The evolution of anti-emetic prescriptions in primary care, between 2006 and 2016.

CONTEXT: Serious adverse events related to the use of domperidone and metoclopramide have been consistently reported in the literature for many years. This led to a restriction of their use in the early 2010s. OBJECTIVE: The main objective was to analyse the evolution of antiemetic prescription rate in French general practise between 2006 and 2016. The secondary objectives were to highlight prescription transfers for metopimazine and to quantify the impact on health expenditures. METHOD: All patients from a representative sample of a national administrative claims database, the French national health insurance database, were included between 2006 and 2016. Trends in annual anti-emetic prescription rates by general practitioners were analysed using logistic regression models adjusted for age, gender and the existence of cancer. The cost of theses changing prescription habits was quantified via Médic'AM, a public drug expenditure database. RESULTS: Around 669 020 individuals were included with a mean 8-year follow-up; 48 634 patients received an anti-emetic at least once between 2006 and 2016. Prescription rates for all antiemetics decreased significantly from 2.1% to 0.4%, especially for metoclopramide from 0.5% to 0.1%, for domperidone from 1.5% to 0.1% and for metopimazine from 0.4% to 0.2%, which is not in favour of prescription transfers. Expenses fell from 30 million euros in 2006 to 10 million in 2016. CONCLUSION: Decreases in anti-emetic prescription rates and public health expenditures preceded the publication of official recommendations to reduce the use of metoclopramide and domperidone, without prescription transfers for metopimazine.

Domperidone for increasing breast milk volume in mothers expressing breast milk for their preterm infants: a systematic review and meta-analysis.

BACKGROUND: Mothers of preterm infants often struggle to produce enough breast milk to meet the nutritional needs of their infant. Galactagogues such as domperidone are often prescribed to increase breast milk supply but evidence supporting their role in clinical practice is uncertain. OBJECTIVE: To evaluate the efficacy and safety of domperidone for increasing breast milk volume in mothers expressing breast milk for their preterm infants. SEARCH STRATEGY: MEDLINE, Embase and Web of Science were searched without language restrictions from first publication until January 2017. Bibliographies of articles and reviews were hand-searched for additional reports. SELECTION CRITERIA: Randomised controlled trials that compared domperidone with placebo in mothers of preterm infants (<37 weeks' gestation) experiencing insufficient milk supply. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion, extracted data and evaluated study quality. Differences in breast milk volume and adverse events were combined using fixed effects meta-analysis. MAIN RESULTS: The pooled analysis of five trials consisting of 194 women demonstrated a moderate increase in daily breast milk volume of 88.3 ml/day (95% CI 56.8-119.8) with the use of domperidone compared with placebo. No difference was evident with respect to maternal adverse events (odds ratio 1.05, 95% CI 0.65-1.71), with no reported cases of prolonged QTc syndrome or sudden cardiac death. Sensitivity analyses showed no important differences in the estimates of effects. CONCLUSIONS: Domperidone is well tolerated and results in a moderate short-term increase in expressed breast milk volume among mothers of preterm infants previously identified as having insufficient breast milk supply. TWEETABLE ABSTRACT: Domperidone leads to short-term improvements in breast milk volume in mothers of preterm infants.

Effectiveness of add-on therapy with domperidone vs alginic acid in proton pump inhibitor partial response gastro-oesophageal reflux disease in systemic sclerosis: randomized placebo-controlled trial.

