Analytical Method Validation and Quality Control of a Seven-Herb Chinese Medicine Formulation Used for the Treatment of Irritable Bowel Syndrome with Constipation.

There is a need for increased QC of complex herbal medicine formulations to ensure product consistency, efficacy, and safety. This study reports an HPLC with photodiode array and electrospray ionization-tandem MS method for quantifying selected analytes in a seven-herb formulation. Fourteen analytes were selected for quantification based on the criteria available from the Herbal Chemical Marker Ranking System, which takes into account the bioavailability, reported bioactivity, and physiological action related to its intended use, as well as commercial availability of the standard. After optimizing the columns and chromatographic conditions, 13 of the 14 analytes were able to be determined in one run, with the remaining analyte analyzed on its own. The method was successfully applied to two different extracts of the formulation, demonstrating an application for the QC of a complex herbal mixture with respect to their chemical characteristics.

Efficacy of a Chinese Herbal Medicine in Providing Adequate Relief of Constipation-predominant Irritable Bowel Syndrome: A Randomized Controlled Trial.

BACKGROUND & AIMS: Irritable bowel syndrome (IBS) is the most common chronic functional bowel disorder, with few treatment options. IBS affects 10%-20% of the population; as many as 58% of patients have constipation-predominant IBS (IBS-C). We evaluated efficacy and safety of a standardized, specifically formulated Chinese herbal medicine (CHM) preparation in treatment of patients with IBS-C. METHODS: We performed a double-blind trial of 125 patients with IBS-C (according to Rome III criteria), who were recruited from 13 medical centers or clinics in Australia from July 2009 through February 2012. Patients were randomly assigned to groups given a standardized extract of 7 selected CHM ingredients (n = 61) or placebo (controls, n = 64) for 8 weeks (5 capsules, twice daily). Subjects were then followed for 16 weeks. Chemical definition, standardization, and stability testing of the formulation were completed. Subjects completed a self-administered, validated binary questionnaire of global symptom improvement at weeks 2, 4, 8, and 16 (primary outcome). Secondary outcomes included results from the self-administered IBS Symptom Severity Scale and the Bristol Stool Form Scale (BSFS), which were completed at weeks 4, 8, and 16. RESULTS: There was statistically and clinically significant (per protocol analyses) improvement among subjects who received CHM (n = 50) vs controls (n = 58) for 8 weeks. A greater proportion of subjects receiving CHM reported adequate relief (P = .010). Compared with controls, the CHM group had improved bowel habits vs controls at week 8, including lower IBS Symptom Severity Scale scores (P < .001), reduced straining during defecation (P = .002), and a significant decrease in hard lumpy stools (P = .031). The CHM group also had increased stool consistency, which was based on the Bristol Stool Form Scale (week 8, P < .001). There was no statistically significant difference between groups in abdominal pain at week 8 (P = .692). The CHM was well-tolerated. CONCLUSIONS: In a prospective, controlled study, CHM reduced symptoms of IBS-C, increased bowel satisfaction and stool consistency, and reduced straining and hard lumpy stools, compared with placebo. Clinical trial registration no: ACTRN12609000558224.