Yogic gut aeration techniques to inhibit Helicobacter pylori-induced acid peptic diseases: A pilot randomized controlled trial

Abstract

Background

The most common cause of acid-peptic diseases (APDs) is Helicobacter Pylori (H. pylori) infection. Conventionally, proton–pump inhibitors (PPIs) are used to manage hyperacidity and dyspepsia. PPIs’ persistent use can lead to bacterial resistance, side effects, poor quality of life (QoL), and increased economic burden. H. pylori, being microaerophilic, can be inhibited by gut aeration. Therefore, yogic gut aeration techniques (YGATs) may be a potential option to mitigate H. pylori-induced APDs and reduce medication doses and economic burden.

Objective

The study aimed to determine the effect of YGATs on gastrointestinal symptoms, stress, and quality of life (QoL) in patients with H. pylori-induced APDs.

Method

Patients with epigastric pain, gastric reflux, and stomach burning were screened and allowed to undergo an endoscopy followed by a rapid urease test (RUT) to confirm H. pylori infection. Thirty-four patients with positive RUT were randomly assigned into two groups. The yoga group (n = 16) received YGAT for two months and seven days in addition to PPI. The control group (n = 18) was provided only PPIs. Signs and symptoms of APD and its co-morbidities (stress and QoL) were measured by using the gastrointestinal symptom rating scale (GSRS), quality of life in reflux and dyspepsia (QOLRAD) questionnaire, and stress indicator questionnaire (SIQ).

Results

Split-plot ANOVA computed with Bonferroni adjusted post hoc analyses for intra and inter-group comparisons using the 24th version of IBM-SPSS showed a significant reduction in gastrointestinal symptoms (p<0.001) and stress (p<0.001) and improvement in QoL (p<0.001) in the yoga group as compared to the control group.

Conclusion

YGATs may be a harmless and inexpensive alternative or add-on therapy to mitigate H. pylori-induced APDs and their psychological co-morbidities.

1. Introduction

Helicobacter pylori (H. pylori) is a gram-negative bacterium that induces most upper GIT infections and life-threatening diseases [1]. Repeated complaints of epigastric pain, sour belching, or abdominal pain could be a result of over secretion of acid. This may be an indicator of the presence of any underlying Acid Peptic Disease (APD) [2]. H. pylori is considered the root cause of APDs. Most conventional antibiotic treatments have shown unfavorable outcomes in 20 % of the cases due to antimicrobial drug-induced resistance [3]. APDs induced by alcohol, smoking, and nonsteroidal anti-inflammatory drugs (NSAIDs) can be treated by restraining the causative factors. APDs induced by H. pylori, which affect 50% of the human population [4], have the potential to cause gastritis, peptic and duodenal ulcers, cancers and gastric mucosal-associated lymphoid-tissue lymphoma; vitamin B-12 deficiency, anemia, gastric atrophy, primary gastric B-cell lymphoma, etcetera [5]. Continued use of proton pump inhibitors (PPIs) to manage APDs leads to hypergastrinemia, as demonstrated in both experimental animals and humans [6]. The result is that the day patients stop taking the PPI, the next day, severe hyperacidity forces the patient to restart the PPI. After one or two such experiences, the patients decide to continue taking the medicine, and that is how we see cases taking the PPIs for several years [6]. Use of PPIs, although it reduces the gastric symptoms, harboring H. pylori infection elicits an immune response, and it sometimes results in autoimmune destruction of gastric mucosa, leading to atrophic gastritis, which results in achlorhydria and cessation of intrinsic factor secretion by the gastric mucosa leading to B-12 deficiency with its consequences—anemia and neurological disorders [7]. Some of the PPIs are known to cause neuropathy, ischaemic heart disease, dementia, and acute kidney injury [8], indigestion, drowsiness, constipation, and inefficacy of some anti-fungal drugs [9]. PPIs' annual direct healthcare cost in the United States is around US$10 billion [10]. This warrants the need for an economical and harmless treatment alternative.

H. pylori is a microaerophilic organism that grows best with little air and more carbon dioxide [11]. With this rationale, Yogic gut aeration is proposed as an effective way to inhibit H. pylori, moderate APDs, and its comorbidities. Yoga advocates that optimal gut health is the key to perfect physical health [12], and various techniques are yet to be examined rationally on a large scale. Air ingestion through the mouth, maneuvering it into the gastrointestinal tract (GIT), then releasing it as flatus is described in a Yogic text (Gherenda Samhita) [13] as vatsara dhauti (gut cleansing by air). A review of existing literature showed that no other study has been conducted to test the effect of YGATs on H. pylori infection [14]. The current study was to check the effect of YGATs on gastrointestinal symptoms, stress level, and quality of life in H. pylori-induced APD patients.