OBJECTIVES: Twice-daily dosing of proton pump inhibitor (PPI), the standard therapy for gastro-oesophageal reflux disease (GERD), is an effective therapy for GERD in SSc. The aim of this study was to compare the efficacy of omeprazole in combination with domperidone vs in combination with algycon in reducing the severity and frequency of reflux symptoms of PPI partial response (PPI-PR) GERD in SSc. METHODS: Adult SSc patients having PPI-PR GERD were randomly assigned to receive domperidone plus algycon placebo or algycon plus domperidone placebo in a 1:1 ratio plus omeprazole for 4 weeks. The assessment included severity of symptom grading by visual analogue scale, frequency of symptoms by frequency scale for symptoms of GERD and quality of life (QoL) by EuroQol five-dimensions questionnaire scoring. RESULTS: One hundred and forty-eight SSc-GERD patients were enrolled, of whom 88 had PPI-PR. Eighty cases were randomized for either domperidone (n = 38) or algycon (n = 37) therapy. The majority in both groups had the diffuse SSc subset. At the end of the study, no significant difference in symptom grading was found between groups. After treatment and compared with baseline, the severity of symptoms, frequency scale for symptoms of GERD and QoL significantly improved in both groups. Five (13.2%) and 8 (21.6%) respective cases in the domperidone and algycon groups did not respond. CONCLUSION: The prevalence of PPI-PR GERD is common. Domperidone and algycon are equally effective treatments in combination with omeprazole. However, ∼17% of patients were non-responsive, so the effectiveness of domperidone, algycon and PPI combination therapy should be further investigated. TRIAL REGISTRATION: https://clinicaltrials.gov (NCT01878526).

[Gastroparesis in Noonan syndrome]. / Gastroparese bei Noonan-Syndrom.

We present a case of a 26-year-old female patient with bloating, postprandial nausea and recurrent vomiting after solid food intake. A gastric emptying scintigraphy showed a delayed gastric emptying, defining gastroparesis. Because of her past medical history of short stature and pulmonary stenosis, we initiated genetic counseling where the diagnosis of Noonan syndrome was made. Dietary therapy and medication with domperidone quickly led to relief of the discomfort due to gastroparesis. However, prokinetics are not indicated for long-term therapy, as cardiac arrhythmia may occur. A risk-benefit assessment should be done. There are several novel approaches which need to be further investigated.

Prokinetics prescribing in paediatrics: evidence on cisapride, domperidone, and metoclopramide.

OBJECTIVES: Domperidone and metoclopramide are prokinetics commonly prescribed off-label to infants and younger children in an attempt to treat gastro-oesophageal reflux symptoms. Another prokinetic drug, cisapride, was used but withdrawn in 2000 in the United Kingdom because of serious arrhythmic adverse events. Medicines and Healthcare Products Regulatory Agency issued safety warnings for domperidone in May 2012 and restricted its indications. We report here national primary care prescribing trends and safety signals of these drugs in children. METHODS: We used data from the General Practice Research Database between 1990 and 2006 for children <18 years. Descriptive statistics and Poisson regressions were performed to characterise prescribing trends. We examined safety signals in nested case-control studies. RESULTS: The proportion of children <2 years old being prescribed one of the medications doubled during the study period. Prescriptions of domperidone increased 10-fold, mainly following the withdrawal of cisapride in 2000. Prescriptions of metoclopramide did not change significantly. Despite the increase in prescriptions of domperidone, no new safety signals were identified. CONCLUSIONS: These data showed dramatic changes in prescribing of cisapride and domperidone despite the lack of good-quality supporting evidence. It is possible that these prescribing trends were influenced by published guidelines. Even if produced without robust efficacy and safety evidence, published guidelines can influence clinicians and consequently affect prescribing. Therefore, improving the evidence base on prokinetics to inform future guidelines is vital. The lack of new safety signals during this period would support the development of suitable powered clinical studies.

Evaluation of domperidone efficacy to prevent aspiration pneumonia in patients with acute ischemic stroke: a randomized clinical trial.

