Hyperemesis gravidarum is a severe form of nausea and vomiting in pregnancy affecting 0.3% to 1.0% of pregnancies, and is one of the most common indications for hospitalization during pregnancy. While a previous Cochrane review examined interventions for nausea and vomiting in pregnancy, there has not yet been a review examining the interventions for the more severe condition of hyperemesis gravidarum.
To assess the effectiveness and safety, of all interventions for hyperemesis gravidarum in pregnancy up to 20 weeks' gestation.
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register and the Cochrane Complementary Medicine Field's Trials Register (20 December 2015) and reference lists of retrieved studies.
Randomized controlled trials of any intervention for hyperemesis gravidarum. Quasi-randomized trials and trials using a cross-over design were not eligible for inclusion.
We excluded trials on nausea and vomiting of pregnancy that were not specifically studying the more severe condition of hyperemesis gravidarum.
Two review authors independently reviewed the eligibility of trials, extracted data and evaluated the risk of bias. Data were checked for accuracy.
Twenty-five trials (involving 2052 women) met the inclusion criteria but the majority of 18 different comparisons described in the review include data from single studies with small numbers of participants. The comparisons covered a range of interventions including acupressure/acupuncture, outpatient care, intravenous fluids, and various pharmaceutical interventions. The methodological quality of included studies was mixed. For selected important comparisons and outcomes, we graded the quality of the evidence and created 'Summary of findings' tables. For most outcomes the evidence was graded as low or very low quality mainly due to the imprecision of effect estimates. Comparisons included in the 'Summary of findings' tables are described below, the remaining comparisons are described in detail in the main text.
No primary outcome data were available when acupuncture was compared with placebo, There was no clear evidence of differences between groups for anxiodepressive symptoms (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.73 to 1.40; one study, 36 women, very low-quality evidence), spontaneous abortion (RR 0.48, 95% CI 0.05 to 5.03; one study, 57 women, low-quality evidence), preterm birth (RR 0.12, 95% CI 0.01 to 2.26; one study, 36 women, low-quality evidence), or perinatal death (RR 0.57, 95% CI 0.04 to 8.30; one study, 36 women, low-quality evidence).
There was insufficient evidence to identify clear differences between acupuncture and metoclopramide in a study with 81 participants regarding reduction/cessation in nausea or vomiting (RR 1.40, 95% CI 0.79 to 2.49 and RR 1.51, 95% CI 0.92 to 2.48, respectively; very low-quality evidence).
In a study with 92 participants, women taking vitamin B6 had a slightly longer hospital stay compared with placebo (mean difference (MD) 0.80 days, 95% CI 0.08 to 1.52, moderate-quality evidence). There was insufficient evidence to demonstrate a difference in other outcomes including mean number of episodes of emesis (MD 0.50, 95% CI -0.40 to 1.40, low-quality evidence) or side effects.
A comparison between metoclopramide and ondansetron identified no clear difference in the severity of nausea or vomiting (MD 1.70, 95% CI -0.15 to 3.55, and MD -0.10, 95% CI -1.63 to 1.43; one study, 83 women, respectively, very low-quality evidence). However, more women taking metoclopramide complained of drowsiness and dry mouth (RR 2.40, 95% CI 1.23 to 4.69, and RR 2.38, 95% CI 1.10 to 5.11, respectively; moderate-quality evidence). There were no clear differences between groups for other side effects.
In a single study with 146 participants comparing metoclopramide with promethazine, more women taking promethazine reported drowsiness, dizziness, and dystonia (RR 0.70, 95% CI 0.56 to 0.87, RR 0.48, 95% CI 0.34 to 0.69, and RR 0.31, 95% CI 0.11 to 0.90, respectively, moderate-quality evidence). There were no clear differences between groups for other important outcomes including quality of life and other side effects.
In a single trial with 30 women, those receiving ondansetron had no difference in duration of hospital admission compared to those receiving promethazine (MD 0.00, 95% CI -1.39 to 1.39, very low-quality evidence), although there was increased sedation with promethazine (RR 0.06, 95% CI 0.00 to 0.94, low-quality evidence) .
Regarding corticosteroids, in a study with 110 participants there was no difference in days of hospital admission compared to placebo (MD -0.30, 95% CI -0.70 to 0.10; very low-quality evidence), but there was a decreased readmission rate (RR 0.69, 95% CI 0.50 to 0.94; four studies, 269 women). For other important outcomes including pregnancy complications, spontaneous abortion, stillbirth and congenital abnormalities, there was insufficient evidence to identify differences between groups (very low-quality evidence for all outcomes). In other single studies there were no clear differences between groups for preterm birth or side effects (very low-quality evidence).
For hydrocortisone compared with metoclopramide, no data were available for primary outcomes and there was no difference in the readmission rate (RR 0.08, 95% CI 0.00 to 1.28;one study, 40 women).
In a study with 80 women, compared to promethazine, those receiving prednisolone had increased nausea at 48 hours (RR 2.00, 95% CI 1.08 to 3.72; low-quality evidence), but not at 17 days (RR 0.81, 95% CI 0.58 to 1.15, very low-quality evidence). There was no clear difference in the number of episodes of emesis or subjective improvement in nausea/vomiting. There was insufficient evidence to identify differences between groups for stillbirth and neonatal death and preterm birth.
