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.

BackgroundThe 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/designThis 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.DiscussionThe 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 registrationThis study is registered with the Chinese Clinical Trial Registry: ChiCTR-TRC-13003026.

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.

IntroductionPostoperative 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 analysisThis 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 disseminationEthics 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 numberChiCTR1800017173

BackgroundDespite 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/designThis 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.DiscussionThis 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 registrationThis study is registered with the Chinese Clinical Trial Registry. The registration number is ChiCTR-TRC-13003197.

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IntroductionPostmenopausal 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 analysisIn 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 disseminationEthics 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 numberChiCTR2100053953.

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