Ondansetron and Dexamethasone Versus Standard Combination Antiemetic Therapy: A Randomized Trial for the Prevention of Acute and Delayed Emesis Induced by Cyclophosphamide‐ Doxorubicin Chemotherapy and Maintenance of Antiemetic Effect at Subsequent Courses Effect of acupuncture compared with placebo-acupuncture at P6 as additional antiemetic prophylaxis in high-dose chemotherapy and autologous peripheral blood stem cell transplantation: a randomized controlled single-blind trial. Acupressure wrist bands to relieve nausea and vomiting in hospice patients: Do they work? Transcutaneous electrical nerve stimulation as an adjunct for controlling chemotherapy-induced nausea and vomiting in gynecologic oncology patients. Electroacupuncture for control of myeloablative chemotherapy-induced emesis: A randomized controlled trial. Acupressure for Nausea and Vomiting of Pregnancy: A Randomized, Blinded Study Acustimulation wrist bands are not effective for the control of chemotherapy-induced nausea in women with breast cancer. Randomized double-blind study of the Reliefband as an adjunct to standard antiemetics in patients receiving moderately-high to highly emetogenic chemotherapy Acustimulation wristbands for the relief of chemotherapy-induced nausea. P6 acupressure may relieve nausea and vomiting after gynecological surgery: an effectiveness study in 410 women Acupressure for nausea: results of a pilot study. The efficacy of acupressure and acustimulation wrist bands for the relief of chemotherapy-induced nausea and vomiting. A University of Rochester Cancer Center Community Clinical Oncology Program multicenter study. Introducing a placebo needle into acupuncture research Traditional Chinese acupuncture: a potentially useful antiemetic? Non-invasive Stimulation of the P6 (Neiguan) Antiemetic Acupuncture Point in Cancer Chemotherapy Nausea and vomiting remain a significant clinical problem: trends over time in controlling chemotherapy-induced nausea and vomiting in 1413 patients treated in community clinical practices. Enhancement of the antiemetic action of metoclopramide against cisplatin-induced emesis by transdermal electrical nerve stimulation.
The antiemctic efficacy of ondansetron and dexamethasone ( Ondex ) was r and omly compared to that of high-dose metoclopramide , dexamethasone , and orphcnadrine ( Control ) in the prevention of emesis induced by cyclophosphamide-doxoruhicin chemotherapy in 64 chemotherapy-naive breast cancer patients . For the control of acute emesis ( day 1 ) , patients were r and omized to receive either ondasetron 8 mg p.o . 1 hour prior to chemotherapy ( CT ) and repeated after 6 and 12 hours plus dexamethasone 20 mg i.v . 40 minutes prior to CT ( Ondex ) or dexamethasone 20 mg i.v . 40 minutes prior to CT , orphenadrine 40 mg i.m . 35 minutes prior to CT and metoclopramide 3 mg/kg i.v . 30 minutes prior to CT and repeated after 90 minutes followed by 40 mg p.o . every 3 hours for 4 times ( Control ) . To control delayed emesis , patients on Ondex received ondansetron 8 mg PO t.i.d . days 2 and 3 and patients in the Control arm received metoclopramide 0.5 mg/kg p.o . q.i.d . and dexamethasone 8 mg i.m . b.i.d . days 2 and 3 . Complete and major control of acute emesis was observed in 74%/94 % and 44%/67 % of patients treated with Ondex and Control , respectively ( p < .01/p < .005 ) . Acute nausea was absent in 38 % and 34 % of patients treated with Ondex and Control , respectively ( p = NS ) . Complete and major control of delayed emesis ( days 2–5 ) was observed in 65%/91 % versus 44%/66 % of patients in the Ondex and Control arms , respectively ( p = NS/p < .01 ) . In patients receiving 6 courses of FEC/FAC , control of acute emesis was significantly superior with Ondex at all treatment courses PURPOSE The purpose is to investigate an additional antiemetic effect to ondansetron with needle acupuncture at P6 compared with nonskin-penetrating placebo acupuncture in patients undergoing high-dose chemotherapy and autologous peripheral blood stem cell transplantation . EXPERIMENTAL DESIGN Eighty patients who were admitted to hospital for high-dose chemotherapy and autologous peripheral blood stem cell transplantation were included into a r and omized placebo-controlled single-blind trial . The patients were r and omized to receive acupuncture ( n = 41 ) or noninvasive placebo acupuncture ( n = 39 ) at the acupuncture point P6 30 min before first application of high-dose chemotherapy and the day after . All patients received 8 mg ondansetron/day i.v . as basic antiemetic prophylaxis . The main outcome measure was the rate of patients who either had at least one episode of vomiting or required