The Effect of Gastric Botox on Body Weight Loss: A Clinical Experience

doi:10.21203/rs.3.rs-4492954/v1

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The Effect of Gastric Botox on Body Weight Loss: A Clinical Experience

https://doi.org/10.21203/rs.3.rs-4492954/v1

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Backround/Aims:

This retrospective cross-sectional study aimed to evaluate the efficacy of gastric botulinum toxin A (BTX-A) injection in the treatment of obesity. Anthropometric changes, diet adaptation, Early feelings of satiety, and constipation status were analyzed in the injected patients during a sixteen-week period.

Materials and Methods

A sample of this study consists of 31 female patients who received BTX-A injections between January and March 2023. Patients' information was accessed from patient follow-up files. The file includes sociodemographic information, anthropometric measurements, dietary adaptation data measured by visual analog score, and data on satiety and constipation. A diet containing 1000 calories of 40% carbohydrates, 25% protein, and 35% fat was given to the patients by the dietitian. The results were calculated with the SPSS 22.0 program and interpreted at a 95% confidence level.

Results

500 U BTX-A injection was effective in reducing body weight, BMI, fat mass and fat percentages. There was a loss of 5.12 kg in body weight and a decrease of 1.8 points in BMI. An important part of weight loss in the body is adipose tissue. There was no significant loss of fat-free mass. Diet adaptation and early satiety were less in the sixteenth week than in the first weeks.

Conclusion

BTX-A injection is effective in losing body weight, BMI, and fat mass together with diet therapy. It is thought that it can be applied in the treatment of obesity together with diet in patients who are suitable for injection. btx-a injection also increases the diet compliance of patients who do not comply with the diet.

botulinum toxin A

weight loss

diet

diet adaptations

early feelings of satiety

1- Gastric BTX-A injection is a method that can be used for weight reduction and obesity treatment.

2- Gastric BTX-A injection is a safe method.

3- Gastric BTX-A injection better results can be obtained when the application is supported with exercise.

Obesity is a chronic disease that occurs due to an increase in body fat mass as a result of more energy intake than energy expenditure. Genetic predisposition, living in an obesogenic environment and low physical activity are the main factors leading to obesity. In addition, obesity is a significant disease that increases the risk of all-cause and cardiovascular events and deaths. On the other hand, it is a significant risk factor that increases the frequency of hypertension, dyslipidemia, type 2 diabetes mellitus, stroke, gallbladder diseases, osteoarthritis, sleep apnea syndrome, and some types of cancer(1).

According to the Turkey Health Survey 2022, the rate of obese individuals aged 15 years and older in Turkey is 20.2%. In women, 23.6% of the population is obese, and 30.9% is pre-obese. Obesity is much higher in women than in men in Turkey(2). Worldwide, obesity has tripled since 1975. More than 2.8 million deaths occur each year due to obesity-related health problems. Obesity, which has become an epidemic in the world, is now a serious public health problem for all countries(1).

Various treatment options have been developed to achieve body weight loss in the treatment of obesity. The first option is to provide lifestyle modification including nutritional therapy and increased physical activity. The Turkish Society of Endocrinology and Metabolism (TEMD), in its Obesity Diagnosis and Treatment Guideline, states that a body weight loss of more than 5% should be achieved after a three-month program to achieve a clinically significant reduction in risk factors. Therefore, TEMD has placed energy restriction at the center of obesity treatment. It emphasized the need to create a 500–1000 calorie deficit in dietary energy intake with the addition of exercise to the daily routine(3).

Pharmacologic treatments and surgical intervention can be performed in individuals who are not successful in lifestyle change treatment. In recent years, gastric botulinum toxin A (BTX-A) injection has come to the fore as a minimally invasive procedure before surgical intervention.

BTX-A is a neurotoxic protein produced by Clostridium botulinum, a gram-positive anaerobic bacterium that potently inhibits muscle contraction by blocking the release of acetylcholine(4). Gastric BTX-A injection delays gastric emptying by inhibiting gastric contraction movements that allow food to pass through the pylorus, and also inhibits the secretion of the hormone ghrelin secreted from the stomach, causing loss of appetite and a feeling of satiety. In clinical trials, BTX-A 200–500 U is injected intramuscularly(5).

