Clinical studies of ionized alkaline water: problems of the gastrointestinal tract and the placebo effect

Placebo controlled double blind tests

by Hirokazu Tashiro, Tetsuji Hokudo, Hiromi Ono, Yoshihide Fujiyama, Tadao Baba (National Ohkura Hospital, Dept. of Gastroenterology; Institute of Clinical Research, Shiga University of Medical Science, Second Dept. of Internal Medicine)

Effect of alkaline ionized water on abdominal complaints was evaluated by placebo controlled double blind
tests. Overall scores of improvement using alkaline ionized water marked higher than those of placebo
controlled group, and its effect proved to be significantly higher especially in slight symptoms of chronic
diarrhoea and abdominal complaints in cases of general malaise. Alkaline ionized water group did not get
interrupted in the course of the test, nor did it show neither serious side effects nor abnormal test data. It
was confirmed that alkaline ionized water is safer and more effective than placebos.

Summary
Effect of alkaline ionized water on abdominal complaints was clinically examined by double blind tests
using clean water as placebo. Overall improvement rate was higher for alkaline ionized water group
than placebo group and the former proved to be significantly more effective than the other
especially in cases of slight symptoms. Examining improvement rate for each case of chronic
diarrhoea, constipation and abdominal complaints, alkaline ionized water group turned out to be more
effective than placebo group for chronic diarrhoea, and abdominal complaints. The test was stopped in
one case of chronic diarrhoea, among placebo group due to exacerbation, whereas alkaline ionized water
group did not stop testing without serious side effects or abnormal test data in all cases. It was confirmed
that alkaline ionized water is more effective than clean water against chronic diarrhoea, abdominal
complaints and overall improvement rate (relief of abdominal complaints) and safer than clean
water.

Introduction
Since the approval of alkaline ionized water electrolyzers by Pharmaceutical Affairs Law in 1966 for its
antacid effect and efficacy against gastrointestinal disorders including hyperchylia, indigestion, abnormal
gastrointestinal fermentation and chronic diarrhoea, they have been extensively used among patients.
However, medical and scientific evaluation of their validity is not established. In our study, we examined
clinical effect of alkaline ionized water on gastrointestinal disorders across many symptoms in various
facilities. Particularly, we studied safety and usefulness of alkaline ionized water by double-blind tests
using clean water as a control group.

Test subjects and methods
163 patients (34 men, 129 women, age 21 to 72, average 38.6 years old) of indigestion, abnormal
gastrointestinal fermentation (with abnormal gas emission and rugitus) and abdominal complaints caused
by irregular dejection (chronic diarrhoea, or constipation) were tested as subjects with good informed
consent. Placebo controlled double blind tests were conducted using alkaline ionized water and clean
water at multiple facilities. An alkaline ionized water electrolyser sold commercially was installed with a
pump driven calcium dispenser in each of the subject homes. Tested alkaline ionized water had pH at 9.5
and calcium concentration at 30ppm. Each subject in placebo group used a water purifier that has the
same appearance as the electrolyser and produces clean water. The tested equipment was randomly
assigned by a controller who scaled off the key code which was stored safely until the tests were
completed and the seal was opened again.


Water samples were given to each patient in the amount of 200ml in the morning with the total of 50OmI
or more per day for a month. Before and after the tests, blood, urine and stool were tested and a log was
kept on the subjective symptoms, bowel movements and accessory symptoms. After the tests, the results
were analyzed based on the log and the test data.

Test Results

1. Symptom
Among 163 tested subjects, alkaline ionized water group included 84 and placebo group 79. Background
factors such as gender, age and basal disorders did not contribute to significant difference in the results.


2. Overall improvement rate
As to overall improvement rate of abdominal complaints, alkaline ionized water group had 2 cases of
outstanding improvement (2.5%), 26 cases of fair improvement (32.1%), 36 cases of slight improvement
(44.4%), 13 cases of no change (16%) and 4 cases of exacerbation (4.9%), whereas placebo group
exhibited 4 (5.2%), 19 (24.7%), 27 (35.1%), 25 (32.5%) and 2 cases (2.6%) for the same category.
Comparison between alkaline ionized water and placebo groups did not reveal any significant difference at
the level of 5% significance according to the Wilcoxon test, although alkaline ionized water group turned
out to be significantly more effective than placebo group at the level of p value of 0.22. Examining overall
improvement rates by a 7, 2 test (with no adjustment for continuity) between the effective and no effective
groups, alkaline ionized water group had 64 (79%) of effective cases and 17 cases (21%) of non effective
cases, whereas placebo group had 50 (64.9%) and 27 (35.1%) cases respectively. The result indicated
that alkaline ionized water group was significantly more effective than placebo group at the level of p value
of 0.0.48. Looking only at 83 slight cases of abdominal complaints, overall improvement rate for alkaline
ionized water group (45 cases) was composed of 11 cases (242%) of fair improvement, 22 cases (48.9%)
of slight improvement, 17 cases (44.7%) of no change and 3 cases (6.7%) of exacerbation, whereas
placebo group (38 cases) had 3 (7.8%), 17 (44.7%), 17 (44.7%) and 1 (2.6%) cases for the same
category. Alkaline ionized water group was significantly more effective than placebo group according to
the comparison between the groups (p value = 0.033).

3. Improvement rate by basal symptom
Basal symptoms were divided into chronic diarrhoea, constipation and abdominal complaints (dyspepsia)
and overall improvement rate was evaluated for each of them to study effect of alkaline ionized water. In
case of chronic diarrhoea, alkaline ionized water group resulted in 94.1% of effective cases and 5.9% of
non effective cases. Placebo group came up with 64,7% effective and 35.3% non effective. These results
indicate alkaline ionized water group proved to be significantly more effective than placebo group. In case
of slighter chronic diarrhoea, comparison between groups revealed that alkaline ionized water group is
significantly more effective than placebo group (p=0.015). In case of constipation, alkaline ionized water
group consisted of 80.5% of effective and 19.5% of non effective cases, whereas placebo group resulted
in 73.3% effective and 26.3 non effective. As to abdominal complaints (dyspepsia), alkaline ionized water
group had 85.7% of effective and 14.3% non effective cases while placebo group showed 47.1% and
62.9% respectively. Alkaline ionized water group proved to be significantly more effective than placebo
group (p=0.025).

4. Safety
Since one case of chronic diarrhoea, in placebo group saw exacerbation, the test was stopped. There
were no such cases in alkaline ionized water group. Fourteen cases of accessory symptoms, 8 in alkaline
ionized water group and 6 in placebo group, were observed, none of which were serious. 31 out of 163
cases (16 in alkaline ionized water group, 15 in placebo group) exhibited fluctuation in test data, although
alkaline ionized water group did not have any problematic fluctuations compared to placebo group. Two
cases in placebo group and one case in alkaline ionized water group have seen K value of serum climb up
and resume to normal value after re testing which indicates the value changes were temporary.

Conclusion
As a result of double blind clinical tests of alkaline ionized water and clean water, alkaline ionized water
was proved to be more effective than clean water against chronic diarrhoea, abdominal complaints
(dyspepsia) and overall improvement rate (relief from abdominal complaints). Also, safety of alkaline
ionized water was confirmed which clinically verifies its usefulness.

06 - 2007