Transcutaneous electrical acupoint stimulation for postoperative nausea and vomiting in patients undergoing craniotomy: A randomized controlled trial.

BACKGROUND: The incidence of nausea and vomiting following craniotomy is high, and pericardium 6 (P6; Neiguan) acupoint stimulation is an important strategy for treating postoperative nausea and vomiting (PONV). Here, we aimed to evaluate the efficacy of transcutaneous electrical acupoint stimulation (TEAS) at P6 as an adjunct to antiemetic drugs to prevent PONV after craniotomy. MATERIALS AND METHODS: This randomized placebo-controlled trial enrolled 120 patients scheduled for craniotomy. The enrolled patients were randomly assigned to a TEAS or sham TEAS group. The incidence of PONV, pain score, and postoperative remedial treatment with antiemetics and analgesics at 0-2, 2-6, and 6-24 h after craniotomy were assessed. RESULTS: The patient characteristics did not significantly differ between the two groups (P > 0.05). During 0-2 and 6-24 h after craniotomy, the incidence of vomiting was not significantly different between the two groups (P > 0.05). During 2-6 h, the incidence of vomiting was higher in the sham TEAS group than in the TEAS group (29.3 % vs. 14.0 %, P = 0.047). During 0-2 and 2-6 h, the pain scores did not differ significantly between the two groups (P > 0.05). During 6-24 h after craniotomy, the pain score was significantly higher in the sham TEAS group than in the TEAS group (P = 0.001). The degree of nausea and proportion of patients requiring antiemetic drugs were not significantly different between the two groups in each period (P > 0.05). CONCLUSION: TEAS at P6 may reduce vomiting incidence and pain scores following craniotomy.

Acupuncture versus sham acupuncture and usual care for Antiandrogen-Induced hot fLashes in prostate cancer (AVAIL): study protocol for a randomized clinical trial.

BACKGROUND: Hot flashes are the common and debilitating symptom among prostate cancer (PCa) patients undergoing androgen deprivation therapy (ADT). Strong evidence from multiple rigorously designed studies indicated that pharmacological option such as venlafaxine provides partial relief, but the tolerability is poor when dose is not tapered. Hence, alternative therapy is needed. Previous studies reported that acupuncture may be helpful in the management of hot flashes. However, the insufficient randomized controlled trial limited the quality of evidence. METHODS: Five hospitals will recruit 120 acupuncture naïve patients with moderate-to-severe hot flashes after prostate cancer received ADT in China from February 2023 to December 2024. Participants will be randomly 2:1:1 allocated to the 18 sessions of verum acupuncture at true acupuncture points plus usual care, 18 sessions of non-penetrating sham acupuncture at non-acupuncture points plus usual care, or usual care alone over 6 weeks. The primary outcome measure is the change of mean weekly hot flashes symptom severity score (HFSSS) at the end of treatment compared with baseline. EXPECTED RESULTS AND CONCLUSION: We will be able to measure the effectiveness of acupuncture for patients with PCa suffering from ADT-induced hot flashes and whether acupuncture is superior to sham acupuncture and usual care. The proposed acupuncture treatment might provide an alternative option for those patients. TRIAL REGISTRATION: Clinicaltrials.gov (NCT05069467).

Gut microbiota interacts with inflammatory responses in acute pancreatitis.

Acute pancreatitis (AP) is one of the most common acute abdominal conditions, and its incidence has been increasing for years. Approximately 15-20% of patients develop severe AP (SAP), which is complicated by critical inflammatory injury and intestinal dysfunction. AP-associated inflammation can lead to the gut barrier and function damage, causing dysbacteriosis and facilitating intestinal microbiota migration. Pancreatic exocrine deficiency and decreased levels of antimicrobial peptides in AP can also lead to abnormal growth of intestinal bacteria. Meanwhile, intestinal microbiota migration influences the pancreatic microenvironment and affects the severity of AP, which, in turn, exacerbates the systemic inflammatory response. Thus, the interaction between the gut microbiota (GM) and the inflammatory response may be a key pathogenic feature of SAP. Treating either of these factors or breaking their interaction may offer some benefits for SAP treatment. In this review, we discuss the mechanisms of interaction of the GM and inflammation in AP and factors that can deteriorate or even cure both, including some traditional Chinese medicine treatments, to provide new methods for studying AP pathogenesis and developing therapies.

Moxibustion as adjuvant therapy for preventing bone loss in postmenopausal women: protocol for a randomised controlled trial.

