mTGV vs Methotrexate in the treatment of active Rheumatoid Arthritis (2014)

This trial compares the efficacy and safety of medicinal Thunder God Vine (mTGV) VS Methotrexate and in combination with Methotrexate.

Rheumatoid Arthritis = RA
Methotrexate = MTX
mTGV = medicinal Thunder God Vine = Tripterygium wilfordii Hook F = TwHF = Lei Gong Teng

See the online abstract: Comparison of Tripterygium wilfordii Hook F with MTX in the treatment of active rheumatoid arthritis (TRIFRA): a randomised, controlled clinical trial.

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Quoting the conclusion of the study

To summarize, the study conclusion is that “Thunder God Vine as a monotherapy is not inferior to MTX. Thunder God Vine + MTX therapy was more effective than MTX monotherapy alone.”

“Adverse events and severe adverse events of Thunder God Vine monotherapy was not higher than in MTX monotherapy.”

Medicinal Thunder God Vine is a long time established treatment in active Rheumatoid Arthritis

In China, mTGV is approved and a first line choice to treat RA. Physicians consider it as a natural DMARD that is both safe, usually as, and often more effective than conventional drugs.

Summary of the study

The study included 207 patients recently diagnosed, having active Rheumatoid Arthritis over a period of 24 weeks (6 months).

This trial was designed at the Beijing Peking Union Medical College Hospital which is one of the most advanced in the world. As a matter of fact, 20 000 new cases of RA are treated every year in this hospital with mTGV, alone or in combination with low doses of MTX with outstanding results (see reference below).

Ref : https://arthritis-research.biomedcentral.com/articles/10.1186/s13075-018-1563-6  (mTGV) “TwHF has been approved to treat RA in China. Our clinical experiences from treating more than 30,000 patients with RA each year in Peking Union Medical College Hospital (PUMCH) also support the high cost effectiveness of TwHF or a combination of MTX + TwHF…”

Patients Groups

  • The first group took MTX 12.5 mg once a week.  Important to note that according to Western standards, this dose is low, whereas in China it is the max dose for MTX in the treatment of RA.
  • The second group took 30mg 3 times a day (90 mg per day) of Thunder God Vine. This is mTGV 9 tablets of 10mg (prescription range of 1 to 1,5 mg/kg/day).
  • The third group took both of the above : 12.5 mg MTX once a week + 90 mg Thunder God Vine per day

Results

The results evaluate the number of patients reaching the American College of Rheumatology score of at least 50 (ACR50) or higher at week 24 (6 months).

  • MTX alone: 46.4%
  • Medicinal Thunder God Vine alone: 55.1%
  • Medicinal TGV + MTX 76.8%
The ACR score is a standardized score indicating how much a person’s RA has improved. The measure takes in consideration the number of painful / swollen joints, the patient’s assessments, the physician’s assessment and the measured levels of inflammation in blood tests.

The ACR is a percentage. An ACR20 means that a person’s RA has improved by 20%, an ARC50 means an improvement of 50%, and ACR70 of 70%.

Other interesting facts

During the trial, patients could continue to take anti-inflammatory drugs. Namely NSAIDs such as Naproxene and not over 10 mg Prednisone or equivalent per day.

Most patients (203 from a total of 207) never used any DMARD or biologic before as they were recently diagnosed.