Is Chios mastic gum effective in the treatment of functional dyspepsia? A prospective randomised double-blind placebo controlled trial
Graphical abstract
Introduction
Dyspepsia is a very common problem that affects large numbers of individuals worldwide especially in the Westernised world. Patients with dyspepsia problems are treated both by primary care physicians as well as gastroenterologists in the different health care systems. Dyspepsia in the absence of an identifiable structural lesion in the upper gastrointestinal system is referred to as functional dyspepsia (Talley et al., 1999).
Treatment of functional dyspepsia remains problematic. Historically the H2-receptor antagonists have been tried in dyspepsia but the results were generally disappointing (Talley et al., 1986, Kato et al., 2005, Ashizawa et al., 2006,). At about the same time prokinetics were also used in functional dyspepsia. Mosapride showed a small improvement in symptoms in a small trial (Wu et al., 2006). Cisapride, a related compound has shown superiority over placebo in meta-analyses but its use is now severely restricted due to cardiac side effects (Veldhuyzen van Zanten et al., 2001). Itopride a newer D2-receptor antagonist has shown some promising results in one large and two smaller trials (Amarapurkar and Rane, 2004, Zhu et al., 2005, Holtmann et al., 2006) but it has failed Phase III trials (Talley et al., 2008). As for proton pump inhibitors recent meta-analyses have shown efficacy but the effect was modest (Moayyedi et al., 2004, Van Zanten et al., 2006). Helicobacter pylori eradication has shown some minor benefit in recent trial and meta-analyses (Moayyedi et al., 2003, Di Mario et al., 2005, Ang et al., 2006). As for alosetron, whose use is restricted in some countries due to side effects it has shown benefit in functional dyspepsia (Talley et al., 2001).
As treatment of functional dyspepsia with conventional medication remains unsatisfactory, herbal remedies such as iberogast (Melzer et al., 2004a, Melzer et al., 2004b, Von Arnim et al., 2007), and artichoke leaf extract (Holtmann et al., 2003, Meier and Brignoli, 2005) have been tried in small studies for the treatment of this condition. The results have been promising and results from bigger trials are awaited.
Chios mastic gum is a resinous exudate which is derived from the stem of the bush Pistacia lentiscus var. chia. Chios mastic gum is usually sold as a chewing gum. It is also used in cooking and cosmetics. There have been references to Chios mastic gum as a medicinal product for gastrointestinal upsets since ancient times (Kaliora et al., 2007). It is still widely used as a remedy for these in many parts of the Mediterranean basin and the Middle East (Triantafyllou et al., 2007).
Although Chios mastic gum is traditionally used in dyspepsia like symptoms no properly designed trial has ever been conducted to test its efficacy. Our aim was to evaluate the efficacy on Chios mastic gum in patients with functional dyspepsia in terms of improvement of the perception of symptoms.
Section snippets
Materials and methods
The trial was a 3-week double-blind randomised placebo controlled study designed to investigate the effects of Chios mastic gum on functional dyspepsia symptoms.
The study was conducted in Chios District General Hospital Skylitsion, Chios, Greece.
The study was approved by the local ethics committee (Reference no. MGCGH0031/05) and the Greek Medicines Agency (Reference no CGH266/05 B). All procedures followed were in accordance with the Declaration of Helsinki (1975, amended 2000) on
Results
Two hundred and forty one patients were assessed for eligibility. Eighty-three patients were excluded for various reasons. One hundred and forty eight patients were enrolled and randomised. Seventy-four received Chios mastic gum and seventy-four received placebo. One patient in the active treatment was lost to follow up. Four patients (one in the active treatment group and three in the placebo group) discontinued treatment because of lack of efficacy. The first patient entered the study in
Discussion
Due to the paucity of effective conventional medication for the treatment of functional disorders of the alimentary tract natural remedies and herbal preparations have been tested for these conditions during the past few years.
A few studies for the treatment of irritable bowel syndrome have confirmed some efficacy for compounds such as peppermint oil, iberogast and Chinese herbal preparations (Liu et al., 1997, Bensoussan et al., 1998, Pittler and Ernst, 1998, Madisch et al., 2004, Hussain and
Role of the funding source
This study was funded by a grant from the Mastic Gum Producers Cooperative to KJ Dabos. The study was designed by the principal investigator and the design was approved by the sponsor. The Statistics Section of the Cooperative provided statistical advice for the analysis and interpretation of the data.
Conflict of interest
KJ Dabos received travel bursaries from the sponsor. E Sfika was an employee of the sponsor during the study period. LJV, DF, GIA, GG, have nothing to declare.
Acknowledgements
The authors acknowledge all those who contributed significantly to this work. In particular Elias Smyrnioudis from the Mastic Gum Growers Cooperative for packaging and assuring blinding of the medication and Christos Kartalis for fruitful discussions about the project. The trial is registered in ISRCTN and its unique ID is ISRCTN51942129.
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