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Discussion | Acupuncture | DISEASES | Glucocorticoid resistance [Our previous research found that nasal acupuncture addresses AR-related nasal mucosal and immune system interactions and the Th1/Th2 imbalance, such that Th2 cells and the secretion of cytokines promotes a Th1/Th2 balance. We also found that clinical symptoms following nasal acupuncture improved, and there was regulation of serum eosinophils and cell counts of IL-4 in nasal secretions in patients with AR [Acupuncture effects produced by stimulation of the corresponding meridian acupoints, and through these meridians that are adjusted through the skin, functional adjustments can be made, the balance of Yin and Yang to correct the pathological phenomena of partial tide can occur, and the function of the body can be brought back to normal status. To achieve the purpose of treating diseases, research has shown that acupuncture points may be a low resistance point, i.e., a subcutaneous adjustment system (meridian) and hub. Acupuncture may be one method by which the central nervous system can be stimulated; subsequent adjustments to the neuroendocrine and humoral immune networks in the central nervous system can then, in turn, affect the target organs. fMRI can monitor the activity of specific brain functional areas under conditions of acupuncture that extract qi. Visualization of the activity of specific acupuncture effects in the brain may provide an effective means for exploring the mechanisms of acupuncture based on the theory of TCM coupled with medical imaging technology.In the current clinic, we have found [ | PMC10175315 |
Conclusions | Nasal acupuncture is an effective treatment for PAR, as it may ameliorate nasal symptoms, improve quality of life, and reduce the dosage of medicine. In conclusion, this study proved that nasal acupuncture is an effective and reliable method for the clinical treatment of PAR with a stable curative effect and is worthy of promotion in clinical application, although the long-term curative effects and mechanisms of action remain to be further studied. Therefore, further validation of these results with larger scale, multicenter clinical trials using more objective indicators could be decisive.
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Acknowledgements | We acknowledge the help from Chaoqun Yan, who is from the Department of Acupuncture, Dongzhimen Hospital, Beijing University of Chinese Medicine, for her assistance in editing and proofreading the manuscript. | PMC10175315 | ||
Funding | The general work performed in this study was supported by the National Natural Science Foundation of China (8190151365), the Beijing Natural Science Foundation of China (7214290), the Beijing Science and Technology Program (Z211100002921022) and the Youth Realism Program of the Chinese Society of Traditional Chinese Medicine (2021-QNQS-06) and Basic Scientific Research Business Fund Project of Beijing University of Traditional Chinese Medicine (2019-JYB-JS-052). | PMC10175315 | ||
Data availability | The datasets used/analyzed during the current study are available from the corresponding author on reasonable request. | PMC10175315 | ||
Declarations | PMC10175315 | |||
Conflict of interest | The authors declare that they have no competing interests. | PMC10175315 | ||
Ethics approval and consent to participate | The study protocol was approved by the Ethics Committee of the Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing (Reference number: BZYYYDX-LL-20150208). Signed ICFs were obtained from participants before they were assigned to the study groups. The study was conducted in accordance with the principles of the Declaration of Helsinki (2004) and in accordance with the Medical Research Involving Human Subjects Act (WMO). Note: the registration was supplemented later in the clinical trial registration center. | PMC10175315 | ||
Consent for publication | All subjects who participated in the image acquisition signed ICFs. The patients agreed that his or her information in this study could be revealed for publication. Signed ICFs from the patients in this study are kept in the author’s institution and are available for review upon request from the Editor-in-Chief. | PMC10175315 | ||
References | PMC10175315 | |||
Introduction | malocclusion, Becker, orthodontic, tooth | ROOT RESORPTION | [version 1; peer review: 2 approvedNo competing interests were disclosed.
There are several approaches to treat the impacted maxillary canines, including no treatment,
The duration of the surgical/orthodontic treatment ranged between 18-30 months.
Stewart
According to the comparative prospective study by Parkin
Becker and Chaushu
The type of surgical exposure technique may affect the treatment duration of impacted canines,
The use of various techniques to accelerate tooth movement during orthodontic treatment of different types of malocclusion, such as retraction of upper canines,
The preliminary split-mouth design study conducted by Fischer
Ferguson
However, the potential effects of such surgical interventions on the root resorption and bone support of the canines and their adjacent teeth have not been evaluated in these previous two studies. Finally, Yussif
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Methods | PMC10618642 | |||
Study design and registration | The current study was designed as a randomized, controlled, two-parallel group clinical trial to investigate the efficacy of the corticotomy technique accompanying surgical exposure enhanced by a subsequent flapless corticotomy in accelerating traction movement of the palatally impacted canines (PICs) and to evaluate the associated dentoalveolar changes compared with traditional traction method
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Calculating the sample size | The desired sample size was established using Minitab
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Recruitment of patients and eligibility standards | Along with contacting and recalling 75 individuals listed in the Orthodontics Department’s archives, 52 referred patients with upper impacted canines were also examined. It was found that 66 of them satisfied the inclusion requirements. Fifty-eight patients were accepted to participate in the study after the treatment plan and the orthodontic/surgical procedures were explained to all patients. Forty-six patients were then chosen at random to enter this study (
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CONSORT flow diagram of patients' recruitment, follow-up, and entry to data analysis. | orthodontic | ROOT RESORPTION, IMPACTION | The following definitions represent the inclusion criteria: (1) patients aged 18 to 28; (2) unilateral palatally or mid-alveolar upper impaction; (3) distally placement of the impacted canine crown to the lateral incisor root midline; (4) no use of any medications that may affect the orthodontic movement. The following conditions were excluded: (1) bilateral or buccal canine impaction cases; (2) more than 45-degree angle between the canine’s longitudinal axis and the vertical facial plane; (3) presence of lateral incisors root resorption; (4) presence of contact between the canine crown and the lateral incisor root; (5) previous orthodontic treatment; (6) any medical condition that prevents oral surgery; (7) oral structural abnormality that is inherited or congenital. | PMC10618642 |
Blinding, randomization, and allocation concealment | The participant patients were randomly assigned to the two study groups based on a list of random numbers created using Minitab
The principal researcher (MRM) and the patients could not have been blinded during the surgical interventions. Blinding, however, was only achievable during the data analysis stage. In other words, the outcome assessors were blinded and unable to determine to which group the patients belonged. | PMC10618642 | ||
Orthodontic procedures | The aligning and leveling of the maxillary dental arch were performed using the fixed orthodontic appliance (MBT prescription; 0.022-in slot, Votion™, Ortho Technology
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(A) Opening additional space before canine traction using a nickel-titanium open-coil spring. (B) Maintaining the opened space using a stainless steel closed-coil spring. | PMC10618642 | |||
Surgical procedures | In both study groups, the impacted canines were surgically exposed using the closed flap approaches. Under the direction of one of the co-authors (OH), the same surgeon from the Department of Oral and Maxillofacial Surgery at Damascus University, Faculty of Dentistry, carried out all surgical procedures.