On the basis of this review, there is little high-quality and consistent evidence supporting any one intervention, which should be taken into account when making management decisions. There was also very limited reporting on the economic impact of hyperemesis gravidarum and the impact that interventions may have.
The limitations in interpreting the results of the included studies highlights the importance of consistency in the definition of hyperemesis gravidarum, the use of validated outcome measures, and the need for larger placebo-controlled trials.
Intervenções para tratar a hiperêmese gravídica
A hiperêmese gravídica é uma forma grave de náuseas e vômitos na gravidez e afeta 0,3 a 1,0% de todas as gestações. É uma das indicações mais comuns de internação durante a gestação. Embora exista uma revisão Cochrane anterior que avaliou intervenções para náuseas e vômitos na gestação, ainda não havia uma revisão avaliando as intervenções para a hiperêmese gravídica.
Avaliar a efetividade e a segurança de todas as intervenções para hiperêmese gravídica em gestações com até 20 semanas.
Pesquisamos nas bases Cochrane Pregnancy and Childbirth Group's Trials Register, Cochrane Complementary Medicine Field's Trials Register (até o dia 20 de dezembro de 2015) e nas listas de referências dos estudos identificados.
Selecionamos todos os ensaios clínicos randomizados e controlados de qualquer intervenção para hiperêmese gravídica. Excluímos os ensaios clínicos quasi-randomizados e os ensaios clínicos que utilizaram um desenho de estudo do tipo cross-over.
Excluímos os estudos sobre náuseas e vômitos da gravidez que não avaliavam especificamente casos de hiperêmese gravídica.
Dois revisores, de forma independente, avaliaram a elegibilidade dos estudos, extraíram os dados e avaliaram os riscos de viés. A acurácia dos dados foi checada.
Encontramos 25 estudos (envolvendo 2.052 mulheres) que preencheram os critérios de inclusão. Porém, a maioria das 18 diferentes comparações descritas nesta revisão veio de dados de estudos isolados que tinham um pequeno número de participantes. As comparações incluíram uma série de intervenções, como: acupressão/acupuntura, tratamento ambulatorial, fluidos intravenosos e várias intervenções medicamentosas. A qualidade metodológica dos estudos incluídos era variada. Avaliamos a qualidade das evidências para algumas comparações e desfechos importantes e criamos “tabelas-resumo de resultados” (summary of findings, ou "SoF tables") para essas comparações e desfechos selecionados. Para a maioria dos desfechos, as evidências foram avaliadas como de qualidade baixa ou muito baixa, principalmente devido à imprecisão das estimativas de efeito. Descrevemos a seguir as comparações incluídas nas SoF; as outras comparações são descritas em detalhe no texto principal.
Para a comparação entre acupuntura e placebo, não encontramos nenhum dado para nosso desfecho primário. Não encontramos diferenças significativas entre os grupos: na melhora dos sintomas de ansiedade e depressão[razão de risco (RR) 1,01, intervalo de confiança de 95% (95% CI) 0,73 a 1,40; um estudo, 36 mulheres, evidência de qualidade muito baixa], aborto espontâneo(RR 0,48, 95% CI 0,05 a 5,03; um estudo, 57 mulheres, evidência de baixa qualidade), parto prematuro(RR 0,12, 95% CI 0,01 a 2,26; um estudo, 36 mulheres, evidência de baixa qualidade), ou óbito perinatal(RR 0,57, 95% CI 0,04 a 8,30; um estudo, 36 mulheres, evidência de baixa qualidade).
Não havia evidências suficientes para identificar diferenças entre acupuntura e metoclopramida, em um estudo com 81 participantes, quanto à redução ou remissão dos sintomas de náuseas e vômitos (RR 1,40, 95% CI 0,79 a 2,49 e RR 1,51, 95% CI 0,92 a 2,48, respectivamente; evidência de qualidade muito baixa).
Um estudo com 92 participantes mostrou que a duração da internação hospitalar das mulheres que tomaram vitamina B6 foi ligeiramente maior do que das que utilizaram placebo (diferença média (DM) 0,80 dias, 95% CI de 0,08 a 1,52, evidência de qualidade moderada). Não havia evidências suficientes para detectar diferença em outros desfechos, como o número médio de episódios de vômito (DM 0,50, 95% CI -0,40 a 1,40, evidência de qualidade baixa) ou de efeitos colaterais.
Na comparação entre metoclopramida e ondansetrona, não identificamos diferença significativa na intensidade das náuseas (DM 1,70, 95% CI -0,15 a 3,55) ou vômitos (DM -0,10, 95% CI -1,63 a 1,43). Esses dados foram provenientes de um estudo com 83 mulheres ( evidência de muito baixa qualidade). No entanto, mulheres que tomaram metoclopramida se queixaram mais de sonolência e de boca seca (RR 2,40, 95% CI 1,23 a 4,69, e RR 2,38, 95% CI 1,10 a 5,11, respectivamente; evidência de qualidade moderada). Não identificamos diferenças significativas entre os grupos para outros efeitos colaterais.
Um único estudo com 146 participantes concluiu que mulheres que tomaram prometazina, comparadas às que tomaram metoclopramida, tiveram mais sonolência, tontura e distonias (contrações involuntárias ou espasmos) (RR 0,70, 95% CI 0,56 a 0,87, RR 0,48, 95% CI 0,34 a 0,69, e RR 0,31, 95% CI 0,11 a 0,90, respectivamente, evidência de moderada qualidade). Não havia diferença significativa entre os grupos para outros desfechos importantes, como qualidade de vida ou outros efeitos colaterais.