any additional antiemetic drugs on the first 2 days of chemotherapy . RESULTS The main outcome measure showed no significant difference ( P = 0.82 ) : 61 % failure in the acupuncture group and 64 % in the placebo acupuncture group ( 95 % confidence interval of 3 % difference : -18.1 and 24.3 % ) . Comparing nausea , episodes of vomiting or retching and number of additionally required antiemetic drugs did not provide any discrepancy with the main result . CONCLUSIONS This study suggests that in combination with ondansetron i.v . , invasive needle acupuncture at P6 compared with nonskin-penetrating placebo acupuncture has no additional effect for the prevention of acute nausea and vomiting in high-dose chemotherapy This study assessed the effects of acupressure wrist b and s on the nausea and vomiting  ofterminally ill patients . Using a single subject experimental design , six hospice patients were exposed to three conditions : • An acupressure wrist b and ; • A placebo wrist b and ; • A no wrist b and condition . Patients and their caregivers rated nausea and vomiting during the treatment . Despitesome difficultyobtaining complete data , the results of this preliminary test indicate that acupressure wrist b and swere not effective in reducing nausea and vomiting in this small sample of hospice patients BACKGROUND To evaluate the efficacy of a miniaturized portable transcutaneous electrical nerve stimulation ( TENS ) unit ( ReliefB and ) as an adjunct to st and ard antiemetic therapy for controlling nausea and vomiting induced by cisplatin-based chemotherapy in gynecologic oncology patients . METHODS Forty-two patients were enrolled in a r and omized , double-blind , placebo-controlled parallel-subjects trial with a follow-up crossover trial . All patients received a st and ardized antiemetic protocol , then wore the ReliefB and continuously for 7 days . RESULTS Thirty-two patients were evaluable for the parallel-subjects component , 16 in each group . The percentage of patients with absent or minimal nausea was 59 % overall , which was similar to that for both the active ( 56 % ) and placebo ( 62 % ) groups . The incidence and severity of nausea and vomiting was similar for each group . Eighteen patients completed two consecutive cycles and were evaluable for the crossover component . The average age of the crossover patients and their dose intensity were comparable with those of the overall study population ( 56.3 versus 58.6 years and 22.7 versus 22.7 mg/m2/week , respectively ) . The percentage of cycles with absent or minimal nausea was 47 % overall , which was similar to that of the active ( 50 % ) and placebo ( 44 % ) cycles . However , the severity of nausea was significantly lower in the active cycles during days 2 to 4 . Patients averaged less than one episode of vomiting daily in each cycle . CONCLUSIONS The ReliefB and is an effective adjunct to st and ard antiemetic agents for controlling nausea induced by cisplatin-based chemotherapy in gynecologic oncology patients CONTEXT High-dose chemotherapy poses considerable challenges to emesis management . Although prior studies suggest that acupuncture may reduce nausea and emesis , it is unclear whether such benefit comes from the nonspecific effects of attention and clinician-patient interaction . OBJECTIVE To compare the effectiveness of electroacupuncture vs minimal needling and mock electrical stimulation or antiemetic medications alone in controlling emesis among patients undergoing a highly emetogenic chemotherapy regimen . DESIGN Three-arm , parallel-group , r and omized controlled trial conducted from March 1996 to December 1997 , with a 5-day study period and a 9-day follow-up . SETTING Oncology center at a university medical center . PATIENTS One hundred four women ( mean age , 46 years ) with high-risk breast cancer . INTERVENTIONS Patients were r and omly assigned to receive low-frequency electroacupuncture at classic antiemetic acupuncture points once daily for 5 days ( n = 37 ) ; minimal needling at control points with mock electrostimulation on the same schedule ( n = 33 ) ; or no adjunct needling ( n = 34 ) . All patients received concurrent triple antiemetic pharmacotherapy and high-dose chemotherapy ( cyclophosphamide , cisplatin , and carmustine ) . MAIN OUTCOME MEASURES Total number of emesis episodes occurring during the 5-day study period and the proportion of emesis-free days , compared among the 3 groups . RESULTS The number of emesis episodes occurring during the 5 days was lower for patients receiving electroacupuncture compared with those receiving minimal needling or pharmacotherapy alone ( median number of episodes , 5 , 10 , and 15 , respectively ; P<.001 ) . The electroacupuncture group had fewer episodes of emesis than the minimal needling group ( P<.001 ) , whereas the minimal needling group had fewer episodes of emesis than the antiemetic pharmacotherapy alone group ( P = .01 ) . The differences among groups were not significant during the 9-day follow-up period ( P = .18 ) . CONCLUSIONS In this study of patients with breast cancer receiving high-dose chemotherapy , adjunct electroacupuncture was more effective in controlling emesis than minimal needling or antiemetic pharmacotherapy alone , although the observed effect had limited duration . JAMA . 