BACKGROUND AND AIM: Aspiration pneumonia is an essential complication of acute ischemic stroke (AIS), which is responsible for increased three-fold mortality within a month. There is an interest towards the effect of prokinetics on prevention of stroke-associated pneumonia. The present study aimed to investigate the effect of domperidone to prevent pneumonia in patients with AIS. METHODS: In this randomized clinical trial, 150 patients with AIS were assigned to receive either domperidone 10 mg daily or placebo during hospitalization. The clinical outcomes including of aspiration pneumonia occurrence, gastrointestinal discomfort, the need for intensive care unit admission, the length of hospitalization, final mRs, and mortality were then evaluated in both groups. RESULTS: 150 [Mean age 67.5 ± 13.5 years, 90 men and 60 women] were randomized in a 1:1 ratio. Both groups were similar in terms of baseline characteristics. The domperidone group experienced significantly less dysphagia, nausea and vomiting, and aspiration pneumonia (P < 0.005). Although domperidone did not considerably reduce the mortality (P = 0.978), it resulted in lower mean mRS and shorter length of hospitalization (P < 0.001). CONCLUSION: Domperidone is an effective and well tolerated agent which could be considered as a promising agent to prevent stroke-associated pneumonia leading to a better clinical recovery.

Functional nausea and vomiting.

BACKGROUND: There is a group of patients who have unexplained chronic nausea and/or vomiting. In the past these patients were labelled as having psychogenic vomiting. However, there is little evidence that such a condition exists. Rather, these patients usually have a functional gastrointestinal disorder (functional nausea and vomiting). OBJECTIVE: This article describes the three important syndromes in adults that clinicians need to recognise: cyclic vomiting syndrome, functional vomiting, and chronic idiopathic nausea. DISCUSSION: Cyclic vomiting syndrome presents with stereotypical episodes of acute nausea and vomiting that may be severe. Patients are generally well between attacks. Cannabis use can cause a similar syndrome. Patients may respond to antimigraine therapy or low dose tricyclic antidepressant treatment. Functional vomiting is rare and presents with more frequent vomiting episodes. Rumination needs to be distinguished from functional vomiting by careful history taking. Tricyclic antidepressants are also useful in functional vomiting whether or not there is associated depression. Chronic idiopathic nausea refers to patients with bothersome nausea occurring several times a week usually not associated with vomiting. Its treatment is poorly defined but a trial of antidepressant therapy anecdotally can be helpful.

[Clinical study on Tangweikang in treating diabetic gastroparesis].

OBJECTIVE: To investigate clinical effects and mechanism of Tangweikang (TWK) in treating diabetic gastroparesis. METHODS: Ninety diabetic gastroparesis patients were randomly assigned to 3 groups. Besides conventional hypoglycemic treatment, the 30 patients in the treated group were given TWK and the 30 in the control group were given Domperidone additionally, while to the 30 in the blank group, no additional drug was given. The clinical efficacy and the changes in level of motilin and gastric emptying rate were observed. RESULTS: TWK showed significant effects in improving clinical symptoms of patients, increasing gastric emptying rate, promoting gastrointestinal kinetics, shortening gastric emptying time and was beneficial to the control of blood sugar, including the 2 h post-prandial blood sugar and fructosamine. The curative rate and total effective rate in the treated group were 63.33% (19/30) and 93.33% (29/30) respectively, significantly different to those in the control group 26.67% (8/30) and 63.33%, also different to those in the blank group 23.33% (3/ 30) and 10.00%, respectively (P < 0.01). The clinical efficacy in the treated group was superior to that in the other two groups. CONCLUSION: TWK has favorable therapeutic efficacy in treating DGP.

[Elongated needle for post-stroke indigestion].

