ARTICLE
Auteur(s) : Hasan Mete Aksoy1, Berna Aksoy2, Didem
Egemen3
1Private Konak Hospital, Plastic
and Reconstructive Surgery Clinic, Yenisehir mah. Donmez sok.
No: 53 Izmit/Kocaeli, Turkey
2Private Konak Hospital, Dermatology Clinic, Yenisehir
mah. Donmez sok. No: 53 Izmit/Kocaeli, Turkey
3Middle East Technical University, Department
of Statistics, Ankara, Turkey
accepté le 8 Mars 2010
Sacrococcygeal pilonidal sinus disease (SPSD) is a common and
well recognized disorder which was first described in 1833 and
named in 1880 [1]. This disorder has been thought to be congenital
or acquired in origin by different authors [1]. The acquired origin
for SPSD proposed by Karydakis and Bascom is more commonly accepted
[1, 2]. SPSD causes considerable loss of productivity and is
associated with a necessity for hospital stay, especially in men
who are of productive age (15 to 60 years of age) [1].
Although surgery is the principal method of treatment for SPSD,
success of the surgical methods used for the treatment of SPSD is
limited as far as morbidity, healing time and recurrence rates are
concerned [1, 2]. Many surgical methods have been proposed but
optimal treatment method for SPSD has not yet been determined by
clear consensus in the literature [2, 3]. The ideal treatment
method should be simple and decrease patient discomfort, loss of
workdays, hospital stay and morbidity [2, 4]. Ideal treatment
methods should have a low risk of complications and be associated
with a low risk of recurrence [1, 2, 4]. None of the current
surgical methods seems to be ideal [1, 4]. So, efforts to
develop less harmful but more effective treatment methods
continue.
Non-operative treatments for SPSD include phenolization of the
sinuses or depilation of buttocks by shaving, laser or creams
[1, 2, 4]. Both methods are closer to an ideal treatment for SPSD
as they are simple and cost-effective outpatient applications with
minimal patient discomfort and disability [4]. However,
phenolization needs an experienced physician and maximum care is
necessary to prevent development of complications during its
application [4].
Humic substances (natural polyphenols) are natural liquid
biopolymers and are by-products of soil organic matter degradation,
present in our environment [5]. Humic substances have been used
worldwide in balneotherapy for a long time [5]. There are various
studies disclosing the biological effects of polyphenols in human
health [5, 6]. Polyphenols are used frequently in the prevention of
heart disease and cancer as they have antioxidant effects against
reactive oxygen species [6]. However, to the best of our knowledge,
the effects of natural polyphenols have not been described in the
treatment of SPSD in the literature. In this study, the aim was to
evaluate the effectiveness of polyphenols produced from humic
substances in the treatment of SPSD.
Patients and methods
This study was performed between November, 8 and December, 21,
2009 following approval by institutional ethics committee. Patients
with SPSD who used Pilonol Set (Koz-Lab Cosmetic and Natural
Products Laboratory, Turkey) were studied retrospectively.
Patients’ files were obtained from the product's production
laboratory. Of the available 279 patient files only the ones
who started treatment in the time period from July 2006 to August
2009 were included in this study. So we tried to reach
258 patients by phone calls. We managed to reach
198 patients and had telephone conversations with them. Six
patients were excluded from the study because 3 of them had
hydradenitis suppurativa and another 3 had anal fistulas.
Clinical and demographic characteristics (figure 1) were all
gathered from patient files or learned from telephone interviews.
The patients were asked about present symptom severity,
satisfaction and severity of drug side effects and they were
required to assess them on a scale from 0 for none to
10 for maximum. Follow up periods were calculated by using
information present in the patient files.
