Mind relaxation effect of Jatamansi Taila Shirodhara on psychological distress in Triple Negative Breast Cancer (TNBC) patients - results of an open-labelled, randomised controlled clinical trial

Abstract

Background

Triple-negative breast cancer (TNBC) is a subtype of breast cancer clinically defined as lacking expression of Estrogen receptor (ER), Progesterone receptor (PR), and Human Epidermal growth factor Receptor (HER2). Psychological distress is a major risk factor of TNBC, patients diagnosed with TNBC are under tremendous stress due to the aggressive nature of the disease. Stress hormones decrease the efficacy of therapeutics. These facts underscore the need for mind relaxation treatment for TNBC patients.

Objectives

To find out the anti-anxiety activity of the Jatamansi Taila in TNBC patients.

Material and methods

This was a two-arm, open-labelled, parallel, prospective controlled clinical study, conducted on 70 patients of TNBC in the age group of 20–70 years who have completed conventional therapy and opted for Ayurvedic Treatment. Patients were divided into 2 groups. Thirty-five patients in Group A were treated with Oral Ayurvedic Medicines (Shamana Chikitsa) and Jatamansi Taila Shirodhara; whereas 35 patients in Group B were treated with only Oral Ayurvedic Medicines.

Results

Jatamansi Taila Shirodhara was found to be effective in relieving symptoms of Anxiety and Psychological distress (Chittodvega) immediately after the procedure, viz. sleep disturbance, difficulty in concentration, and fearfulness. Jatamansi Taila Shirodhara was found to be highly effective in improving Quality of Life (QoL), especially in improving functional ability, well-being and reducing symptomatology related to breast cancer, measured by scores of QLQ C30 and symptom score of QLQ BR23.

Conclusion

This study emphasizes the role of Jatamansi Taila Shirodhara therapy for mind and body relaxation in psychological distress seen in breast cancer especially, in TNBC patients.

1. Introduction

Breast cancer is the most common female cancer worldwide representing nearly 25% of all cancers with an estimated 1.67 million new cancer cases diagnosed yearly [1]. Among them, Triple Negative Breast Cancer (TNBC), a subtype of breast cancer, has an aggressive natural history and worse disease-specific outcomes compared with other breast cancer subtypes [2]. Its onset is at an early age, with higher mean tumour size, higher grade tumours, higher rate of node positivity, more aggressive, less or unresponsive to standard receptor-mediated treatments, associated poorer overall patient prognosis, visceral and soft-tissue relapse are common features [3]. Breast cancer diagnosis, treatment, and the period following primary therapy can be incredibly challenging and stressful for most women. While it's common for women to experience normal distress during this time, there is a subset of individuals who may develop clinically significant depression that could benefit from specialized psychiatric intervention [4]. Studies reported interestingly that differences in prevalence between high levels of distress (41%) and major depressive disorder (MDD) (11%) among newly diagnosed breast cancer patients [5]. A recent cross-sectional study on 178 patients with cancer showed that almost half of them had significant anxiety, but anxiety disorder and its subtype was present in 18 % of patients. Breast-specific post-traumatic stress symptoms were noted in 24 % but only 9 % reported post-traumatic stress disorder and the majority had co-morbid major depressive disorder [6]. Psychological distress is a major risk factor of TNBC. It plays a significant role in the aetiology, progression of disease, and prognosis of the disease. Prolonged exposure to these stress hormones and physiological responses can disrupt various systems in the body, including immune function and inflammation regulation [7].

