EFFECT OF LOW LEVEL LASER THERAPY VERSUS ELECTROACUPUNCTURE ON POSTNATAL SCANTY MILK SECRETION

A randomized controlled study conducted on 60 healthy primiparous mothers with insufficient lactation. The participants were divided randomly into three equal groups, Group (A) control, Group (B) received low power He-Ne laser beam on both breasts and Group (C) received faradic current stimulation at Spleen 6, Liver 3 and Small Intestine 1 acupuncture points on both sides, all participants received 10 mg domperidone 3 times a day and advice about lactation, nutrition and fluid intake. Evaluation was done before and after the treatment program

Study Overview

• Status: Completed
• Conditions: Insufficient Lactation
• Intervention / Treatment: Drug: domperidone; Device: He-Ne laser (Bravo TrezaSerie) device; Device: faradic current

Detailed Description

Women in Group (A) acted as a control group and only received medical treatment in the form of 10 mg domperidone 3 times a day after meals) and advice about lactation, nutrition and fluid intake all through the treatment period (4 weeks) Each woman in group (B) lied in supine lying position on the treatment plinth wearing the protective eyewear as precautionary measures for her safety and exposing her breast out of her clothes then the breast was cleaned by alcohol. The laser apparatus was directed perpendicularly over the treated breast at a distance 50 cm from it, all metal objects must be removed from the range of action of laser (i.e. necklaces). The laser scan beam was adjusted to the size of the treated breast for 10 minutes with wave length 632.8 nm and power output 25 mw after the end of treatment session the machine switched off automatically then, it was adjusted again to start irradiation by the same procedures for the other breast. The mother had one session every other day, three sessions weekly for four weeks. (Total 12 sessions). He-Ne laser (Bravo TrezaSerie) device was used. The equipment was designed in compliance with international technical standards UNI EN ISO 9002 and En 46002 and complies with the safety requirements.

Group (B) had received 12 sessions of irradiation by low power He-Ne laser beam on both sides of the breasts 10 minutes on each side. One session every other day, three sessions weekly for four weeks beside the medical treatment (10 mg domperidone 3 times a day after meals) and advice about lactation, nutrition and fluid intake all through the treatment period Group (C) women were treated by faradic stimulation (Body shaping System, model B-333, made in China) , at the following acupuncture points on both sides: Spleen 6 (Sanyinjiao), Liver 3 (Taichong) and Small Intestine 1 (Shaoze) using surface electrodes in addition to medical treatment (10 mg domperidone 3 times a day after meals) and advice about lactation, nutrition and fluid intake allthrough the treatment period

SP-6 Acupuncture Point lies on the inner leg aspect about 3 cm higher than the medial malleolus, along the posterior tibial border. Fig. (2)

LIV-3 Acupuncture Point is the one that lies in the depressed area between the 1st 2 metatarsal bones proximal to the metatarsophalangeal joints on the dorsal foot aspect Fig. (2)

SI.1 Acupuncture point is located on the little finger, ulnar to the distal phalanx, at the intersection of the vertical line of ulnar border of the nail and the horizontal line of the base of the little fingernail. Fig. (2)

Each woman in group (C) was asked to be in a long sitting or half lying position, When the points were located, the electrodes were fastened securely with an adhesive tape or an elastic band to ensure good contact between the skin and the electrode over the acupuncture points. The intensity control of the stimulator was slowly increased until the patient could just feel the stimulation. The session lasted for 30 minutes. One session every other day, 3 sessions weekly for 4 weeks. (Total 12 sessions).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12151
    • Kasr Alainy medical school

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Their age ranged between 20 and 35 years old
• 25 to 30 kg/m² body mass index (BMI).
• They attended the breast feeding clinic complaining from insufficiency of lactation within the 1st month after normal vaginal delivery and they were using mixed feeding (Both breast and bottle feeding at least 3 bottles per day and not more than 6 bottles).
• They had approximately the same nutrition as well as, education level

Exclusion Criteria:

• lactating mothers who suffered from post-partum hemorrhage
• cardio respiratory disease
• diabetes mellitus
• breast cancer
• previous surgeries in the chest, breast or the surrounding area
• anemia
• those who had any causes that hindering their normal breast feeding as (retraced, cracked, inflamed or inverted nipples)
• Women receiving contraceptive pills,
• conditions related to the infant that affect the lactation process were excluded such as congenital conditions of infant mouth: tongue tie, cleft of the soft palate and congenital heart disease of the infant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; 10 mg domperidone 3 times a day after meals) and advice about lactation, nutrition and fluid intake all through the treatment period (4 weeks)	Drug: domperidone; 10 mg domperidone 3 times a day after meals
Active Comparator: Laser group; The laser scan beam was adjusted to the size of the treated breast for 10 minutes with wave length 632.8 nm and power output 25 mw after the end of treatment session on both breasts. The mother had one session every other day, three sessions weekly for four weeks. (Total 12 sessions)	Drug: domperidone; 10 mg domperidone 3 times a day after meals; Device: He-Ne laser (Bravo TrezaSerie) device; The laser scan beam was adjusted to the size of the treated breast for 10 minutes with wave length 632.8 nm and power output 25 mw after the end of treatment session
Active Comparator: Electro acupuncture group; faradic stimulation (Body shaping System, model B-333, made in China) , at the following acupuncture points on both sides: Spleen 6 (Sanyinjiao), Liver 3 (Taichong) and Small Intestine 1 (Shaoze) using surface electrodes	Drug: domperidone; 10 mg domperidone 3 times a day after meals; Device: faradic current; faradic stimulation (Body shaping System, model B-333, made in China) , at the following acupuncture points on both sides: Spleen 6 (Sanyinjiao), Liver 3 (Taichong) and Small Intestine 1 (Shaoze)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum prolactin	the mean difference in the value of serum prolactin between the three studied groups measured at post-treatment	12 weeks after treatment

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Maged AM, Hassanin ME, Kamal WM, Abbassy AH, Alalfy M, Askalani AN, El-Lithy A, Nabil M, Farouk D, Hussein EA, Hammad B. Effect of Low-Level Laser Therapy versus Electroacupuncture on Postnatal Scanty Milk Secretion: A Randomized Controlled Trial. Am J Perinatol. 2020 Oct;37(12):1243-1249. doi: 10.1055/s-0039-1693428. Epub 2019 Jul 21.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Actual): December 4, 2018
• Study Completion (Actual): January 2, 2019

Study Registration Dates

• First Submitted: January 13, 2019
• First Submitted That Met QC Criteria: January 13, 2019
• First Posted (Actual): January 16, 2019

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 13, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dopamine Agents; Dopamine Antagonists; Domperidone
• Other Study ID Numbers: 48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No