Under local anaesthesia (lidocaine HCL 2% - epinephrine 1:80000), a full-thickness palatal flap was raised (
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(A) Raising of a full-thickness palatal flap. (B) Bonding an eyelet attachment with a hand-made twisted ligature wire to the exposed canine crown. |
During the surgical exposure phase, patients in this group underwent a corticotomy procedure by drilling a series of circular holes (1 mm in diameter, 1-2 mm deep and spaced about 1.5 mm apart) in the cortical bone. These holes drilled at the area where the impacted canine would be moved towards as well as in the mesial and distal sides of the canine crown (
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The corticotomy procedures. | IMPACTION | (A) The first corticotomy procedure involved drilling a series of circular holes (1 mm in diameter, 1-2 mm deep and spaced about 1.5 mm apart) in the cortical bone. (B) The second corticotomy procedure performed using piezosurgery. Two to three vertical gingival incisions with a height of 8 mm were made at the buccal side of the impaction area using a surgical scalpel. Then, the cortical cuts were created using BS1 tip with a cutting depth of 2 to 3 mm and 2-mm spaces between the cuts. Each cut was 1-mm width.Two months after the first corticotomy intervention, the second flapless corticotomy procedure was performed using piezosurgery (Mectron PIEZOSURGERY
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Follow-up orthodontic procedures | IMPACTION | The traction force was applied for the first time two weeks after the surgical exposure using active power chain tied on one end to the twisted ligature wire and on the other end to the first molar band hook on the impaction side. The intensity of the applied traction force was 60 g
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Outcome measures | lateral incisors, orthodontic, tooth | SECONDARY, ROOT RESORPTION, IMPACTION | For all patients, two cone-beam computed tomography (CBCT) images of the maxillary jaw were obtained. The first CBCT image was obtained two weeks before the beginning of treatment while the second image was obtained right on the day the fixed appliance was removed. The CBCT system was a CBCT Picasso
The principal researcher (MRM) performed the measurements and evaluated all variables. The primary outcomes were (1) traction duration, (2) total treatment duration, and (3) the velocity of traction movement. The traction duration is measured as the interval between the onset of orthodontic traction on the impacted canine and the emergence of half of its clinical crown. The total treatment duration calculated as the time between the bonding of the fixed orthodontic appliance until it is removed. The velocity of traction movement is determined by dividing the depth of impaction, which is defined as the distance from the impacted canine cusp tip to the occlusal plane, by the traction duration.The secondary outcomes were (1) bone support of the aligned canine (BS-IC), (2) bone support of the contralateral naturally erupting canine (BS-CON), (3) bone support of the adjacent lateral incisor (BS-LI), (4) bone support of the adjacent first premolar (BS-PR), and (5) root resorption of the adjacent lateral incisor (RR-LI). Bone support was evaluated on the posttreatment CBCT scans. It was assessed on the mesial, distal, buccal, and palatal aspects of the canines, lateral incisors and first premolar. The total bone support ratio was calculated by averaging the four measurements made on each tooth. The alveolar bone level was measured from the root apex of the evaluated tooth to the alveolar crest, whereas the root length of the evaluated tooth was measured from root apex to the midpoint of a line connecting the mesial and distal points on the cemento-enamel junction of this tooth. The ratio of alveolar bone level to the root length was considered the percentage of bone support.
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The error of the method and the reliability assessment | The method error was assessed by repeating the CBCT measurements for twenty patients selected by random (ten from each group) thirty days after the first measurement. The interclass correlation coefficients (ICCs) were used to determine the presence of any random error, and the paired sample t-tests were used to determine the presence of any systematic error. | PMC10618642 | ||
Statistical analysis | Minitab
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Results | PMC10618642 | |||
Patient recruitment and baseline sample characteristics | The baseline characteristics of the sample are shown in
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Basic sample characteristics at the beginning of the treatment. | mid-alveolar impaction | IMPACTION | TT: traditional traction group; CAT: corticotomy-assisted traction group; N: number of patients; SD: standard deviation; M: male; F: female; P: palatal impaction; Mid: mid-alveolar impaction.Employing two-sample t-test.Employing chi-square test. | PMC10618642 |
Method error | MINOR | The ICCs were in the 0.989 to 0.996 range, demonstrating the high reliability of the measurement method. The Paired-sample t-tests results showed that there was no significant difference between the two measurements, indicating the minor and insignificant systematic errors (
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The error of method and the intra-observer reliability. | Paired t-tests were used to detect significant differences.Intraclass correlation coefficients; P<0.05 was considered statistically significant. | PMC10618642 | ||
Outcome measures | The mean duration of active traction was 9.68±3.24 months in the TT group and 6.13±1.81 months in the CAT group with a significant difference between the two groups (P=0.015,
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Descriptive statistics of the traction duration, total treatment duration and traction movement velocity as well as the
| P<0.05 was considered statistically significant; TT: traditional traction group; CAT: corticotomy-assisted traction group; N: number of patients; SD: standard deviation; Min: minimum; Max: maximum.Two-sample t-test was used.Regarding the bone support ratio, the differences between the aligned and contralateral canines were non-significant in both study groups (P≈1.000; P=0.559, in the TT and CAT group, respectively;
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Descriptive statistics of the bone support of the impacted and contralateral canines as well as the
| TT: traditional traction group; CAT: corticotomy-assisted traction group; SD: standard deviation; Min: minimum; Max: maximum.Paired t-test was used to detect the statistically significant differences. P<0.05 was considered statistically significant; | PMC10618642 | ||
Descriptive statistics of the bone support of the impacted canine and the adjacent teeth and of the lateral incisor root resorption as well as the P-values of significance tests. | ROOT RESORPTION | TT: traditional traction group; CAT: corticotomy-assisted traction group; N: number of patients; SD: standard deviation; Min: minimum; Max: maximum.Two-sample t-test was used. P<0.05 was considered statistically significant.The mean bone support ratio of the aligned canines in the TT group was 89% (SD: 0.04), while it was 88% (SD: 0.03) in the CAT group. As for the mean bone support ratio of the contralateral canines, the mean bone support ratio was 90% (SD: 0.03) and 89% (SD: 0.02), in the TT and the CAT group, respectively (
The mean amount of root resorption of the adjacent laterals was 1.22±1.02 mm in the TT group and 1.30±1.18 mm in the CAT group, with no significant differences between the two study groups (P=0.612,
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Discussion | orthodontic movements, incisors | ROOT RESORPTION, ERUPTION | There is little published data on the effect of the corticotomy techniques on the acceleration of palatally impacted canine traction movement, even though these techniques have been shown to be effective in accelerating several orthodontic movements.
