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Kepada Yth.

dr. Sri Wahdini, M.Biomed,Sp.Ak

Pembacaan Jurnal III

Akupunktur Laser Mengurangi Gejala dan Meningkatkan Kualitas Hidup pada Pasien
Perempuan dengan Overactive Bladder: Uji Coba Terkendali Acak Tersamar Ganda

Sumber: https://www.hindawi.com/journals/ecam/2020/1705964/

Presentan : dr.Rahmania Kannesia Dahuri


Pembimbing : dr. Sri Wahdini, M.Biomed,Sp.Ak
Hari/Tanggal :

PROGRAM STUDI SPESIALIS AKUPUNKTUR MEDIK

FAKULTAS KEDOKTERAN UNIVERSITAS INDONESIA

JAKARTA

2021
Akupunktur Laser Mengurangi Gejala dan Meningkatkan Kualitas Hidup pada Pasien
Perempuan dengan Overactive bladder: Uji Coba Terkendali Acak Tersamar Ganda

Yu-Wei Chang,1 Tsia Shu Lo,2,3,4 Hsin-Ning Chang,1,5 Yi-Hsien Shiao,1 dan Yuan-Chieh

Yeh1,6

1
Departemen Pengobatan Tradisional TIongkok, Rumah Sakit Chang Gung, Pusat Kesehatan Keelung, Keelung, Taiwan
2
Divisi Uroginekologi, Departemen Obstetri dan Ginekologi, Rumah Sakit Memorial Chang Gung, Pusat Medis Linkou,
3
Departemen Obstetri dan Ginekologi, Rumah Sakit Memorial Chang Gung, Pusat Medis Keelung, Keelung, Taiwan
4
Universitas Chang Gung, Fakultas Kedokteran, Taoyuan, Taiwan
5
Lulusan Institut Ilmu Kedokteran Klinis, Fakultas Kedokteran, Universitas Chang Gung, Taoyuan, Taiwan
6
Program Kedokteran Molekuler, Sekolah Ilmu Hayati, Universitas Nasional Yang Ming, Taipei, Taiwan

ABSTRAK

Tujuan: Tujuan dari penelitian ini adalah untuk mengetahui kemanjuran klinis akupunktur
laser untuk pengobatan wanita dengan overactive bladder (OAB) di Taiwan.

Metode: Sebuah uji coba terkontrol secara acak tersamar ganda dilakukan pada pasien wanita
dengan gejala OAB yang dirujuk dari ginekolog, dan subyek dibagi menjadi dua kelompok
menggunakan pengacakan yang diblokir. LaserPan (RJ-Laser, Jerman) diaplikasikan pada
tujuh titik akupunktur terpilih. Subyek menerima akupunktur laser 3 kali seminggu selama 3
minggu, total 9 sesi. Data dasar pasien, Skor Gejala Overactive Bladder Symptom Score
(OABSS), Kuesioner Dampak Inkontinensia / Incontinence Impact Questionnaire (IIQ-7),
dan Skor Urogenital Distress Inventory (UDI-6) dicatat sebelum perawatan pertama dan pada
akhir perawatan ke-3, ke-6, dan ke-9.

Hasil: Tiga puluh pasien diikutkan dalam penelitian ini, dan dua puluh tujuh pasien
menyelesaikan seluruh perawatan dalam penelitian ini. Skor total OABSS kelompok
eksperimen menurun secara signifikan masing-masing sebesar 3,13 (p≤0,001), 4,60
(p≤0,001), dan 3,79 (p≤0,001) setelah perlakuan ke-3, ke-6, dan ke-9, dibandingkan dengan
kelompok kontrol. Skor IIQ-7 menurun secara signifikan dari kondisi awal sebesar 4,57
(p≤0,003) dan 3,63 (p≤0,023) setelah perawatan ke-3 dan ke-6, masing-masing, dibandingkan
dengan kelompok kontrol. Demikian pula, skor UDI-6 dari kelompok eksperimen
menunjukkan penurunan yang signifikan dari kondisi awal sebesar 1,90 (p<0,042) dan 2,25
(p<0,025) setelah intervensi ke-6 dan ke-9, masing-masing, dibandingkan dengan kelompok
kontrol.
Kesimpulan: Studi ini menunjukkan bahwa akupunktur laser dapat meringankan gejala OAB
dan meningkatkan kualitas hidup. Perangkat non-invasif ini bisa menjadi terapi yang efektif
untuk wanita dengan OAB.
PENDAHULUAN

Menurut International Continence Society, sindrom overactive bladder (OAB) didefinisikan


pada tahun 2002 sebagai "urgensi, dengan atau tanpa inkontinensia urgensi, biasanya dengan
frekuensi dan nokturia," tanpa adanya infeksi yang terbukti atau patologi lain yang jelas.1.
Secara umum, perempuan lebih banyak menderita sindrom OAB daripada laki-laki di
dunia tetapi faktor yang berkontribusi masih perlu dijelaskan.2. Menurut statistik di
2,3
berbagai negara, prevalensi OAB pada wanita berkisar antara 6,0 hingga 17,4% dan
meningkat seiring bertambahnya usia.4. OAB telah menjadi masalah kesehatan wanita
utama di seluruh dunia. Di Taiwan, prevalensi OAB yang disesuaikan dengan usia masing-
masing adalah 16% pada pria dan 18,3% pada wanitaWanita.5.

OAB menimbulkan dampak keuangan yang signifikan di AS dengan biaya medis berkisar
antara 656 hingga 860 USD per pasien per tahun.6. Dalam survei berbasis populasi AS tahun
2009, total biaya OAB spesifik penyakit diperkirakan mencapai 24,9 hingga 36,5 miliar
USD.7. Berbagai metode untuk mengobati OAB telah dikembangkan. Intervensi lini
pertama konvensional dalam pengelolaan OAB meliputi intervensi perilaku seperti
manajemen asupan cairan, pelatihan kandung kemih, dan latihan otot panggul.8.
Antimuskarinik oral (seperti solifenacin dan tolterodine) atau agonis 3-adrenoseptor oral
(mirabegron) biasanya digunakan sebagai pengobatan lini kedua. Namun, mulut kering,
sembelit, ketidakteraturan penglihatan, sakit kepala, hipertensi, dan masalah keamanan
kardiovaskular lainnya menjadi perhatian pasien yang diobati dengan obat ini 9. Dokter
mungkin menawarkan stimulasi saraf tibialis posterior yang lebih invasif / posterior
tibial nerve stimulation (PTNS), injeksi onabotulinumtoxinA (Botox®)
intradetrusor, dan neuromodulasi sacral / sacral neuromodulation (SNS) sebagai
pengobatan lini ketiga untuk pasien yang refrakter terhadap terapi lini kedua.10-12.

Pengobatan Tradisional Tiongkok / Traditional Chinese Medicine (TCM) telah bertahun-


tahun menggunakan obat herbal, akupunktur, dan moksibusi untuk mengobati gejala saluran
kemih bagian bawah / lower urinary tract syndrome (LUTS).13-15. Beberapa tinjauan
sistematis telah menyimpulkan bahwa akupunktur dapat memperbaiki gejala OAB dan
meningkatkan kinerja dalam tes urodinamik objektif. Namun, adanya efek seperti nyeri
dan hematoma membatasi penerimaan dan penggunaan pengobatan akupunktur.16,17.
Akupunktur laser, yang termasuk dalam kategori Low-Level Laser Therapy (LLLT),
umumnya diyakini sebagai pengobatan yang aman dan non-invasif tanpa efek samping yang
jelas.18. Namun, efek terapi akupunktur laser pada wanita dengan OAB belum diteliti. Studi
ini adalah uji coba terkontrol acak tersamar ganda untuk menilai efikasi akupunktur laser
pada wanita dengan OAB di Taiwan.
MATERI DAN METODE

2.1. Peserta

Uji klinis ini telah disetujui oleh Institutional Review Board of Chang Gung Medical
Foundation (Izin no. 201801679A3) dan terdaftar di ClinicalTrial.gov (ClinicalTrials.gov
Identifier: NCT03829137).

Menurut penelitian sebelumnya yang menilai efikasi moksibusi pada pasien dengan OAB,
diperkirakan bahwa 14 orang akan diperlukan untuk setiap kelompok uji untuk mendapatkan
kekuatan statistik 90%. Whitehead dkk.19 juga merekomendasikan jumlah sampel
percobaan per kelompok pengobatan sebanyak 15 orang untuk ukuran efek standar. Oleh
karena itu, 30 peserta direkrut untuk uji klinis ini.

Pasien yang direkrut yang memenuhi kriteria inklusi melakukan tes urodinamik (untuk
menyingkirkan kandung kemih neurogenik), pemeriksaan per-vaginam dan skrining awal
(untuk menyingkirkan indikasi operasi besar) oleh ginekolog berpengalaman. Semua peserta
memulai uji setelah memahami secara menyeluruh penelitian dan menandatangani formulir
persetujuan.

