Published in IJCP April 2021
Clinical Study
Tropical Spastic Paraparesis Management with Herbal Neurogenic: A New Hope
April 14, 2021 | Avinash Shankar, Amresh Shankar, Anuradha Shankar
     


Abstract

Tropical spastic paraparesis (TSP), a disease of the nervous system, is caused by human T-lymphotropic virus type 1, thus also known as HTLV-1 associated myelopathy. It is common among females of age group 30-50 years. In spite of advancement in diagnostic procedures, i.e., CT scan, MRI, etc., its treatment with α-interferon, steroids, antiviral drugs, neuro-vitamin supplementation, physiotherapy fails to ensure cure or improve quality-of-life except transient pain relief with analgesics and muscle relaxants. Thus, a therapeutic regime composite consisting of a proven herbal neurogenic has been evaluated. Objective of the study: To assess the herbal neurogenic and immune boosting composite in ensuring clinical relief and improving quality-of-life in patients deterred from various medicenters without any relief. Material and methods: Sixty-three diagnosed and already treated cases of tropical spastic paraparesis, attending the Centre for Critical Care, National Institute of Health and Research, Warisaliganj (Nawada), Bihar, were selected, interrogated, examined clinically, assessed and analyzed for their previous investigation reports, therapy taken and their effect. Irrespective of their clinical severity, all patients were advocated the prescribed regime and were followed for 2 years post-therapy for which patients were given a follow-up card to record the changes. Result: Approximately 88.9% patients had Grade I clinical response while rest 11.1% had Grade II clinical response without any untoward effect or any withdrawal during post-therapy 2 years follow-up. Conclusion: The present regime constituting intravenous calcium gluconate, intravenous methylcobalamin + pyridoxine + niacin, self-blood (2 mL) and intramuscular betamethasone 2 mg, capsule cholecalciferol 60K, syrup herbal neurotonic proved its worth in the management of TSP even in chronic and long-term treated cases.

Keywords: Tropical spastic paraparesis, human T-lymphotropic virus type 1, CT, MRI, herbal neurogenic, quality-of-life

Tropical spastic paraparesis (TSP), a chronic and progressive clinical condition affecting the nervous system, remained of obscure etiopathogenesis for long, but nowadays, an important association of this condition has been established with human retrovirus (Human T-cell lymphotropic virus type 1), thus this condition is also termed as HTLV-1 associated myelopathy (HAM).

As per World Health Organization (WHO) estimate, worldwide 10-20 million people are carrying HTLV-1 and 5% of them are affected with TSP in the age group of 30-50 years.

TSP is very common in Latin America, the Caribbean Basin, sub-Saharan Africa and Japan, but these days, incidence of this clinical state is increasing even in India.

Common presentation of the clinical condition is:

  • Gradual weakening and stiffening of lower extremity
  • Radiating back pain down to legs
  • Burning and pricking sensation (paresthesia)
  • Urinary and bowel function disturbances
  • Erectile dysfunction in males
  • Inflammatory skin condition, like dermatitis or psoriasis
  • Rarely may present with eye inflammation, arthritis and muscle inflammation.

The common mode of transmission of this virus is through:

  • Breastfeeding
  • Sharing infected needles during intravenous drug use
  • Sexual activity
  • Blood transfusions.

In spite of advancement in diagnostics (computed tomography [CT] scan and magnetic resonance imaging [MRI]) and its established etiopathogenesis, till date, no established therapeutic regime has ensured its reversal but only symptomatic relief through α-interferon, intravenous immunoglobulin, antiviral drugs and muscle relaxants is available.

Signs and symptoms vary but may include slowly progressive weakness and spasticity of one or both legs, exaggerated reflexes, muscle contractions in the ankle and lower back pain. Other features may include urinary incontinence and minor sensory changes, especially burning or prickling sensations and loss of vibration sense.

Considering the poor quality-of-life with present therapeutics, a clinical study was planned to evaluate the clinical efficacy of proved neurogenic herbal composite with neuromodulator at National Institute of Health and Research and Centre for Research in Indigenous Medicine.

Objective of the Study

To evaluate the clinical efficacy and safety profile of herbal neurogenic with neuromodulator in TSP.

Duration of Study

January 2014 to December 2018.

Material and Methods

Material

Proved and treated cases of TSP without any clinical response, attending the Centre for Critical Care, National Institute of Health and Research, Warisaliganj (Nawada), Bihar were considered for evaluation of the herbal neurogenic constituting therapeutic regime.

Methods

Patients of spastic paraparesis diagnosed by myelogram, CT and MRI were interrogated thoroughly for the onset, duration and evolution of the disease, family history of neurological illness, history of extramarital sexual exposure, abortion, blood transfusions, dietary choices with emphasis on strict vegetarianism, Lathyrus sativus use, socioeconomic status, housing, sanitary conditions, treatment taken and their response. A detailed general examination and a meticulous neurological assessment were done.