2. Method

2.1. Ethical approval and trial registration

This study was approved by the Institutional Ethical Committee of the University of Patanjali, Haridwar, Uttarakhand (UOP/IEC/2018/11) and (LLRM) Medical College, Meerut, Uttar Pradesh (No./SC-1/2021/6195) and registered with Clinical Trial Registry-India (CTRI No.: CTRI/2018/12/01650). Those who were found eligible and willing to participate in the study were explained the purpose, nature, process, intervention protocol, and expected outcomes of the study in a language understandable to them. The subjects were informed of their right to withdraw from the trial at any point in time if they wished not to continue. In addition, the queries/doubts of trial subjects, if any, were clarified before signing the consent form. Signed informed consent forms were obtained from all participants before their voluntary participation in the study.

2.2. Participants

We wanted to undertake a study by considering 0.6 [15] of a standard deviation between two groups to be worthwhile, as filed in CTRI. Such a study would require about 78 participants (assuming 80 % power, a two-sided alpha of 5 %, and 10 % dropouts). Using a confidence interval (CI) approach, we calculated the pilot sample size required to produce an upper limit of a one-sided 80 % CI, which excludes 0.6, assuming that the treatment estimate from the pilot was zero or less. Seven participants (approximately 9 % of the main sample size) would be required to produce a one-sided 80 % confidence limit, excluding this estimate (i.e., upper 80 % CI) consequently, if we conducted such a pilot with that sample size and found an estimate larger than zero by showing the feasibility of recruiting and retaining the participants. However, 9 % of the main study's sample size is the minimum size of a pilot study rather than the maximum [[16], [17], [18]]. Therefore, we considered a 34 sample size, 3 times more than the minimum sample size needed for a pilot study. Males and females with H. pylori-induced APDs (gastroesophageal reflux disease: GERD, hyperacidity, 1st stage gastric ulcer) aged between 20 and 60 (mean age: 32.46 and SD: 11.72) years with H. pylori-positive, willingness to participate in the study and no habit of doing other exercises were included. Patients with tonsillectomy, recent abdominal surgery, pregnancy, hypertension, severe spinal problems, addictive behaviors (smoking, alcohol), NSAIDS, or other chronic illnesses were excluded.

Subjects were screened from Medicine outpatient department (OPD) of LLRM Medical College, Meerut, Uttar Pradesh, India, from September 17, 2019 to March 13, 2020. Patients who did not consume alcohol or NSAIDs, smoke, and had APD symptoms for more than a month were advised to undergo endoscopy to check hyperemia of the stomach linings. Of 157 screened patients, 34 patients who underwent an endoscopy and were found to have positive rapid urease test (RUT) were recruited. During endoscopy, a biopsy sample was taken from the pyloric and duodenum of the stomach, followed by RUT to determine H. pylori infection. This process took 2–3 days for a single patient. RUT is the gold standard for detecting H. pylori-induced diseases [19]. A tissue sample was extracted from the GI linings during endoscopy and sent for the RUT [20]. RUT is also known as the CLO test (Campylobacter‐like organism test). This diagnostic test is a rapid, economical, and simple to detect the presence of a urease enzyme secreted by H. pylori in or on the gastric mucosa. RUT is of three kinds: liquid-based, gel‐based, and dry cool. We used the dry test kit. A tissue sample was extracted from the GI linings while doing endoscopy. The biopsy sample was placed on a medium containing urea and an indicator such as phenol red (RUT kit) [21], and one drop of distilled water was dropped on the specimen. After a few minutes, the yellow portion of the kit turned pink in case of H. pylori infection. The urease produced by H. pylori hydrolyzes urea to ammonia, which raises the medium's pH and changes the specimen's color from yellow (negative) to red (positive). The sensitivity of this test is high and has been approved for human use [22]. A sample of 34 was allocated into yoga group (YG) and control group (CG) by following the pre-decided random sequence. The sampled participants' demographic outcomes and baseline measurements were equivalent between YG and CG, as depicted in Table 1.

Table 1.

Demographics of the study participants.

Characteristics	YG (n = 13)	CG (n = 13)
Sex (male: Female)	8:5	7:6
Age (mean ± SD)	32.46 ± 11.72	34.69 ± 10.91

2.3. Study design

This was a pilot, open-labeled, randomized trial with a non-blinded endpoint assessment to determine the effect of YGATs on patients with H. pylori-induced APDs. It was a single-center study conducted at a tertiary care hospital. Thirty-four patients visiting the Medicine OPD of LLRM medical college Meerut, Uttar Pradesh, India, were recruited based on the inclusion and exclusion criteria and screened based on the duration of their APD symptoms and the RUT. As mentioned in the CTRI application, 78 participants were randomly allocated into equal-sized yoga and control groups before recruiting the patients using an online randomizer tool (https://www.randomizer.org/). Unexpectedly, the sudden outburst of the COVID-19 pandemic compromised the proposed sample size, study design, pre-decided allocation of the participants in YG and CG (i.e., 16 and 18), the duration of intervention, and the conduct of RUT. As considered in the pilot trial, the random allocation sequence was generated for 78, not 34, participants. Each patient was getting medical treatment as deemed suitable by the physician. During endoscopy, a biopsy sample was taken from the pyloric region of the stomach and duodenum, followed by a urease test to determine H. pylori infection. Baseline assessment included GI symptoms, QOL, and stress levels, using three standard validated questionnaires: Gastrointestinal symptom rating scale (GSRS), quality of life in reflux and dyspepsia (QOLRAD) questionnaire, and stress indicator questionnaire (SIQ).

