Materials and Methods
The study was approved by our institutions’s Ethics’ Committe (SBU/21.11.2018/B.10.1.TKH.4.34.H.GP.0.01/137). Patients’ written consents were also taken after explanation of the expected effects and possible adverse effects of SJW oil macerate. Pre- and post-treatment pictures were taken for follow-up and educational purposes, and used with permission. In patients with suspected IGM, ultrasound (US) was carried out on all, and mammography (MMG) was obtained from the ones ≥ 40 years. Magnetic resonance (MR) scan was also used for the differential diagnosis in complicated cases. The diagnosis was confirmed by CNB. All abscesses ≥2 cm were drained. In all patients with infectious or inflammatory signs, a broad spectrum empiric antibiotic was employed for at least 10 days. Following the definitive diagnosis of IGM was obtained, all used oral corticosteroid (Prednisolone 16 mg, Mustafa Nevzat Ilac San AS, Istanbul) treatment with the same high-dose as 64 mg/day for the first four weeks, and then the dose was tapered in the following 2 weeks. In persistent or recurrent cases, the same treatment cycle was used one more time, following a 4-week interval. All IGM patients presenting with intractable skin lesions between May 2016 and September 2019 were included.
The study was designed prospectively, but all data were interrogated retrospectively, and all patients who completed a second cycle of treatment and still have a skin lesion were started on SJW treatment. SJW oil massage (two times daily, for two minutes) was prescribed to all with on-going skin lesions such as hyperemia/erythema, scaling, induration, fissure/ulceration. Ready-made SJW olive oil macerates (280 g fresh SJW flowers macerated for 28 days with 500 ml olive oil and exposed to sunlight during extraction), containing pseudohypericin (0.1–3.3 µg/g), flavonoid (0.35-3.5 µg/g), hypericin (0.3–6.6 µg/g) and hyperforin (1–2.4 µg/g) in different trade-marks were used, and patients were free to choose one. All of these patients were recalled for control at two-week intervals and were asked for any possible side-effects. The treatment was stopped when the lesion disappears or at the end of 6 weeks. Patients without follow-up were excluded from the study.
Severity of erythema, scaling, induration and fissure/ulcer were evaluated and graded as previously cited (Table 1).8The definitions of the lesions are as following:
At the end of the treatment, a mini-questionnaire form including 3 simple questions was filled in for each patient. The questions were:
Statistical analysis was performed using SPSS Statistics 20 software. Continuous variables were compared using t-test. Categorical variables were compared using Fisher’s exact test. P< 0.05 was considered statistically significant.