Based on clinical presentation, patients were classified as summarized in Table 1.

Table 1. Clinical Presentation-based Classification

Severity Grade

Characteristics

Mild

Patients presenting with back pain, tingling and numbness in the leg

Moderate

Patient presenting with back pain, tingling and numbness, tendency to fall, heaviness in the lower extremity, leg weakness

Severe

Back pain, gait disturbance, stumbling, leg weakness, hyperreflexia and extensor plantar reflex, overactive bladder, constipation and sexual dysfunction

Patients were investigated for hemoglobin concentration, total and differential leukocyte count, erythrocyte sedimentation rate (ESR), peripheral smear, fasting and postprandial blood sugar, renal and liver function tests and serological test for syphilis. Common presentation of TSP is summarized in Table 2.

Table 2. Common Presentation of Tropical Spastic Paraparesis

Disturbances

Symptoms

Signs

Motor

Gait disturbance, tendency to fall, stumbling and leg weakness

Spastic paraparesis, weakness hyperreflexia lower limb, clonus, extensor plantar reflex

Sensory

Pain, numbness at lumbar level and backache

Feet paresthesia, loss of light touch sensory level at lower thoracic level

Autonomic

Urinary dysfunction, constipation, sexual dysfunction

Neurogenic or overactive bladder, diminished peristalsis, erectile dysfunction

All patients underwent conventional myelography, CT and MRI scans. The serum samples of all the patients were tested for HTLV-1 antibodies by the Serodia technique. All patients presenting with this crippling disease were advised and administered the following therapeutic regime after due awareness counseling and encouragement:

  • Injection calcium gluconate 1 amp every 15th day intravenous, very slow
  • Injection methylcobalamin + pyridoxine + niacinamide + pantothenic acid + betamethasone every week
  • Injection self-blood + betamethasone 2 mg every 10th day intramuscular
  • Capsule vitamin D3 60K every week orally
  • Syrup herbal neurogenic 10 mL every 12 hours/Capsule herbal neurogenic 1 cap every 12 hours
  • Active and passive exercise of the extremity
  • Diet: High protein vegetarian diet.

Herbal composite neurogenic capsule 500 mg or syrup 5 mL constitutes 100 mg each of Acorus calamus (rhizome), Nardostachys jatamansi (flower), Herpestis monniera (leaf), Convolvulus pluricaulis (flower) and Cassia acutifolia (seed).

Patients were assessed for improvement in tone and power of the muscle, tingling and numbness, gait and autonomic function (passage of stool and urine) for which patients were given a follow-up card to mention date of achievement and any untoward manifestation experienced. Patients were advised to visit the center on any unusual manifestation or contact on helpline for needful redresses. To adjudge the safety profile of the regime practiced, basic bio-parameters were repeated every month for first 3 months and then every 3 months.

Based on the clinical outcome and safety profile therapeutic response was graded as Table 3.

Table 3. Grade of Therapeutic Response

Clinical Grade

Characteristics

Grade I

Complete recovery of power and tone without any residual neurological deficit and adversity

Grade II

Improvement in power and tone with residual paresis and sensory deficit without any adversity

Grade III

No alteration in status

Result

Sixty-three identified, diagnosed and treated patients of TSP were considered for the study and out of them, majority (30/63) were in the age group 30-35 years with female dominance (Table 4 and Fig. 1) and all were from rural background. The community representation is depicted in Figure 2.

Table 4. Distribution of Patients as per Age and Sex

Age group (years)

Number of patients

 

Male

Female

Total

30-35

02

28

30

35-40

04

12

16

40-45

-

06

06

45-50

-

11

11

Figure 1. Pie diagram showing distribution as per sex.

Figure 2. Pie diagram showing distribution of patients as per community.

Majority of the patients was nonvegetarian and none had any history of taking Lathyrus sativus (Fig. 3).

Figure 3. Pie diagram showing distribution of patients as per dietary status.

The age of onset of clinical presentation varied from 20 to 40 years and duration of illness from 1 to 12 years (Fig. 4). Symptoms at the onset were difficulty in walking, stiffness of legs, back pain, weakness of legs, leg pain and urinary discomfort (Table 5) while presentation at our center included disturbed gait, leg stiffness, back pain, leg pain, urinary discomfort, urinary retention, tingling and numbness and erectile dysfunction in males (Table 5).

Figure 4. Bar diagram showing distribution of patients as per duration of illness.