Our study findings showed that both the duration of active traction and the total treatment duration were significantly shorter in the CAT group compared to the TT group. In other words, the velocity of traction movement in the CAT group was significantly greater. This can be attributed to the fact that the corticotomy interventions decreased the cortical bone mass and its resistance to the impacted canine forced eruption movement due to its weakening by cortical cuts.
The results of the current study were in line with the previous studies that compared the acceleration and the conventional traction methods in terms of the incidence of acceleration but were inconsistent with those studies’ results regarding the amount of acceleration obtained. The mean traction movement velocity in the current study was greater (0.37 mm/wk.) than that of Fischer (0.26 mm/wk.).
In contrast, Ferguson et al.
This study showed that the posttreatment bone support ratios of the aligned canines did not differ significantly between the TT and CAT groups as well as when compared to the contralateral canines in both study groups. In addition, the results of the inter-group comparison showed that there were no significant differences in the mean bone support ratios of the adjacent lateral incisors and the first premolars. These results can be explained by the use of the same orthodontic traction techniques in both study groups, the use of light traction force in a direction that resembles the normal eruption path, and the fact that the amount of bone removed during surgical interventions was minimal. The results of the current study were in agreement with those of Fischer
No clinical trials have been published in the medical literature evaluating the level of bone support of the teeth adjacent to the PICs underwent corticotomy-assisted orthodontic treatment until now. Therefore, the results of the CAT group in the current work cannot be compared with others due to the lack of similar studies.The mean amount of root resorption of the adjacent laterals was almost similar in the two study groups with no significant differences. The light traction force used and its direction that from the beginning of its application was away from the root of the lateral incisors, could explain the presence of the low percentage and mild degree of root resorption of the adjacent laterals. Due to the lack of similar studies, the results obtained in the current study are only compared with the results of studies that used the traditional traction methods.The results of the current study were consistent with those of Arriola-Guillén
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Limitations | bucco-lingual angulation | The current study included a specific type of upper canine impactions. Therefore, the effects of different probabilities of the initial location, mesiodistal and bucco-lingual angulation of the impacted canines on the traction movement velocity were not evaluated. Secondly, only one type of mechanical traction means was used and the effectiveness of other traction techniques were not evaluated. Thirdly, this trial did not assess the effects of gender and age on the traction movement rate, for which a larger sample size would be necessary. | PMC10618642 | |
Generalizability | canine impaction, particular impaction | As the present study included particular impaction conditions with particular impacted canine’s locations and conducted on a specific patient group treated with specific mechanical orthodontic and surgical techniques in only one teaching hospital, the results of the current study can be limitedly generalized. In order to acquire results that are more generalizable, more randomized controlled trials with larger sample sizes should be carried out in diverse populations with various types of canine impaction. | PMC10618642 | |
Conclusions | ROOT RESORPTION | Orthodontic traction assisted with minimally-invasive corticotomy was effective in increasing the rate of traction movement of the palatally impacted canines, thereby decreasing the traction duration and the overall treatment duration. The acceleration surgical interventions used did not cause significant changes in the bone support ratios of the aligned canines and the adjacent teeth compared with the traditional traction method. Finally, the acceleration procedure did not result in any significant difference regarding the amount of root resorption of adjacent laterals compared with the traditional treatment methods. | PMC10618642 | |
Ethical statement | The approval of the Local Research Ethics Committee of Damascus University was obtaining before conducting this study (UDDS-499-01022020/SRC-2195). This study was registered at
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Data availability | ROOT RESORPTION, IMPACTED | Figshare. Accelerated Traction of Impacted Canines. DOI:
This project contains the following underlying data:
01 Baseline Sample Characteristics.xlsx. (This file contains the data used to summarize the characteristics of the include patients in this study).02 Duration of treatment.xlsx (This file contains the variables used to measure the duration of the provided treatment for each patient).03 Bone Support and Root Resorption.xlsx (This file contains the variables used to evaluate the percentages of bone support and the amount of root resorption observed on the lateral incisors adjacent to the impacted canines)Information Sheet.pdf (This is the information sheet distributed to the candidate patients for inclusion in this study)CONSORT2010 checklist v01.pdf (This checklist contains the 25 items of the CONSORT guidelines and the pages where these items can be found).
Data are available under the terms of the
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References | corticotomy-assisted orthodontic, confusion, palate, tooth, cleft lip, orthodontic | MINOR, IMPACTION |
The study was to evaluate the effectiveness of a minimally-invasive corticotomy-assisted treatment of palatally impacted canines (PICs) compared with the traditional method by evaluating treatment time, the velocity of movement, and the associated dentoalveolar changes. It was an interesting study, but still needs to address the following questions- 1. For palatally impacted canines, the traditional treatment during surgical procedure was to remove some bone and reduce some obstacle. Therefore, the corticotomy seems not very necessary from this point. 2. The duration time was closely related to impaction distance. it is very important to analyze the detailed result. 3. The literature showed "They found that the duration of treatment was 25.8 months for unilateral impaction cases, and in bilateral cases, the duration of treatment was 32.3 months." Actually, the treatment time in this study was too short compared to the previous study. 4. The author should simplify the introduction, not like a review to show all studies. 5. Figure 3B and Figure 4B look like the same picture. Please clarify it.Is the work clearly and accurately presented and does it cite the current literature?PartlyIf applicable, is the statistical analysis and its interpretation appropriate?I cannot comment. A qualified statistician is required.Are all the source data underlying the results available to ensure full reproducibility?YesIs the study design appropriate and is the work technically sound?PartlyAre the conclusions drawn adequately supported by the results?YesAre sufficient details of methods and analysis provided to allow replication by others?PartlyReviewer Expertise:orthodonticsI confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.