Kriteria inklusi adalah sebagai berikut:

(1) Wanita berusia minimal 20 tahun dengan diagnosis banding yang dilakukan oleh dokter
kandungan sebelum dirujuk ke Klinik Rawat Jalan Pengobatan Tiongkok

(2) Kesehatan yang baik secara umum tanpa kondisi medis utama lainnya dan bersedia
menandatangani persetujuan serta merespon penilaian skala evaluasi

(3) Gejala OAB sedang sampai berat dengan skor total OABSS > 6 dan skor pertanyaan ke-3
OABSS > 2

(4) Penghentian antimuskarinik dan agonis adrenoseptor 3 selama minimal 2 minggu


memastikan efek obat hilang

Kriteria eksklusi adalah sebagai berikut:

(1) Kehamilan atau niat untuk hamil

(2) Pendarahan vagina atau infeksi saluran kemih

(3) Penggunaan injeksi onabotulinumtoxinA intradetrusor (Botox®), PTNS, SNS, atau terapi
intervensi lainnya dalam 12 bulan sebelum pendaftaran studi
(4) Terapi herbal dan cerita rakyat lainnya yang didapatkan untuk meredakan gejala OAB

2.2. Desain penelitian

Dari awal tahun 2019, 40 pasien dirujuk dari departemen ginekologi dan 30 pasien
diantaranya memenuhi kriteria inklusi. Subyek kemudian dibagi menggunakan pengacakan.20
ke dalam kelompok eksperimen yang menerima perawatan laser verum (n = 15) dan
kelompok kontrol yang menerima perawatan laser paltsu (n = 15). Semua subjek menerima
akupunktur laser 3 kali seminggu selama 3 minggu, total 9 sesi, dengan sedikit modifikasi
sesuai dengan praktik klinis. Data dasar pasien, skor OABSS, UDI-6, dan IIQ-7 dicatat
sebelum perawatan pertama dan pada akhir perawatan ke-3, ke-6, dan ke-9. Efek samping
selama uji klinis juga dicatat. Flowchart penelitian ini ditunjukkan pada Gambar 1.

Baik pasien maupun peneliti tidak diberitahu tentang pengelompokan tersebut. Oleh karena itu,
penelitian ini merupakan uji coba terkontrol acak tersamar ganda prospektif.

Mengikutkan 40 peserta yang


dirujuk dari ginkeolog dengan
diagnosis banding OAB

Eksklusi (n=10)
Ambil data dan nilai awal
6 peserta menolak
dari kuisioner: 4 peserta tidak sesuai kriteria inklusi
1.OABSS, 2.UDI-6, 3.IIQ-7 OABSS < 6 poin

Randomisasi
(n=30)

AAlokasi

Alokasi akupunktur Alokasi akupunktur


laser sejati (n=15) laser palsu (n=15)

Menyelesaikan 3 terapi dan Menyelesaikan 3 terapi dan


menjawab kuisioner menjawab kuisioner
1 psn menghilang 1 psn menghilang
karena tidak puas karena tidak puas
dengan terapi dengan terapi
Menyelesaikan 6 terapi dan Menyelesaikan 6 terapi dan
menjawab kuisioner menjawab kuisioner

1 psn menghilang
karena kecelakaan
terjatuh

Menyelesaikan 9 terapi dan Menyelesaikan 9 terapi dan


menjawab kuisioner menjawab kuisioner

Analisis
Statistik GEE
30 peserta semua diikutkan walaupun loss to follow-up

Gambar 1. Flowchart penelitian


2.3. Intervensi

Titik akupunktur termasuk Taixi (KI3), Sanyinjiao (SP6), Guanyuan (CV4), Qihai (CV6),
Zhongliao (BL33), Xialiao (BL34), dan Baihui (GV20) dipilih sesuai dengan pedoman lokasi
titik akupresur standar WHO. Perawatan akupunktur laser dilakukan oleh dokter TCM
berlisensi. Pasien dibaringkan dalam posisi terlentang sebelum perawatan dan LaserPan
gallium aluminium arsenide (daya maksimal, 150mW; panjang gelombang, 810 nm; area
probe, 0,13cm2; kerapatan daya, 1,19W/cm2; gelombang berdenyut; RJLaser, Reimers &
Janssen GmbH , Waldkirch, Jerman) kemudian diberikan pada di setiap titik akupuntur yang
dipilih. Subyek dalam kelompok akupunktur laser verum menerima energi total 6 joule pada
setiap titik akupuntur dengan frekuensi yang ditentukan menurut Reininger Meridian
Frekuensi: Taixi (KI3, ginjal; 611 Hz), Sanyinjiao (SP6, limpa; 702 Hz), Zhongliao (BL33,
kandung kemih; 667 Hz), dan Xialiao (BL34, kandung kemih; 667 Hz). Namun, frekuensi
Governor Vessel (GV) dan Conception Vessel (CV) tidak ditentukan dan frekuensi Guanyuan
(CV4; Conception Vessel, 1102 Hz), Qihai (CV6; Conception Vessel, 1102 Hz), dan Baihui
(GV20; Governor Vessel , 637 Hz) dipilih berdasarkan pengalaman (ditunjukkan pada
Gambar 2). Subyek dalam kelompok kontrol menerima perawatan akupunktur laser palsu
tanpa keluarnya laser.

Gambar 2. Tujuh titik akupunktur terpilih dan frekuensi yang diberikan


2.4. Pengukuran Luaran

Luaran utama meliputi Skor Gejala Kandung Kemih yang Berlebihan / Overactive Bladder
Symptom Score (OABSS), sedangkan hasil sekunder mencakup skor yang diperoleh dengan
menggunakan Formulir Singkat Kuesioner Dampak Inkontinensia / Incontinence Impact
Questionnaire-Short Form (IIQ 7) dan Urogenital Distress Inventory (UDI-6).

OABSS dikembangkan untuk menilai perbaikan gejala dan efikasi pengobatan dalam praktek
klinis sehari-hari.21. OABSS terdiri dari empat item gejala (frekuensi siang hari, frekuensi
malam hari, urgensi, dan inkontinensia urgensi), total 15 poin, diterjemahkan ke dalam
bahasa Cina dan divalidasi di Taiwan.22,23 dipilih untuk menjadi pengukuran hasil utama
dalam penelitian ini. Sangat sensitif terhadap perubahan terkait pengobatan dalam gejala
OAB, OABSS dapat menjadi alternatif pengganti untuk buku harian kandung kemih /
bladder diary untuk penilaian gejala dan efikasi dalam praktik klinis sehari-hari.21. Baik
UDI-6 dan IIQ-7 (versi Cina) yang telah menunjukkan korelasi dengan frekuensi buang air
kecil di siang hari dan episode inkontinensia.24 digunakan untuk mengevaluasi bagaimana
gejala OAB yang berdampak pada kualitas hidup pasien (QoL).

2.5. Analisis Statistik

Analisis dilakukan dengan menggunakan perangkat lunak SPSS (IBM Corp. Dirilis 2015.
IBM SPSS Statistics for Windows, Version 23.0. Armonk, NY: IBM Corp.). Nilai p <0,05
dianggap signifikan secara statistik. Persamaan estimasi umum / generalized estimating
equation (GEE) digunakan untuk menilai rasio peningkatan pada skor OABSS, UDI-6, dan
IIQ-7. Uji T sampel independen, uji Chi-kuadrat, dan uji nonparametrik (uji Mann-Whitney
U) dilakukan untuk menganalisis karakteristik dasar dan data mentah antara kedua kelompok.
HASIL

Dari awal 2019, terdapat 40 pasien yang dirujuk dari ginekolog disaring dan 30 terdaftar
sebagai peserta. Mereka Pasien kemudian secara acak dialokasikan dalam kelompok untuk
menerima akupunktur laser verum (n = 15) atau akupunktur laser palsu (n = 15). Dari
merekatotal pasien, 27 (90%) menyelesaikan pengobatan; satu pasien dalam kelompok
eksperimen keluar karena konflik jadwal dan dua pasien dalam kelompok kontrol
menghentikan percobaan karena gejala OAB yang berkembang dan patah tulang pinggul
akibat kecelakaan terjatuh. Karakteristik dasar serupa antara kedua kelompok (Tabel 1).
Tabel data mentah dari ketiga kuesioner menunjukkan tren penurunan skor secara
ketergantungan waktu antara dua kelompok yang dihitung dengan uji nonparametrik (Tabel
2).

Menurut kalkulus logika GEE, data tiga subjek yang tidak menyelesaikan uji coba masih
dimasukkan dalam statistik. Titik waktu dikurangi baseline intragroup dan slope antara dua
kelompok dihitung menggunakan pendekatan persamaan estimasi umum (GEE) untuk hasil
berikut. Nilai p < 0,05 merupakan perbedaan yang signifikan dari lereng kemiringan antara
dua kelompok.

Tabel 1. Karakteristik dasar peserta

Karakteristik Grup eksperimental (n = 15) Grup kontrol (n = 15) P value


Usia, mean (SD) 56.4 (14.3) 60.9 (10.2) 0.33a
Tinggi (SD) 156.9 (4.2) 153 (6.2) 0.06a
Berat(SD) 59.5 (13.9) 60.83 (17.9) 0.90c
IMT (SD) 24.1 (4.6) 25.9 (7.3) 0.49c
Diabetes mellitus (%) 2 (13.3) 3 (20) 0.63b
HRT, n (%) 1 (6.7) 0 (0) 0.31b
Edukasi, n (%) 0.30b
SMP atau dibawah 5 (33.3) 5 (33.3)
SMA 6 (40.0) 9 (60.0)
Kuliah atau diatas 4 (26.7) 1 (6.7)
Status menopause, n (%) 0.65b
Pre 5 (33.3) 4 (26.7)
Pasca 10 (66.7) 11 (73.3)
Paritas, mean (SD, range) 2.4 (1.4, 0–5) 2.3 (1.4, 0–5) 0.90a
Persalinan, n (%) 1.0b
Persalinan normal spontan 11 (73.3) 11 (73.3)
Sectio caesarea 2 (13.3) 2 (13.3)
Operasi terkait ginekologi (%) 5 (33.3) 8 (53.3) 0.27b
Tipe OAB (%) 0.69b
OAB Basah 10 (66.7) 11 (73.3)
OAB Kering 5 (33.3) 4 (26.7)
Uji urodinamik, mean ( SD )
Profil tekanan uretra: kapasitas buli 292.3 (129.3) 262.6 (101.4) 0.51c
(ml)
CMG + EMG: Pves-Pabd (CmH2O) 12.3 (28.5) 10.4 (21.2) 0.81c
Luaran utama, mean ( SD )
OABSS 8.7 (1.8) 8.5 (1.8) 0.74c
Q1 (frekuensi siang hari) 1.5 (0.5) 1.7 (0.5) 0.22c
Q2 (nokturia) 2.3 (0.9) 2.4 (0.9) 0.81c
Q3 (urgensi) 3.9 (0.9) 3.7 (1.1) 0.78c
Q4 (urgensi inkontinensia) 1.1 (1.4) 0.7 (1.2) 0.33c
Luaran sekunder, mean ( SD )
UDI-6 6.0 (2.5) 5.7 (2.4) 0.62c
IIQ-7 9.9 (5.7) 10.8 (3.9) 0.41c