Methods for the use of Polyphenol Set
in SPSD
Sodium humate 25% was used as the source of polyphenol. There were
three natural polyphenol product forms used in the treatment of
pilonidal sinus disease in this method. The problematic skin region
was depilated before starting treatment. When a razor was used, it
was used once. The major form “Pilonol L25®” was used
before going to bed. A teaspoon full of Pilonol
L25® was poured onto the problematic region and the area
was massaged for two to three minutes. Later the area was covered
with gauze and the gauze was left in place until the morning. In
the morning the medication was washed out by “Pilonol
gel®”. Afterwards “Pilonol cream®” was
applied and covered by a gauze. The treatment continued daily like
this. After the treatment session was completed, all of the
patients were advised to obey general personal hygiene rules, to
have baths frequently and to keep the sacrococcygeal region
depilated for at least one year.
Statistical analyses
The ratings for present symptom severity, satisfaction and severity
of drug side effects were grouped as less than 5 and equal to
or higher than 5 for statistical analyses. Disease duration,
time past since last operation, follow up period and time passed
until relapse were expressed as months and duration of total and
regular drug usage were expressed as weeks. Patients’ body mass
indexes (BMI) were calculated by the help of patients’ weight and
height and grouped as low when index was less than 18.5, normal
when it was between 18.5 and 24.9, overweight when it was between
25 and 29.9, obese when it was between 30 and 39.9, and
morbidly obese when it was equal to or above 40.0. The effects of
demographic and clinical parameters and characteristics of
treatment on benefit ratings were detected by using PLUM Ordinal
Regression analysis and their effects on satisfaction and presence
of relapse were detected by using Binary Logistic Regression
analysis. The level of significance was determined to be 0.05.
R. Square detected by Nagelkerke-method (the coefficient of
determination) was used as a measure of the strength of
the model fit. The expected ordered log odds were also
calculated. The primary end points were to find out the
effectiveness of the polyphenols in SPSD, patients’ satisfaction
after the treatment, and rate of recurrence. The secondary end
point was to find out the clinical and treatment characteristics
significantly affecting the primary end points. All statistical
analyses were performed by using SPSS version 13.0 for Windows.
Results
Characteristics of patients are shown in table 1. Thirty-seven (19.3%) patients were
students and 143 (74.5%) patients had jobs that necessitated
sitting for more than 50% of their working time. Forty-eight
(25.0%) patients had some type of previous operation history. One
hundred and eighty one (94.3%) patients had no comorbidities.
Eighty (41.7%) patients did not have hyperhidrosis in the nearby
regions and 111 (57.8%) patients did not wear tight fitting
clothes. Ninety nine (51.6%) patients gave a history of sitting for
long periods of time and 83 (43.2%) patients smoked regularly.
While median time duration for total daily treatment was
12 weeks (2-52 weeks), 161 (83.9%) patients used the treatment
regularly for a median duration of 8.5 weeks (0-52 weeks). Mean
follow up period after starting treatment was 21.8 ± 9.80 months
(4-40 months).
One hundred and five (54.7%) patients rated their present
symptoms to be zero and sixty three (32.8%) patients rated their
satisfaction to be ten. Altogether 154 (80.2%) patients rated their
satisfaction to be equal to or greater than five. While 26 (13.5%)
patients did not get any benefit from the treatment, 166 (86.5%)
patients got benefit [58 (30.2%) patients – partial benefit] from
the treatment as they stated that most or all of their sinus
openings were closed and drainage stopped. Fifty one (26.6%)
patients had some type of temporary side effects with changing
severity ratings from one to ten. The most common side effects were
irritation and erythema (n:25, 49%), burning sensation (n:20,
39.2%) and mild pain (n:12, 23.5%). The other infrequent side
effects were itching, development of ulceration, skin peeling,
maceration and development of hyperpigmentation. In 64 (33.3%)
patients a relapse occurred following topical polyphenol treatment
after a median time period of 4 months (1-24 months). Thirty
four (53.1%) patients who experienced a relapse after the first
treatment session used polyphenols again for the subsequent
relapses with similar effectiveness. Patients were able to continue
their normal routine life during the whole treatment period without
loss of work days.
