- Email: [email protected]
Additional benefits of homeopathy in the treatment of chronic periodontitis: A randomized clinical trial
Complementary Therapies in Clinical Practice 19 (2013) 246e250
Contents lists available at SciVerse ScienceDirect
Complementary Therapies in Clinical Practice journal homepage: www.elsevier.com/locate/ctcp
Additional benefits of homeopathy in the treatment of chronic periodontitis: A randomized clinical trial L.C. Mourão a, b, *, H. Moutinho b, A. Canabarro a, c, * a
Department of Periodontology, School of Dentistry, Veiga de Almeida University (UVA), Rio de Janeiro, Brazil Hahnemanniano Institute of Brazil (IHB), Rio de Janeiro, Brazil c Departament of Periodontology, State University of Rio de Janeiro, Rio de Janeiro, Brazil b
a b s t r a c t Keywords: Chronic periodontitis Conventional periodontal treatment Homeopathy
Background and objective: Homeopathic medicine (HM) in the treatment of Chronic Periodontitis (CP) aims to restore the vital energy balance of the patient allowing the body to heal itself. Thus, the aim of this study was to evaluate the additional benefits of HM as an adjunctive to conventional periodontal treatment (CPT). Materials and methods: After sample size calculation, sixty individuals of both genders, and ages varying between 35 and 70 years old, 40 with chronic periodontitis (CP group e CPG) and 20 without CP (Healthy Group e HG) participated in this “Single-Blind Randomized Controlled Clinical Trial”. The CP patients were divided into two groups: one was submitted only to CPT (CP Control Group e CPT-C) and the other group was submitted to CPT and HM, according to the similia principle (CP Test Group e CPTT). Assessments were made at baseline and after 90 days of treatments. The local and systemic responses to the treatments were evaluated by clinical and laboratory parameters, respectively. Data were analyzed by parametric and nonparametric tests. The level of significance was 5%. Results: At baseline, CP patients presented higher values of LDL cholesterol and blood glucose than HG individuals. After the treatment, all the systemic parameters evaluated decreased in CP patients, except LDL and HDL Cholesterol in CPT-C, and HDL Cholesterol in CPT-T. There was a statistical gain in clinical attachment level only in CPT-T (þ0.51 mm) after 90 days; however, there was a reduction in probing depth, in the level of visible plaque and in the bleeding on probing, in both CP groups (CPT-C and CPT-T) after 90 days. Conclusion: The findings of this 3-month follow-up study concluded that H M, as an adjunctive to CPT, can provide additional benefits in the treatment of CP. Ó 2013 Published by Elsevier Ltd.
1. Background Chronic periodontitis (CP) is a chronic inflammatory disease resulting from a complex polymicrobial infection that leads to the destruction of the periodontal tissues. This infection is a result of the disruption of homeostasis between subgingival microbiota and host defenses [1]. Severe CP occurs all over the world and affects approximately 10e15% of adults [2]. Although severe loss of attachment is usually only evident in a few sites [3], it deteriorates with age [4]. Thus, if the disease is left untreated [5], a loss of many teeth may occur [3]. Oral health can significantly affect an
* Corresponding authors. Department of Periodontology, Veiga de Almeida University (UVA), Rua Ibituruna 108, Casa 3, Sala 201, Tijuca, 20271-020 Rio de Janeiro, RJ, Brazil. Tel.: þ55 21 25748871; fax: þ55 21 32343024. E-mail addresses: [email protected] (L.C. Mourão), andradejr@ gmail.com (A. Canabarro). 1744-3881/$ e see front matter Ó 2013 Published by Elsevier Ltd. http://dx.doi.org/10.1016/j.ctcp.2013.05.002
individual’s quality of life. Many studies have shown that the absence of teeth affects food intake and also psychosocial behavior [6,7]. CP may also aggravate pre-existing diseases, because it induces systemic host changes [8]. Homeopathy is a well-defined scientific system based on the “principle of similar” (similia similibus curantur) d like cures like, with a growing body of evidence [9,10]. The major principle of homeopathy claims that a disease can be cured using a much diluted form of a substance that induces the same symptoms in a healthy person [10]. Clinical experience suggests that HM is effective, relatively inexpensive and has high patient satisfaction and a low incidence of side effects [11]. Dentists use homeopathic medicines in everyday practice as an adjunct to conventional treatment for a range of treatments, including complex chronic pathologies, such as CP [11]. However, high-quality studies assessing efficacy and safety of such treatments are urgently needed [12].
L.C. Mourão et al. / Complementary Therapies in Clinical Practice 19 (2013) 246e250
The use of HM in this study aims to balance the physiological and metabolic dysfunction systemic of CP patients allowing the body to heal itself. Therefore, the patients in this study used HM as an adjuvant in the treatment of CP, in order to provide evidence that such substances have an additional effect on the conventional therapy for CP patients.
247
days), time required for stimulation of the organ in question (liver). (2) Acute Drug: These medicines are prescribed in low concentrations in order to cover all signs and symptoms of local lesions e Mercurius solubilis/Belladona/Hepar sulphur e 6CH (dose of two tablets, three times a day) for 15 days. (3) Nosodes: These medicines are used for chronic stimulation of the individual’s energy e Pyrogenium e 200 CH, a single weekly dose (total of 2 weeks).