2000;284:2755 - 2761 Objective : To evaluate the effectiveness of acupressure in reducing nausea and vomiting of pregnancy .  Methods : Symptomatic pregnant women were r and omized to one of two acupressure groups : one treatment group using an acupressure point ( PC-6 ) and one sham control group using a placebo point . Subjects were blind to the group assignment . Each evening for 10 consecutive days , the subjects completed an assessment scale describing the severity and frequency of symptoms that occurred . Data from the first 3 days were used as pre-treatment scores . Beginning on the morning of the fourth day , each subject used acupressure at her assigned point for 10 minutes four times a day . Data from day 4 were discarded to allow 24 hours for the treatment to take effect . Data from days 5 - 7 were used to measure treatment effect . Results : Sixty women completed the study . There were no differences between groups in attrition  ,  parity , fetal number , maternal age , gestational age at entry , or pre-treatment nausea and emesis scores . Analysis of variance indicated that both groups improved significantly over time , but that nausea improved significantly more in the treatment group than in the sham control group ( F1,58=10.4 , P = .0021 ) . There were no differences in the severity or frequency of emesis between the groups . There was a significant positive correlation ( r=0.261 , P = .044 ) between maternal age and severity of nausea . Conclusion : Our results indicate that acupressure at the PC-6 anatomical site is effective in reducing symptoms of nausea but not frequency of vomiting in pregnant women This experiment examined the efficacy of an acustimulation wrist b and for the relief of chemotherapy-induced nausea using a r and omized three-arm clinical trial ( active acustimulation , sham acustimulation , and no acustimulation ) in 96 women with breast cancer who experienced nausea at their first chemotherapy treatment .  Five outcomes related to  wrist b and efficacy ( acute nausea , delayed nausea , vomiting , QOL , and total amount of antiemetic medication used ) were examined . The five outcomes were examined separately using analysis of covariance controlling for age and severity of past nausea . There were no significant differences in any of these study measures among the three treatment conditions ( P>0.1 for all ) . Study results do not support the hypothesis that acustimulation b and s are efficacious as an adjunct to pharmacological antiemetics for control of chemotherapy-related nausea in female breast cancer patients Goals Our goal was to evaluate the efficacy and tolerability of the Reliefb and as an adjunct to st and ard antiemetics in patients receiving moderately-high to highly emetogenic chemotherapy . Patients and methods Forty-nine adult cancer patients receiving moderately-high or highly emetogenic chemotherapy were r and omized to receive either the active Reliefb and ( n=26 ) or an inactive device ( n=23 ) . Patients continued to receive all scheduled and as needed antiemetic agents as prescribed . The device was worn the day of chemotherapy administration for 5 days ( days 1–5 ) . Patients maintained a daily dairy of nausea severity , vomiting and retching episodes , and antiemetic medications taken . Each patient completed a Functional Living Index Emesis ( FLIE ) and a tolerability survey at the conclusion of the study . A Wilcoxon rank sum test was used to compare the number of vomiting episodes , severity of nausea and FLIE scores between the two groups . Main results Patients wearing the active Relifb and experienced less vomiting ( Reliefb and 1.9 versus inactive device 4.6 mean episodes ; p=0.05 ) , retching ( 1.4 versus 3.6 mean episodes ; p=0.05 ) , and nausea severity ( 0.91 versus 1.65 mean cm/day ; p=0.01 ) over the 5-day period compared to patients wearing the inactive device . Vomiting was statistically significantly reduced during the delayed period ( 0.42 versus 1 ; p=0.032 ) , whereas nausea was significantly reduced