Benefit from the treatment was affected by the presence and
number of previous operations, duration of follow up from the
beginning of the treatment, severity of present symptoms and side
effects (table 2). Satisfaction
from the treatment was affected by the presence of smoking habit,
present symptom severity, burning as a side effect and any relapse
following treatment of 1st relapse (table 2). Having a relapse after treatment
was negatively affected by the present symptom severity and
presence of any relapse following treatment of the 1st relapse
(table 2). The other non-mentioned
parameters about patient and treatment characteristics did not
significantly affect these three end points, namely, benefit,
satisfaction and recurrence (data not shown).
While one pack of drug was generally enough for a three month
treatment period, the amount of drug needed could change with the
number of sinus openings and size of the area of involved
skin. So it could be concluded that generally one pack of drug was
enough for most of the patients and it cost approximately
230 USD or £150.
Table 1 Demographic and clinical characteristics
of the patients
|
N (%)
|
Mean (SD)/ Median (Min-Max)
|
|
Age
|
192 (100)
|
30.1 (8.89) (14-63)
|
|
Gender
|
|
|
|
Male
|
176 (91.7)
|
|
|
Female
|
16 (8.3)
|
|
|
BMI
|
192 (100)
|
26.7 (3.61) (19.0-42.4)
|
|
Normal
|
65 (33.8)
|
|
|
Overweight
|
94 (49.0)
|
|
|
Obese and morbid obese
|
33 (17.2)
|
|
|
Job
|
|
|
|
Sedentary
|
143 (74.5)
|
|
|
Ambulatory
|
49 (25.5)
|
|
|
N of sinus openings
|
192 (100)
|
2 (1-7)
|
|
Disease duration (months)
|
192 (100)
|
24 (1-480)
|
|
N of Previous operations
|
48 (25.0)
|
1 (1-5)
|
|
Time passed since the last operation (months)
|
48 (25.0)
|
24 (1-180)
|
Table 2 Determinants of benefit, satisfaction and
relapse
|
R2
|
Log odds
|
P
|
|
Benefit
|
|
|
|
|
Presence of previous operations
|
0.029
|
–0.744
|
0.033
|
|
Number of previous operations
|
0.139
|
–0.787
|
0.015
|
|
Duration of follow up
|
0.039
|
0.036
|
0.013
|
|
Severity of present symptoms
|
0.142
|
1.577
|
0.000
|
|
Severity of side effects
|
0.034
|
0.939
|
0.016
|
|
Satisfaction
|
|
|
|
|
Smoking
|
0.042
|
–1.273
|
0.035
|
|
Severity of present symptoms
|
0.092
|
1.314
|
0.001
|
|
Side effect - burning
|
0.149
|
–1.738
|
0.037
|
|
Presence of relapse after treatment of 1st relapse
|
0.174
|
–1.678
|
0.012
|
|
Relapse
|
|
|
|
|
Severity of present symptoms
|
0.160
|
–1.685
|
0.000
|
|
Presence of relapse after treatment of 1st relapse
|
0.259
|
–2.159
|
0.003
|
Discussion
Interpretation of study findings
Most of our patient population was comprised of overweight and
obese males with sedentary jobs and this finding was in accordance
with a previous study [7]. In this study patients used polyphenols
topically over the diseased skin and they applied the drug with
massage. Most of (86.5%) our patients got benefit from local
polyphenol treatment. Only one patient out of four experienced some
type of side effect and one patient out of three experienced a
recurrence. Only 13.5% of all patients did not get any benefit from
this method. We propose that these ratios are acceptable and
not worse than results of some types of surgical treatment
methods [1-3]. The interesting point is that one out of every two
patients with recurrent disease continued to use polyphenols for
their subsequent relapses with similar effectiveness. To the best
of our knowledge this is the first report on the effectiveness of
topical humic polyphenols in the treatment of SPSD in the
literature. The major disadvantage of the topical polyphenol
treatment is the need for regular topical applications which may be
boring and unbearable for some patients. So some of our patients
found it difficult to continue topical polyphenol treatment until
the time when healing was complete. Instead of topical use, in
selected cases polyphenols can be applied intralesionally to speed
up healing and to deal with the problem of patient non-compliance.
