Alpha transcranial alternating current stimulation as add-on to neglect training: a randomized trial.

Visuospatial neglect is a common and debilitating condition following unilateral stroke, significantly impacting cognitive functioning and daily life. There is an urgent need for effective treatments that can provide clinically relevant and sustained benefits. In addition to traditional stroke treatment, non-invasive brain stimulation, such as transcranial alternating current stimulation, shows promise as a complementary approach to enhance stroke recovery. In the current study, we aimed to evaluate the additive effects of multi-session transcranial alternating current stimulation at alpha frequency when combined with visual scanning training in chronic stroke patients with visuospatial neglect. In this double-blind randomized controlled trial, we compared the effects of active transcranial alternating current stimulation at alpha frequency to sham (placebo) transcranial alternating current stimulation, both combined with visual scanning training. Both groups received eighteen 40-minute training sessions over a 6-week period. A total of 22 chronic visuospatial neglect patients participated in the study (active group n = 12, sham group n = 10). The median age was 61.0 years, with a median time since stroke of 36.1 months. We assessed the patients at six time-points: at baseline, after the first, ninth and eighteenth training sessions, as well as 1 week and 3 months following the completion of the combined neuromodulation intervention. The primary outcome measure was the change in performance on a visual search task, specifically the star cancellation task. Secondary outcomes included performance on a visual detection task, two line bisection tasks and three tasks evaluating visuospatial neglect in daily living. We found significantly improved visual search (primary outcome) and visual detection performance in the neglected side in the active transcranial alternating current stimulation group, compared to the sham transcranial alternating current stimulation group. We did not observe stimulation effects on line bisection performance nor in daily living. Time effects were observed on all but one outcome measures. Multi-session transcranial alternating current stimulation combined with visual scanning training may be a more effective treatment for chronic visuospatial neglect than visual scanning training alone. These findings provide valuable insights into novel strategies for stroke recovery, even long after the injury, with the aim of enhancing cognitive rehabilitation outcomes and improving the overall quality of life for individuals affected by this condition. Trial registration: ClinicalTrials.gov; registration number: NCT05466487; https://clinicaltrials.gov/ct2/show/NCT05466487.

[Cold reducing acupuncture as adjunctive therapy for wrist joint disorder of active rheumatoid arthritis with dampness-heat obstruction：a randomized controlled trial].

OBJECTIVE: To compare the clinical efficacy between cold reducing acupuncture combined with western medication and western medication alone for wrist joint disorder of active rheumatoid arthritis (RA) with dampness-heat obstruction. METHODS: A total of 80 patients with wrist joint disorder of active RA with dampness-heat obstruction were randomly divided into a combination group (40 cases, 3 cases dropped out) and a western medication group (40 cases, 3 cases dropped out). The western medication group was treated with methotrexate tablets, 15 mg each time, once a week. The combination group was treated with cold reducing acupuncture at bilateral Hegu (LI 4), Houxi (SI 3), Waiguan (TE 5), etc. on the basis of the western medication group, once a day, 5 times a week. Both groups were treated for 8 weeks. The pain visual analogue scale (VAS) score, swelling score, morning stiffness score, Cooney wrist joint function score, ultrasound of wrist joint and serum level of C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) before and after treatment were compared in the two groups. RESULTS: After treatment, the pain VAS scores, swelling scores, morning stiffness scores, grey scale ultrasound (GSUS) grade of synovitis, power doppler ultrasound (PDUS) grade of synovitis of wrist joint and serum levels of CRP and ESR in the two groups were reduced compared with those before treatment (P<0.05), the Cooney wrist joint function scores were increased compared with those before treatment (P<0.05); the pain VAS score, swelling score, PDUS grade of synovitis of wrist joint and serum level of CRP and ESR in the combination group were lower than those in the western medication group (P<0.05), the Cooney wrist joint function score was higher than that in the western medication group (P<0.05). CONCLUSION: Cold reducing acupuncture combined with western medication could improve clinical symptoms and joint function, reduce inflammatory response in patients with wrist joint disorder of active RA with dampness-heat obstruction, and the efficacy is better than that of western medication alone.

[Pelvic floor muscle training combined with electroacupuncture for bladder dysfunction after incomplete spinal cord injury: a randomized controlled trial].

