CONTRIBUTION OF PHOTOTHERAPY TO THE TREATMENT OF EPISIOTOMIES 1 CONTRIBUTION OF PHOTOTHERAPY TO THE TREATMENT OF EPISIOTOMIES Jaroslava Kymplová, M.D., 1,2Leoš Navrátil*, Assoc. Prof., M.D., Ph.D., 3Jiří Knížek, Dipl. Ing., Ph.D. 1,2 1 University of South Bohemia, Faculty of Social and Health Studies, Sect.. of Radiobiology and Toxicology of Dept. of Radiology, Ceske Budejovice, Czech Republic 2 Department of Clinical Radiobiology, Institute of Biophysics, First Medical Faculty, Charles University, Praha 2, Czech Republic 3 Czech Academy of Sciences ITIA, Prague, Czech Republic email: Leos Navratil*, Assoc. Prof., M.D., Ph.D. leos.navratil@volny.cz; *Correspondence to Leoš Navrátil, Laser Centrum THERAP-TILIA, Seydlerova 2451, CZ 155 00 Praha 5, Czech Republic Keywords episiotomy, therapeutic laser, polarized light Abstract BACKGROUND AND OBJECTIVE The purpose of the present study was an objective consideration of possible benefits of phototherapy implemented with therapeutic laser or possibly polarized light in treating the episiotomy, which is the most frequent obstetric intervention. STUDY DESIGN/MATERIALS AND METHODS In the present study, the authors treated total of 2436 women. The light sources were as follows: a laser of a wave length 670 nm, power 20 mW, with continuous alternations of frequencies 10 Hz, 25 Hz and 50 Hz, a polarized light source of a wave length in an interval of 400 to 2000 nm, power 20 mW and frequency 100 Hz and a monochromatic light source of a wave length 660 nm and power 40 mW, with simultaneous application of a magnetic field at an induction 8 mT. RESULTS CONTRIBUTION OF PHOTOTHERAPY TO THE TREATMENT OF EPISIOTOMIES 2 The work demonstrated high healing effects with minimum secondary complications in the treatment of episiotomies with therapeutic laser at an energy density of 2 J/cm2. The application of polarized light at an energy density of 5 J/cm2 also exerted favorable therapeutic effects. CONCLUSIONS This study has been financially supported by the Ministry of Education, grant No.: FJ MSM 111100005 (New technologies and approaches in diagnostic, prevention and treatment). Renaissance of the use of light energy in the therapy is currently encountered (1, 2). This is a good direction of development with respect to negligible negative adverse effects (3). Generally accepted therapeutic protocols are, however, missing. Each institution working with light radiation sources has probably its own, in many cases adopted from other institutions, approaches, which are not adequately verified. Even as sensitive discipline as obstetrics and gynecology presents no exception from this rule. Since 1990, our institutions try to bring their knowledge and experiences to eliminate these drawbacks (4). Thus, our attention is also paid to problems of studying biological effects of the light radiation on living tissues. We tried to bring a contribution to this topics by the analysis of the non-invasive laser analgesic effect mechanisms (5). The purpose of our study was an objective consideration of possible benefit of phototherapy in the treatment of episiotomies, which are the most frequent interventions in obstetrics (in as much as 90% of deliveries). This is a prophylactic intervention, which is supposed to protect the perineum from its rupture. The episiotomy is implemented during the top contraction, at the end of the second period of the delivery, in the course of the head presentation, particularly in primiparae, where the perineum prevents further continuation of the delivery and, in addition, there is a danger of the rupture. After the termination of the delivery, the episiotomy is sutured layer by layer under local anesthesia with the use of catgut. CONTRIBUTION OF PHOTOTHERAPY TO THE TREATMENT OF EPISIOTOMIES 3 The episiotomy is suitable for studying healing, since this is a short wound (of about 3 to 5 cm) exposed to adverse conditions due to a possibility of easy infection, bruising and frequently occurring hematomas. Methods Light sources THERAPEUTIC LASER ML - MEDICA Therapeutic laser for non-invasive laser therapy was made by the company EL-Medica Kladno, Czech Republic. This is a semiconductor laser, which can operate in continuous as well as pulsed regimes. Laser medium: laser diode GaA/As, infrared, 670 nm power 20 mW Pulse modulation: 0 to 10 000 Hz Method of application: replaceable probe for point application Presettable time of application: 6 s to 600 s Beam spread: 15° BIOPTRON BIOPTRON, a product of the company Bioptron AG, Möchaldorf, Switzerland, is a compact appliance having a halogen lamp as a light source. The light passes through a polarizer utilizing Brewster mirrors. At the point of output, there is a filter for the elimination of wave lengths shorter