Ayurveda evam Samagra Swasthya Shodhamala 2019;1(1):1

Simultaneous Management of Symptoms of Osteopenia and Osteoarthritis of Knee Through Panchakarma Therapy: Concept and Application

Alka Mishra1, Lalima Batham1, Saurabh Mishra2,*,  Vandana Shrivastava1

1Department of Ayurveda and Holistic Health, Dev Sanskriti Vishwavidyalaya, Gayatrikunj-Shantikunj, Haridwar, Uttarakhand, India

2Dev Sanskriti Vishwavidyalaya, Gayatrikunj-Shantikunj, Haridwar, Uttarakhand, India

*Corresponding Author: Saurabh Mishra - Email: sau.dsvv@gmail.com

Cite this research article as follows:

Mishra A, Batham L, Mishra S, Shrivastava V. Simultaneous management of symptoms of osteopenia and osteoarthritis of knee through panchakarma therapy: concept and application. Ayurveda evam Samagra Swasthya Shodhamala. 2019;1(1):1. [cited date]. Available from: https://sites.google.com/dsvv.ac.in/shodhamala-dahh/asssm11/asssm111

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Department of Ayurveda and Holistic Health

Dev Sanskriti Vishwavidyalaya

Gayatrikunj-Shantikunj, Haridwar - 249411

Uttarakhand, India

Email: dahh@dsvv.ac.in

Mobile: +91 9258360953, +91 8954890390

Website: http://www.dsvv.ac.in/dahh

Abstract

Background: Osteoarthritis of knee (Janu sandhigata vata) is a major cause of mobility impairment, particularly among females. Osteopenia (Asthi kshaya) is a common musculoskeletal disorder, characterized by below normal bone mineral density, resulting in an increased risk of fragile fractures, and associated physical disability, pain, degradation in quality of life, etc. Effective and simultaneous management of symptoms associated with these disorders, in a short duration of time, is not readily achieved. Panchakarma therapy of Ayurveda has shown noticeable effectiveness in the individual management of these disorders.

Methodology: Panchakarma therapy was administered for 14 days to a female patient suffering from multiple musculoskeletal disorders including Osteoarthritis of knee and Osteopenia of spine. According to Ayurveda, both these complaints are associated with Vata imbalance. Hence, Vata pacifying herbal medicines, that also provide nourishing effect to the degenerative tissues of the knees, spine, etc. were used. Later, herbal medicines were also prescribed for self-management at home.

Results: The patient experienced relief in pain and swelling in B/L knee joints, relief in pain in lower back, neck and B/L shoulder joints. Overall, the patient reported a good experience. In a followup taken after about three and a half months, the patient reported noticeable relief in knee and back pain as compared to that in previous winters.

Conclusion: Panchakarma therapy showed encouraging results in simultaneous management of symptoms associated with multiple musculoskeletal disorders, in short duration of time.

Keywords: Asthi kshaya, Ayurveda, Janu sandhigata vata, Osteoarthritis of knee, Osteopenia, Panchakarma

1. Introduction

        Osteoarthritis (OA) of knee is a major cause of mobility impairment, particularly among females [1]. Side-effect free, long-term management of this musculoskeletal disorder is still a challenge [2,3]; hence, there is a definite need to look for effective therapies for patients suffering from OA of the knee.

        Osteopenia is a common musculoskeletal disorder, characterized by below normal bone mineral density (BMD) [4-6], which results in an increased risk of fragile fractures, and associated physical disability, pain, degradation in quality of life, etc. The fact that in USA alone about 50 million adults suffer from Osteopenia [6], indicates its significant presence. Effective, long-term management of this disorder for mitigating fracture risk is still not achieved [6]; hence, there is a definite need to look for effective therapies for patients suffering from osteopenia.        

        According to Ayurveda, a healthy human body is supposed to have a relatively stable equilibrium (congenial homeostasis) of Dosha (psycho-biological rhythm - Vata, Pitta, Kapha), Dhatu (body tissues and their nourishing elements) and Mala (excreta) [7,8]; Acharya Sushruta defines health as an equilibrium of Dosha (psycho-biological rhythm), Agni (digestion and metabolism), Dhatu (body tissues), Malakriya (excretory function), as well as the well being of soul, senses and mind [7,8]. Imbalance in this equilibrium leads to disease, and the aim of the therapy is to restore this balance [8,9]. Treatment of disease involves procedures for purifying the biological system by removing the vitiated elements from the entire body, and thus causing disease prevention, as well as health promotion [7-12].  