In Ayurvedic literature various terminologies i.e. irritable mind (Chittakshobha-TaptaChitta- Manavikshobha) [8], Chikitsa Sthana, 7/46,78 [9], Nidan Sthana, 1/35, fickle or unstable mind (Asvastha Chitta- Anavasthita-Chitta) [9, Sootra Sthana, 20/11; Chikitsa Sthana, 9/20], and anxiety (Chittodvega) [9, Viman Sthana, 6/5] denoted for the disturbed state of mind. Several factors like perverted use of senses (Asatmendriyartha samyoga), volitional transgression (Pradnyaparadha), perverted incidence of seasons (Parinama) leads to faulty diet and lifestyle, causing disturbance in physiological levels of body elements (doshas i.e., increased Pittadosha, reduced Kaphadosha, reduced Oja), are responsible for disturbance in status of mind [9, Viman Sthana, 6/6]. Three treatment modalities are described for psychological distress (Chittodvega) i.e. treatment based on the past deeds and pleasing of god (Daivavypashraya), treatment for disease management (Yuktivyapashraya), non-pharmacological treatment for mental disorder (Sattvavajaya) [9, Sootra Sthana, 11/54]. Mind relaxation can be achieved with any or all of these three treatments. Yuktivyapashraya Chikitsa includes Medication, Panchakarma and allied therapies. Allied therapies include procedures like Shirodhara, Shirobasti, Viddhakarma, Agnikarma etc. Therapies advised for relaxation include nasal drops (Nasya), medicated oil is retained over the head for a certain period (Shirobasti), head massage (Shirobhyanga), medicated oil pouring over the forehead (Shirodhara), cotton swabs dipped in medicated oil are placed on the scalp (Shiropichu), whole body massage (Abhyanga), foot massage (Padabhyanga) with medicated oils, ghee etc. [9, Sootra Sthana, 11/55].

Shirodhara, one of the oil treatments for the head, is useful in various conditions like the ulceration of the scalp, burning sensation, headache, wounds and for mind and body relaxation [8], Sootra Sthan, 22/23–25]. The open-labelled study carried out on 16 healthy volunteers to evaluate the psycho-physiological profile of Shirodhara stated that Shirodhara leads to a state of alert calmness similar to the relaxation response observed in meditation. The clinical benefits observed with Shirodhara in anxiety neurosis, hypertension, and stress aggravation due to chronic degenerative diseases could be mediated through these adaptive physiological effects [10].

Nardostachys jatamansi (Jatamansi) is a rhizomatous herb, pungent and astringent in taste, cold in potency, improves intellectual (Medhya), physical strength (Balya), and skin complexion (Kanti); useful in burning sensation (Daha), erysipelas (Visarpa), skin disorders (Kushtha). The research studies are also reported regarding its central nervous system depressant activity [11] and memory restorative activity [12].

Keeping these points in view, the study was planned to evaluate the anti-anxiety effect of Yuktivyapashraya and Sattvavajaya chikitsa by Jatamansi Taila Shirodhara to improve the QoL of TNBC patients.

2. Methods

2.1. Trial design

This was an open-labelled, double-arm, randomized clinical trial to assess the efficacy of Jatamansi Taila in TNBC with mild-moderate psychologically distressed patients. The study was conducted at a single centre at Pune and its sub-branch located in Mumbai.

2.1.1. Inclusion-exclusion criteria

The patients with age 20–70 years, diagnosed with TNBC (proven with histopathology and immunohistochemistry-Oestrogen, Progesterone, and HER-2 receptor negative), who have completed their conventional treatment with mild to moderate symptoms of psychological distress and are willing to get enrolled in the study were included while the patients below 20 and above 70 years, having a history of other psychological illnesses prior to breast cancer, and those who are not willing to participate in the study were excluded.

Psychological distress (Chittodvega) can be either Anxiety (Anavasthita Chitta) or Depression (Manovasada). The group of symptoms was selected on the basis of signs and symptoms mentioned in the classics of Ayurveda as well as modern science. The severity of the Anxiety and Depression was assessed by SAS [13] and SDS [14]. According to the scale, 20–44 are considered normal, 45–59 mild to moderate disease, 60-74 marked severe, and 75 above referred to as extreme disease condition.

All routine haematological investigations like Hemogram, Liver Function Test (LFT), Renal Function Test (RFT), C-Reactive Protein (CRP), and Cancer Antigen for breast cancer (CA15.3) were carried out initially to exclude other comorbidities as well as monitor the progression of the disease. Likewise, the status of TNBC, conventional and ayurvedic treatment taken, an association of psychological stress as one of the causative factors of malignancy, disturbed psyche (Manovaha Srotodushti) as symptom and/or consequence of malignancy.

Detailed information about the study was given to the patients; verbally and through a specially prepared Patient Information Sheet and written Informed Consent of all patients was taken before including them in the study. The study period was between 2016 and 2019. The study was approved by the Institutional Human Ethics Committee (Ayu/16/30) of Tilak Maharashtra Vidyapeeth, Pune.