OBJECTIVE: To observe the clinical efficacy difference among elongated needle, filiform needle and medication for post-stroke indigestion. METHODS: Sixty cases of post-stroke indigestion were randomly assigned into an elongated needle group, a filiform needle group and a medication group, 20 cases in each one. Acupuncture of restoring consciousness and inducing resuscitation and conventional medical treatment were applied in the three groups. 125 mm elongated needles were perpendicularly inserted at Zhongwan (CV 12), Liangmen (ST 21) and Tianshu (ST 25) in the elongated needle group; 20 to 30 mm perpendicular filiform at the same points in the filiform needle group. All the treatment was given for 4 weeks, 6 times a week, 1 time a day. Domperidone was prescribed orally in the medication group for 4 weeks, 3 times a day and once 10 mg. The indexes were dyspepsia TCM symptom score, Liz dyspepsia questionnaire (LDQ), Nepean Dyspepsia Index of quality of life (NDLQI), Safety Data Sheet (SDS) self rating scale and side effect scale (TESS). The effects were evaluated. RESULTS: The scores of TCM symptom, LDQ, SDS scores in the three groups decreased and NDLQI increased after 7-day, 14-day, and 28-day treatment as compared with those before treatment (P<0.05, P<0.01). The TCM symptom score and LDQ score in the elongated needle group after 28-day treatment were lower than those in the filiform needle and medication groups (P<0.05, P<0.01). The SDS score in the medication group was lower than that in the elongated needle and filiform needle group (both P<0.05). There were no significant statistical difference for NDLQI score in the three groups (P>0.05). The total effective rate was 90% (18/20) in the elongated needle group; those in the filiform needle group and medication group were 70% (14/20) and 75% (15/20) respectively, indicating statistical significance (P<0.01). CONCLUSION: Acupuncture with elongated needle can obviously improve symptoms in the patients with post-stroke indigestion, which is better than filiform needle and medication.

Indução da lactação em mulheres nuligestas: relato de experiência / Inducción de la lactancia en mujeres nuligestas: informe de experiencia / Lactation induction in women who never got pregnant: experience report

Resumo Objetivo relatar a experiência de indução da lactação em nuligestas realizada por enfermeira consultora em aleitamento. Método relato de experiência. O processo de indução láctea foi realizado com três mulheres por motivo de gestação em útero de substituição e relacionamento homoafetivo. Resultados todas perceberam o aumento de tamanho e a sensibilidade nas mamas, bem como apresentaram secreção láctea. No entanto, a continuidade da amamentação foi diferenciada entre elas. A primeira não recebeu apoio de profissionais de saúde no contexto de pós-parto hospitalar, nem em casa, e não deu continuidade à amamentação. A segunda recebeu apoio da equipe do hospital e da parceira, amamentando por três meses. A terceira, com o apoio da parceira, amamentou por dois meses, mas interrompeu por sentir-se inibida por familiares. Conclusão e implicações para a prática a técnica de indução é capaz de desencadear a produção láctea. Já o processo de amamentação só se estabeleceu mediante a associação com a rede de apoio, o acolhimento, o incentivo da equipe de saúde e o olhar integral à mulher e sua família. Dessa forma, o cuidado de Enfermagem na indução láctea não deve focar apenas no manejo da indução, mas transcender o aspecto técnico, o que se mostra como fundamental para a proteção, o estabelecimento e a continuidade da amamentação.

Resumen Objetivo reportar la experiencia de inducir la lactancia en nuligestas realizada por una consultora de enfermería en lactancia materna. Método relato de experiencia. El proceso de inducción de la leche se realizó con tres mujeres por embarazo en útero de reemplazo y relación homoafectiva. Resultados todas notaron el aumento de tamaño y la sensibilidad en las mamas, además de presentar secreción de leche. Sin embargo, la continuidad de la lactancia materna se diferencia entre ellos. La primera no recibió apoyo de los profesionales de la salud en el contexto posparto hospitalario, ni en el domicilio, y no continuó con la lactancia. La segunda recibió apoyo del personal del hospital y su pareja, amamantando durante tres meses. La tercera, con el apoyo de su pareja, amamantó durante dos meses, pero la interrumpió porque se sentía inhibida por familiares. Conclusión e implicaciones para la práctica la técnica de inducción es capaz de desencadenar la producción de leche. El proceso de lactancia materna, en cambio, solo se estableció a través de la asociación con la red de apoyo, la acogida, el estímulo del equipo de salud y la mirada integral a la mujer y su familia. Así, el cuidado de Enfermería en la inducción de la leche no debe enfocarse solo en el manejo de la inducción, sino trascender el aspecto técnico, que se muestra fundamental para la protección, el establecimiento y la continuidad de la lactancia materna.