INTRODUCTION: Postmenopausal osteoporosis, caused by ageing and oestrogen deficiency, seriously threatens women's physical and mental health. Postmenopausal osteopenia is the transition from healthy bone to osteoporosis, and it may be the key period for preventing bone loss. Moxibustion, a physical therapy of Traditional Chinese Medicine, has potential benefits for osteoporosis treatment and prevention, but it has not been adequately studied. This study aims to explore the clinical effects and safety of moxibustion in delaying bone loss in postmenopausal women. METHODS AND ANALYSIS: In this parallel-design, randomised, patient-blind and assessor-blind, controlled clinical study, 150 women with osteopenia at low fracture risk will be randomly assigned to a moxibustion treatment (MT) group or a placebo-moxibustion control (PMC) group in a 1:1 ratio. In addition to the fundamental measures (vitamin D3 and calcium) as recommended by the guidelines, participants of the two groups will receive MT or PMC treatment for 42 sessions over 12 months. The primary outcome will be the bone mineral density (BMD) of the lumbar spine at the end of the 12-month treatment, and secondary outcomes will be the BMD of the femoral neck and total hip, T-scores, bone turnover markers, serum calcium levels, serum magnesium levels, serum phosphorus levels, serum parathyroid hormone levels and 25-hydroxyvitamin D levels, intensity of bone pain, quality of life, incidence of osteoporosis and fractures, usage of emergency drugs or surgery, participant self-evaluation of therapeutic effects and the rate of adverse events. All statistical analyses will be performed based on the intention-to-treat and per-protocol principle. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the Ethics Committee on Biomedical Research, West China Hospital of Sichuan University (permission number: 2021-1243). The results are expected to be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ChiCTR2100053953.

Acupuncture at the P6 Acupoint to Prevent Postoperative Pain after Craniotomy: A Randomized, Placebo-Controlled Study.

OBJECTIVE: Acute pain management after craniotomy can be challenging. Previous studies have shown inadequate pain control following the procedure. Oral medication can sometimes be delayed by postoperative nausea, and use of anesthetics may impair the assessment of brain function. We conducted this prospective study to evaluate the effect of acupuncture at the P6 acupoint on postoperative pain, nausea, and vomiting in patients undergoing craniotomy. METHODS: The authors conducted a randomized, placebo-controlled trial among 120 patients scheduled for craniotomy under general anesthesia. 120 patients were randomly assigned into an acupuncture group or a sham acupuncture group. All patients received standardized anesthesia and analgesia treatment. Acupuncture was executed in the recovery room after surgery. For the acupuncture group, the P6 points on each wrist were punctured perpendicularly to a depth of 20 mm. Needles were retained for 30 min and stimulated every 10 min to maintain the De-Qi sensation. For the sham acupuncture group, sham points on each wrist were punctured perpendicularly to a depth of 5 mm. Needles were retained for 30 min with no stimulation during the duration. The postoperative pain scores, PONV, and dose of tramadol were assessed 24 h, 48 h, and 72 h after surgery. RESULTS: A total of 117 patients completed the study. There was no statistically significant difference in baseline data between the two groups (P > 0.05). The VAS pain score of the acupuncture group was lower than that of the sham acupuncture group, and this difference was statistically significant (P=0.002). There was no difference in pain scores between the two groups during 0-24 h and 48-72 h (P > 0.05). The incidence of vomiting in the acupuncture group was lower than that in the sham acupuncture group during the 0-24 h period (13.8% vs. 28.8%, P=0.048). There was no difference in vomiting, however, during the 24-72 h period (P > 0.05). No significant differences were found in the degree of nausea and the dose of tramadol between the two groups at either time point in the acupuncture group and sham acupuncture group. CONCLUSION: The use of acupuncture at the P6 acupoint in neurosurgery patients did result in significantly lower pain scores and reduction in the incidence of vomiting after craniotomy. There were no significant side effects. Acupuncture at the P6 acupoint was well tolerated and safe in this patient population.

The effects of mindfulness-based intervention on quality of life and poststroke depression in patients with spontaneous intracerebral hemorrhage in China.