The concerned physician counseled the participants about their lifestyle modifications, including sleep, diet, and mental relaxation. Eight patients (intervention‐3 and control‐5) did not respond to the multiple telephonic calls, limiting 26 participants (14 males and 12 females) for post-measurements. The CONSORT diagram is depicted in Fig. 1.

Fig. 1.

CONSORT diagram.

2.4. Outcome measures

2.4.1. Gastrointestinal symptom rating scale (GSRS)

This GSRS is a self-administered questionnaire with 15 items clustered into five factors: reflux, abdominal pain, indigestion, diarrhea, and constipation. Each item is rated on a 7-point Likert scale with response options from no discomfort (1) to severe discomfort (7). Higher scores mean higher GI symptoms and fewer scores mean fewer GI symptoms. This scale was developed for adults with irritable bowel syndrome and peptic ulcer disease. As reported by Kulich et al. , GSRS had internal consistency from 0.43 to 0.87, and test-retest reliability from 0.36 to 0.75 [23]. In the current study, the value of Cronbach's alpha was 0.609 for total GSRS, and 0.037, 0.075, 0.481, 0.608, and 0.13 for reflux, abdominal pain, indigestion, diarrhea and constipation, respectively.

2.4.2. Quality of life

QOLRAD is a disease-specific questionnaire that measures the QoL of patients with gastric illness. It comprises 25 items combined into five domains: emotional distress, sleep disturbance, food/drink problems, physical/social functioning, and vitality. Questions are rated on a 7-point Likert scale where a score of 1 = all of the time/a great deal; 7 = none of the time/none at all. Higher scores indicate better QOL; the lower the value, the more severe the impact on daily functioning. The internal consistency reliability of QOLRAD was 0.79–0.95, and test-retest reliability was 0.41–0.82 [23]. The value of Cronbach's alpha for the QOLRAD scale and its subscales from the current sample were 0.82, and 0.44 (emotional distress), 0.44 (sleep disturbance), 0.569 (food/drink problems), 0.51 (physical/social functioning), and 0.75 (vitlity).

2.4.3. Stress indicator questionnaire (SIQ)

This is a 73-item self-reported questionnaire to measure stress. Each item is rated on a 5-point Likert scale. It assesses physical indicators, sleep indicators, behavioral indicators, emotional indicators, and personal habits. Higher scores indicate a high stress level, and lower scores indicate less stress. From the current sample, values of Cronbach's alpha were 0.96, 0.91, 0.76, 0.96, 0.88, and 0.84 for total SIQ, and its subscales (physical indicator, sleep, behavioral indicator, emotional indicator and personal habits), respectively.

2.4.4. Intervention

The intervention included a systematic yoga protocol and the standard medical treatment and was given from September 20, 2019, to October 30, 2020 (i.e.,7 days for contact sessions and 2 months for self-practice). The YG underwent a supervised 40-minute YGAT regimen (Table 2) for seven consecutive days at the hospital by a certified yoga expert, followed by self-practice for the next two months at home. The intervention started with preparatory practices (mild bhastrika pranayama and kapola shakti vikasaka) [24] for 5 minutes, followed by 5 minutes of manduki mudra [13]. For aeration, subjects had two options based on their capability to perform. They either practiced kaki mudra or the pierced straw technique for 10 minutes. We used Malshe's pierced straw technique. A plastic straw commonly used for drinking juices was pierced, making a pinhole about one-and-a-half inch below its upper end. In this technique, one drank 50–100 ml of water to ingest double air volume into the stomach preceding water ingestion [14]. Drinking 100 ml of water through the pierced straw was expected to push approximately 200 ml of air into the stomach (Fig. 2) [14]. Immediately after air ingestion, participants performed an inverted posture (shashankasana, parvatasana, and sarvangasana), which helps maneuver air from the fundus to the pyloric region of the stomach (Fig. 3), followed by relaxation in shavasana and makarasana for 5 minutes. Control group patients did not receive any additional care with standard treatments (PPIs: omeprazole, pantoprazole, etc.) prescribed by the physician.

Table 2.

Protocol for yogic gut aeration techniques.

S. N.	Yoga technique	Rounds	Duration
1	Preparation	2 each	5 min
	Mild Bhastrika [11]
	Kapola shakti vikasaka [16]
2	Lubrication of GIT	5	5 min
	Manduki mudra [11]
3	Aeration of GIT	10	15 min
	Kaki mudra [11] or air drinking through pierced straw technique [12]
4	Maneuvering air into the GIT	5 min each	10 min
	Inverted postures
	Shashankasana/Parvatasana/Sarvangasana with aids [12]
5	Relaxation	1	5 min
	Makarasana [11]
	Total duration		40 min

Fig. 2.

Air drinking (Kaki mudra and punctured straw) and X-ray after drinking air

Footnote: A black, round bubble in the fundus site of the stomach in a Barium Meal X-ray indicates the accumulation of air after air ingestion either through Kaki mudra or pierced straw technique.