2. Materials and methods 3. Examiner calibration 2.1. Subjects Forty subjects with CP and twenty healthy ones (HG) participated in this “Single-Blind Randomized Controlled Clinical Trial”. The subjects of both genders, aged from 35 to 70 years old, were enrolled at the Dental Clinic of Center for Health at Veiga de Almeida University (UVA), Rio de Janeiro, Brazil (Table 1). All subjects were randomly selected among patients referred for periodontal (CP group) and restorative treatment (HG) at the Dental Clinic, after approval by the Ethics and Research Committee of UVA (CEP/UVA protocol number 285-11), according to the following criteria (Fig. 1): The inclusion criteria for the CP group were: the presence of clinical attachment level (CAL) 3 mm in proximal sites of two non-adjacent teeth; bone loss confirmed by periapical radiographs; bleeding on probing (BOP) and probing depth (PD) > 3 mm should also be present [13]. For the HG group: CAL and PD < 3 mm in all elements and absence of BOP. 2.2. Treatment protocols 2.2.1. Conventional periodontal therapy All CP patients (n ¼ 40) were submitted to conventional nonsurgical periodontal treatment. The proposed therapy had the following stages: 1. First visit (60 min): personal oral hygiene instructions, a brief description of periodontal disease and its local and systemic effects (w20 min) and supragingival scaling (w40 min) that was performed by ultrasonic scaler tips (Profi Neo, Dabi Atlante, Ribeirão Preto, SP, Brazil). Other visits: consultations for subgingival scaling and root planning e the number of consultations needed to obtain clinical outcome was standardized to four (one per quadrant). If there was no tooth in a given quadrant, the number of visits was reduced to the number of quadrants present. Instrumentation was performed by hand with subgingival curettes (Gracey curettes, Trinity, Sao Paulo, SP, Brazil), for 10 min per tooth. 2.2.2. Additional homeopathic therapy Twenty patients were also submitted to homeopathic therapy (CPT-T). The medicines used in this study were based on the whole symptomatic of periodontal disease and were selected according to the similia principle. (1) Depurative medicine: This type of medicine presents an elective action on the tissue or organ malfunction which prevents elimination of substances produced or introduced into the body e Berberis 6CH (dose of two tablets twice daily, 45 Table 1 Main characteristics of the subjects studied. Characteristics
S/P(saud)
S/H(CP)
C/H(CP c/Hom)
Age(Years) Gender: male/female Number of teeth CAL (mm) BOP (%) Extension of CP
48.6 7.4 8/12 24.45 3.21 e e e
49.4 8.6 7/13 24.65 3.15 4.52 0.45 4.06 0.14 6/12
49.7 8.7 10/10 23.45 4.41 4.63 0.37 4.10 0.21 6/17
Examiner calibration was performed during development of a pilot study that preceded the present investigation. All measures (CAL), (PD), BOP and Plaque Index (PI) were carried out by just one examiner at different times, observing intervals of one week. All teeth from eight patients with CP and six sites per tooth were examined. The Inter-Class Correlation Coefficient (ICC) was 0.82 (p ¼ 0.57, t test), 0.84 (p ¼ 0.79, t test), 0.99 (p ¼ 0.93, t test) and 0.97 (p ¼ 0.92, t test) for CAL, PD, BOP and PI, respectively, which indicated an intraexaminer agreement statistically acceptable. 3.1. Clinical parameters An oral mirror (Trinity, São Paulo, Brazil) and periodontal probe (Trinity) were used for the clinical examination. The distance from the gingival margin to the bottom of the gingival sulcus, was recorded at six points of all teeth (except the third molars) three in the buccal (mesiobuccal, buccal, and distobuccal) and three lingual or palatal (mesiopalatal or mesiolingual, lingual or palatal and disto-lingual or disto-palatal). First, the PD and BOP were recorded. Then the CAL was recorded adding the value of the gingival recession (distance from the cementoenamel junction to the gingival margin) to the PD value. PI was used to measure the presence or absence of supragingival plaque. Visible plaque was recorded at six points of all teeth, except third molars, before periodontal probing [14]. 3.2. Serologic parameters Blood tests were requested of all participants and were carried out in laboratories in Rio de Janeiro, Brazil, that used the same methodologies. The constituents of the lipid profile were measured by the enzymatic colorimetric method. Total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides were obtained also by the enzymatic colorimetric method (Automation, Modular Roche Diagnostics AG, Mannheim, Germany). The fasting plasma glucose (mg/dL) was determined by the GOD-PAD Automation method (Roche). Uric acid was measured by a colorimetric test kit Pap 80 (ABX Diagnostic e SP, Montpellier, France). 3.3. Statistics 3.3.1. Sample size calculation The minimum sample size based on a 2-group comparison with the independent t test was estimated to be 20 cases in each group, considering a confidence level of 95%. Sample size was calculated to provide 80% power to detect statistically significant differences in mean levels of the main outcome (CAL) between the 2 treatments that are as small as 88% of the applicable standard deviation, using the 2-sided 0.05 significance test. The estimated standard deviation of CAL is 0.44 and the minimum detectable difference is 0.39. 3.3.2. Statistical data analysis Statistical evaluation was done using SPSS 17.0 for Windows (SPSS Inc., Chicago, IL). The normality of the numerical data (gender, age and metabolic systemic parameters) was evaluated by
248
L.C. Mourão et al. / Complementary Therapies in Clinical Practice 19 (2013) 246e250
Fig. 1. Ethics and Research Committee of UVA-Brazil.
the KolmogoroveSmirnov test. Subsequently, the parametric Student t test for independent samples was used to analyze differences between the 2 groups. The paired t test was used to analyze differences between baseline and the 90-day values and the ANOVA followed by the Duncan test was used to compare the three groups. p < 0.05 was considered significant. 4. Results
significant difference between them (p ¼ 0.388, t test). After 90 days, there was a significant gain in CPT-T (þ0.51 mm, Table 2). In CPT-C, the difference found was not significant (0.15 mm, Table 2). Table 2 Clinical periodontal parameters initial (baseline) and (90 days) after conventional therapy (GPC) and conventional therapy plus homeopathic (GPT). Parameters
Groups
Initial
4.1. Clinical parameters NIC
4.1.1. CAL e Clinical attachment level All clinical and serologic analyses were recorded by a “blind” examiner. The initial evaluation of the CAL showed similar values for the CP patients that were submitted only to CPT (CPT-C group) and for the CP patients that were submitted to CPT and to homeopathy (CPT-T group). The values at baseline were 4.63 0.39 for the CPT-C group and 4.52 0.44 for the CPT-T group, with no
Mean DP
OS IS (%) IP (%)
GPT GPC GPT GPC GPT GPC GPT GPC
4 4 4 4 54.30 50 73.46 76.77
p Final
0.15 0.09 0.36 0.19 15.03 10.7 4.54 5.21
411 4.66 3.8 4 9.17 10.07 5.65 8.99
0.1 0.06 0.19 0 6.29 6.26 3.37 5.20
Note: SD standard deviation. * Statistically significant (paired t test).