OBJECTIVE: To observe the efficacy of pelvic floor muscle training combined with electroacupuncture (EA) for bladder dysfunction after incomplete spinal cord injury (SCI). METHODS: Ninety patients with bladder dysfunction after incomplete SCI were randomly divided into an EA group (30 cases), a pelvic floor muscle training group (30 cases, 1 case dropped out), and a combined group (30 cases, 1 case dropped out). All groups received routine rehabilitation. The EA group received EA at Zhongji (CV 3), Guanyuan (CV 4), Mingmen (GV 4), Yaoyangguan (GV 3), bilateral Shenshu (BL 23), Ciliao (BL 32), and Pangguangshu (BL 28), with continuous waves at frequency of 100 Hz, and the needles were retained for 30 min, once daily, 6 times a week for 6 weeks. The pelvic floor muscle training group underwent pelvic floor muscle training two times a day, for 6 weeks. The combined group received both EA and pelvic floor muscle training. The daily average number of urinations, daily average number of urinary leakages, urodynamic indexes (residual urine volume, maximum bladder capacity, bladder compliance, and maximum urine flow rate), and generic quality of life inventory-74 (GQOLI-74) were compared before and after treatment in each group. RESULTS: Compared before treatment, the daily average number of urinations and urinary leakages were decreased (P<0.05), residual urine volume, maximum bladder capacity, and bladder compliance were reduced (P<0.05), and maximum urine flow rate and GQOLI-74 scores were increased (P<0.05) after treatment in all groups. After treatment, the combined group showed greater differences in the daily average number of urinations, daily average number of urinary leakages, residual urine volume, maximum bladder capacity, bladder compliance, maximum urine flow rate, and GQOLI-74 score compared to the EA group and the pelvic floor muscle training group (P<0.05). There was no statistically significant differences in the changes in these indexes between the EA group and the pelvic floor muscle training group (P>0.05). CONCLUSION: Pelvic floor muscle training combined with EA can effectively alleviate urination problems in patients with bladder dysfunction after incomplete SCI, improve bladder function, and enhance patients' quality of life.

[Acupuncture at Niwanneibazhen points combined with vestibular rehabilitation for unilateral peripheral vestibular dysfunction: a randomized controlled trial].

OBJECTIVE: To observe the clinical effect on unilateral peripheral vestibular dysfunction treated with acupuncture at Niwanneibazhen points combined with vestibular rehabilitation. METHODS: A total of 84 patients with unilateral peripheral vestibular dysfunction were randomly divided into a trial group (42 cases, 2 cases dropped out) and a control group (42 cases, 1 case dropped out). In the control group, vestibular rehabilitation was given. In the trial group, based on the treatment in the control group, Niwanneibazhen points were located. Taking Baihui (GV 20) as the center, three equal section was divided on the line from Baihui (GV 20) to Yintang (GV 24+). A circle was drawn with the radius from the inner 1/3 equal-section point to Baihui (GV 20), and divided into eight equal parts. Acupuncture was delivered at Baihui (GV 20) and the eight equal-part points, with needles retained for 30 min. The intervention with acupuncture was operated once every three days, twice a week, consecutively for 4 weeks. Before and after treatment completion, using the Berg balance scale (BBS), dizziness handicap inventory (DHI), hospital anxiety and depression scale (HADS), and Pittsburgh quality index (PSQI), the balance function, the degree of vertigo, emotional conditions, and sleep quality were evaluated in the patients of the two groups, and the clinical effect was assessed. RESULTS: After 4 weeks of treatment, the BBS scores were higher than those before treatment (P<0.01), and the scores of DHI, HADS, and PSQI were lower than those before treatment (P<0.01) in the two groups. The reduction of HADS and PSQI scores in the trial group was larger than that of the control group (P<0.01). The total effective rate was 90% (36/40) in the trial group, higher than that of the control group (78.1%, 32/41, P<0.05). CONCLUSION: Acupuncture at Niwanneibazhen points combined with vestibular rehabilitation can effectively ameliorate balance function and vertigo degree, relieve the emotions of anxiety and depression, and improve the quality of sleep in the patients with unilateral peripheral vestibular dysfunction.

[Dose-effect relationship of moxibustion for rheumatoid arthritis of liver and kidney deficiency and its effect on fatigue: a randomized controlled trial].