Table 5. Distribution of Patients as per their Clinical Presentation

Clinical presentation

Number of patients

Difficulty in walking

63

Leg stiffness

63

Back pain

43

Weakness of the legs

63

Leg pain

63

Tingling and numbness

63

Gait disturbance

50

Urinary discomfort

50

Sexual weakness

06

History of surgery, abortion and blood transfusion

None

No history of blood transfusion, abortion, delivery or surgery prior to onset of the disease was evident but serum samples tested positive for HTLV-1 in 49 cases out of 63 (Fig. 5). In addition, all the bio-parameters (hepatic, hematological and renal profile) were normal. No patients were positive for tuberculosis, any sexually transmitted disease. In terms of clinical severity, out of 63 patients, 13 were of moderate and 50 were of severe status (Fig. 6).

Figure 5. Pie diagram showing HTLV-1 status of the patients.

Figure 6. Bar diagram sowing clinical severity of illness.

Patients had taken treatment with a-interferon, muscle relaxants, neuro-vitamin supplementation at various medicare centers without any positive therapeutic outcome (Table 6). Symptomatic relief started from 4th week of therapy and by 24th week, all had symptomatic relief (Fig. 7).

Table 6. Treatments Taken in Past

Therapy taken

Number of patients

α-interferon

43

Antiviral drug

49

Muscle relaxants

63

Neuro-vitamin supplement

63

Active and passive exercise

63

Figure 7. Graph showing duration required for improvement in presentation.

The minimum and maximum duration of therapy required for complete reversal of clinical presentation (both symptom and sign) was 9 months and 2 years, respectively. In all, 56 patients achieved Grade I clinical improvement and 7 achieved Grade II improvement (Fig. 8). No patients had shown any adversity, recurrence of presentation or any alteration in bio-parameters in 2 years of post-therapy follow-up (Table 7).

Figure 8. Bar diagram showing grades of clinical response.

Table 7. Outcome of the Study

Particulars

Number of patients

Duration in months

1

2

3

4

5

6

9

12

24

Clinical relief

6

24

34

44

56

63

63

63

63

Back pain

14

24

32

45

63

63

63

63

63

Tingling numbness

12

19

26

39

53

63

63

63

63

Pain in legs

12

21

24

37

48

63

63

63

63

Autonomic disturbance

-

-

19

30

42

50

63

63

63

Gait

-

4

14

22

32

50

63

63

63

Post-therapy bio-parameters

Hepatic profile:

                 

SGOT (<35 IU)

63

63

63

63

63

63

63

63

63

SGPT (<35 IU)

63

63

63

63

63

63

63

63

63

Alkaline phosphatase (<100)

63

63

63

63

63

63

63

63

63

Renal parameters

                 

Blood urea (<26 mg%)

63

63

63

63

63

63

63

63

63

Serum creatinine (<1.5 mg%)

63

63

63

63

63

63

63

63

63

Urine

                 

Albumin-Negative

63

63

63

63

63

63

63

63

63

RBC-Negative

63

63

63

63

63

63

63

63

63

Hematological

                 

Hemoglobin (>10 gm%)

52

58

59

63

63

63

63

63

63

Clinical grade

                 

Grade I

               

56

Grade II

               

07

Grade III

                 

Discussion

Tropical spastic paraparesis is becoming a common neurological disorder in India though it is common in different parts of the world including Jamaica, Martinique, Seychelles, Colombia and Japan. While it was considered as a neurological disorder of obscure etiology, these days, it is proved to be caused by HTLV-1. In spite of advancement in diagnostics like CT, MRI, cerebrospinal fluid (CSF) and serum for HTLV-1 antigen, the therapeutics used, i.e., α-interferon, muscles relaxant and neuro-vitamin supplement, fail to ensure cure or improve quality-of-life, except for transient symptomatic relief.

The current study showed clinical supremacy in terms of marked improvement in pain, sensation and gait of the already treated patients with other regime and achieving Grade I clinical response in 88.9% patients and Grade II in rest 11.1%. No patients had any withdrawal or drug adversity in 2 years post-therapy follow-up. This clinical efficacy can be explained considering the pathogenesis and causation due to HTLV-1 infected T cells (Fig. 9).

Figure 9. Pathogenesis and causation due to HTLV-1 infected T cells.

Self-blood with betamethasone intramuscular induces antibody formation against the released toxin and ensure their neutralization, while betamethasone, acting as anti-inflammatory agent, reduces neural edema, which is synergized by intravenous calcium administration.

Methylcobalamin, pyridoxine, niacin and pantothenic acid support neural cells in its normal neural conduction and a herbal neurogenic, by its neurogenic activity helps in restoration of neural viability and vitality which combinely ensure relief in pain, neuropathic manifestation, gait and autonomic function and provide better quality-of-life to all.

Conclusion

Present regime constituting calcium gluconate intravenous, methylcobalamin + pyridoxine + niacin intravenous, self-blood (2 mL) and betamethasone 2 mg intramuscular, capsule cholecalciferol 60K, syrup herbal neurogenic proved its worth in the management of TSP even in chronic and long-term treated cases.

Suggested reading

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