This is an excellent piece of research which is based on randomized control trial at the top of the hierarchy of scientific evidence in the literature. The study was well conducted, the results are comprehensive and answers the research question. I have recommended the indexing of the manuscript, with minor corrections, in recognition of its high quality. The following minor corrections may be considered:
I suggest the "velocity" of tooth movement should be replaced by the the "average rate".What is (BS1)?A new photo (4B) showing the buccal gingival cuts and the cortctotomy would be ideal.Please add a sentence regarding the hypothesis that was tested in this study.Please add a sentence regarding future studies.Is the work clearly and accurately presented and does it cite the current literature?YesIf applicable, is the statistical analysis and its interpretation appropriate?YesAre all the source data underlying the results available to ensure full reproducibility?YesIs the study design appropriate and is the work technically sound?YesAre the conclusions drawn adequately supported by the results?YesAre sufficient details of methods and analysis provided to allow replication by others?YesReviewer Expertise:Orthognathic surgery, 3D image analysis, bone bioengineering.I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.
The effectiveness of minimally-invasive corticotomy-assisted orthodontic treatment of palatally impacted canines compared to the traditional traction method in terms of treatment duration, velocity of traction movement and the associated dentoalveolar changes: A randomized controlled trial. This is an interesting study that is investigating the effectiveness of minimally-invasive corticotomy-assisted orthodontic treatment of palatally impacted canines compared to the traditional traction method. The RCT design of this manuscript as well as the layout is nicely written. There are, however, few minor modifications that need to be addressed by the authors. My recommendation is to accept this manuscript. Title: The title is too long, please consider rewriting the title to indicate the main key factors that are investigated in this study, it could be shortened as follows: The effectiveness of minimally-invasive corticotomy-assisted orthodontic treatment of palatally impacted canines compared to the traditional traction method: A randomized controlled trial. Introduction: The literature review is too long and the authors provide a detailed review of several similar key studies (page 2: 2
Consider replacing the word “troubling” with “challenging” in the text: “The time required for orthodontic traction of impacted canines is a particularly troubling clinical problem because it prolongs the orthodontic treatment duration.” Methods: The authors need to justify and discuss why they considered the use of a closed surgical technique to align the palatally impacted canines. The literature supports the use of open surgical technique to align impacted canines that are palatally positioned. Results: This section could be modified in order to avoid repeating the reported results in different format. The authors could describe the general trends of the results in text and refer the reader to tables and figures instead of reporting the same numbers, values and percentages in text and tables. Figures and Tables: Figure 1 and 2: please consider removing these figures as it does not illustrate any details relevant to the investigated variables Figure 4B: there is a confusion with regards to the description of procedure on the buccal side of the impaction while the photographs depict a palatal view of the impaction. Please consider replacing the photograph with an appropriate illustration of the procedure performed in the buccal side of the impaction. Table 2: no need to include this table as the results are reported in full in text. Please consider removing this table Is the work clearly and accurately presented and does it cite the current literature?YesIf applicable, is the statistical analysis and its interpretation appropriate?YesAre all the source data underlying the results available to ensure full reproducibility?YesIs the study design appropriate and is the work technically sound?YesAre the conclusions drawn adequately supported by the results?YesAre sufficient details of methods and analysis provided to allow replication by others?YesReviewer Expertise:Orthodontic treatment, cleft lip and palate, Oral health ralted quality of lifeI confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. | PMC10618642 |
Subject terms | SAM, weight gain, malnutrition | MALNUTRITION | Severe acute malnutrition (SAM) is a major global public health problem. We aimed to assess the effects of probiotic and synbiotic supplementation on rate of weight gain and change in length in young SAM infants. This study was substudy of a single-blind randomized clinical trial (NCT0366657). During nutritional rehabilitation, 67 <6 months old SAM infants were enrolled and randomized to receive either probiotic ( | PMC9890433 |
Introduction | acute illness, malnutrition | MALNUTRITION | Globally, 13.6 million children under the age of five are affected by severe acute malnutrition (SAM)The human digestive system possesses a diverse microbial community (the gut microbiome) which mediates various metabolic functions essential to the host physiologyPrebiotics generally refer to oligosaccharides that are indigestible to the host, but are consumed by gut microflora, including any added probioticsThis current study was conducted to explore the role of probiotic and synbiotic supplementation on the ponderal and linear growth of partially/non-breastfed infants of 2–6 months of age with SAM, recovering from acute illness in a hospital. | PMC9890433 |
Methods | PMC9890433 | |||
Study design | It was a single-blind randomized clinical trial. | PMC9890433 | ||
Study settings and participants | malnutrition | MALNUTRITION | The study was conducted at Dhaka Hospital (icddr,b). The institution has well-equipped clinical care set ups as well as laboratory facilities capable of performing all the analyses required. After acute phase management, children with severe acute malnutrition (SAM) were transferred to the Nutritional Rehabilitation Unit (NRU) for stabilization and preparation for discharge for home. | PMC9890433 |
Working definitions | PMC9890433 | |||
Severe acute malnutrition (SAM) | pedal edema | PEDAL EDEMA | Defined by weight for length Z score < − 3, according to WHO growth standard or presence of bilateral pedal edema, independent of anthropometric measurements | PMC9890433 |
Study completion of an infant | From the start of enrolment, 28 days supplementation period, and four weeks of post supplementation follow-up. | PMC9890433 | ||
Rate of weight gain | weight gain | The rate of weight gain (gm/kg/day) was measured using the following formula, | PMC9890433 | |
Trial groups with interventions | SAM infants between 2 and 6 months of age were randomized upon completion of antibiotic treatment at the NRU into one of the three supplementation groups:Placebo (Lactose)Probiotic (Synbiotic: Probiotic (Each group was assigned to receive the standard of care and diet as practiced in Dhaka Hospital, icddr,b. | PMC9890433 | ||
Randomization | Randomization for supplementation allocation was done in a 1:1 ratio using stratification by age (2–3.9 months vs. 4–5.9 months) to ensure equal participation of infants by age groups. Allocation was achieved by using random permuted blocks of the size of three prepared by a third party not related to the study. | PMC9890433 | ||