0.001* 0.232 <0.001* 0.002* <0.001* <0.001* <0.001* <0.001*
L.C. Mourão et al. / Complementary Therapies in Clinical Practice 19 (2013) 246e250
4.1.2. PD e Probing depth The initial assessment of PD at baseline also showed similar values for both groups (4.10 0.21 vs 4.06 0.14, CPT-T and CPT-C, respectively), with no statistical difference between them (p ¼ 0.532, t test). After 90 days, the PD decreased significantly in both groups (0.34 mm and 0.15 mm, for CPT-T and CPT-C, respectively) (Table 2). 4.1.3. PI e Plaque index At baseline, significantly more plaque was observed in the CPT-T group than in the CPT-C group (p ¼ 0.038, t test), however, at 90 days, there was significantly less plaque in CPT-T than in CPT-C (p ¼ 0.021, t test) Comparing baseline and the 90-day values, there was a significant reduction in both groups (Table 2). 4.1.4. BOP e Bleeding on probing Similar levels of bleeding on probing were observed with no significant differences between the CPT-T and CPT-C groups at baseline and at 90 days (p ¼ 0.304 and p ¼ 0.653, respectively, t test). However, there was a significant reduction in both groups, comparing baseline and the 90-day values (Table 2). 4.2. Serologic parameters Individuals with CP (CPT-T and CPT-C) compared with HG showed statistically higher initial levels of LDL (p ¼ 0.043, ANOVA), glucose (p < 0.001, ANOVA) and uric acid (p ¼ 0.001, ANOVA). However, these differences were not found between CPT-T and CPTC (p > 0.05, ANOVA). For the other parameters, HDL cholesterol, total cholesterol and triglycerides, no significant differences among the 3 groups were found (p > 0.05, ANOVA). Intra group comparisons showed a significant reduction in total cholesterol, triglycerides, glucose and uric acid in both CP groups (Table 3). However, a significant reduction in LDL cholesterol was only observed in CPT-T (Table 3). 5. Discussion CP is a chronic infection that produces local and systemic inflammatory responses [15]. The high incidence of CP in the Table 3 Initial laboratory parameters (baseline) and final (90 days) after conventional therapy (GPC) and conventional therapy plus homeopathic (GPT) compared to the control group (GSC). Parameters
Groups
Mean DP Initial
Colesterol LDL
Cholesterol HDL
Cholesterol Total
Triglycerides
Glucose
Acid Uric
GPT GPC GSC GPT GPC GSC GPT GPC GSC GPT GPC GSC GPT GPC GSC GPT GPC GSC
157.32 130.59 116.11 49.30 52.18 50.53 219.81 204.22 191.47 146.52 152.65 125.74 102.38 99.79 86.37 6.42 5.29 4.77
p Final
72.16 37.3 11.49 10.11 13.75 7 79.04 35.92 18.28 65.61 74.85 27.83 12.09 9.86 6.81 1.37 1.52 1.19
118.52 125.72 e 52.57 51.29 e 185.81 191.43 e 108.57 138.00 e 89.29 93.15 e 4.74 5.05 e
4.39 31.67
0.001* 0.315 e
7.22 8.99
0.073 0.663 e
43.99 28.21
0.001* 0.010* e
42.27 56.43 5.44 6.00 0.96 1.19
Note: SD standard deviation. * Statistically significant (paired t test).
0.003* 0.042* e <0.001* 0.018* e <0.001* 0.043* e
249
population has generated growing interest from researchers in, not only, the local effects, already well known, but also in its systemic effects. The present study found that, in comparison to a group of healthy people, patients with CP have higher systemic levels of important metabolic markers, including cholesterol. This finding could be explained by the fact that levels of anxiety and stress associated with a calorie diet can lead to increased cholesterol. Protein intake and excess fat causes an increase of ammonia, uric acid, triglycerides and cholesterol [16]. When high serum levels of uric acid persist, a precipitation of urate in the synovial fluid of temporomandibular joints and periodontal tissue due to hepatic blocking may take place [17]. glycemic indices were higher in the CP groups compared to the healthy group. Glycemic decompensation has been associated with changes in the synthesis and maturation of collagen connective tissue, which probably enables the development of periodontal disease [18]. Conventional (mechanical) periodontal treatment was performed on the CP groups (CPT-C and CPT-T) as it is still the gold standard treatment for CP [19]. Only the CP patients were monitored for a period of 90 days and they did not use any placebo medicine. As stated before, placebo-controlled clinical trials do not seem to be ethical, especially when standard treatment exists [20]. Homeopathy is one of the most frequently used systems of alternative medicine especially indicated for the treatment of individuals “as a whole”, making it a natural choice for the treatment of chronic diseases [10]. Several studies reported positive results when HMs were used to treat infected organisms. However, many different low dose preparations have been proven effective only in basic “in vitro” research experiments [21]. After the conventional periodontal treatment alone or the treatment associated with homeopathy, there was a significant reduction for all parameters in both groups, except HDL and LDL cholesterol in the CPT-C group and HDL cholesterol in the CPT-T group, showing the importance of conventional periodontal treatment in reducing the metabolites studied. Despite all the skepticism about homeopathy efficacy, the additional improvement in CPT-T (LDL) must be due to the choice of medications. For example, Berberis acts as a depurative medicine preventing hepatic congestion and increasing the ability of the liver to function correctly [22]. At baseline, high values of PI were observed in both groups with CP. These results are in agreement with a previous study which showed that CP probably reduces the motivation for a satisfactory oral hygiene [23]. After 90 days of treatment, PI decreased significantly in both groups, especially in the CPT-T group. Remembering that the participants received information on the CP disease and were given personal oral hygiene instructions this result demonstrates that periodontal treatment contributed to a successful outcome. Homeopathy induced an additional improvement at the end of the 90-day. period, because it acts favorably on the body’s vital dynamics [24], which could increase the motivation for a more regular and effective oral hygiene. In relation to BOP, a significant reduction in both groups with CP was also observed. All individuals at 90 days showed low levels of bleeding on probing (w 10% of the areas). Thus, all patients were considered to be at low risk for the recurrence of periodontal disease and tooth loss [25], since the presence of bleeding is considered a prerequisite for new episodes of CAL. The increased motivation to perform adequate oral procedures contributes to the biofilm control and consequently reduces the bleeding [25]. The significant gain in clinical attachment of 0.51 mm in the CPT-T group suggests, in addition to the factors reported above concerning plaque and bleeding reduction, the efficacy of HM
