A sabon bincike ya gano cewa Prozac (sunan suna fluoxetine) ba shi da aminci kuma ba shi da inganci don magance bakin ciki a cikin yara da matasa.
Takardun tsari sun nuna cewa mahalarta gwaji sun yi ƙoƙarin kashe kansu bayan shan fluoxetine, amma an cire waɗannan abubuwan daga ƙarshe. buga jarida.
Na sanar da jaridar sabon binciken, amma editan ya ƙi gyara rikodin.
Amincewar Prozac
A cikin 2002, Prozac (fluoxetine), wanda Eli Lilly ya kera, ya kasance An yarda da FDA don maganin ciwon ciki a cikin yara da matasa bisa ga bayanai daga gwaji na asibiti guda biyu.
An buga gwaje-gwajen biyu a cikin mujallun da aka bita a cikin 1997 (XNUMX).nazarin 1) da 2002 (nazarin 2).
Dukansu wallafe-wallafen sun ba da rahoton ƙaramin fa'idar fluoxetine akan placebo a cikin matasa masu bacin rai kuma da alama babu wata babbar damuwa ta aminci.
Daga baya, fluoxetine ya zama ɗaya daga cikin magungunan antidepressants da aka tsara don yara masu shekaru 0-19. a Amurka, kuma yana cikin manyan magunguna 5 da aka fi rubutawa a Ingila.
Maido da tsoffin gwaji
Wani shiri da ake kira Maido da Gwaje-gwajen da Ba a Ganuwa da Wassu (RIAT) ya baiwa masu bincike damar "mayar da" tsoffin wallafe-wallafen gwaji na asibiti ta hanyar nazarin takardun da kamfanonin magunguna suka gabatar wa masu kula da magunguna.
Wadannan nazarin sun nuna cewa munanan illolin ƙwayoyi ko dai ba a ba da rahoto ba ko kuma an cire su gaba ɗaya daga mujallolin likita.
Likita Peter Gøtzsche da likitan hauka David Healy sun sami takaddun ka'idoji (ka'idoji da rahotannin binciken asibiti) daga mai kula da magunguna na Burtaniya (MHRA) na gwaje-gwajen fluoxetine guda biyu waɗanda suka tabbatar da amincewar miyagun ƙwayoyi a cikin 2002.
Rashin daidaituwa
An gano matsaloli da yawa lokacin da Gøtzsche da Healy suka kwatanta rahotannin binciken asibiti na gwaje-gwajen fluoxetine guda biyu, tare da abin da aka buga a cikin mujallolin likita.
Yawancin abubuwan da suka faru na kashe kansu a cikin mutanen da ke shan fluoxetine sun ɓace ko kuma an yi musu lakabi da kuskure a cikin rahotannin da aka buga.
Alal misali, a nazarin 1, Rahoton binciken asibiti ya bayyana marasa lafiya biyu da suka yi ƙoƙarin kashe kansu bayan kwanaki 12 da 15 na shan fluoxetine, amma an cire waɗannan abubuwan da suka faru daga labarin jarida.
Sun sami matsaloli tare da 'makãho' a cikin gwaje-gwajen biyu, ma'ana masu binciken gwajin sun san ko wanene marasa lafiya ke kan maganin ko placebo.
Sun kuma gano cewa mutanen da aka dauka aiki a cikin shari'ar, kuma wadanda suka riga sun sha maganin rage damuwa, an ba su mako guda kawai don "wanke" miyagun ƙwayoyi daga tsarin su kafin su fara aikin bazuwar.
Wannan ya haifar janyewa mai tsanani bayyanar cututtuka a wasu mahalarta waɗanda suka ƙare a cikin ƙungiyar placebo, yana da wuya a gano ainihin matakin cutarwa a cikin ƙungiyar kulawa.
A ƙarshe, lokacin da Gøtzsche da Healy suka waiwayi baya kuma suka bincika bayanan daga sakamakon farko - wanda shine baƙin ciki - babu wani fa'ida mai ma'ana daga fluoxetine idan aka kwatanta da placebo.
Jaridu sun rufe ido?
I rubuta zuwa ga mujallun biyu suna tambayar ko masu gyara za su yi la'akari da gyara bambance-bambancen kuma za su bayyana abubuwan da ba su da kyau waɗanda ba a ba da rahoto ba a cikin labaran da aka buga ta hanyar kuskure.
Babu wata jarida da ta yi haka.
Editan a Arch Gen dabbai (yanzu ana kiranta JAMA Psychiatry) ya yi watsi da damuwar game da yunkurin kashe kansa guda biyu da aka tsallake daga buga ta nazarin 1, kuma bai yi wani gyara ko bayani ba.
Da yake mayar da martani, Gøtzsche ya ce, "Ba abin yarda ba ne kwata-kwata. Lokacin da aka bar yunƙurin kashe kansa daga cikin labaran mujallu, wanda ya faru a yawancin irin waɗannan gwaje-gwajen, yana canza yanayin lafiyar magungunan gaba ɗaya. Wannan muhimmin bayani ne da ya kamata marasa lafiya su sani kafin yin la'akari da shan kwayoyin."