2.2. Participants

Patients with restlessness, anxiety, irritability, difficulty in concentrating, worthlessness, crying spells, fearfulness, tingling & numbness in limbs, dryness of mouth, dyspnoea, tachycardia, sleep disturbances, easy fatigability, suicidal thoughts, fainting, increased frequency of passing urine & stools were screened for the study. Eligible and consenting patients were enrolled. The records regarding demographic data, medical history, history of present illness, conventional treatment details, etc. were noted in the specially designed Case Record Form.

2.3. Sample size

The sample size was calculated as per the standard equation and formula. Allocation concealment was done by the lottery method. In total, 84 patients were screened for the study. Among them, 70 patients were found to be eligible for the study, hence 35 patients were allocated in each group (Fig. 1.).

Fig. 1.

Flow chart of patients.

Group A received Shirodhara with Jatamansi Taila for 7 days along with continued Palliative treatment (Shamana chikitsa) and Group B received only Palliative treatment (Shamana chikitsa). Patients of both the groups were treated with Shamana Chikitsa protocol - Suvarna Bhasmadi Vati (395 mg with cow's ghee twice a day after morning and evening breakfast), Suvarnamalini Vasant (250 mg with cow's ghee twice a day after morning and evening breakfast), Shatavari Vati (500 mg with water after lunch and dinner), Triphala Guggulu (500 mg with water after lunch and dinner), Aarogyavardhini Vati (500 mg with water after lunch and dinner), Mouktik Kamdudha Vati (500 mg with cow's milk twice a day after morning and evening breakfast).

2.4. Interventions

2.4.1. Procurement of Jatamansi Taila

The study trial drug was procured from Atharva Nature Healthcare Pvt. Ltd., Wagholi, Pune (FDA approved and GMP certified- FDA, M.S., Product No. 417809). The trial drug was standardized in the authorized analytical laboratory.

One part of authenticated coarse powder of Nardostachys jatamansi (Jatamansi) rhizomes was soaked in the 8 parts of potable water for 18 h in Stainless Steel (SS) vessels. The study herb was standardized in laboratory and approved. The next day, the mixture was boiled and reduced to half of its original quantity on medium flame and then filtered through mesh #40 in hot condition. The prepared decoction was mixed with equal parts of sesame oil (v/v) in tin-coated brass vessels for preparing Jatamansi Taila. The mixture was continuously stirred while heating till water got evaporated. The endpoint was ascertained by classical signs of end point of processing oil (snehasiddhi) and proper standard preparation (Madhyampaka) was attained.

2.4.2. Shirodhara procedure

The patients of Group A; who received Shirodhara treatment were admitted to the in-patient department of our centre for 7 days. Prior to the commencement of treatment, they were investigated for routine blood investigations to rule out the possibility of any acute illnesses. They were treated with pre-procedures namely Oleation (Snehana) and Sudation (Swedana).

The procedure was conducted every morning for 20–30 min of duration. The patient was asked to lie down in the supine position on the Shirodhara table. A small pillow or towel was kept under the neck for proper support. Shirodhara pot was adjusted in such a way so that the oil from the pot falls directly onto the forehead. The distance between the Shirodhara pot and the forehead was kept at approximately 10 cm. After that, lukewarm Jatamansi Taila (500ml/setting) was poured into the pot and started pouring oil on the forehead of the patient. The patient was asked to relax and feel the pleasure of oil dropping onto the head. The continuous motion of the oil was checked and maintained till the end of the procedure. The pot was slightly moved from one side to another side of the forehead so that the stream of oil goes from left to right, the lateral part of the forehead and vice versa. The oil falling from the forehead was recollected, reheated lukewarm to the temperature of 40 °C and poured into the pot to continue this process for 20–30 min. After the completion of the procedure, the oil was wiped off the forehead of the patient and asked to relax for 30–60 min and allow the oil to seep deep inside the head. Patients were instructed to avoid direct exposure to wind and sunlight, chilled and heavy food intake and daily head bath.

2.4.3. Follow-up

During the baseline visit (Day 0- Time point ‘D0’), the patient was evaluated clinically, and assessed with SAS, SDS and Kernofsky Performance status (KPS). The health-related QoL was measured based on QLQ C-30, BR-23. Also, the blood sample was withdrawn before commencement and after completion of the study for haematological, biochemical parameters, and inflammatory, tumour markers. The study duration is of 30 days and she was followed twice, i.e. at the end of the treatment (7th Day- Timepoint ‘D7’) and after 1 month (30th Day- Timepoint ‘D30’). These all scales and Questionnaires were filled on all three time points.

