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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 9 studies · 3 RCTs · 14 total participants
Confidence
Moderate
By outcome
Sleep & insomnia
Mostly mechanism / observational6 studies
Anxiety & stress
Too few graded studies2 studies
Pain & analgesia
Too few graded studies1 study
Older research base
Newest study from 2011
198419972011
1RCT2009
DSIP significantly increased heart rate, decreased HRV and, paradoxically, significantly reduced delta rhythm along with reducing burst suppression and increasing BIS at 25 nmol kg(-1) during isoflurane anaesthesia.
Pomfrett CJ, Dolling S, Anders NR, Glover DG, Bryan A, Pollard BJ. · Eur J Anaesthesiol (2009)
Randomized human study (24 female patients; 12 saline controls, 12 DSIP at 25/50/100 nmol/kg) testing DSIP as an adjunct to isoflurane anaesthesia
Contrary to the 'sleep-deepening' hypothesis, DSIP paradoxically reduced delta rhythm and increased the bispectral index — i.e. lightened anaesthetic depth
DSIP also increased heart rate and decreased heart-rate variability, suggesting reduced parasympathetic tone, and altered EEG hemispheric symmetry
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
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.
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
4Animal2009
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
5RCTn=14 · very small study1987
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
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
7Review1984
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
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
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.