Gøtzsche ya zana kamanceceniya zuwa wani gwajin sarrafa placebo a cikin samari waɗanda suka yi amfani da miyagun ƙwayoyi Paxil (paroxetine).
GlaxoSmithKline's nazarin 329 sanannen da'awar cewa "Paroxetine gabaɗaya yana da jurewa kuma yana da tasiri," amma lokacin da masu bincike dawo da bayanan gwaji ta yin amfani da takaddun tsari, akasin haka ya zama gaskiya.
"Mayar da bayanai daga Nazarin 329 ya nuna cewa paroxetine ba shi da lafiya ko tasiri don magance bakin ciki a cikin yara da matasa," in ji Gøtzsche.
"Yawancin abubuwan da suka faru na kashe kansa a kan paroxetine an cire su ko kuma an ba su suna mara kyau kamar rashin tausayi. Na yi la'akari da wannan zamba," in ji shi.
Editan a J Am Acad Child Adolesc Psychiatry (JAACAP), wanda aka buga nazarin 2 na fluoxetine ya ce ba za su mayar da martani ga sukar ba har sai an buga bambance-bambancen da Gøtzsche da Healy suka rubuta a cikin wata mujalla da aka yi bita.
Tsarin ya ɗauki sama da shekara guda, amma yanzu an buga takardar Gøtzsche da Healy a cikin wani nazarin ɗan adam jarida kuma aika zuwa JAACAP don dubawa.
Kungiyar ta JAACAP ta ce a cikin wata sanarwa.
JAACAP tana ɗaukar alhakinta na tabbatar da amincin kimiyya. Kamar yadda aka bayyana a cikin jagorar mawallafa, za a gudanar da bita na sharhin bayan-buga bisa ga jagororin Kwamitin Da'a na Wallafa (COPE). Za mu sanar da ku sakamakon aikin bita…
Me ya sa yake da matsala?
Maido da tsofaffin gwaje-gwaje ya bayyana wa marasa lafiya da likitoci cewa yawancin bayanai a cikin mujallun da aka yi bita na ƙwararru ba su cika ba, masu son zuciya, kuma galibi ana zaɓen ceri.
Ware yunƙurin kashe kansa da kashe kansa yana gurbata wallafe-wallafen likitanci da ƙayyadaddun ƙa'idodin da ba za a iya amincewa da su ba. Hakanan yana iya rage zaɓuɓɓuka don mafi aminci, mafi inganci shisshigi kamar psychotherapy.
Gøtzsche ya ce: "Na ji ta bakin iyalai da yawa da 'ya'yansu suka kashe kansu saboda maganin rage damuwa, bai kamata mu rika rubuta su ga matasa ba."
"Mu meta-bincike na gwaje-gwaje goma sun nuna cewa ilimin halin dan Adam ya rage yawan faruwar sabbin yunƙurin kashe kansa a cikin marasa lafiya da aka yarda da su bayan ƙoƙarin kashe kansa. Psychotherapy shine abin da yakamata su samu, ba kwayoyi ba, ”in ji shi.
A ƙarshe, marasa lafiya ne ke biyan farashi, wani lokacin tare da rayuwarsu, daga gurbataccen bayanan asibiti, da kuma daga mujallu waɗanda suka ƙi gyara kurakurai masu haske.
Magungunan antidepressants kamar fluoxetine sun ninka haɗarin kashe kansa da zalunci a cikin yara da matasa, sukan haifar da raguwar ingancin rayuwa, suna haifar da tabarbarewar jima'i a ciki game da 50 bisa dari na masu amfani, kuma waɗannan lahani na iya ci gaba da daɗewa bayan sun yi ƙoƙari su daina.
A ƙarshe, da alama babu wata ma'ana don amfani da fluoxetine a cikin matasa don magance bakin ciki - sabon bincike ya ƙare da miyagun ƙwayoyi ba shi da lafiya kuma ba shi da amfani.
ƙwaƙƙwafi: Na karɓi kuɗi daga Cibiyar Tallafawa ta RIAT don buga Bayanin Damuwa guda biyu a cikin 2021. An sake buga wannan yanki daga marubucin. Mayarwa
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Maryanne Demasi, 2023 Brownstone Fellow, ɗan rahoto ne na likita mai bincike tare da PhD a cikin ilimin rheumatology, wanda ya rubuta don kafofin watsa labarai na kan layi da manyan mujallu na likita. Sama da shekaru goma, ta samar da shirye-shiryen talabijin na Kamfanin Watsa Labarai na Australiya (ABC) kuma ta yi aiki a matsayin mai rubuta magana da mai ba da shawara kan harkokin siyasa na Ministan Kimiyya na Kudancin Australiya.
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