, Oswestry Disability Index, and short-form McGill Pain Questionnaire. Measurements will be obtained prior to the start of the clinical trial, 4 weeks after the interventional procedure, 8 weeks after the procedure, and 4 weeks after the end of the interventional procedure. Blood tests and adverse reactions will be performed to ensure safety of the treatments.Conclusion:We expect that this study will provide basic data for future large-scale acupotomy studies regarding LSS.     

Effect of amlodipine versus bisoprolol in hypertensive patients on maintenance hemodialysis: A randomized controlled trial

Background:Left ventricular hypertrophy and asymmetric dimethylarginine (ADMA) are surrogate markers of cardiovascular disease (CVD) in the dialysis population. This study aimed to evaluate the effect of a calcium channel blocker-based antihypertensive regimen compared to a beta-blocker-based antihypertensive regimen on left ventricular mass index (LVMI) and ADMA levels in hypertensive patients on hemodialysis (HD).Methods:This was a parallel-design, open-label, single-center randomized controlled trial on 46 hypertensive patients on maintenance HD, with no history of CVD. Patients were randomly assigned to receive amlodipine 10 mg/d (n = 23) or bisoprolol 10 mg/d (n = 23). Office-based blood pressure (BP) was targeted to ≤ 140/ 90 mm Hg. The outcome was the change in LVMI and ADMA from baseline to 6 months.Results:Baseline demographic and clinical characteristics did not vary between groups. After 6 months of treatment, amlodipine-based therapy induced a greater reduction in LVMI from baseline than bisoprolol-based treatment (35 ± 34.2 vs 9.8 ± 35.9 gm/m²; P = .017). A similar reduction in the mean BP occurred with treatment in both groups. ADMA concentration decreased significantly from baseline in the amlodipine group (0.75 ± 0.73 to 0.65 ± 0.67 nmol/mL; P = .001), but increased nonsignificantly in the bisoprolol group (0.64 ± 0.61 to 0.78 ± 0.64 nmol/mL; P = .052).Conclusion:This study showed that compared to a bisoprolol-based regimen, an amlodipine-based antihypertensive regimen resulted in a significantly greater reduction in LVMI and ADMA levels from baseline in hypertensive patients on HD despite similar BP reduction in both groups. These findings support the re-evaluation of amlodipine as a potential first-line antihypertensive treatment in patients on HD without previous CVD.Trial Registration:Clinicaltrials.gov Identifier: NCT04085562, registered September 2019.     

The efficacy and safety of different bismuth agents in Helicobacter pylori first-line eradication: A multicenter,randomized, controlled clinical trial

Background:The aim of this study was to evaluate the efficacy and safety of bismuth pectin capsules and bismuth pectin granules in the first-line quadruple treatment of Helicobacter pylori (H. pylori).Methods:This study was a multicenter, randomized, open-labelled controlled clinical trial. Patients with a H. pylori infection were randomized into 4 groups (1:1:1:1) and treated with a 14-day bismuth-containing quadruple therapy. The 4 groups received either bismuth potassium citrate capsules (220 mg), colloidal bismuth pectin capsules (200 mg), bismuth pectin granules (150 mg), or bismuth pectin granules (300 mg). The primary outcome was the eradication rate of H. pylori. The secondary outcomes included symptom improvement, patient compliance, and incidence of adverse events. This study was registered at ClinicalTrials.gov (NCT04209933).Result(s):A total of 240 patients were included in this study, and 211 patients completed the follow-up. An intention-to-treat analysis showed that the H. pylori eradication rates of the 4 groups were 73.3%, 76.7%, 75.0%, and 71.7%, respectively. The per-protocol analysis showed that the H. pylori eradication rates of the 4 groups were 86.3%, 82.1%, 83.3%, and 86.0%. There was no significant difference among the 4 groups in the H. pylori eradication rate (P > .05). There were also no significant differences in the symptom improvement rate, overall adverse reaction rate, or patient compliance among the 4 groups.Conclusion(s):Bismuth pectin capsules and bismuth pectin granules had similar efficacy and safety for H. pylori eradication compared to bismuth potassium citrate. These data suggest that bismuth pectin can be an alternative to bismuth potassium citrate to eradicate H. pylori when using bismuth-containing quadruple therapy.     