Um único estudo com 30 mulheres comparou o uso de ondansetrona com prometazina e não encontrou diferenças na duração da internação hospitalar (DM 0,00, 95% CI -1,39 a 1,39, evidência de qualidade muito baixa), embora houvesse maior sedação no grupo da prometazina (RR 0,06, 95% CI 0,00 a 0,94, evidência de qualidade baixa).
Um estudo com 110 participantes comparou o uso de corticoides versus placebo e não detectou diferença na duração da internação hospitalar (DM -0,30, 95% CI -0,70 a 0,10 dias; evidência de qualidade muito baixa). Porém, o uso de corticoide reduziu as taxas de reinternação (RR 0,69, 95% CI 0,50 a 0,94; quatro estudos, 269 mulheres). Para outros desfechos importantes, incluindo complicações na gestação, abortos espontâneos, natimortos e anormalidades congênitas, a evidência era insuficiente para identificar diferenças entre os grupos (evidência de qualidade muito baixa para todos os desfechos). Outros estudos únicos não detectaram diferenças significativas entre os grupos para partos prematuros ou efeitos colaterais (evidência de qualidade muito baixa).
Para a comparação entre hidrocortisona e metoclopramida, não encontramos nenhum dado para nossos desfechos primários e não havia diferenças nas taxas de reinternação hospitalar (RR 0,08, 95% CI 0,00 a 1,28; um estudo, 40 mulheres).
Um estudo com 80 mulheres relatou que as participantes que receberam prednisolona, comparadas àquelas que usaram prometazina, tiveram aumento das náuseas na avaliação de 48 (RR 2,00, 95% CI 1,08 a 3,72; evidência de baixa qualidade), mas não na avaliação de 17 dias (RR 0,81, 95% CI 0,58 a 1,15, evidência de qualidade muito baixa). Não havia uma clara diferença no número de episódios de vômitos ou melhora subjetiva das náuseas e vômitos. Não havia evidência suficiente para identificar diferenças entre os grupos quanto ao número de natimortos, óbitos neonatais ou partos prematuros.
Esta revisão aponta que existe pouca evidência consistente e de alta qualidade que apoie qualquer uma das intervenções testadas para hiperêmese gravídica. Essa conclusão deve ser levada em consideração na tomada de decisões nesses casos. Encontramos poucos relatos sobre o impacto econômico da hiperêmese gravídica e os efeitos que as intervenções podem ter sobre essa questão.
As limitações na interpretação dos resultados dos estudos incluídos reforçam a importância de se usar uma definição consistente de hiperêmese gravídica, de usar instrumentos validados para avaliar os desfechos, e a necessidade de ensaios clínicos controlados por placebo que sejam maiores.
Tradução do Centro Cochrane do Brasil (Fernando Takashi Kojima Marques). Contato: tradutores@centrocochranedobrasil.org.br
Interventions for treating severe nausea and vomiting during pregnancy (hyperemesis gravidarum)
What is the issue and why is it important?
Although severe nausea and vomiting in pregnancy (hyperemesis gravidarum) rarely causes death, it is an important cause of ill health with emotional, physical, and economic consequences. Women may need hospital treatment and may not be able to work and it occasionally causes pregnancy complications and adverse outcomes for babies such as low birthweight. Many pharmaceutical, complementary, and alternative therapies are available and the objective of this review was to examine the effectiveness and safety of interventions for hyperemesis gravidarum.
What evidence did we find?
Twenty-five trials (involving 2052 women) were included examining 18 different comparisons covering a range of interventions including acupressure/acupuncture, outpatient care, intravenous fluids, and various commonly used anti-sickness drugs. The quality of included studies was mixed and for most outcomes findings were from single studies with low numbers of women taking part and the evidence was assessed as being of low or very low quality. We have described findings for selected important comparisons below, the remaining comparisons are described in detail in the main text.
There was no clear evidence of differences between acupuncture and placebo for symptoms of anxiety or depression, spontaneous abortion, preterm birth or perinatal death.
There was insufficient evidence to identify clear differences between acupuncture and metoclopramide (an anti-nausea medication) for reduction or cessation in nausea or vomiting.
Women taking vitamin B6 had a slightly longer hospital stay compared with placebo but there was no clear evidence of differences in other outcomes including the average number of episodes of vomiting, hospital readmission rate, or side effects.
A comparison between two anti-nausea medications, metoclopramide and ondansetron, identified no clear difference in the severity of nausea or vomiting, but more women taking metoclopramide complained of drowsiness and dry mouth. In a study comparing metoclopramide with promethazine, more women taking promethazine reported drowsiness and dizziness but there were no clear differences between groups for other important outcomes including quality of life and other side effects. In a study looking at ondansetron versus promethazine women spent similar lengths of time in hospital but there was increased sedation with promethazine.
Regarding corticosteroids, there was no difference in days of hospital admission compared to placebo, but there was a decreased readmission rate. For other important outcomes including pregnancy complications, spontaneous abortion, stillbirth and congenital abnormalities, preterm birth and side effects, there was insufficient evidence to identify differences between groups.
In a study comparing hydrocortisone (a corticosteroid) with metoclopramide, no data were available for primary outcomes, but there was no difference in hospital readmission rate.
