scholarly journals Effectiveness of chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7-14 years. A randomised clinical trial

2020 ◽  
Author(s):  
Susanne Lynge ◽  
Kristina Boe Dissing ◽  
Werner Vach ◽  
Henrik Wulf Christensen ◽  
Lise Hestbaek
Keyword(s):  
Treatment Group ◽  
Side Effects ◽  
Pain Intensity ◽  
Active Treatment ◽  
Spinal Manipulation ◽  
Controlled Trial ◽  
Active Treatment Group ◽  
Text Messages ◽  
Control Group ◽  
Fixed Sequence

Abstract Background To investigate the effectiveness of chiropractic spinal manipulation versus sham manipulation in children aged 7-14 with recurrent headaches.Methods Design: A two-arm, single-blind, superiority randomised controlled trial.Setting: One chiropractic clinic and one paediatric specialty practice in Denmark Participants: 199 children aged 7 to 14 years, who experienced at least one episode of headache per week for the previous 6 months and with at least one musculoskeletal dysfunction identified. Interventions: All participants and parents received standard oral and written advice to reduce headaches. In addition, children in the active treatment group received chiropractic spinal manipulation and children in the control group received sham manipulation for a period of 4 months. Number and frequency of treatments were based on the chiropractor’s individual evaluation in the active treatment group, and the children in the control group received approximately eight visits during the treatment period.Primary outcome measures: ‘Number of days with headache’, ‘pain intensity’ and ‘medication’ were reported weekly by text messages, and global perceived effect by text message after 4 months. A planned fixed sequence strategy based on an initial outcome data analysis was used to prioritize outcomes. ‘Number of days with headache’ and ‘pain intensity’ were chosen as equally important outcomes of highest priority, followed by global perceived effect and medication. The significance level for the first two outcomes was fixed to 0.025 to take multiplicity into account.Results Chiropractic spinal manipulation resulted in significantly fewer days with headaches (reduction of 0.81 vs. 0.41, p=0.019, NNT=7 for 20% improvement) and better global perceived effect (dichotomized into improved/not improved, OR=2.8 (95% CI: 1.5-5.3), NNT=5) compared with a sham manipulation procedure. There was no difference between groups for pain intensity during headache episodes. Due to methodological shortcomings, no conclusions could be drawn about medication use.Conclusions Chiropractic spinal manipulation resulted in fewer headaches and higher global perceived effect, with only minor side effects. It did not lower the intensity of the headaches.Since the treatment is easily applicable, of low cost and minor side effects, chiropractic spinal manipulation might be considered as a valuable treatment option for children with recurrent headaches.Trial registration ClinicalTrials.gov, identifier NCT02684916, registered 02/18/2016 – retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT02684916

scholarly journals Effectiveness of chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7-14 years. A randomised clinical trial

2020 ◽  
Author(s):  
Susanne Lynge ◽  
Kristina Boe Dissing ◽  
Werner Vach ◽  
Henrik Wulf Christensen ◽  
Lise Hestbaek
Keyword(s):  
Treatment Group ◽  
Side Effects ◽  
Pain Intensity ◽  
Active Treatment ◽  
Spinal Manipulation ◽  
Controlled Trial ◽  
Active Treatment Group ◽  
Text Messages ◽  
Control Group ◽  
Fixed Sequence

Abstract Background: To investigate the effectiveness of chiropractic spinal manipulation versus sham manipulation in children aged 7-14 with recurrent headaches. Methods: Design: A two-arm , single - blind, superiority randomised superiority single-blinded clinical controlled trial. Setting: One chiropractic clinic and one paediatric specialty practice in Denmark Participants : 199 children aged 7 to 14 years, who experienced at least one episode of headache per week for the previous 6 months and with at least one musculoskeletal dysfunction identified. Interventions: All participants and parents received standard oral and written advice to reduce headaches. In addition, children in the active treatment group received chiropractic spinal manipulation and children in the control group received sham manipulation for a period of 4 months. The n N umber and frequency of treatments were based on the chiropractor’s individual evaluation in the active treatment group, and the children in the control group received approximately eight visits during the treatment period. Primary outcome measures: ‘Number of days with headache’, ‘pain intensity’ and ‘medication’ were reported weekly by text messages, and global perceived effect by text message after 4 months. A planned fixed sequence strategy based on an initial outcome data analysis was used to prioritize outcomes. ‘Number of days with headache’ and ‘pain intensity’ were chosen as equally important outcomes of highest priority, followed by global perceived effect and medication. The significance level for the first two outcomes was fixed to 0.025 to take multiplicity into account. Results: Chiropractic spinal manipulation resulted in significantly fewer days with headaches (reduction of 0.81 vs. 0.41, p=0.019, NNT=7 for 20% improvement ) and better global perceived effect ( dichotomized into improved/not improved, OR= 2.8 (95% CI: 1.5-5.3) 2.63 vs. 3.24 , p<0.001 , NNT=5) compared with a sham manipulation procedure. There was no difference between groups for pain intensity during headache episodes. Due to methodological shortcomings, no conclusions could be drawn about medication use. Conclusions: Chiropractic spinal manipulation resulted in fewer headaches and higher global perceived effect, with only minor side effects. It did not lower the intensity of the headaches. Since the treatment is easily applicable, of low cost and minor side effects, chiropractic spinal manipulation might be considered as a valuable treatment option for children with recurrent headaches.

