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Dsi2.0

DSIP Research

Mostly mechanism / observational

12 peer-reviewed studies

What the evidence says

Mostly mechanism / observational

Most DSIP studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.

Most evidence is from mixed-quality randomised trials published 1984–2011 with a typical study size of 14 participants.

Based on 12 studies · 6 RCTs · 14 total participants

Confidence

Moderate confidence

By outcome

Sleep & insomniaDelta sleep-inducing peptide studied for sleep in severe insomnia; only small, old, equivocal human data and unknown long-term/modern safety. · Not established
Mostly mechanism / observational8 studies
Anxiety & stressProposed stress-protective/adaptive activity (preclinical) with reduced chronic pain and depressive states in an open pilot; low-quality evidence. · Not established
Too few graded studies2 studies
Pain & analgesia
Too few graded studies1 study

Older research base

Newest study from 2011

198419972011

1RCT2009

Pomfrett CJ, Dolling S, Anders NR, Glover DG, Bryan A, Pollard BJ · Eur J Anaesthesiol (2009)

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2RCT1989

Bjartell A, Ekman R, Bergquist S, Widerlöv E · Psychoneuroendocrinology (1989)

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3RCT1992

Bes F, Hofman W, Schuur J, Van Boxtel C · Neuropsychobiology (1992)

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4RCT1994

Chiodera P, Volpi R, Capretti L, Giacalone G, Caffarri G, Davoli C · Horm Res (1994)

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5Observational1992

In plain English: CSF DSIP-LI was significantly correlated with polysomnography the night before the LP: with stage 3 sleep... Whether this first report of a potential relationship between CSF DSIP-LI and slow-wave sleep in man might be generalized to sleep in nonpsychiatric subjects awaits further study.

van Kammen DP, Widerlöv E, Neylan TC, Ekman R, Kelley ME, Mouton A, et al. · Sleep (1992)

Measured cerebrospinal-fluid DSIP-like immunoreactivity (DSIP-LI) and polysomnography in 15 drug-free male schizophrenic volunteers
Endogenous CSF DSIP-LI correlated with stage 3 / delta slow-wave sleep measures the night before lumbar puncture
This is a correlational study of endogenous DSIP — it did not administer exogenous DSIP

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6RCTn=14 · very small study1987

In plain English: DSIP was administered under placebo-controlled, double-blind conditions for 7 successive nights... The treatment substantially improved night sleep with the first and additionally with repeated doses... The study demonstrates the efficacy of DSIP for the treatment of impaired sleep and daytime functions as well.

Schneider-Helmert D. · Eur Neurol (1987)

Placebo-controlled, double-blind study of intermediate-term DSIP over 7 successive nights in 14 middle-aged chronic insomniacs
Reported that DSIP substantially improved night sleep (acutely and with repeated doses) and that sleep efficiency and daytime alertness/performance reached normal-control levels
Single author (Schneider-Helmert) — the same investigator behind most of the positive 1980s DSIP sleep claims

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7Animal2009

In plain English: Last 10% (most aged) of mice which received Deltaran lived for 16% longer than the controls... Also Deltaran slowed the spontaneous carcinogenesis parameters.

Voĭtenkov VB, Popovich IG, Zabezhinskiĭ MA, Iurova MA, Piskunova TA, Mikhaleva II. · Adv Gerontol (2009)

Female SHR mice received monthly 5-day subcutaneous courses of the DSIP preparation 'Deltaran' across their lifespan
The most-aged 10% of treated mice lived ~16% longer than controls, with higher locomotor and exploratory activity
Treated mice showed anxiolytic-type behaviour (more time in open arms of the elevated plus maze) and slowed spontaneous carcinogenesis

8RCT1987

In plain English: For NREM sleep time and stage 2 sleep differences between DSIP and a placebo were significant, but the same differences existed already for the baseline values. It can be concluded that sleep improvement under DSIP treatment is of little clinical significance.