Abstract Objective to report the experience of lactation induction in women who never got pregnant by a lactation consultant nurse. Method experience report. The process of lactation induction was performed with three women due to surrogate pregnancy and homosexual relationships. Results all noticed an increase in the size and sensitivity of the breasts, as well as milk secretion. However, the continuity of breastfeeding was different between them. The first did not receive support from health professionals in the postpartum hospital setting, nor at home, and did not continue breastfeeding. The second received support from the hospital staff and her partner, breastfeeding for three months. The third, with the support of her partner, breastfed for two months, but stopped because she felt inhibited by family members. Conclusion and implications for practice the induction technique is capable of triggering milk production. However, the breastfeeding process was only established through the association with the support network, the reception, the encouragement of the health team, and the comprehensive view of the woman and her family. Thus, nursing care in lactation induction should not focus only on the management of induction, but transcend the technical aspect, which is essential for the protection, establishment, and continuity of breastfeeding.

Clinical and psychological assessment on xinwei decoction for treating functional dyspepsia accompanied with depression and anxiety.

The purpose of this study is to explore the psychological efficacy of Xinwei Decoction, a traditional Chinese herbal medicine, to treat functional dyspepsia (FD) accompanied with depression and anxiety. Seventy-three subjects, divided into three groups, had been given herbal medicine (Xinwei Decoction), prokinetic agent (Domperidone) and placebo, respectively for 8 weeks. Before and after treatment, all subjects were examined with FD symptom scale, Hamilton Depression Scale (HAMD) and Hamilton Anxiety Scale (HAMA). As a result, the total scores of the three groups in FD symptom scale, HAMD and HAMA after treatment decreased in different levels, with the decrease in the herbal group more significant than the other two groups (p < 0.01), indicating the efficacy of the herbal medicine. The total effective rates of the herbal, Domperidone and placebo groups were 90%, 67% and 31%, respectively, which indicated significant effect differences between Xinwei Decoction and Domperidone (p < 0.05) and between Xinwei Decoction and placebo (p < 0.01), showing that the efficacy of herbal therapy was superior to that of the other two therapies. Furthermore, there was no one in the Domperidone and placebo groups being cured of depression and anxiety, while the curing rate in the herbal group was about 70%, indicating the efficacy of herbal medicine in comparison to that of Domperidone and placebo for anti-depression and anti-anxiety. The result demonstrated that Xinwei Decoction could not only alleviate FD symptoms but also relieve depression and anxiety.

[Use of estrogens in post-coital contraception. Our case material of 243 cases]. / Uso degli estrogeni nella contraccezione post-coitale. Nostra casistica di 243 casi.

PIP: 294 women between 18 and 35 years of age -- without absolute contraindications to estrogen use, with regular menses, who had had intercourse from 3 days before to 2 days after presumptive ovulation -- were given ethinyl estradiol (EE) in dosages of 5 mg/day and domperidon 20 ng twice/day for 5 days between and 72 hours from intercourse. Follow-up visits 30 days later showed that only 243 women had adhered to the protocol. It was calculated that 32.9 pregnancies were statistically probable in the absence of therapy in the study group; none actually occurred. Even among the 27 women who presented not having followed the therapeutic protocol correctly, there were no pregnancies. Side-effects such as vomiting, nausea and breast tenderness occurred in 54% of the patients, even though domperidon is an efficacious anti-emetic.^ieng

Modern management of dyspepsia.

Dyspepsia affects one in four Australians; of those who present in general practice, the majority will have functional or non-ulcer dyspepsia, with no structural explanation for their symptoms. Older patients who present for the first time with dyspepsia, and those with 'alarm features' deserve immediate investigation (preferably by upper endoscopy), to exclude cancer, peptic ulcer or oesophagitis. Other patients may be given empiric therapy (for example, a prokinetic or H2 blocker) initially, but require investigation if this fails. The role of Helicobacter pylori infection in functional dyspepsia is uncertain.