In a study comparing promethazine and prednisolone (a corticosteroid) those receiving prednisolone had increased nausea at 48 hours but not at 17 days. There was no clear difference in the number of episodes of vomiting. There was insufficient evidence to identify differences between groups for stillbirth and neonatal death and preterm birth
What does this mean?
Given that there was little evidence to support the superiority of one intervention over another in the treatment of hyperemesis, larger controlled trials are needed on these therapies. More research should be done comparing the side effects and safety, as well as the economic costs and benefits of these interventions to aid in the selection of the optimal treatment.
Reporting on adverse maternal and infant outcomes was limited and we did not find any studies on dietary or other lifestyle interventions.
Postupci za prekomjerno povraćanje u trudnoći
Zašto je ovaj sustavni pregled važan?
Iako teška mučnina i povraćanje u trudnoći (hyperemesis gravidarum) rijetko uzrokuju smrt, važan su uzrok lošeg zdravlja s emocionalnim, tjelesnim i ekonomskim posljedicama. Ženama će možda trebati liječenje u bolnici i nisu sposobne obavljati svoj posao; to stanje ponekad uzrokuje komplikacije u trudnoći i štetne posljedice za dijete, kao što je niska težina pri porodu. Dostupne su mnoge farmaceutske, dopunske i alternativne terapije i cilj ovog Cochrane sustavnog pregleda literature bio je istražiti učinkovitost i sigurnost tih terapija u liječenju prekomjernog povraćanja u trudnoći.
Rezultati istraživanja
Uključeno je 25 ispitivanja (na 2052 žene) koja su uključivala 18 različitih usporedba terapija različitih vrsta poput akupunkture, ambulantno liječenje, intravenske tekućine i različite lijekove protiv povraćanja. Kvaliteta rezultata je bila mješovita, većina rezultata je dobivena iz ispitivanja provedenih na malom broju žena i ocijenjeni su kao dokazi niske ili vrlo niske kvalitete. Opisali smo rezultate za neke važne usporedbe dalje u tekstu sažetka, a ostatak usporedbi je opisan detaljno u glavnom tekstu.
Nije bilo jasnih razlika između akupunkture i placeba za simptome anksioznosti ili depresije, spontani pobačaj, preuranjeni porod ili smrt u doba oko porođaja (perinatalna smrt).
Nije bilo dovoljno dokaza kako bi se otkrile jasne razlike između akupunkture i metoklopramida (lijeka protiv povraćanja) u smanjenju ili prestanku mučnine i povraćanja.
Ispitanice koje su uzimale vitamin B6 su imale nešto duži boravak u bolnici u usporedbi s placebom, ali ne postoje jasne razlike u drugim posljedicama kao što su prosječan broj povraćanja, stopa ponovnog upisa u bolnicu ili drugih nuspojava.
Usporedba dvaju lijekova protiv povraćanja (metoklopramida i ondansetrona) nije pokazala jasne razlike u jačini mučnine ili povraćanja, ali se više žena koje su uzimale metoklopramid žalilo na pospanost i suha usta. U studiji koja je usporedila metoklopramid i prometazin, više je ispitanica koje su uzimale prometazin prijavilo pospanost i vrtoglavicu, ali ne postoje jasne razlike između grupa za druge nuspojave. Po pitanju usporedbe ondansetrona s prometazinom, ispitanice su provele slično vrijeme u bolnici, ali je uočena veća sedacija s prometazinom.
U pogledu kortikosteroida, ne postoji razlika u broju dana provedenih u bolnici u usporedbi s placebom, ali postoji smanjenje broja ponovnog primitka u bolnicu. Što se tiče drugih važnih posljedica kao što su komplikacije u trudnoći, spontani pobačaji, mrtvorođenčad, prirođene abnormalnosti, prijevremeni porod i drugi štetni učinci, ne postoji dovoljno dokaza kako bi se utvrdile razlike između ispitivanih grupa.
U usporedbi hidrokortizona (kortikosteroida) s metoklopramidom, nije bilo nikakvih podataka u vezi glavnih rezultata, ali nije postojala ni razlika u stopi ponovnog primitka trudnica u bolnicu.
U usporedbi prometazina s prednizonom (kortikosteroidom), ispitanice koje su uzimale prednizon su imale povećanu mučninu nakon 48 sati, ali ne nakon 17 dana. Nije postojala jasna razlika u broju epizoda povraćanja. Nije bilo dovoljno dokaza kako bi se utvrdile razlike između grupa u pogledu mrtvorođenčadi, smrti novorođenčadi i preranog poroda.
Što ti rezultati znače?
Budući da ne postoji dovoljno dokaza koji bi dokazali da je neka metoda liječenja povraćanja u trudnica bolja od neke druge, potrebno je nastaviti provoditi velike kliničke studije o djelotvornosti i sigurnosti tih terapija. Potrebno je više istraživanja u kojima će se ispitati nuspojave i sigurnost, kao i ekonomske troškove i prednosti ovih metoda liječenja kako bi se pomoglo u odabiru optimalnog liječenja.
Podatci o štetnim posljedicama za majku i dijete su bili ograničeni i nismo pronašli nikakva istraživanja koja su ispitala djelotvornost promjena prehrane ili promjena drugih životnih navika.
