Effects of Preoperative Acupuncture on Prevention of Nausea and Vomiting and Plasma Serotonin Values in the Hysterectomy Postoperative Period: a Randomized Clinical Trial.

Background: Nausea and vomiting are frequent complications of anesthesia in the postoperative period. Acupuncture at the pericardium point 6 (PC6) is known to be effective in preventing postoperative nausea and vomiting (PONV). Objectives: The objective of the present study is to investigate the effects of acupuncture performed at the PC6 point in the prevention of PONV in women undergoing elective open hysterectomy under general inhalational anesthesia and to assess its association with plasma serotonin levels. Methods: 97 patients undergoing elective open hysterectomy were randomly divided into two groups: acupuncture group (bilateral acupuncture at PC6, n = 49), and a control group (no acupuncture, n = 48). All patients prophylactically received ondansetron and dexamethasone and, as rescue medication, metoclopramide in case of occurrence of PONV. The primary outcome evaluated was occurrence of nausea and vomiting within 24 hours after surgery. Serotonin plasma levels were measured before and after acupuncture prior to anesthesia induction. For the control group, the repeat measurement was performed 30 minutes after admission to the preoperative unit. Results: Acupuncture at PC6 significantly reduced the incidence of nausea (29.2% vs. 6.1%; p > 0.003), and the need of rescue medication (metoclopramide) (33.3% vs. 10.2%; p > 0.006), but not vomiting (4.2 vs. 4.1; p > 0.98). The plasma serotonin levels between control and acupuncture groups did not differ. Conclusion: This study shows that acupuncture at PC6 resulted in a lower incidence of postoperative nausea in patients undergoing hysterectomy.

Differences between the real and the desired worlds in the results of clinical trials.

OBJECTIVE: We refer to the effectiveness (known as pragmatic or real world) and efficacy (known as explanatory or desired or ideal world) of interventions. However, these terms seem to be randomly chosen by investigators who design clinical trials and do not always reflect the true purpose of the study. A pragmatic-explanatory continuum indicator summary tool was thus developed with the aim of identifying the characteristics of clinical trials that distinguish between effectiveness and efficacy issues. We verified whether clinical trials used the criteria proposed by the indicator summary tool, and we categorized these clinical trials according to a new classification. METHOD: A systematic survey of randomized clinical trials was performed. We added a score ranging from 0 (more efficacious) to 10 (more effective) to each domain of the indicator summary tool and proposed the following classifications: high efficacy (<25), moderate efficacy (25-50), moderate effectiveness (51-75), and high effectiveness (<75). RESULTS: A total of 844 randomized trials were analyzed. No analyzed trials used the criteria proposed by the indicator summary tool. Approximately 44% of the trials were classified as having moderate effectiveness, and 43.82% were classified as having moderate efficacy. CONCLUSIONS: Most clinical trials used the term "efficacy" to illustrate the application of results in clinical practice, but the majority of those were classified as having moderate effectiveness according to our proposed score. The classification based on the 0-100 score is still highly subjective and can be easily misunderstood in all domains based on each investigator's own experiences and knowledge.