        As per the classical texts of Ayurveda, the disease that resembles the symptoms associated with OA of knee is Janu Sandhigata Vata. Vata is the governing factor that maintains equilibrium in the Universe, as well as in the human body; as a person grows older, the influence of Vata Dosha increases, resulting in the gradual degeneration of the body [13]. Sandhigata Vata can be defined as a disease of sandhi (articulation) with symptoms of - sandhi shool (joint pain), sandhi shotha (swelling in joints), akunchana prasarana pravritti savedana (pain during movements like flexion and extension), atopa / sandhisphutana (crepitus), and in later stage, it converts into hanti sandhigatah (restricted movement of joints) [8,10,11,14,15]. It is a type of Vata-vyadhi (Vata related disease), which mainly occurs in old age due to ‘dhatukshaya’ (depletion of dhatus), which limits everyday activities such as walking, dressing, bathing, etc., thus making the patient disabled [16]. When Vata involves janu sandhi (knee joint), it is called ‘Janu Sandhigata Vata’ - OA of the knee.

        In Ayurveda, Acharya Sushruta has mentioned the treatment for Sandhigata vata as Snehan (oleation), Swedan (sudation), Upanaha (poultice), Agnikarma (cauterization), Bandhana (bandage) and Unmardana (massage) {Sushrut Samhita - Chikitsa Sthan 4/8} [8]. Panchakarma is a purificatory Ayurvedic procedure, which includes Snehan (oleation) and Swedan (sudation) as Poorva Karma (pre-procedures); Vaman (therapeutic emesis), Virechan (therapeutic purgation), Anuvasana Basti (oil enema), Asthapana Basti (decoction enema) and Nasya (nasal insuffolation) as Pradhan Karma (main-procedure); and, Sansarjan Kram (graduated diet) as Paschat Karma (post-procedure) [10,11,17]. Janu Basti procedure of Panchakarma gives encouraging results in relieving the symptoms of Janu Sandhigata Vata [3].

        As per the classical texts of Ayurveda, the condition that resembles the symptoms associated with Osteopenia is Asthi kshaya [7], which means a decrease in the bone tissue. A brief review of the conceptual foundation of Ayurveda will help in understanding this condition better. As described above, according to Ayurveda, a healthy human body is supposed to have a relatively stable equilibrium of Dosha (psycho-biological rhythm - Vata, Pitta, Kapha), Dhatu (body tissues and their nourishing elements) and Mala (excreta) [7,8]. The disturbance of this equilibrium is termed as disease, and the basic aim of the Ayurvedic treatment is to restore this equilibrium [8,9]. The function of Asthi dhatu is to give shape to the body, as well as protect the vital organs [7]. It can be considered as a combination of the sthayi Asthi dhatu (bone tissue) and the poshaka Asthi dhatu, i.e. the nutrients that nourish the bone tissue, like calcium, phosphorus, etc. [7]. The decrease in Asthi dhatu is termed as Asthi kshaya (decrease in bone tissue); the symptoms associated with Asthi kshaya include Asthi-sandhi shoola (joint pain), as well as distortion, weakness and fall of hair, nails, etc. that are supposed to be the Mala (excreta) of Asthi dhatu [7].

        Asthi dhatu is one of the main seat of Vata dosha, and these are inversely correlated, i.e. when Vata increases, Asthi dhatu decreases [7]. Thus, factors responsible for the increase in Vata are the primary factors for the occurrence of Asthi kshaya [7]. The inadequate nourishment of the Asthi dhatu also leads to Asthi kshaya [7]. Hence, treatments that balance the Vata dosha and provide the required nourishing effect may be useful in the management of Asthi kshaya and the associated symptoms.

        Kadlimatti et al. (2009) [7] stated that Asthi kshaya can be managed by administering the basti treatment of Panchakarma therapy, as well as by the oral use of shamana dravya (drugs that pacify the doshas) and Rasayana (provide nourishment). Kadlimatti et al. (2011) [18] showed that Ayurvedic Rasayana compound consisting of Ashwagandha (Withania somnifera), Shatavari (Asparagus resimosa), Shukti bhasma and Lakshadi guggulu provided relief in various symptoms associated with osteopenia.

