Therapeutic effects of nandrolone and testosterone in adult male HIV patients with AIDS wasting syndrome (AWS): a randomized, double-blind, placebo-controlled trial.
OBJECTIVE
We aimed to compare therapeutic effects of intramuscular (IM) nandrolone decanoate and IM testosterone enanthate in male HIV patients with AIDS wasting syndrome (AWS) with placebo control.


METHODS
In this randomized, double-blind, placebo-controlled, 12-week trial, 104 patients with AWS who satisfied our inclusion criteria were randomly allotted in a 2:2:1 ratio to the 3 intervention groups: nandrolone, testosterone, and placebo. We administered 150 mg nandrolone and 250 mg testosterone (both IM, biweekly). The primary outcome measure was a comparison of absolute change in weight at 12 weeks between the nandrolone decanoate, testosterone, and placebo groups.


RESULTS
Intent-to-treat analysis was done. The nandrolone group recorded maximum mean increase in weight (3.20 kg; post hoc P < .01 compared to placebo). Body mass index (BMI) of subjects in the nandrolone group had a significantly greater increase (mean = 1.28) compared to both testosterone (post hoc P < .05) and placebo (post hoc P < .01). Waist circumference and triceps skinfold thickness of patients on nandrolone showed similar results. Nandrolone also ensured a better quality of life. Patients with low testosterone level (<3 ng/mL) benefited immensely from nandrolone therapy, which increased their weight and BMI significantly compared to placebo (P < .05).


CONCLUSIONS
Our trial demonstrates the superior therapeutic effects of nandrolone in male AWS patients, including the androgen deficient.
Sardar
Partha
P
Department of General Medicine, Medical College Kolkata, Kolkata, West Bengal, India. medicopartha@gmail.com
Jha
Ayan
A
Roy
Deeptarka
D
Majumdar
Uddalak
U
Guha
Pradipta
P
Roy
Sabyasachi
S
Banerjee
Ramtanu
R
Banerjee
Amit Kumar
AK
Bandyopadhyay
Dipanjan
D
D000328:Adult; D001823:Body Composition / Q000502:physiology; D015992:Body Mass Index; D004311:Double-Blind Method; D005640:Follicle Stimulating Hormone / Q000097:blood; D006678:HIV / Q000276:immunology*; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D019247:HIV Wasting Syndrome / Q000097:blood / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D006801:Humans; D007273:Injections, Intramuscular; D007986:Luteinizing Hormone / Q000097:blood; D008297:Male; D009277:Nandrolone / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077603:Nandrolone Decanoate; D011788:Quality of Life; D012885:Skinfold Thickness; D013739:Testosterone / Q000008:administration & dosage / Q000031:analogs & derivatives*; D055105:Waist Circumference / Q000502:physiology; D015430:Weight Gain / Q000187:drug effects / Q000502:physiology
D013739:Testosterone; D009277:Nandrolone; C004648:testosterone enanthate; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone; D000077603:Nandrolone Decanoate