Gastric BTX-A injection seems to be a preferable treatment option for obese patients who are not successful in lifestyle change but do not meet the appropriate criteria for surgical intervention or do not want to undergo surgery. BTX-A is a minimally invasive procedure. It is injected into the antrum, corpus, and fundus of the gastric. Its effect ends in approximately 3–6 months. The patient loses approximately 6–20 kg of body weight during this period. A 10% reduction in body weight significantly reduces the risks associated with obesity(6).

BTX-A injection is an endoscopic obesity treatment option that delays gastric emptying. However, there is little conflicting information on the treatment efficacy of BTX-A injection(7). This study aims to evaluate the efficacy of BTX-A injection in the treatment of obesity in a retrospective descriptive and cross-sectional study.

Method, sample size, and time

This is a retrospective cross-sectional study. Gastric BTX-A injection was started to be performed in Kastamonu Training and Research Hospital as of January 2023. However, as of March 2023, patient intake was discontinued due to complication notifications made to the Ministry of Health throughout the country. During this period, 33 female and 1 male patients underwent BTX-A injection at Kastamonu Training and Research Hospital and were followed up in the diet outpatient clinic for sixteen weeks.These patients were called for a check-up once a week fort he first month and once a month thereafter. The data were strictly recorded. Thirty-one patients were included in the study.

Data collection

Individuals' information was accessed from patient follow-up files. The patient file contains data on anthropometric measurements and nutrition follow-up. Individuals' information was accessed from patient follow-up files.

Inclusion and exclusion criteria

Over 18 years of age, uncomplicated individuals with a Body Mass Index (BMI) of 30 kg/m2 and above received BTX-A injections.

Male patients were excluded to ensure homogeneity because men have different body composition compared to women and this affects body weight loss. 2 female patients were also excluded from the study due to incomplete files.

Gastric BTX-A procedure

BTX-A injection is administered to each of the antrum, corpus, and fundus regions of the stomach with a sclerotherapy needle diluted with 10 ml 0.9% saline for a total of 500 U under sedation. Dysport brand BTX-A is injected intramuscularly at 20 points in the antrum and corpus, 20 points in the fundus, and 0.5 ml in each point. Patients are kept under observation for 4 hours after the procedure.

Follow-up of Patients in Diet Polyclinic

Sociodemographic and health information and anthropometric measurements are taken from patients referred to the Diet Outpatient Clinic. Oral intake is opened after 2.5-3 hours. A liquid diet is applied for the first 72 hours, and the diet is gradually opened for the next 72 hours and the diet is switched to a normal diet. After 1 week, the patients were called for follow-up and given a 1000-calorie diet containing 40% carbohydrate, 25% protein, and 35% fat. Patients were called to the nutrition and diet outpatient clinic for follow-up at the fourth and sixteenth weeks. Diet compliance, early feelings of satiety, constipation, body weight loss, and body composition were monitored.

Body weight, BMI, and body composition were measured with a Densi GL 150 height meter and Tanita TBF-300 bioelectrical impedance analyzer (BIA). Patients were measured in thin clothes and without shoes.

Dietary compliance was assessed by a visual analog scale (VAS)(8). The VAS is a 10 cm long ruler with 10 equally spaced sections. The last end is numbered as 0 and the rightmost end is numbered as 10. The individuals participating in the study mark their dietary compliance on this ruler. As the mark approaches 0, dietary compliance decreases, and as it approaches 10, it increases. The feeling of fullness and constipation was determined according to the patient's "yes or no" statement.

Statistical Analysis

The data were analyzed with SPSS 22.0 program. The normality test of the numerical data was interpreted based on skewness and kurtosis values (-1.5 - +1.5). Friedman's test, repeated measures ANOVA, and Cochran's Q test were used for comparisons according to the test results. For post-hoc analyses, pairwise comparisons were made, and Wilcoxon Signed Rank test, Bonferroni correction, and McNemar tests were used. Data were interpreted at 95% confidence level.

The mean age of the individuals included in the study was 38.58 ± 7.55 years. 83.87% of the participants were married. Anthropometric measurements, and diet adaptation of the individuals are given in Table 1, and early feelings of satiety and constipation are given in Table 2.