Fig. 3.

Inverted posture after air ingestion and barium meal X-ray in inverted position

Footnotes: Barium meal X-ray taken during inverted pose performed after air ingestion to show air movement from the fundus to the pyloric region.

2.4.5. Data analysis

For normal data regarding GSRS, QOLRD and SIQ and their subscales with insignificant Shapiro–Wilk test (p ≥ 0.001) and Levene's test (p ≥ 0.05) [25], Split-plot analysis of variance was computed to assess inter-group (group: CG-1, YG-2), within-group (time: before-1 and after-2), and interactive effects along with Bonferroni adjusted post hoc analyses for inter and intra-group pairwise comparisons. IBM SPSS (25th version, SPSS South Asia Private Limited, Bangalore, India) was used for data analysis.

2.4.6. Compliance and follow-up

The participants were motivated to clear any doubts by telephone or visiting the hospital. We ensured compliance by four telephonic calls (1/week) each month from the hospital to the patients of each group. They were asked about their symptoms and were reminded to follow the lifestyle changes prescribed by the consulting physician. The field investigator followed each patient for the outcome measures at the end of two months. The same investigator did randomization, and outcome assessments. A flow chart depicting the trial design is presented in Fig. 1.

3. Results

3.1. Intergroup analysis

Between-group comparison of the post means related to GSRS (reflux, abdominal pain, indigestion, diarrhea, constipation, total GSRS), QOLRAD (emotional quality, sleep quality, social relation, food tolerance, vitality, total QOLRAD), and SIQ (physical, emotional, behavioral, sleep, personal habit, total SIQ) questionnaires for YG and CG, showed post-GSRS, QOLRAD, and SIQ scores in YG significantly improved (p<0.001) than that of CG with 95 % CI (−0.69, 0.84) for overall GSRS score, (−0.42, 1.12) for overall QOLRAD and (−0.74, 0.79) for overall SIQ with associated effect sizes −1.98, 3,35, and −1.89, respectively. There was an insignificant difference between the pre-measures of YG and CG related to the different subscales in the three questionnaires as depicted in Table 3.

Table 3.

Summary of results regarding intergroup comparisons.

	Yoga (n = 13), Mean ± SD				Control (n = 13), Mean ± SD
Factors	YG Pre	CG Pre	CI [LL, UL]	Cohen's d	YG Post	CG Post	CI	Cohen's d
GSRS
Reflux	12.92 ± 0.862	13.31 ± 0.751	[-0.06, 0.84]	0.48	2.46 ± 0.519∗∗	8.31 ± 3.794	[-0.75, 1.99]	−2.16
Abdominal pain	19.85 ± 1.068	19.77 ± 1.301	[-0.58, 0.74]	0.06	3.92 ± 0.760∗∗	12.31 ± 5.978	[6.01, 10.76]	−1.96
Indigestion	25.92 ± 1.754	25.85 ± 2.035	[-0.98, 1.12]	0.03	4.46 ± 0.519∗∗	15.69 ± 9.086	[7.64, 14.81]	−1.74
Diarrhea	20.31 ± 0.855	19.77 ± 2.488	[-0.49, 1.57]	0.29	3.00 ± 0.00∗∗	13.00 ± 7.246	[7.15, 12.85]	−1.95
Constipation	20.23 ± 0.725	20.23 ± 1.013	[-0.49, 0.49]	0	3.08 ± 0.277∗∗	13.00 ± 7.416	[6.99, 12.84]	−1.89
Total GSRS	99.23 ± 3.16	98.92 ± 4.80	[-0.69, 0.84]	0.07	16.92 ± 0.95∗∗	62.46 ± 32.43	[-2.92, −1.04]	−1.98
QOLRAD
Emotional/distress	10.23 ± 1.641	9.85 ± 2.267	[-0.72, 1.48]	0.19	41.23 ± 1.013∗∗	20.46 ± 10.611	[16.57, 24.96]	2.75
Sleep disturbance	7.85 ± 1.463	8.00 ± 1.780	[-0.75, 1.05]	−0.09	34.54 ± 0.776∗∗	16.00 ± 8.307	[15.25, 21.82]	3.14
Food/drink problems	10.31 ± 1.843	9.69 ± 2.955	[-0.75, 1.99]	0.25	41.00 ± 0.577∗∗	19.00 ± 9.283	[18.34, 25.66]	3.34
Physical/social isolation	9.08 ± 2.597	7.46 ± 1.330	[0.47, 2.76]	0.78	34.46 ± 0.660∗∗	16.92 ± 7.511	[14.56, 20.51]	3.28
Vitality	4.38 ± 0.961	4.31 ± 0.855	[-0.43, 0.57]	0.076	20.08 ± 1.320∗∗	9.00 ± 4.359	[9.28, 12.87]	3.44
Total QOLRAD	41.85 ± 6.98	39.31 ± 7.60	[-0.42, 1.12]	0.34	171.31 ± 1.84∗∗	81.38 ± 37.8	[2.16, 4.54]	3.35
Stress
Physical	67.92 ± 17.68	68.30 ± 21.22	[-0.78, 0.74]	−0.01	23.61 ± 1.55∗∗	44.84 ± 12.19	[-3.45, −1.42]	−2.44
Emotional	88.76 ± 9.04	85.38 ± 15.84	[-0.5, 1.03]	0.26	23.46 ± 2.53∗∗	45.53 ± 17.05	[-2.72, −0.89]	−1.81
Behavioral	48.69 ± 23.50	54.38 ± 24.10	[-1.01, 0.53]	−0.23	20.00 ± 3.53∗∗	33.23 ± 16.17	[-1.95, - 0.30]	−1.13
Sleep	19.76 ± 3.58	19.00 ± 5.27	[-0.60, 0.93]	0.16	5.23 ± 0.59∗∗	12.15 ± 3.41	[-3.91, −1.74]	−2.82
Personal habits	39.30 ± 5.55	36.15 ± 7.54	[-0.30, 1.25]	0.47	9.68 ± 1.18	20.38 ± 9.84	[-2.40, −0.65]	−1.52
Total stress score	264.46 ± 44.88	263.23 ± 60.43	[-0.74, 0.79]	0.02	82.00 ± 5.32	156.12 ± 54.94	[-2.82, - 0.97]	−1.89