2.5. Outcome measure

The primary outcome was to observe the change in psychological distress by evaluating SAS and SDS. Secondly, the improvement in the QoL was measured by noticing the changes in KPS; functional score (FS), Symptom score (SS), and Global score (GS) of C-30, and BR-23-FS, BR-23 SS scores.

Clinical assessment of commonly observed symptoms was measured with psychological distress scale, graded from 0 to 4 (scale developed by author) (Supplementray file 1). Grade ‘0’ denotes the absence of symptoms and the lower scale denotes less severity of the symptoms, while KPS (Grading for well-being on a 0 to 100 scale, a higher score denotes better performance), both were reported and analysed by investigator. QLQ C30 and QLQ BR23 of EORTC [QoL Questionnaire-C30 and QLQ-BR23 (specially designed for breast cancer patients) by European Organisation for Research and Treatment of Cancer, determined based on patient's own perspective about her wellbeing]. QLQ C30 was interpreted as Symptomatology (SS), ability to perform routine activities (FS), and overall well-being (GS), while QLQ BR-23 as FS and SS. The raw score of FS, SS and GS was transformed to linear scale 0–100 by using scoring manual. SAS and SDS are questionnaire-based scale, from patient's perspective. It is type of symptom scales. These are calculated and reported by investigator. The scoring of SAS was interpreted as Normal (20–44), Mild to moderate anxiety (45–59), Marked to severe anxiety (60–74), Extreme anxiety (75+) while SDS explained as Normal (25–49), Mild depression (50–59), Moderate (60–69), Severe depression (70+).

2.6. Statistical analysis

Basic data on patient demographic, anthropometry, and clinical investigations were captured according to the scale of measurement. The data was stored in the pre-designed Microsoft Excel 2019 worksheet for each patient according to visit. The KPS score, QLQ-C30 assessment scores (Functional, Global, and Symptom scale items) and BR-23 scores (functional and symptoms scale items) were linearly transformed to a 0–100 scale according to the scoring manual.

The data generated is presented as Mean ± SE. The difference in means of symptoms among the two groups was analysed by Chi-square test and analysis of scores of different scales was done by Unpaired t-test. The comparison of time points ‘D7’ and ‘D30’ with ‘D0’ was calculated by paired t-test. The statistical significance was considered at p < 0.05 for all comparisons. All the analysis was done by InStat 3.0 software.

3. Results

3.1. Analysis of recruited patients

The distribution of TNBC patients in both the groups was almost equal, resulting in the assessment of the effectiveness of Jatamansi Taila Shirodhara in identical data of both Group A and B. In the present study, the maximum number of patients belong to 41–60 years of age (group A- 77%, group B- 54%), of stage II (46%) and III (29%) and Grade III (69%). Majority of women received conventional treatment including surgery, chemotherapy and radiotherapy (Table 1).

Table 1.

Interpreting the demographic and clinico-pathological data of both the groups.

Parameters		Number of Patients (%)
		Group A	Group B
Age (in years)	21–30	01 (2.85)	01 (2.85)
	31–40	03 (8.55)	06 (17.1)
	41–50	17 (48.45)	08 (22.8)
	51–60	10 (28.5)	11 (31.35)
	61–70	04 (11.4)	09 (25.65)
Stage	0	00 (0.00)	01 (2.85)
	I	06 (17.1)	03 (8.55)
	II	13 (37.05)	19 (54.15)
	III	11 (31.35)	09 (25.65)
	IV	05 (14.25)	04 (11.4)
Grade	II	12 (34.2)	10 (28.5)
	III	23 (65.55)	25 (71.25)
Treatment received	Chemotherapy	07 (19.95)	01 (2.85)
	Chemotherapy, Radiotherapy	01 (2.85)	00 (0.00)
	Surgery, Chemotherapy	10 (28.5)	21 (59.85)
	Surgery, Chemotherapy, Radiotherapy	17 (48.45)	13 (37.05)

3.2. Effect of Shirodhara on the symptoms of Chittodvega (psychological distress) at different time points in both groups

The comparative analysis of symptoms gradation was carried out at time point ‘D7’ and ‘D30’ (7 days and 30 days after treatment) so as to find out the immediate and long-term effect of Shirodhara in both groups of TNBC patients (Table 2a).

Table 2a.

Showing immediate and long-term effect of Shirodhara treatment on the psychological distress symptoms in TNBC patients (Inter group analysis).