Table 1

Evaluation of anthropometric measurements and dietary adaptation of individuals
Parameteres	Preoperative (1)		1. week (2)		4. weeks (3)		16. weeks (4)		χ2/F	p	Significancy
Parameteres	Mean ± SD	Median (Q₁-Q₃)	Mean ± SD	Median (Q₁-Q₃)	Mean ± SD	Median (Q₁-Q₃)	Mean ± SD	Median (Q₁-Q₃)	χ2/F	p	Significancy
Body weight (kg)	92,33 ± 15,68	87,9 (81,8–97,95)	88,8 ± 15,36	85,4 (79,7–94,8)	85,69 ± 15,8	82,7 (77–90)	87,21 ± 14,58	83,5 (78,85–93,93)	45,505 _χ2	< 0,001** _a	1 > 2,3,4 2 > 3
Body Mass Index (kg/m²)	36,84 ± 6,36	34,75 (32,7–41,28)	35,62 ± 6,27	33 (31,2–38,6)	34,3 ± 6,64	31,9 (30–37,1)	35,04 ± 5,84	33,25 (31,13–38,28)	41,136 _χ2	< 0,001** _a	1 > 2,3,4 2 > 3
Fat Percentace (%)	44,84 ± 5,05	44,55 (40,85 − 48,73)	44,67 ± 5,37	43,6 (41,3–46,6)	43,52 ± 6,21	41,7 (39,8–47)	42,02 ± 4,78	41 (38,05–43,88)	24,811 _χ2	< 0,001** _a	1 > 4 2 > 3,4
Fat Mass (kg)	41,89 ± 11,35	38,15 (33,55 − 49,25)	40,37 ± 11,92	36,4 (32,1–44,2)	38,03 ± 12,66	34,4 (29,5–42,4)	37,36 ± 11,15	33,9 (30,3–38,95)	25,938 _χ2	< 0,001** _a	1 > 2,3,4 2 > 3,4
Fat Free Mass (kg)	49,49 ± 6,73	49,15 (45,93 − 52,6)	47,92 ± 6,61	48,2 (44,6–50,6)	47,64 ± 4,84	47,4 (44,8–49,7)	49,3 ± 5,84	48,7 (45,95 − 51,58)	12,427 _χ2	0,006* _a	1,4 > 2,3
Body liquit (kg)	36,98 ± 4,96	36,05 (33,73 − 38,25)	36,26 ± 4,97	35,4 (33–38,6)	35,67 ± 5,31	35,4 (32,4–37,8)	37,13 ± 4,65	35,9 (34,03–38,6)	25,720 _χ2	< 0,001** _a	4 > 2,3
Diet adaptation (VAS)	ND	ND	7,9 ± 1,95	8 (7–9)	7,17 ± 2,91	8 (5–10)	2 ± 2,33	1 (0–4)	63,003 _F	< 0,001** _b	1,2 > 3
a:Friedmann Test; b:Repeated Measures ANOVA; :p < 0,01; *:p < 0,001; Significancy: Wilcoxon Signed Rank
ND: No data

Table 2

Evaluation of individuals' early feelings of satiety and constipation in the postoperative weeks
Parameteres		1. week	4. weeks	16. weeks	P
Parameteres		n (%)	n (%)	n (%)	P
Early feelings of satiety	Yes	23 (74,19)	28 (90,32)	2 (6,45)	< 0,001*
Early feelings of satiety	No	8 (25,81)	3 (9,68)	29 (93,55)	< 0,001*
Constipation	Yes	5 (16, 12)	8 (25,80)	5 (16,12	0,717
Constipation	No	26 (83,88)	23 (74,20)	26 (83,88)	0,717
Cochran’s Q test; :p < 0,001*

In this study, statistically significant differences were found between body weight, BMI, fat percentage, fat mass, lean mass, and body fluid. From preoperative to the sixteenth week, an average body weight loss of 5.12 kg was achieved. This corresponds to a body weight loss of 5.55%. The highest body weight loss during this period was 23.7 kg (20.68% of total body weight). The lowest body weight loss was 0.2 kg. The loss in fat mass was 4.53 kg at week sixteen. There was no statistically significant loss in lean tissue between baseline and week sixteen (p > 0.001).

Early satiety was significantly less in the sixteenth week compared to the others. There was no significant difference between week one and week four (p = 0.125 > 0.05).

BTX-A injection for the treatment of obesity changes dietary intake by delaying gastric emptying and reducing appetite. The results of studies on the efficacy of BTX-A are contradictory. While some studies reported that it was effective, some studies reported that it was not effective(4, 5, 7, 9). In this study, body composition, diet compliance, and feeling of satiety were evaluated in individuals administered BTX-A.

