Combined electroacupuncture and auricular acupuncture for postoperative pain after abdominal surgery for gynecological diseases: study protocol for a randomized controlled trial.

BACKGROUND: Postoperative pain is a major complaint following abdominal surgery for gynecological diseases. Effective postoperative pain control after abdominal surgery is particularly important for patient recovery, mobility, and satisfaction. Acupuncture has been commonly used for pain management. However, its efficacy in postoperative pain control is inconclusive and health economic evaluation is limited. METHODS: A randomized, sham-controlled, patient- and- assessor-blind trial is designed to evaluate the efficacy and safety of acupuncture in managing postoperative pain following abdominal surgery of gynecological diseases. Patients who are eligible for laparotomy with a midline incision for gynecological neoplasia, including ovarian mass, uterine mass, and cervical lesions, will be recruited. Seventy-two participants will be randomly allocated to an acupuncture or non-invasive sham control in a 1:1 ratio. Treatment will be done within 2 h before operation, upon arrival to the ward and once daily for 5 days. The Pain Numerical Rating Scale (NRS) on the first 5 days during hospitalization will be the primary outcome and will be analyzed using the area-under-the-curve (AUC) method. The secondary outcome measures include frequency of rescue analgesic use during hospital stay, cumulative morphine consumption; quality of recovery as measured by time to recovery variables and the Quality of Recovery-9 (QoR-9); quality of life as measured by the Short Form-6 dimension (SF-6D) and EuroQol-5 Dimension-5 Level (EQ-5D-5 L). The incremental cost-effectiveness ratio of acupuncture vs sham acupuncture will be calculated. DISCUSSION: This study protocol provides an example of integrative medicine practice in a hospital setting for the management of postoperative pain using acupuncture treatment. The acupuncture treatment protocol, if proven to be effective, can be implemented in routine settings to play a role in postoperative pain management for patients who have undergone abdominal surgery for gynecological diseases. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02851186 . Registered on 19 July 2016.

Short-term intensive training attenuates the exercise-induced interaction of mono-1/2 cells and platelets after coronary bypass in cardiac patients.

The interaction between platelets and monocytes plays a critical role in the pathogenesis and progression of cardiovascular diseases. This study investigated how short-term intensive training (SIT) influences monocyte subset characteristics and exercise-induced monocyte and platelet aggregates (MPAs) following elective coronary bypass (CABG) in cardiac patients. Forty-nine patients hospitalised for CABG were randomised into SIT (N=26) and conventional training (CT, N=23) groups. The SIT subjects underwent supervised aerobic training at 80~120 % of the ventilatory anaerobic threshold based on sub-maximal exercise tests performed 7 days post-CABG for 20 sessions with two sessions/day and 30 min/session, which were completed within four weeks after surgery. The CT subjects performed light-intensity conditioning exercise for ≤4 sessions. Resting and maximal exercise-mediated monocyte characteristics and MPA were determined before and following intervention. The SIT group had a larger improvement in ventilation efficiency and anaerobic threshold than the CT group; the SIT group exhibited larger reductions in blood monocyte subtypes 1 and 2 (Mono1 and 2) counts at rest than the CT group; the SIT group but not the CT group exhibited attenuated formation of Mono1/platelet hetero-aggregation (MPA1) and CD42b expression on Mono1/2 caused by strenuous exercise; and plasma levels of macrophage inflammatory protein-1ß and soluble P-selectin showed similar trends as Mono1/2 and MPA1, respectively. In conclusion, SIT modestly improved aerobic capacity in patients following CABG. Moreover, SIT simultaneously ameliorated the CD42b expression of Mono1/2 cells and maximal exercise-induced MPA1, which may reduce the risk of inflammatory thrombosis.

Effect of YH0618 soup on chemotherapy-induced toxicity in patients with cancer who have completed chemotherapy: study protocol for a randomized controlled trial.

BACKGROUND: The incidence of cancer has been staying at a high level worldwide in recent years. With advances in cancer diagnosis and therapy strategy, the survival rate of patients with cancer has been increasing, but the side effects of these treatments, especially chemotherapy, are obvious even when the chemotherapy ceases. YH0618, a prescription, has showed efficacy in reducing chemotherapy-induced toxicity through long clinical practice. However, there is no scientific research exploring the effects of YH0618 in patients with cancer. Therefore, using a randomized controlled trial, this study will explore the efficacy of YH0618 on ameliorating chemotherapy-induced toxicity including dermatologic toxicity, myelosuppression, hepatotoxicity and nephrotoxicity and improving fatigue in cancer patients who have completed chemotherapy. METHODS/DESIGN: This is a prospective assessor-blinded, parallel, randomized controlled trial. Patients with cancer at any stage who have completed chemotherapy within two weeks will be randomly divided into group A (YH0618) and group B (wait-list) using a 1:1 allocation ratio. The chemotherapeutic agents include taxanes or anthracyclines. Subjects assigned to group A will receive YH0618 soup 6 days a week for 6 weeks and uncontrolled follow-up for 6 weeks, while group B are required to wait for 6 weeks before receiving YH0618 intervention. The primary outcome of this study is the incidence of protocol-specified grade ≥2 dermatologic toxicities graded by NCI CTCAE Chinese version 4.0 and changes of fingernail color, face skin color and tongue color evaluated by the L*a*b system within 6 weeks. There are some secondary outcomes associated with dermatologic toxicity including fatigue and clinical objective examination. DISCUSSION: There are few scientific and safe methods in ameliorating chemotherapy-induced toxicity. The proposed study may provide direct and convincing evidence to support YH0618 as an adjuvant treatment for reducing chemotherapy-induced toxicity, which could be introduced into clinical settings. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR-IOR-15006486 . Registered on 21 May 2015.

Modified high-intensity interval training increases peak cardiac power output in patients with heart failure.

PURPOSE: Although high-intensity interval aerobic training (HIT) effectively improves aerobic fitness, the risk of cardiac arrest transiently increases during strenuous physical exertion in patients with cardiovascular disease. For safety and efficacy concerns, this investigation explored the effect of a modified HIT (mHIT) on exertional ventilatory-hemodynamic efficiency in heart failure patients with reduced ejection fraction (HFREF). METHODS: HFREF patients were prospectively assigned to two groups: mHIT and usual healthcare (UC). The former comprised supervised continuous aerobic training at ventilatory anaerobic threshold for 50 min/day, 3 days/week for 4 weeks, and then 3-min intervals at 40 and 80% VO2 reserve for 50 min/day, 3 days/week for 8 weeks. The latter received optimal medical treatment only. Ventilatory and hemodynamic responses during exercise were measured before and after the intervention. Paired-t and repeated measures ANOVA with post hoc tests were adopted. RESULTS: Each group had an N of 33. The mHIT and UC group had matched baseline characteristics including health-promotion concept and behavior score. The mHIT for 12 weeks (1) increased VO2, cardiac output, and notably, cardiac power output at peak workload (1,151 ± 573 vs. 1,306 ± 596 L/min/mmHg); (2) reduced V E/VO2 (32.4 ± 4.6 vs. 30.0 ± 4.0), breathing frequency, ventilation, and enhanced stroke volume compliance at identical submaximal intensity (50% peak workload at pre-intervention evaluation). No significant changes in ventilatory and hemodynamic responses to exercise were observed following the UC. CONCLUSIONS: The mHIT regimen improves peak cardiac pumping capacity with reducing cardiac after-load and simultaneously increases ventilation efficiency during exercise in patients with HFREF. Thereby, aerobic fitness is ameliorated.