Sample size | For this pilot trial, the sample size was 67 SAM infants. As it was a pilot trial, the minimum number of patients was included in each arm. | PMC9890433 | ||
Ethical approval | The randomized controlled trial was registered at ClinicalTrials.gov (NCT03666572) on 12/09/2018 ( | PMC9890433 | ||
Management of the study participants | PMC9890433 | |||
SAM infants | Eligible SAM infants were treated for the acute phase management in the Longer Stay Unit by the standardized icddr,b treatment protocol for children with SAMThe infants were discharged upon being declared clinically well and, if possible, upon attainment of a WLZ ≥ − 2Infant formula provided to the study participant mothers who were not breastfeeding or patially breast feeding their infants did not contain any probiotics or prebiotics. | PMC9890433 | ||
Follow-up | infection | INFECTION | Infants were followed up through home visits by Field Research Assistants (FRA) twice weekly throughout the entire study period of 8 weeks (4 weeks supplementation + 4 weeks post-supplementation follow-up). Caregivers were asked to keep empty sachets after administration of supplements. FRAs collected the information on daily administration of supplements. Missing doses were not repeated. Infants developing an infection during the follow-up period were re-admitted to the hospital. | PMC9890433 |
Outcome measures | weight gain |
Change in rate of weight gain (g/kg per day) with supplementsChange in Length-for-age Z score with supplements | PMC9890433 | |
Data collection | Data were collected by study physician in the case record forms. Data were randomly checked by co-investigators. Data will be immediately copied on the hard disks of two computers as soon as data verification is completed. | PMC9890433 | ||
Data analysis | edema, nutritional edema, weight gain | REGRESSION, EDEMA | Data were analyzed through the statistical software Stata (15.0 version for windows) after cleaning with repeated checks. To explore demographic, clinical, and socioeconomic data, we used the median with an interquartile range (IQR) for asymmetric quantitative data and frequency with proportion for categorical data. To evaluate the difference in baseline characteristics Krusker wallis test was done in the continuous dataset of three supplements. Chi square test was done for categorical data set of baseline characteristics.As 47 infants had edema during enrolment, the rate of weight gain was calculated from the change of weight at hospital discharge to the end of study period. It was not possible to calculate WAZ during enrolment of patients with nutritional edema as it would not represent their actual Z score. To keep the uniformity of data, the change in LAZ was assessed from discharge to study completion.The effect of the supplements on the rate of weight gain of the infants as well as the change in LAZ from discharge to study completion was examined using multivariable linear regression models. The rate of weight gain model was adjusted for sex, age (in months), and WAZ at the time of discharge. The change in LAZ model was adjusted for sex, age (in months), and LAZ at the time of discharge. For a sensitivity analysis, we examined the effects of probiotic and synbiotic supplementation on weekly WAZ scores from the first week following enrollment to study completion in a mixed-effects multiple linear regression model specifying a random effect at the child level to account for within-child correlations. The mixed-effects model was adjusted for sex, age (in months), and WAZ at enrollment. We had 8 data points per infant in our total 8-week study period for WAZ. Three infants had edema in the first week following enrollment, so they were excluded and analysis were carried out on 64 infants. The strength of association was expressed as β (95% CI), where P < 0.05 was considered significant. | PMC9890433 |
Results | weight gain | A total of 67 SAM infants were included in the analysis. Out of 67 SAM infants, 23 infants were in the placebo group, 21 infants were in the probiotic group, and 23 infants were in the synbiotic group. Table Sociodemographic, anthropometric and clinical characteristics of SAM infants of different supplementation arms on admission.Table Rate of weight gain for SAM infants with three supplementations (from discharge to study completion).In the adjusted model, a significant increase in weight gain of 2.03 units was observed with the probiotic group compared to the placebo group. A lesser, but still significant increase in weight gain vs. placebo was also seen in the symbiotic group (Table Infant weight gain from discharge to study completion in Probiotic and Synbiotic Groups vs, placebo after adjustment for age during discharge from hospital, sex, WAZ during discharge from hospital.Change in infant length for age (LAZ) from discharge to study completion in Probiotic and Synbiotic Groups vs, placebo after adjustment for age during discharge from hospital, sex, LAZ during discharge from hospital.In the linear mixed-effect model the probiotic was significantly associated with the weekly change in WAZ after for adjusting sex, age and WAZ during the first week Table Linear mixed-effects models to identify the longitudinal effects of probiotic or synbiotic on WAZ (from the first week following enrollment to study completion).Placebo is the reference group. Adjusted for age on 1st week, sex, WAZ on 1 | PMC9890433 | |
Discussion | pneumonia, well-nourished, diarrhea, infections, weight gain, height gain, upper gastrointestinal system, sepsis, breast milk | VITAMIN DEFICIENCIES, PNEUMONIA, INFECTIONS, MALNOURISHED, MALNUTRITION, SEPSIS | There is paucity of studies assessing the impact of probiotic and synbiotic supplementation on rate of weight gain among young malnourished infants. In this respect, this is the first randomized clinical trial on probiotic and synbiotic supplementation in young infants with severe acute malnutrition. The most important finding of this study was that the infants supplemented with The mean rate of weight gain for SAM infants (discharge from hospital to study completion) was 4.35 g/kg/day in placebo arm, 5.90 g/kg/day in probiotic arm and 4.77 g/kg/day in synbiotic arm, with the rate for the probiotic arm being graded as moderate by WHOMore complex HMOs, LNT, and LNnT core can comprise up to 70% of total HMOsFollow-up after discharge from NRU can help to assess the growth and development of children. Previous studies have highlighted the mortality outcome after discharge from facility-based management of SAMThe importance of the gut microbiome in child growth has been well recognized in previous studies. Some probiotics may help to improve child growth indirectly through the prevention of infections and micronutrient and vitamin deficiencies (e.g., calcium, zinc and vitamin B12)The effect of a four-probiotic supplement (Synbiotic 2000 Forte) comprising The benefit of dietary intake of probiotics mixed with infant formula in terms of weight and height gain in malnourished children and possible benefits in terms of weight gain in well-nourished children in developing countries has been reviewedDietary carbohydrates, especially the fibre that is not digested in the upper gastrointestinal system, are known to boost growth and functionality of the gut microbiota communityWe have observed that probiotic supplements comprising A systematic review has shown the effect of different probiotics in different studiesWe have observed that