2015 Clinical Trial: Thunder God Vine VS AZA in Crohn’s disease

2015 Clinical Trial: Thunder God Vine VS AZA in Crohn’s disease
September 24, 2018 Nathalie

A Crohn’s Disease natural treatment

Medicinal Thunder God Vine is an established treatment of active Crohn’s Disease

Medicinal Thunder God Vine (mTGV) is a common Crohn’s Disease natural treatment in China for the past 30 years in mildly or moderately active Crohn’s Disease.

It is also a first intention prescription for a number of other autoimmune conditions and inflammatory disorders. Physicians consider it as a natural  treatment that is both safe and usually as and often more efficient than many conventional drugs. Although medicinal TGV is not known outside of China, many studies and clinical trials have been carried out. A few few are translated and published in English.

Thunder God Vine = TGV = Tripterygium wilfordii Hook F = Lei Gong Teng = TwHF

Medicinal Thunder God Vine VS AZA in post surgical recurrence : a 1 year study with 90 patients (2015)

This study is quite interesting to illustrate the safety and efficacy of medicinal Thunder God Vine in Crohn’s Disease. It compares mTGV with Azathioprine (AZA) during 52 weeks (1 year). The goal was to explore efficacy and safety of mTGV as a treatment to prevent relapse after a surgical resection.

The full study is not available to read online for free, only the abstract: Tripterygium wilfordii Hook. f. versus azathioprine for prevention of postoperative recurrence in patients with Crohn’s disease: a randomized clinical trialIf you are interested to read it in its entirety, email me on the Contact page and I will share it with you.

2 groups

  • Group 1 : 45 patients took AZA 2mg/kg/day
  • Group 2 : 45 patients took mTGV at 1,5mg/kg/day

Other medication was not allowed during the trial, including other immunosuppressants or conventional CD treatments, corticosteroids, oral antibiotics for more than 2 weeks, NSAIDs for more than 1 week.

About endoscopic recurrence and clinical recurrence

Recurrence of Crohn’s Disease can be assessed in a number of different ways. The 2 most useful are endoscopic and clinical.  It is important to note that clinical recurrence tends to lag behind endoscopic recurrence. Most patients have clinically silent disease, yet endoscopically inflammation is present…

Adverse reactions

Group 1 (AZA)
At week 26, 27/45 of patients had experienced an adverse event and 35/45  at week 52.

Group 2 (mTGV)
At week 26, 16/45 of patients had experienced an adverse event and 22/45  at week 52.

The comment on this result is that there were less adverse reactions with mTGV at week 26 (p=0,02). But at week 52, this difference was not significant anymore. A total of 7/45 patients discontinued in the AZA group and 4/45 in the mTGV group due to adverse events.

Results for clinical recurrence

Group 1 (AZA)
At week 26, 4/45 patients had clinical recurrence and 8/45  at week 52.

Group 2 (mTGV)
At week 26, 6/45 patients had clinical recurrence and 12/45  at week 52.

The comment on this result is that although AZA seems to perform better than mTGV at week 26, and week 52 they are not significantly different when it comes to analyzing the numbers statistically speaking. This is made possible thanks to the calculation of the P value. The P value should be inferior to 0,05 to say that there is a significant difference in results. In the present case P= 0,45 at week 52 and P=0,79 at week 26.

Results of endoscopic recurrence

Group 1 (AZA)
At week 26, 21/44 patients had endoscopic recurrence and 21/42  at week 52.

Group 2 (mTGV)
At week 26, 25/44 patients had endoscopic recurrence and 32/43  at week 52.

The comment on this result is that although AZA seems to perform better than mTGV at week 26 (p=0,52), they are not significantly different statistically speaking. But at week 52, AZA shows to perform better in preventing endoscopic recurrence with a P=0,03

Here I quote the conclusion of the study

” Although the data indicated that AZA may be more effective for maintaining endoscopic recurrence at week 52, our results also suggest that TwHF is safe and effective in preventing postoperative clinical recurrence.”

 

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