scholarly journals Effectiveness of chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7–14 years - a randomised clinical trial

2021 ◽  
Vol 29 (1) ◽  
Author(s):  
Susanne Lynge ◽  
Kristina Boe Dissing ◽  
Werner Vach ◽  
Henrik Wulff Christensen ◽  
Lise Hestbaek
Keyword(s):  
Treatment Group ◽  
Side Effects ◽  
Pain Intensity ◽  
Active Treatment ◽  
Spinal Manipulation ◽  
Controlled Trial ◽  
Active Treatment Group ◽  
Text Messages ◽  
Control Group ◽  
Fixed Sequence

Abstract Background To investigate the effectiveness of chiropractic spinal manipulation versus sham manipulation in children aged 7–14 with recurrent headaches. Methods Design: A two-arm, single-blind, superiority randomised controlled trial. Setting: One chiropractic clinic and one paediatric specialty practice in Denmark, November 2015 to August 2020. Participants: 199 children aged 7 to 14 years, with at least one episode of headache per week for the previous 6 months and at least one musculoskeletal dysfunction identified. Interventions: All participants received standard oral and written advice to reduce headaches. In addition, children in the active treatment group received chiropractic spinal manipulation and children in the control group received sham manipulation for a period of 4 months. Number and frequency of treatments were based on the chiropractor’s individual evaluation in the active treatment group; the children in the control group received approximately eight visits during the treatment period. Primary outcome measures: ‘Number of days with headache’, ‘pain intensity’ and ‘medication’ were reported weekly by text messages, and global perceived effect by text message after 4 months. A planned fixed sequence strategy based on an initial outcome data analysis was used to prioritize outcomes. ‘Number of days with headache’ and ‘pain intensity’ were chosen as equally important outcomes of highest priority, followed by global perceived effect and medication. The significance level for the first two outcomes was fixed to 0.025 to take multiplicity into account. Results Chiropractic spinal manipulation resulted in significantly fewer days with headaches (reduction of 0.81 vs. 0.41, p = 0.019, NNT = 7 for 20% improvement) and better global perceived effect (dichotomized into improved/not improved, OR = 2.8 (95% CI: 1.5–5.3), NNT = 5) compared with a sham manipulation procedure. There was no difference between groups for pain intensity during headache episodes. Due to methodological shortcomings, no conclusions could be drawn about medication use. Conclusions Chiropractic spinal manipulation resulted in fewer headaches and higher global perceived effect, with only minor side effects. It did not lower the intensity of the headaches. Since the treatment is easily applicable, of low cost and minor side effects, chiropractic spinal manipulation might be considered as a valuable treatment option for children with recurrent headaches. Trial registration ClinicalTrials.gov, identifier NCT02684916, registered 02/18/2016 – retrospectively registered.

scholarly journals Effectiveness of chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7-14 years. A randomised clinical trial

2020 ◽  
Author(s):  
Susanne Lynge ◽  
Kristina Boe Dissing ◽  
Werner Vach ◽  
Henrik Wulf Christensen ◽  
Lise Hestbaek
Keyword(s):  
Clinical Trial ◽  
Treatment Group ◽  
Side Effects ◽  
Pain Intensity ◽  
Active Treatment ◽  
Spinal Manipulation ◽  
Active Treatment Group ◽  
Text Messages ◽  
Control Group ◽  
Fixed Sequence

