'Evidence-based Clinical Practice Guidelines for Chronic Constipation 2017' were published, and concrete guidelines for chronic constipation in Japan were finally presented. Taking these circumstances into consideration, we examined the clinical effects of mashiningan for elderly patients with chronic constipation and sennoside A and B resistance.

The study included 25 elderly patients aged 75 years or older (15 men, 10 women, 75-84 years [79.0 ± 0.53: median ± standard error]) with a diagnosis of chronic constipation with no secondary constipation. The patients were constipated despite taking 3 tablets of sennoside A and B  daily for at least 3 months, with a stool frequency twice per week or less, and defecation difficulty with a sensation of incomplete evacuation, bloating, abdominal and/or anal pain. Mashiningan 7.5 g was administered 3 times daily before meals for 4 weeks and the effects were evaluated. The study data collected before and after administration of mashiningan included: stool frequency per week, Bristol Stool Form Scale (BSFS) score, sensation of incomplete evacuation visual analog scale (VAS) score (none, 0; extremely severe, 10), bloating VAS score, abdominal and/or anal pain VAS score, overall satisfaction with defecation (very satisfied, 0; extremely unsatisfied, 10), and quality of daily life (QOL) (very satisfied, 0; extremely unsatisfied, 10). Patients were advised to continue their usual diet and exercise habits as much as possible during the study period.

Before administration of mashiningan, all patients had abdominal bloating and poor intestinal peristalsis with a wiry pulse and abdominal strength of 2-4/5 as well as mild skin dryness and received a diagnosis of blood deficiency. Anal sphincter tone was normal to slightly decreased at times of resting and contracting.
After taking mashiningan, stool frequency improved from 2.0 ± 0.1 to 3.1 ± 0.1 times per week. Significant improvement was observed in all assessment items: 1.0 ± 0.1 to 3.0 ± 0.1 for BSFS, 8.0 ± 0.2 to 1.0 ± 0.2 for sensation of incomplete evacuation VAS, 8.0 ± 0.2 to 2.0 ± 0.2 for bloating VAS, 7.0 ± 0.2 to 3.0 ± 0.3 for abdominal and/or anal pain VAS, 9.0 ± 0.2 to 1.0 ± 0.2 for overall defecation satisfaction, and 8.0 ± 0.2 to 2.0 ± 0.3 for QOL (p<0.0001 for all). Mashiningan was found to be clinically effective regardless of age or sex on multivariate analysis (p<0.0001). No apparent adverse events were observed associated with short term administration of mashiningan.

Appropriate management of chronic constipation is extremely important for the elderly. It is most important to provide instructions for lifestyle habits; however, concurrent drug therapy is often sometimes required. Mashiningan, a laxative for the elderly, is comprised of mashinin 5 g, rhubarb 4 g, immature orange 2 g, apricot kernel 2 g, magnolia bark 2 g, and peony root 2 g. Mashinin, immature orange, and apricot kernel contain significant amounts of oils and should soften stools. These have a combined laxative effect, together with the effects of colon stimulation by rhubarb, blood replenishment, refill of Qi, and relief of hypertonic bowel by peony root, and relief of bloating by immature orange and magnolia bark. Since the preparation contains no licorice, the risk of developing pseudo-hyperaldosteronism is low, which is also advantageous.

This study found that mashiningan (a Kampo preparation) is extremely useful for elderly patients with chronic constipation who also have hypertonic bowel and Qi deficiency.

Evidence-based Clinical Practice Guidelines for Chronic Constipation 2017