	Time-points	D7			D30
	Symptoms	Group A	Group B	p-value	Group A	Group B	p-value
1.	Restlessness, Anxious	1.17 ± 0.13	1.17 ± 0.19	NS	0.71 ± 0.11	0.46 ± 0.11	NS
2.	Irritability	0.77 ± 0.12	0.80 ± 0.13	NS	0.34 ± 0.09	0.43 ± 0.09	NS
3.	Difficulty in concentration	0.29 ± 0.08	0.14 ± 0.07	NS	0.11 ± 0.05	0.00 ± 0.00	0.03
4.	Worthlessness	0.06 ± 0.04	0.06 ± 0.04	NS	0.03 ± 0.03	0.06 ± 0.04	NS
5.	Crying spells	0.46 ± 0.11	0.86 ± 0.13	0.02	0.14 ± 0.06	0.34 ± 0.08	0.05
6.	Fearfulness	0.77 ± 0.14	1.29 ± 0.14	0.01	0.34 ± 0.08	0.57 ± 0.12	0.04
7.	Tingling and numbness in limbs	0.89 ± 0.15	0.66 ± 0.10	NS	0.29 ± 0.08	0.37 ± 0.09	NS
8.	Dryness of mouth	0.06 ± 0.04	0.03 ± 0.03	NS	0.00 ± 0.00	0.00 ± 0.00	NS
9.	Dyspnoea	0.20 ± 0.08	0.09 ± 0.05	NS	0.06 ± 0.04	0.00 ± 0.00	NS
10.	Tachycardia/Palpitation	0.37 ± 0.01	0.17 ± 0.08	NS	0.09 ± 0.05	0.03 ± 0.03	NS
11.	Sleep disturbances	0.97 ± 0.16	1.43 ± 0.18	NS	0.29 ± 0.09	0.54 ± 0.11	NS
12.	Easy fatiguability	0.83 ± 0.12	1.09 ± 0.30	NS	0.31 ± 0.09	0.29 ± 0.08	NS
13.	Suicidal thoughts	0.17 ± 0.09	0.09 ± 0.06	NS	0.06 ± 0.04	0.00 ± 0.00	NS
14.	Fainting	0.06 ± 0.04	0.00 ± 0.00	NS	0.03 ± 0.03	0.00 ± 0.00	NS
15.	Increased frequency of passing urine and stools	0.41 ± 0.01	0.11 ± 0.05	NS	0.24 ± 0.08	0.09 ± 0.05	NS

Data presented in Mean ± SE, the differences in mean of symptoms gradation of Group A and B was compared by Chi-square test at time point ‘D7’ (Day 7 - Completion of treatment with Shirodhara treatment) and ‘D30’ (Day 30–1 month after Shirodhara treatment). ∗p < 0.05, considered as significant. NS: Non-significant.

The symptoms like crying spells (p = 0.02, 0.05), and fearfulness (p = 0.01, 0.04) were found to be significantly increased in the control patients in both the time points while difficulty in concentration (p = 0.03) was observed to be remarkably increased in study patients at time point ‘D30’. There were no statistically significant changes observed in the restlessness, anxiety, irritability, worthlessness in both the groups at time points ‘D7’. While, restlessness and anxiety were found to be decreased in Group B however, irritability increased in Group B at time point ‘D30’.

Other symptoms like dryness of mouth, easy fatigability, suicidal thoughts, tachycardia, sleep disturbance, dyspnoea, the increased frequency at urine and stool, tingling and numbness, fainting did not show significant difference at both time points in both the groups. Significant improvement was observed in Group A patients at time point ‘D7’ and ‘D30’.

3.3. Effect of Shirodhara on different scores at different time points in both groups

KPS was significantly improved in the Group A as compared to the Group B, indicating improvement in functional impairment and survival (Table 2b). FS (p < 0.0001) of QLQ C-30 was found to be improved in the Group A as compared to the Group B at both the time points while SS (p < 0.0001) was significantly decreased in the Group A as compared to the Group B indicating the lower symptom load. The GS did not show any significant alterations in both groups at all time points (Table 2b).

Table 2b.

Showing the immediate and long-term effect of Shirodhara treatment on the different scales (health-related) in TNBC patients (Inter group analysis).