Notes: Yoga group (YG), Control Group (CG), Gastro-Intestinal Symptom Rating Scale (GSRS), Quality of Life in Reflux and Dyspepsia (QOLRAD), Confidence Interval (CI), ∗∗stands for p < 0.001 for intergroup comparisons, LL and UL represent lower limit and upper limit of CI.

3.2. Intragroup analysis

Intra-group comparisons of pre-means and post-means related to GSRS, QOLRAD, and SIQ in YG showed post-GSRS, QOLRAD, and SIQ scores significantly improved (p<0.001) than their respective baseline measurements with 95 % CIs (25.65, 44.89), (−32.29, −18.42) and (3.97, 7.44) and the associated effect sizes 35.27, −25.36, and 5.7, respectively. Similarly, significant improvement was also found in the post measures of overall GSRS, QOLRAD, and SIQ scores in CG than their respective baseline values with 95 % CIs (0.69, 2.45), (−2.41, −0.66), and (0.93, 2.77) and associated effect sizes 1.573, −1.53, and 1.85 respectively. The mean values, SD, CI, and p-values are depicted in Table 4.

Table 4.

Summary of results regarding Intra-group comparisons.

	Yoga (n = 13), Mean ± SD				Control (n = 13), Mean ± SD
Factors	Pre	Post	CI [LL, UL]	Cohen's d	Pre	Post	CI	Cohen's d
GSRS
Reflux	12.92 ± 0.862	2.46 ± 0.519∗∗	[10.46, 10.85]	14.70	13.31 ± 0.751	8.31 ± 3.794	[3.47, 6.52]	1.82
Abdominal pain	19.85 ± 1.068	3.92 ± 0.760∗∗	[15.41, 16.44]	17.18	19.77 ± 1.301	12.31 ± 5.978	[5.05, 9.86]	1.72
Indigestion	25.92 ± 1.754	4.46 ± 0.519∗∗	[20.73, 22.18]	16.59	25.85 ± 2.035	15.69 ± 9.086	[6.49, 13.82]	1.54
Diarrhea	20.31 ± 0.855	3.00 ± 0.00∗∗	[16.97, 17.64]	28.63	19.77 ± 2.488	13.00 ± 7.246	[3.75, 9.78]	1.24
Constipation	20.23 ± 1.013	3.08 ± 0.277∗∗	[16.73, 17.56]	23.09	20.23 ± 1.013	13.00 ± 7.416	[4.28, 10.17]	1.36
Total GSRS	99.23 ± 3.16	16.92 ± 0.95∗∗	[25.65, 44.89]	35.27	98.92 ± 4.80	62.46 ± 32.43	[0.69, 2.45]	1.573
QOLRAD
Emotional/distress	10.23 ± 1.641	41.23 ± 1.013∗∗	[30.24, 31.75]	−22.73	9.85 ± 2.267	20.46 ± 10.611	[6.33, 14.88]	−1.38
Sleep disturbance	7.85 ± 1.463	34.54 ± 0.776∗∗	[26.03, 27.34]	−22.79	8.00 ± 1.780	16.00 ± 8.307	[4.65, 11.35]	−1.33
Food/Drink	10.31 ± 1.843	41.00 ± 0.577∗∗	[29.92, 31.45]	−22.47	9.69 ± 2.955	19.00 ± 9.283	[5.47, 13.14]	−1.35
Physical/Social Isolation	9.08 ± 2.597	34.46 ± 0.660∗∗	[24.32, 26.43]	−13.39	7.46 ± 1.330	16.92 ± 7.511	[6.45, 12.46]	−1.75
Vitality	4.38 ± 0.961	20.08 ± 1.320∗∗	[15.05, 16.34]	−13.59	4.31 ± 0.855	9.00 ± 4.359	[2.94, 6.43]	−1.49
Total QOLRAD	41.85 ± 6.98	171.31 ± 1.8∗∗	[-32.29, −18.42]	−25.36	39.31 ± 7.60	81.38 ± 37.88	[-2.41, −0.66]	−1.53
Stress
Physical	67.92 ± 17.68	23.61 ± 1.55∗∗	[ 2.30, 4.76]	3.53	68.30 ± 21.22	44.84 ± 12.19	[0.50, 2.20]	1.35
Emotional	88.76 ± 9.04	23.46 ± 2.53∗∗	[7.05, 12.61]	9.83	85.38 ± 15.84	45.53 ± 17.05	[1.40, 3.43]	2.42
Behavioral	48.69 ± 23.50	20.00 ± 3.53	[0.80, 2.60]	1.70	54.38 ± 24.10	33.23 ± 16.17	[0.21, 1.84]	1.03
Sleep	19.76 ± 3.58	5.23 ± 0.59∗∗	[3.94, 7.38]	5.66	19.00 ± 5.27	12.15 ± 3.41	[0.66, 2.41]	1.54
Personal habits	39.30 ± 5.55	9.68 ± 1.18∗∗	[5.23, 9.53]	7.38	36.15 ± 7.54	20.38 ± 9.84	[0.88, 2.71]	1.79
Total stress	264.46 ± 44.88	82.00 ± 5.32∗∗	[3.97, 7.44]	5.70	263.23 ± 60.43	156.12 ± 54.4	[0.93, 2.77]	1.85