        Under practical circumstances, patients suffer from multiple kinds of musculoskeletal disorders, as well as other associated ailments, and, they want relief in all the problems in a limited time frame. A case report about a female patient, who was simultaneously suffering from OA of the knee and Osteopenia in the spine, as well as other associated ailments, is being presented here. Since both the major complaints are associated with Vata imbalance, hence, in view of the above discussion Panchakarma therapy can be a viable option in this case. Hence, the present article explores the effectiveness of short term Panchakarma treatment for this patient.

2. Materials and Methods

2.1 Case Report

        A 46 year old female patient (height 160 cm, weight 65 kg) came to the out patient section of the Department of Ayurveda and Holistic Health (DAHH) at Dev Sanskriti Vishwavidyalaya, Haridwar, in October 2018, with multiple complaints; the detailed description of the same is as follows:

* Pain in bilateral (B/L) knee joints (more severe in left knee) since last nine years

* Swelling (massive) in left knee joint

* Pain at B/L lower extremity from knee to calf muscle, along with stiffness

* Pain in lower back, neck and B/L shoulder joints, and sometimes B/L scapular pain also

* Difficulty in sitting in criss-cross position, walking, standing for long duration, going up and down the stairs

* Swelling in B/L fingers of hands

* Acidic regurgitation and burning sensation in chest and throat

* Disturbed sleep, constipation, gastric upset

* Vitamin D deficiency

* Weight gain after menopause, which was at the age of 41 years

* Weakness

* Past history of sinusitis, which was controlled at this time by yoga

* Past history of gastric ulcer

        A bone mineral density (BMD) test (dated about four months prior to this visit), done using the Lunar DPX DXA System (analysis version 13.60) manufactured by GE Healthcare, gave a T-score between -1.0 and -2.5 (Osteopenia) for AP Spine L1 (-1.6), L2 (-1.6) and L3 (-1.8), and a T-score slightly less than -2.5 (i.e. -2.7) (Osteoporosis) for AP Spine L4, indicating the presence of Osteopenia and Osteoporosis.

        The patient had no past history of diabetes mellitus, hypertension, asthma, hypothyroidism,  rheumatoid arthritis. Based on the above mentioned medical history and further discussion with the doctor, the current diagnosis for the patient included Osteoarthritis in the left knee, with Osteopenia in the spine, with vitamin D deficiency, with Gastric ulcer, with disturbed sleep, with weak memory.

2.2 Therapeutic Intervention

        As mentioned above, the patient was suffering from multiple kinds of musculoskeletal disorders (associated with Vata imbalance), as well as other associated ailments. Furthermore, the patient had come to the Out Patient section, and had limited time to take the therapy; hence, the therapeutic intervention was planned accordingly.

        Informed consent was obtained from the patient before the start of the therapy.

        The therapeutic intervention included Panchakarma therapy, which was administered to the patient for 14 days as given in Table 1. Botanical names of medicinal plants used in the present study are given in Table 2.

        As shown in Table 1, the patient was given Deepan Pachan drugs on the first 5 days.

        The snehan (oleation) therapies administered to the patient were as follows:

* Abhyangam (Sarvanga) (Full Body Massage) - from day 1 to day 4, and from day 7 to day 11

* Abhyangam (Ekanga) (Local Massage) - on the knees on day 6

* Janu Basti was given on the left knee, which was more severely affected, from day 2 to day 9 (excluding day 5). Janu Basti involves retaining the warm medicated oil over the affected knee joint for certain period of time [19].

* Janu Pichu was given on the right knee from day 2 to day 9 (excluding day 5). Janu Pichu involves applying cotton mesh soaked in warm medicated oil on the affected knee joint.

        The snehan therapy was followed by swedan (sudation) therapy. The swedan therapies administered to the patient were as follows:

* Vashpa Sweda (Sarvanga) (Full Body Steam) was given on 12 out of 14 days

* Nadi Sweda (Local Steam) was given on day 6

* On last three days, Patra Pottali Sweda (Sarvanga) (Full Body) was administered to the patient along with mild Vashpa Sweda for wiping off the oil. Patra Pottali Sweda involves making a pottali (bundle) of leaves of medicinal plants (Eranda, Madar, Nirgundi, Dhatura, Shigru) in cotton cloth; keeping it in the mixture of above mentioned oils, that is continuously being heated; once the pottali is sufficiently heated, it is massaged over the entire body to induce sudation.