Tabel 2. Data mentah OABSS, UDI-6, and IIQ-7

Luaran Eksperimental (n) Kontrol (n) p


OABSS (mean ± SD)
Nilai awal/dasar 8.7 ± 1.8 (15) 8.5 ± 1.8 (15) 0.74
Kunjungan 1 4.7 ± 2.4 (15) 7.7 ± 1.4 (15) ≤0.001∗∗

Kunjungan 2 3.4 ± 1.9 (14) 7.8 ± 1.9 (14) ≤0.001∗∗


Kunjungan 3 3.1 ± 1.6 (14) 6.7 ± 2.8 (13) ≤0.001∗∗


UDI-6 (mean ± SD)


Nilai awal/dasar 6.0 ± 2.5 (15) 5.7 ± 2.4 (15) 0.62
Kunjungan 1 3.5 ± 1.9 (15) 4.1 ± 2.3 (15) 0.41
Kunjungan 2 2.3 ± 1.8 (14) 3.9 ± 2.1 (14) 0.03∗
Kunjungan 3 2.4 ± 1.6 (14) 4.3 ± 2.9 (13) 0.03∗
IIQ-7 (mean ± SD)
Nilai awal/dasar 9.9 ± 5.7 (15) 10.8 ± 3.9 (15) 0.41
Kunjungan 1 4.2 ± 2.3 (15) 9.9 ± 4.2 (15) ≤0.001∗∗

Kunjungan 2 4.2 ± 3.2 (14) 9.4 ± 3.9 (14) 0.001∗∗


Kunjungan 3 3.0 ± 2.5 (14) 8.5 ± 3.7 (13) ≤0.001∗∗

3.1. Perubahan Gejala OAB

Pada pengukuran hasil primer, skor total OABSS dari kelompok eksperimen menurun secara
signifikan sebesar 3,13 (p 0,001) setelah perlakuan ke-3 dibandingkan dengan kelompok
kontrol. Perbedaan skor OABSS dari baseline antara kelompok eksperimen dan kelompok
kontrol berubah adalah 4,60 (p 0,001) setelah perlakuan ke-6 dan 3,79 (p 0,001) setelah
perlakuan ke-9 (Tabel 3(a), Gambar 3(a) )).

3.2. Perubahan QoL Peserta

Setelah perlakuan ke-3, skor UDI-6 dari kelompok eksperimen sedikit menurun (0,87),
menunjukkan tidak ada perubahan yang signifikan dibandingkan dengan kelompok kontrol
tetapi menunjukkan penurunan yang nyata dari baseline setelah intervensi ke-6 dan ke-9
(−1,90; p < 0,042 dan 2.25; p < 0,025, masing-masing) (Tabel 3(b)). Untuk IIQ-7, skor
kelompok eksperimen menunjukkan peningkatan yang signifikan dari baseline setelah
perawatan ke-3 dan ke-6 (−4.57; p 0,003 dan 3,62; p 0,023, masing-masing) dibandingkan
dengan kelompok kontrol, tetapi hanya a sedikit penurunan yang tidak signifikan (−3,42; p
0,073) dari baseline setelah pengobatan ke-9 (Tabel 3(c)). Hasil GEE ditunjukkan pada
Gambar 3(b) dan 3(c).
Tabel 3. Analisis persamaan estimasi umum dari pengukuran hasil. OABSS (a) sebagai hasil
utama, UDI-6 (b), dan IIQ 7 (c) sebagai hasil sekunder.

ß SE P
(a)
Grup
Eksperimental 0.20 0.753
Kontrol 0a
Grup ∗ perjalanan waktu
(experimental vs control)
Terapi ke-3 vs. Nilai awal
∗∗∗
Terapi ke-6 vs. Nilai awal −4.60 0.91 ≤0.001
Terapi ke-9 vs.Nilai awal −3.79 1.09 ≤0.001∗∗∗
(b)
Grup
Eksperimental 0.33 0.699
Kontrol 0a
Grup ∗ perjalanan waktu
(experimental vs control)
Terapi ke-3 vs. Nilai awal −0.87 0.99 0.382
Terapi ke-6 vs. Nilai awal −1.90 0.93 0.042∗
Terapi ke-9 vs.Nilai awal −2.25 1.01 0.025∗
(c)
Grup
Eksperimental −2.16 0.309
Kontrol 0a
Grup ∗ perjalanan waktu
(experimental vs control)
Terapi ke-3 vs. Nilai awal −4.57 1.51 0.003∗∗
Terapi ke-6 vs. Nilai awal −3.63 1.60 0.023∗
Terapi ke-9 vs.Nilai awal −3.42 1.91 0.073

Kunjungan Kunjungan

0 1 2 3 0 1 2 3
0 0

–2 –2

–4 –4
∗ ∗
∗ –6
–6 ∗
∗ ∗ ∗
∗ ∗
–8 ∗ ∗ –8
Kontrol Kontrol
Eksperimental Eksperimental

(a) (b)

Kunjungan
0 1 2 3
0

–2

–4

–6
∗ ∗
–8 ∗
Kontrol
Eksperimental
(c)

Gambar 3. Bagan garis hasil primer dan sekunder. Perubahan rata-rata skor OABSS (a),
UDI-6 (b), dan IIQ-7 (c) pada perlakuan ke-3, ke-6, dan ke-9 antara kelompok
eksperimen dan kelompok kontrol.
3.3. Frekuensi, Urgensi, Nokturia, dan Inkontinensia Urgensi Siang Hari

Urgensi, Nokturia, dan Inkontinensia Urgensi. Mengingat urgensi sebagai gejala inti OAB,
pertanyaan “seberapa sering Anda memiliki keinginan tiba-tiba untuk buang air kecil, yang
sulit untuk ditunda” diambil dari OABSS untuk menilai secara spesifik tingkat keparahan
urgensi. Hasil menunjukkan kelompok eksperimen telah menandai penurunan urgensi
signifikansi statistik setelah perawatan ke-6 dan ke-9 (−1,88; p < 0,001 dan 1,26; p < 0,030,
masing-masing) dibandingkan dengan kelompok kontrol (Tabel 4(a), Gambar 4(a)). Selain
itu, gejala nokturia dan inkontinensia urgensi juga meningkat secara signifikan setelah
perawatan akupunktur laser (Tabel 4(b) dan 4(c); Gambar 4(b) dan 4(c)). Tidak ada
perbedaan yang signifikan dalam frekuensi buang air kecil di siang hari antara kedua
kelompok (Tabel 4(d), Gambar 4(d)).

Tabel 4. Analisis persamaan estimasi umum dari empat pertanyaan OABSS. Urgensi di Q3
(a), nokturia di Q2 (b), inkontinensia urgensi di Q4 (c), dan frekuensi buang air kecil di siang
hari di Q1 (d).
B SE p
(a)
Grup
Eksperimental −1.974E− 16 1.000
Kontrol 0a
Grup ∗ perjalanan waktu (experimental vs
control)
Terapi ke-3 vs. Nilai awal −0.80 0.65 0.220
Terapi ke-6 vs. Nilai awal −1.88 0.57 0.001∗∗
Terapi ke-9 vs.Nilai awal −1.26 0.58 0.030∗
(b)
Grup
Eksperimental −0.27 0.327
Kontrol 0a
Grup ∗ perjalanan waktu (experimental vs
control)
Terapi ke-3 vs. Nilai awal −0.87 0.31 0.005∗∗
Terapi ke-6 vs. Nilai awal −1.11 0.31 ≤0.001∗∗∗
Terapi ke-9 vs.Nilai awal −1.02 0.29 ≤0.001∗∗∗
(c)
Grup
Eksperimental 0.47 0.297
Kontrol 0a
Grup ∗ perjalanan waktu (experimental vs
control)
Terapi ke-3 vs. Nilai awal −0.67 0.47 0.157
Terapi ke-6 vs. Nilai awal -0.93 0.47 0.050
Terapi ke-9 vs.Nilai awal -0.98 0.47 0.038*
(d)
Grup
Eksperimental −0.342 0.053
Kontrol 0a
Grup ∗ perjalanan waktu (experimental vs
control)
Terapi ke-3 vs. Nilai awal −1.92 0.20 0.336
Terapi ke-6 vs. Nilai awal −2.48 0.20 0.224
Terapi ke-9 vs.Nilai awal −1.73 0.31 0.580
Kunjungan
Kunjungan
0 1 2 3 0 1 2 3
0 0

–2 –2 ∗ ∗ ∗
∗ ∗ ∗
∗ ∗
∗ ∗
–4 ∗ –4

–6 –6

–8 –8
Kontrol Kontrol
Eksperimental Eksperimental

( a) ( b)
Kunjungan Kunjungan
0 1 2 3 0 1 2 3
2 0

–2
0

–4

–2
–6

–4 –8
Kontrol Kontrol
Eksperimental Eksperiimental

(c) ( d)

Gambar 4. Diagram garis dari empat pertanyaan OABSS. Perubahan mean urgensi (Q3) (a),
nokturia (Q2) (b), iinkontinensia urgensi (Q4) (c), dan frekuensi siang hari (Q1) (d) antara grup
eksperimental dan grup kontrol. Kunjungan 1, 2, dan 3 mewakili terapi ke-3, ke-6, dan ke-9,
berturut0turut. *p<0.05, ** p<0.01, *** p<0.001
DISKUSI

Menurut American Urological Association (AUA) dan Society of Urodynamics, Female


Pelvic Medicine and Urogenital Reconstruction (SUFU) OAB Guideline, terapi OAB dimulai
dengan modifikasi pola makan dan perilaku dan berlanjut ke farmakoterapi serta terapi lini
ketiga termasuk neuromodulasi, PTNS , dan seterusnya. Namun, pedoman tersebut menyoroti
bahwa setiap pasien tidak harus menjalani setiap lini pengobatan dalam urutan yang
ditentukan.8. Mengingat fakta yang disebutkan di atas, banyak pengobatan alternatif seperti
akupunktur, stimulasi magnetik ekstrakorporeal, pengobatan laser YAG, stimulasi rol
elastomer perineum dan, moksibusi telah dikembangkan dan divalidasi.14,25-27. Sejauh
pengetahuan kami, ini adalah uji klinis pertama yang menilai efek terapeutik akupunktur
laser pada pasien dengan OAB.