Notes: Gastro-Intestinal Symptom Rating Scale (GSRS), Quality of Life in Reflux and Dyspepsia (QOLRAD), Confidence Interval (CI), ∗∗stands for p < 0.001 for intragroup comparisons.

Within-group comparison (ANOVA) for subscales and overall GSRS, QOLRAD, and SIQ scores showed their significant increase (p<0.001) after YGAT adminsteration, (F (1, 24) = 199.18; F (1, 24) = 184.58; F (1, 24) = 167.49; F (1, 24) = 164.70, F (1, 24) = 144.03, F (1, 24) = 189.6); (F (1, 24) = 193.65; F (1, 24) = 249.41; F (1, 24) 273.82; F (1, 24) = 231.48; F (1, 24) = 213.55; F (1, 24) = 269.133); and (F (1, 24) = 118.501; F (1, 24) = 492.776; F (1, 24) = 45.194; F (1, 24) = 142.986; F (1, 24) = 279.561; F (1, 24) = 466.465), respectively (Table 5).

Table 5.

ANOVA results of GSRS, QOLRAD, and SIQ related to within, between, and interactive effects.

	Within-subject factor (time point)			Between subject factor (Group)			Interaction (Time∗ Group)
GSRS
	F	df	p	F	df	p	F	df	p
Reflux	199.18	1.24	<0.001	30.87	1.24	<0.001	24.85	1.24	<0.001
Abdominal pain	184.58	1.24	<0.001	22.56	1.24	<0.001	24.16	1.24	<0.001
Indigestion	167.49	1.24	<0.001	15.77	1.24	<0.001	21.42	1.24	<0.001
Diarrhea	164.7	1.24	<0.001	15.92	1.24	<0.001	31.55	1.24	<0.001
Constipation	144.03	1.24	<0.001	21.48	1.24	<0.001	23.85	1.24	<0.001
Total GSRS score	189.6	1.24	<0.001	22.07	1.24	<0.001	28.25	1.24	<0.001
QOLRAD
Emotional/distress	193.65	1.24	<0.001	45.92	1.24	<0.001	46.46	1.24	<0.001
Sleep disturbance	249.41	1.24	<0.001	50.45	1.24	<0.001	72.4	1.24	<0.001
Food/drink problems	273.82	1.24	<0.001	54.81	1.24	<0.001	78.26	1.24	<0.001
Physical/social isolation	231.48	1.24	<0.001	76.27	1.24	<0.001	48.33	1.24	<0.001
Vitality	213.55	1.24	<0.001	82.939	1.24	<0.001	62.18	1.24	<0.001
Total QOLRAD	269.13	1.24	<0.001	66.54	1.24	<0.001	69.84	1.24	<0.001
STRESS
Physical	118.5	1.24	<0.001	4.58	1.24	<0.001	38.74	1.24	<0.001
Emotional	492.77	1.24	<0.001	4.68	1.24	<0.001	21.3	1.24	<0.001
Behavioral	45.19	1.24	<0.001	2.21	1.24	<0.001	8.3	1.24	<0.001
Sleep	142.98	1.24	<0.001	7.71	1.24	<0.001	51.92	1.24	<0.001
Personal habits	279.56	1.24	<0.001	2.67	1.24	<0.001	15.11	1.24	<0.001
Total stress scores	466.46	1.24	<0.001	4.58	1.24	<0.001	23.46	1.24	<0.001

Notes: Split-plot ANOVA was run to compute between-group (G), within-group (Time), and interactive effects (GXT). Gastro-Intestinal Symptom Rating Scale (GSRS), Quality of Life Reflux and Dyspepsia (QOLRAD), Stress Indicator Questionnaire (SIQ), Confidence Interval (CI), p < 0.001 stands level of significance.

