Tesis

Efikasi Gel Pelembab Polikarbofil Dibandingkan dengan Plasebo pada Wanita Pascamenopause dengan Keluhan Kekeringan Vagina = Efficacy of Polycarbophil Moisturizing Gel Compared to Placebo in Postmenopausal Women with Vaginal dryness.

Latar belakang : Angka harap hidup wanita lansia yang semakin tinggi dan usia menopause yang relatif sama, membuat keluhan penyakit pascamenopause meningkat. Salah satu keluhan yang dirasakan adalah vulvovaginal atrofi atau Genitourynary symtomps menopausal (kekeringan vagina, gatal dan iritasi, disuria, dispareuni, kenaikan pH). Keluhan ini dapat menurunkan kualitas hidup wanita dan kehidupan sexual. Saat ini, terapi lini pertama pada kekeringan vagina adalah pelembab nonhormonal. Beberapa penelitian telah meneliti gel pelembab bioadesif nonhormonal seperti polikarbofil, namun belum ada di Indonesia. Gel ini dipercaya mempunyai efikasi yang sama baiknya apabila dibandingkan dengan gel hormonal estrogen. Tujuan : Menguji efikasi terapi pada gel polikarbofil dibandingkan placebo pada wanita pascamenopause dengan keluhan kekeringan vagina Metode : Uji klinis randomized clinical trial, dilaksanakan di RSCM pada April hingga Desember 2019 pada 43 subjek, yaitu 22 subjek kelompok polikarbofil dan 21 subjek plasebo. Polikarbofil (Regell) dan plasebo diberikan sebanyak 2-3 kali per minggu selama 3 minggu. Penilaian saat sebelum terapi sebagai baseline dan minggu ke 3. Efikasi yang dinilai adalah Vaginal Health Index Score (VHIS) yaitu elastisitas, cairan vagina, pH, integritas epitel, kelembapan dan total skor Hasil : Hilangnya keluhan kekeringan vagina pada polikarbofil adalah pada minggu ke 2 (48%), gatal dan iritasi pada minggu ke 2 (10%) dan nyeri saat berhubungan minggu ke 2 (38%). Kedua perlakuan polikarbofil dan placebo mempunyai perbedaan bermakna pada total skor, cairan vagina dan kelembapan di minggu ke 3. Penggunaan polikarbofil 2-3 kali perhari selama 3 minggu dapat menurunkan skor pH pada VHIS. Tidak terdapat perbedaan bermakna pada penilaian efikasi antara kedua perlakuan, namun terdapat perbedaan efikasi terhadap pH. Tidak ada efek samping terhadap kedua perlakuan. Kesimpulan :Tidak ada perbedaan efikasi antara gel polikarbofil dengan placebo, namun terdapat perbedaan efikasi terhadap pH vagina setelah penggunaan gel polikarbofil
Kata kunci : Pascamenopause, kekeringan vagina, polikarbofil, vaginal health index score, pH


Background : The life expectancy of elderly women is getting higher but the menopausal age is relatively the same, making complaints of postmenopausal disease increase. One of the complaints is vulvovaginal atrophy or menopausal genitourynary symptom (vaginal dryness, itching and irritation, dysuria, dyspareuni, raised pH). This complaint can reduce the quality of life for women and sexual life. Currently, the firstline therapy for vaginal dryness is nonhormonal vaginal moisturizer. Several studies have examined nonhormonal bioadhesive moisturizer gel such as polycarbophil, but not yet in Indonesia. This gel is believed to have the same efficacy as compared to the estrogen hormonal gel. Aim: To compare the efficacy of polycarbophil moisturizer gel and placebo for postmenopausal women with vaginal dryness Methods: Randomized clinical trial with a total of 43 subjects were enrolled RSCM from April to December 2019, 22 subjects were in the polycarbophil group and 21 subjects were in the placebo group. Polycarbophil (Regell) and placebo were given 23 times per week for 3 weeks. Assessment of time before therapy as baseline and at the end of study. The efficacy assessed was the Vaginal Health Index Score (VHIS), elasticity, fluid volume, pH, epithelial integrity, vaginal moisture and total score. Result: The disappearance of vaginal dryness in polycarbophils group was at week 2 (48%), itching and irritation at week 2 (10%) and pain during intercourse week 2 (38%). Both polycarbophil and placebo treatments had significant differences in total score, fluid volume and vaginal moisture at week 3. The use of polycarbophils 2-3 times per day for 3 weeks can reduce the pH score on VHIS. There was no significant difference in the efficacy assessment between the two treatments, but there was a difference in the efficacy against pH. There were no side effects to either treatment. Conclusion: There was no difference in efficacy between polycarbophil gel and placebo, but there was a difference in efficacy on vaginal pH after using polycarbophil gel.
Keywords: Postmenopausal, vaginal dryness, polycarbonate, vaginal health index score, pH