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    Evidence-Based Medicine Treatment For Symptomatic Bacterial Vaginosis A Randomized Controlled Trial

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    Muchammad Alfiansyah
    Multiple doses of vaginal clindamycin were found to be superior to a single oral dose of secnidazole for treating bacterial vaginosis according to a randomized controlled trial. The trial assigned 192 women diagnosed with bacterial vaginosis to receive either clindamycin vaginal cream twice daily for 7 days or a single 2-gram dose of secnidazole. At the 15-day follow up, 96.6% of those receiving clindamycin were cured compared to only 23% of those receiving secnidazole. The study provides evidence that clindamycin is more effective than secnidazole for treating bacterial vaginosis.

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    Evidence-Based Medicine Treatment For Symptomatic Bacterial Vaginosis A Randomized Controlled Trial

    Uploaded by

    Muchammad Alfiansyah
    13 views8 pages
    Multiple doses of vaginal clindamycin were found to be superior to a single oral dose of secnidazole for treating bacterial vaginosis according to a randomized controlled trial. The trial assigned 192 women diagnosed with bacterial vaginosis to receive either clindamycin vaginal cream twice daily for 7 days or a single 2-gram dose of secnidazole. At the 15-day follow up, 96.6% of those receiving clindamycin were cured compared to only 23% of those receiving secnidazole. The study provides evidence that clindamycin is more effective than secnidazole for treating bacterial vaginosis.

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    Multiple doses of vaginal clindamycin were found to be superior to a single oral dose of secnidazole for treating bacterial vaginosis according to a randomized controlled trial. The trial assigned 192 women diagnosed with bacterial vaginosis to receive either clindamycin vaginal cream twice daily for 7 days or a single 2-gram dose of secnidazole. At the 15-day follow up, 96.6% of those receiving clindamycin were cured compared to only 23% of those receiving secnidazole. The study provides evidence that clindamycin is more effective than secnidazole for treating bacterial vaginosis.

    Copyright:

    © All Rights Reserved
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    Download as docx, pdf, or txt
    13 views8 pages

    Evidence-Based Medicine Treatment For Symptomatic Bacterial Vaginosis A Randomized Controlled Trial

    Uploaded by

    Muchammad Alfiansyah
    Multiple doses of vaginal clindamycin were found to be superior to a single oral dose of secnidazole for treating bacterial vaginosis according to a randomized controlled trial. The trial assigned 192 women diagnosed with bacterial vaginosis to receive either clindamycin vaginal cream twice daily for 7 days or a single 2-gram dose of secnidazole. At the 15-day follow up, 96.6% of those receiving clindamycin were cured compared to only 23% of those receiving secnidazole. The study provides evidence that clindamycin is more effective than secnidazole for treating bacterial vaginosis.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
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    of 8

    EVIDENCE-BASED MEDICINE

    CRITICAL APPRAISAL
    “TREATMENT FOR SYMPTOMATIC BACTERIAL
    VAGINOSIS A RANDOMIZED CONTROLLED TRIAL”

    Disusun Oleh:
    Muchammad Alfiansyah
    NPM 1102013177

    Pembimbing:
    dr. Erlina Wijayanti, MPH, DipIDK

    KEPANITERAAN KEDOKTERAN KELUARGA


    ILMU KESEHATAN MASYARAKAT
    FAKULTAS KEDOKTERAN UNIVERSITAS YARSI
    TREATMENT FOR SYMPTOMATIC BACTERIAL VAGINOSIS A
    RANDOMIZED CONTROLLED TRIAL

    ABSTRACT

    Objective: To compare the efficacy of multiple doses of vaginal clindamycin with


    a single oral dose of secnidazole for the treatment of bacterial vaginosis.


    Study Design: Double-blinded randomized controlled trial.


    Place and Duration of Study: Shifa Foundation Community Health Center, from
    March 2012 till February 2015.

    Methodology: After obtaining written informed consent, a pelvic examination was


    performed for the confirmation of symptoms of milky white vaginal discharge on
    speculum examination, positive Amine test and presence of clue cells on
    microscopy. Pregnant women, known diabetes or any immunocompromised
    condition, were excluded. Blinding of the patient, doctor, and the pharmacist was
    done. Study cohort was then divided into two groups, Group A received medicine
    pack A which contained active clindamycin and placebo oral preparation, whereas
    group B was given pack B which contained active 2-gm secnidazole with placebo
    vaginal cream. Primary outcome and therapeutic success were defined by correction
    of two out of three (normal Nugent score, negative Amine test, and no milky white
    discharge) on day 15.

    Results: At 15th day of treatment, 96.6% participants in vaginal clindamycin group


    (Group A), recovered from the bacterial vaginosis; whereas, (group B) 23% patients
    were cured in oral secnidazole group.

    Conclusion: Multiple doses of vaginal clindamycin are superior to single dose of


    oral secnidazole for the treatment of bacterial vaginosis.

    2
    SKENARIO
    Pasien Ny. Y datang ke Puskesmas Kecamatan Tanah Abang pada
    tanggal 24 april 2019 dengan keluhan keputihan. Keluhan tersebut sudah dirasakan
    sejak 1 bulan yang lalu. Keputihan berwarna putih keabuan, encer, jumlah banyak,
    dan barbau amis, tidak berbuih. Keputihan muncul setiap hari selama satu minggu
    dan keluar banyak setelah pasien berhubungan dengan suaminya. Ny. Y juga
    mengatakan ia sering mengganti pakaian dalam dan membersihkan area genitalnya
    dengan sabun sirih. Ny. Y belum pernah berobat terkait keluhannya tersebut
    sebelumnya dan belum pernah mengobatinya.
    Selain keputihan, pasien juga mengeluh gatal dan agak panas pada
    kemaluannya. Pasien menyangkal merasakan nyeri dan perih di sekitar kemaluan.
    Pasien juga menyangkal adanya nyeri pada perut bagian bawah. Keluhan nyeri dan
    berdarah saat berhubungan seksual juga disangkal oleh pasien.
    .