Interaction effects of time points and group for GSRS, QOLRAD, and physical, emotional, sleep, personal habit, and total score of SIQ showed their significant improvement (p<0.001) after YGAT, (F (1, 24) = 24.85; F (1, 24) = 24.16; F (1, 24) = 21.42; F (1, 24) = 31.55; F (1, 24) = 23.85, F (1, 24) = 28.252); (F (1, 24) = 46.46; F (1, 24) = 72.40; F (1, 24) = 78.26; F (1, 24) = 48.33; F (1, 24) = 62.18; F (1, 24) = 69.841); and (F (1, 24) = 38.747; F (1, 24) = 21.307; F (1, 24) = 51.923; F (1, 24) = 15.116; F (1, 24) = 23.462), respectively. Only the behavioral indicator significantly improved F (1, 24) = 8.305 at p = 0.008. A summary of the results is shown in Table 5.

4. Discussion

Many studies have been done in the past decades regarding treatment for eradicating H. pylori. However, no study has developed any cost-effective treatment measure so far. Evidence showed that its pathology could cause life-threatening GI diseases [26], and the available treatment methods, whether allopathic or herbal treatments, have shown several side effects [27]. About 5 years back, we learned about the use of Lactobacillus reuteri, a flagellate bacterium, which, by different mechanisms, inhibits H. pylori suggestive to stop using the combination of Amoxicillin, Tinidazole, Clarithromycin along with a PPIs [28]. To our knowledge, this is the first study investigating the effect of YGATs on H. pylori-induced APDs. It lays out preliminary findings on the efficacy of YGATs, firstly in reducing GI symptoms and stress levels and secondly in improving QoL. At the baseline, YG and CG were homogeneous in their socio-demographic profile. The number of males was higher than that of females in both groups. There were 8 participants as dropouts. Three participants in the YG were found to be not practicing the intervention protocol on inquiry via telephonic calls. Five participants in the CG stopped responding to the compliance calls for a long time. Non-compliance with yoga interventions at home is a significant limitation in most yoga-related clinical trials. There could be several reasons, such as lack of time for practice, loss of motivation for yoga practice, loss of hope, lack of proper space for practice, an inadequate environment, or simply lack of interest in physical activities.

Our findings show significant improvement in the GI symptoms of the YG participants after the YGAT intervention. The total GSRS mean scores reduced from 99.23 to 16.92 in YG and 98.92 to 62.46 in CG. The mean scores for all five domains of GSRS (reflux, abdominal pain, symptoms of indigestion, diarrhea, and constipation) were significantly lower in YG after two months. Around an 80 % reduction in subscales and overall post-GSRS score was found compared to the baseline score. That may be due to the inhibition of H. pylori caused by the additional administration of YGAT in YG compared to CG. However, this claim remains a hypothesis for further RCT without a post-intervention RUT. Earlier evidence also supports that yoga intervention can improve reflux [29], abdominal pain [30], diarrhea, and constipation [31]. Regarding constipation and diarrhea, we can assume that fewer antibiotics in YG may have a less negative influence on gut microbiota, indicating less disturbance in bowel movement. Guo et al. showed that successful H. pylori eradication restores gastric microbiota to a similar status as in non-infected individuals [32]. The reduction in APD symptoms indicates a weakening of the H. pylori infection. Significant results in YG (p<0.001) suggest that YGATs helped balance gut microbiota, control acid refluxes, and overcome other GI symptoms. Consistently, Testerman and Morris (2014) claimed that H. pylori, a microaerophilic bacteria, can be killed by atmospheric oxygen. Exposure of samples to ambient oxygen, as well as complement and phagocytic cells from the blood, may also kill some of the bacteria before they can be cultured [33].

In the present study, QOLRAD mean scores were higher in YG (171.31, Cohen's d = −25.36) than in CG (81.38, Cohen's d = −1.53). The reduction of GI symptoms was higher in YG could be a reason for better outcomes in the YG. This signifies that QoL not only depends on H. pylori eradication but also on treatment options. In earlier research, H. pylori eradication was associated with improving QoL [34]. A multicenter prospective study conducted in 15 institutions on 165 patients infected with H. pylori showed that QoL might be enhanced regardless of the success of eradication. However, the same study linked lower QoL scores before eradication therapy to a higher QoL post-treatment [35]. Mestrovic et al. [36] assessed two therapies for H. pylori eradication; both presented similar clinical outcomes, suggesting that QoL can be improved regardless of the choice of eradication therapy. A pilot study by the Sri Institute for Advanced Research [37] found that 50 days of customized meditation significantly improved gastrointestinal QoL. However, the study subjects showed no significant signs of GI disorders at baseline. Kelley & Kelley conducted a reanalysis of a meta-analysis on older adults practicing yoga using the quality effects model. Yoga was highly beneficial in improving QoL and moderately beneficial in improving mental well-being. A meta-analysis by Ban et al. concluded that yoga could improve QoL more than any other therapy [38], inspiring and motivating further research and application of yoga in GI disorder treatment. The unexpected increase in the sleep disturbance subscale of QoL after the intervention might be attributed to the prevailing fear of the COVID-19 pandemic and exponentially high infection trend, its uncertain preventive, diagnostic, and therapeutic measures, and rumors spread by electronic media.