approximately 15% of the study infants with SAM (n = 9) became sick and were shifted to the longer stay ward while on supplementation in NRU and then treated accordingly. When they became well and were discharged from hospital they continued with the study supplements at home. The reasons of transfer from the NRU were pneumonia (6 cases), diarrhea (2 cases) and sepsis (1 case). These infections were thought to be hospital acquired and the rate was similar to a previous study conducted in same settingOne limitation of the study was that the infants were only followed for a period of 8 weeks so longer term outcome effects of the supplements are unknown. We had no record on the volume of breast milk or infant formula during follow up period. We could not control the use of antibiotics during follow up period in the community as they may have visited local physicians or pharmaciess without informing the study staff. Although our research assistants collected data twice a week from SAM infants the actual intake of feed was not meticulously measured and we had to rely on the mothers’ information on diet and supplemetation. Daily visit of field staffs could minize these undue activities of caregivers. Finally, some of the infants started complementary feeding after 6 months and such feeding data were not included in the analysis.The findings from the study support the possibility of establishing a moderate weight gain in infants hospitalized with SAM by using a probiotic supplementation protocol comprising | PMC9890433 |
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-29095-w. | PMC9890433 | ||
Acknowledgements | MALNOURISHED, DISEASE, MALNUTRITION | Data were extracted from the study entitled, “Pilot of a prebiotic and probiotic trial in young infants with severe acute malnutrition” (NCT03666572). This research study was funded by Bill and Melinda Gates Foundation, USA (Grant no.: OPP1179599). icddr,b acknowledges with gratitude the commitment of Bill and Melinda Gates Foundation (BMGF) to its research efforts. icddr,b also gratefully acknowledges the following donors who provide unrestricted support: Government of the People’s Republic of Bangladesh; Global Affairs Canada (GAC); Swedish International Development Cooperation Agency (Sida) and the Department for International Development (UK Aid). We also acknowledge generous support with F-75 and F-100 formula used for the treatment of malnourished infants of the study by Hexagon Nutrition Limited, Maharashtra, India. The authors gratefully acknowledge these donors for their support and commitment to International Centre for Diarrhoeal Disease Research, Bangladesh’s research endeavours. | PMC9890433 | |
Author contributions | T.A. originated the idea for the study and led the protocol design. T.A., S.M.T.H., M.I., P.P., M.R.I., M.M., M.A.A., R.L.F., D.J.K. and S.N. participated in the design of the study and the data analysis plan. T.A., M.I., M.M., S.A.S., and S.N. were involved in the development of the study protocol. T.A., M.I., M.M., R.L.F., D.J.K., S.N., M.R.I., P.P. were involved in the implementation of protocol. All authors read and approved the final manuscript. | PMC9890433 | ||
Funding | This research study was funded by Bill and Melinda Gates Foundation, USA (Grant no: OPP1179599). The funders had no role in the study design, implementation, data collection, data analysis and manuscript drafting. | PMC9890433 | ||
Data availability | This data set contains some personal information of the study patients (such as name, admission date, month, area of residence). Thus, the policy of our center (icddr,b) is that we should not make the availability of whole data set in the manuscript, the supplemental files, or a public repository. Our IRB has required that the personal information of the participants is not disclosed. The data that support the findings of this study are available from Armana Ahmed (armana@icddrb.org) to the Research Administration of icddr,b ( | PMC9890433 | ||
Competing interests | The authors declare no competing interests. | PMC9890433 | ||
References | PMC9890433 | |||
Abstract | PMC10469752 | |||
Background | NPC | NASOPHARYNGEAL CARCINOMA, ORAL MUCOSITIS | To explore a new method to reduce radiation‐induced oral mucositis by scheduling radiotherapy for patients with nasopharyngeal carcinoma (NPC) in the corresponding time window of the cycle of oral mucosal cells. | PMC10469752 |
Methods | NPC | Eighty‐two NPC patients were randomly divided into a day group ( | PMC10469752 | |
Results | ORAL MUCOSITIS | The incidence of Grade 2 oral mucositis was 87.8% (36/41) and 63.4% (26/41) in the night group and day group, respectively ( | PMC10469752 | |
Conclusion | NPC | ORAL MUCOSITIS | By scheduling radiotherapy based on the corresponding time window of the cycle of oral mucosal cells, the severity of oral mucositis in NPC patients was reduced.
Jun Lv and Shibin Liao authors have contributed equally to this work and share the first authorship. | PMC10469752 |
INTRODUCTION | NPC, toxicities | NASOPHARYNGEAL CARCINOMA, ORAL MUCOSITIS, COMPLICATION | Radiotherapy serves as the main therapy for nasopharyngeal carcinoma (NPC). However, radiation‐related toxicities cannot be avoided, for example, oral mucositis during radiotherapy is a common complication in NPC patients.The normal operation during a cell cycle is mainly regulated by cyclins, protein‐dependent kinases, and protein‐dependent kinase inhibitors.Therefore, we designed a prospective randomized controlled study to observe the severity of oral mucositis and oral pain caused by radiotherapy in a corresponding time window of different cycles of oral mucosal cells and explore a new method to reduce radiation‐induced oral mucositis in NPC patients. | PMC10469752 |
METHODS AND MATERIALS | PMC10469752 | |||
Study design | NPC, pain | ORAL MUCOSITIS | The study, as a prospective randomized clinical trial, aims to compare the severity of oral mucositis and the degree of oral pain in NPC patients treated with radiotherapy at different time points during the cycle of oral mucosal cells. The clinical trial was approved by the Ethics Committee of the First Affiliated Hospital of Guangxi Medical University and successfully registered with the China Clinical Trial Registry (ChiCTR2100047661). All the patients signed an informed consent form before treatment was started. | PMC10469752 |
Patients | treatment‐naive NPC, infection, liver and kidney function, bone marrow dysfunction, abnormal sleep habits, Cancer | MUCOSAL DISEASE, BLEEDING TENDENCY, INFECTION, DISEASES OF THE HEART, DISEASES, CANCER | A total of 82 treatment‐naive NPC patients, who were diagnosed by pathological biopsy in our hospital from August 2019 to December 2020, were included in this study. The inclusion criteria include treatment‐naive NPC patients with a Karnofsky Performance Status (KPS) score ≥ 70 points; patients who received intensity‐modulated radiation therapy (IMRT); patients with normal oral mucosa; patients who did not receive other anti‐tumor treatment before radiotherapy or chemotherapy, patients without serious diseases of the heart, lung, liver, and kidney; and patients who voluntarily signed the informed consent. The exclusion criteria include patients with abnormal sleep habits, oral mucosal injury, or oral mucosal diseases which may affect observation before radiotherapy in case of active infection; patients with a bleeding tendency or immune diseases; patients who lack self‐thinking and expression ability; patients who are unable to complete oral scoring criteria; and patients with severe bone marrow dysfunction.The eighth edition criteria issued by the Union for International Cancer Control (UICC) were referred for clinical staging in the study.All the patients underwent dental evaluation before radiotherapy, and nasopharyngoscopy was completed for all of them. Their imaging examinations included enhanced MRI of the nasopharynx and cervical soft tissues, chest CT, whole‐body bone scan, and abdominal ultrasound or abdominal CT. If required, whole‐body PET/CT would be performed. Hematological evaluation (platelet count ≥100,000/μL, hemoglobin ≥10 gm/dL, and absolute neutrophil count ≥1500/μL), liver and kidney function evaluation (serum bilirubin, alanine aminotransferase, aspartate aminotransferase equal to or 1.5 times higher than the upper limit of normal, endogenous creatinine clearance ≥60 mL/min) would be performed. | PMC10469752 |