250
L.C. Mourão et al. / Complementary Therapies in Clinical Practice 19 (2013) 246e250
working together to reduce the edema and to heal the periodontal tissue. In summary, a significant improvement after 90 days of follow up in patients submitted to conventional periodontal therapy was observed. The significant reductions of local and systemic parameters once again demonstrated the effectiveness of this gold standard therapy. Homeopathy as an adjunct therapy promoted additional clinical responses by optimizing the reduction of some parameters, especially gain of clinical attachment. In fact, these results were expected since homeopathy is most effective in terms of adding values to conventional therapies and in reducing the demand for allopathic drugs [26]. To our knowledge, the present study is the first to evaluate additional benefits of HM in the treatment of CP. It is also important to note that homeopathic therapy is inexpensive and has no known side effects. Thus, its use as an adjunct to conventional periodontal treatment should be considered. Further studies are needed to verify if the improvements in the parameters observed in this short term “SingleBlind Randomized Controlled Clinical Trial” can remain for longer periods and if the same results can also be observed in other populations. 6. Conclusion The findings of this 3-month follow-up study suggest that HM, as an adjunctive to CPT, can provide additional benefits for the treatment of CP. Conflict of interest statement The authors declare that they have no conflict of interest. References [1] Sanz M, van Winkelhoff AJ. Periodontal infections: understanding the complexity e consensus of the Seventh European Workshop on Periodontology. J Clin Periodontol 2011;38(11):3e6. [2] Petersen PE, Ogawa H. Strengthening the prevention of periodontal disease: the WHO approach. J Periodontol 2005;76(12):2187e93. [3] Locker D, Slade GD, Murray H. Epidemiology of periodontal disease among older adults: a review. Periodontol 2000 1998;16:16e33. [4] Brown LJ, Brunelle JA, Kingman A. Periodontal status in the United States, 1988e1991: prevalence, extent, and demographic variation. J Dent Res 1996;75:672e83. [5] Harris RJ. Untreated periodontal disease: a follow-up on 30 cases. J Periodontol 2003;74(5):672e8.
[6] Davis DM, Fiske J, Scott B, Radford DR. The emotional effects of tooth loss: a preliminary quantitative study. Br Dent J 2000;188(9):503e6. [7] Sheiham A, Watt R. The common risk factor approach: a rational basis for promoting oral health. Community Dent Oral Epidemiol 2000;28(6):399e406. [8] Ebersole JL, Machen RL, Steffen MJ, Willmann DE. Systemic acute-phase reactants, C-reactive protein and haptoglobin, in adult periodontitis. Clin Exp Immunol 1997;107(2):347e52. [9] Srivastava P. Periodontal diseases and homeopathy. Homeopath J 2012;5(3):1e3. [10] Witt CM, Lüdtke R, Baur R, Willich SN. Homeopathic medical practice: longterm results of a cohort study with 3981 patients. BMC Public Health 2005;5(3):115e23. [11] Eames S, Darby P. Homeopathy and its ethical use in dentistry. Br Dent J 2011;210(7):299e301. [12] Joos S. Review on efficacy and health services research studies of complementary and alternative medicine in inflammatory bowel disease. Chin J Integr Med 2011;17(6):403e9. [13] Tonetti MS, Claffey N., European Workshop in Periodontology Group C. Advances in the progression of periodontitis and proposal of definitions of a periodontitis case and disease progression for use in risk factor research. J Clin Periodontol 2005;32(6):210e3. [14] Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J 1975;25(4):229e35. [15] Beck JD, Offenbacher S. Systemic effects of periodontitis: epidemiology of periodontal disease and cardiovascular disease. J Periodontol 2005;76(11): 2089e100. [16] Cutler CW, Shinedling EA, Nunn M, Jotwani R, Kim BO, Nares S, et al. Association between periodontitis and hyperlipidemia: cause or effect? J Periodontol 1999;70(12):1429e34. [17] Khosla P, Gogia A, Agarwal PK, Pahuja A, Jain S, Saxena KK, et al. Concomitant gout and rheumatoid arthritis e a case report. Indian J Med Sci 2004;58:349e52. [18] Rubin RR, Peyrot M. Quality of life and diabetes. Diabetes Metab Res Rev 1999;15(3):205e18. [19] Preshaw PM, Hefti AF, Jepsen S, Etienne D, Walker C, Bradshaw MH. Subantimicrobial dose doxycycline as adjunctive treatment for periodontitis. A review. J Clin Periodontol 2004;31(9):697e707. [20] Simon R. Are placebo-controlled clinical trials ethical or needed when alternative treatments exist? Ann Intern Med 2000;133(6):474e5. [21] Clausen J, van Wijk R, Albrecht H. Infection models in basic research on homeopathy. Homeopathy 2010;99(4):263e70. [22] Imanshahidi M, Hosseinzadeh H. Pharmacological and therapeutic effects of Berberis vulgaris and its active constituent, berberine. Phytother Res 2008;22(8):999e1012. [23] Leão AT, Sheiham A. The development of a socio-dental measure of dental impacts on daily living. Community Dent Health 1996;13(1):22e6. [24] Bell IR, Lewis 2nd DA, Lewis SE, Brooks AJ, Schwartz GE, Baldwin CM. Strength of vital force in classical homeopathy: bio-psycho-social-spiritual correlates within a complex systems context. J Altern Complement Med 2004;10(1): 123e31. [25] Lang NP, Tonetti MS. Periodontal risk assessment (PRA) for patients in supportive periodontal therapy (SPT). Oral Health Prev Dent 2003;1(1):7e16. [26] Fisher P. Homeopathy and The Lancet. Evid Based Complement Alternat Med 2006;3(1):145e7.