Additionally, polyphenols can be used with the same method as the
method used for phenolization to treat 13.5% of patients who are
refractory to topical use of polyphenols.
One in four treated patients experienced some type of local
temporary side effects like irritation, erythema, burning and
aching sensation. These side effects were generally caused by the
use of more of the drug than necessary. There is no clear consensus
on long term side effects of natural polyphenols when they are
applied topically [8].
The cost for SPSD surgical treatment was reported to be £670 for
day-care patients and £2400 for in-patients [9]. In contast, this
new polyphenol treatment method for SPSD cost most of our patients
(58.3%) approximately £150. As the treatment duration increased the
treatment cost increased proportionally for every
12 weeks.
Proposed mechanisms of action of natural polyphenols
in SPSD treatment
Polyphenols have been shown to be absorbed percutaneously when they
were applied topically over the skin [10]. We can consider SPSD as
an open wound. If we replace the deficient factor in wound healing,
an open wound could heal normally. Most probably, natural
polyphenols eradicate SPSD by two mechanisms:
- 1) Polyphenols remove the microorganisms located in the
wound bed. Polyphenols cover and fill SPSD related cavities. In
this way polyphenols prevent atmospheric oxygen from reaching the
microorganisms. Polyphenols also prevent the microorganisms from
using oxygen present in blood and neighboring tissues. They produce
these effects by their potent antioxidant actions (buffering
effect) [5]. Polyphenols increase the chemotaxis of phagocytes to
the diseased area [11]. Additionally they enhance the capacity of
granulocytes to engulf bacteria [11, 12]. Polyphenols also increase
the activities of lysosomal enzymes which are transferred into the
phagolysosomes and lyse bacteria [12].
- 2) Promotion of wound healing is also achieved by the
effects of polyphenols [8]. Polyphenols promote cytokine,
interferon and tumor necrosis factor alpha (TNF-α) synthesis for
faster healing [13, 14]. In other words, polyphenols exert
anti-inflammatory actions and cause the wound healing process to
proceed better [5]. Thus healthy fibrin formation and collagen
synthesis result in better wound healing and consequently in better
healing of SPSD. So, the SPSD wound heals with the help of
polyphenols in the same way as they heal erosive cervicitis
[15].
Polyphenols versus surgery in the treatment
of SPSD
For acute abscesses, the preferred form of treatment is drainage
with or without curettage [1, 2]. After incision and drainage the
overall cure rate of up to 75% and recurrence rates of up to 25%
are expected [1, 2]. Various treatment methods have been reported
to be effective in chronic and recurrent SPSD with varying degrees
of effectiveness and recurrence rates. Meticulous and regular hair
control with shaving combined with intermittent granulation tissue
scraping and laser epilation of natal cleft have been reported to
speed up healing and to be useful in controlling recurrences [1, 2,
16].
Surgical methods used for the treatment of SPSD could be
summarized as limited or wide excision with or without (healing by
secondary intention) primary closure or closure with flap
techniques [1, 3]. Lord-Millar procedure is a simple excision
procedure in which healing occurs by secondary intention [3]. This
procedure is associated with a mean healing period of 39 to
43 days and with recurrence rates of up to 39% in treated
patients [3]. When incision and curettage procedure is combined
with suturing, the healing time shortens to a median of
14 days instead of 35 days, with approximately 18% chance
of recurrence [3]. Fistulotomy and curetting the base of the tracts
have varying recurrence rates of up to 19% with a prolonged healing
time and meticulous wound care is required [3]. Marsupialization
has a mean healing time period of 20 to 35 days and is
associated with recurrence rates of up to 6% [2, 3]. Simple
excision could be performed by using radiofrequency without any
change in recurrence rates [17]. Excision and primary closure have
the advantages of a shorter hospital stay, shorter healing time,
earlier return to work and lower frequency of infectious
complications compared to simple excision and letting the wound
heal secondarily [3, 18]. But this procedure is associated with an
increased risk of recurrence (up to 25%) [3, 18]. The lowest
recurrence rate of up to 4.4% is obtained by the Karydakis method
of off-midline closure [3, 18]. Fibrin glue can be applied to
surgical wounds in excision and primary closure patients to promote
healing and obliterate dead space [3]. This method was reported to
be associated with lower recurrence rates [3]. Flap repair
procedures can be performed by rhomboid flaps (Limberg flaps),
V-Y advancement flaps, Z-plasty and Gluteus maximus myocutaneous
flaps and these procedures generally have better outcomes and are
associated with no or lower recurrence rates (up to 9.5%) [3,
19].