during the acute ( 0.71 versus 2.3 ; p=0.028 ) and delayed ( 1.8 versus 3.3 ; p=0.020 ) periods . FLIE scores did not differ between the two treatment groups ( 91 versus 80 ; p=0.088 ) . Conclusions This study suggests that patients receiving moderately-high to highly emetogenic chemotherapy who experience nausea and vomiting despite scheduled antiemetics may benefit from the use of the Reliefb and as an adjunct to antiemetics . Limitations of this study include differences in risk factors for emesis , chemotherapy , and antiemetic regimens . A larger , better , controlled r and omized study is needed to better define optimal use of this device CONTEXT Substantial evidence suggests that acupuncture-point stimulation may be effective in controlling side effects of chemotherapy . OBJECTIVE To examine the efficacy of an acustimulation wristb and for the relief of chemotherapy-induced nausea . DESIGN R and omized clinical trial using a 3-level crossover design . SETTING Three outpatient oncology clinics in the northeastern United States . PARTICIPANTS Twenty-five women and 2 men who experienced moderate or more severe nausea following their first chemotherapy treatment . INTERVENTION We compared active acustimulation of the Pericardium 6 ( PC-6 ) point on the ventral surface of the wrist with sham acustimulation ( a corresponding point on the posterior surface of the wrist ) . A control group received no acustimulation . OUTCOME MEASURES Severity of nausea and quantity of antiemetic medication used . RESULTS No statistically significant differences in average severity of nausea were observed between the 3 interventions . However , the data showed a difference close to statistical significance in the severity of delayed nausea reported during active acustimulation compared to no acustimulation ( P < .06 ) . In addition , patients took fewer antinausea pills during the active-acustimulation cycle of this experiment compared to the no-acustimulation phase ( P < .05 ) . CONCLUSION Findings on the efficacy of an acustimulation b and for the control of chemotherapy-induced nausea are positive but not conclusive . These findings provide ample justification for further study of acustimulation in clinical oncology Purpose To investigate the effect of sensory stimulation of the P6 point on postoperative nausea and vomiting ( PONV )  after gynecological surgery in the everyday clinical setting ( effectiveness study ) . Methods Four hundred and ten women undergoing general anesthesia for elective gynecological surgery were included in a prospect i ve , consecutive , r and omized , multicentre , placebo-controlled , double-blind clinical trial with a reference group . One group was given bilateral P6 acupressure ( n = 135 ) , a second group similar pressure on bilateral non-acupressure points ( n = 139 ) , and a third group ( n = 136 ) served as reference  group . Nausea ( scale 0–6 ) , vomiting , pain , and satisfaction with the treatment were recorded . Primary outcome was complete response , i.e. , no nausea , vomiting or rescue medication for 24 hr . Results were analyzed by applying logistic regression with indicators of treatments , type of operation and risk score for PONV as explanatory variables . Results Complete response was more frequent in the P6 acupressure group than in the reference group ( P = 0.0194 ) Conversely , the incidence of PONV was 46 % in the reference group , 38 % after pressure on a non-acupoint and 33 % after P6 acupressure . The decrease from 46 % to 33 % was statistically significant . When considering vaginal cases separately , the decrease in PONV was from 36 % to 20 % ( P = 0.0168 ) . The corresponding decrease from 59 % to 55 % in the laparoscopic surgery group was not statistically significant . Conclusion P6 acupressure is a non-invasive method that may have a place as prophylactic antiemetic therapy during gynecological surgery . RésuméObjectifRechercher l’effet d’une stimulation sensorielle acupressive en P6 sur les nausées et vomissements postopératoires ( NVPO ) à la suite d’une intervention chirurgicale gynécologique dans un cadre clinique normal ( étude d’efficacité).MéthodeUn essai clinique prospect if , r and omisé , multicentrique , en double aveugle contre placebo et comportant un groupe de référence a été réalisé auprès de 410 femmes qui se sont présentées successivement pour une intervention gynécologique non urgente sous anesthésie générale . Les patientes d’un premier groupe ont reçu de l’acupression en P6 ( n = 135 ) , celles d’un second groupe ont reçu une  pression semblable sur des points bilatéraux , non d’acupression , ( n = 139 ) et un troisième groupe ( n = 136 ) a servi de