Contents lists available at SciVerse ScienceDirect
Complementary Therapies in Clinical Practice journal homepage: www.elsevier.com/locate/ctcp
Additional benefits of homeopathy in the treatment of chronic periodontitis: A randomized clinical trial L.C. Mourão a, b, *, H. Moutinho b, A. Canabarro a, c, * a
Department of Periodontology, School of Dentistry, Veiga de Almeida University (UVA), Rio de Janeiro, Brazil Hahnemanniano Institute of Brazil (IHB), Rio de Janeiro, Brazil c Departament of Periodontology, State University of Rio de Janeiro, Rio de Janeiro, Brazil b
a b s t r a c t Keywords: Chronic periodontitis Conventional periodontal treatment Homeopathy
Background and objective: Homeopathic medicine (HM) in the treatment of Chronic Periodontitis (CP) aims to restore the vital energy balance of the patient allowing the body to heal itself. Thus, the aim of this study was to evaluate the additional benefits of HM as an adjunctive to conventional periodontal treatment (CPT). Materials and methods: After sample size calculation, sixty individuals of both genders, and ages varying between 35 and 70 years old, 40 with chronic periodontitis (CP group e CPG) and 20 without CP (Healthy Group e HG) participated in this “Single-Blind Randomized Controlled Clinical Trial”. The CP patients were divided into two groups: one was submitted only to CPT (CP Control Group e CPT-C) and the other group was submitted to CPT and HM, according to the similia principle (CP Test Group e CPTT). Assessments were made at baseline and after 90 days of treatments. The local and systemic responses to the treatments were evaluated by clinical and laboratory parameters, respectively. Data were analyzed by parametric and nonparametric tests. The level of significance was 5%. Results: At baseline, CP patients presented higher values of LDL cholesterol and blood glucose than HG individuals. After the treatment, all the systemic parameters evaluated decreased in CP patients, except LDL and HDL Cholesterol in CPT-C, and HDL Cholesterol in CPT-T. There was a statistical gain in clinical attachment level only in CPT-T (þ0.51 mm) after 90 days; however, there was a reduction in probing depth, in the level of visible plaque and in the bleeding on probing, in both CP groups (CPT-C and CPT-T) after 90 days. Conclusion: The findings of this 3-month follow-up study concluded that H M, as an adjunctive to CPT, can provide additional benefits in the treatment of CP. Ó 2013 Published by Elsevier Ltd.
1. Background Chronic periodontitis (CP) is a chronic inflammatory disease resulting from a complex polymicrobial infection that leads to the destruction of the periodontal tissues. This infection is a result of the disruption of homeostasis between subgingival microbiota and host defenses [1]. Severe CP occurs all over the world and affects approximately 10e15% of adults [2]. Although severe loss of attachment is usually only evident in a few sites [3], it deteriorates with age [4]. Thus, if the disease is left untreated [5], a loss of many teeth may occur [3]. Oral health can significantly affect an
* Corresponding authors. Department of Periodontology, Veiga de Almeida University (UVA), Rua Ibituruna 108, Casa 3, Sala 201, Tijuca, 20271-020 Rio de Janeiro, RJ, Brazil. Tel.: þ55 21 25748871; fax: þ55 21 32343024. E-mail addresses: [email protected] (L.C. Mourão), andradejr@ gmail.com (A. Canabarro). 1744-3881/$ e see front matter Ó 2013 Published by Elsevier Ltd. http://dx.doi.org/10.1016/j.ctcp.2013.05.002
individual’s quality of life. Many studies have shown that the absence of teeth affects food intake and also psychosocial behavior [6,7]. CP may also aggravate pre-existing diseases, because it induces systemic host changes [8]. Homeopathy is a well-defined scientific system based on the “principle of similar” (similia similibus curantur) d like cures like, with a growing body of evidence [9,10]. The major principle of homeopathy claims that a disease can be cured using a much diluted form of a substance that induces the same symptoms in a healthy person [10]. Clinical experience suggests that HM is effective, relatively inexpensive and has high patient satisfaction and a low incidence of side effects [11]. Dentists use homeopathic medicines in everyday practice as an adjunct to conventional treatment for a range of treatments, including complex chronic pathologies, such as CP [11]. However, high-quality studies assessing efficacy and safety of such treatments are urgently needed [12].
L.C. Mourão et al. / Complementary Therapies in Clinical Practice 19 (2013) 246e250
The use of HM in this study aims to balance the physiological and metabolic dysfunction systemic of CP patients allowing the body to heal itself. Therefore, the patients in this study used HM as an adjuvant in the treatment of CP, in order to provide evidence that such substances have an additional effect on the conventional therapy for CP patients.
247
days), time required for stimulation of the organ in question (liver). (2) Acute Drug: These medicines are prescribed in low concentrations in order to cover all signs and symptoms of local lesions e Mercurius solubilis/Belladona/Hepar sulphur e 6CH (dose of two tablets, three times a day) for 15 days. (3) Nosodes: These medicines are used for chronic stimulation of the individual’s energy e Pyrogenium e 200 CH, a single weekly dose (total of 2 weeks).