Prevention of postoperative adhesions after flexor tendon repair with acellular dermal matrix in Zones III,IV, and V of the hand: A randomized controlled (CONSORT-compliant) trial

Background:Various techniques have been attempted for preventing postoperative flexor tendon adhesion, such as modification of suture technique, pharmacological agents, and mechanical barriers. However, there is no evidence of the efficacy of these methods in clinical settings. In this study, we present the long-term outcomes of a randomized prospective study in which acellular dermal matrix (ADM) was used to prevent postoperative adhesions after tendon injury in the hand.Methods:From January 2017 to January 2020, all patients with an acute single flexor tendon injury in hand Zones III, IV, or V were candidates. A single-digit, total tendon rupture repaired within 48 hours, from the index finger to the little finger, was included in the study. Patients were randomly allocated to either a control or ADM group. Complications and the range of movements were recorded. Functional outcomes and a patient satisfaction questionnaire were evaluated after 12 months following the tendon repair surgery. The present study is adhered to the CONSORT guidelines.Results:A total of 25 patients was enrolled in the study: 13 patients in the ADM group and 12 in the control group. According to Buck-Gramcko II criteria, the postoperative functional outcome score was 14.38 ± 1.71 in the ADM group and 13.08 ± 1.82 in the control group (P value = .0485). Patient satisfaction was recorded at 8.38 ± 1.44 in the ADM group and 7.08 ± 1.58 in the control group (P value = .0309), a significant difference. There were no differences in complications between the 2 groups.Conclusion:The beneficial effects of ADM after tendon repair were confirmed by improved postoperative functional outcome at flexor Zones III, IV, and V, preventing peritendinous adhesions and acting effectively as an anti-adhesive barrier.     

Graded motor imagery training as a home exercise program for upper limb motor function in patients with chronic stroke: A randomized controlled trial

Purpose:Although several types of occupational therapy for motor recovery of the upper limb in patients with chronic stroke have been investigated, most treatments are performed in a hospital or clinic setting. We investigated the effect of graded motor imagery (GMI) training, as a home exercise program, on upper limb motor recovery and activities of daily living (ADL) in patients with stroke.Methods:This prospective randomized controlled trial recruited 42 subjects with chronic stroke. The intervention group received instruction regarding the GMI program and performed it at home over 8 weeks (30 minutes a day). The primary outcome measure was the change in motor function between baseline and 8 weeks, assessed the Manual Function Test (MFT) and Fugl-Meyer Assessment (FMA). The secondary outcome measure was the change in ADL, assessed with the Modified Barthel Index (MBI).Results:Of the 42 subjects, 37 completed the 8-week program (17 in the GMI group and 20 controls). All subjects showed significant improvements in the MFT, FMA, and MBI over time (P < .05). However, the improvements in the total scores for the MFT, FMA, and MBI did not differ between the GMI and control groups. The MFT arm motion score for the GMI group was significantly better than that of the controls (P < .05).Conclusions:The GMI program may be useful for improving upper extremity function as an adjunct to conventional rehabilitation for patients with chronic stroke.     

Effectiveness and safety of acupuncture combined with traditional Chinese medicine in the treatment of chronic prostatitis: A systematic review and meta-analysis

Objective:Chronic prostatitis (CP) is a common disease in the outpatient department of males and urology. Clinical studies have found that acupuncture combined with traditional Chinese medicine (TCM) has achieved good results in treating CP, but its efficacy and safety are not completely clear. This study aimed to investigate the efficacy and safety of acupuncture combined with TCM in the treatment of CP.Methods:Randomized controlled trials of acupuncture combined with TCM in treating CP were screened by searching PubMed, Embase, Cochrane Library, CNKI, etc. The retrieval time was from the database establishment date to March 31, 2021. The Cochrane Collaborative Risk Bias Assessment tool was used to evaluate literature''s methodological quality of the literature. The RevMan5.4 software was used for the meta-analysis of outcome indicators. The TSA v0.9 software was used for sequential trial analysis (TSA) of effectiveness.Results:In this study, 19 related randomized controlled trial studies were included, with a total of 1831 cases. The results of the meta-analysis showed that acupuncture combined with TCM could significantly improve the clinical efficacy of CP (OR = 3.76, 95%CI: 2.82 to 5.02, P < .00001), reduce the total score of The National Institutes of Health chronic prostatitis symptom index (MD = −4.00, 95%CI: −4.67 to 3.33, P < .00001), and improve patients’ urination symptoms (MD = −1.10, 95%CI: −1.23 to −0.97, P < .00001), alleviated the pain symptoms of patients (MD = −2.38, 95%CI: −2.41 to −2.35, P < .00001), improved the quality of life of patients (MD = −1.69, 95%CI: −1.97 to −1.41, P < .00001), decreased the scores of TCM symptoms of patients (MD = −2.39, 95%CI: −3.45 to −1.33, P < .00001), and did not increase the adverse reactions of patients (MD = 1.09, 95%CI: 0.57 to 2.06, P = .8). The results of publication bias showed that this study was not affected by publication bias, and the conclusion was reliable. TSA showed that acupuncture combined with TCM was effective in treating CP.Conclusion:Acupuncture combined with TCM is safe and effective for alleviating CP. It can be used as an effective treatment for chronic prostatitis in the clinic.Registration number: DOI 10.17605/OSF.IO/Z8FJM.     