than 400 nm. The instrument operates in a continuous regime and it is equipped with acoustic signalization. Basic technical parameters of the appliance: CONTRIBUTION OF PHOTOTHERAPY TO THE TREATMENT OF EPISIOTOMIES 4 Light wave length: 400 to 2000 nm Mean value of light power output during the halogen lamp emission: 20 W Power density: 40 mW/cm2 Energy density: 2.4 J/cm2 FOTOMAGNETIK The photomagnetic healing stimulator is an appliance produced and delivered by the company AMBICO s.r.o., Rožnov pod Radhoštěm, Czech Republic. Its combined irradiation head consists of a light source and magnetic applicator. The light source of the irradiation head is equipped with a group of light emitting diodes (LEDs) circularly arranged about the magnetic applicator (central prominence of the irradiation head). The light source of a luminance of 70 cd at a distance of 1 cm from the head edge illuminates an area of 4 to 5 cm in diameter. The instrument can provide two regimes as follows: pulsed operation with alternating the activity of the light and magnetic sources, the pulse length is of 1 s, the magnetic applicator being active for 60% of the pulse period, the light source for the remaining portion of time. The two sources never operate simultaneously; continuous operation of the light source. Principal technical parameters of the appliance: Light wave length: 660 nm Mean value of light power: 40 mW Power density: 2.9 mW/cm2 Modulation frequency: 100 Hz Luminance: 70 cd Magnetic induction: 8 mT Magnetic field modulation: 100 Hz Pulsed regime frequency: 1 Hz CONTRIBUTION OF PHOTOTHERAPY TO THE TREATMENT OF EPISIOTOMIES 5 Groups followed Women, which were followed within the study, were divided into four groups (for age characteristics of all the groups followed see Table 1). Group A In 748 women, therapeutic laser was applied once a day at an energy density of 2 J/cm2 with continuous alternation of frequencies of 10 Hz, 25 Hz and 50 Hz. The treatment was started on the day of the delivery or on the next day and it continued for the whole hospitalization period of the woman after the delivery. The average number of application events was of 3.99. Group B Group B included 581 women. The episiotomy treatment was implemented with the help of the BIOPTRON lamp in the light source continuous regime. It was started as soon as possible after the delivery and it continued for the whole hospitalization period (typically for 4 to 6 days). The total energy density in the course of¨one application was of 5 J/cm2, the average number of application events was of 4.37. Group C This group included 715 women. The phototherapy was applied once a day under conditions of the same regime as in group A. In the PHOTOMAGNETIC appliance, a combined regime was employed (for details see the technical description of the instrument). In one application, the operation wound was exposed to a total light energy density of 0.7 J/cm2. The period of the pulsed magnetic field application was of 3 min, the average number of applications was of 4.83. Group K CONTRIBUTION OF PHOTOTHERAPY TO THE TREATMENT OF EPISIOTOMIES 6 In the control group, there were 592 women, in which the episiotomy was implemented in the course of the delivery and neither pharmacological nor physical methods were employed in their treatment. Statistical methods The statistical evaluation of the age of patients in particular groups was carried out with the help of the two-sided t-test of the difference between relevant polynomial regression functions for dense networks (1 000 points) of an independent variable, i.e. age of the persons examined. For testing the difference between the polynomial regression functions as whole, mean integral probabilities (of agreement) were always used throughout the interval of the independent variable, i.e. age of the persons examined. Treated groups A, B and C were evaluated against control group K. The statistical evaluation of the results obtained was carried out by the Fisher (factorial) test (extended by data from binomial distributions) of equality of parameters 1 and 2 of two binomial distributions against the alternative of their difference 12. Treated groups A, B and C were evaluated against the control group K. Results The percent abundance of the number of application events in particular groups followed is summarized in Table 3, results of the statistical evaluation of the groups carried out by the Fischer test in Table 4. In the statistical evaluation of the age average of the groups studied, in none of the mutually considered pairs of tabulated dependences, it was possible to conclude that the groups exerted statistically significant differences, since the relevant mean integral probability was always higher than 0.1. A statistically