        Before starting the Basti treatment, Virechan vati - Myrolax tablet (Nagarjuna company) along with Avipattikar churna was given to the patient on day 5 for low-grade purification of gastro-intestinal tract (Koshtha Shuddhi). (Note: As Koshtha Shuddhi was done on day 5, hence full body massage and full body steam were not administered on the next day, i.e. day 6).

        Basti treatment was given to the patient for eight days (called Yog Basti, as per the traditional classification based on the number of total Basti given) [10,11], which included giving Anuvasana Basti and Asthapana Basti on alternate days from day 7 to day 12, followed by Anuvasana Basti on days 13 and 14. Anuvasana Basti (oil enema) [20] and Asthapana Basti (decoction enema) [21] are the process of drug administration through the rectal route, wherein oil or other oleaginous substance is the major content in case of Anuvasana Basti, while medicated decoction is the major part in Asthapana Basti. Total of 5 Anuvasana and 3 Asthapana Basti were administered to the patient.

        Nasya (nasal insuffolation), with Shadbindu Taila (numbers given in Table 1 represent the number of drops in each nostril), was administered to the patient for the first 9 days (excluding day 5). The pre-procedure (purva karma) of Nasya involves doing massage (abhyangam) and hot fomentation (swedan) on the face and head [22-24]. This is followed by the main-procedure (pradhan karma) of Nasya, wherein the medicine is administered through the nasal route by pouring it, drop by drop, in both the nostrils [22]. Shadbindu Taila commonly includes Til Taila (Sesamum indicum L.), Bhringa (Eclipta alba (L.) Hassk.), Aja Paya (goat milk), Eranda (Ricinus communis L.), Tagara (Valeriana wallichii DC.), Shatahva (Anethum sowa Roxb.), Jivanti (Leptadenia reticulata [Retz.] Wight and Arn.), Rasna (Pluchea lanceolata), Vidanga (Embelia ribes Burm.f.), Yashti (Glycyrrhiza glabra L.), Shunthi (Zingiber officinale Roscoe.), and Saindhava Lavana (Rock salt) [25].

        Shirodhara was administered to the patient on the last five days of the therapy. The procedure of Shirodhara involves continuous pouring of medicated liquid on the forehead of the patient, which creates specific pressure and vibration on the forehead [26,27].

        Local paste (Sthanika lepa) was also administered on waist and back from day 4 to day 10 (excluding day 5).

        The patient was also given a Kwatha (decoction) of Vata pacifying (Vata-shamak) and tissue nourishing (Vrinhan) herbal medicines on all the days of the therapy (excluding day 5).

        Some other associated methodologies that were administered and the advice that was rendered along with the above therapeutic procedure are as follows.

        Dietary restrictions were prescribed, which included not taking Vata aggravating diet like brinjal, pea, potato, rice, pumpkin, jack fruit, cold and sour things. It was advised to take only warm water to drink, and for bathing etc. Other behavioral regimen were also prescribed, such as, do not indulge in fear, anxiety, stress, anger, and any other negative thought; do not roam around too much; do not obstruct your natural urges like hunger, thirst, sleep, yawning, tear, etc. Try to keep your mind calm and happy, try to be silent, go early to bed and wake up early in the morning.

        Almost daily the doctor talked to the patient about her condition, and provided both clinical and motivational guidance, i.e. did regular counseling with positive thoughts. Each therapy was started with the chanting of Gayatri Mantra.

        Informed consent was obtained from the patient before the start of the therapy.

Table 1: Therapeutic intervention administered to the patient over a period of 14 days. The letter 'Y' indicates that the therapeutic procedure mentioned in that row, was administered on that day.  

Table 2: Botanical names of medicinal plants used in the present study.

3. Results

        In this case report, the outcomes were assessed in a qualitative (subjective) manner based on the doctor's pre and post examination, and, patient's experiential feedback, as given in Table 3.

Table 3: Pre Therapy and Post Therapy Observations

        Before the start of the therapy the patient reported pain in bilateral (B/L) knee joints (more severe in left knee), along with massive swelling in the left knee joint. After 14 days of the Panchakarma treatment, the patient reported significant improvement in the knee pain, i.e. up to 50% improvement in pain in both the knees. Visual analysis showed that the swelling present in the left knee also reduced by about 50%.