Dalam penelitian ini, pasien dengan gejala sedang hingga berat (OABSS> 6) dan urgensi
lebih dari sekali seminggu (Q3, pertanyaan ke-3 OABSS> 2) diikutkan, dan skor total
OABSS adalah 8,7 dan 8,5 (p 0,76) di kelompok eksperimen dan kontrol, masing-masing,
sebelum pengobatan. Setelah perawatan ke-3, ke-6, dan ke-9, skor total OABSS menurun
secara signifikan pada kelompok eksperimen dibandingkan dengan kelompok kontrol, yang
menunjukkan bahwa akupunktur laser dapat memperbaiki gejala OAB sedang hingga berat.
Selanjutnya, gejala urgensi (Q3 OABSS) dan nokturia (Q2, pertanyaan ke-2 OABSS)
meningkat secara signifikan setelah perawatan ke-3, ke-6, dan ke-9, dengan inkontinensia
urgensi (Q4, pertanyaan ke-4 OABSS) membaik setelah perawatan ke-9, sedangkan siang
hari frekuensi (Q1, pertanyaan 1 OABSS) menunjukkan tren penurunan yang tidak
signifikan.

UDI-6 dan IIQ-7 (versi Cina) adalah pengukuran hasil sekunder dalam penelitian ini menilai
dampak gejala OAB pada kualitas hidup pasien. Skor IIQ-7 meningkat secara signifikan dari
baseline setelah perlakuan ke-3 dan ke-6 pada kelompok eksperimen dibandingkan pada
kelompok kontrol, tetapi perbedaan peningkatan setelah perlakuan ke-9 antara kedua
kelompok tidak signifikan (Tabel 3(c); Gambar 3( c)). Hasil tersebut dapat dikaitkan dengan
efek plasebo terkait dalam pengobatan jangka panjang. Skala UDI 6 berfokus pada seberapa
mengganggu gejala OAB, terutama inkontinensia urin. Temuan ini mengungkapkan
peningkatan yang signifikan dalam skor UDI-6 pada kelompok eksperimen setelah intervensi
ke-6 dan ke-9 (Tabel 3(b); Gambar 3(b)), yang konsisten dengan hasil yang diperoleh untuk
Q4 OABSS.

Akupunktur telah diterapkan sebagai pengobatan OAB selama bertahun-tahun. Penelitian


sebelumnya tentang OAB pada wanita mengungkapkan bahwa akupunktur bahkan dapat
dibandingkan dengan antikolinergik (tolterodine tartrate) dalam mengurangi frekuensi
urin siang hari, inkontinensia, dan nokturia dan meningkatkan volume berkemih per
miksi.28. Selain itu, ulasan lain menyarankan bahwa akupunktur dapat mengurangi frekuensi
buang air kecil, inkontinensia, dan nokturia dan meningkatkan volume buang air
kecil.16,17. Mengingat efek samping terkait seperti nyeri, hematoma, dan granuloma.16,17
pengobatan akupunktur laser noninvasif mungkin menjadi pilihan yang lebih baik daripada
akupunktur jarum.

Akupunktur laser, sejenis LLLT telah digunakan selama lebih dari 40 tahun dalam mengobati
penyakit hewan atau manusia.29. Menjadi non-invasif dan dengan efek samping minimal,
akupunktur laser telah dipromosikan sebagai alternatif bebas rasa sakit yang lebih aman
untuk akupunktur jarum. Namun, mekanisme, efektivitas, dan indikasi akupunktur laser
masih belum diketahui18. Sampai saat ini, masih menjadi tantangan untuk memilih parameter
yang tepat termasuk panjang gelombang, output daya, dosis energi, dan frekuensi dalam
situasi tertentu karena heterogenitas antara teori terapi dan pigmen kulit individu, ketebalan,
dan lokasi pada tubuh30. Dalam penelitian ini, titik akupuntur yang dipilih dianggap sesuai
dengan meridian, dan frekuensi yang diterapkan mengikuti Frekuensi Meridian
Reininger. Tujuh titik akupunktur yang dipilih (KI3, SP6, CV4, CV6, GV20, BL33, dan
BL34) umumnya digunakan dalam mengobati OAB, inkontinensia urin, dan LUTS menurut
teori TCM dan efek terapeutik telah ditunjukkan dalam banyak penelitian modern.16,17. Kami
mengambil makalah dan ulasan uji klinis ini sebagai referensi untuk memilih titik
akupunktur. Karena karakteristik postur pasien yang berubah-ubah dan waktu perawatan
yang singkat dalam akupunktur laser, tujuh titik akupunktur terpilih yang terletak di berbagai
bagian tubuh dapat distimulasi dalam sesi yang sama. Alasan untuk memilih titik akupunktur
ini disimpulkan pada Tabel 5 dan hasil uji klinis kami menunjukkan bahwa titik akupunktur
ini diterapkan dengan Frekuensi Meridian Reininger memberikan pengobatan yang efektif
untuk wanita dengan OAB.

Untuk menjelaskan mekanisme yang mungkin dari sudut pandang neurologis, BL33 dan
BL34, masing-masing, terletak di foramen sakral ke-3 dan ke-4 di daerah lumbosakral,
dan saraf tulang belakang sakral S2-S4 bersama-sama membentuk saraf pudendal yang
mempersarafi sfingter uretra eksternal. SNS adalah teknik terapi invasif dengan elektroda
yang ditempatkan di foramen sakral S3-S4 untuk menghasilkan stimulasi listrik jangka
panjang dari saraf sakral untuk memulihkan kebiasaan berkemih normal. Mekanisme
hipotesis yang paling dapat menjelaskan dengan baik efek tersebut adalah stimulasi serat
aferen alfa bermielin dan serat C tidak bermielin di panggul S3 dan S4, akar saraf splanknik
panggul, dan akar saraf pudendal
yang mempengaruhi refleks berkemih.10,35. Menurut pendapat kami, teori neuromodulasi
sakral dapat menjelaskan kemungkinan mekanisme stimulasi BL33 dan BL34. Selain itu,
terapi neuromodulasi yang tersedia secara klinis untuk OAB menargetkan tidak hanya
akar saraf sakral tetapi juga saraf tibialis posterior dan saraf genital dorsal untuk stimulasi.12.
PTNS memberikan stimulasi retrograde ke kompleks sakral melalui elektroda yang
ditempatkan di dekat saraf tibialis posterior di lokasi yang mirip dengan titik akupunktur KI3
dan SP6. Namun, mekanisme akupunktur laser mungkin berbeda dari stimulasi listrik yang
diberikan oleh PTNS. Sebagai akibatnya, kami menganggap mekanisme kedua titik
akupunktur ini mungkin memiliki beberapa jalur umum yang dapat dicapai oleh
akupunktur jarum, akupunktur laser, dan PTNS. Selain itu, beberapa penelitian
menggunakan moksibusi pada meridian Kapal Konsepsi 3, 4, atau 6 (CV3, CV4, atau CV6)
untuk meringankan OAB dan LUTS lainnya.14. Mekanisme spekulatif moksibusi pada
meridian CV melibatkan regulasi langsung atau tidak langsung dari sistem saraf otonom
(ANS)36 tetapi prinsip pasti di baliknya masih belum diketahui. Apakah akupunktur laser
mencapai efek terapeutik melalui mekanisme neurologis yang serupa atau teori lain, seperti
teori Qi atau meridian, masih harus dipelajari lebih lanjut. Mekanisme spekulatif akupunktur
laser ditunjukkan pada Gambar 5.

Tabel 5. Alasan pemilihan titik akupunktur


Acupoints (lokasi) Alasan pemilihan titik akupunktur Kemungkinan Rujukan
mekanisme
Titik akupunktur yang sering digunakan dalam LUTS adalah
BL31 hingga BL35. Mereka terletak di atas foramen sakral,
masing-masing terletak di atas akar saraf sakral pertama
BL33 and BL34 hingga keempat. Titik-titik akupunktur ini sesuai dengan Stimulasi nervus
[31]
(area lumbar sacrum) persarafan segmental saraf parasimpatis kandung kemih. sakral
Sebuah RCT yang diterbitkan di JAMA mengkonfirmasi efek
elektroakupunktur yang melibatkan daerah lumbosakral
untuk wanita dengan SUI.
Menurut teori TCM, OAB dan LUTS disebabkan oleh
ketidakseimbangan organ Zang-Fu ginjal, limpa, dan hati.
KI3 and SP6 (tungkai KI3 (meridian ginjal) dan SP6 (meridian limpa) biasanya Srimulasi nervus
[28, 32]
bawah) digunakan untuk mengatur keseimbangan Yin-Yang dalam tibialis posterior
OAB dan LUTS dan telah dimasukkan dalam beberapa
penelitian.
Dalam teori TCM, disfungsi kandung kemih disebabkan oleh
insufisiensi Yang Qi. Konsepsi Vessel meridian disarankan
CV4 and CV6 Regulasi sistem
sebagai pilihan pengobatan karena beberapa penelitian [14, 33]
(abdomen bawah) saraf otonom
menggunakan moksibusi atau akupunktur pada CV3, CV4,
atau CV6 untuk meringankan OAB dan LUTS lainnya.
GV20, salah satu titik akupuntur yang paling penting dari
pembuluh utama, biasanya digunakan dalam neurologi dan
psikiatri. Stimulasi pada GV20 akan meningkatkan perfusi
Meningkatkan perfusi
serebral di korteks serebral, menstabilkan emosi, dan
serebri dalam korteks
GV20 (kepala) menurunkan aktivitas simpatis dalam respon stres. Studi telah [34]
serebri untuk stabilisasi
melaporkan stimulasi GV20 dapat mengangkat Yang Qi yang
mood
jatuh sesuai dengan teori TCM; oleh karena itu, kami
memilih GV20 untuk menenangkan emosi dan mengangkat
Yang Qi pasien.
n. parasimpatis