2. Materials and methods 3. Examiner calibration 2.1. Subjects Forty subjects with CP and twenty healthy ones (HG) participated in this “Single-Blind Randomized Controlled Clinical Trial”. The subjects of both genders, aged from 35 to 70 years old, were enrolled at the Dental Clinic of Center for Health at Veiga de Almeida University (UVA), Rio de Janeiro, Brazil (Table 1). All subjects were randomly selected among patients referred for periodontal (CP group) and restorative treatment (HG) at the Dental Clinic, after approval by the Ethics and Research Committee of UVA (CEP/UVA protocol number 285-11), according to the following criteria (Fig. 1): The inclusion criteria for the CP group were: the presence of clinical attachment level (CAL) 3 mm in proximal sites of two non-adjacent teeth; bone loss confirmed by periapical radiographs; bleeding on probing (BOP) and probing depth (PD) > 3 mm should also be present [13]. For the HG group: CAL and PD < 3 mm in all elements and absence of BOP. 2.2. Treatment protocols 2.2.1. Conventional periodontal therapy All CP patients (n ¼ 40) were submitted to conventional nonsurgical periodontal treatment. The proposed therapy had the following stages: 1. First visit (60 min): personal oral hygiene instructions, a brief description of periodontal disease and its local and systemic effects (w20 min) and supragingival scaling (w40 min) that was performed by ultrasonic scaler tips (Profi Neo, Dabi Atlante, Ribeirão Preto, SP, Brazil). Other visits: consultations for subgingival scaling and root planning e the number of consultations needed to obtain clinical outcome was standardized to four (one per quadrant). If there was no tooth in a given quadrant, the number of visits was reduced to the number of quadrants present. Instrumentation was performed by hand with subgingival curettes (Gracey curettes, Trinity, Sao Paulo, SP, Brazil), for 10 min per tooth. 2.2.2. Additional homeopathic therapy Twenty patients were also submitted to homeopathic therapy (CPT-T). The medicines used in this study were based on the whole symptomatic of periodontal disease and were selected according to the similia principle. (1) Depurative medicine: This type of medicine presents an elective action on the tissue or organ malfunction which prevents elimination of substances produced or introduced into the body e Berberis 6CH (dose of two tablets twice daily, 45 Table 1 Main characteristics of the subjects studied. Characteristics
S/P(saud)
S/H(CP)
C/H(CP c/Hom)
Age(Years) Gender: male/female Number of teeth CAL (mm) BOP (%) Extension of CP
48.6 7.4 8/12 24.45 3.21 e e e
49.4 8.6 7/13 24.65 3.15 4.52 0.45 4.06 0.14 6/12
49.7 8.7 10/10 23.45 4.41 4.63 0.37 4.10 0.21 6/17
Examiner calibration was performed during development of a pilot study that preceded the present investigation. All measures (CAL), (PD), BOP and Plaque Index (PI) were carried out by just one examiner at different times, observing intervals of one week. All teeth from eight patients with CP and six sites per tooth were examined. The Inter-Class Correlation Coefficient (ICC) was 0.82 (p ¼ 0.57, t test), 0.84 (p ¼ 0.79, t test), 0.99 (p ¼ 0.93, t test) and 0.97 (p ¼ 0.92, t test) for CAL, PD, BOP and PI, respectively, which indicated an intraexaminer agreement statistically acceptable. 3.1. Clinical parameters An oral mirror (Trinity, São Paulo, Brazil) and periodontal probe (Trinity) were used for the clinical examination. The distance from the gingival margin to the bottom of the gingival sulcus, was recorded at six points of all teeth (except the third molars) three in the buccal (mesiobuccal, buccal, and distobuccal) and three lingual or palatal (mesiopalatal or mesiolingual, lingual or palatal and disto-lingual or disto-palatal). First, the PD and BOP were recorded. Then the CAL was recorded adding the value of the gingival recession (distance from the cementoenamel junction to the gingival margin) to the PD value. PI was used to measure the presence or absence of supragingival plaque. Visible plaque was recorded at six points of all teeth, except third molars, before periodontal probing [14]. 3.2. Serologic parameters Blood tests were requested of all participants and were carried out in laboratories in Rio de Janeiro, Brazil, that used the same methodologies. The constituents of the lipid profile were measured by the enzymatic colorimetric method. Total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides were obtained also by the enzymatic colorimetric method (Automation, Modular Roche Diagnostics AG, Mannheim, Germany). The fasting plasma glucose (mg/dL) was determined by the GOD-PAD Automation method (Roche). Uric acid was measured by a colorimetric test kit Pap 80 (ABX Diagnostic e SP, Montpellier, France). 3.3. Statistics 3.3.1. Sample size calculation The minimum sample size based on a 2-group comparison with the independent t test was estimated to be 20 cases in each group, considering a confidence level of 95%. Sample size was calculated to provide 80% power to detect statistically significant differences in mean levels of the main outcome (CAL) between the 2 treatments that are as small as 88% of the applicable standard deviation, using the 2-sided 0.05 significance test. The estimated standard deviation of CAL is 0.44 and the minimum detectable difference is 0.39. 3.3.2. Statistical data analysis Statistical evaluation was done using SPSS 17.0 for Windows (SPSS Inc., Chicago, IL). The normality of the numerical data (gender, age and metabolic systemic parameters) was evaluated by
248
L.C. Mourão et al. / Complementary Therapies in Clinical Practice 19 (2013) 246e250
Fig. 1. Ethics and Research Committee of UVA-Brazil.
the KolmogoroveSmirnov test. Subsequently, the parametric Student t test for independent samples was used to analyze differences between the 2 groups. The paired t test was used to analyze differences between baseline and the 90-day values and the ANOVA followed by the Duncan test was used to compare the three groups. p < 0.05 was considered significant. 4. Results
significant difference between them (p ¼ 0.388, t test). After 90 days, there was a significant gain in CPT-T (þ0.51 mm, Table 2). In CPT-C, the difference found was not significant (0.15 mm, Table 2). Table 2 Clinical periodontal parameters initial (baseline) and (90 days) after conventional therapy (GPC) and conventional therapy plus homeopathic (GPT). Parameters
Groups
Initial
4.1. Clinical parameters NIC
4.1.1. CAL e Clinical attachment level All clinical and serologic analyses were recorded by a “blind” examiner. The initial evaluation of the CAL showed similar values for the CP patients that were submitted only to CPT (CPT-C group) and for the CP patients that were submitted to CPT and to homeopathy (CPT-T group). The values at baseline were 4.63 0.39 for the CPT-C group and 4.52 0.44 for the CPT-T group, with no
Mean DP
OS IS (%) IP (%)
GPT GPC GPT GPC GPT GPC GPT GPC
4 4 4 4 54.30 50 73.46 76.77
p Final
0.15 0.09 0.36 0.19 15.03 10.7 4.54 5.21
411 4.66 3.8 4 9.17 10.07 5.65 8.99
0.1 0.06 0.19 0 6.29 6.26 3.37 5.20
Note: SD standard deviation. * Statistically significant (paired t test).