Abstract BackgroundTo investigate the effectiveness of chiropractic spinal manipulation versus sham manipulation in children aged 7-14 with recurrent headaches.MethodsDesign: A two-arm randomised superiority single-blinded clinical trial.Setting: One chiropractic clinic and one paediatric specialty practice in Denmark Participants: 199 children aged 7 to 14 years, who experienced at least one episode of headache per week for the previous 6 months and with at least one musculoskeletal dysfunction identified. Interventions: All participants and parents received standard oral and written advice to reduce headaches. In addition, children in the active treatment group received chiropractic spinal manipulation and children in the control group received sham manipulation for a period of 4 months. The number and frequency of treatments were based on the chiropractor’s individual evaluation in the active treatment group, and the children in the control group received approximately eight visits during the treatment period.Primary outcome measures: ‘Number of days with headache’, ‘pain intensity’ and ‘medication’ were reported weekly by text messages, and global perceived effect by text message after 4 months. A planned fixed sequence strategy based on an initial outcome data analysis was used to prioritize outcomes. ‘Number of days with headache’ and ‘pain intensity’ were chosen as equally important outcomes of highest priority, followed by global perceived effect and medication. The significance level for the first two outcomes was fixed to 0.025 to take multiplicity into account.ResultsChiropractic spinal manipulation resulted in significantly fewer days with headaches (reduction of 0.81 vs. 0.41, p=0.019, NNT=7) and better global perceived effect (2.63 vs. 3.24, p<0.001, NNT=5) compared with a sham manipulation procedure. There was no difference between groups for pain intensity during headache episodes. Due to methodological shortcomings, no conclusions could be drawn about medication use.Conclusions Chiropractic spinal manipulation resulted in fewer headaches and higher global perceived effect, with only minor side effects. It did not lower the intensity of the headaches.Since the treatment is easily applicable, of low cost and minor side effects, chiropractic spinal manipulation might be considered as a valuable treatment option for children with recurrent headaches.Trial registrationClinicalTrials.gov, identifier NCT02684916, registered 02/18/2016 – retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT02684916

scholarly journals Effectiveness of chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7-14 years. A randomised clinical trial

2020 ◽  
Author(s):  
Susanne Lynge ◽  
Kristina Boe Dissing ◽  
Werner Vach ◽  
Henrik Wulf Christensen ◽  
Lise Hestbaek
Keyword(s):  
Clinical Trial ◽  
Treatment Group ◽  
Side Effects ◽  
Pain Intensity ◽  
Active Treatment ◽  
Spinal Manipulation ◽  
Active Treatment Group ◽  
Text Messages ◽  
Control Group ◽  
Fixed Sequence

Abstract Background: To investigate the effectiveness of chiropractic spinal manipulation versus sham manipulation in children aged 7-14 with recurrent headaches.Method: Design: A two-arm randomised superiority single-blinded clinical trial.Setting: One chiropractic clinic and one paediatric specialty practice in DenmarkParticipants: 199 children aged 7 to 14 years, who experienced at least one episode of headache per week for the previous 6 months and with at least one musculoskeletal dysfunction identified.Interventions: All participants and parents received standard oral and written advice to reduce headaches. In addition, children in the active treatment group received chiropractic spinal manipulation and children in the control group received sham manipulation for a period of 4 months. The number and frequency of treatments were based on the chiropractor’s individual evaluation in the active treatment group, and the children in the control group received approximately eight visits during the treatment period.Primary outcome measures: ‘Number of days with headache’, ‘pain intensity’ and ‘medication’ were reported weekly by text messages, and global perceived effect by text message after 4 months. A planned fixed sequence strategy based on an initial outcome data analysis was used to prioritize outcomes. ‘Number of days with headache’ and ‘pain intensity’ were chosen as equally important outcomes of highest priority, followed by global perceived effect and medication. The significance level for the first two outcomes was fixed to 0.025 to take multiplicity into account.Results: Chiropractic spinal manipulation resulted in significantly fewer days with headaches (reduction of 0.81 vs. 0.41, p=0.019, NNT=7) and better global perceived effect (2.63 vs. 3.24, p<0.001, NNT=5) compared with a sham manipulation procedure. There was no difference between groups for pain intensity during headache episodes. Due to methodological shortcomings, no conclusions could be drawn about medication use.Conclusions: Chiropractic spinal manipulation resulted in fewer headaches and higher global perceived effect, with only minor side effects. It did not lower the intensity of the headaches.Since the treatment is easily applicable, of low cost and minor side effects, chiropractic spinal manipulation might be considered as a valuable treatment option for children with recurrent headaches.Trial registrationClinicalTrials.gov, identifier NCT02684916, registered 02/18/2016 – retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT02684916