Radiotherapy | PMC10469752 | |||
Delineating target volume | tumor, primary tumors, palate | TUMOR, METASTASIS, PRIMARY TUMORS, INNER EAR, OPTIC NERVE, NASOPHARYNGEAL CARCINOMA, LENS, PRIMARY TUMOR | Gross tumor volume of nasopharyngeal carcinoma (GTVnx) refers to the area of primary tumors in the nasopharynx observed in clinical practice and various imaging studies. Gross tumor volume of cervical node (GTVnd) refers to the area of enlarged lymph nodes observed in clinical practice and/or imaging studies. The clinical target volume (CTV) range is mainly divided into high‐ and low‐risk areas according to the local progression of NPC. Clinical target volume 1 (CTV1) is defined as the adjacent area around a primary tumor that is very likely to be invaded by the tumor or the area to which the tumor is very likely to metastasize. Clinical target volume 2 (CTV2) is defined as a lymph node region with possible metastasis deduced from the biological behavior of a tumor, including the cervical lymphatic drainage area without metastatic lymph nodes.Organs at risk (OAR) should be delineated by including the brainstem, cervical spinal cord, temporal lobe, optic nerve, optic chiasm, pituitary gland, lens, temporomandibular joint, mandible, inner ear, and parotid gland.Oral delineation ranged from the hard palate to the floor of the mouth, from the buccal mucosa around the teeth to the lingual surface and uvula. | PMC10469752 |
Preparing dose prescription, and submitting, designing, and evaluating plan | All patients received IMRT. The prescribed dose was 68–72 Gy, 68–70 Gy, 60–62 Gy, and 54–56 Gy, in 30–32 fractions, for the planning target volumes derived from GTVnx, GTVnd, CTV1, and CTV2, respectively. QUANTEC (2012 Standard) was referred for limiting dose to OAR. | PMC10469752 | ||
Radiotherapy schedule | NPC | Eighty‐two NPC patients were randomly divided into two groups, a day group, and a night group, according to the corresponding period of different cycles of human oral mucosal cells during a day. Radiotherapy was scheduled for the patients in the two groups between 11:30 ~ 15:30 (S phase) at noon and 19:00 ~ 23:00 (M phase) at night, respectively. | PMC10469752 | |
Chemotherapy | toxicity, hematological toxicity, hepatorenal function impairment | ORAL MUCOSITIS | A chemotherapy regimen might be concurrent chemotherapy or induction chemotherapy plus concurrent chemotherapy. In this study, the observation of oral mucositis was terminated at the end of radiotherapy. All patients used a 3‐week regimen of platinum‐based drugs. Chemotherapy was suspended if severe hematological toxicity or hepatorenal function impairment occurred during treatment. Symptomatic and supportive treatment was performed in time for acute toxicity. The treatment plan was delayed or stopped according to the patient's condition, if necessary. | PMC10469752 |
Evaluation criteria | PMC10469752 | |||
Scoring mucosal injury | ONCOLOGY | According to the grading criteria for acute mucosal reactions in the Evaluation Criteria for Acute Radiation Injury, issued by the Radiation Therapy Oncology Group (RTOG), | PMC10469752 | |
Grading pain response | According to the Verbal rating scale (VRS), | PMC10469752 | ||
Management of oral mucositis | pain | After agreeing to join the study, the patients were asked to keep oral hygiene, brush their teeth in the morning and evening, and rinse their mouths after each meal. Once the radiotherapy was started, the patients should gargle with Compound Borax Solution/baking soda daily. Non‐steroidal anti‐inflammatory drugs were given for pain relief as oral pain worsened. Radiotherapy should be suspended if there were Grade 4 oral mucosal reactions. | PMC10469752 | |
Statistical analysis | In this study, SPSS 23.0 was used for the statistical analysis of the data. All normal measurement data were expressed as mean ± standard deviation, and the independent normal and equal variance data of the two groups were compared with the t‐test of two independent samples. All the computing data were expressed as case numbers and percentages. The chi‐square test was used for comparison between the two groups, and the continuous correction chi‐square test was adopted when there was 1 < theoretical frequency (T) < 5. The test level α = 0.05 was taken in the statistical analysis. | PMC10469752 | ||
RESULTS | PMC10469752 | |||
Baseline data of patients | NPC, carcinoma | CARCINOMA | A total of 82 NPC patients diagnosed in our hospital were included in this study. Of them, 62 (75.6%) were male and 20 (24.4%) females, with an average age of 48.29 ± 12.62 years. There were 12 patients in stages I and II, and 70 in stages III and IV. Their chemotherapy regimen was induction chemotherapy plus concurrent chemotherapy or concurrent chemotherapy, and the pathological type was undifferentiated non‐keratinizing carcinoma for most of the patients. The differences in the general data had no statistical significance (Basic data statistics of research objects. | PMC10469752 |
Comparison of the severity of oral mucositis | ORAL MUCOSITIS | In the night group, 41 patients reported Grade 1 oral mucositis, 36 ones Grade 2 oral mucositis, and 27 ones Grade 3 oral mucositis during the radiotherapy; the incidence of Grade 2 and 3 oral mucositides was 87.8% (36/41) and 65.9% (27/41), respectively. In the day group, 41 patients reported Grade 1 oral mucositis, 26 ones Grade 2 oral mucositis, and 9 ones Grade 3 oral mucositis during the radiotherapy; the incidence of Grade 2 and 3 oral mucositides was 63.4% (26/41) and 22.0% (9/41), respectively. The incidence of Grade 2 and 3 oral mucositides was lower in the day group than that in the night group, and the differences were statistically significant (Incidence of acute oral mucositis during radiotherapy in the two groups ( | PMC10469752 | |
Comparison of the onset time of oral mucositis | mucositis | MUCOSITIS, ORAL MUCOSITIS | As the exposure dose was increased in the radiotherapy, the cumulative incidence of Grade 2 and 3 oral mucositis gradually increased in the patients of the two groups (as shown in Figure Cumulative incidence of Grade 2 mucositis in the night and day groups during radiotherapy.Cumulative incidence of Grade 3 mucositis in the night and day groups during radiotherapy.The mean value of radiotherapy for the patients to develop Grade 2 oral mucositis was 15.67 ± 5.05 and 20.92 ± 6.21 in the night group and the day group, respectively. Compared with the night group, the patients needed more exposure to develop Grade 2 oral mucositis in the day group, which also meant that the time to develop Grade 2 oral mucositis was significantly delayed for the day group. Their difference was statistically significant ( | PMC10469752 |