0.001* 0.232 <0.001* 0.002* <0.001* <0.001* <0.001* <0.001*
L.C. Mourão et al. / Complementary Therapies in Clinical Practice 19 (2013) 246e250
4.1.2. PD e Probing depth The initial assessment of PD at baseline also showed similar values for both groups (4.10 0.21 vs 4.06 0.14, CPT-T and CPT-C, respectively), with no statistical difference between them (p ¼ 0.532, t test). After 90 days, the PD decreased significantly in both groups (0.34 mm and 0.15 mm, for CPT-T and CPT-C, respectively) (Table 2). 4.1.3. PI e Plaque index At baseline, significantly more plaque was observed in the CPT-T group than in the CPT-C group (p ¼ 0.038, t test), however, at 90 days, there was significantly less plaque in CPT-T than in CPT-C (p ¼ 0.021, t test) Comparing baseline and the 90-day values, there was a significant reduction in both groups (Table 2). 4.1.4. BOP e Bleeding on probing Similar levels of bleeding on probing were observed with no significant differences between the CPT-T and CPT-C groups at baseline and at 90 days (p ¼ 0.304 and p ¼ 0.653, respectively, t test). However, there was a significant reduction in both groups, comparing baseline and the 90-day values (Table 2). 4.2. Serologic parameters Individuals with CP (CPT-T and CPT-C) compared with HG showed statistically higher initial levels of LDL (p ¼ 0.043, ANOVA), glucose (p < 0.001, ANOVA) and uric acid (p ¼ 0.001, ANOVA). However, these differences were not found between CPT-T and CPTC (p > 0.05, ANOVA). For the other parameters, HDL cholesterol, total cholesterol and triglycerides, no significant differences among the 3 groups were found (p > 0.05, ANOVA). Intra group comparisons showed a significant reduction in total cholesterol, triglycerides, glucose and uric acid in both CP groups (Table 3). However, a significant reduction in LDL cholesterol was only observed in CPT-T (Table 3). 5. Discussion CP is a chronic infection that produces local and systemic inflammatory responses [15]. The high incidence of CP in the Table 3 Initial laboratory parameters (baseline) and final (90 days) after conventional therapy (GPC) and conventional therapy plus homeopathic (GPT) compared to the control group (GSC). Parameters
Groups
Mean DP Initial
Colesterol LDL
Cholesterol HDL
Cholesterol Total
Triglycerides
Glucose
Acid Uric
GPT GPC GSC GPT GPC GSC GPT GPC GSC GPT GPC GSC GPT GPC GSC GPT GPC GSC
157.32 130.59 116.11 49.30 52.18 50.53 219.81 204.22 191.47 146.52 152.65 125.74 102.38 99.79 86.37 6.42 5.29 4.77
p Final
72.16 37.3 11.49 10.11 13.75 7 79.04 35.92 18.28 65.61 74.85 27.83 12.09 9.86 6.81 1.37 1.52 1.19
118.52 125.72 e 52.57 51.29 e 185.81 191.43 e 108.57 138.00 e 89.29 93.15 e 4.74 5.05 e
4.39 31.67
0.001* 0.315 e
7.22 8.99
0.073 0.663 e
43.99 28.21
0.001* 0.010* e
42.27 56.43 5.44 6.00 0.96 1.19
Note: SD standard deviation. * Statistically significant (paired t test).
0.003* 0.042* e <0.001* 0.018* e <0.001* 0.043* e
249
population has generated growing interest from researchers in, not only, the local effects, already well known, but also in its systemic effects. The present study found that, in comparison to a group of healthy people, patients with CP have higher systemic levels of important metabolic markers, including cholesterol. This finding could be explained by the fact that levels of anxiety and stress associated with a calorie diet can lead to increased cholesterol. Protein intake and excess fat causes an increase of ammonia, uric acid, triglycerides and cholesterol [16]. When high serum levels of uric acid persist, a precipitation of urate in the synovial fluid of temporomandibular joints and periodontal tissue due to hepatic blocking may take place [17]. glycemic indices were higher in the CP groups compared to the healthy group. Glycemic decompensation has been associated with changes in the synthesis and maturation of collagen connective tissue, which probably enables the development of periodontal disease [18]. Conventional (mechanical) periodontal treatment was performed on the CP groups (CPT-C and CPT-T) as it is still the gold standard treatment for CP [19]. Only the CP patients were monitored for a period of 90 days and they did not use any placebo medicine. As stated before, placebo-controlled clinical trials do not seem to be ethical, especially when standard treatment exists [20]. Homeopathy is one of the most frequently used systems of alternative medicine especially indicated for the treatment of individuals “as a whole”, making it a natural choice for the treatment of chronic diseases [10]. Several studies reported positive results when HMs were used to treat infected organisms. However, many different low dose preparations have been proven effective only in basic “in vitro” research experiments [21]. After the conventional periodontal treatment alone or the treatment associated with homeopathy, there was a significant reduction for all parameters in both groups, except HDL and LDL cholesterol in the CPT-C group and HDL cholesterol in the CPT-T group, showing the importance of conventional periodontal treatment in reducing the metabolites studied. Despite all the skepticism about homeopathy efficacy, the additional improvement in CPT-T (LDL) must be due to the choice of medications. For example, Berberis acts as a depurative medicine preventing hepatic congestion and increasing the ability of the liver to function correctly [22]. At baseline, high values of PI were observed in both groups with CP. These results are in agreement with a previous study which showed that CP probably reduces the motivation for a satisfactory oral hygiene [23]. After 90 days of treatment, PI decreased significantly in both groups, especially in the CPT-T group. Remembering that the participants received information on the CP disease and were given personal oral hygiene instructions this result demonstrates that periodontal treatment contributed to a successful outcome. Homeopathy induced an additional improvement at the end of the 90-day. period, because it acts favorably on the body’s vital dynamics [24], which could increase the motivation for a more regular and effective oral hygiene. In relation to BOP, a significant reduction in both groups with CP was also observed. All individuals at 90 days showed low levels of bleeding on probing (w 10% of the areas). Thus, all patients were considered to be at low risk for the recurrence of periodontal disease and tooth loss [25], since the presence of bleeding is considered a prerequisite for new episodes of CAL. The increased motivation to perform adequate oral procedures contributes to the biofilm control and consequently reduces the bleeding [25]. The significant gain in clinical attachment of 0.51 mm in the CPT-T group suggests, in addition to the factors reported above concerning plaque and bleeding reduction, the efficacy of HM
