Compound Sleep Preparation Shows Promise in Clinical Trial
Chronic insomnia is a serious problem for millions of adults
in the USA and worldwide. Synthetic sleep aids can affect liver
and kidney function and are often habit forming. The search for
natural products that enhance sleep has spanned many centuries.
In a recent study, researchers at Nizam's Institute of Medical
Sciences in Hyderabad, India, studied a compound herbal formula
using both subjective evaluations and objective measures (Rani
et al., 1998). The formula tested contained 100 mg alcohol
extract of Indian snakeroot (Rauvolfia serpentina [L.]
Benth. ex Kurz, Apocynaceae) root (the source of the prescription
hypotensive drug reserpine), 100 mg spikenard (Nardostachys
jatamansi (D. Don) DC., Valerianaceae) rhizome powder, and
100 mg aqueous extract of root stem and leaf of Tinospora cordifolia
(Willd.) Miers, Menisperamaceae (an herb used in Ayurvedic and
Unani medicine as a mild sedative). Nardostachys is related
to valerian and used for similar purposes in Indian traditional
medicine. The preparation was deemed by the authors to be effective
"without any major side effects."
It is important to note that Rauvolfia contains the potent
alkaloid reserpine, which in clinical doses does have significant
and serious side effects. Since reserpine is a prescription drug,
the combination tested in this study will not be available as
a dietary supplement or over-the-counter drug in the United States.
In this small open clinical trial, 39 subjects with chronic insomnia
took a placebo for three weeks before initial testing using polysomnographic
recording. This procedure, used in sleep disorder clinics and
laboratories worldwide, measures brain waves (EEG), muscle activity
(EMG), and eye movements to chart key sleep quality parameters
throughout the night. In this study, researchers measured sleep
latency (the amount of time it takes to get to sleep), number
of awakenings, sleep efficiency (the percentage of time in bed
spent asleep), amount of time awake during the night, and the
amount of time in each of the phases of sleep (stage I to stage
IV).
To establish a baseline, subjects took a placebo for three weeks,
at which time polysomnographic recording was conducted. Subjects
meeting the inclusion criteria for the study then took the herbal
sleep preparation just before bedtime for 21 days. In addition
to polysomnographic measurement in 10 subjects, each of the 39
subjects kept a daily sleep log. Comparing polysomnography before
and after the 21-day treatment period, persistent sleep latency
declined from 85 minutes (+/- 23) to 24 minutes (+/- 5.7), total
sleep time increased by nearly one hour (204 to 262 minutes),
and waking time during the night declined from 275 to 191 minutes.
Eleven patients (nearly one-third of the 39 patients) complained
of mild stomach upset.
The authors concluded: "The present herbal preparation containing
three ingredients known to have sleep modulating properties, improved
duration, quality and total sleep time and reduced sleep latency
and number of awakenings. There was no significant alteration
of biochemical, hematological, hepatic or renal parameters. Most
patients tolerated test drug well without any major side effects.
Problems like hangover and daytime sedation commonly observed
with other hypnotic drugs were not seen.
"Thus it can be concluded that the present herbal drug can
be used as a good therapeutic alternative for the management of
insomnia."
It is important to note that this preliminary study suffers from
some serious shortcomings and errors. The study is small, and
there are disturbing errors in the reporting. For example, the
study results and summary claim 191 minutes as the waking period
during sleep, while Table 1 says 181. Similarly, the text says
changes in REM sleep were insignificant, while Table 1 shows highly
significant changes. These errors, as several reviewers point
out, call into question the results of the study. -
Rob McCaleb, HRF
[Rani PU, Naidu MUR. Subjective
and polysomnographic evaluation of a herbal preparation in insomnia.
Phytomedicine 1998; 5(4): 253-257.] |