OBJECTIVE: To observe the effects of moxibustion with different frequency on the disease activity and fatigue of rheumatoid arthritis (RA) with liver and kidney deficiency on the basis of western medication treatment. METHODS: A total of 135 RA patients with liver and kidney deficiency were randomly divided into a high-frequency moxibustion group (45 cases, 3 cases dropped out), a low-frequency moxibustion group (45 cases, 2 cases dropped out) and a western medication group (45 cases, 2 cases dropped out, 1 case discontinued). Leflunomide tablet was taken orally in the western medication group, once a day, 20 mg a time. On the basis of the treatment in the western medication group, moxibustion was applied at ashi points and bilateral Shenshu (BL 23) and Sanyinjiao (SP 6) in the two moxibustion groups, 15 min a time. The treatment was given once a day, 5 times a week in the high-frequency moxibustion group and once every other day, 3 times a week in the low-frequency moxibustion group. A total of 12-week treatment was required in the 3 groups. Before and after treatment, the 28 joint disease activity score (DAS28), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), rheumatoid factor (RF), TCM syndrome score, average grip strength (GS) of both hands, 30-second sit-to-stand (STS), timed up and go (TUG), 20-meter walk test (20MWT), self rating anxiety scale (SAS) score and self rating depression scale (SDS) score were observed; before treatment, after treatment and in follow-up of 1, 3 months after treatment completion, the scores of fatigue visual analogue scale (VAS), Bristol rheumatoid arthritis fatigue numerical rating scale (BRAF-NRS) and Bristol rheumatoid arthritis fatigue multi-dimensional questionnaire (BRAF-MDQ) were observed, and the relieving of disease was evaluated by American College of Rheumatology (ACR)20/50/70 standards in the 3 groups. RESULTS: After treatment, the DAS28 scores, ESR, CRP, RF, TCM syndrome scores, TUG, 20MWT, SAS scores and SDS scores were decreased compared with those before treatment (P<0.01, P<0.05), while the average GS of both hands and STS were increased compared with those before treatment (P<0.01, P<0.05) in the 3 groups. After treatment, in the high-frequency moxibustion group, the DAS28 score, ESR, CRP, TCM syndrome score, SAS score and SDS score were lower (P<0.01, P<0.05), while the average GS of both hands and STS were higher (P<0.01, P<0.05) than those in the low-frequency moxibustion group and the western medication group; the TUG and 20MWT were decreased compared with those in the western medication group (P<0.01, P<0.05). After treatment, in the low-frequency moxibustion group, the DAS28 score, ESR, CRP, TCM syndrome score, TUG, SAS score and SDS score were lower (P<0.05, P<0.01), while the average GS of both hands was higher (P<0.01) than those in the western medication group. In each time point after treatment, the scores of fatigue VAS and BRAF-NRS were decreased compared with those before treatment in the 3 groups (P<0.01), while the BRAF-MDQ scores were decreased compared with those before treatment in the high-frequency moxibustion group and the low-frequency moxibustion group (P<0.01). After treatment, the BRAF-MDQ score was decreased compared with that before treatment in the western medication group (P<0.01). In the high-frequency moxibustion group, the scores of fatigue VAS, BRAF-NRS and BRAF-MDQ of each time point after treatment were lower than those in the western medication group (P<0.01), the scores of fatigue VAS and BRAF-NRS in follow-up of 1 month after treatment completion as well as the BRAF-MDQ score after treatment were lower than those in the low-frequency moxibustion group (P<0.01, P<0.05). In the low-frequency moxibustion group, the scores of fatigue VAS, BRAF-NRS and BRAF-MDQ of each time point after treatment were lower than those in the western medication group (P<0.01, P<0.05). After treatment, the proportions of ACR20 and ACR50 in the high-frequency moxibustion group and the low-frequency moxibustion group were higher than those in the western medication group (P<0.01), the proportion of ACR70 in the high-frequency moxibustion group was higher than those in the low-frequency moxibustion group and the western medication group (P<0.05, P<0.01), and the proportion of ACR70 in the low-frequency moxibustion group was higher than that in the western medication group (P<0.05). CONCLUSION: On the basis of the western medication treatment, moxibustion can effectively reduce the disease activity and improve fatigue status in RA patients with liver and kidney deficiency, and its efficacy is positively correlated with treatment frequency.

[Effect of oblique insertion at ashi point with long needle on joint function in female patients with knee osteoarthritis of early and middle stages].

OBJECTIVE: To compare the improvement of joint function in female patients with early-middle-stage knee osteoarthritis (KOA) treated by oblique insertion at ashi point with long needle and oral celecoxib capsule. METHODS: A total of 105 female patients with early-middle-stage KOA were randomly divided into an observation group (65 cases, 6 cases dropped out, 3 cases were discontinued) and a control group (40 cases, 6 cases dropped out, 2 cases were discontinued). Patients in the observation group were treated with oblique insertion at ashi point (hard knots of quadriceps femoris, hamstring muscle, popliteal muscle, etc.) with long needle, once every other 3 days, twice a week, for a total of 2 weeks. Patients in the control group were treated with oral celecoxib capsules, 0.2 g each time, once a day for 2 weeks. Both groups started functional exercise after 2 weeks of treatment. The joint function score of Western Ontario and McMaster Universities osteoarthritis index (WOMAC) and pain visual analogue scale (VAS) score of the two groups were observed before and after treatment and after 6 weeks of treatment completion (follow-up), the 12-item short-form health survey (SF-12) score was compared between the two groups before treatment and in follow-up, and the safety of the two groups was evaluated. RESULTS: After treatment and during the follow-up, the joint function scores of WOMAC and VAS scores of the two groups were lower than those before treatment (P<0.05). During the follow-up, the joint function scores of WOMAC and VAS scores were lower than those after treatment (P<0.05), and the SF-12 scores were higher than those before treatment (P<0.05) in the two groups. After treatment, the joint function score of WOMAC of the observation group was lower and the VAS score was higher than those of the control group (P<0.001, P<0.01). During the follow-up, the SF-12 score of the observation group was higher than that of the control group (P<0.05). No serious adverse reactions occurred in both groups. CONCLUSION: The treatment of oblique insertion at ashi point with long needle can improve the knee joint function and quality of life of female patients with early-middle-staqe KOA, which is better than oral celecoxib capsule.

[Analysis of status quo on the outcome indexes in randomized controlled trials of acupuncture for polycystic ovary syndrome].