Bilješke prijevoda
Hrvatski Cochrane
Preveo: Domagoj Kihas
Ovaj sažetak preveden je u okviru volonterskog projekta prevođenja Cochrane sažetaka. Uključite se u projekt i pomozite nam u prevođenju brojnih preostalih Cochrane sažetaka koji su još uvijek dostupni samo na engleskom jeziku. Kontakt: cochrane_croatia@mefst.hr
Intervensi untuk merawat loya yang teruk dan muntah-muntah semasa mengandung (hiperemesis gravidarum)
Apakah isu ini dan mengapa ia penting?
Walaupun loya yang teruk dan muntah semasa kehamilan (hiperemesis gravidarum) jarang menyebabkan kematian, ia adalah penyakit yang membawa kesan-kesan emosi, fizikal, dan ekonomi. Wanita mungkin memerlukan rawatan hospital dan mungkin tidak dapat bekerja dan ia kadang-kadang menyebabkan komplikasi kehamilan dan kesan yang buruk kepada bayi seperti berat lahir rendah. Terdapat banyak farmaseutikal, "complementary" dan " alternative" terapi yang sedia ada, dan objektif kajian ini adalah untuk mengkaji keberkesanan dan keselamatan intervensi untuk hiperemesis gravidarum.
Apakah bukti yang kita dapati?
Dua puluh lima kajian (yang melibatkan 2052 wanita) telah dimasukkan. Kajian-kajian tersebut memeriksa 18 perbandingan berbeza yang meliputi pelbagai intervensi termasuk akutekanan / akupunktur, rawatan pesakit luar, cecair intravena, dan pelbagai ubat-ubatan anti-penyakit yang biasa digunakan. Kualiti kajian termasuk adalah bercampur dan bagi kebanyakan hasil kajian adalah daripada kajian tunggal dengan jumlah bilangan peserta wanita yang rendah, dan ini menyumbangkan kualiti bukti yang rendah atau sangat rendah. Di sini kami telah menyatakan hasil kajian untuk perbandingan penting yang terpilih, perbandingan lain diterangkan secara terperinci dalam teks utama.
Tidak ada bukti yang jelas tentang perbezaan antara akupunktur dan plasebo untuk gejala kebimbangan atau kemurungan, keguguran spontan, kelahiran pramatang atau kematian perinatal.
Tiada bukti yang cukup untuk mengenalpasti dengan jelas perbezaan antara akupunktur dan metoclopramide (ubat anti-loya) untuk pengurangan atau pemberhentian loya atau muntah-muntah.
Wanita yang mengambil vitamin B6 mempunyai penginapan hospital yang lebih panjang dibanding dengan plasebo tetapi tidak ada bukti yang jelas tentang perbezaan dalam keputusan lain, termasuk purata bilangan episod muntah-muntah, kadar kemasukan semula hospital, atau kesan sampingan.
Perbandingan antara dua ubat-ubatan anti-loya, metoclopramide dan ondansetron, dikenalpasti tiada perbezaan ketara dalam loya atau muntah kritikal, tetapi lebih wanita yang mengambil metoclopramide mengadu mengantuk dan mulut kering. Dalam satu kajian perbandingan metoclopramide dengan promethazine, lebih ramai wanita mengambil promethazine melaporkan mengantuk dan pening kepala tetapi tidak terdapat perbezaan yang jelas antara kumpulan untuk hasil penting yang lain termasuk kualiti hidup dan kesan sampingan yang lain. Dalam satu kajian dimana ondansetron berbanding dengan promethazine, masa penginapan hospital adalah lebih kurang sama, tetapi terdapat peningkatan ubat pelali dengan promethazine.
Mengenai kortikosteroid, tidak ada perbezaan pada hari-hari kemasukan hospital berbanding dengan plasebo, tetapi kadar kemasukan semula adalah lebih rendah di kalangan peserta-peserta yang menerima cortocosteroids. Untuk hasil penting yang lain termasuk komplikasi kehamilan, keguguran spontan, kelahiran mati dan kecacatan sejak lahir, kelahiran pramatang dan kesan sampingan, tiada bukti yang cukup untuk mengenalpasti perbezaan antara kumpulan.
Dalam satu kajian yang membandingkan hydrocortosone (kortikosteroid) dengan metoclopramide, tiada data untuk hasil yang utama, tetapi tidak ada perbezaan dalam kadar kemasukan semula hospital.
Dalam satu kajian yang membandingkan promethazine dan prednisolone (kortikosteroid) mereka yang menerima prednisolone bertambah loya pada 48 jam tetapi tidak pada 17 hari. Tiada perbezaan yang jelas dalam bilangan episod muntah-muntah. Bukti tidak cukup untuk mengenalpasti perbezaan antara kumpulan untuk kelahiran mati dan kematian neonatal dan kelahiran pramatang
Apakah maksud ini?
Memandangkan terdapat sedikit bukti untuk menyokong keunggulan satu intervensi atas yang lain dalam rawatan hiperemesis, kajian terkawal yang lebih besar diperlukan bagi terapi ini. Lebih banyak penyelidikan perlu dilakukan yang membandingkan kesan-kesan sampingan dan keselamatan, serta kos ekonomi dan faedah intervensi ini untuk membantu dalam pemilihan rawatan yang optimum.
Melaporkan tentang kesan buruk daripada keputusan ibu dan bayi adalah terhad dan kami tidak menjumpai sebarang kajian mengenai intervensi gaya hidup pemakanan atau lain-lain.