	D7			D30
	Group A	Group B	p-value	Group A	Group B	p-value
FS	90.29 ± 1.45	79.68 ± 1.10	<0.0001	96.44 ± 0.77	88.06 ± 1.02	<0.0001
GS	82.14 ± 2.11	82.86 ± 0.76	NS	88.33 ± 1.61	88.81 ± 1.08	NS
SS	10.18 ± 1.02	20.22 ± 1.21	<0.0001	6.01 ± 0.76	14.65 ± 1.15	<0.0001
BR23-FS	11.60 ± 0.64	11.23 ± 0.20	NS	10.66 ± 0.52	9.63 ± 0.16	NS
BR23-SS	17.71 ± 0.67	20.26 ± 0.29	0.0009	16.14 ± 0.44	17.69 ± 0.25	0.003
KPS	90.29 ± 1.19	82.86 ± 1.13	NS	93.71 ± 1.09	88.29 ± 1.04	NS
SAS	37.51 ± 1.84	40.09 ± 1.42	0.05	34.31 ± 1.75	34.00 ± 1.35	NS
SDS	36.26 ± 2.05	39.31 ± 1.22	0.05	33.06 ± 1.77	34.57 ± 1.32	NS

Data presented in Mean ± SE, the differences in mean of scores of Group A and Group B was compared by Unpaired t-test at time point ‘D7’ and ‘D30’. NS: Non-significant, FS: Functional scale, GS: Global scale, SS: Symptom scale, KPS: Karnofsky Performance Score, SAS: Zung's Self-rating Anxiety Scale, SDS: Zung's Self-rating Depression Scale.

The SS of BR-23 showed marked significant decrease in Group A at both the time points (p = 0.0009, 0.003), while functional score of BR 23 did not show any significant difference in the study and Group B at both time points (D7 & D30) in QLQ BR23 Score (Table 2b).

3.4. Effect of Shirodhara on SAS and SDS at different time points in both groups

The SAS and SDS in both the groups after 7th and 30th day were within normal scale. However, SAS and SDS were found to be significantly decreased in Group A at ‘D7’ timepoint as compared to Group B (Table 2b).

3.5. Effect of Shirodhara on psychological distress symptoms, KPS and QoL scores at day 7th and day 30th of Group A

The immediate and long-term effects of Shirodhara therapy on psychological distress symptoms were found to be significantly decreased in the Group A patients compared to Day 0, except for dyspnoea, feelings of worthlessness, dryness of mouth, suicidal thoughts, and increased frequency of passing urine and stools. Additionally, significant improvements were observed in KPS, FS, and GS. While, SS was found to be statistically decreased compared to Day 0. Both the SAS and SDS scores also showed significant decreases compared to Day 0 (Table 3a).

Table 3a.

Showing immediate and long-term effect of Shirodhara therapy on different symptoms of psychological distress (Intra-group analysis).

		D0	D7	p-value	D30	p-value
1.	Restlessness, Anxious	2.77 ± 0.90	1.17 ± 0.13	NS	0.71 ± 0.11	0.02
2.	Irritability	1.00 ± 0.14	0.77 ± 0.12	0.009	0.34 ± 0.09	<0.0001
3.	Difficulty in concentration	0.60 ± 0.12	0.29 ± 0.08	0.003	0.11 ± 0.05	<0.0001
4.	Worthlessness	0.14 ± 0.07	0.06 ± 0.04	NS	0.03 ± 0.03	NS
5.	Crying spells	0.97 ± 0.13	0.46 ± 0.11	<0.0001	0.14 ± 0.06	<0.0001
6.	Fearfulness	1.49 ± 0.16	0.77 ± 0.14	<0.0001	0.34 ± 0.08	<0.0001
7.	Tingling and numbness in limbs	1.40 ± 0.18	0.89 ± 0.15	<0.0004	0.29 ± 0.08	<0.0001
8.	Dryness of mouth	0.17 ± 0.09	0.06 ± 0.04	NS	0.00 ± 0.00	NS
9.	Dyspnoea	0.43 ± 0.10	0.20 ± 0.08	NS	0.06 ± 0.04	NS
10.	Tachycardia/Palpitation	0.97 ± 0.12	0.37 ± 0.10	<0.0001	0.09 ± 0.05	<0.0001
11.	Sleep disturbances	2.06 ± 0.15	0.97 ± 0.16	<0.0001	0.29 ± 0.09	<0.0001
12.	Easy fatiguability	1.54 ± 0.15	0.83 ± 0.12	<0.0001	0.31 ± 0.09	<0.0001
13.	Suicidal thoughts	0.17 ± 0.09	0.17 ± 0.09	NS	0.06 ± 0.04	NS
14.	Fainting	0.14 ± 0.07	0.06 ± 0.04	NS	0.03 ± 0.03	0.04
15.	Increased frequency of passing urine and stools	0.63 ± 0.13	0.41 ± 0.10	0.0003	0.24 ± 0.08	<0.0001