OBJECTIVE: To analyze the application and status quo of the outcome indexes in randomized controlled trials (RCTs) of acupuncture for polycystic ovary syndrome (PCOS) so as to provide a favorable reference for the construction of the core outcome set. METHODS: RCTs of acupuncture for PCOS were searched in databases, i. e. CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library and Web of Science, from January 1st, 2018 to June 28th, 2023. The relevant outcome indexes were extracted, collected and analyzed to collate the index domains of acupuncture for PCOS. RESULTS: A total of 60 articles were included, involving 123 outcome indexes. The outcome indexes of the physical and chemical detection were the highest in frequency (65.79%), followed by the symptoms/signs (23.37%), safety events (4.02%), TCM syndrome (3.10%), quality of life (1.86%) and the long-term prognosis (1.86%). None of the RCTs included the indexes for the economic evaluation. Regarding the status quo of outcome indexes, the primary outcome index was not distinguished from secondary one, the types of outcome indexes were various, the effect evaluation was not specified, and the assessment of quality of life and safety was ignored. CONCLUSION: The status quo of the outcome indexes in RCTs of acupuncture for PCOS is not conducive to pooling and comparing the data and the results among the different trials. It is recommended to structure the core outcome index set consistent with the therapeutic characteristics of TCM so as to improve the standardization of the clinical design of acupuncture and the quality of evidence in the trials.

Using PRECIS-2 in Chinese herbal medicine randomized controlled trials for irritable bowel syndrome: A methodological exploration based on literature.

Background: The pragmatism levels of randomized controlled trials (RCTs) mean how similar the interventions delivered in the trial setting match those in the setting where the results will be applied. We aimed to investigate the association between the consistency of pragmatism among the characteristics of RCT design and its effect size of results in Chinese herbal medicine (CHM) for irritable bowel syndrome (IBS). Methods: Eight English and Chinese language databases were searched for RCTs on CHM for IBS. Six reviewers independently assessed the pragmatism of trials using the pragmatic-explanatory continuum indicator summary 2 (PRECIS-2) tool. The consistency of pragmatism levels among the characteristics of RCT design was calculated using the coefficient of variation. Linear regression models were adopted to explore influence factors of the pragmatism of RCTs. Results: 78 RCTs were included. The level of consistency in the pragmatism for RCT's design was significantly correlated with the effect size of the results (binary outcome, r = -0.413; P = 0.005; continuous outcome, r = -0.779, P < 0.001). PRECIS-2 score was higher in trials with individualized interventions than fixed interventions (3.29 [0.32] vs 2.90 [0.32]; Cohen's d relative effect size, 0.52; P < 0.001) and in standard or usual-treatment-controlled trials than placebo-controlled (3.05 [0.37] vs 2.83 [0.28]; Cohen's d relative effect size, 0.32; P = 0.048). Conclusion: The consistency of pragmatism level across the 9 domains of the PRECIS-2 tool in CHM IBS RCTs was positively correlated with the effect size of the results.

The European Larynx Organ Preservation Study [MK-3475-C44].

The European Larynx Organ Preservation Study (ELOS; NCT06137378) is a prospective, randomized, open-label, two-armed parallel group controlled, phase II multicenter larynx organ preservation (LOP) trial in locoregionally advanced (LA) stage III, IVA/B head and neck squamous cell carcinoma of the larynx or hypopharynx (LHSCC) amenable for total laryngectomy (TL) with PD-L1 expression within tumor tissue biopsy, calculated as CPS ≥ 1. Induction chemotherapy (IC) with docetaxel and cisplatin (TP) followed by radiation will be compared to TP plus PD-1 inhibition by pembrolizumab (MK-3475; 200 mg i.v. starting day 1 q3w for 17 cycles). After a short induction early response evaluation (ERE) 21 ± 3 days after the first cycle of IC (IC-1), responders achieving endoscopic estimated tumor surface shrinkage (ETSS) ≥30% will get an additional two cycles of IC followed by intensity-modulated radiotherapy 70-72 Gy (EQD2/α/ß = 10) aiming at LOP. Nonresponders (ETSS < 30% or progressing disease) will receive TL and bilateral neck dissection followed by postoperative radiation or chemoradiation as recommended by the clinic's multidisciplinary tumor board. Pembrolizumab treatment will be continued in the intervention arm regardless of ETSS status after IC-1 in both responders and laryngectomized nonresponders, independent of subsequent decisions on adjuvant therapy after TL. Clinical Trial Registration: clinicaltrials.gov, identifier NCT06137378.

[Pricking-cupping combined with auricular thumbtack needle for postherpetic neuralgia of qi stagnation and blood stasis on chest and waist: a randomized controlled trial].