Comparison of oral pain severity | pain | Forty patients reported Grade 1 oral pain, 20 ones Grade 2 oral pain, and 2 ones Grade 3 oral pain in the night group so that their incidence of Grade 2 and 3 oral pain was 48.8% (20/41) and 4.9% (2/41), respectively; while 40 patients reported Grade 1 oral pain, 9 ones Grade 2 oral pain, and 1 one Grade 3 oral pain in the day group so that their incidence of Grade 2 and 3 oral pain was 22.0% (9/41) and 2.4% (1/41), respectively. The incidence of Grade 2 oral pain was lower in the day group compared with the night group, and the difference was statistically significant (Analysis of the onset of oral pain in the two groups during radiotherapy ( | PMC10469752 | |
Tumor regression | SD | DISEASE | Within 1 month after the radiotherapy, 3 patients achieved complete response (CR), 36 achieved partial response (PR) and 2 ones achieved stable disease (SD) in the night group, with a CR rate and PR rate of 7.3% (3/41) and 87.8% (36/41), respectively, while five patients achieved CR, 35 ones PR and 1 one SD in the day group, with CR rate and a PR rate of 12.2% (5/41) and 85.4% (35/41), respectively. The overall response rate (ORR = CR + PR) of the patients was 95.1% (39/41) and 97.6% (40/41) in the night group and day group, respectively.The differences in CR rate, PR rate and ORR were not statistically significant between the night group and day group (Evaluation of the curative effect in the two groups within one month after radiotherapy ( | PMC10469752 |
Comparison of bone marrow suppression and weight loss | weight loss, bone marrow suppression | BONE MARROW SUPPRESSION | During the radiotherapy, 17 patients experienced Grade 1 bone marrow suppression, 16 ones Grade 2 bone marrow suppression, and 7 ones Grade 3 bone marrow suppression in the night group so that their incidence of Grade 2 and Grade 3 bone marrow suppression was 39.0% (16/41) and 17.1% (7/41), respectively; while 15 ones Grade 1 bone marrow suppression, 13 ones Grade 2 bone marrow suppression, and 11 ones Grade 3 bone marrow suppression in the day group, so that their incidence of Grade 2 and Grade 3 bone marrow suppression was 31.7% (13/41) and 26.8% (11/41), respectively. There was no statistical significance in the incidence difference of Grade 2 and 3 bone marrow suppression between the two groups (χOnset of bone marrow suppression in the two groups during radiotherapy (The mean weight loss after radiotherapy was 6.38 ± 2.85 kg and 5.53 ± 2.40 kg in the night group and day group, respectively. There was no statistical significance in the difference in such mean weight loss between the two groups ( | PMC10469752 |
DISCUSSION | tumor, NPC, cancer, toxicity, pain, bone marrow suppression, weight loss | TUMOR, ORAL MUCOSITIS, PRIMARY TUMOR, CANCER, DISEASES, DISEASE, BONE MARROW SUPPRESSION, ADVERSE EFFECTS, CAVITY, ULCERATION, REGRESSION, PATHOGENESIS | In clinical practice, the vast majority of NPC patients would experience varying degrees of oral mucositis during radiotherapy, and the incidence of severe radiation‐induced oral mucositis ranges from 20% to 40%.The pathogenesis of oral mucositis resulting from concurrent chemo‐radiotherapy is mainly divided into five stages, namely, initiation, upregulation/activation, signal amplification, ulceration, and healing stages.Due to the rotation of the earth, organisms constantly cycle during daytime and nighttime, and most of them have their circadian rhythms, which regulate the body's physiological and metabolic processes to adapt to different times in the day.In this study, based on the cycle of oral mucosal cells, radiotherapy was scheduled in the corresponding time window of the cell cycle according to the different cycle distribution patterns of oral mucosal cells in a day, to explore a new method to reduce radiation‐induced oral mucositis in NPC patients. We found that Grade 2 and 3 oral mucositis caused by radiotherapy at noon (11:30 ~ 15:30) was milder than that caused by radiotherapy at night (19:00 ~ 23:00), and the occurrence time of Grade 2 oral mucositis after radiotherapy conducted at noon was also delayed compared with radiotherapy conducted at night. We also found that the incidence of Grade 2 oral pain caused by radiotherapy conducted at noon was milder than that caused by radiotherapy conducted at night. There was no significant difference in the short‐term efficacy of tumor regression between the day group and night group, nor in the degree of bone marrow suppression or weight loss during treatment.Bjarnason et al.Fang Yi et al.In addition, the cases in previous studies include a variety of diseases, and the anatomical location of the primary tumor is different, which may affect the reliability of the research conclusions. With sufficient disease sources, Guangxi, China is of a high incidence of NPC. In our study, NPC was studied by separately selecting the relatively fixed locations of the primary tumor and relatively the same exposure dose to the oral cavity. At the same time, it was analyzed when there was no significant difference in the exposure dose to the oral cavity between the two groups, so the correlation between radiation‐induced oral mucositis and radiotherapy time window in NPC patients was demonstrated in a comparably better manner.Oral pain score is generally related to the severity of oral mucositis.Previous studies have shown that weight loss due to radiotherapy has adverse effects on the prognosis of NPC patients.Since bone marrow suppression was mainly caused by chemotherapy and there was no significant difference in the number of patients undergoing concurrent chemotherapy between the two groups, there was no significant difference in the degree of bone marrow suppression between the two groups.At the same time, we also compared the tumor regression between the two groups, and there was no significant statistical difference in this regard in the two groups, either. This indicates that radiotherapy at the different time points of the cycle of oral mucosal epithelial cells does not affect the short‐term efficacy of cancer treatment.This study has several limitations. Due to time constraints, we included a small number of cases. Also, due to machine failure, working system, and staffing, we could not ensure that all radiotherapy operations for the patients were scheduled within the predetermined period, but have ensured that over 90% of radiotherapy operations for all the patients were conducted within the predetermined period. We will also count the differences in the relapse rate and overall survival rate of patients between the two groups in the future. In addition, the duration and recovery time of oral mucositis of patients after radiotherapy were not further tracked, therefore, they need to be further explored in future studies.In summary, our results suggest that by scheduling radiotherapy based on the corresponding time window of the cycle of oral mucosal cells, the severity of oral mucositis and oral pain was reduced in NPC patients during radiotherapy. It neither affected the efficacy nor increase treatment toxicity. Therefore, this radiotherapy mode might be an effective way to reduce radiation‐induced oral mucositis but not increase the cost in NPC patients. | PMC10469752 |
AUTHOR CONTRIBUTIONS | PMC10469752 | |||
FUNDING INFORMATION | Not applicable. | PMC10469752 | ||
CONFLICT OF INTEREST STATEMENT | All authors made no disclosures. | PMC10469752 |
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