n. skiatik

n. pudenda

Spingter internal
Spingter eksternal
n. tibialis
posterior

Gambar 4. Mekanisme spekulatif akupunktur laser dari sudut pandang neurologis

4.1 Keterbatasan

Ada beberapa kuesioner yang divalidasi untuk penilaian OAB yang dikembangkan
untuk mengevaluasi validitas dan reliabilitas23,37. Namun, skala penilaian subjektif ini
tidak memiliki data objektif. Dalam beberapa tahun terakhir, banyak penelitian telah
melaporkan bahwa faktor pertumbuhan saraf (NGF), faktor neurotropik yang diturunkan dari
otak (BDNF), protein C-reaktif (CRP), prostaglandin, dan sitokin dapat digunakan
sebagai biomarker potensial OAB tetapi tidak satupun dari ini memenuhi kriteria untuk
menjadi penanda OAB terisolasi38. Sebuah biomarker potensial, seperti NGF, dapat dipilih
untuk menjadi salah satu hasil sekunder dalam penelitian masa depan.
Tidak seperti kuesioner tradisional dengan skor minimum dan maksimum yang sama,
OABSS menilai item yang berbeda menggunakan skor maksimal yang berbeda (2, 3, 5, dan 5
untuk frekuensi siang hari, frekuensi malam hari, urgensi, dan inkontinensia urgensi, masing-
masing.). Namun, skor frekuensi OABSS, mulai dari 0 hingga 2, terlalu sempit untuk
menggambarkan situasi frekuensi buang air kecil yang sebenarnya di siang hari. Untuk
penelitian selanjutnya, harus dihitung dengan menggunakan jumlah buang air kecil yang
dicatat dalam buku harian kandung kemih 3 hari.

Penelitian dDibatasi oleh dana dan sumber daya penelitian yang terbatas, penelitian ini hanya
menunjukkan efek jangka pendek dari akupunktur laser tanpa tindak lanjut jangka panjang.
Uji klinis jangka panjang dan multi-center diperlukan untuk evaluasi lebih lanjut.
KESIMPULAN

Sampai saat ini, ini adalah uji klinis pertama yang mengevaluasi efek akupunktur laser pada
pasien perempuan dengan OAB. Hasil saat ini menunjukkan bahwa akupunktur laser dapat
meringankan gejala OAB dan meningkatkan kualitas hidup wanita yang menderita OAB.
Akupunktur laser mungkin merupakan intervensi yang aman dan efektif untuk mengobati
gejala OAB.

Ketersediaan Data

Data yang mendukung temuan penelitian ini tersedia dari penulis yang sesuai atas permintaan.

Penyingkapan

Presentasi lisan dari data dalam naskah dipresentasikan di WFAS 2019 Turki. Gambar 5 dibuat
dengan http://BioRender.com.

Konflik kepentingan

Para penulis menyatakan bahwa mereka tidak memiliki konflik kepentingan.

Kontribusi Penulis

Yu-Wei Chang, Tsia-Shu Lo, Hsin-Ning Chang, dan Yuan-Chieh Yeh memberikan
kontribusi besar pada konsepsi atau desain karya tersebut. Yu-Wei Chang, Yuan-Chieh Yeh,
dan Tsia- Shu Lo memperoleh dan menganalisis data. Yu-Wei Chang, Tsia-Shu Lo, Hsin-
Ning Chang, dan Yuan-Chieh Yeh menafsirkan hasilnya. Yu-Wei Chang dan Yuan-Chieh
Yeh menyusun artikel aslinya. Yi-Hsien Shiao merevisi analisis statistik untuk revisi besar.
Semua penulis secara kritis merevisi draf dan menyetujui versi final untuk diterbitkan.

Ucapan Terima Kasih

Penulis berterima kasih kepada semua pasien atas partisipasinya dalam penelitian ini dan Dr.
Bing-Yu Chen di Departemen Penelitian dan Pengembangan Medis, Rumah Sakit Memorial
Keelung Chang Gung untuk konsultasi statistik dan analisis data.
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Hindawi
Evidence-Based Complementary and Alternative Medicine
Volume 2020, Article ID 1705964, 11 pages
https://doi.org/10.1155/2020/1705964

Research Article
Laser Acupuncture Alleviates Symptoms and Improves Quality
of Life in Women with Overactive Bladder: A Double-Blind,
Pilot Randomized Controlled Trial

Yu-Wei Chang,1 Tsia-Shu Lo,2,3,4 Hsin-Ning Chang,1,5 Yi-Hsien Shiao,1


and Yuan-Chieh Yeh 1,6
1
Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital, Keelung Medical Center, Keelung, Taiwan
2
Division of Urogynecology, Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Linkou Medical
Center, Linkou, Taoyuan, Taiwan
3
Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Keelung Medical Center, Keelung, Taiwan
4
Chang Gung University, School of Medicine, Taoyuan, Taiwan
5
Graduate Institute of Clinical Medicine Sciences, College of Medicine, Chang Gung University, Taoyuan, Taiwan
6
Program in Molecular Medicine, School of Life Sciences, National Yang Ming University, Taipei, Taiwan

Correspondence should be addressed to Yuan-Chieh Yeh; b9005030@gmail.com

Received 21 January 2020; Revised 12 March 2020; Accepted 28 March 2020; Published 25 April 2020

Academic Editor: Jose´ L. Rios

Copyright © 2020 Yu-Wei Chang et al. This is an open access article distributed under the Creative Commons Attribution
License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is
properly cited.

Objective. The aim of this study was to investigate the clinical efficacy of laser acupuncture for the treatment of women with
overactive bladder (OAB) in Taiwan. Methods. A double-blind randomized controlled trial was conducted on female patients
with OAB symptoms referred from gynecologists, and subjects were divided into two groups using blocked randomization.
LaserPan (RJ-Laser, Germany) was applied to seven selected acupuncture points. The subjects received laser acupuncture 3
times per week for 3 weeks, 9 sessions in total. Basic patient data, Overactive Bladder Symptom Score (OABSS), Incontinence
Impact Questionnaire (IIQ-7), and Urogenital Distress Inventory (UDI-6) scores were recorded prior to first treatment and at the
end of 3rd, 6th, and 9th treatments. Results. Thirty patients were enrolled, and twenty-seven patients completed all treatments in
rd th
this study. Thegroup
experimental OABSS total score
decreased of the by 3.13 (p ≤
significantly
0.001), 4.60 (p 0.001), and 3.79 (p th0.001) after 3 , 6 , and 9 treatments,
≤ ≤
respectively, compared with that of the control group. The IIQ-7 score declined significantly from baseline by 4.57 (p0.003) � and
rd th
3.63 (p � 0.023) after 3 and 6 treatments, respectively, compared with that of the control group. Similarly, the UDI-6 score of
the experimental group exhibited a significant decrease from baseline by 1.90� (p 0.042) and 2.25 (p
0.025) after 6th and 9th in-
terventions, respectively, compared with that of the control group. Conclusions. This study demonstrates that laser acupuncture
can alleviate OAB symptoms and improve quality of life. This noninvasive device could be an effective therapy for women
with OAB.

1. Introduction According to statistics in different countries, the prevalence of OAB


among females
According to International Continence Society, the
overactive bladder (OAB) syndrome was defined in 2002 as
“urgency, with or without urgency incontinence, usually
with frequency and nocturia,” in the absence of proven
infection or other obvious pathology [1]. In general, females
suffered more from OAB syndrome than males in the world
but the contributing factors remain to be elucidated [2].
ranges from 6.0 to 17.4% [2, 3] and increases
with age [4]. OAB has become a major women
health issue worldwide. In Taiwan, the age-
adjusted prevalence of OAB is 16% in men and
18.3% in women, respectively [5].
OAB poses significant financial impact in the
US with medical costs ranging from USD 656 to
860 per patient annually [6]. In a US population-
based survey of 2009, the total cost of disease-
specific OAB was estimated at USD 24.9 to 36.5
billion [7]. Various methods for treating OAB
have been developed. Conventional first-line
interventions in the management of
2 Evidence-Based Complementary and Alternative Medicine