OBJECTIVE: To observe the clinical effect of pricking-cupping combined with auricular thumbtack needle for postherpetic neuralgia (PHN) of qi stagnation and blood stasis on chest and waist. METHODS: A total of 98 patients with PHN of qi stagnation and blood stasis on chest and waist were randomized into an observation group (49 cases, 1 case was eliminated, 1 case dropped out) and a control group (49 cases, 1 case dropped out). In the observation group, treatment of pricking-cupping combined with auricular thumbtack needle was delivered, pricking and cupping were applied at Jiaji points (EX-B 2) at the related spinal segments corresponding to the pain sites and regional ashi points, once every other day, auricular thumbtack needle was applied at Xin (CO15), Shenmen (TF4), Neifenmi (CO18), Pizhixia (AT4), etc., once every 3 days. In the control group, pregabalin capsule was taken orally, 75 mg a time, twice a day. The treatment of 4 weeks was required in the two groups. Before and after treatment, the scores of TCM symptom, visual analogue scale (VAS), Pittsburgh sleep quality index (PSQI), self-rating depression scale (SDS) and self-rating anxiety scale (SAS) were observed, the serum levels of immunoglobulin G (IgG), interleukin-6 (IL-6), C-reactive protein (CRP) were detected, and the clinical efficacy and safety were evaluated in the two groups. RESULTS: After treatment, the item scores and total scores of TCM symptom, as well as the scores of VAS, PSQI, SDS and SAS were decreased compared with those before treatment (P<0.05); the item scores of pruritus degree, tactile sensitivity, skin numbness and total score of TCM symptom, as well as the scores of VAS, PSQI, SDS and SAS in the observation group were lower than those in the control group (P<0.05). After treatment, the serum levels of IgG were increased (P<0.05), while the serum levels of IL-6 and CRP were decreased (P<0.05) compared with those before treatment in the two groups; in the observation group, the serum level of IgG was higher (P<0.05), while the serum levels of IL-6 and CRP were lower (P<0.05) than those in the control group. The total effective rate was 95.7% (45/47) in the observation group, which was superior to 77.1% (37/48) in the control group (P<0.05). The incidence rate of adverse reaction was 6.4% (3/47) in the observation group, which was lower than 12.5% (6/48) in the control group (P<0.05). CONCLUSION: Pricking-cupping combined with auricular thumbtack needle can effectively relieve the clinical symptoms in patients with PHN of qi stagnation and blood stasis on chest and waist, reduce the pigmentation of herpes and improve itch or burning, numb sensations in the skin lesions, improve the sleep quality and relieve anxiety and depression.

[Effects of thunder-fire moxibustion on balance function and musculoskeletal metabolism in female patients of primary osteoporosis with low muscle mass].

OBJECTIVE: To observe the effects of thunder-fire moxibustion on the balance function and musculoskeletal metabolism in female patients of primary osteoporosis (POP) with low muscle mass. METHODS: Sixty female patients of POP with low muscle mass were randomly divided into an observation group (30 cases, 5 cases dropped out) and a control group (30 cases, 2 cases dropped out). The patients in the control group were treated with oral administration of Caltrate D (1.5 g calcium carbonate + 125 IU vitamin D3), one tablet per day for 12 weeks. In addition to the control treatment, the patients in the observation group were treated with thunder-fire moxibustion at Mingmen (GV 4), Yaoyangguan (GV 3), bilateral Ganshu (BL 18), Shenshu (BL 23), and Dachangshu (BL 25), 30 min per acupoint, once every other day, three times a week, for 12 weeks. Balance function indexes (95% confidence ellipse area of the center of pressure [COP], total displacement, average speed), lumbar pain visual analogue scale (VAS), serum muscle metabolism factors (myostatin [MSTN], peroxisome proliferator-activated receptor γ coactivator-1α [PGC-1α]) and bone metabolism factors (aminoterminal propeptide typeⅠ procollagen [PINP], C-terminal telopeptide of typeⅠcollagen [CTX-Ⅰ]) were compared before and after treatment in both groups. RESULTS: Compared before treatment, the 95% confidence ellipse area of COP, total displacement, and average speed in the observation group were decreased after treatment (P<0.01), and the above indexes in the observation group were lower than those in the control group (P<0.05). Compared before treatment, the VAS scores in both groups were decreased after treatment (P<0.01), the score in the observation group was lower than that in the control group (P<0.01). Compared before treatment, the serum levels of MSTN, PINP and CTX-Ⅰ in the observation group were reduced after treatment (P<0.01), while the serum level of PGC-1α was increased (P<0.01). The control group showed a decrease in serum level of MSTN (P<0.05). The observation group had lower serum levels of MSTN and PINP (P<0.05) and higher serum level of PGC-1α (P<0.01) compared to the control group. CONCLUSION: The thunder-fire moxibustion can effectively relieve lumbar pain, improve balance function, and regulate musculoskeletal metabolism in female patients of POP with low muscle mass.

[Guasha-fangsha therapy combined with electroacupuncture in treatment of greater occipital neuralgia: a randomized controlled trial].

OBJECTIVE: To observe the clinical effect of guasha-fangsha (scrapping and bleeding) therapy combined with electroacupuncture (EA) on greater occipital neuralgia. METHODS: Ninety patients with greater occipital neuralgia were randomly divided into an observation group (45 cases) and a control group (45 cases, 2 cases dropped out). In the control group, EA was delivered at Fengfu (GV 16) and bilateral Tianzhu (BL 10), Fengchi (GB 20), Wangu (GB 12), Yuzhen (BL 9) and Houxi (SI 3), with disperse-dense wave, at 2 Hz/100 Hz in frequency and 2 mA to 6 mA in intensity, for 30 min in each intervention, once every other days, 3 times a week. In the observation group, on the basis of the intervention as the control group, guasha-fangsha therapy was used along the distribution of the bladder meridian of foot-taiyang on the occipital region and that of the gallbladder meridian of foot-shaoyang on the lateral side of the head, once weekly. The duration of treatment was 3 weeks in the two groups. In the two groups, before treatment, after 1, 2 and 3 weeks of treatment and in follow-up visit after 3 weeks of treatment completion, the score of visual analogue scale (VAS) was observed; before and after treatment, as well as in follow-up visit after 3 weeks of treatment completion, the scores of self-rating anxiety scale (SAS), self-rating depression scale (SDS) and 36-item short-form health survey (SF-36) were observed; after treatment and in follow-up visit after 3 weeks of treatment completion, the clinical efficacy was evaluated. RESULTS: After one week of treatment, the VAS score in the observation group decreased when compared with that before treatment (P<0.05), while the scores in 2 and 3 weeks of treatment and in follow-up visit after 3 weeks of treatment completion were lower than those before treatment in the two groups (P<0.05) separately. At each time point after treatment, the VAS scores in the observation group were lower than those in the control group (P<0.05). After treatment and during the follow-up visit, the scores of SAS and SDS decreased when compared with those before treatment in the two groups (P<0.05), and the scores in the observation group were lower than those in the control group (P<0.05); the scores of each item in SF-36 were elevated in comparison with those before treatment in the two groups (P<0.05), and the scores in the observation group were higher than those in the control group (P<0.05). After treatment, the total effective rate of the observation group was 91.1% (41/45), higher than that (76.7%, 33/43) of the control group (P<0.05). In follow-up visit, the total effective rate of the observation group was 91.1% (41/45), which was higher than 72.1% (31/43) of the control group (P<0.05). CONCLUSION: Guasha-fangsha therapy combined with electroacupuncture can effectively relieve greater occipital neuralgia, alleviate pain severity, ameliorate anxiety and depression and improve the quality of life in the patients.