A Clinical Trial of Hydroxyethylrutosides in the Treatment of Haemorrhoids of Pregnancy

1992 ◽  
Vol 20 (1) ◽  
pp. 54-60 ◽  
Author(s):  
H Wijayanegara ◽  
JC Mose ◽  
L Achmad ◽  
R Sobarna ◽  
W Permadi
Keyword(s):  
Clinical Trial ◽  
Treatment Group ◽  
Side Effects ◽  
Active Treatment ◽  
Controlled Trial ◽  
Active Treatment Group ◽  
Subjective Symptoms ◽  
Drug Related Problems ◽  
Double Blind ◽  
Safety And Efficacy

The safety and efficacy of 500 mg O-( β-hydroxyethyl)rutosides given orally twice daily in the treatment of 97 patients with first-, second-, or third-degree haemorrhoids were investigated in a double-blind, randomized placebo-controlled trial. The rutosides produced a significant ( P < 0.001) improvement in patient-assessed subjective symptoms (pain, bleeding, exudation and pruritus) compared with placebo. There was also a significant ( P < 0.0001) improvement in clinician-assessed subjective and objective signs (bleeding, inflammation and dilatation of the haemorrhoidal plexus) after 2 and 4 weeks' treatment compared with placebo. There were three mild, transient side-effects reported in the active treatment group and no drug-related problems in the pregnancy or delivery were observed. The results suggest that O-( β-hydroxyethyl)rutosides provide a safe and effective treatment for women with haemorrhoids of pregnancy.

scholarly journals Effectiveness of an app for perinatal home visitation by nurses in preventing infant abuse in Japan

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
A Isumi ◽  
S Doi ◽  
T Fujiwara
Keyword(s):  
Public Health ◽  
Treatment Group ◽  
Child Maltreatment ◽  
Active Treatment ◽  
Intervention Study ◽  
Home Visitation ◽  
Active Treatment Group ◽  
Health Centers ◽  
Public Health Nurses ◽  
Control Group

Abstract Background In Japan, public health nurses provide home visitation with pregnant women who are at high risk for child maltreatment, but its effectiveness in preventing child maltreatment has not been evaluated because contents and quality of home visitation vary from municipality to municipality. This study aims to evaluate whether the tablet app developed to standardize and assist perinatal home visitation by public health nurses is effective in preventing child maltreatment. Methods An intervention study was conducted in 2018 in Adachi City, Tokyo, Japan. Public health nurses at two public health centers used the tablet app when they support high-risk pregnant women through home visitation and interviews, while public health nurses at the other three public health centers provided support as in the past. Because two public health centers were different in usage of the app, the treatment group was further divided into two groups: active and inactive. As fatal abuse among infants, frequency of shaking and smothering was assessed as an outcome through a self-reported questionnaire at the 4-month health check, and compared between the active treatment group, inactive treatment group, and control group, using multiple logistic regression (N = 5,651). Results Prevalence of infant abuse was 0.82% in the active treatment group, 1.34% in the inactive treatment group, and 1.50% in the control group. When adjusted for parental demographics and parenting situations, mothers in the active treatment group were less likely to shake or smother their baby than those in the control group (Odds ratio: 0.51, p = 0.093). Conclusions It possibly suggests that the tablet app developed to assist perinatal home visitation by public health nurses was effective in preventing infant abuse. Key messages An intervention study was conducted at public health centers in Adachi City, Tokyo, Japan, using the tablet app developed to standardize and assist perinatal home visitation by public health nurses. The finding suggested that the tablet app may be effective in preventing shaking and smothering among 4-month old infants.

Hay Fever Treatment in General Practice: A Randomised Controlled Trial Comparing Standardised Western Acupuncture with Sham Acupuncture

1996 ◽  
Vol 14 (1) ◽  
pp. 6-10 ◽  
Author(s):  
L Williamson ◽  
P Yudkin ◽  
R Livingstone ◽  
K Prasad ◽  
A Fuller ◽  
...  
Keyword(s):  
Treatment Group ◽  
Active Treatment ◽  
Sham Group ◽  
Controlled Trial ◽  
Active Treatment Group ◽  
Sham Acupuncture ◽  
Hay Fever ◽  
Good Effect ◽  
Symptom Scores ◽  
Randomised Controlled

