Mediators of Inflammation / 2015 / Article / Tab 1

Review Article

Botanical Drugs as an Emerging Strategy in Inflammatory Bowel Disease: A Review

Table 1

Clinical trials of botanical drugs in patients with inflammatory bowel disease.

Herbal preparationStudy designNumber of patientsIBD typeDoseComparatorFrequencyEndpointReference

Aloe veraRandomized, double-blind controlled study44UC100 mL twice/dayPlacebo4 weeksAloe vera produced a significantly better clinical response than in those receiving placebo. The Simple Clinical Colitis Activity Index and histological scores decreased significantly during treatment with Aloe vera but not with placebo[14]

Andrographis paniculata
(HMPL-004)
Randomized, double-blind multicentre study120UC1.2 g/dayMesalazine (4.5 mg/day)8 weeksThere were no significant differences between the two treated groups when considering the clinical efficacy rates or the safety profile[15]
Randomized, double-blind placebo-controlled study224UC1.2 g/day and 1.8 g/dayPlacebo8 weeksPatients treated with the extract, mainly at the highest doses, were more likely to achieve clinical response than those receiving placebo, whereas the incidence of adverse events was similar among groups, although the occurrence of rash was higher in the HMPL-004 extract groups[16]

Artemisia absinthiumRandomized, double-blind multicentre study40CD3 × 500 mg/dayPlacebo10 weeksAfter 8 weeks of treatment with wormwood, there was almost complete remission of symptoms in 65% of the patients, whereas no beneficial effect was observed in those receiving the placebo[17]
Randomized, double-blind multicentre study20CD3 × 750 mg/day (in addition to standard therapy)Standard therapy + placebo6 weeksWormwood administration promoted the clinical improvement of the symptoms in all the patients. The beneficial effect was associated with a significant decrease in TNFα serum levels in comparison with those obtained in the placebo group, where no amelioration in the disease was observed[18]

Boswellia serrata
(Gum resin)
?UC750 mg
(3 × 250 mg)
Sulfasalazine 3 g (3 × 1 g)6 weeksAll parameters tested improved after treatment with Boswellia serrata gum resin, with the results being similar compared to controls: 82% out of treated patients went into remission; in case of sulfasalazine remission rate was 75%[19]
(Gum resin)30UC?900 mg
(3 × 300 mg)
Sulfasalazine 3 g (3 × 1 g)6 weeksPatients showed an improvement in several parameters: stool properties, histopathology, and scanning electron microscopy, besides haemoglobin, serum iron, calcium, phosphorus, proteins, total leukocytes, and eosinophils. The remission was higher in patients treated with Boswellia serrata[20]
(Boswelan)Randomized, double-blind, multicentre placebo-controlled study82CD2.4 g/dayPlacebo12 months
(52 weeks)
Boswelan showed a safety profile during the long-term therapy but the results obtained did not show a higher efficacy when compared with placebo[21]

Cannabis sativaRetrospective
observation study
30CDCannabis administration was associated with an improvement in disease activity and a reduction in the need of other medications, as well as a reduced risk of surgery[22]
Prospective
Placebo-controlled study
21CD2 cigarettes containing 115 mg of THC/day Placebo 8 weeksA significant amelioration of the CD activity index has been reported in the majority of the subjects after cannabis treatment in comparison with placebo administration; in fact, complete remission was achieved in half of the subjects in the cannabis group, whereas it only occurred in 10% of the placebo group patients[23]

Curcuma longaOpen-label pilot study 

Open-label pilot study
5 



5
UC  



CD
1.100 g/day (550 mg × 2) for 1 month, then 1.650 g/day (550 mg × 3) for 1 month and 
1.080 g/day (360 mg × 3) for 1 month, and then 1.440 g/day for two months
— 



2 months 



3 months
The results from this study revealed that the treatment of these patients with curcumin for two months resulted in an overall improvement in all the patients, as evidenced by amelioration of the serological parameters evaluated (erythrocyte sedimentation rate and C-reactive protein) as well as the disease activity index followed, together with a reduction in the dose of medication, or even suppression. In the CD group, all patients also reported fewer bowel movements, less diarrhoea, and less abdominal pain and cramping[24]
Randomized, double-blind multicentre placebo-controlled study89UC2 g/day plus sulfasalazine or mesalazinePlacebo plus sulfasalazine or mesalazine6 monthsThe relapse rate was significantly higher in the placebo group, receiving only the aminosalicylate (20.5%), than in the curcumin-treated cohorts (4.7%). During the period of the study, a marked reduction of the disease-associated clinical activity index and the endoscopic index scores was reported[25]