Clinical Research on Ayurvedic Therapeutics : Myths, Realities and Challenges
JAPI, Vol.49,May 2001, p.558-561.
Although ayurvedic treatment is gaining popularity, there is a need to conduct globally acceptable clinical research in ayurvedic therapeutics (80). The following researches are essential:
1) Selection of appropriate ayurvedic therapy.
2) Non-drug and drug ayurvedic therapy, so as to provide control to treatment on the effect of ayurvedic therapy.
3) Objective outcomes.
4) Placebo/positive controls.
5) Use of double-blind technique to guard against bias.
6) Scientific planning for the duration of trials.
7) Number of patients so as to lead to some statistical conclusions
8) Dose optimisation
9) The need to establish reasonable safety.
Servier’s Dual Approach to Osteoporosis
Scrip May 17th, 2002, pg. 26
Servier’s novel osteoporosis product, Protos (strontium ranelate), has a dual action in prevention and treatment of osteoporosis. Protos stimulates bone formation (osteoblast action) and inhibits bone absorption (osteoclast action).
The sum total is increased bone density. Clinical trials have demonstrated this effect.
Adefovir Set to Shake up Hepatitis B Market
Scrip No. 2742, May 1st, 2002 Pg. 26
Gilead Sciences’ once-daily oral nucleotide analogue, adefovir dipivoxil has significant advantages over lamivudine for the treatment of hepatitis B infections.
Untreated hepatitis B leads to severe liver damage, cirrhosis and liver cancer in 1/3rd of patients. Lamivudine is very effective in treatment of hepatitis B to very low levels but resistance develops in 2 years. Adefovir is likely to be free from these disadvantages.
Early NICE Draft Rejects Glivec
Scrip No. 2736, April 10th, 2002 Pg. 5
National Institute for Clinical Excellence (NICE) has rejected the product Glivec for the treatment of myeloid leukemia.
Glivec has been approved in many countries. However, the British Society of Haematology says that to prove any improvement in survival rate with Glivec will take some time.
ReQuip Slows Parkinson’s Progression
Scrip No. 2739, April 19th, 2002 Pg. 25
GlaxoSmithKline’s dopamine agonist (D2/D3) also known as ReQuip (ropinirole) has been shown to slow down the progression of Parkinson’s disease as compared to the standard therapy.
The classical treatment of Parkinson’s disease is levodopa. There are at least 5 or 6 dopamine agonists, which are marginally or doubtfully superior to levodopa.
NICE Backs TNF-Alpha Blockers for Rheumatoid Arthritis
Scrip No. 2732, March 27th, 2002 Pg. 4
The UK National Institute for Clinical Excellence has given the NHS the go-ahead to fund two expensive treatments for rheumatoid arthritis – the anti-TNF-alpha products, infliximab (Centocor/Schering-Plough’s Remicade) and etanercept (Wyeth/Immunex’s Enbrel) – which have long been subject to postcode prescribing.
Nimesulide Suspended in Finland
Scrip No. 2732, March 27th, 2002 Pg. 19
In most countries nimesulide has not been approved because of its hepatotoxic effect. Known amongst the few countries, which approve nimesulide, Finland has banned nimesulide.
Pfizer’s Vfend Approved in EC
Scrip No. 2732, March 27th, 2002 Pg. 21
Fungal infections in immunocompromised patients due to rapid progression of infections usually leading to death.
This is particularly common with Aspergillas, Candida, Scedosporium, and Fusarium.
Fluconazole has been used until now. Pfizer’s novel antifungal voriconazole (Vfend) has been approved for the treatment of such potentially fatal fungal infections.
US Reports Link Vioxx to Meningitis
Scrip No. 2733, March 29th, 2002 Pg. 29
5 serious cases of aseptic meningitis associated with rofecoxib (Vioxx) have been reported by the FDA.