significant difference was found only in certain (relatively narrow) age intervals. CONTRIBUTION OF PHOTOTHERAPY TO THE TREATMENT OF EPISIOTOMIES 7 The result shows a statistically significant higher abundance of complications in controls. Discussion Laser treatment and the whole discipline named phototherapy was considerably developed and found wide applications during the last years almost in all the clinical medical but also veterinary disciplines. Its definite advantage is a minimum abundance of clearly defined undesirable side effects and low number of contraindications (6, 7, 8). As mentioned above, phototherapy may be employed in the most different indications in obstetrics and gynecology. In the gravidity, we avoid the direct exposure of the abdomen and the intravaginal application with therapeutic laser due to a possible damage to the fetus. It is to emphasize that in special literature, no work has been yet published, which would demonstrate teratogenic effects. This contraindication, however, does not hold for polarized light. Works are of interest, where the effect of non-invasive laser therapy on certain pathological conditions in the gravidity was investigated. The therapeutic laser was used in the complex treatment of threatening abortion due to a hypofunction of the ovaria (7). A beneficial effect of laser acupuncture on the condition of the fetus and general improvement of problems of gravid women with late toxicosis was described, where a reduction of the blood pressure, increase of the diuresis and reduction of the proteinuria were observed (3). During the delivery, endonasal irradiation of pregnant women with assumed high degree of risk of a weak uterus activity was employed. The method has no side effects, maturation of the cervix score (neck index) was observed with reducing the length of the delivery time by 2 to 3 hours, no hypertonus was observed, no hasty deliveries were encountered. Repeated cardiotocographic examination showed no pathological reactions in the fetus. No bleeding was encountered in the puerperium, the lactation remained unaltered (9, 10). In the present study, we compared three procedures (polarized light, polarized light complemented by pulsed magnetic field and therapeutic laser) in the treatment of episiotomies (11) where, due to complicated healing, a keloid scar or contracture on the perineum can be formed (12, 13, 14). These two complications can be not only unpleasant in the sexual life of the women, however, they can also result in problems during the next delivery. The CONTRIBUTION OF PHOTOTHERAPY TO THE TREATMENT OF EPISIOTOMIES 8 importance of the phototherapy is also given by the subjective feeling of the patient, where multiparae reported that, in comparison with former deliveries, they can sit more comfortably, their walking is improved and the perineum is not painful. Phototherapy with any of the sources used reduced the occurrence of complications in healing the episiotomies at a highly significant level (p<0.01). There was a considerable reduction of complications in healing the scar. Absolutely best results were achieved after the use of the therapeutic laser, when a slight complication in the course of healing (reddening in the upper pole) was observed only in two cases. When considering groups treated with polarized light (15) or possibly with a combination of monochromatic light complemented by pulsed magnetotherapy, we observed no statistically significant differences between these groups. In the group treated with polarized light, we observed 3 complications (a coated suture and partial separation in the upper pole), in the group treated with monochromatic light, 8 complications (in 3 cases complete decay, in further 3 cases a partial skin dehiscence, in the remaining cases coated suture without the dehiscence). We consider these complications to be due to a lower energy density, which resulted in insufficient anti-inflammatory action. The complications in women after the delivery, which were not treated with any form of the phototherapy (control groups), were essentially more severe (complete decay with resuture, subcutaneous and cutaneous dehiscence with purulent secretion), and they started to occur most frequently of the fourth day after the delivery. The treatment typically consists of the local pharmacotherapy and taking bath. The result of these procedures is usually a keloid scar, which is of course unpleasant for the woman and which must sometimes be solved by a plastic surgery intervention. Conclusion The results of the present study demonstrated a contribution of the phototherapy to the treatment of the episiotomies. The authors achieved the best results after the application of therapeutic laser. This therapy may be complemented by applying polarized light. It is advantages that the woman after the delivery can implemented it herself at home, which is CONTRIBUTION OF PHOTOTHERAPY TO THE TREATMENT OF EPISIOTOMIES 9 impossible in the case of laser with respect to relevant safety regulations. Pulsed magnetotherapy brings no benefit in the indication chosen. References 1. Baxter, G. D., Diamantopoulos, C., Kane, S., Shields, T. D.: Therapeutic Lasers. Theory and Practice. Edinburgh, London, Churchil Livingstone, 1994, 259 pp. 2. Kolářová, H., Ditrichová, D.: Laser radiation in medicine (in Czech). UP Publishing House, ISBN 80-7067-608-6, Olomouc 1996, 15-25. 