OBJECTIVE: Spontaneous intracerebral hemorrhage (sICH) is a devastating disease that can lead to poststroke depression (PSD) and greatest impact on the quality of life (QOL) of patients. Mindfulness meditation was viewed as one of the effective ways to reduce PSD in patients with cancer. The present study tried to investigate whether mindfulness meditation has potential benefits in PSD and QOL for sICH patients in China. METHODS: Two hundred and two patients in West China Hospital, Sichuan University, enrolled from January 2017 to December 2018 were included in a randomized controlled trial. After removing missing values, there were 67 in control group and 67 in intervention group. Patients in intervention group received 2-month mindfulness-based cognitive therapy, and patients in control group received stress management education (ie, an active control). RESULTS: The results suggested that the significant differences of depression, trait mindfulness, social well-being, emotional well-being, and total score of QOL were found in intervention group from time 1 to time 2. Physical well-being and the score of NIH stroke scale experienced significant changes in both control group and intervention group over time. CONCLUSIONS: Mindfulness-based intervention has positive effects on sICH patients' depression, social well-being, and emotional well-being. However, the change of trait mindfulness over time could not explain these positive effects. Future studies could explore the mechanism of mindfulness-based intervention on sICH patients' depression and QOL and clarify the boundaries of the positive effects of mindfulness-based intervention.

Intradermal thumbtack needle buried Neiguan (P6) point for prevention of postoperative nausea and vomiting in patients undergoing craniotomy: study protocol for a randomised controlled trial.

INTRODUCTION: Postoperative nausea and vomiting (PONV) is among the most common adverse reactions following anaesthesia and surgery. Recent clinical studies have reported that the average incidence is about 30%, while in patients specifically undergoing neurosurgery, the incidence can be as great as 73%. Studies also suggest that its occurrence increases the risk of intracranial haematoma and haemorrhage. The objective of this study is to evaluate the effectiveness of intradermal thumbtack needle buried Neiguan (pericardium 6 (P6)) point therapy in the prevention of PONV in patients undergoing craniotomy under general anaesthesia. METHODS AND ANALYSIS: This is a single-centre, three-arm, randomised controlled trial. 180 participants are randomly assigned to either an acupuncture, intradermal thumbtack needle or control group in a 1:1:1 ratio. The P6 of the acupuncture group is punctured at both sides perpendicularly to a depth of 20 mm. Needles are retained for 30 min and stimulated every 10 min to maintain the de qi. The therapy includes two treatments; the acupuncture is administered immediately after and 24 hours after surgery. For the intradermal thumbtack needle group, the intradermal thumbtack needle is quickly inserted into the skin and embedded at P6 acupoints bilaterally. Patients and their families are asked to press the needlepoint with the onset of nausea, vomiting, bloating, pain and other reported discomforts. The needle is replaced after 24 hours. The therapy is administered immediately after and 24 hours after surgery. For the control group, no intervention is carried out. The incidence of PONV within 48 hours after craniotomy across the three groups is observed. Other observations include: (1) assessment of nausea score (severity of nausea) and pain score (visual analogue scale) 0-2, 2-6, 6-24 and 24-48 hours after craniotomy under general anaesthesia; (2) assessment of total rescue antiemetic dosage 0-48 hours after craniotomy under general anaesthesia; (3) length of hospital stay and (4) patient satisfaction score with PONV management. We will perform all statistical analysis following the intention-to-treat principle. ETHICS AND DISSEMINATION: Ethics approval has been granted by the Bioethics Subcommittee of the West China Hospital, Sichuan University: the approval number is 2018 (number 231). Results will be expected to be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ChiCTR1800017173.

[Observation on the Efficacy of Electroacupuncture for Functional Constipation].

OBJECTIVE: To investigate the therapeutic rule of electroacupuncture (EA) in treating functional constipation. METHODS: Eighty-eight patients with severe chronic functional constipation were randomized divided into EA (n=45) and sham-EA (n=43) groups. Patients in the EA group were treated with EA at bilateral Tianshu (ST 25), Fujie (SP 14), Shangjuxu (ST 37), and those in the sham-EA group were received superficial acupuncture at 1 cun lateral to the identical acupoints without electrical current delivery. The number of patients with complete spontaneous bowel movements (CSBM) was weekly compared between the EA and sham-EA groups at baseline week, during 8 weeks' treatment, as well as the follow-up 4th, 8th and 12th weeks after treatment. The Bristol Stool Chart (BSC) and defecation difficulty scores were also weekly compared from baseline until 8 weeks. RESULTS: The CSBM showed significant differences from 3 to 8 weeks and at 4th, 8th and 12th weeks post-treatment (P<0.05), but not within the first two weeks between the EA and sham-EA groups. The number of patients who had more than 3 times of CSBM per week was increased in the EA group(P<0.05). The therapeutic effect of EA group was superior to that of the sham-EA group in improving BSC over the 4th and 5th weeks (P<0.05). The defecation difficulty score was improved in the EA group than in the sham-EA group since the 4th week (P<0.05). CONCLUSIONS: EA shows therapeutic effect for functional constipation by improving CSBM and BSC.