The total SIQ mean scores reduced from 264.46 to 82.00 in YG and 263.23 to 156.12 in CG. Stress levels were significantly reduced in the YG (Cohen's d = 5.70, p<0.001) as compared to the CG (Cohen's d = 1.85, p<0.001). The behavioral factor has shown the most minor improvement; the short duration of the intervention might not have been sufficient to change the behavioral and stress symptoms. Overall, the YGAT was found to help reduce the stress response of the digestive tract (p<0.001). Fink G Selye claimed that gastro-duodenal ulcer is a result of the overproduction of chemicals and hormones accompanied by chronic stress [27]. A higher stress level increases acid secretion, a major risk factor for developing peptic ulcers [26]. Hence, this can be further studied as a potential treatment option for APDs. Mukhtar et al. also reported that individuals with GI illnesses exhibit abnormalities in the hypothalamus-pituitary-adrenal (H. pylori) axis's functioning. [39]. Alterations and disturbances in serotonergic signaling may cause abnormal intestine GI activity and result in a GI disorder [40].

In the past decades, many resources have been exhausted for a cost-effective, and harmless treatment for eradicating H. pylori. Evidence shows its pathology to cause life-threatening GI diseases [41], and the available treatment methods, whether pharmaceutical or herbal, have demonstrated several side effects [42]. Physicians usually prescribe PPIs such as omeprazole, lansoprazole, pantoprazole, etc. for symptomatic relief. In many instances, the patients keep on taking these PPIs for a longer time without the consultation of a physician. The drugs are meant to be taken in a prescribed manner. For example, if the dose of 40 mg per day is prescribed for two weeks, then after initial symptomatic relief, the dose should be reduced to 20 mg per day, then gradually on alternate days, then reduced to once a week. However, due to a lack of awareness or improper communication, patients, rather than tapering-off the recommended dose, stop taking these drugs suddenly after initial symptomatic relief. This causes hyper gastrinemia, associated with rebound hyper-acidity because the use of PPIs is always associated with increased gastrin secretion. In this scenario, the patient knows that taking PPIs will give them relief, so they start the course independently without consulting a physician, and the endless loop goes on. This not only degrades physical health but also adds to the economic burden on the patient. Our study shows the effectiveness of the YGATs on H. pylori-induced GI diseases after two months of regular practice. This yogic intervention was designed to eradicate the microaerophilic H. pylori bacteria by maneuvering air into the pyloric region where this bacterium resides. The yoga intervention was carefully planned and no participant faced complications due to this practice.

5. Conclusions

Our results indicated YGAT's potential in treating H. pylori-induced APDs by improving gastrointestinal symptoms, stress, and quality of life indicative of H. pylori inhibition. However, this could not be confirmed without the skipped post-rapid urease test due to restrictions imposed during the COVID-19 pandemic. The study strengthens Malshe's hypothesis, published in a journal, Medical Hypothesis, and provides a base for further well-designed RCTs to enhance our findings' internal and external validity. YGAT may be a cost-effective and low-harm option to mitigate H. pylori-induced APDs, reduce patients' medical costs, and improve their stress, quality of life, and work efficiency, decreasing the healthcare system's burden.

5.1. Limitations and recommendations

Our study was not blinded at any point. The sample size was very small, which limits the results’ generalizability. A multi-centric trial with a larger sample size would suffice to remove this limitation. The participants of YG continued yoga practice without a yoga expert for two months, which might have affected the nature and quality of the intervention. We suggest having more supervised sessions once a week and practicing with an expert to maintain the evenness of the sessions. Although compliance was maintained for lifestyle changes in both groups, there is a probability of dishonest responses from the subjects with their dietary habits during the study. Any other change in the lifestyle was not monitored, which could have been a confounding factor. Any unwanted stress-causing life event during the study was not assessed that may have impacted the stress and QOL outcomes. The frequency and dosage of medication could have been noted for the groups. One major limitation we faced during this study was the COVID-19 pandemic that compelled us to remove post-endoscopy-based RUT from our outcomes, keeping in mind the safety of our subjects. For further studies, we strongly advise pre- and post-endoscopy-based RUT to confirm reduced bacterial levels as the effect of YGATs with blinding of subjects and assessors. Additional controls should be addressed to counter significant factors altering QoL and stress.

Author contribution statement

Rohini Dayma: Investigation, Data Curation, Visualization, Writing- original draft.Rudra B. Bhandari: Conceptualization, Supervision, Methodology, Formal Analysis, Writing-original draft, Writing-review and editing, Validation, Visualization, Project Administration. Prakash Chintamani Malshe: Conceptualization, Supervision, Writing-review and editing. Tung Vir Singh Arya: Investigation & Supervision.

Conflict of interests

None

Declaration of generative AI in scientific writing

The authors also declare no use of generative AI in scientific writing.

Funding sources

The authors did not receive any funding to carry out the study.