OAB include behavioral interventions such as fluid intake


(4) Discontinuation of antimuscarinic and β3-adreno-
management, bladder training, and pelvic muscle exercises [8].
ceptor agonists for at least 2 weeks ensuring drug
Oral antimuscarinics (such as solifenacin and tolterodine) or effect being washed out
oral β3-adrenoceptor agonists (mirabegron) are commonly
used as second-line treatments. However, dry mouth, con- The exclusion criteria were as follows:
stipation, vision irregularity, headache, hypertension, and other (1) Pregnancy or intention to get pregnant
cardiovascular safety issues are of concern to patients treated
with these drugs [9]. Clinicians may offer more invasive pos- (2) Vaginal bleeding or urinary tract infection
terior tibial nerve stimulation (PTNS), intradetrusor onabotu- (3) Use of intradetrusor onabotulinumtoxinA injection
linumtoxinA (Botox ) injection, and sacral neuromodulation
®
(SNS) as third-line treatments for patients who are refractory
®
(Botox ), PTNS, SNS, or other interventional therapies
within 12 months prior to study enrollment
to second-line therapies [10–12]. (4) Other herbal and folklore therapies received to re-
Traditional Chinese medicine (TCM) has for many years lieve OAB symptoms
utilized herbal medicine, acupuncture, and moxibustion to treat
lower urinary tract symptoms (LUTS) [13–15]. Some
systematic reviews have concluded that acupuncture can 2.2. Study Design. From early 2019, 40 patients were referred
improve OAB symptoms and enhance performance in from the gynecology department and 30 patients met the in-
objective urodynamic tests. However, both pain and clusion criteria. The subjects were then divided using blocked
hematoma limit the acceptance of acupuncture treatment [16, randomization [20] into the experimental group receiving
17]. verum laser treatment (n = 15) and the control group receiving
Laser acupuncture, belonging to the category of Low- sham laser treatment (n = 15). All subjects receive laser acu-
Level Laser Therapy (LLLT), is commonly believed to be a puncture 3 times per week for 3 weeks, 9 sessions in total,
safe and noninvasive treatment with no obvious side effect with minor modifications according to clinical practice. Basic
[18]. How- ever, the therapeutic effect of laser acupuncture on patient data, OABSS, UDI-6, and IIQ-7 scores were recorded
women with OAB has not yet been examined. This study is a prior to 1st treatment and at the end of 3rd, 6th, and 9th
double-blind, pilot randomized controlled trial for assessing the treatments. Adverse effects during the clinical trial were also
efficacy of laser acupuncture on women with OAB in recorded. The flowchart of this study is shown in Figure 1.
Taiwan. Neither patients nor investigators were informed of the
grouping. Therefore, this study was a prospective double-
2. Materials and Methods blind randomized controlled trial.

2.1. Participants. This clinical trial was approved by the


Institutional Review Board of Chang Gung Medical Foun- 2.3. Intervention. Acupuncture points including Taixi (KI3),
dation (Permit no. 201801679A3) and registered at Sanyinjiao (SP6), Guanyuan (CV4), Qihai (CV6), Zhongliao
ClinicalTrial.gov (ClinicalTrials.gov Identifier: (BL33), Xialiao (BL34), and Baihui (GV20) were selected
NCT03829137). according to the WHO standardized acupressure point location
According to prior research assessing the efficacy of guideline. The laser acupuncture treatment was administered
moxibustion on patients with OAB [14], it was estimated by a licensed TCM physician. The patient laid in the supine
that 14 people would be required for each arm to reach 90% po- sition before treatment and the gallium aluminum arsenide
statistical power. Whitehead et al. [19] also recommended LaserPan (maximal power, 150 mW; wavelength, 810 nm;
2 2
pilot trial sample size per treatment arm of 15 for stan- area of probe, 0.13 cm ; power density, 1.19 W/cm ; pulsed
dardized effect size. Therefore, 30 participants were wave; RJ- Laser, Reimers & Janssen GmbH, Waldkirch,
recruited for this clinical trial. Germany) was then applied to each selected acupoint. Subjects
The recruited patients who met the inclusion criteria in the verum laser acupuncture group received a total energy
completed the urodynamic test (to rule out neurogenic of 6 joule at each acupoint with frequency prescribed
bladder), per vaginal examination and initial screening (to according to Reininger Meridian Frequencies: Taixi (KI3,
rule out major surgery indication) by an experienced gy- kidney; 611 Hz), Sanyinjiao (SP6, spleen; 702 Hz), Zhongliao
necologist. All participants started the trial after under- (BL33, bladder; 667 Hz), and Xialiao (BL34, bladder; 667 Hz).
standing thoroughly the study and signing informed However, the frequencies of Governor Vessel (GV) and
consent forms. Conception Vessel (CV) were undefined and frequencies of
The inclusion criteria were as follows: Guanyuan (CV4; Conception Vessel, 1102 Hz), Qihai (CV6;
Conception Vessel, 1102 Hz), and Baihui (GV20; Governor
(1) Female at least 20 years old with differential diag- Vessel, 637 Hz) were chosen according to experience (shown
nosis performed by a gynecologist prior to being in Figure 2). Subjects in the control group received sham laser
referred to the Chinese Medicine Outpatient Clinic acupuncture treatment without laser output.
(2) Good health in general with no other major medical
conditions and willing to sign the consent as well as
responding to evaluation scales 2.4. Outcome Measurements. Primary outcomes included
Overactive Bladder Symptom Score (OABSS), whereas
(3) Moderate to severe OAB symptoms with total secondary outcomes included scores obtained using
rd
>
scores of OABSS 6 and the score of 3 question
of
OABSS >
2
Evidence-Based Complementary and Alternative Medicine 3

Enrollment
40 participants referred from
gynecologist with differential
diagnosis of OAB.
Collect baseline and scores Excluded (n = 10)

from questionnaires 6 participants declined to participate.

1.OABSS 4 participants did not meet inclusion
2.UDI-6 criteria.
3.IIQ-7 -OABSS < 6 points.
Randomized
n = 30

Allocation

Allocated to sham
Allocated to verum
laser acupuncture
laser acupuncture
group (n = 15)
group (n = 15)

Completed 3 treatments Completed 3 treatments


and answered and answered
1 p’t loss to questionnaires 1 p’t loss to
questionnaires
follow-up due to follow-up due to
dissatisfaction dissatisfaction
with treatment. Completed 6 treatments Completed 6 treatments with treatment.
and answered and answered
questionnaires questionnaires 1 p’t loss to
follow-up due to
Completed 9 treatments Completed 9treatments fall accident.
and answered and answered
questionnaires questionnaires

Analysis GEE statistics


30participants all included whether loss to follow-up or not

Figure 1: Flowchart of the study.

Baihui (GV20, 637 Hz)

Qihai (CV6, 1102


Hz)
Zhongliao (BL33, 667 Hz)

Guanyuan (CV4, 1102 Hz


)

Xialiao (BL34, 667 Hz)

Sanyinjiao (SP6, 702 Hz)

Taixi(KI3,611 Hz)

Figure 2: The seven selected acupuncture points and frequencies applied.


4 Evidence-Based Complementary and Alternative Medicine

Incontinence Impact Questionnaire-Short Form (IIQ-7) and ≤ th


(p 0.001) after the 6 treatment and 3.79 (p 0.001) after
Urogenital Distress Inventory (UDI-6). th
OABSS was developed for assessing symptom im- the 9 treatment (Table 3(a), Figure 3(a)).
provement and treatment efficacy in daily clinical practice ≤
[21]. OABSS comprising four symptom items (daytime 3.2. Changes in QoL of Participants. After the 3rd treatment,
frequency, nighttime frequency, urgency, and urgency in- the UDI-6 score of the experimental group declined slightly
continence), 15 points in total, translated into Chinese and (0.87), showing no significant change compared with that of
validated in Taiwan [22, 23] was selected to be the primary the control group but exhibited a marked decrease from
outcome measurement in this study. Highly sensitive to th th
baseline after 6 and 9 interventions (−1.90; p 0.042 and
treatment-related changes in OAB symptoms, OABSS can − 2.25; p 0.025, respectively) (Table 3(b)). For IIQ-7, the
be an alternative to a bladder diary for symptom and score of the experimental group exhibited a significant
efficacy assessment in daily clinical practice [21]. Both rd th
improvement from baseline after 3 and 6 treatments
UDI-6 and IIQ-7 (Chinese version) which showed − � −
( 4.57; p 0.003 and 3.62; p 0.023, respectively) com-
correlation with daytime urinary frequency and incontinent pared with�that of the control group, but only a slight in-
episodes [24] were employed to evaluate how OAB significant decrease −( 3.42; p 0.073) from baseline after
symptoms impact patients’ quality of life (QoL). the 9th treatment (Table 3(c)). The GEE results are shown in
Figures 3(b) and 3(c).
2.5. Statistical Analysis. Analysis was performed using
SPSS software (IBM Corp. Released 2015. IBM SPSS 3.3. Daytime Urinary Frequency, Urgency, Nocturia, and
Statistics for Windows, Version 23.0. Armonk, NY: IBM Urgency Incontinence. In view of urgency being the core
of p
Corp.). Values OAB symptom, the question “how often do you have a
< 0.05 were considered to be statistically significant. sudden desire to urinate, which is difficult to defer” was
Generalized estimating equation (GEE) was utilized to taken from OABSS to assess specifically severity of
assess improvement ratios on scores of OABSS, UDI-6, urgency. The results showed the experimental group had
and IIQ-7. Independent samples T test, Chi-square test, and marked decrease in urgency of statistical significance after
non- parametric test (Mann-Whitney U test) were −
6th and 9th treatments� − and 1.26; p 0.030,
( 1.88; p 0.001
conducted to analyze baseline characteristics and raw data � with the control group (Table
respec- tively) compared
between the two groups. 4(a), Figure 4(a)). In addition, the symptoms of nocturia
and urgency incontinence also improved significantly after
laser acupuncture treatment (Tables 4(b) and 4(c); Figures
3. Results 4(b) and 4(c)). There is no significant difference in daytime
From early 2019, 40 patients referred from a gynecologist urinary frequency between the two groups (Table 4(d),
were screened and 30 were enrolled as participants. They Figure 4(d)).
were then randomly assigned to receive verum laser acu-
puncture (n � 15) or sham laser acupuncture (n 15). Of 4. Discussion
them, 27 (90%) finished treatment; one patient in the ex-
According to the American Urological Association (AUA)
perimental group dropped out because of schedule conflict
and the Society of Urodynamics, Female Pelvic Medicine
and two patients in the control group discontinued the trial
and Urogenital Reconstruction (SUFU) OAB Guidelines,
due to progressed OAB symptoms and hip fracture in a fall
OAB therapy starts with dietary and behavioral
accident, respectively. The baseline characteristics were
modification and progresses to pharmacotherapy as well as
similar between the two groups (Table 1). A table of raw
data from the three questionnaires showed the trend of score third-line therapies including neuromodulation, PTNS, and
declining in time dependent manner between two groups so on. However, the guidelines highlight that each patient
calculated by nonparametric test (Table 2). should not be required to go through each line of treatment
According to the logic calculus of GEE, data of the in the order specified [8]. In view of the above-mentioned
three subjects who did not complete the trial were still facts, many alternative treatments such as acupuncture,
included in the statistics. The time point subtracted baseline extra- corporeal magnetic stimulation, Erbium: YAG laser
intragroup and the slope between two groups were treat- ment, elastomer roller perineal stimulation and,
calculated using the generalized estimating equation (GEE) moxibustion have been developed and validated [14, 25–
approach for the following<results. p value 0.05 represents 27]. To our knowledge, this is the first clinical trial
the significant difference of the slopes between two assessing the therapeutic effect of laser acupuncture on
groups. patients with OAB.
In this study, patients with moderate to severe
symptoms
> (OABSS 6) and urgency more than once a
question of OABSS week (Q3, 3
rd
3.1. Changes in OAB Symptoms. In primary outcome mea-
surement, the OABSS total score of the experimental group > 2) were enrolled, and the OABSS total
rd scores were 8.7 and 8.5 (p�0.76) in the experimental and
decreased significantly by 3.13 (p≤ 0.001) after the 3 rd th
control group, respectively, prior to treatment. After 3 , 6 ,
treatment compared with that of the control group. The th
difference in score of OABSS from baseline between the and 9 treatments, the OABSS total score decreased sig-
experimental group and control group changed was 4.60 nificantly in the experimental group in comparison with that
Evidence-Based Complementary and Alternative Medicine 5