[Prokinetic drugs in digestive disorders]. / I procinetici in patologia digestiva.

In this paper the authors review the main prokinetic drugs analyzing their pharmacological properties, therapeutic indications and adverse effects. In addition, some more recently introduced substances are taken into consideration which, although they were not initially used for digestive tract dyskinesias, can nevertheless be used in certain conditions. From this point of view, calcium blocking agents employed in spastic conditions of the esophagus and the new antiserotoninergic drugs for treatment of anticancer chemotherapy-induced vomiting are of particular interest.

[Prophylactic antiemetic treatment for cancer chemotherapy--comparison of domperidone and chlorpromazine].

The antiemetic effect of domperidone against nausea, vomiting, and anorexia induced by antineoplastic agents was compared with that of chlorpromazine. Twenty patients with malignant neoplasms given 2 cycles of a combination chemotherapy including cisplatinum and adriamycin received domperidone in one cycle and chlorpromazine in another cycle. Antiemetics 10-20 mg were given 30 minutes before chemotherapy and every 4-6 hours afterwards by div, iv, or po. No significant differences in severity of nausea and vomiting and duration of anorexia were noted between domperidone and chlorpromazine. Side effects were observed in 11 patients who received chlorpromazine, while none was observed in domperidone. It was concluded that domperidone was as effective as chlorpromazine as antiemetics and more useful because of its lower incidence of side effects. The antiemetic effect of domperidone, however, was not great enough for some patients, especially when they received cisplatinum. A higher dose of domperidone or domperidone with concomitant use of glucocorticoids should be considered as promising antiemetics for these patients.

[Pharmaceutical treatment of lactation deficiency lacks evidence]. / Manglende evidens for medicinsk behandling af ammeinsufficiens.

In this review we have looked at the evidence for the pharmacological treatment of lactation deficiency. Five RCTs (n = 166) of metoclopramide found no effect on lactation and two RCTs (n = 26) of older date and lesser quality found significant effect. One RCT (n = 51) of syntocinon found no effect on lactation and two older RCTs (n = 60) of lesser quality found significant effect. Three RCTs (n = 105) found significant effect of domperidone on lactation. Education on breastfeeding is important to avoid the need for pharmacological treatment.

[Efficacy controlled observation on acupuncture and western medicine for gastrointestinal dysmotility in liver cirrhosis].

OBJECTIVE: To observe the therapeutic effect of acupuncture on gastrointestinal dysmotility in liver cirrhosis. METHODS: Forty cases of gastrointestinal dysmotility in liver cirrhosis were randomized into an acupuncture group and a motilium group, 20 cases in each one. In the acupuncture group, on the basis of the conventional treatment, electroacupuncture was applied at Zusanli (ST 36), Sanyinjiao (SP 6) and Taichong (LR 3) for 30 min, once a day. In the motilium group, on the basis of the conventional treatment, motilium was taken orally 30 min before meals, 10 mg each time, three times a day. The treatment was required for 2 weeks in both groups. The changes in the digestive tract symptom score and liver function Child-Pugh score were observed and the efficacy was assessed. RESULTS: The total effective rate of digestive tract symptoms was 85.0% (17/20) in the acupuncture group and 70.0% (14/20) in the motilium group. The score improvements in abdominal distention, belching and vomiting in the acupuncture group were superior to those in the motilium group (all P < 0.05). In the acupuncture group, the liver function Child-Pugh total score was 8.40 +/- 0.22 before treatment and reduced to 5.36 +/- 0.17 after treatment, in which the scores for ascites, serum bilirubin and albumin were all reduced (all P < 0.05) and the reducing range was increased in tendency with the improvements in digestive tract symptoms. In the motilium group, Child-Pugh score was not changed obviously as compared with that before treatment. CONCLUSION Acupuncture effectively alleviates digestive tract symptoms and improves liver function for the patients of liver cirrhosis, its efficacy on gastrointestinal dysmotility in liver cirrhosis is superior to motilium.