A total of 94 patients with moderate to severe acne vulgaris treated with systemic isotretinoin and 100 sex- and age-matched controls who were admitted to Ankara Training and Research Hospital, Department of Dermatology, between September 2018 and April 2019 were enrolled in this cross-sectional study. The local ethics committee approved the study. All participants were informed about the study and their written consent form was obtained.
The patients with moderate to severe acne vulgaris who receiving no other treatment modalities, no history of low back pain, ankylosing spondylitis and spondyloarthropathy, and aged over than 18 years were included in the study. Isotretinoin group included the patients under isotretinoin treatment for acne vulgaris, but had no history of rheumatologic syndromes. The control group was selected from among health professionals who had received a routine medical checkup in the hospital.
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Exclusion criteria for this study were the presence of any chronic rheumatological, dermatological diseases or any patients with a history of mechanical back pain, inflammatory back pain, sacroiliitis, enthesitis, before starting isotretinoin, history suggestive of spondyloarthropathies (reactive arthritis, ankylosing spondylitis, inflammatory bowel disease, and psoriasis), or systemic autoimmune disorders. We did not include the patients who had musculoskeletal symptoms such as low back pain before isotretinoin usage in the patient’s anamnesis. Also, the patients with depression or similar psychiatric diseases, had renal and liver function disorders, those who were pregnant or using any systemic drugs for other diseases, were not included.
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All participants were firstly evaluated by a dermatologist and questioned carefully about the musculoskeletal symptoms. Only the patients who had musculoskeletal symptoms such as myalgia, arthralgia, back pain were determined and enrolled in the study. They were referred to the physical medicine and rehabilitation department and examined by a specialist. Sociodemographic information, including age, sex, history of drug use (dose and duration), history of chronic diseases were recorded. A detailed anamnesis was obtained and a careful dermatological and physical examination was performed by both of the specialists. It was queried that whether myalgia, arthralgia and low back pain occurred after starting isotretinoin treatment. Data were recorded on a standardized pre-prepared evaluation form. The pain severity of the participants was evaluated by visual analog scale (VAS) based on a chart numbered from 0 (no symptom) to 10 (maximum severity).
The severity of acne vulgaris was assessed by using Global Acne Grading Scale (GAGS). According to GAGS, the body was divided into six regions -forehead, nose, each cheek, chin and back. In each region, each type of lesion is given a number: zero for no lesion, one for comedones, two for papules, three for pustules and four for nodules. Acne severity based on the GAGS score is considered as mild (1-18), moderate (19-30), severe (31-38) and very severe (≥39).
It was investigated that whether there was a enthesitis by a detailed clinical examination. The presence of enthesitis was assessed with detecting tenderness by pressure to each enthesis until blanching of the examiner’s nail bed [21, 22]. The following entheses were examined for tenderness and swelling bilaterally: common extensor tendon insertion on the lateral epicondyle of the humerus, quadriceps tendon, patellar tendon, tibial tuberosity, knee medial collateral ligament, Achilles tendon, and plantar fascia insertion on the calcaneus [23]. The presence of spontaneous entheseal pain, entheseal pain generated by pressure and/or mobilisation and/or contraction against resistance, or local entheseal swelling was interpreted as clinically enthesitis [24]. If there was a swelling and erythema, it was considered as inflammatory enthesitis. The absence of swelling or erythema was considered to be mechanical enthesitis.
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Inflammatory low back pain was evaluated by Assessment of Spondyloarthritis International Society (ASAS) criteria [25]. The ASAS criteria consist of commencement under the age of 40, insidious onset, relief with exercise, no relief with rest and nocturnal pain (improving with rising up from bed). These 4 items are essential in diagnosing inflammatory low back pain. The various imaging modalities, including conventional radiography, computed tomography (CT), magnetic resonance imaging (MRI) and bone scintigraphy are used for investigation of inflammatory changes at the sacroiliac joints. In early and acute stages of sacroiliitis the diagnosis can be difficult because conventional radiographs may be normal. Inflammatory back pain is not a specific indicator of sacroiliitis. Therefore, there is need for valuable imaging methods. Scintigraphy lacks specificity. CT is a very good method for visualization of established bony destruction or ossification. MRI can identify both inflammation and structural changes, localise different degrees of inflammation and bone marrow edema, and differentiate a possible septic sacroiliitis. MRI is the most sensitive and specific modality for sacroiliitis by directly imaging changes in the synovium, articular cartilage, and subchondral bone [26,27,28]. In our study, the patients meeting ASAS criteria for inflammatory back pain were evaluated in detail and requested both sacroiliac radiography and sacroiliac MRI. Sacroiliac MRI was performed on 1.5 T systems. At least 12 slices of coronal oblique T1-weighted turbo spin-echo and short tau inversion recovery (STIR) sequences of the sacroiliac joints were acquired. The slice thickness was 4 mm. This images were interpreted by the same reader who had received standardized training and were blinded with regard to the study groups. In addition, laboratory blood tests including rheumatoid factor (RF), erythrocyte sedimentation rate (ESR) and c-reactive protein (CRP) values were requested. Anti-nuclear antibody (ANA) was ordered to rule out other connective tissue diseases.
Sample size calculation
G*Power sample size calculation program [29] was used to determine the sample size. The power analysis revealed that this study had 90% power using type I error (α) = 0.05, effect size = 0.5, and a two-sided t test.
Statistical analysis
Data were analyzed using SPSS software version21.0 (IBM Corp., Armonk, NY, USA). The normality of the data was tested by Kolmogorov-Smirnov test. Categorical datawere presented as the number (percent), and continuous data were expressed as the mean ± standard deviation or as the median (interquartile range: IQR) as appropriate. For the comparison of the paired groups, the independent samples t-test (normal distribution) and the Mann-Whitney U test (non-normal distribution) were used for the quantitative data. Chi-squared test was used to evaluate whether there was a difference in terms of musculoskeletal symptoms between the study groups. The relationship between the non-normally distributed variables was analysed with Spearman’s correlation analysis and between the normally distributed variables with the Pearson’s correlation analysis. Linear regression analysis test was used to evaluate the relationships between arthralgia, myalgia, lumbalgia, sacroiliitis and tendinopathy/entesopathy complaints and age, drug dose (isotretionin), duration of use. In all tests, p < 0.05 was considered as statistically significant.
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This post was last modified on Tháng mười một 23, 2024 3:56 chiều