[Electroacupuncture for severe acute pancreatitis accompanied with paralytic ileus:a randomized controlled trial].

OBJECTIVE: To observe the clinical efficacy differences between electroacupuncture (EA) and regular treatment for severe acute pancreatitis accompanied with paralytic ileus. METHODS: This was a prospective pragmatic randomized controlled trial. A total of 140 cases of severe acute pancreatitis accompanied with paralytic ileus were randomly assigned into an EA group and a regular treatment group, 70 cases in each one. The patients in the regular treatment group were treated with regular treatment, including intensive care, gastrointestinal decompression, fasting, blood capacity supplement, acid suppression treatment, internal environment maintenance, infection prevention, inhibition of pancreatic exocrine secretion, etc. Based on the regular treatment, patients in the EA group were treated with EA at Zusanli (ST 36) and Zhigou (TE 6), 30 min for each treatment, once a day for totally 5 days. The VAS-based abdominal distension severity scale and abdominal pain severity scale were compared before and during treatment in the two groups, moreover, the number of patients who transferred to surgery or ICU was compared. RESULTS: (1) After the 1st EA, the abdominal pain and distension severity scales were both improved in the EA group, which were superior to those of the regular treatment group (all P<0.05); afterwards, the abdominal distension and pain severity scales of each day in the EA group were all significantly superior to those of the regular treatment group (all P<0.05). (2) The number of patients who transferred to surgery or ICU was not significantly different between the two groups (P>0.05). CONCLUSIONS: EA at Zusanli (ST 36) and Zhigou (TE 6) can significantly reduce the abdominal distension and pain severity scales in patients of severe acute pancreatitis accompanied with paralytic ileus, indicating positive clinical significance; in addition, EA is safe and can be recommended to the treatment of severe acute pancreatitis in combination with treatment plan of integrated Chinese and western medicine.

[Improving the researchers' compliance and the quality of clinical study on acupuncture and moxibustion:thoughts on the role conflict between doctors and researchers].

The coordination and collaboration of many links are required to achieve the successful development of a high-quality clinical randomized controlled trial, in which, the compliance of the researchers affects the ultimate results and quality of the study since it is responsible for the safety and benefits of subjects in the trials and study quality. Focusing on the researchers' compliance, it is believed that the improvements in the researchers' compliance are very significant in the implementation of study scheme. At present, commonly, the researchers are of the low compliance, manifest as failure to obey the study scheme (such as inclusive criteria, enrollment sequence), failure to obey the rules of operation and data collection, failure to store the original documents but to modify the data, failure to report timely adverse events, etc. In view of clinical research monitors, the reasons on the low compliance are analyzed and the solutions are proposed.

[Effect of acupuncture and moxibustion on depressive states of stroke patients' spouses].

OBJECTIVE: To verify the clinical efficacy of acupuncture and moxibustion on depressive states of stroke patients' spouses. METHODS: Forty-four subjects who were stroke patients' spouses and according with inclusive criteria with mild or moderate depressive states were randomly divided into an acupuncture-moxibustion group and a blank control group, 22 cases in each group. In the acupuncture-moxibustion group, acupuncture was applied at Baihui (GV 20), Shenting (GV 24), Sishencong (EX-HN 1), Hegu (LI 4), Zusanli (ST 36) and Taichong (LR 3), and suspended moxibustion was used at Shenque (CV 8), Guanyuan (CV 4) and Zhongwan (CV 12). The treatment was given twice a week for continuous 8 weeks. In the blank control group, neither acupuncture nor moxibustion treatment was given, and the patients were only treated with health and psychological guidance. Before treatment and after 8-week treatment, scores of self-rating depression scale (SDS) and numbers of insomnia severity grade were observed. RESULTS: In the two groups, the scores of SDS were both reduced than those before treatment (both P<0.05), and the decrease in the acupuncture-moxibustion group was more obvious (P<0.05). After treatment, the number of insomnia severity grade in the acupuncture-moxibustion group was improved than that before treatment (P<0.001), and the improvement was evidently superior to that in the blank control group (P<0.05). The numbers of insomnia severity grade of the blank control group before and after treatment had no statistic significance (P>0.05). CONCLUSION: The acupuncture and moxibustion intervention plan has clinical treatment significance on the improvement of mild and moderate depressive states for the stroke patients' primary caregivers who are the patients' spouses.