The effect of standardised, Western acupuncture on hay fever symptoms was investigated in a randomised, controlled, single-blind trial in comparison with “sham” acupuncture. Three general practices, in Oxfordshire (rural), Lincolnshire (semi-rural), and Peterborough (urban), recruited 102 patients aged 16 or over with long-standing, moderate or severe hay fever symptoms that had required continuous therapy for at least one month of the year for three or more consecutive years. The patients were asked to keep a diary to record: the amount of medication used daily; a daily symptom score (using a ten-point scale), from which was derived a weekly remission of symptoms score; and their assessment of the effect of acupuncture on the hay fever symptoms. Symptom scores and use of medication were similar in the two groups. In the four-week period following each patient's first treatment, remission of symptoms was reported by 39.0% in the active treatment group and 45.2% in the sham group; mean weekly symptom scores were 18.4 and 17.6 respectively; and mean units of medication used were 4.1 and 5.0 respectively. Sixteen out of 43 patients in the active treatment group and 14 out of 43 in the sham group felt that the acupuncture had had an excellent or very good effect on their hay fever. The treatments were simple, safe, reproducible and perceived as equally effective. Whether this represented an acupuncture effect, a placebo effect, or natural variation in a fluctuating condition, is not clear.

scholarly journals A Web-Based Transdiagnostic Intervention for Affective and Mood Disorders: Randomized Controlled Trial

2018 ◽  
Vol 5 (2) ◽  
pp. e36 ◽  
Author(s):  
Bogdan Tudor Tulbure ◽  
Andrei Rusu ◽  
Florin Alin Sava ◽  
Nastasia Sălăgean ◽  
Todd J Farchione
Keyword(s):  
Treatment Group ◽  
Emotional Disorders ◽  
Active Treatment ◽  
Active Treatment Group ◽  
Self Report ◽  
Control Group ◽  
Obsessive Compulsive ◽  
Web Based ◽  
Transdiagnostic Treatment

Background Research increasingly supports a transdiagnostic conceptualization of emotional disorders (ie applying the same underlying treatment principles across mental disorders, without tailoring the protocol to specific diagnoses), and many international researchers are currently investigating this issue. Objective The aim of this study was to evaluate the efficacy and acceptability of a Web-based transdiagnostic program using a sample of Romanian adults diagnosed with anxiety and/or depression. Methods Volunteer participants registered for the study and completed a series of online self-report measures. Participants who fulfilled basic inclusion criteria on these measures were contacted for a telephone diagnostic interview using the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Axis I Disorders (SCID-I). Enrolled participants were randomized to either the active treatment group (N=69) or the wait-list control group (N=36) using a 2:1 ratio. The transdiagnostic treatment was based on the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al, 2011) that addresses common underlying mechanisms of anxiety and depression. Participants randomized to the active treatment condition received 10 weeks of Web-based treatment based on the UP. Throughout treatment, graduate students in clinical psychology provided guidance that consisted of asynchronous written communication on a secure Web platform. After the intervention, participants in both study conditions were invited to complete a set of self-report measures and a postintervention SCID-I interview conducted by a different team of graduate students blinded to participants’ group and diagnostic status. Six months later, participants in the active treatment group were invited to complete an online follow-up assessment. Results During the intervention, active treatment participants completed on average 19 homework assignments (SD 12.10), and we collected data from 79.0% (83/105) at postintervention and 51% (35/69) at follow-up for self-report measures. Postintervention SCID-I interviews were collected from 77.1% (81/105) participants. Relative to the wait-list control group, the transdiagnostic intervention yielded overall medium to large effect sizes for the primary outcome measures (within-group Hedges g=0.52-1.34 and between-group g=0.39-0.86), and also for anxiety sensitivity (g=0.80), symptom interference (g=0.48), and quality of life (g=0.38). Significant within-groups effects only were reported for the active treatment group on Panic Disorder Severity Scale-Self Report (PDSS-SR, g=0.58-0.65) and Yale-Brown Obsessive Compulsive Scale (Y-BOCS, g=0.52-0.58). Conclusions Insignificant between-group differences for the Y-BOCS and PDSS-SR could be explained by the small number of participants with the associated primary diagnostic (eg, only 3 participants with obsessive compulsive disorder) by the choice of outcome measure (PDSS-SR was not rated among the evidence-based measures) and by the fact that these disorders may be more difficult to treat. However, the overall results suggest that the transdiagnostic intervention tested in this study represents an effective treatment option that may prove easier to disseminate through the use of Web-based delivery systems. Trial Registration ClinicalTrials.gov CT02739607; https://clinicaltrials.gov/ct2/show/study/NCT02739607 (Archived by WebCite at http://www.webcitation.org/6yY1VeYIZ)

scholarly journals Comparison of combination of probiotic and standard therapy compared to standard therapy on eradication of Helicobacter pylori infection in children