[Fu's subcutaneous needling combined with monkshood cake-separated moxibustion for primary dysmenorrhea with cold congealing and blood stasis: a randomized controlled trial].

OBJECTIVE: To observe the clinical efficacy of Fu's subcutaneous needling combined with monkshood cake-separated moxibustion for primary dysmenorrhea with cold congealing and blood stasis. METHODS: Sixty patients with primary dysmenorrhea of cold congealing and blood stasis were randomly divided into an observation group (30 cases, 1 case dropped out) and a control group (30 cases, 2 cases dropped out). The control group received monkshood cake-separated moxibustion at Shenque (CV 8) and bilateral Zigong (EX-CA 1), while the observation group received Fu's subcutaneous needling based on the control group. The muscles were palpated and the affected muscles were determined. Needles were inserted 5-10 cm away from the affected muscles and reperfusion activity was performed simultaneously. All the treatment started on the first day of menstrual cycle pain, once a day, for 3 days, totaling for 3 menstrual cycles. The visual analogue scale (VAS) score, Cox menstrual symptom scale (CMSS) score, and traditional Chinese medicine (TCM) syndrome score in the two groups were observed before treatment, after 2 treatment courses and after 3 treatment courses. The serum prostaglandin F2α(PGF2α) levels before and after 3 treatment courses were measured, and the clinical efficacy of the two groups was evaluated. RESULTS: After 2 and 3 treatment courses, the VAS scores, CMSS scores, and TCM syndrome scores in the two groups were lower than those before treatment (P<0.05), and the scores in the observation group were lower than those in the control group (P<0.05). After 3 treatment courses, the PGF2α level in the observation group was decreased (P<0.05), and were lower than that in the control group (P<0.05). The total effective rate was 96.6% (28/29) in the observation group, which was higher than 64.3% (18/28) in the control group (P<0.05). CONCLUSION: Fu's subcutaneous needling combined with monkshood cake-separated moxibustion could effectively reduce the pain intensity, improve clinical symptoms of dysmenorrhea, and lower PGF2α level in patients with primary dysmenorrhea of cold congealing and blood stasis.

Enhancing Interest in Smoking Cessation Programs With Nudge-Incorporated Flyers: A Randomized Controlled Trial Among Occupational Health Staff and Workers in Japan.

Purpose This study aimed to investigate the willingness to use and the application interest toward a smoking cessation program flyer among occupational health staff and smokers, utilizing a nudge approach. Methods A control group (typical flyer) and a nudge group (flyer improved according to the Easy, Attractive, Social, Timely (EAST) framework from the control flyer) were established. Occupational health staff and workers with a desire to quit smoking were randomly divided into two groups, and a web survey was conducted. Results Among occupational health staff, the nudge group flyers received significantly higher evaluations with desires "to apply" (control group: 1.7±0.7 vs. nudge group: 3.7±1.2: 5-point scale) and "to recommend to colleagues in the same profession" (control group: 1.7±2.4 vs. nudge group: 6.6±2.4: 11-point scale), and the reading completion rates were 7.0% for the control group vs. 70.7% for the nudge group (p<0.001). Although there was no significant difference in smokers' willingness "to apply" (control group: 2.9±1.2 vs. nudge group: 3.1±1.2: 5-point scale; p=0.388), the nudge group flyer was significantly more likely to be "want to recommend to other smokers" (control group: 4.9±2.4 vs. nudge group: 5.5±2.4: 11-point scale; p=0.032), with reading completion rates of 73.1% for the control group and 87.4% for the nudge group (p=0.001). Conclusion Typical flyers were not preferred by occupational health staff and may not have been effectively promoted to workers wishing to quit smoking. This study suggests that the combination of the EAST nudges could potentially increase the appeal to occupational health staff. To enhance the application interest among workers wishing to quit smoking, introducing other methods such as incentives might be necessary.

[Clinical observation on acupuncture at infusion points of "four seas" on refractory peripheral facial paralysis].