        Before the start of the therapy, the patient reported pain in lower back, neck and B/L shoulder joints. After the therapy, the patient reported significant improvement in the pain, i.e. up to 70% improvement in pain in lower back, neck and B/L shoulder joints.

        Before the start of the therapy, the patient reported swelling in B/L fingers of hands. After the therapy, visual analysis showed that very slight swelling was remaining in the B/L fingers of hands.

        The complaint of acidic regurgitation with burning sensation at the chest was also improved after the therapy.

        Overall, the patient reported a good experience after taking the therapy.

3.1 Followup

        About three and a half months after taking the above therapeutic procedure, a verbal feedback was taken from the patient over telephone in February 2019 regarding her current condition. The patient reported noticeable relief in knee and back pain as compared to that in previous winters; although, on and off there was some swelling in the knee because of winter season. She was feeling healthier than earlier time. All this while, she had been taking the ayurvedic medicines and decoction of medicinal herbs (twice daily), that were prescribed at the time of completion of the above therapeutic procedure, with regards to self-management of the disease at home.

4. Discussion

        A case report about a female patient, who was simultaneously suffering from multiple musculoskeletal disorders including OA of knee and Osteopenia in spine, as well as other associated ailments, is being presented here. Since both the major complaints are associated with Vata imbalance, hence, Panchakarma therapy was administered to the patient accordingly.

        The results given in Table 3 indicate that Panchakarma therapy gives encouraging outcomes, even in short duration. This result may be attributed to the therapeutic action of various Ayurvedic procedures administered to the patient.

        To begin with, Deepan Pachan medicines are administered for enhancing the digestive fire [28,29], for digestion of the Ama Dosha (undigested toxins of the body that are responsible for the blockage of micro-channels, i.e. srotas), as well as for the preparation of the body for next therapies.

        The snehan (oleation) and swedan (sudation) therapies are the prime modalities of treatment in the management of sandhigata vata [8]. The oils used in snehan therapies have snigdha (unctuous), guru (heavy) and mridu (soft) properties, which are opposite to the properties of Vata; hence Abhyangam reduces the vitiated Vata (which is responsible for the decay in the dhatus) [13]. The oils also provide nourishing effect (Vrinhan) to the degenerative tissues of the knees, spine, etc. Swedan has actions like stambhaghna (relieves stiffness), sweda-karak (creates perspiration), and, gauravaghna (cures heaviness) [13]. The mwdicinal herbs used in the swedan therapy also have Vata pacifying (Vata-shamak) [30,31] and tissue nourishing (Vrinhan) properties.

        The Koshtha Shuddhi procedure does a low-grade purification of the gastro-intestinal tract, and prepares the body for the Basti treatment.

        Basti is one of the best treatment in the case of Vata disorders [21], as stated by Acharya Charak (Vastirvaataharaannaam) {Charak Samhita - Sutra Sthan 25/40} [10]. Anuvasana Basti (oil enema) nourishes the dhatus, promotes strength and cures Vata related diseases; Asthapana Basti (decoction enema) cleanses the colon and cures Vata related diseases [21].

        The pre-procedure (purva karma) of Nasya (nasal insuffolation) causes the softening and liquifying of the vitiated Doshas [22-24]. The vasodilation caused by the pre-procedure is supposed to increase the permeability of the blood vessels, which makes the absorption of the medicine faster [23]. The main-procedure (pradhan karma) of Nasya involves administering the medicinal oil through the nasal route, by pouring it, drop by drop, in both the nostrils [22]. Nasya primarily affects the urdhvajatrugata pradesha (supra-clavicular region) [22,32]. According to Acharya Vagbhatta, nose is one of the most convenient routes to convey medicinal effects to the cranial cavity [22]. According to Acharya Charaka, nasya drug usually acts through absorption by the Shringataka marma (a vital spot in the head region situated at the site of the union of the nerves, supplying to the nose, ears, eyes, and tongue); after absorption, the medicine acts on the diseases of shoulder, neck, etc., and the vitiated Doshas are expelled from the head region [22]. Thus, the administered medicine moves up to the Shringataka marma, spreads all over the head, channels of eyes, ears and throat, and removes vitiated Doshas from there [22,32]. Nasya was done with Shadbindu Taila, whose ingredients have beneficial effects with regards to balancing the vitiated Vata and Kapha doshas; one of such ingredients is Rasna (Pluchea lanceolata) [33].