Table 1: Baseline characteristics of participants.


Characteristics Experimental group (n � 15) Control group (n � 15) P value
a
Age, mean (SD) 56.4 (14.3) 60.9 (10.2) 0.33
Height (SD) 156.9 (4.2) 153 (6.2) 0.06a
Weight (SD) 59.5 (13.9) 60.83 (17.9) 0.90c
BMI (SD) 24.1 (4.6) 25.9 (7.3) 0.49c
b
Diabetes mellitus (%) 2 (13.3) 3 (20) 0.63
HRT, n (%) 1 (6.7) 0 (0) 0.31b
Education, n (%) 0.30b
Junior high school or below 5 (33.3) 5 (33.3)
Senior high school 6 (40.0) 9 (60.0)
College or above 4 (26.7) 1 (6.7)
Menopausal status, n (%) 0.65b
Pre 5 (33.3) 4 (26.7)
Post 10 (66.7) 11 (73.3)
a
Parity, mean (SD, range) 2.4 (1.4, 0–5) 2.3 (1.4, 0–5) 0.90
Child delivery, n (%) 1.0b
Normal spontaneous delivery 11 (73.3) 11 (73.3)
Cesarean section 2 (13.3) 2 (13.3)
b
Gynecology-related surgery (%) 5 (33.3) 8 (53.3) 0.27
b
Type of OAB (%) 0.69
Wet OAB 10 (66.7) 11 (73.3)
Dry OAB 5 (33.3) 4 (26.7)
Urodynamic test, mean (SD)
c
Urethral pressure profile: bladder capacity (ml) 292.3 (129.3) 262.6 (101.4) 0.51
CMG + EMG: Pves-Pabd (CmH2O) 12.3 (28.5) 10.4 (21.2) 0.81c
Primary outcome, mean (SD)
OABSS 8.7 (1.8) 8.5 (1.8) 0.74c
Q1 (daytime frequency) 1.5 (0.5) 1.7 (0.5) 0.22c
c
Q2 (nocturia) 2.3 (0.9) 2.4 (0.9) 0.81
Q3 (urgency) 3.9 (0.9) 3.7 (1.1) 0.78c
c
Q4 (urgency incontinence) 1.1 (1.4) 0.7 (1.2) 0.33
Secondary outcome, mean (SD)
c
UDI-6 6.0 (2.5) 5.7 (2.4) 0.62
IIQ-7 9.9 (5.7) 10.8 (3.9) 0.41c
a b c
Independent samples T test. Chi-square test, Pearson Chi-square, asymptotic significance (2-sided). Nonparametric test (Mann-Whitney U test). SD:
standard deviation. BMI: body mass index. HRT: hormone replacement therapy. CMG: cystometry. EMG: external sphincter electromyogram. Pves:
vesical pressure. Pabd: abdominal pressure. OABSS: overactive bladder symptom score. Q1: 1st question of OABSS, Q2: 2nd question of OABSS, Q3: 3rd
question of OABSS, Q4: 4th question of OABSS. UDI-6: Urogenital Distress Inventory. IIQ-7: Incontinence Impact Questionnaire.

in the control group, indicating that laser acupuncture can


improvement in UDI-6 score in the experimental group
ameliorate moderate to severe OAB symptoms. Further- th th
more, the symptoms of urgency (Q3 of OABSS) and after 6 and 9 interventions (Table 3(b); Figure 3(b)),
nocturia (Q2, 2
nd
question of OABSS) improved which was consistent with the results obtained for Q4 of
rd th th OABSS.
significantly after 3 , 6 , and 9 treatments, with urgency
th Acupuncture has been applied as OAB treatment for
incontinence (Q4, 4 question of OABSS) improving after years. Previous research on OAB in females revealed that
th st
9 treatment, while daytime frequency (Q1, 1 question of acupuncture could even be comparable to anticholinergics
OABSS) showed an insignificant trend of decrease. (tolterodine tartrate) in reducing the frequency of daytime
UDI-6 and IIQ-7 (Chinese version) are secondary urinary, incontinence, and nocturia and increase volume
outcome measurements in this study assessing the impact of voided per micturition [28]. Moreover, other reviews sug-
OAB symptoms on patients’ QoL. The IIQ-7 score gested that acupuncture could reduce the frequency of
rd th
improved significantly from baseline after 3 and 6 urination, incontinence, and nocturia and increase the
treatments in the experimental group compared that in the volume of urination [16, 17]. In view of related adverse
control group, but the difference in improvement after the effects such as pain, hematoma, and granuloma [ 16, 17],
th
9 treatment be- tween the two groups was insignificant noninvasive laser acupuncture treatment may be a better
(Table 3(c); Figure 3(c)). Such results can be attributed to option than needle acupuncture.
related placebo effect in long-term treatment. The UDI-6 Laser acupuncture, a kind of LLLT has been used for
scale focuses on how troubling OAB symptoms are, more than 40 years in treating veterinary or human disease
especially urinary in- continence. The present findings [29]. Being noninvasive and with minimal adverse effects,
revealed significant laser acupuncture has been promoted as a safer pain-free
6 Evidence-Based Complementary and Alternative Medicine

OABSS (mean ± Table 2: Raw data of OABSS, UDI-6, and IIQ-7.


SD)
Outcome Experimental (n) Control (n) p

Baseline 8.7 ± 1.8 (15) 8.5 ± 1.8 (15) 0.74


Visit 1 4.7 ± 2.4 (15) 7.7 ± 1.4 (15) ≤0.001 ∗∗∗
Visit 2 ± 3.4 ± 1.9 (14) 7.8 ± 1.9 (14) ≤0.001∗∗∗
SD)
Visit
Baseline
UDI-6 3
(mean 3.1 ± 2.5
6.0 1.6 (15)
(14) 6.7 ±
5.7 2.8 (15)
2.4 (13) ≤0.001
0.62∗∗∗

Visit 1 3.5 ±
± 1.8 (14) 3.9 ± 2.1 (14) 0.03
Visit 3 ± 2.4 ±1.6 (14) 4.3 ± 2.9 (13) 0.03∗
SD)
Baseline
IIQ-7 (mean 9.9 ± 5.7 (15) 10.8 ± 3.9 (15) 0.41
∗∗∗

Visit 1 4.2 ± ±
≤ 3.2 (14) 9.4 ± 3.9 (14) 0.001
Visit 3 3.0 ±2.5 (14) 8.5 ± 3.7 (13) ≤0.001∗∗∗
Op <
ABSS:
0.05, ov
p<e ractive
0.01, bla
p <d 0.001,
der symptom
calculatedscore. IIQ-7: Incontinence
using nonparametric Impact Questionnaire.
test (Mann–Whitney U test). UDI-6: Urogenital Distress Inventory. SD: standard
∗ ∗ ∗ ∗ ∗∗
deviation.

II Q -7 (c) as secondary outcomes. (N � 30). p < 0.05,


∗ ∗ ∗ dividuals’ skin pigment, thickness, and location on the body
∗ ∗∗
p<
p < 0.001.
0.01,

Table 3: Generalized estimating equation analysis of outcome output, energy dosage, and frequency in a specific situation

measurements. OABSS (a) as primary outcome, UDI-6 (b), and due to heterogeneity among therapeutic theories and in-
[30]. In this study, selected acupoints were assumed to
ß SE P correspond to meridians, and the frequencies thus applied
(a) followed the Reininger Meridian Frequencies. The seven
Group selected acupuncture points (KI3, SP6, CV4, CV6, GV20,
Experimental 0.20 0.753 BL33, and BL34) are commonly used in treating OAB,
Control 0a urinary incontinence, and LUTS according to TCM theory
Group time course (experimental vs.
control) and the therapeutic effects have been demonstrated in many

3rd treatment vs. baseline −3.13 0.87 ≤0.001∗∗∗ modern studies [16, 17]. We took these clinical trial papers
th
69th treatment
treatment vs.
vs. baseline −4.60 0.91
−3.79 1.09 and reviews as reference for selecting acupuncture points.
≤ 0.001 0.001 Due to the characteristics of patient’s posture changeable
(b) ∗∗∗
and short treatment time in laser acupuncture, the seven
Group≤ selected acupuncture points located in different parts of
Experimental 0.33 0.699 body can be stimulated in the same session. The reasons for
Control 0a selecting these acupuncture points concluded in Table 5 and
∗ the results of our clinical trial showed that these acupuncture

th ∗
6
th ∗
treatment vs.course
baseline 1.90 0.93 0.042 9 points applied with Reininger Meridian Frequencies provide
Group time (experimental vs.
treatment vs. baseline −2.25 1.01 0.025

control)
3rd treatment vs. baseline −0.87 0.99 0.382
− time course (experimental vs.
control)
(c)
rd
3 treatment vs. baseline −4.57 1.51 0.003
∗∗
Group
th
9th treatment vs. baseline −3.42 1.91 0.073
Experimental −2.16 0.309 a. Set to zero because this parameter is redundant. ß. Estimate parameter. SE: standard
∗ a
Control 6 0treatment vs. error.
Group

alternative to needle acupuncture. However, the
mechanism, effectiveness, and indication of laser
acupuncture are still unknown [18]. Until now, it remains a
challenge to select appropriate parameters including
wavelength, power

an effective treatment for women with OAB.