Monti JM, Debellis J, Alterwain P, Pellejero T, Monti D. · Int J Clin Pharmacol Res (1987)

Double-blind, placebo-controlled crossover polysomnography trial of IV DSIP (25 nmol/kg) over four nights in insomniac patients, by an independent (Uruguayan) group
Some sleep parameters (awakenings, NREM latency, waking time) decreased under DSIP, but differences from placebo were not clearly attributable to the peptide — the same differences already existed at baseline
Slow-wave sleep (stages 3 and 4) and REM were not modified

9Animal2011

In plain English: Subcutaneous injection to the rats... with 10 microg/100 g body weight of delta-sleep inducing peptide (DSIP) suppresses lipid peroxidation preventing the increasing of malonic dialdehyde level in rats tissues and plasma, possesses a powerful antioxidant effect.

Bondarenko TI, Maĭboroda EA, Mikhaleva II, Prudchenko IA. · Adv Gerontol (2011)

Rat study of DSIP's proposed geroprotective/antioxidant mechanism across ages 2-24 months
Subcutaneous DSIP suppressed lipid peroxidation and lowered malondialdehyde in tissues and plasma
Stimulated endogenous antioxidant defences — superoxide dismutase, catalase, and ceruloplasmin activities, plus non-enzymatic antioxidants

10Review1984

In plain English: Two different studies showed improvement of sleep following single injections of 25 nmol/kg b.w. before sleep. Repeated administrations indicated a buildup with normalization of sleep structure after four administrations.

Schneider-Helmert D. · Eur Neurol (1984)

Summary of early human investigations of DSIP injections in insomnia
Reported improved sleep after single 25 nmol/kg subcutaneous injections before sleep, with normalization of sleep structure after repeated administration
Morning injections still improved night sleep, while two daily doses did not — pointing to a complex, non-dose-linear effect

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11Open-Label1984

In plain English: DSIP lowered significantly the pain levels of 6 out of 7 patients after intravenous administration on 5 consecutive days followed by 5 injections every 48-72 h. Remarkably, a simultaneous significant reduction of the concomitantly occurring depressive states was observed.

Larbig W, Gerber WD, Kluck M, Schoenenberger GA. · Eur Neurol (1984)

Open clinical pilot of 7 patients with chronic pain (migraine, vasomotor headache, chronic tinnitus, psychogenic pain attacks)
Intravenous DSIP significantly lowered pain levels in 6 of 7 patients, with baseline-versus-follow-up comparison
A simultaneous significant reduction in concomitant depressive states was reported

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12Open-Label1984

In plain English: In an open study 7 patients with severe insomnia were treated by a series of 10 injections with the delta-sleep-inducing peptide (DSIP). In all but 1 case sleep was normalized for follow-up periods of 3-7 months.

Kaeser HE. · Eur Neurol (1984)

Open (uncontrolled) study of 7 patients with severe insomnia given a series of 10 DSIP injections
Sleep was reported normalized in all but 1 patient, with follow-up of 3-7 months, and daytime mood/performance improved
Tiny, open-label, 1984 study with no placebo control — hypothesis-generating only

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View in Research Library

DSIP Research

Mostly mechanism / observational

Delta sleep-inducing peptide alters bispectral index, the electroencephalogram and heart rate variability when used as an adjunct to isoflurane anaesthesia.

Reduction of immunoreactive ACTH in plasma following intravenous injection of delta sleep-inducing peptide in man.

Effects of delta sleep-inducing peptide on sleep of chronic insomniac patients. A double-blind study.

Different effects of delta-sleep-inducing peptide on arginine-vasopressin and ACTH secretion in normal men.

Delta sleep-inducing-peptide-like immunoreactivity (DSIP-LI) and delta sleep in schizophrenic volunteers.

Effects of delta-sleep-inducing peptide on 24-hour sleep-wake behaviour in severe chronic insomnia.

Effect of delta-sleep inducing peptide preparation Deltaran on longevity, physiological functions, and carcinogenesis in mice.

Study of delta sleep-inducing peptide efficacy in improving sleep on short-term administration to chronic insomniacs.

Mechanism of delta-sleep inducing peptide geroprotective activity.

DSIP in insomnia.

Therapeutic effects of delta-sleep-inducing peptide (DSIP) in patients with chronic, pronounced pain episodes. A clinical pilot study.

A clinical trial with DSIP.