Adverse reaction of Parasika Yavani (Hyoscyamus niger Linn): Two case study reports

Introduction

Ayurveda offers a system of natural healing that is very complete both in terms of its treatment and also in its understanding of the human being. It offers a vision of healing for curing disease, for preventive health, and ultimately for spiritual liberation.[1] Since ages, Ayurveda is being practiced in India. Now in this era of globalization, certain concerns are being raised with regards to the safety of plants or plant based products. Adverse reactions of many Ayurvedic medicines are yet to be reported. Ayurveda has categorized toxic plants separately and for their use, special processing is essential.[2] If not processed properly and not used judiciously, these drugs may prove to be fatal. It is the need of the hour to report all such adverse drug reactions (ADRs) associated with administration of Ayurvedic drugs.

An ADR can be termed as “an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration, and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product.“[3] ADRs are classified into six types: Dose-related (augmented), dose-related (bizarre), dose-related and time-related (chronic), time-related (delayed), withdrawal (end of use), and failure of therapy (failure). Timing, the pattern of illness, the results of investigations, and rechallenge can help attribute causality to a suspected ADR. Management includes withdrawal of the drug, if possible and specific treatment of its effect.[3] Few such adverse reactions are observed while administering the single drug Parasika Yavani (Hyoscyamus niger Linn.).

Parasika Yavani commonly known as Henbane is considered as a Madaka Dravya (narcotic) by Bhavaprakasa.[4] It is useful in conditions such as Unmada (psychological disorders), Anidra (insomnia), etc.[5] In the present study, Parasika Yavani Beeja Churna (seed powder) was given in the treatment of Chittodwega (anxiety).

Case Reports

Discussion

Parasika Yavani seeds are Katu (bitter), acrid, Madaka (narcotic), Vedanasthapaka (analgesic), Krimighna (antihelminthic), Sulaprashamana (antispasmodic), Nidrajanaka (induces sleep), anti-inflammatory, and expectorant.[6] They are useful in Unmada (psychological disorders), Anidra (insomnia), Pralapa (restlessness), odontalgia, bleeding gums, dental caries, orchitis, rheumatoid arthritis, dyspepsia, worm infestation, cardiac debility, flatulence, colic, asthma, bronchitis, neuritis, fever, meningitis, amenorrhea, urinary tract infection, and irritability.[57] It contains tropane alkaloids called, hyoscine (scopolamine), hyoscyamine (L-atropine), and atropine (DL-hyoscyamine).[6] In higher dose, it causes dry mouth, thirst, difficulty in swallowing, and speaking, warm flushed skin, dilated pupils, blurred vision, and photophobia, vomiting, urinary retention, tachycardia, pyrexia, drowsiness, slurred speech, hyper-reflexia, auditory, visual, or tactile hallucinations, confusion, disorientation, delirium, agitation, and combative behavior. In severe cases, there may be hypertension, coma, and convulsions.[68]

The dosage of seed powder given in different Ayurvedic and modern texts vary from 125 mg to 3 g.[5] In above reported cases, the dosage given was within the advised therapeutic dosage limit. 500mg capsule were given to many patients, but no adverse reactions were noticed except in above given two cases. So, the dose was tapered down to avert the adverse reactions and to fix the therapeutic dose. The reactions observed in the current study can be categorized under type A/dose-related ADR. On analysis, these two individuals were found to be of Pitta Prakriti. Parasika Yavani is found to increase Pitta.[6] Possibly, the drug aggravates Pitta in such individuals and triggers the establishment of ADRs. It was also observed in the same research study that the patients belonging to Kapha and Vata Prakriti did not develop any adverse reactions.

The principles of Ayurvedic treatment were established on the basis of “Purusham Purusham Veekshya” that is, each patient is unique, and different.[9] Ancient texts were very well aware of the toxicity and provided guidelines to avoid such manifestations. Prakriti of the patient plays a very important role in the drug administration, and metabolism. So while administering therapeutic dosage, physician should be vigilant.

Conclusion

In the current study, it is observed that 500 mg of Parasika Yavani powder in Pitta Prakriti individuals triggered ADRs. It was also observed that Kapha and Vata Prakriti patients did not develop any adverse reactions. And as per observations from study 250 mg once daily is found to be ideal in Pitta Prakriti.