        Shirodhara creates specific pressure and vibration on the forehead, with beneficial therapeutic effect in terms of relieving stress, anxiety, etc. [26,27]. Ksheer Bala Taila was used in Shirodhara; this taila has milk and Bala Taila as ingredients; Bala Taila has beneficial effect on all the sensory organs, and affects the mind in such a way that the patient experiences relief from anxiety and stress [26]; milk has Madhura Rasa (sweet in taste), Snigdha Guna (oily property), Sheeta Veerya (cold in nature) and Madhura Vipaka (effect after bio-transformation), which pacify Vata and Pitta Doshas [27]. Dhanvantar Taila has Vata pacifying properties [32].

        Local paste (Sthanika lepa) was also administered on waist and back, to provide relief from pain. The herbal ingredients used therein have Vata pacifying and tissue nourishing properties [30,31].

        The patient was also given a Kwatha (decoction) of Vata pacifying (Vata-shamak) and tissue nourishing (Vrinhan) drugs [30,31].

        Almost daily the doctor talked to the patient about her condition, and provided both clinical and motivational guidance; the purpose was to instill confidence in the patient that her condition can be improved, and she has to herself take responsibility of bringing about this change by diligently following the prescribed treatment and guidelines.

        Each therapy was started with the chanting of Gayatri Mantra, which causes beneficial effects with regards to various physical and mental conditions like attention, concentration, etc. [34-39]. The patient must also have benefited from the spiritually charged environment of Dev Sanskriti Vishwavidyalaya, Haridwar.

        During Panchakarma therapy, it is advised to avoid 'Ashta-Maha-Doshkar-Bhav' (eight types of behavioral and dietetic practices that cause obstructions in micro-channels, srotas, leading to aggravation of the diseases) so that better results can be observed. The following of these practices must also have contributed in providing the observed relief.

        The above discussion reveals that since the major complaints of the patient were associated with Vata imbalance, hence, the therapeutic procedures administered to the patient had Vata pacifying (Vata-shamak) and tissue nourishing (Vrinhan) effects, which must have caused the amount of relief experienced by the patient in such a short duration of therapy. Also, in place of using a single therapy, a combination of different therapeutic procedures, along with multiple herbs, were used, in order to achieve simultaneous management of the symptoms associated with multiple ailments.

        Although the results are qualitative in nature, yet the degree of benefit attained in simultaneously addressing multiple types of ailments is noteworthy, especially considering the fact that the patient was an Outdoor Patient, had genuine limitations in following the dietary restrictions, and the therapy was administered for quite short duration.

        With regards to the long term impact of the therapeutic procedure, in a followup taken about three and a half months after taking the above therapeutic procedure, the patient reported noticeable relief in knee and back pain as compared to that in previous winters, as well as a healthier feeling. All this while, she had been taking the ayurvedic medication prescribed at the time of completion of the above therapeutic procedure, with regards to self-management of the disease at home. This is definitely an encouraging outcome.

        Further in-depth quantitative study would definitely be worthwhile to establish the mode of operation of the administered therapeutic procedure in the light of modern scientific understanding.

5. Conclusions

        Panchakarma therapy was administered in the present study for the simultaneous management of the symptoms associated with multiple musculoskeletal disorders including Osteoarthritis (OA) of the knee and Osteopenia of spine. A single case study involving female patient was presented. Various therapeutic procedures were administered to the Out Patient section patient over a period of 14 days. Qualitative analysis showed encouraging results, with the patient experiencing relief in various symptoms associated with OA of knee, Osteopenia in spine, and other associated ailments, in a short duration of time.

Acknowledgements

        Authors would like to acknowledge the subtle guidance of their spiritual guide, Revered Pandit Shriram Sharma Acharya, who founded the organization, All World Gayatri Pariwar (www.awgp.org). The authors thank the faculty and staff of the Department of Ayurveda and Holistic Health, Dev Sanskriti Vishwavidyalaya, Haridwar for their support in conducting this study.

Compliance with ethical standards: Informed consent was obtained from the patient before the start of the therapy.

Conflict of interest: The authors declare that they have no conflict of interest.

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