Catatan terjemahan
Diterjemahkan oleh Nila Pillai (Penang Medical College). Disunting oleh Lai Nai Ming, (School of Medicine, Taylor's University, Malaysia). Untuk sebarang pertanyaan mengenai terjemahan ini sila hubungi nila@pmc.edu.my.
Maßnahme zur Behandlung von schwerer Übelkeit und Erbrechen während der Schwangerschaft (Hyperemesis gravidarum)
Was ist das Problem und warum ist es wichtig?
Obwohl starke Übelkeit und starkes Erbrechen in der Schwangerschaft (Hyperemesis gravidarum) selten zum Tod führt, ist es eine bedeutende Ursache für schlechte Gesundheit mit emotionalen, körperlichen und wirtschaftlichen Folgen. Frauen könnten eine Krankenhausbehandlung benötigen und arbeitsunfähig sein und es verursacht gelegentlich Schwangerschaftskomplikationen und unerwünschte Folgen für das Neugeborene, wie ein niedriges Geburtsgewicht. Es sind viele pharmakologische, ergänzende und alternative Behandlungen verfügbar und die Zielsetzung dieses Reviews war die Untersuchung der Wirksamkeit und Sicherheit der Maßnahmen für Hyperemesis gravidarum.
Gefundene Evidenz
Fünfundzwanzig Studien (2052 Frauen umfassend) wurden eingeschlossen, die 18 verschiedene Vergleiche untersuchten und dabei ein ganzes Spektrum an Maßnahmen abdecken: Akupressur/Akupunktur, ambulante Versorgung, intravenöse Flüssigkeiten und geläufig verwendete Medikamente gegen Übelkeit. Die Qualität der eingeschlossenen Studien war gemischt und für die meisten Endpunkte kamen die Ergebnisse aus Einzelstudien mit einer niedrigen Anzahl an teilnehmenden Frauen und die Qualität der Evidenz wurde als sehr niedrig oder niedrig beurteilt. Wir haben im Folgenden Ergebnisse für ausgewählte wichtige Vergleiche beschrieben, eine detaillierte Beschreibung der restlichen Vergleiche ist im Haupttext zu finden.
Es gab keine eindeutige Evidenz für Unterschiede zwischen Akupunktur und Placebo bezogen auf Symptome von Angstgefühlen oder Depression, Fehlgeburten, Frühgeburten oder perinatalem Tod.
Es liegt unzureichende Evidenz vor, um klare Unterschiede zwischen Akupunktur und Metoclopramid (ein Medikament gegen Übelkeit) zu bestimmen, bezogen auf die Reduktion oder dem vollständigen Abklingen von Übelkeit oder Erbrechen.
Frauen die Vitamin B6 einnahmen, hatten einen etwas längeren Krankenhausaufenthalt verglichen mit der Placebogruppe. Aber es gab keine eindeutige Evidenz für Unterschiede in anderen Endpunkten, wie die durchschnittliche Anzahl an Erbrechensphasen, Krankenhauswiederaufnahmeraten oder Nebenwirkungen.
Ein Vergleich von zwei Medikamenten gegen Übelkeit, Metoclopramid und Ondansetron, zeigte keine eindeutigen Unterschiede in der Schwere der Übelkeit oder des Erbrechens, jedoch beschwerten sich mehr Frauen die Metoclopramid einnahmen, über Müdigkeit und einen trockenen Mund. In einer Studie, die Metoclopramid mit Promethazin verglich, berichteten mehr Frauen die Promethazin einnahmen über Müdigkeit und Schwindelgefühl, jedoch gab es keine eindeutigen Unterschiede zwischen den Gruppen bezüglich anderer wichtiger Endpunkte, wie Lebensqualität oder anderen Nebenwirkungen. In einer Studie, die Ondansetron mit Promethazin verglich, verbrachten die Frauen eine ähnlich lange Dauer im Krankenhaus, jedoch kam es zu einer Erhöhung von Sedierungen bei Frauen mit Promethazin
Bezüglich Kortikosteroiden gab es, verglichen mit Placebo, keine Unterschiede in der Anzahl der Tage des Krankenhausaufenthalts, aber es zeigte sich eine verringerte Wiederaufnahmerate. In Bezug auf andere wichtige Endpunkte, wie Schwangerschaftskomplikationen, Fehlgeburten, Todgeburten und Fehlbildungen, Frühgeburten und Nebenwirkungen, lag nur unzureichende Evidenz vor, um Unterschiede zwischen den Gruppen identifizieren zu können.
In einer Studie, die Hydrocortison (ein Kortikosteroid) mit Metoclopramid verglich, waren keine Daten für primäre Endpunkte verfügbar, aber es gab keine Unterschiede in der Krankenhauswideraufnahmerate.
In einer Studie, die Promethazin und Prednisolon (ein Kortikosteroid) verglich, kam es bei der Einnahme von Prednisolon vermehrt zu Übelkeit innerhalb von 48 Stunden, aber nicht nach 17 Tagen. Es gab keine eindeutigen Unterschiede in der Anzahl an Erbrechensphasen. Es gab unzureichende Evidenz, um Unterschiede zwischen den Gruppen zu identifizieren, bezüglich Todgeburten, Tod des Neugeborenen oder Frühgeburten.