Data presented as Mean ± SE, the comparison of time point D7 and D30 with baseline (time point D0) of Group A was compared by paired ‘t’ test. NS: Non-significant.

4. Discussion

Acharya Charak has explained the concept of psychological set-up (Manovaha Srotasa) in the context of psychological disorders (Manasvyadhi) namely Delusional Disorders (Unmada). The mental enemies/dosha (Malas-Sharira and Manasa Dosha) located in the Manovaha Srotas of timid (Alpa-Sattva) persons vitiate the Hridaya situated in the Buddhi thus giving rise to mental disorders [9, Chikitsa Sthan, 9/5]. Here, Manovaha Srotasa is considered to be spread throughout the body. The mind (Manas) along with the sense organs virtually travel all over the body supposedly starting from the heart [9, Viman Sthan, 5/7] (Table 3b).

Table 3b.

Showing immediate and long-term effect of Shirodhara treatment on different health related scales in TNBC patient (Intra-group analysis).

	D0	D7	p-value	D30	p-value
FS	82.54 ± 2.14	90.29 ± 1.45	<0.0001	96.44 ± 0.77	<0.001
GS	74.05 ± 3.09	82.14 ± 2.11	<0.0007	88.33 ± 1.61	<0.0001
SS	14.58 ± 1.36	10.18 ± 1.02	<0.0001	6.01 ± 0.76	<0.0001
BR23-FS	12.91 ± 0.71	11.60 ± 0.64	<0.0004	10.66 ± 0.52	<0.0001
BR23-SS	19.66 ± 0.81	17.71 ± 0.67	<0.0001	16.14 ± 0.44	<0.0001
KPS	86.29 ± 1.17	90.29 ± 1.19	<0.0001	93.71 ± 1.09	<0.0001
SAS	43.09 ± 2.26	37.51 ± 1.84	<0.0001	34.31 ± 1.75	<0.0001
SDS	40.37 ± 2.40	36.26 ± 2.05	<0.0001	33.06 ± 1.77	<0.0001

Data presented as Mean ± SE, the comparison of time point D7 and D30 with baseline (time point D0) of Group A was compared by paired ‘t’ test. NS: Non-significant, FS: Functional scale, GS: Global scale, SS: Symptom scale, KPS: Karnofsky Performance Score, SAS: Zung's Self-rating Anxiety Scale, SDS: Zung's Self-rating Depression Scale.

Breast milk (Stanya) is subordinate tissue (Upadhatu) of primitive component for nourishment of body and mind (Rasadhatu) [9, Chikitsa Sthan, 15/17]. Main site or site of origin (Moolasthan) of blood and lymphatic system (Rasavaha Srotasa) is heart (Hridaya) [9, Viman Sthan, 5/8]. Channels nourishing cell and tissues (Rasavaha Srotasa) gets vitiated due to excessive worry or stress (Chintyanam Cha Atichintanat) [9, Viman Sthan, 5/13]. Hence, it can be said that, as stressful conditions vitiate primitive component for nourishment of body and mind (Rasadhatu), it's subordinates, the lactiferous glands and channels (Stanyavaha Srotasa) must be getting vitiated by stressful conditions. These vitiated subordinate tissues can lead to various breast related diseases (Stanaroga). Among the breast related disease, breast cancer, especially TNBC is been observed as a dangerous type as it has a genetic quotient, early onset, limitations about conventional therapies, high chance of recurrence. All these factors lead to stress-induced psychological disturbance in patients with TNBC. The degree and extent of distress are naturally high in TNBC patients [15]. Further, physical and psychological changes occurring at this stage are mainly due to hormonal imbalance which make women more vulnerable to anxiety, depression in the peri-menopausal period, hampering QoL in the patients [16,17].