2016 ◽  
Vol 50 (1) ◽  
pp. 38
Author(s):  
Fransisca Theresia Aryani ◽  
Agus Firmansyah ◽  
Abdul Latief
Keyword(s):  
Helicobacter Pylori ◽  
Treatment Group ◽  
Side Effects ◽  
Standard Therapy ◽  
Eradication Rate ◽  
Controlled Trial ◽  
Control Group ◽  
Double Blind ◽  
Cancer Management ◽  
H Pylori

Background Helicobacter pylori (H. pylori) infection is thought to be the etiology of chronic gastritis, peptic ulcer, and risk factor for gastric cancer. Management of H. pylori infection in children is associated with several problems such as compliance to therapy, untolerated side effects, and antibiotic resistance. Probiotic is reported to give beneficial effect in the management of H. pylori infection and there is no study yet on the effect of probiotic in eradication of H. pylori infection in Indonesian children.Objectives To study the effect of additional probiotic in the standard therapy on the rate of H. pylori infection eradication in children and its side effect.Methods This was a double blind randomized controlled trial performed in 23 children with H. pylori infection at Kampung Melayu and Rawa Bunga District. The diagnosis was determined based on Helicobacter pylori stool antigen test (HpSA). Subjects were randomly assigned to either receive receive amoxiycilin, clarithromycin, omeprazole, and probiotic (2 x 109 cfu of Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12) or amoxicillin, clarithromycin, omeprazole dan placebo (maltodextrin). HpSA examination was evaluated again after 2 weeks of therapy.Results Two of 13 subjects in the treatment group and 6 of 10 subjects in the control group experienced side effects. Eradication rate in the treatment group is higher than the control group (13/13 vs 7/10) but the correlation between additional probiotic with the eradication rate of H. pylori is not statistically significant.Conclusions Probiotic can reduce the incidence of side effects due to antibiotic used in H. pylori eradication (2/13 vs 6/10, p < 0.012). [Paediatr Indones. 2010;50:38-41].

scholarly journals A Clinical Study on the Efficacy and Tolerability of a New Topical Gel and Toothpaste in Patients with Xerostomia: A Randomized Controlled Trial

2021 ◽  
Vol 10 (23) ◽  
pp. 5641
Author(s):  
Pia López Jornet ◽  
Laureano Hernandez ◽  
Francisco Gomez García ◽  
Fe Galera Molero ◽  
Eduardo Pons-Fuster López ◽  
...  
Keyword(s):  
Placebo Group ◽  
Clinical Study ◽  
Treatment Group ◽  
Active Treatment ◽  
Symptom Relief ◽  
Active Treatment Group ◽  
Tocopheryl Acetate ◽  
Control Group ◽  
Topical Gel ◽  
Randomized Controlled

Objective: xerostomia is a very common problem in the general population. The objective of this study was to determine the efficacy of a new gel and toothpaste in patients with xerostomia, analyze the role of salivary cytokines as biomarkers of xerostomia and assess the possible changes in salivary cytokines following treatment. Materials and methods: A randomized, controlled double-blind clinical study was carried out in 73 patients with xerostomia divided into two groups: placebo and active treatment (cymenol; tocopheryl acetate; D-panthenol; Aloe barbadensis; citrate tribasic dihydrate; fluoride) with oral gel and toothpaste three times a day for four consecutive weeks. The Thomson Xerostomia Inventory was applied, with the assessment of oral quality of life (OHIP-14) at baseline and after four weeks of application of the product. Sialometry was also performed in both groups, with analysis of the IL-1b, IL-6, IL-8 and TNFa levels in saliva. Results: In the active treatment group, the xerostomia scores decreased significantly at the end of the study versus baseline, from 33.47 to 27.93 (p < 0.001). No significant decrease was recorded in the placebo group (34.5 to 32.75; p = 0.190). There were no adverse effects in either group. Regarding the saliva samples, the active treatment group showed significant differences in IL-6 concentration versus the control group (18.55 pg/mL (8–38.28) and 5.83 pg/mL (1.19–12.04), respectively; p = 0.002). No significant differences in salivary cytokines were observed in either the treatment group or the control group. Conclusions: The use of a new toothpaste and gel developed for patients with xerostomia proved effective, with greater symptom relief than in the placebo group. Further clinical studies involving longer time periods and larger samples are advisable in order to confirm the benefits of the described treatment.

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