OBJECTIVE: To observe the clinical effect of acupuncture at the infusion points of "four seas" for refractory peripheral facial paralysis on the basis of conventional acupuncture. METHODS: A total of 52 patients with refractory peripheral facial paralysis were randomized into an observation group (26 cases, 2 cases dropped out) and a control group (26 cases, 1 case dropped out). On the basis of conventional acupuncture (Yintang [GV 24+] and Yangbai [GB 14], Dicang [ST 4] at affected side, etc.), acupuncture at the infusion points of "four seas", i.e. Baihui (GV 20), Dazhui (GV 14) and bilateral Shangjuxu (ST 37), Xiajuxu (ST 39), Zusanli (ST 36), was delivered in the observation group. On the basis of conventional acupuncture, shallow acupuncture was applied at corresponding non-meridian and non-acupoint points of the infusion points of "four seas" in the control group. The needles were maintained for 30 min, the treatment was given once every other day, 3 times a week for 4 weeks in the two groups. Before and after treatment, the House-Brackmann (H-B) facial nerve grading and the dynamic view score of the facial nerve function scoring system were observed, and the clinical efficacy was evaluated after treatment in the two groups. RESULTS: After treatment, the H-B facial nerve grading was improved compared with that before treatment in the two groups (P<0.05), and the grading in the observation group was superior to that in the control group (P<0.05); the dynamic view scores of the facial nerve function scoring system were increased compared with those before treatment in the two groups (P<0.05), and the score in the observation group was higher than that in the control group (P<0.05). The total effective rate was 91.7% (22/24) in the observation group, and that in the control group was 84.0% (21/25), there was no significant difference in the total effective rate between the two groups (P>0.05). The cure rate was 62.5% (15/24) in the observation group, which was higher than 20.0% (5/25) in the control group (P<0.05). CONCLUSION: On the basis of conventional acupuncture, acupuncture at infusion points of "four seas" can effectively treat refractory peripheral facial paralysis, improve the facial nerve function and increase the cure rate.

Efficacy of electro-acupuncture on pregnancy outcomes for women undergoing in vitro fertilization: study protocol for a pilot randomized controlled trial.

Introduction: In vitro fertilization (IVF) is a technology that assists couples experiencing infertility to conceive children. However, unsuccessful attempts can lead to significant physical and financial strain. Some individuals opt for electro-acupuncture (EA) during IVF, even though there is limited evidence regarding the efficacy of this practice. Thus, this pilot study aims to explore the effectiveness and safety of EA during IVF on pregnancy outcomes. Methods and analysis: This clinical trial is a parallel, randomized, sham-controlled study. It aims to include a total of 118 infertile women who intend to undergo IVF. The participants will be randomly divided into three groups in a 1:1:1 ratio: the EA + IVF group, the placebo electro-acupuncture (pEA) +IVF group, and the IVF control group. All of the patients will be required to use ovarian stimulation drugs, while those in the EA + IVF and pEA + IVF groups will receive acupuncture treatment at three sessions per week (every other day) until trigger day with a minimum five session. The primary outcome of this trial will focus on the clinical pregnancy rate (CPR). CPR is defined as the rate of achieving clinical pregnancy from the first fresh/frozen embryo transfer cycle with an ultrasound-confirmed gestational sac in the uterine cavity. The secondary outcomes will assess embryology data, biochemical pregnancy rate, early miscarriage rate, Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), Pittsburgh Sleep Quality Index (PSQI), Fertile Quality of Life (FertiQoL), patient retention rate, treatment adherence, and safety outcomes. Ethics and dissemination: Ethics approval was obtained from the Ethics Committee of Sichuan Jinxin Xi'nan Women and Children Hospital (number 2021-007). The results will be disseminated through peer-reviewed publications. The participants gave informed consent to participate in the study before taking part in it. Clinical trial registration: https://www.chictr.org.cn, identifier ChiCTR2300074455.

The evaluation of nightshade elimination diet (NED) on inflammatory and rheumatologic markers of rheumatoid arthritis patients: study protocol for a randomized controlled trial.

BACKGROUND: Rheumatoid arthritis (RA) is a chronic disease with a global prevalence rate of 1%. Patients with RA often associate specific foods like tomatoes and eggplants with adverse symptoms. These plants contain solanine, which could potentially contribute to bone and joint damage. Despite patient reports, there is a lack of randomized controlled trials (RCTs) investigating the effects of nightshades on patients with RA. This study aims to assess the effect of nightshade elimination diet (NED) on inflammatory and rheumatologic marker levels in rheumatoid arthritis patients for the first time. METHODS: A single-blinded controlled trial will be conducted to evaluate the effect of an NED on 40 participants over 8 weeks (2 months). Participants will be equally divided into intervention and placebo groups. Both groups will receive general anti-inflammatory dietary recommendations, with the intervention group undergoing an NED during the study. Clinical symptoms will be assessed using questionnaires, and blood samples will be collected to measure relevant indicators. DISCUSSION: This RCT signifies a groundbreaking exploration into NED effects on RA markers, potentially initiating crucial discussions in the field. Its outcomes could serve as a cornerstone for larger and more robust trials, offering pivotal insights to nutritionists and physicians for the nuanced management of patients with RA. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT20230220057465N1 ( https://irct.behdasht.gov.ir/trial/68959 ). Registered on 8 April 2023.