For BTX-A used in the treatment of obesity, the doses used and the site of injection are important. Generally, the administration dose ranges from 20 U to 500 U and is injected into the antrum, corpus, and fundus regions of the stomach(7). Topazian et al. injected BTX-A at two different doses, 100 U and 300 U(10). The 300 U administration was reported to significantly increase satiety and was associated with body weight loss. In this study, patients who received a total of 500 U BTX-A in the antrum, corpus, and fundus regions of the stomach were evaluated.

In a systematic review, Yen et al. examined the data of 192 patients with 6 randomized controlled trials(7). 200 U and above BTX-A injection was reported to be effective in the treatment of obesity and diet control was reported to be very important. Kaya et al. performed BTX-A injections in 56 patients(11). Patients were on a liquid diet for the first 72 hours after the procedure and then received a 1200-calorie diet containing 30% carbohydrate, 30% protein, and 40% lipid for 6–9 months. The patients were called for dietary control every three weeks. At the end of the study, a mean body weight loss of 9 kg was achieved. Şen and Türkçapar administered a 1200 calorie low carbohydrate diet for six months to 13 patients who received BTX-A injections(12). At the end of six months, a mean body weight loss of 3.3 kg was achieved, 4 patients lost 50% of their excess body weight, while 6 patients failed to lose body weight. Researchers reported that BTX-A administration did not give effective results. Hsu et al. administered a low-energy, high-protein diet for twelve weeks to patients with and without BTX-A injections(13). At the end of the study, body weight loss was 11.5% in the BTX-A group and 1.8% in the diet group. In this study, patients were given a 1000-calorie diet containing 40% carbohydrate, 25% protein, and 35% fat after BTX-A administration and were followed up for sixteen weeks. The mean body weight was 92.33 ± 15.68 kg at baseline, 88.8 ± 15.36 kg at week one, 85.69 ± 15.8 kg at week four, and 87.21 ± 14.58 kg at week sixteen. Body weight loss was statistically significant (p < 0,001). In this duration, a body weight loss of 5.12 kg was achieved from preoperative to week sixteen. This corresponds to a loss of 5.55% of total body weight. TEMD recommends a body weight loss of more than 5% in a three-month program(3).

Gameel et al. injected a 100 U BTX-A in 25 patients with BMI over 30. At the end of sixteen weeks, an 11.92 kg (10.8%) reduction in body weight and 4.5 points reduction in BMI were reported, and the results were statistically significant(14). In a randomized controlled clinical trial conducted in Brazil, super obese patients received 200 U BTX-A or 0.9% saline injection. Followed every month for six months, it was reported that significant body weight loss was achieved in both groups compared to baseline, but neither body weight nor BMI loss was significant between the groups. It was concluded that BTX-A injection was not effective in super-obese patients(15). Kanlıöz and Ekici administered a hypocaloric diet to 178 patients who received 200 U BTX-A injections and followed them for six months(16). At the end of 6 months, BMI reduction was not statistically significant. However, when classification was made by paying attention to pyloric tone, it was reported that the BMI loss of patients with normotonic pyloric structure was statistically significant. Therefore, Kanlıöz and Ekici suggested that pyloric tone should be considered when performing gastric BTX-A and BTX-A should be performed in patients with normotonic pyloric structure. In this study, while the mean BMI was 36.84 ± 6.36 kg/m2 before BTX-A administration, it decreased to 35.62 ± 6.27 kg/m2 after one week and to 34.3 ± 6.64 kg/m2 after four weeks. At the end of the sixteen weeks, the mean BMI was 35.04 ± 5.84 kg/m2. There was a statistically significant between preoperative BMI and first week, four weeks, and sixteen weeks BMI results (p < 0.001). However, in this study, no data on pyloric tone were included in the patient follow-up file. It is thought that pyloric structure should be taken into consideration in future studies.

One of the important findings of this study is that patients who received BTX-A injections had BIA results. This information shows whether the body weight loss of the patients was from adipose tissue. In diet therapy, it is recommended that body weight loss should be mainly from adipose tissue, with minimal loss of non-adipose tissue(17). In this study, fat mass decreased from 41.89 ± 11.35 kg during the preoperative to 37.36 ± 11.15 kg in the sixteenth week, which was statistically significant (p < 0.001). At the end of this period, a fat tissue loss of 4.53 kg was achieved. Non-fat tissue was 49.49 ± 6.73 kg at baseline and 49.3 ± 5.84 kg at the sixteenth week. The loss of fat-free mass at baseline and week sixteen was statistically insignificant. This result shows that body weight loss was achieved from fat. This result can also be seen from the fat ratio data. While the fat ratio at preoperative was 44.84 ± 5.05 kg, it was 42.02 ± 4.78 in the sixteenth week. The difference is statistically significant (p < 0.001). When body fluid mass was evaluated, there were no statistically significant results at the preoperative of the study and the sixteenth week, while the difference between the sixteenth week and the first and fourth weeks was significant (p < 0.001). Loss of body fluid during the first weeks of the diet is an expected outcome(3). Torralvo et al. reported that body fat percentage and fat mass decreased significantly in patients treated with BTX-A compared to the control group. No significant difference was found between the groups in lean body mass(18).