In addition to the higher cost of surgical treatment, the
healing period following surgical therapies is distressing and
painful to patients with the need for a long bed rest period.
Patients have difficulties in sitting and walking for a long period
of time. So there is much more loss of work after surgery than
previously thought. There are also the psychological effects of
undergoing an operation and having an anatomical change. Topical
treatment with natural polyphenols has comparable success rates and
the relapse ratio of this method is comparable to some forms of
surgical treatment. The advantages of topical polyphenol treatment
over surgical therapies for SPSD are its cheapness, similar results
in terms of success, the absence of a need to stay in a hospital
and the absence of loss of work days. Another major advantage is
that the anatomy of the patient is not distorted in the natal cleft
region. There is a risk of recurrence after all the described
methods of treatment of SPSD, resulting in psychological distress
for the patient. Topical polyphenols are comparable to some
surgical methods in terms of recurrence rates with a major
difference; patients use the same topical treatment by themselves
for each relapse with similar effectiveness.
Polyphenols versus phenol treatment in SPSD
Intralesional phenol injections could be given after curettage of
the sinus tracts with similar results to surgery but with shorter
hospital stays and an earlier return to work [1, 4]. The results
after phenol injection were promising with success rates of 60% to
100% [3, 4]. However, it has some disadvantages, like a need for
multiple applications (with 1 to 6 week intervals), a
long healing time and the need for maximum care during its
application [3, 4].
Topical polyphenols, however, do not share the risks of phenol
injection but they have similar success rates and patient
satisfaction ratios. Similarly, topical polyphenols are a cheap,
effective and easy treatment for SPSD with no need for a hospital
stay and no loss of work days.
Limitations
The major limitation of this study was the fact that this was a
retrospective study performed via telephone survey by a physician.
The results are based solely on survey answers of patients but not
on physical examination. Based on these preliminary retrospective
results, more comprehensively planned, prospective, randomized
controlled studies are needed.
Conclusion
Natural polyphenols are one step closer to the ideal treatment of
SPSD. They are easy to apply, safe, have a low risk of
complications and are cheaper than surgical treatment methods.
Their use is not associated with work loss, the need for
hospitalization or anatomical distortion of the natal cleft area.
This form of treatment does not have the risks of other treatment
methods. Based on the findings of this retrospective study, natural
polyphenols may be the first line treatment of choice for the
treatment of SPSD. When natural polyphenols fail, as observed in
one out of three patients treated in this study, other therapeutic
methods like surgery or phenolization could be used as a second
line treatment choice for SPSD treatment as they are invasive,
expensive, uncomfortable to the patients, and cause longer healing
times and loss of work days. There is a need to explore the long
term effects of the topical use of natural polyphenols in the
treatment of SPSD in well planned prospective studies.
Acknowledgements
The authors thank Koz-Lab Cosmetic and Natural Products Laboratory
for providing patients’ files and their support during conduction
of this study. The authors also thank Mümin Dizman for his valuable
effort in the development of the polyphenol product and preparation
of parts of the draft; and Faruk Demirhan, Zafer Kurumlu, Nihat
Bengisu, Seyhan Yalaz and Okan Yeşilli for their contributions in
patient follow up. Financial support: This study was supported by
Koz-Lab Cosmetic and Natural Products Laboratory. Conflict of
interest: none.
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