Effect of perioperative intravenous lidocaine for patients undergoing spine surgery: A meta-analysis and systematic review

Background:Perioperative intravenous lidocaine has been reported to have analgesic and opioid-sparing effects in many kinds of surgery. Several studies have evaluated its use in the settings of spine surgery. The aim of the study is to examine the effect of intravenous lidocaine in patients undergoing spine surgery.Methods:We performed a quantitative systematic review. Databases of PubMed, Medline, Embase database and Cochrane library were investigated for eligible literatures from their establishments to June, 2019. Articles of randomized controlled trials that compared intravenous lidocaine to a control group in patients undergoing spine surgery were included. The primary outcome was postoperative pain intensity. Secondary outcomes included postoperative opioid consumption and the length of hospital stay.Result:Four randomized controlled trials with 275 patients were included in the study. postoperative pain compared with control was reduced at 6 hours after surgery (WMD −0.50, 95%CI, −0.76 to −0.25, P < .001), at 24 hours after surgery (WMD −0.50, 95%CI, −0.70 to −0.29, P < .001) and at 48 hours after surgery (WMD −0.57, 95%CI, −0.96 to −0.17, P = .005). The effect of intravenous lidocaine on postoperative opioid consumption compared with control revealed a significant effect (WMD −15.36, 95%CI, −21.40 to −9.33 mg intravenous morphine equivalents, P < .001).Conclusion:This quantitative analysis of randomized controlled trials demonstrated that the perioperative intravenous lidocaine was effective for reducing postoperative opioid consumption and pain in patients undergoing spine surgery. The intravenous lidocaine should be considered as an effective adjunct to improve analgesic outcomes in patients undergoing spine surgery. However, the quantity of the studies was very low, more research is needed.     

Effects of Phenotypic and Genotypic Factors on the Lipid Responses to Niacin in Chinese Patients With Dyslipidemia

The acyl-CoA:diacylglycerol acyltransferase (DGAT) enzymes DGAT1 and DGAT2 catalyze the final step in triglycerides biosynthesis. This study examined the relationships of baseline phenotypes and the common polymorphisms in DGAT1 and DGAT2 with the lipid responses to niacin.Lipid responses in Chinese patients with dyslipidemia treated with the extended release (ER) niacin/laropiprant combination 1000/20 mg for 4 weeks and then 2000/40 mg for 8 weeks (n = 121, the primary study) or with ER niacin 1500 mg for at least 4 weeks (n = 68, the replication study) were analyzed according to genotypes of DGAT1 rs7003945 T>C and DGAT2 rs3060 T>C polymorphisms.Treatment with ER niacin improved all lipid parameters in both studies. Absolute and percentage changes in lipids were related to their baseline levels, particularly for low-density lipoprotein cholesterol (LDL-C). The DGAT2 rs3060 T>C polymorphism was associated with lower baseline LDL-C, apoB, high-density lipoprotein cholesterol (HDL-C), and apoAI in patients on statin therapy in the primary study. Subjects with the DGAT2 rs3060 T>C variant had less reduction in LDL-C in the primary study and smaller changes in triglyceride and HDL-C in the replication study but these associations became non-significant after adjusting for baseline lipid values. The DGAT1 rs7003945 T>C polymorphism was not related to lipid baseline values or changes in either study. Concomitant statin therapy and lower body weight were also associated with greater reduction in LDL-C.Baseline lipid levels were the main determinants of lipid responses especially for LDL-C. The DGAT2 rs3060 polymorphism might influence the lipid responses depending on baseline phenotype, but this association did not persist after adjustment for the baseline lipid levels.     

Effect of platelet-rich plasma injections for chronic nonspecific low back pain: A randomized controlled study