référence . Les nausées ( échelle de 0–6 ) , les vomissements , la douleur et la satisfaction face au traitement ont été notés . Le premier résultat était une réponse complète , donc absence de nausées , de vomissements ou de médication de secours pendant 24 h. Les résultats ont été analysés par régression logistique avec des indicateurs de traitements , le type d’intervention et le taux de risque de NVPO comme variables explicatives . RésultatsLa réponse complète a été plus fréquente avec l’acupression en P6 que chez les patientes témoins ( P = 0,0194 ) . Inversement , l’incidence de NVPO a été de 46 % dans le groupe de référence , 38 % après une pression de points non acupresseurs et 33 % après l’acupression en P6 . La diminution de 46 % à 33 % était significative . L’examen séparé des cas d’intervention vaginale indique une baisse des NVPO de 36 % à 20 % ( P = 0,0168 ) . La baisse correspondante de 59 % à 55 % dans les cas d’intervention laparoscopique n’était pas significative . Conclusion L’acupression en P6 représente une méthode non effractive de traitement antiémétique prophylactique qui peut avoir sa place pendant une intervention gynécologique PURPOSE / OBJECTIVES To compare differences in nausea experience and intensity in women undergoing chemotherapy for breast cancer between those receiving usual care plus acupressure training and treatment and those receiving only usual care .  DESIGN Single-cycle , r and omized clinical trial . SETTING Outpatient oncology clinic in a major teaching medical center and a private outpatient oncology practice . SAMPLE Seventeen women participated in the study . The typical participant was 49.5 years old ( SD = 6.0 ) , Caucasian ( 59 % ) , not married/partnered ( 76 % ) , on disability ( 53 % ) , born a U.S. citizen ( 76 % ) , and heterosexual ( 88 % ) ; lived alone ( 59 % ) ; had at least graduated from high school ( 100 % ) ; and had an annual personal income of $ 50,000 or greater ( 65 % ) . METHODS The intervention included finger acupressure bilaterally at P6 and ST36 , acupressure points located on the forearm and by the knee . Baseline and post study question naires plus a daily log were used to collect data . MAIN RESEARCH VARIABLES Nausea experience measured by the Rhodes inventory of Nausea , Vomiting , and Retching and nausea intensity . FINDINGS Significant differences existed between the two groups in regard to nausea experience ( p < 0.01 ) and nausea intensity ( p < 0.04 ) during the first 10 days of the chemotherapy cycle , with the acupressure group reporting less intensity and experience of nausea . CONCLUSIONS Finger acupressure may decrease nausea among women undergoing chemotherapy for breast cancer . IMPLICATION S FOR NURSING PRACTICE This study must be replicated prior to advising patients about the efficacy of acupressure for the treatment of nausea As an adjunct to st and ard antiemetics for the relief of  chemotherapy-induced nausea and vomiting ( NV ) , 739 patients were r and omly assigned to either : 1 ) acupressure b and s , 2 ) an acustimulation b and , or 3 ) a no b and control condition . Patients in the acupressure condition experienced less nausea on the day of treatment compared to controls ( P<0.05 ) . There were no significant differences in delayed nausea or vomiting among the three treatment conditions . Additional analyses revealed pronounced gender differences . Men in the acustimulation condition , but not the acupressure condition , had less NV compared to controls ( P<0.05 ) . No significant differences among the three treatment conditions were observed in women , although the reduction in nausea on the day of treatment in the acupressure , compared to the no b and condition , closely approached statistical significance ( P=0.052 ) . Expected efficacy of the b and s was related to outcomes for the acupressure but not the acustimulation conditions BACKGROUND A problem acupuncture research has to face is the concept of a control group . If , in control groups , non-acupoint needling is done , physiological acupuncture effects are implied . Therefore the effects shown in this group are often close to those shown in the acupuncture group . In other trials , control groups have received obviously different treatments , such as transcutaneous electrical nervous stimulation or TENS-laser treatment ; it is not clear if the effects of acupuncture are due only to the psychological effects of the treatment . METHODS We developed a placebo acupuncture needle , with which it should be possible to simulate an acupuncture procedure without penetrating the skin . In a cross-over experiment with 60 volunteers we tested whether needling with