Schlussfolgerungen
Angesichts dessen, dass es nur wenig Evidenz gibt, die die Überlegenheit einer Maßnahme im Vergleich zu einer anderen Maßnahme bei der Behandlung von Hyperemesis unterstützt, sind größer angelegte kontrollierte Studien bezüglich dieser Maßnahmen nötig. Mehr Forschung zu einem Vergleich von Nebenwirkungen und Sicherheit, sowie von wirtschaftlichen Kosten und Nutzen dieser Maßnahmen ist nötig, um bei der Auswahl der optimalen Behandlung zu helfen.
Berichte über unerwünschte Endpunkte bei Mutter oder Säugling waren begrenzt und wir fanden keine Studie zu Ernährungs- oder anderen Lebensstilinterventionen.
Anmerkungen zur Übersetzung
I.Nolle, freigegeben durch Cochrane Deutschland.
Interwencje w leczeniu nudności i wymiotów w ciąży o dużym nasileniu (niepowściągliwe wymioty ciężarnych)
Jaki jest cel i co jest istotne?
Mimo, że ciężkie nudności i wymioty w ciąży (niepowściągliwe wymioty ciężarnych) rzadko powodują zgon, są poważną przyczyną złego stanu zdrowia, a ponadto mają konsekwencje emocjonalne, fizyczne i ekonomiczne. Kobiety mogą wymagać leczenia szpitalnego oraz mogą nie być w stanie pracować. Czasami wymioty mogą także powodować powikłania w ciąży i niepożądane skutki dla niemowląt, takie jak mała masa urodzeniowa. Dostępnych jest wiele leków, komplementarnych i alternatywnych metod leczenia. Celem niniejszego przeglądu była ocena skuteczności i bezpieczeństwa interwencji stosowanych w leczeniu niepowściągliwych wymiotów ciężarnych.
Jakie dane naukowe znaleźliśmy?
Włączono dwadzieścia pięć badań (w których uczestniczyły 2052 kobiety), obejmujących 18 różnych porównań interwencji o szerokim zakresie, takich jak: akupresura/akupunktura, opieka ambulatoryjna, dożylne podawanie płynów oraz różne powszechnie stosowane leki przeciwwymiotne. Jakość włączonych badań była zróżnicowana i dla większości wyników, dane z pojedynczych badań, obejmujących małą liczbę uczestników, oceniono jako niskiej lub bardzo niskiej jakości. Poniżej opisaliśmy wyniki dla wybranych, ważnych porównań, pozostałe porównania zostały szczegółowo opisane w tekście głównym.
Nie odnaleziono jednoznacznych danych naukowych wskazujących na różnice pomiędzy akupunkturą i placebo w częstości występowania objawów lęku i depresji, samoistnego poronienia, przedwczesnego porodu lub zgonu okołoporodowego.
Nie odnaleziono wystarczających danych naukowych wskazujących na jednoznaczne różnice pomiędzy akupunkturą a metoklopramidem (lek o działaniu przeciwwymiotnym) w zmniejszeniu nasilenia lub częstości ustąpienia nudności lub wymiotów.
Kobiety stosujące witaminę B6 były nieco dłużej hospitalizowane w porównaniu do kobiet otrzymujących placebo, jednakże nie wykazano jednoznacznych różnic dla innych wyników, takich jak: średnia liczba epizodów wymiotów, wskaźnik ponownej hospitalizacji lub działania niepożądane.
W porównaniu dwóch leków przeciwwymiotnych - metoklopramidu i ondansetronu, nie wykazano jednoznacznych różnic w nasileniu nudności lub wymiotów, jednak większość kobiet przyjmujących metoklopramid skarżyła się na senność i suchość w ustach. W badaniu porównującym metoklopramid z prometazyną, więcej kobiet przyjmujących prometazynę zgłaszało senność i zawroty głowy, jednakże nie było jednoznacznych różnic pomiędzy grupami w odniesieniu do innych wyników, w tym jakości życia oraz innych działań niepożądanych. W badaniu porównującym ondansetron z prometazyną, kobiety spędziły podobny czas w szpitalu, jednakże prometazyna zwiększała sedację (uspokojenie, zmniejszenie napięcia i niepokoju, często w połączeniu z sennością; przyp. tłum.).
W odniesieniu do kortykosteroidów, nie zaobserwowano różnic w liczbie dni hospitalizacji w porównaniu z placebo, jednakże zaobserwowano spadek częstości powtórnej hospitalizacji. Dla innych wyników takich jak powikłania ciąży, poronienia, martwe urodzenia i wady wrodzone, przedwczesny poród oraz działania niepożądane, nie było wystarczających danych naukowych, aby wykazać różnice pomiędzy grupami.
W badaniu porównującym hydrokortyzon (kortykosteroid) z metoklopramidem, dla głównego punktu końcowego (wyniku) nie było dostępnych danych, ale nie stwierdzono różnic pod względem częstości powtórnej hospitalizacji.
W badaniu porównującym prometazynę i prednizolon (kortykosteroid), w grupie otrzymującej prednizolon zaobserwowano zwiększenie nasilenia nudności po 48 godzinach ale nie w okresie 17 dni. Nie było jednoznacznych różnic w liczbie epizodów wymiotów. Nie było wystarczających danych pozwalających na stwierdzenie różnic pomiędzy grupami w odniesieniu do martwych urodzeń, zgonów noworodków oraz przedwczesnego porodu.
Co to oznacza?