Ferhatoğlu et al. also evaluated diet adaptation with VAS(19). It was observed that diet adaptation was higher in the BTX-A and high-protein diet group compared to patients who received only diet or only BTX-A. In this study, diet adaptation was evaluated with VAS. It was found that diet adaptation was statistically significantly higher in the first and fourth weeks compared to the sixteenth week (p < 0.001). The main reason for reduced dietary adherence over time may be that following a low-energy diet is not a sustainable dietary modal for long periods of time(3).

Gök et al. administered BTX-A to 67 patients and were followed up for one year(20). A mean body weight loss of 26 kg was achieved, and 85% of the patients reported early satiety. Torralvo et al. evaluated the patients in terms of satiety perception and appetite biomarkers(18). They reported that VAS at 2,4,8,16, and 24 weeks was not significant between the groups. Similarly, Kaya et al. reported that 87.5% of patients had decreased appetite and early feelings of satiety(11). In this study, early satiety was significantly less in the sixteenth week compared to the others. There was no significant difference between week one and week four. Considering that BTX-A administration maintains its efficacy for approximately 16–20 weeks, it is possible that the feeling of satiety decreases in the sixteenth week(21). In addition, the decreased efficacy of BTX-A, a long-term low-energy diet may have triggered hedonic hunger in patients(22). This may also cause a decrease in the feeling of satiety. In this study, BTX-A did not affect constipation. Hsu et al. reported that 24.4% of the participants had constipation in their study(13). Although constipation is a common symptom in BTX-A, its absence in these patients may be due to regular dietary monitoring.

BTX-A injection stands out as a frequently used method in the treatment of obesity in Turkey in recent years. It is thought to be preferred because of its effects such as being a minimally invasive procedure and reducing appetite(5, 11, 20). In this study, no complications developed among the individuals. However, the BTX-A injections should not be considered risk-free. The small number of participants in this study and the fact that BTX-A was administered only once can be considered as limitations of the study. More effective body weight loss can be achieved with regular injections. On the other hand, the diet and anthropometric measurements of the patients were followed up under the control of a dietician after BTX-A administration. We recommend that patients should be followed up by a dietitian after BTX-A administration. In this study, diet compliance, the feeling of satiety, and constipation status were evaluated according to a patient declaration. For future studies, dietary compliance can be evaluated by taking food consumption records. Since there was no such data in this study, no evaluation could be made.

BTX-A injections are effective in reducing body weight, BMI, fat mass, and fat ratio in obesity treatment. There was an average body weight loss of 5.12 kg and a 1.8-point decrease in BMI in sixteen weeks. A significant portion of body weight loss was achieved from adipose tissue. However, dietary adaptation and early satiety decreased at sixteen weeks. BTX-A injection provides positive results in the treatment of obesity by increasing diet compliance,especially in patients who are non-compliant with the diet.

Ethics Committee Approval: Ethical approval was optained from Kastamonu University Clinical Research Ethics Committee (date of 05.07.2023 and decree number of 2023-KEAEK-65). This article does not contain any studies with human participants or animals performed by any of the authors

Informed Consent: -

Peer-review: -

Declaration of Interests: The authors have no conflict of interest to declare.

Funding: This study received no funding

Author Disclosures: Authors have no conflicts of interest or financial ties to disclose.

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No competing interests reported.

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The Effect of Gastric Botox on Body Weight Loss: A Clinical Experience

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Abstract

Backround/Aims:

Materials and Methods

Results

Conclusion

Main Points

INTRODUCTION

MATERIALS AND METHODS

Method, sample size, and time

Data collection

Inclusion and exclusion criteria

Gastric BTX-A procedure

Follow-up of Patients in Diet Polyclinic

Statistical Analysis

RESULTS

DISCUSSION

CONCLUSION

Declarations

References

Additional Declarations

Status:

Version 1