    Pertanyaan (Foreground Question)


    Apakah penggunaan secnidazole oral lebih baik sebagai terapi Bacterial Vaginosis
    daripada penggunaan Clindamycin Vaginal?

    PICO
    Population (P) : Ny. Y, 43 tahun
    Intervention (I) : Secnidazole oral
    Comparison (C) : Clindamycin vaginal
    Outcomes (O) : efektivitas sebagai terapi Bacterial vaginosis

    Pencarian bukti ilmiah:


    Alamat website : https://www.ncbi.nlm.nih.gov/pubmed
    Kata kunci : comparison and bacterial vaginosis and treatment
    and clindamycin and secnidazole
    Limitasi : Januari 2014 – Juni 2019 (5 tahun)
    Hasil pencarian :5

    3
    Dipilih artikel berjudul :
    Treatment for Symptomatic Bacterial Vaginosis A Randomized Controlled Trial

    CRITICAL APPRAISAL
    VALIDITY
    1. Apakah penempatan pasien ke dalam kelompok terapi dirandomisasi?
    Ya, penempatan pasien dilakukan secara randomisasi (acak). Pada
    penelitian ini dibagi menjadi kelompok penelitian dengan terapi multiple
    dose Clindamycin vaginal dan kelompok penelitian dengan terapi Single
    dose oral secnidazole

    2. Apakah semua pasien yang dimasukkan ke dalam penelitian


    dipertimbangkan dan disertakan dalam pembuatan kesimpulan?

    a. Apakah follow-up lengkap?


    Ya, follow up dilakukan selama 15 hari

    b. Apakah pasien dianalisis pada kelompok randomisasi semula?


    Tidak. Terdapat 10 pasien yang drop out dari jumlah total 192 pasien dalam
    penelitian ini.

    4
    3. Apakah pasien, klinisi dan staf peneliti dibutakan terhadap terapi?
    Ya, dokter, farmasi dan pasien dibutakan dalam penelitian ini.

    4. Apakah kedua kelompok sama pada awal penelitian?


    Ya,kedua kelompok sama pada awal penelitian, karena untuk memulai
    penelitian ini digunakan beberapa kriteria tertentu.

    5. Selain perlakuan eksperimen, apakah kedua kelompok mendapat perlakuan


    yang sama?
    Tidak ada perlakuan lain selain eksperimen terhadap kedua kelompok

    IMPORTANCE
    6. Berapa besar efek terapi?

    + - JUMLAH (Ʃ)

    Senidazole oral 15 76 91

    5
    Clindamycin 84 7 91
    vaginal
    JUMLAH 99 83 182

    a. EER (Experimental Event Rate)


    Proporsi outcome pada kelompok eksperimental.
    𝒂 𝟏𝟓
    Rumus : 𝒂+𝒃 = 𝟗𝟏 = 0,16 = 16%

    b. CER (Control Event Rate)


    Proporsi outcome pada kelompok kontrol.
    𝒄 𝟖𝟒
    Rumus : 𝒄+𝒅 = 𝟗𝟏 = 0.92 = 92%

    c. RR (Relative Risk)
    Perbandingan antara insiden penyakit yang muncul dalam kelompok
    terpapar dengan insiden penyakit yang muncul dalam kelompok
    tidak terpapar.

    𝑬𝑬𝑹
    Rumus : 𝑪𝑬𝑹

    𝟎.𝟏𝟔
    = 𝟎,𝟗𝟐 = 0,173
    = 17%

    d. RRR (Relative Risk Reduction)


    Berapa persen terapi yang diuji memberikan perbaikan dibanding
    kontrol.
    Rumus : 1 – RR
    = 1 – 0,17
    = 83%
    e. ARR (Absolute Risk Reduction)
    Beda proporsi kesembuhan atau kegagalan antara terapi eksperimen
    dan kontrol.
    Rumus : CER – EER
    = 0,92 - 0,16= 0.76
    = 76%

    6
    f. NNT (Number Needed to Treat)
    Berapa jumlah pasien yang harus diterapi dengan obat eksperimental
    untuk memperoleh tambahan satu kesembuhan atau menghindari
    kegagalan.
    Rumus : 1/ARR
    = 1/0,76
    = 131

    7. Bagaimana presisi estimasi efek terapi?

    APPLICABILITY
    8. Apakah hasil ini dapat diterapkan kepada pasien saya?
    Ya, hasil penelitian ini dapat diterapkan kepada pasien saya karena pasien
    memiliki kriteria yang sama dengan penelitian pada jurnal, namun ada
    beberapa faktor yang dapat mempengaruhi outcome seperti kebersihan
    pasien, aktivitas seksual dan juga resistensi pasien.

    9. Menentukan potensi keuntungan dan kerugian bagi pasien.


    Keuntungan : Secnidazole lebih mudah karena peroral dan single dose
    sedangkan klindamisin pervaginal dan multiple dose. Sehingga cost yang
    dikeluarkan juga akan lebih minimal

    7
    Kerugian : Pada penelitian ini hasil dari kesembuhan menggunakan
    secnidazole 2mg oral merupakan hasil terendah dibandingkan beberapa
    penelitian sejenisnya. Kemudian ada beberapa efek samping dari
    penggunaan secnidazole oral

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