Herb World News Online

Herb Research Foundation


 Top News  |  World  |  Science  |  Research Reviews  |  Politics  |  Industry  |  Features
 Research Reviews

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

Full article $20 - Review Order
[Rani PU, Naidu MUR. Subjective and polysomnographic evaluation of a herbal preparation in insomnia. Phytomedicine 1998; 5(4): 253-257.]

 Top News  |  World  |  Science  |  Research Reviews  |  Politics  |  Industry  |  Features

Back to the Herb World News Online Front Page

© 2003 by Herb Research Foundation, Boulder, CO, USA.

Main Page