250
L.C. Mourão et al. / Complementary Therapies in Clinical Practice 19 (2013) 246e250
working together to reduce the edema and to heal the periodontal tissue. In summary, a significant improvement after 90 days of follow up in patients submitted to conventional periodontal therapy was observed. The significant reductions of local and systemic parameters once again demonstrated the effectiveness of this gold standard therapy. Homeopathy as an adjunct therapy promoted additional clinical responses by optimizing the reduction of some parameters, especially gain of clinical attachment. In fact, these results were expected since homeopathy is most effective in terms of adding values to conventional therapies and in reducing the demand for allopathic drugs [26]. To our knowledge, the present study is the first to evaluate additional benefits of HM in the treatment of CP. It is also important to note that homeopathic therapy is inexpensive and has no known side effects. Thus, its use as an adjunct to conventional periodontal treatment should be considered. Further studies are needed to verify if the improvements in the parameters observed in this short term “SingleBlind Randomized Controlled Clinical Trial” can remain for longer periods and if the same results can also be observed in other populations. 6. Conclusion The findings of this 3-month follow-up study suggest that HM, as an adjunctive to CPT, can provide additional benefits for the treatment of CP. Conflict of interest statement The authors declare that they have no conflict of interest. References [1] Sanz M, van Winkelhoff AJ. Periodontal infections: understanding the complexity e consensus of the Seventh European Workshop on Periodontology. J Clin Periodontol 2011;38(11):3e6. [2] Petersen PE, Ogawa H. Strengthening the prevention of periodontal disease: the WHO approach. J Periodontol 2005;76(12):2187e93. [3] Locker D, Slade GD, Murray H. Epidemiology of periodontal disease among older adults: a review. Periodontol 2000 1998;16:16e33. [4] Brown LJ, Brunelle JA, Kingman A. Periodontal status in the United States, 1988e1991: prevalence, extent, and demographic variation. J Dent Res 1996;75:672e83. [5] Harris RJ. Untreated periodontal disease: a follow-up on 30 cases. J Periodontol 2003;74(5):672e8.
[6] Davis DM, Fiske J, Scott B, Radford DR. The emotional effects of tooth loss: a preliminary quantitative study. Br Dent J 2000;188(9):503e6. [7] Sheiham A, Watt R. The common risk factor approach: a rational basis for promoting oral health. Community Dent Oral Epidemiol 2000;28(6):399e406. [8] Ebersole JL, Machen RL, Steffen MJ, Willmann DE. Systemic acute-phase reactants, C-reactive protein and haptoglobin, in adult periodontitis. Clin Exp Immunol 1997;107(2):347e52. [9] Srivastava P. Periodontal diseases and homeopathy. Homeopath J 2012;5(3):1e3. [10] Witt CM, Lüdtke R, Baur R, Willich SN. Homeopathic medical practice: longterm results of a cohort study with 3981 patients. BMC Public Health 2005;5(3):115e23. [11] Eames S, Darby P. Homeopathy and its ethical use in dentistry. Br Dent J 2011;210(7):299e301. [12] Joos S. Review on efficacy and health services research studies of complementary and alternative medicine in inflammatory bowel disease. Chin J Integr Med 2011;17(6):403e9. [13] Tonetti MS, Claffey N., European Workshop in Periodontology Group C. Advances in the progression of periodontitis and proposal of definitions of a periodontitis case and disease progression for use in risk factor research. J Clin Periodontol 2005;32(6):210e3. [14] Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J 1975;25(4):229e35. [15] Beck JD, Offenbacher S. Systemic effects of periodontitis: epidemiology of periodontal disease and cardiovascular disease. J Periodontol 2005;76(11): 2089e100. [16] Cutler CW, Shinedling EA, Nunn M, Jotwani R, Kim BO, Nares S, et al. Association between periodontitis and hyperlipidemia: cause or effect? J Periodontol 1999;70(12):1429e34. [17] Khosla P, Gogia A, Agarwal PK, Pahuja A, Jain S, Saxena KK, et al. Concomitant gout and rheumatoid arthritis e a case report. Indian J Med Sci 2004;58:349e52. [18] Rubin RR, Peyrot M. Quality of life and diabetes. Diabetes Metab Res Rev 1999;15(3):205e18. [19] Preshaw PM, Hefti AF, Jepsen S, Etienne D, Walker C, Bradshaw MH. Subantimicrobial dose doxycycline as adjunctive treatment for periodontitis. A review. J Clin Periodontol 2004;31(9):697e707. [20] Simon R. Are placebo-controlled clinical trials ethical or needed when alternative treatments exist? Ann Intern Med 2000;133(6):474e5. [21] Clausen J, van Wijk R, Albrecht H. Infection models in basic research on homeopathy. Homeopathy 2010;99(4):263e70. [22] Imanshahidi M, Hosseinzadeh H. Pharmacological and therapeutic effects of Berberis vulgaris and its active constituent, berberine. Phytother Res 2008;22(8):999e1012. [23] Leão AT, Sheiham A. The development of a socio-dental measure of dental impacts on daily living. Community Dent Health 1996;13(1):22e6. [24] Bell IR, Lewis 2nd DA, Lewis SE, Brooks AJ, Schwartz GE, Baldwin CM. Strength of vital force in classical homeopathy: bio-psycho-social-spiritual correlates within a complex systems context. J Altern Complement Med 2004;10(1): 123e31. [25] Lang NP, Tonetti MS. Periodontal risk assessment (PRA) for patients in supportive periodontal therapy (SPT). Oral Health Prev Dent 2003;1(1):7e16. [26] Fisher P. Homeopathy and The Lancet. Evid Based Complement Alternat Med 2006;3(1):145e7.