mTGV vs AZA in Crohn's Disease Post Surgical Recurrence (2015)
This study examines 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 mTGV as a treatment to prevent relapse after a surgical resection.
mTGV = medicinal Thunder God Vine = Tripterygium wilfordii Hook F = TwHF = Lei Gong Teng
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Quoting 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.”
Medicinal Thunder God Vine is an established treatment in 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.
Physicians consider it as a natural treatment that is both safe, usually as, and often more effective than conventional drugs.
Summary of the study
The patients were randomly affected a group.
– Group 1 : 45 patients took AZA 2mg/kg/day
– Group 2 : 45 patients took mTGV at 1,5mg/kg/day
Other medications were 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 2 most useful ways: the endoscopic aspect and the clinical aspect.
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 of 45 of patients had experienced an adverse event.
At week 52: 35 of 45 of patients had experienced an adverse event.
Group 2 (mTGV)
At week 26: 16 of 45 of patients had experienced an adverse event.
At week 52: 22 of 45 of patients had experienced an adverse event.
The comment on this result is that there were less adverse reactions with mTGV at week 26. 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 of 45 patients had clinical recurrence
At week 52: 8 of 45 patients had clinical recurrence
Group 2 (mTGV)
At week 26: 6 of 45 patients had clinical recurrence
At week 52: 12 of 45 patients had clinical recurrence
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 of 44 patients had endoscopic recurrence
At week 52: 21 of 42 patients had endoscopic recurrence
Group 2 (mTGV)
At week 26: 25 of 44 patients had endoscopic recurrence
At week 52: 32 of 43 patients had endoscopic recurrence
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