Background:Patient with chronic nonspecific low back pain is weakened ligament, and prolotherapy is the effective treatment but their use remains controversial. These ligaments can be strengthened by platelet-rich plasma injection. We hypothesized that the effectiveness of platelet-rich plasma injection and prolotherapy may decrease pain and improved disability of patient with chronic low back painMethods:This study was a prospective, double-blind, randomized controlled trial and was conducted for 3 years for patient enroll and follow-up. Thirty-four patients with chronic nonspecific low back pain (duration of at least 3 months) refectory to conventional management were randomized to platelet-rich plasma injection and lidocaine injection. Patients were treated with weekly platelet-rich plasma or lidocaine injections at the lumbopelvic ligaments for 2 weeks and then weekly prolotherapy with 15% glucose for 2 weeks and followed up 6 months. Visual analog scale, Oswestry Disability Index, and Roland–Morris Disability Questionnaire were evaluated at initial, 4 weeks, 3 months, and 6 months. Four patients did not complete this trial. Three were in the platelet-rich plasma injection and 1 was in the lidocaine injection.Results:The intensity of pain was significantly decreased in platelet-rich plasma injections at 6 months as compared lidocaine injections; between-group differences were 0.9 (95% confidence interval 0.10–1.75 [P = .027]). All participants were significantly decreased pain and disability index at 4 weeks, 3 months, and 6 months but there were no significant differences between groups except for visual analog scale at 6 months. The baseline parameters were no significant differences in both groups.Conclusions:In chronic nonspecific low back pain, the platelet-rich plasma injection in combination with prolotherapy is an effective intervention and either lidocaine or platelet-rich plasma injection significantly reduced disability. And injection at the lumbopelvic ligaments using the platelet-rich plasma and prolotherapy is also an effective treatment for pain.     

Effects of robot (SUBAR)-assisted gait training in patients with chronic stroke: Randomized controlled trial

Background:SUBAR is a new ground walking exoskeletal robot. The objective of this study is to investigate SUBAR-assisted gait training''s effects in patients with chronic stroke.Methods:This preliminary study is a prospective randomized controlled trial. Thirty adults were enrolled 6 months after the onset of stroke with functional ambulation category scores ≥ 3. Patients were randomly assigned to receive robot-assisted gait training (SUBAR group, n = 15) or conventional physiotherapy (control group, n = 15). All patients received a total of 10 treatment sessions of 30 minutes each for 3 weeks. Before and after the 10-treatment sessions, patients were evaluated. The primary outcome is the 10 meter walk test and the secondary outcomes were the functional ambulation category scale, the Motricity Index-Lower, Modified Ashworth Scale (MAS), timed up and go, Rivermead Mobility Index, Berg Balance Scale (BBS), and gait analysis.Results:In the SUBAR group, MAS and step length were significantly improved between pre- and posttreatment measurements (Δmean ± SD: −1.1 ± 1.6 and 5.5 ± 7.6, P = .019 and .016, respectively). The SUBAR group improved the stride length and step length of the affected limb but not significantly. The control group had significant improvements in the BBS, MAS, and stride length between pre- and posttreatment measurements (Δmean ± SD: 3.5 ± 4.6, −0.8 ± 1.5, and 6.5 ± 9.5; P = .004, .031, and .035, respectively). The BBS improved more in the control group than in the SUBAR group. There were no other differences between the SUBAR group and the control group.Conclusion:Our results suggest that SUBAR-assisted gait training improved gait parameters in patients with chronic stroke. However, there was no significant difference in most outcome measures compared to conventional physiotherapy. Further research is warranted to measure the effects of SUBAR-assisted gait training.     

Efficacy and safety of adalimumab in hidradenitis suppurativa: A systematic review and meta-analysis of randomized controlled trials

Background:Adalimumab is used as a first-line biologic agent in the management of moderate-to-severe hidradenitis suppurativa (HS). The objective of the present study was to evaluate the efficacy and safety of adalimumab in patients with moderate-to-severe HS.Methods:We performed a systematic review and meta-analysis according to Preferred Reporting Items for Systematic reviews and Meta-Analysis guidelines. Pooled estimates, namely standardized mean difference (SMD) and relative risk (RR), were calculated using random-effect model with trial sequential analysis. Small study effects were examined using the Doi plot. Certainty of evidence (CoE) was assessed using “The Grading of Recommendations Assessment, Development, and Evaluation” approach, and number-needed-to-treat (NNT) was calculated.Results:Five randomized controlled trials, involving 1014 patients, were included. We performed subgroup analysis of adalimumab administered subcutaneously both weekly and every other week. Adalimumab administered weekly was associated with better clinical response achievement (RR 1.76, 95% confidence interval [95% CI] 1.35–2.29; trial sequential analysis TSA-adjusted CI 1.01–3.08; CoE: low; NNT = 5) and a significant improvement in modified Sartorius score (SMD = −0.45, 95% CI = −0.76 to −0.13; CoE: very low; NNT = 10) and dermatology life quality index (DLQI) (SMD −0.47, 95% CI −0.61 to −0.32; CoE: low; NNT = 10). Nevertheless, adalimumab administered every other week showed an improvement only in modified Sartorius score. The pooled RRs of adverse events in both groups revealed no statistical significance when compared with the placebo.Conclusions:Adalimumab administered weekly resulted in not only better clinical responses than placebo but also significantly improved disease severity and quality of life of patients with moderate-to-severe HS. Our study provides supporting evidence to the current guidelines and aids decision-making in the application of adalimumab in HS management.