To explain the possible mechanism from the neuro-

logical point of view, BL33 and BL34 are, respectively, lo-

rd th
cated in the 3 and 4 sacral foramen at the lumbosacral
region, and sacral spinal nerves S2–S4 together form the
pudendal nerve which innervates external urethral sphinc-
ter. SNS is an invasive therapeutic technique with
electrodes placed in the S3–S4 sacral foramen to produce
long-term electric stimulation of the sacral nerves for
restoring normal voiding habits. The most well-accepted
hypothesized mechanism for such effect is stimulation of
the alpha my- elinated afferent fibers and unmyelinated C
fibers in the S3 and S4 pelvic, pelvic splanchnic nerve
roots, and pudendal nerve roots that affect the micturition
reflex [10, 35]. In our opinion, sacral neuromodulation
theory may explain the possible mechanism of the
stimulation of BL33 and BL34. Moreover, clinically
available neuromodulation therapies for OAB target not
only the sacral nerve roots but also the posterior tibial nerve
and dorsal genital nerve for stimulation



∗ ∗ ∗
∗ ∗
∗ ∗
Evidence-Based Complementary and Alternative Medicine 7

Visit Visit
0 1 2 0 1 2 3
3 0
0 ∗ ∗

–2
–2

Score
–4

Score

–4 ∗
–6
–6
–8
–8 Control
Control Experimental
Experimental
(b)
(a)
Visit
0 1 2 3
0

–2
Score

–4

–6

–8
Control
Experimental

(c)


t r eatments
< 0.01, b p e<tween
0.001.experimental group and control group. Visits 1, 2, and 3 represent 3rd, 6th, and 9th treatments, respectively. p <
∗p ∗ ∗∗ ∗ rd th
Figure 3: Line chart of primary and secondary outcomes. The mean change in OABSS (a), UDI-6 (b), and IIQ-7 (c) scores at 3 , 6 , and
0th05,
9

Table 4: Generalized estimating equation analysis of the four questions of OABSS. U rgency in Q 3 (a), nocturia in Q2 (b), urgency
incontinence in Q4 (c), and daytime urinary frequency in Q1 (d). (N � 30) p ∗< 0.05, p∗ <∗ 0.01, p ∗∗
< 0∗.001.

β SE
(a) p
Group
Experimental −1.974E− 16 1.000
Control 0a
Group ∗ time course (experimental vs. control)
rd
3 treatment vs. baseline −0.80 0.65 0.220
∗∗
6th treatment vs. baseline −1.88 0.57 0.001
th ∗
9
(b)treatment vs. baseline −1.26 0.58 0.030
Group
Experimental −0.27 0.327
Control
Group ∗ time course (experimental vs. control)
rd ∗∗
3
∗∗∗
6treatment
th
treatment vs. baseline
vs. baseline −1.11
−0.87 0.31
0.31 0.001
0.005
9th treatment vs. baseline −1.02 0.29

(c) 0.001
Group
∗∗∗
Experimental 0.47 0.297

Control 0a
Group time course (experimental vs. control)
3rd treatment vs. baseline −0.67 0.47 0.157
8 Evidence-Based Complementary and Alternative Medicine

Table 4: Continued.
β SE p ∗
th
6 treatment vs. baseline −0.93 0.47 0.050
th ∗ ∗
− 9
(d)treatment vs. baseline ∗ 0.98 0.47 0.038
Group
Experimental −0.342 0.053
a
Control 0
Group time course (experimental vs. control)
rd
∗ 3 treatment vs. baseline −1.92 0.20 0.336
6th treatment vs. baseline −2.48 0.20 0.224
th
9 treatment vs. baseline −1.73 0.31 0.580
a
Set to zero because this parameter is redundant. ß. Estimate parameter. SE: standard error.

Visit Visit
0 1 2 0 1 2 3
3 0
0
–2
–2 Score

–4
Score

–4
–6
–6
–8
–8 Control
Control Experimental
Experimental
(b)
(a)
Visit
Visit
0 1 2 3
0 1 2 3 0
2

–2
0
Score

Score

–4

–2
–6

–4
–8
Control
Control
Experimental Experimental
(c) (d)

treatments, respectively. p < < <


Figure 4: Line chart of the four questions of OABSS. The mean change urgency (Q3) (a), nocturia (Q2) (b), urgency incontinence (Q4)
(c), and daytime urinary frequency (Q1) (d) between experimental group and control group. Visits 1, 2, and 3 represent 3rd, 6th,
and 9thPTNS delivers retrograde
[12]. ∗
0.05, ∗∗ stimulation
p 0.01, pto 0.001.
the sacral In addition, several studies used moxibustion on
∗∗∗
complex through electrodes placed near the posterior tibial Conception Vessel meridian 3, 4, or 6 (CV3, CV4, or CV6)
nerve at locations similar to acupuncture points KI3 and to alleviate OAB and other LUTS [14]. The speculative
SP6. However, the mechanism of laser acupuncture may be mechanism of moxibustion on CV meridian involves direct
different from electrical stimulation provided by PTNS. As or indirect regulation of the autonomic nervous system
a consequence, we suppose the mechanism of these two (ANS) [36] but the exact principle behind is still unknown.
acupuncture points may share some common pathways that Whether laser acupuncture achieves therapeutic effect
needle acupuncture, laser acupuncture, and PTNS can through similar neurological mechanism or other theories,
reach. such as Qi or
Evidence-Based Complementary and Alternative Medicine 9

Table 5: The reasons for the acupuncture points selection.

Acupoints (location) The reasons for the acupuncture points selection Possible mechanism Reference
The acupuncture points frequently used in LUTS are BL31 to
BL35. They are located above the sacral foramen lie over the
BL33 and BL34 first to fourth sacral nerve roots, respectively. These
(lumbar sacrum acupuncture points correspond to the segmental innervation Sacral nerve stimulation. [31]
region) of bladder’s parasympathetic nerve. A RCTpublished in
JAMA confirmed the effect of electroacupuncture involving
the
lumbosacral region for women with SUI.
According to TCM theory, OAB and LUTS are due to Zang-Fu
KI3 and SP6 (lower organ imbalance of kidney, spleen, and liver. KI3 (kidney
leg) meridian) and SP6 (spleen meridian) are commonly used to Posterior tibial nerve stimulation. [28, 32]
adjust Yin-Yang balance in OAB and LUTS and have been
included in several studies.
In TCM theory, bladder dysfunction is due to insufficiency of
CV4 and CV6 (lower Yang Qi. Conception Vessel meridian is suggested as a
Autonomic nervous system
abdomen) treatment option as several studies used moxibustion or
regulation.
acupuncture on CV3, CV4, or CV6 to alleviate OAB and [14, 33]
other
LUTS.
GV20, one of the most important acupoints of the government
vessel, is commonly used in neurology and psychiatry.
Stimulation at GV20 will increase cerebral perfusion in the
Increasing the cerebral perfusion in
cerebral cortex, stabilize emotions, and reduce sympathetic
GV20 (head) the cerebral cortex for mood [34]
activity in stress response. Studies have reported stimulating
stabilization.
GV20 can lift fallen Yang Qi in accordance with TCM
theory; therefore, we selected GV20 to calm emotions and lift
patient’s
Yang Qi.
LUTS: lower urinary tract symptoms. RCT: randomized controlled trial. JAMA: The Journal of the American Medical Association. SUI: Stress Urinary
Incontinence. TCM: traditional Chinese medicine.

Parasympathetic n.

S3 BL33
S4 BL34

Sciatic n.

Pudendal n.
Pelvic splanchnic
n.
? Int. sphincter
Post. tibial n.
Ext. sphincter

SP6

CV6
CV4 KI3
Figure 5: Speculative mechanism of laser acupuncture from neurological point of view.
10 Evidence-Based Complementary and Alternative Medicine

meridian theories, remains to be further studied. The Tsia-Shu Lo acquired and analyzed the data. Yu-Wei
speculative mechanism of laser acupuncture is shown in Chang, Tsia-Shu Lo, Hsin-Ning Chang, and Yuan-Chieh
Figure 5. Yeh interpreted the results. Yu-Wei Chang and Yuan-Chieh
Yeh drafted the original article. Yi-Hsien Shiao revised
4.1. Limitations. There are several validated questionnaires statistical analysis for the major revision. All authors
for OAB assessment being developed to evaluate the critically revised the draft and approved the final version
validity and reliability [23, 37]. However, these subjective to be published.
assessment scales lack objective data. In recent years, many
studies have reported that the nerve growth factor (NGF),
Acknowledgments
brain-derived neurotrophic factor (BDNF), C-reactive
protein (CRP), prostaglandins, and cytokines may be used The authors thank all patients for participation in this study
as potential biomarkers of OAB but none of these meets the and Dr. Bing-Yu Chen at the Department of Medical Re-
criteria for becoming an isolated OAB marker [38]. A search and Development, Keelung Chang Gung Memorial
potential bio- marker, such as NGF, may be selected to be Hospital for statistical consultation and data analysis.
one of the secondary outcomes in future research.
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