The efficacy and safety of Baoji Tablets for treating common cold with summer-heat and dampness syndrome: study protocol for a randomized controlled trial.

BACKGROUND: Despite the high incidence and the economic impact of the common cold, there are still no effective therapeutic options available. Although traditional Chinese medicine (TCM) is widely used in China to treat the common cold, there is still a lack of high-quality clinical trials. This article sets forth the protocol for a high-quality trial of a new TCM drug, Baoji Tablets, which is designed to treat the common cold with summer-heat and dampness syndrome (CCSDS). The trial is evaluating both the efficacy and safety of Baoji Tablets. METHODS/DESIGN: This study is designed as a multicenter, phase II, parallel-group, double-blind, double-dummy, randomized and placebo-controlled trial. A total of 288 patients will be recruited from four centers. The new tablets group are administered Baoji Tablets 0.9 g and dummy Baoji Pills 3.7 g. The old pills group are administered dummy Baoji Tablets 0.9 g and Baoji Pills 3.7 g. The placebo control group are administered dummy Baoji Tablets 0.9 g and dummy Baoji Pills 3.7 g. All drugs are taken three times daily for 3 days. The primary outcome is the duration of all symptoms. Secondary outcomes include the duration of primary and secondary symptoms, changes in primary and secondary symptom scores and cumulative symptom score at day 4, as well as an evaluation of treatment efficacy. DISCUSSION: This is the first multicenter, double-blind, double-dummy, randomized and placebo-controlled trial designated to treat CCSDS in an adult population from China. It will establish the basis for a scientific and objective assessment of the efficacy and safety of Baoji Tablets for treating CCSDS, and provide evidence for a phase III clinical trial. TRIAL REGISTRATION: This study is registered with the Chinese Clinical Trial Registry. The registration number is ChiCTR-TRC-13003197.

P6 acupoint stimulation for prevention of postoperative nausea and vomiting in patients undergoing craniotomy: study protocol for a randomized controlled trial.

BACKGROUND: The incidence of postoperative nausea and vomiting (PONV) is 50 to 79% after neurosurgery. Our study is designed to evaluate the efficacy of pericardium 6 (P6; also known as Neiguan) acupoint stimulation versus placebo, and versus routine antiemetic for the prevention of PONV after craniotomy, as well as to compare the efficacy of invasive acupuncture with non-invasive transcutaneous electrical nerve stimulation (TENS) on P6. METHODS/DESIGN: This is a single-center, prospective, double-blind, five-arm, parallel-group, randomized controlled trial (RCT). All groups will be given routine intravenous ondansetron 8 mg administered before skin closure. Upon regaining consciousness from general anaesthesia, patients will receive one of five interventions: 1) P6 acupuncture bilaterally for 30 minutes, stimulated every 10 minutes to keep de qi sensation; 2) sham acupuncture bilaterally for 30 minutes with no stimulation; 3) P6 stimulation via active TENS electrodes bilaterally for 30 minutes, with stimulation frequency and intensity set to when de qi sensation is felt; 4) sham P6 stimulation via inactive TENS electrode bilaterally for 30 minutes; and 5) usual practice of pharmacological emesis prevention. The incidence of postoperative vomiting during the first 24 hours is the main outcome. Secondary outcomes include: complete response rate, severity of nausea, total rescue metoclopramide dose used and patient satisfaction with PONV management. DISCUSSION: The results from this study could potentially confirm that P6 acupoint stimulation is an effective adjunct to standard antiemetic drug therapy for the prevention of PONV in patients undergoing craniotomy. Our study may also confirm that conventional acupuncture is more effective than TENS. TRIAL REGISTRATION: This study is registered with the Chinese Clinical Trial Registry: ChiCTR-TRC-13003026.

[Survey study of conditions of patients with acute stroke seeking for acupuncture treatment].

To explore possible factors that affecting patients with acute stroke seeking for acupuncture treatment by questionnaire survey. The average age of the 202 patients was 63.14. Before the survey, only 66 patients had received acupuncture treatment, and 136 patients did not consider accepting acupuncture treatment. After the survey, there were more patients want to accept acupuncture treatment (P < 0.05). Patients expressed three major opinions about acupuncture, i.e., lack of knowledge of acupuncture, analgesia after needling, and slow effectiveness. Patients lack awareness of acupuncture and cultural identity. Therefore, it is urgent to promote awareness of acupuncture, strengthen culture identity which will facilitate the development of acupuncture.