the placebo needle feels any different from real acupuncture . FINDINGS Of 60 volunteers , 54 felt a penetration with acupuncture  ( mean visual analogue scale [ VAS ] 13.4 ; SD 10.58 ) and 47 felt it with placebo ( VAS 8.86 ; SD 10.55 ) , 34 felt a dull pain sensation ( DEQI ) with acupuncture and 13 with placebo . None of the volunteers suspected that the needle may not have penetrated the skin . INTERPRETATION The placebo needle is sufficiently credible to be used in investigations of the effects of acupuncture Two consecutive studies were undertaken to evaluate the effectiveness of acupuncture as an antiemetic used in addition to premedication with opioids in patients undergoing minor gynaecological operations . In the first study 25 of the 50 patients underwent acupuncture immediately after premedication with 100 mg meptazinol , the rest receiving the drug alone , and in the second 75 patients were allocated r and omly to one of three groups : a group receiving 10 mg nalbuphine and acupuncture , a group receiving premedication and dummy acupuncture , and a group receiving premedication alone . Manual needling for five minutes at the P6 acupuncture point ( Neiguan ) result ed in a significant reduction in perioperative nausea and vomiting in the 50 patients who underwent acupuncture compared with the 75 patients who received no acupuncture . These findings can not be explained , but it is recommended that the use of acupuncture as an antiemetic should be explored further The beneficial effects of transcutaneous electrical stimulation of the P6 antiemetic point ( Neiguan ) as an adjuvant to st and ard antiemetics was studied in over 100 patients in whom chemotherapy-induced sickness was not adequately controlled by antiemetics alone .  Although the results were not quite as good as with invasive acupuncture , more than 75 % patients achieved considerable benefit from what was a nontoxic procedure . The use of large diffuse low impedence electrodes simplifies the technique . The 2 hourly application of Sea B and s prolongs the antiemetic action . Best results were obtained from the 2 hourly self-administration of 5 min of transcutaneous electrical stimulation of P6 using a simple battery-operated TENS machine ( 15 Hz ) to activate a large , easy-to-place surface electrode and increasing current until Qi is elicited Data from 1413 out patients in community-based clinical practice s were collected in order to characterize the use and effectiveness of 5-HT(3 ) receptor antagonists for control of chemotherapy-induced nausea and vomiting ( NV ) . Patients were divided by treatment starting date into six cohorts for trend analysis . In addition , NV symptoms were compared in 252 patients treated prior to the commercial introduction of the 5-HT(3 ) receptor antagonist antiemetics  , and an equal number of patients treated after their introduction . A comparison of cohorts revealed a significant ( P = 0 . 027 ) downward trend over time for the frequency of post-treatment vomiting episodes , but not for frequency of post-treatment nausea ( P = 0.69 ) . The average duration of nausea following treatment increased significantly over time ( P = 0.003 ) . Although the introduction of 5-HT(3 ) receptor antagonist antiemetics has apparently led to a significant reduction in the frequency of post-treatment vomiting , there has been an accompanying increase in the duration of post-treatment nausea In a double-blind sequential trial , the influence of transdermal electrical nerve stimulation ( TENS ) was studied in patients who were treated with total infusions of metoclopramide 3.5 mg/kg to counter the emetic action of cisplatin 60 - 90 mg/m2 .  Transdermal electrical nerve stimulation further reduced the emetic episodes in ten of 11 treatment pairs ( 2 alpha = .10 ) . This effect was blocked by naloxone . More surprisingly , TENS reduced the incidence of extrapyramidal effects of metoclopramide ( i.e. , akathisia and dystonia ) . These effects may be explained by the involvement of central nervous and peripheral TENS-induced production of opioid neuromodulators . An alternate hypothesis is the stimulation of serotonergic mechanisms via neuromodulation by opioid peptides , or by involvement of both systems
BACKGROUND There have been recent advances in chemotherapy-induced nausea and vomiting using 5-HT(3 ) inhibitors and dexamethasone .
However , many still experience these symptoms , and expert panels encourage additional methods to reduce these symptoms .
OBJECTIVES The objective was to assess the effectiveness of acupuncture-point stimulation on acute and delayed chemotherapy-induced nausea and vomiting in cancer patients .