The death of a neurotrauma trial lessons learned from the prematurely halted randomized evaluation of surgery in elderly with traumatic acute subdural hematoma (RESET-ASDH) trial.

Introduction: Acute subdural hematoma (ASDH) due to traumatic brain injury (TBI) constitutes an increasing global health problem, especially in the elderly population. Treatment decisions on surgical versus conservative management pose a neurosurgical dilemma. Large practice variation exists between countries, hospitals, and individual neurosurgeons, illustrating the presence of 'clinical equipoise'. The RESET-ASDH trial aimed to address this dilemma but was terminated prematurely due to insufficient patient recruitment. Research question: What factors may have contributed to the premature discontinuation of the RESET-ASDH trial? Materials and methods: The RESET-ASDH was a multicenter randomized controlled trial (RCT) comparing functional outcome at 1 year after early surgery or an initial conservative treatment in elderly patients (≥65 years) with a traumatic ASDH. Logs of registry data, medical-ethical approval timelines and COVID-19 related research documents were analyzed. Furthermore, non-structured interviews with involved clinical research personnel were conducted. Results: The concept of clinical equipoise was broadly misinterpreted by neurosurgeons as individual uncertainty, hampering patient recruitment. Also, the elderly target population complicated the inclusion process as elderly and their informal caregivers were hesitant to participate in our acute surgical trial. Moreover, the COVID-19 pandemic added additional hurdles like delayed medical-ethical approval, a decline in eligible patients and repeated trial halts during the peaks of the pandemic. Discussion and conclusion: The premature termination of the RESET-ASDH study may have been related to the trial's methodology and target population with an additional impact of COVID-19. Future acute neurosurgical trials in elderly may consider these challenges to prevent premature trial termination.

[Experience with an international study on standard-risk relapsed childhood acute lymphoblastic leukemia (IntReALL SR 2010 study) in Japan].

Many effective new agents for relapsed childhood acute lymphoblastic leukemia (ALL) are now becoming available, and international standard chemotherapy should be developed to optimize use of these agents. Randomized controlled trials (RCTs) are needed to establish a standard treatment, but few have been conducted for relapsed childhood ALL in Japan due to the small patient population. Participation in international RCTs is necessary to access sufficient patients for informative study results, but differences in approved drugs and healthcare systems between countries make this challenging. In 2014, the Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) participated in an international study on standard-risk relapsed childhood ALL (IntReALL SR 2010) involving two RCTs and multiple drugs not approved in Japan, which was addressed by replacing the unapproved drugs with alternative approved drugs with the same or similar efficacy. This article discusses the historical background of treatment development for relapsed childhood ALL, our experience in participating in the IntReALL SR 2010 trial, and prospects for treating relapsed childhood ALL.

Virtual Reality Simulation for the Acquisition and Retention of Electrocardiogram Interpretation Skills: A Randomized Controlled Trial Among Undergraduate Medical Students.

Introduction The electrocardiogram (ECG) is one of the most important tools in diagnosing cardiac abnormalities, particularly arrhythmias and myocardial infarction. It is one of the certifiable competencies for final-year medical undergraduate students. We determined virtual reality's effectiveness in acquiring and retaining ECG interpretation skills among medical students compared to traditional teaching. Methods One hundred and forty students were randomized into two groups. Seventy-one students (immersion group) were trained using virtual reality simulation to acquire and retain interpretation skills of normal and abnormal ECG. Sixty-nine students (traditional group) were trained in the classroom using chalk and board. The primary outcome of change in acquiring knowledge of the interpretation of ECG was determined by comparing pre and post-test scores. The secondary outcome of retention of knowledge was determined by comparing pre-test and second post-test scores conducted after eight weeks of intervention. The p-value of <0.05 was considered significant. Results Out of 140 students, 50 (35.7%) were males and 90 (64.3%) were female. The mean age of the students was 22.1 (SD 1.1), with 69.3% of them between the ages of 21 and 22 years. Mean pre-test scores for the interpretation of normal ECG among immersion and traditional groups were 9.8 (SD 8.4) and 8.3 (SD 7.5), respectively, and post-test scores for the acquisition of knowledge were 24.3 (SD 5.5) and 24.8 (SD 6.3), respectively. The post-test scores for retention skills were 25.3 (SD 5.6) and 20.7 (SD 6.9) respectively (p<0.001). The mean pre-test scores for the interpretation of abnormal ECG of both groups were 7.0 (SD 6) and 8.3 (SD 6.6), respectively. Mean post-test scores for acquiring knowledge to interpret abnormal ECG were 23.5 (SD 6.2) and 17.7 (SD 9), respectively (p<0.001), and mean post-test scores for retention of interpretation skills of abnormal ECG were 19.2 (SD - 6.9) and 13.3 (SD 10.2) respectively (p=0.001). The pairwise comparison of the immersion group indicates that all the combinations that changed in score from the pre to post-intervention time points, from pre-to-retention time, and from the post-to-retention time were significant (p<0.001). Conclusion Virtual reality teaching had a better impact on acquiring and retaining the skill for interpreting normal and abnormal electrocardiograms.