The management of psychological distress in breast cancer patient often explore different modalities ranging from pharmacological to non-pharmacological aspect. However, non-pharmacological aspects are more acceptable in cancer patients due to some unpleasant side effects of the conventional therapy. Hence, mind relaxation therapies play important role [18]. Psychological interventions could provide support, coping strategies, and emotional well-being to individuals with breast cancer. The different psychological approaches include psycho-educational therapy (includes CBT + group therapy + education), Cognitive behavioural therapy (CBT-learn how to identify and change the destructive or disturbing thought patterns that have a negative influence on their behaviour and emotions), Supportive-expressive therapy (it promotes development of social support and reduces the emotional distress related to breast). The studies had been reported in effectiveness of these approaches in anxiety, depression and improving the QoL of patients [19]. The mind-body category consists of mindfulness-based stress reduction, art therapy, meditation, yoga, massage etc. the various researches showed that this aspect could reverse the harmful effects of stress by affecting neurotransmitters and neuromodulators, maintains the equilibrium between the parasympathetic and sympathetic nervous system, required to relieve the stress [20].

On this line, local therapy like Shirodhara could be safe, effective and beneficial to avoid additional oral administration of drugs for psychological distress along with oral ayurvedic medicines (Shamana chikitsa). Sesame oil medicated with rhizomes of Jatamansi was selected as it has potent intellect boosting (Medhya) action. Jatamansi by virtue of its characters that exhibit stability to the mind (Mano-Sthairyakara), promotes positive thinking (Modakrut), and relieves anxiety by inducing sleep (Nidrajanana) effect [21]. Sesame oil is used to control vitiated Vatadosha (vitiated due to chronicity and dreadfulness of disease) and virtue of mind which helps in activities (Raja) leading to anxiety and depression (due to pessimism and long-standing anxiety) [22]. According to proposed mechanism, the warm oil stimulates either the thermosensors or pressure sensors present in the skin or hair follicles of the forehead. These sensors are believed to transmit signals to the brain via the trigeminal cranial nerve, which is responsible for sensory information from the face and head. The stimulation of these sensors triggers a cascade of physiological responses, ultimately leading to a relaxed state. It is suggested that the relaxation induced by Shirodhara helps in maintaining psycho-physiological balance. Secondly, it also produces psycho-neuro-immunological effect by decreasing nor-adrenaline level, exhibiting sympatholytic action, increasing natural killer cells with activation of peripheral skin circulation [23].

In this study, Jatamansi Taila Shirodhara showed extremely significant improvement in the functional score at time points ‘D7’ and ‘D30’; which is indicative of the short and long-term effectiveness of Jatamansi Taila Shirodhara in functional ability of TNBC patients in daily life. This reflects mental relaxation of TNBC patients caused due to anti-anxiety effect of Jatamansi Taila Shirodhara. However, the short duration Shirodhara therapy could be able to manage some of the symptoms of distress while it may give good results in other symptoms if administered for a longer duration (14–21 days or more) or successive sitting of Shirodhara. So, need of Shirodhara course for a longer duration is again emphasized as intensity of vitiated body elements (Doshabala) and intensity of disease (Vyadhibala) is strong (Uttam).

Hence, future study can be planned with oral ayurvedic medications along with other allied procedures like Shiropichu, Padabhyanga for longer duration and/or successive sittings in large sample size.

5. Conclusion

Jatamansi Taila Shirodhara is found to be highly effective in improving the QoL of TNBC patients, especially in improving functional ability, and well-being and reducing symptomatology related to breast cancer. It is found to be effective immediately and in longer duration. It is beneficial in relieving symptoms of Anxiety and Psychological Stress (Chittodvega), indicating its anti-anxiety effect.

Authors contributions

SPS, AJ, VD: helped to conception and design of the work. AD, VG, SG, BS: data collection, data analysis and interpretation. AP: data curation, analysis and interpretation, writing original draft. SB: data analysis, interpretation, critical revision of article. All the authors have finalized the draft before submission.

Declaration of generative AI in Scientific writing

During this work, author did not use AI tools in writing the draft of the paper.

Funding sources

None.

Conflict of interest

Jatamansi Taila has been partly included along with the mentioned Shamana Chikitsa as “A Herbo-Mineral Metallic Pharmaceutical Kit” application no. 202121011657 for an Indian patent and published as well as in PCT application no. PCT/IB2022/052192 for Triple Negative Breast Cancer patients.

Appendix A. Supplementary data

The following are the Supplementary data to this article: