Two-step irradiance schedule versus single-dose tramadol sustained-release tablets for pain control during topical 5-aminolevulinic acid-photodynamic therapy of condyloma acuminatum in Chinese patients: a randomized comparative study.
OBJECTIVE
Photodynamic therapy with 5-aminolevulinic acid (ALA-PDT) offers promising results for the treatment of condyloma acuminatum. However, patients have to dwell with pain to benefit from this otherwise effective and safe "off-label" treatment modality. Several techniques have been explored to control ALA-PDT-induced pain, but the desperate search for a universally accepted method is still ongoing. This study compares the two-step irradiance approach with single-dose administration of 100 mg tramadol sustained-release tablets for pain induced by ALA-PDT of condyloma acuminatum in Chinese patients.


METHODS
Adult Chinese patients with condyloma acuminatum were enrolled in a randomized comparative study. Pain levels were compared using the Numeric Rating Scale (NRS) at pre-defined assessment points during and after irradiation.


RESULTS
The pain was dominated by characteristics such as burning and pricking and was almost always local and superficial.
The median pain scores were lower in the two-step irradiance group at 1 minute (U = 621.5, P = 0.002) but higher at 20 minutes (U = 585.5, P = 0.002). The median pain scores between the two groups did not differ significantly at other assessment points. The pain was moderate in both groups and peaked earlier in the analgesics group (median: 5 minutes) but later in the two-step irradiance group (median: 15 minutes).
The pain was generally mild. The median pain scores were equal at each assessment point, except at 3 hours where the median was lower in the analgesics group (1.0) as compared with the two-step irradiance group (2.0) (U = 725.0, P = 0.056).


CONCLUSIONS
Pain in the two-step irradiance protocol is irradiance-dependent. The two-step irradiance approach produces significant benefits over analgesics during the initial stages of therapy but analgesics offer significant benefits thereafter. There are potential benefits of combining the two approaches in minimizing ALA-PDT-induced pain.
Department of Dermatology, Affiliated Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Department of Internal Medicine, Mbeya Referral Hospital, P.O. Box 419, Mbeya, Tanzania.
Uwesu O
UO
Mchepange
Chun-Yan
CY
Huang
Yi
Y
Sun
Ya-Ting
YT
Tu
Juan
J
Tao
D000328:Adult; D000622:Aminolevulinic Acid / Q000627:therapeutic use*; D000701:Analgesics, Opioid / Q000627:therapeutic use*; D002681:China; D003218:Condylomata Acuminata / Q000188:drug therapy* / Q000208:ethnology; D003692:Delayed-Action Preparations; D004334:Drug Administration Schedule; D005260:Female; D005831:Genital Diseases, Female / Q000188:drug therapy / Q000208:ethnology; D005832:Genital Diseases, Male / Q000188:drug therapy / Q000208:ethnology; D006801:Humans; D054023:Lasers, Semiconductor / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010147:Pain Measurement; D010778:Photochemotherapy / Q000009:adverse effects / Q000379:methods*; D017319:Photosensitizing Agents / Q000627:therapeutic use*; D013607:Tablets; D014147:Tramadol / Q000627:therapeutic use*; D016896:Treatment Outcome
D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D017319:Photosensitizing Agents; D013607:Tablets; D014147:Tramadol; D000622:Aminolevulinic Acid
5-aminolevulinic acid; Chinese; analgesics; condyloma acuminatum; pain; photodynamic therapy; tramadol sustained-release tablets; two-step irradiance