Biorąc pod uwagę, że dostępnych jest niewiele danych naukowych potwierdzających przewagę jednej interwencji nad drugą w leczeniu niepowściągliwych wymiotów ciężarnych, niezbędne są większe badania z grupą kontrolą w celu oceny omawianych terapii. Należy przeprowadzić więcej badań porównujących działania niepożądane i bezpieczeństwo, jak również koszty ekonomiczne oraz korzyści z interwencji, aby ułatwić wybór optymalnego leczenia.
Dostępność danych naukowych dotyczących działań niepożądanych występujących u matki i dziecka była ograniczona i nie odnaleźliśmy żadnych badań oceniających dietę lub inne interwencje związane ze stylem życia.
Uwagi do tłumaczenia
Tłumaczenie Magdalena Koperny Redakcja Joanna Zając
Intervenções para tratar náuseas e vômitos intensos durante a gravidez (hiperêmese gravídica)
Qual é o problema e por que ele é importante?
Embora náuseas e vômitos intensos durante a gravidez raramente sejam fatais, a hiperêmese gravídica é um problema de saúde importante, com consequências emocionais, físicas e econômicas. As mulheres com esse problema podem precisar ficar internadas no hospital e faltar ao trabalho. Por vezes, a hiperêmese pode levar a complicações na gravidez e trazer consequências negativas para os bebês, como o baixo peso ao nascer. Existem muitas formas de tratar a hiperêmese, incluindo remédios e terapias complementares ou alternativas. O objetivo desta revisão foi avaliar a eficácia e a segurança dos tratamentos existentes para hiperêmese gravídica.
Que evidências encontramos?
Foram incluídos 25 estudos (envolvendo 2.052 mulheres) que fizeram 18 comparações diferentes entre uma série de intervenções como: acupressão/acupuntura, atendimento ambulatorial, tomar soro na veia, e vários remédios contra as náuseas (antieméticos) comumente utilizados. A qualidade dos estudos incluídos era variada. Os resultados para a maioria dos desfechos vieram de estudos isolados, que tinham incluído um número pequeno gestantes. As evidências foram classificadas como sendo de baixa ou de muito baixa qualidade. Abaixo descrevemos os achados mais importantes de algumas comparações específicas; as comparações restantes são descritas em detalhes no texto principal.
Não encontramos uma clara evidência de diferenças entre o uso de acupuntura versus um placebo para o alívio de sintomas de ansiedade ou depressão nem sobre a taxa de abortos espontâneos, partos prematuros ou óbitos perinatais.
Não encontramos evidência suficiente de diferenças entre o uso da acupuntura versus metoclopramida (uma medicação antiemética) para redução ou remissão da náusea ou vômitos.
As mulheres que tomaram vitamina B6 tiveram um número de internações hospitalares ligeiramente maior do que aquelas que receberam placebo, mas não havia uma clara evidência de diferença entre esses dois tratamentos para outros desfechos, incluindo o número médio de episódios de vômitos, taxas de reinternação hospitalar ou efeitos colaterais.
A comparação entre duas medicações antieméticas, a metoclopramida e a ondansetrona, não mostrou nenhuma diferença evidente sobre a intensidade das náuseas e vômitos. Porém, as mulheres que tomaram metoclopramida se queixaram mais de sonolência e de boca seca. Um estudo comparou metoclopramida versus prometazina e concluiu que as mulheres que tomaram prometazina relataram mais sonolência e vertigem, mas não havia grandes diferenças entre os grupos para outros desfechos importantes, incluindo qualidade de vida ou outros efeitos colaterais. Um estudo comparou ondansetrona versus prometazina e concluiu que o tempo de internação hospitalar foi semelhante entre as duas drogas, porém a prometazina aumentava a sedação (diminuição do nível de consciência).
O uso de corticosteroides, em comparação com placebo, não mudou o número de dias de internação hospitalar mas reduziu a taxa de reinternações. Não havia evidências suficientes para identificar diferenças entre os grupos para outros desfechos importantes, como complicações na gravidez, abortos espontâneos, natimortos e anormalidades congênitas, parto prematuro e efeitos colaterais.
Um estudo comparou hidrocortisona (que é um corticosteroide) com metoclopramida, mas não apresentou dados para os desfechos primários, e não mostrou diferenças nas taxas de reinternação hospitalar.
Em um estudo comparando prometazina e prednisolona (um corticosteroide), mulheres que receberam prednisolona tinham aumento das náuseas nas primeiras 48 horas, mas não aos 17 dias, quando foi feita outra avaliação. Não havia diferenças significativas no número de episódios de vômitos. Não havia evidências suficientes para identificar diferenças entre os grupos em relação ao número de natimortos, óbitos neonatais ou partos prematuros.
O que isto significa?
Uma vez que existe pouca evidência indicando que uma intervenção seja melhor do que outra no tratamento de hiperêmese gravídica, os pesquisadores precisam fazer mais ensaios clínicos controlados, com um grande número de gestantes, comparando esses tratamentos. Para que possamos decidir quais tratamentos são melhores, também são necessárias mais pesquisas comparando os efeitos colaterais e a segurança dos diversos tratamentos, assim como os custos e os benefícios econômicos dessas intervenções.
Os estudos existentes apresentaram poucos relatos de efeitos adversos maternos ou do bebê. Não encontramos nenhum estudo que avaliasse tratamentos dietéticos ou outras intervenções no estilo de vida como forma de tratar a hiperêmese gravídica.
Notas de tradução
Tradução do Centro Cochrane do Brasil (Fernando Takashi Kojima Marques). Contato: tradutores@centrocochranedobrasil.org.br