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:
- Erythema: Redness of the skin or mucous membranes, caused by hyperemia
(increased blood flow) in superficial capillaries.
- Scaling (desquamation): Loss of the outer layer of the epidermis. The
skin appears dry and cracked.
- Induration: Hardening of an area of the body as a reaction to
inflammation, hyperemia or neoplastic infiltration.
- Fissure/ulcer: A linear-like cleavage or sore of skin, extending into
the dermis.
At the end of the treatment, a mini-questionnaire form including 3
simple questions was filled in for each patient. The questions were:
- Did you apply the SJW oil on your skin lesion two times daily for two
minutes with gentle massage, and continue the treatment for 6 weeks?
Please answer as yes or no.
- Did you experience any side effects such as itching, burning or
prickling, increase in hyperemia, deepining of fissures etc.? Please
answer as yes or no, if yes, please specify
- Are you satisfied with the treatment? Please answer as yes or no, if
no, please specify
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.