3. Pöntinen, P. J., Pothmann, R.: Laser in der Akupunktur, Stuttgart. Hippokrates Verlag, 1993, 191 pp. 4. Navrátil, L., Dylevský, I.: Mechanisms of biostimulating effects of therapeutic laser in vivo. Sborn. lék. 1996, 97: 521-527. 5. Navrátil, L., Dylevský, I.: Mechanisms of the analgesic effect of therapeutic lasers in vivo. Laser Therapy 1997, 9: 33-40. 6. Kert, J., Rose, L.: Clinical laser therapy. Low level laser therapy. Scandinavian Medical Laser Technology, Veksoe 1986, 240 pp. 7. Navrátil, L. et al: Noninvasive laser therapy (in Czech). Manus, Praha 1997, 148 pp. 8. Pöntinen, P. J.: Low level laser therapy as a medical treatment modality. Art Urpo Ltd., Tampe, 1992, 215 pp. 9. Barták, A.: The use of low-level lasers in gynecology and obstetrics (in Czech). Gynekolog 1995, 4: 71-74. 10. Havlík, I.: The use of low-level lasers in gynecology and obstetrics (in Czech). Gynekolog 1998, 7: 89-92. 11. Karu, T.: The Science of Low-Power laser Therapy. Gordon and Breach Science Publishers, Amsterdam, 1998, 299 pp. 12. Bahmer, F., Seipp, W.: Dermatologische Lasertherapie, Stuttgart, Wiss. Verl.-Ges., 1996, 217 pp. 13. Karu, T. I., Pyatibrat, L. V., Kalendo, G. S., Esenaliev, R. O.: Effects of monochromatic low-intensity light and laser irradiation on adhesion of HeLa cells in vitro. Lasers Surg. Med 1996, 18: 171-177. CONTRIBUTION OF PHOTOTHERAPY TO THE TREATMENT OF EPISIOTOMIES 10 14. Luža, J., Hubáèek, J.: In vitro He-Ne laser effect on phagocytic activity of the polymorphonuclears (PMN) and monocytes (MO) in rabbits. Physiological Research, 44, 1995: 23-28. 15. Samoilova, K. A., Zubanova, O. I., Snopov, S. A., Mukhuradze, N. A., Mikhelson, V. M.: Single skin exposure to visible polarized light induced rapid modification of entire circulating blood. 2. Appearance of soluble factors restoring proliferation and chromosome structure in X-damaged lymphocytes. EUROPTO Conference of Effects of Low-Power Light on Biological Systems, Stockholm 1998: 26-33. CONTRIBUTION OF PHOTOTHERAPY TO THE TREATMENT OF EPISIOTOMIES Table 1 - Age distribution in particular groups followed. Age 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 Number of patients in particular groups (n) Treatment with Treatment with Treatment with Controls therapeutic laser polarized light polarized light (group K) (group A) (group B) and pulsed magnetic field (group C) 0 0 1 0 3 3 4 0 4 7 5 2 27 23 23 7 29 24 26 23 39 50 50 35 72 60 61 49 91 71 77 87 88 67 79 66 62 45 84 67 61 41 58 57 55 37 54 41 49 38 34 35 39 27 32 27 27 19 21 30 22 23 24 19 17 9 14 25 17 12 21 24 12 9 18 13 9 7 9 13 7 2 4 8 6 3 5 5 4 1 2 4 3 0 2 3 2 1 4 2 1 1 1 4 1 1 1 1 1 0 1 1 11 CONTRIBUTION OF PHOTOTHERAPY TO THE TREATMENT OF EPISIOTOMIES 12 Table 2 - Number of applications expressed in percent in particular groups followed. Number of applications 1 2 3 4 5 6 7 8 Number of patients in percent (%) Treatment with Treatment with Treatment with polarized light and therapeutic laser polarized light pulsed magnetic (group A) (group B) field (group C) 0 1.03 0 8.33 4.3 1.54 22.22 14.11 7.13 38.89 33.22 27.7 25 34.26 39.99 4.17 10.33 18.74 1.39 2.75 3.5 0 0 1.4 Table 3 - Fisher (two-sided) tests of the difference of the relative numbers of cases with complications in treatment (x1/n1) in comparison with randomly selected controls (x2/n2) GROUP K GROUP A GROUP B GROUP C x1 2 3 8 n1 748 581 715 x2 58 58 58 n2 592 592 592 p 0.000*** 0.000*** 0.000*** n2 748 748 p 0.767 0.093* n2 581 p 0.386 GROUP A GROUP B GROUP C x1 3 8 n1 581 715 x2 2 2 GROUP B GROUP C x1 8 n1 715 x2 3 * at a limit of statistical significance (p<0.1) ** statistically significant difference (p<0.05) *** statistically highly significant difference (p<0.01). CONTRIBUTION OF PHOTOTHERAPY TO THE TREATMENT OF EPISIOTOMIES 13 Table 4 – Comparison of particular groups including abundance in percent. Type of group controls (K) laser treatment (A) polarized light (B) combined treatment (C) Leoš Navrátil Phone: +420603 435 273 Fax: +4202 41 77 06 80 E-mail: leos.navratil@volny.cz Number of patients (n) 592 748 581 715 Number of complications n % 58 9.8 2 0.27 3 0.52 8 1.1